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Meta-Analysis
. 2024 Dec 5;12(12):CD011044.
doi: 10.1002/14651858.CD011044.pub3.

Chemotherapy and radiotherapy for advanced pancreatic cancer

Lucy Haggstrom  1   2   3 , Wei Yen Chan  1   4 , Adnan Nagrial  5   6 , Lorraine A Chantrill  2   7 , Hao-Wen Sim  1   3   8 , Desmond Yip  9   10 , Venessa Chin  1   3   11
Affiliations
Meta-Analysis

Chemotherapy and radiotherapy for advanced pancreatic cancer

Lucy Haggstrom et al. Cochrane Database Syst Rev. .

Abstract

Background: Pancreatic cancer (PC) is a lethal disease with few effective treatment options. Many anti-cancer therapies have been tested in the locally advanced and metastatic setting, with mixed results. This review synthesises all the randomised data available to help better inform patient and clinician decision-making. It updates the previous version of the review, published in 2018.

Objectives: To assess the effects of chemotherapy, radiotherapy, or both on overall survival, severe or life-threatening adverse events, and quality of life in people undergoing first-line treatment of advanced pancreatic cancer.

Search methods: We searched for published and unpublished studies in CENTRAL, MEDLINE, Embase, and CANCERLIT, and handsearched various sources for additional studies. The latest search dates were in March and July 2023.

Selection criteria: We included randomised controlled trials comparing chemotherapy, radiotherapy, or both with another intervention or best supportive care. Participants were required to have locally advanced, unresectable pancreatic cancer or metastatic pancreatic cancer not amenable to curative intent treatment. Histological confirmation was required. Trials were required to report overall survival.

Data collection and analysis: We used standard methodological procedures expected by Cochrane.

Main results: We included 75 studies in the review and 51 in the meta-analysis (11,333 participants). We divided the studies into seven categories: any anti-cancer treatment versus best supportive care; various chemotherapy types versus gemcitabine; gemcitabine-based combinations versus gemcitabine alone; various chemotherapy combinations versus gemcitabine plus nab-paclitaxel; fluoropyrimidine-based studies; miscellaneous studies; and radiotherapy studies. In general, the included studies were at low risk for random sequence generation, detection bias, attrition bias, and reporting bias, at unclear risk for allocation concealment, and high risk for performance bias. Compared to best supportive care, chemotherapy likely results in little to no difference in overall survival (OS) (hazard ratio (HR) 1.08, 95% confidence interval (CI) 0.88 to 1.33; absolute risk of death at 12 months of 971 per 1000 versus 962 per 1000; 4 studies, 298 participants; moderate-certainty evidence). The adverse effects of chemotherapy and impacts on quality of life (QoL) were uncertain. Many of the chemotherapy regimens were outdated. Eight studies compared non-gemcitabine-based chemotherapy regimens to gemcitabine. These showed that 5-fluorouracil (5FU) likely reduces OS (HR 1.69, 95% CI 1.26 to 2.27; risk of death at 12 months of 914 per 1000 versus 767 per 1000; 1 study, 126 participants; moderate certainty), and grade 3/4 adverse events (QoL not reported). Fixed dose rate gemcitabine likely improves OS (HR 0.79, 95% CI 0.66 to 0.94; risk of death at 12 months of 683 per 1000 versus 767 per 1000; 2 studies, 644 participants; moderate certainty), and likely increase grade 3/4 adverse events (QoL not reported). FOLFIRINOX improves OS (HR 0.51, 95% CI 0.43 to 0.60; risk of death at 12 months of 524 per 1000 versus 767 per 1000; P < 0.001; 2 studies, 652 participants; high certainty), and delays deterioration in QoL, but increases grade 3/4 adverse events. Twenty-eight studies compared gemcitabine-based combinations to gemcitabine. Gemcitabine plus platinum may result in little to no difference in OS (HR 0.94, 95% CI 0.81 to 1.08; risk of death at 12 months of 745 per 1000 versus 767 per 1000; 6 studies, 1140 participants; low certainty), may increase grade 3/4 adverse events, and likely worsens QoL. Gemcitabine plus fluoropyrimidine improves OS (HR 0.88, 95% CI 0.81 to 0.95; risk of death at 12 months of 722 per 1000 versus 767 per 1000; 10 studies, 2718 participants; high certainty), likely increases grade 3/4 adverse events, and likely improves QoL. Gemcitabine plus topoisomerase inhibitors result in little to no difference in OS (HR 1.01, 95% CI 0.87 to 1.16; risk of death at 12 months of 770 per 1000 versus 767 per 1000; 3 studies, 839 participants; high certainty), likely increases grade 3/4 adverse events, and likely does not alter QoL. Gemcitabine plus taxane result in a large improvement in OS (HR 0.71, 95% CI 0.62 to 0.81; risk of death at 12 months of 644 per 1000 versus 767 per 1000; 2 studies, 986 participants; high certainty), and likely increases grade 3/4 adverse events and improves QoL. Nine studies compared chemotherapy combinations to gemcitabine plus nab-paclitaxel. Fluoropyrimidine-based combination regimens improve OS (HR 0.79, 95% CI 0.70 to 0.89; risk of death at 12 months of 542 per 1000 versus 628 per 1000; 6 studies, 1285 participants; high certainty). The treatment arms had distinct toxicity profiles, and there was little to no difference in QoL. Alternative schedules of gemcitabine plus nab-paclitaxel likely result in little to no difference in OS (HR 1.10, 95% CI 0.82 to 1.47; risk of death at 12 months of 663 per 1000 versus 628 per 1000; 2 studies, 367 participants; moderate certainty) or QoL, but may increase grade 3/4 adverse events. Four studies compared fluoropyrimidine-based combinations to fluoropyrimidines alone, with poor quality evidence. Fluoropyrimidine-based combinations are likely to result in little to no impact on OS (HR 0.84, 95% CI 0.61 to 1.15; risk of death at 12 months of 765 per 1000 versus 704 per 1000; P = 0.27; 4 studies, 491 participants; moderate certainty) versus fluoropyrimidines alone. The evidence suggests that there was little to no difference in grade 3/4 adverse events or QoL between the two groups. We included only one radiotherapy (iodine-125 brachytherapy) study with 165 participants. The evidence is very uncertain about the effect of radiotherapy on outcomes.

Authors' conclusions: Combination chemotherapy remains standard of care for metastatic pancreatic cancer. Both FOLFIRINOX and gemcitabine plus a taxane improve OS compared to gemcitabine alone. Furthermore, the evidence suggests that fluoropyrimidine-based combination chemotherapy regimens improve OS compared to gemcitabine plus nab-paclitaxel. The effects of radiotherapy were uncertain as only one low-quality trial was included. Selection of the most appropriate chemotherapy for individuals still remains unpersonalised, with clinicopathological stratification remaining elusive. Biomarker development is essential to assist in rationalising treatment selection for patients.

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Conflict of interest statement

LH: none known.

WC: none known.

VC: Venessa Chin received scholarship funding from the Research and Education Foundation of the Royal Australasian College of Physicians, Pancare Australia, Sydney Catalyst, National Health and Medical Research Council, and the Garvan Institute of Medical Research for work related to this review.

AN: none known.

H‐WS: none known.

LC: Lorraine Chantrill has been paid as an advisory board member in relation to chemotherapy for pancreas cancer and has been paid for formulating educational materials and presentations. She has received grants for the practice of clinical trials in pancreas and other cancers.

DY: Advisory Board Member, Specialised Therapeutics, and paid consultant for Amgen and Servier Pharmaceuticals.

Update of

References

References to studies included in this review

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    1. Riess H, Helm A, Niedergethmann M, Schmidt-Wolf I, Moik M, Hammer K, et al. A randomised, prospective, multicenter, phase III trial of gemcitabine, 5-fluorouracil (5-FU), folinic acid vs. gemcitabine alone in patients with advanced pancreatic cancer. Journal of Clinical Oncology 2005;23(16 Suppl):LBA4009.
Rinaldi 2020 {published data only}
    1. Rinaldi Y, Wahiba B, Pointet A-L, Khemissa Akouz F, Le Malicot K, Louafi S, et al. Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: the Federation Francophone de Cancerologie Digestive-PRODIGE37 randomised phase II study (FIRGEMAX). European Journal of Cancer 2020;136:25-34. - PubMed
    1. Taieb J, Rinaldi Y, Pointet AL, Barbier E, Khemissa F, Gratet A, et al. Gemcitabine plus nab-paclitaxel until progression or given sequentially with 5- fluorouracil plus irinotecan (FOLFIRI.3) for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC): a randomized phase II study (PRODIGE 37- FIRGEMAX). Journal of Clinical Oncology 2018;36(15 Suppl):[no pagination]. 24073957
Rocha Lima 2004 {published data only}
    1. Rocha Lima CM, Green MR, Rotche R, Miller WH Jr, Jeffrey GM, Cisar LA. Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate. Journal of Clinical Oncology 2004;22(18):3776-83. - PubMed
Scheithauer 2003 {published data only}
    1. Scheithauer W, Schull B, Ulrich-Pur H, Schmid K, Raderer M, Haider, et al. Biweekly high-dose gemcitabine alone or in combination with capecitabine in patients with metastatic pancreatic adenocarcinoma: a randomized phase II trial. Annals of Oncology 2003;14(1):97-104. - PubMed
Singhal 2014 {published data only}
    1. Singhal MK, Kapoor A, Bagri PK, Narayan S, Singh D, Nirban RK, et al. A phase III trial comparing of FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. Annals of Oncology 2014;25:iv210.
Smith 2003 {published data only}
    1. Smith D, Gallagher N. A phase II/III study comparing intravenous ZD9331 with gemcitabine in patients with pancreatic cancer. European Journal of Cancer 2003;39(10):1377-83. - PubMed
Stathopoulos 2006 {published data only}
    1. Stathopoulos GP, Syrigos K, Aravantinos G, Polyzos A, Papakotoulas P, Fountzilas G, et al. A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer. British Journal of Cancer 2006;95(5):587-92. - PMC - PubMed
Takada 1998 {published data only}
    1. Takada T, Nimura Y, Katoh H, Nagakawa T, Nakayama T, Matsushiro T, et al. Prospective randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C for non-resectable pancreatic and biliary carcinoma: multicenter randomized trial. Hepato-gastroenterology 1998;45(24):2020-6. - PubMed
Tempero 2003 {published data only}
    1. Tempero M, Plunkett W, Ruiz Van Haperen V, Hainsworth J, Hochster H, Lenzi R, et al. Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. Journal of Clinical Oncology 2003;21(18):3402-8. - PubMed
Topham 1991 {published data only}
    1. Topham C, Glees J, Rawson NS, Woods EM, Coombes RC. Randomised trial of epirubicin alone versus 5-fluorouracil, epirubicin and mitomycin C in locally advanced and metastatic carcinoma of the pancreas. British Journal of Cancer 1991;64(1):179-81. - PMC - PubMed
Ueno 2013 {published data only}
    1. Hagiwara Y, Ohashi Y, Okusaka T, Ueno H, Ioka T, Boku N, et al. Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer: GEST study. European Society of Medical Oncology Open 2017;2(1):e000151. [DOI: 10.1136/esmoopen-2016-000151] - DOI - PMC - PubMed
    1. Okusaka T, Miyakawa H, Fujii H, Nakamori S, Satoh T, Hamamoto Y, et al. Updated results from GEST study: a randomized, three-arm phase III study for advanced pancreatic cancer. Journal of Cancer Research and Clinical Oncology 2017;143(6):1053-9. 24073913 - PMC - PubMed
    1. Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, et al. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. Journal of Clinical Oncology 2013;31(13):1640-8. - PubMed
Ueno 2013 – EPA study {published data only}
    1. Ueno M, Kobayashi S, Ohkawa S, Kameda R, Andou T, Sugimori K, et al. Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer. Journal of Clinical Oncology 2013;31:e15109.
Viret 2004 {published data only}
    1. Viret F, Ychou M, Lepille D, Mineur L, Navarro F, Topart D, et al. Gemcitabine in combination with cisplatin (GP) versus gemcitabine (G) alone in the treatment of locally advanced or metastatic pancreatic cancer: final results of a multicenter randomized phase II study. Journal of Clinical Oncology 2004;22(14 Suppl):4118.
Von Hoff 2013 {published data only}
    1. Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, et al. Tumor reduction in primary and metastatic pancreatic cancer lesions with nab-paclitaxel and gemcitabine: an exploratory analysis from a phase 3 study.. Pancreas 2017;46(2):203-8. - PMC - PubMed
    1. Peron J, Giai J, Maucort-Boulch D, Buyse M. The benefit-risk balance of nab-paclitaxel in metastatic pancreatic adenocarcinoma. Pancreas 2019;48(2):275-80. 24073927 - PubMed
    1. Tabernero J, Kunzmann V, Scheithauer W, Reni M, Li J S, Ferrara S, et al. Nab-paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. OncoTargets and Therapy 2017;10:591-6. 24073953 - PMC - PubMed
    1. Von Hoff DD, Ervin TJ, Arena FP, Chiorean G, Infante JR, Moore MJ, et al. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). Journal of Clinical Oncology 2013;31(4 Suppl):LBA148.
Wainberg 2023 {published data only}
    1. Wainberg ZA, Melisi D, Macarulla T, Pazo-Cid R, Chandana SR, De La Fouchardiere C, et al. NAPOLI-3: A randomized, open-label phase 3 study of liposomal irinotecan + 5-fluorouracil/ leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Journal of Clinical Oncology 2023;41(4 Suppl):LBA661.
Wang 2002 {published data only}
    1. Wang X, Ni Q, Jin M, Li Z, Wu Y, Zhao Y, et al. Gemcitabine or gemcitabine plus cisplatin for in 42 patients with locally advanced or metastatic pancreatic cancer. Chinese Journal of Oncology 2002;24(4):404-7. - PubMed
Xinopoulos 2008 {published data only}
    1. Xinopoulos D, Dimitroulopoulos D, Karanikas I, Fotopoulou A, Oikonomou N, Korkolis D, et al. Gemcitabine as palliative treatment in patients with unresectable pancreatic cancer previously treated with placement of a covered metal stent. A randomized controlled trial. Journal of the Balkan Union of Oncology 2008;13(3):341-7. - PubMed
Yalcin 2018 {published data only}
    1. Yalcin S, Dane F, Oksuzoglu B, Yildirim N, Isikdogan A, Ozkan M, et al. Quality of life study in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine in combination with nab-paclitaxel versus gemcitabine alone: Ax-panc-sy001: a phase II randomized study. Journal of Clinical Oncology 2018;36(4 Suppl 1):[no pagination]. - PMC - PubMed
Yamaue 2017 {published data only}
    1. Yamaue H, Shimizu A, Hagiwara Y, Sho M, Yanagimoto H, Nakamori S, et al. Multicenter, randomized, open-label Phase II study comparing S-1 alternate-day oral therapy with the standard daily regimen as a first-line treatment in patients with unresectable advanced pancreatic cancer. Cancer Chemotherapy and Pharmacology 2017;79(4):813-23. - PubMed
Zhou 2020 {published data only}
    1. Zhou L, Yang H, Qian J, Xie L, Sun J, Zhu L. Comparison of image-guided iodine-125 seed interstitial brachytherapy and local chemotherapy perfusion in treatment of advanced pancreatic cancer. Journal of Investigative Surgery 2020;35(1):1-6. - PubMed
Zong 2021 {published data only}
    1. Zong Y, Peng Z, Wang X, Shen L, Zhou J. Efficacy and safety of nab-paclitaxel plus S-1(nab-P/S-1) versus nab-paclitaxel plus gemcitabine (nab-P/Gem) for firstline chemotherapy in advanced pancreatic ductal adenocarcinoma (aPDAC): a randomized study. Journal of Clinical Oncology 2020;38(4):717. 24073991
    1. Zong Y, Yuan J, Peng Z, Lu M, Wang X, Shen L, et al. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study. Journal of Cancer Research and Clinical Oncology 2021;147(5):1529-36. - PMC - PubMed

References to studies excluded from this review

Abdel Wahab 1999 {published data only}
    1. Abdel-Wahab M, El-Shennawy F, Agha S, Ragab E, Fathi O, Sultan A, et al. Evaluation of cell mediated immunity in advanced pancreatic carcinoma before and after treatment with interleukin-2 (IL-2). Hepato-gastroenterology 1999;46(Suppl 1):1293-6. - PubMed
Aigner 1998 {published data only}
    1. Aigner K R, Gailhofer S, Kopp S. Regional versus systemic chemotherapy for advanced pancreatic cancer: a randomized study. Hepato-gastroenterology 1998;45(22):1125-9. - PubMed
Alberts 2005 {published data only}
    1. Alberts S R, Foster N R, Morton R F, Kugler J, Schaefer P, Wiesenfeld M, et al. PS-341 and gemcitabine in patients with metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group (NCCTG) randomized phase II study. Annals of Oncology 2005;16(10):1654-61. - PubMed
Andersen 1981 {published data only}
    1. Andersen JR, Friis-Moller A, Hancke S, Roder O, Steen J, Baden H. A controlled trial of combination chemotherapy with 5-FU and BCNU in pancreatic cancer. Scandinavian Journal of Gastroenterology 1981;16(8):973-5. - PubMed
Ardalan 1988 {published data only}
    1. Ardalan B, Singh G, Silberman H. A randomized phase I and II study of short-term infusion of high-dose fluorouracil with or without N-(phosphonacetyl)-L-aspartic acid in patients with advanced pancreatic and colorectal cancers. Journal of Clinical Oncology 1988;6(6):1053-8. - PubMed
Arscott 2021 {published data only}
    1. Arscott WT, Nead KT, Bear A, Venigalla S, Shabason J, Lukens JN, et al. Concurrent nab-paclitaxel and radiotherapy: novel radiosensitization for borderline resectable or unresectable pancreatic cancer. American Journal of Clinical Oncology 2021;44(9):469-74. - PMC - PubMed
Astsaturov 2011 {published data only}
    1. Astsaturov IA, Meropol NJ, Alpaugh RK, Burtness BA, Cheng JD, McLaughlin S, et al. Phase II and coagulation cascade biomarker study of bevacizumab with or without docetaxel in patients with previously treated metastatic pancreatic adenocarcinoma. American Journal of Clinical Oncology 2011;34(1):70-5. - PMC - PubMed
Baker 1976 {published data only}
    1. Baker LH, Vaitkevicius VK, Gehan E. Randomized prospective trial comparing 5-fluorouracil (NSC-19893) to 5-fluorouracil and methyl-CCNU (NSC-95441) in advanced gastrointestinal cancer. Cancer Treatment Reports 1976;60(6):733-7. - PubMed
Benavides 2014 {published data only}
    1. Benavides M, Gallego Plazas J, Guillen C, Vera R, Iranzo V, Diaz I, et al. Gemcitabine (G)/erlotinib (E) versus gemcitabine/erlotinib/capecitabine (C) in the first-line treatment of patients with metastatic pancreatic cancer (mPC): Efficacy and safety results of a phase IIb randomized study from the Spanish TTD Collaborative Group. Journal of Clinical Oncology 2014;32:5s. - PubMed
Benson 2014 {published data only}
    1. Benson A, Bendell J, Wainberg ZA, VyushkovD, Acs P, Kudrik F, et al. A phase 2 randomized, double-blind, placebo controlled study of simtuzumab or placebo in combination with gemcitabine for the first line treatment of pancreatic adenocarcinoma. In: Annals of Oncology. Vol. 25. 2014:iv210. - PMC - PubMed
Benson 2017 {published data only}
    1. Benson AB, Wainberg ZA, Hecht JR, Vyushkov D, Dong H, Bendell J, et al. A phase II randomized, double‐blind, placebo‐controlled study of simtuzumab or placebo in combination with gemcitabine for the first-line treatment of pancreatic adenocarcinoma. Oncologist 2017;22(3):241. - PMC - PubMed
Berglund 2010 {published data only}
    1. Berglund A, Bystrom P, Johansson B, Nygren P, Frodin JE, Pedersen D, et al. An explorative randomised phase II study of sequential chemotherapy in advanced upper gastrointestinal cancer. Medical Oncology 2010;27(1):65-72. - PubMed
Boku 2017 {published data only}
    1. Boku N, Uesaka K. Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer. European Journal of Cancer 2017;72 Suppl 1:S77.
Bramhall 2001 {published data only}
    1. Bramhall SR, Rosemurgy A, Brown PD, Bowry C, Buckels JA. Marimastat as first-line therapy for patients with unresectable pancreatic cancer: a randomized trial. Journal of Clinical Oncology 2001;19(15):3447-55. - PubMed
Bramhall 2002 {published data only}
    1. Bramhall SR, Schulz J, Nemunaitis J, Brown PD, Baillet M, Buckels JA. A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer. British Journal of Cancer 2002;87(2):161-7. - PMC - PubMed
Brunner 2019 {published data only}
    1. Brunner M, Wittel U, Croner R, Ghadimi M, Jacobasch L, Neumann U, et al. R0-resection following chemotherapy or chemoradiation improves survival of primary inoperable pancreatic cancer patients. Interim results of the CONKO-007 prospective randomized multicenter trial. Zeitschrift für Gastroenterologie 2019;57(9):[no pagination].
    1. Fietkau R, Semrau S, Rutzner S, Lubgan D, Grutzmann R, Hohenberger W M, et al. R0 resection following chemo (radio)therapy improves survival of primary inoperable pancreatic cancer patients. Interim results of the German randomized CONKO-007+/- trial. Strahlentherapie und Onkologie 2021;197(1):8-18. 24073839 - PMC - PubMed
Buanes 2009 {published data only}
    1. Buanes T, Maurel J, Liauw W, Hebbar M, Nemunaitis J. A randomized phase III study of gemcitabine (G) versus GV1001 in sequential combination with G in patients with unresectable and metastatic pancreatic cancer (PC). Journal of Clinical Oncology 2009;27(15S):4601.
Bukowski 1993 {published data only}
    1. Bukowski RM, Fleming TR, Macdonald JS, Oishi N, Taylor SA, Baker LH. Evaluation of combination chemotherapy and phase II agents in pancreatic adenocarcinoma. A Southwest Oncology Group study. Cancer 1993;71(2):322-5. - PubMed
Burtness 2016 {published data only}
    1. Burtness B, Powell M, Catalano P, Berlin J, Liles DK, Chapman AE, et al. Randomized phase II trial of irinotecan/docetaxel or irinotecan/docetaxel plus cetuximab for metastatic pancreatic cancer: an Eastern Cooperative Oncology Group Study. American Journal of Clinical Oncology 2016;39(4):340-5. [10.1097/COC.0000000000000068] - PMC - PubMed
Cantore 2004 {published data only}
    1. Cantore M, Fiorentini G, Luppi G, Rosati G, Caudana R, Piazza E, et al. Gemcitabine versus FLEC regimen given intra-arterially to patients with unresectable pancreatic cancer: a prospective, randomized phase III trial of the Italian Society for Integrated Locoregional Therapy in Oncology. Journal of Chemotherapy (Florence) 2004;16(6):589-94. - PubMed
Caparello 2017 {published data only}
    1. Caparello C, Vivaldi C, Montagnani F, Musettini G, Pasquini G, Pecora I, et al. Second-line (SL) chemotherapy containing oxaliplatin (OXA) in metastatic pancreatic cancer (PC): whom should we trust? Journal of Clinical Oncology 2017;35(15 Suppl 1):..
Cascinu 2008 {published data only}
    1. Cascinu S, Berardi R, Labianca R, Siena S, Falcone A, Aitini E, et al. Cetuximab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone in patients with advanced pancreatic cancer: a randomised, multicentre, phase II trial. Lancet Oncology 2008;9(1):39-44. - PubMed
Cascinu 2013 {published data only}
    1. Cascinu S, Berardi R, Sobrero A, Bidoli P, Labianca R, Siena S, et al. Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer: a GISCAD randomized phase II study. Digestive and Liver Disease 2013;46(2):182-6. - PubMed
Cascinu 2021 {published data only}
    1. Cascinu S, Casadei Gardini A, Berardi R, Bittoni A, Bianco R, Marciano R, et al. Nab-paclitaxel/gemcitabine combination is more effective than gemcitabine alone in locally advanced, unresectable pancreatic cancer - A GISCAD phase II randomized trial. European Journal of Cancer 2021;148:422-9. - PubMed
Catenacci 2013 {published data only}
    1. Catenacci DVT, Bahary N, Nattam SR, Marsh RW, Wallace JA, Rajdev L, et al. Final analysis of a phase IB/randomized phase II study of gemcitabine (G) plus placebo (P) or vismodegib (V), a hedgehog (Hh) pathway inhibitor, in patients (pts) with metastatic pancreatic cancer (PC): a University of Chicago phase II consortium study. Journal of Clinical Oncology 2013;31(15 Suppl):4012.
Chai 2013 {published data only}
    1. Chai K, Ai YQ, Jiang LW. Phase II study of dendritic cell vaccination combined with recombinant adenovirus-p53 in treatment for patients with advanced pancreatic carcinoma. Journal of Clinical Oncology 2013;31:3049.
Chauffert 2008 {published data only}
    1. Chauffert B, Mornex F, Bonnetain F, Rougier P, Mariette C, Bouche O, et al. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study. Annals of Oncology 2008;19(9):1592-9. - PubMed
Chen 2006 {published data only}
    1. Chen J, Röcken C, Nitsche B, Hosius C, Gschaidmeier H, Kahl S, et al. The tyrosine kinase inhibitor imatinib fails to inhibit pancreatic cancer progression. Cancer Letters 2006;233(2):328-37. - PubMed
Chen 2019 {published data only}
    1. Chen LT, Hitre E, Lee WJ, Bai LY, Papai Z, Kang SY, et al. A randomized controlled, open label, adaptive phase III Trial to evaluate safety and efficacy of endoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment. Annals of Oncology 2019;30 Suppl 5:V321.
Chen G 2017 {published data only}
    1. Chen G, Xu YP, Sun CH, Qiu YK. Clinical efficacy of gemcitabine combined with intensity modulated radiotherapy in treatment of pancreatic cancer. World Chinese Journal of Digestology 2017;25(16):1511-5.
Chen LT 2017 {published data only}
    1. Chen LT, Macarulla TM, Blanc J, Mirakhur B, De Jong FA, Belanger B, et al. Impact of dose reduction or dose delay on the efficacy of liposomal irinotecan (nal-IRI)15-fluorouracil/leucovorin (5-FU/LV): survival analysis from NAPOLI-1. Annals of Oncology 2018;29(Suppl 8:VIII):250. 24073814
    1. Chen LT, Siveke JT, Wang-Gillam A, Li C-P, Bodoky G, Dean AP, et al. Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: expanded analysis of a global phase 3 trial. European Journal of Cancer 2018;105:71-8. 24073816 - PubMed
    1. Chen LT, Wang-Gillam A, Yanshen S, Macarulla T, Blanc JF, Hubner R, et al. Efficacy and safety of liposomal irinotecan (nal-IRI) + 5-fluorouracil and leucovorin (5-FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) who previously received gemcitabine (gem)-based therapy: post-hoc analysis of the NAPOLI-1 trial. Journal of Clinical Oncology: American Society of Clinical Oncology 2017;35(4 Suppl 1):[no pagination].
Chiorean 2018 {published data only}
    1. Chiorean EG, Von Hoff D, Wan Y, Margunato-Debay S, Botteman M, Goldstein D. Performance status dynamics during treatment with nab-paclitaxel plus gemcitabine versus gemcitabine alone for metastatic pancreatic cancer. Cancer Management and Research 2018;10:1389-96. - PMC - PubMed
Chiritescu 2018 {published data only}
    1. Chiritescu G, Dumon K, Verslype C, Houbiers G, Peeters M, Janssens J, et al. Final results of a phase II quality of life (QOL) randomized, cross-over (CO) study with gemcitabine (Gem) and nab-paclitaxel (n-P) in locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC): QOLINPAC. Annals of Oncology 2018;29:viii252.
    1. Chiritescu G, Dumon K, Verslype C, Prenen H, Houbiers G, Peeters M, et al. Gemcitabine with nab-paclitaxel in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC): a quality of life randomized cross-over study (QOLINPAC). Annals of Oncology 2018;29(v101):[no pagination].
Chung 2004 {published data only}
    1. Chung HW, Bang SM, Park SW, Chung JB, Kang JK, Kim JW, et al. A prospective randomized study of gemcitabine with doxifluridine versus paclitaxel with doxifluridine in concurrent chemoradiotherapy for locally advanced pancreatic cancer. International Journal of Radiation Oncology, Biology, Physics 2004;60(5):1494-501. - PubMed
Chung 2015 {published data only}
    1. Chung VM, McDonough SL, Philip PA, Cardin DB, Wang-Gillam A, Hui L, et al. SWOG S1115: Randomized phase II trial of selumetinib (AZD6244; ARRY 142886) hydrogen sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in pretreated patients (Pts) with metastatic pancreatic cancer. Journal of Clinical Oncology 2015;33:4119.
Ciuleanu 2009 {published data only}
    1. Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, et al. A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. European Journal of Cancer 2009;45(9):1589-96. - PubMed
CN‐01903250 {published data only}
    1. CN-01903250. A clinical study to assess the comparative blood concentration of two anti-cancer drugs (test and marketed Irinotecan) when given along with other anti-cancer drugs (fluorouracil and leucovorin) in patients with pancreatic cancer. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2018/04/013114 (first registered 9 April 2018). [CTRI ID: CTRI/2018/04/013114]
Cohen 2005 {published data only}
    1. Cohen SJ, Dobelbower R Jr, Lipsitz S, Catalano PJ, Sischy B, Smith TJ, et al. A randomized phase III study of radiotherapy alone or with 5-fluorouracil and mitomycin-C in patients with locally advanced adenocarcinoma of the pancreas: Eastern Cooperative Oncology Group study E8282. International Journal of Radiation Oncology, Biology, Physics 2005;62(5):1345-50. - PubMed
Cohen 2010 {published data only}
    1. Cohen SJ, Zalupski MM, Conkling P, Nugent FW, Ma W, Modiano M, et al. A phase II randomized double blind multicenter trial of gemcitabine (Gem) plus imexon (IMX) versus Gem plus placebo (P) in patients with chemotherapy-naive pancreatic adenocarcinoma (PC). Journal of Clinical Oncology 2010;28:4076. - PubMed
Conroy 2018 {published data only}
    1. Conroy T, Chone L, Hammel P, Sauvanet A, Hebbar M, Ben Abdelghani M, et al. FOLFIRINOX or gemcitabine as adjuvant therapy for pancreatic cancer. New England Journal of Medicine 2018;379(25):2395-406. - PubMed
    1. Conroy T, Hammel P, Hebbar M, Abdelghani MB, Wei AC, Raoul JL, et al. Unicancer GI PRODIGE 24/CCTG PA.6 trial: a multicenter international randomized phase III trial of adjuvant mFOLFIRINOX versus gemcitabine (gem) in patients with resected pancreatic ductal adenocarcinomas. Journal of Clinical Oncology: American Society of Clinical Oncology 2018;36(18 Suppl 1):[no pagination].
Dahan 2010 {published data only}
    1. Dahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, et al. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut 2010;59(11):1527-34. - PMC - PubMed
Dalgleish 2015 {published data only}
    1. Dalgleish AG, IMAGE I Trial Investigators. A multicenter randomized, open-label, proof-of-concept, phase II trial comparing gemcitabine with and without IMM-101 in advanced pancreatic cancer. Journal of Clinical Oncology 2015;33:3051.
Dean 2020 {published data only}
    1. Dean A, Bekaii-Saab T, Boland PM, Dayyani F, Macarulla T, Mody K, et al. First-line liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin in patients with pancreatic ductal adenocarcinoma: results from a phase 1/2 study. Asia-Pacific Journal of Clinical Oncology 2020;16 Suppl 8:118.
De la Fouchardiere 2020 {published data only}
    1. De la Fouchardiere C, Hammel P, Launay S, Vienot A, Raimbourg J, Perrier H, et al. PRODIGE 65 - UCGI 36 - GEMPAX: a unicancer phase III randomized study evaluating gemcitabine and paclitaxel versus gemcitabine alone after FOLFIRINOX failure or intolerance in metastatic pancreatic ductal adenocarcinoma. Annals of Oncology 2020;31 Suppl 4:S954-5.
Deplanque 2015 {published data only}
    1. Deplanque G, Demarchi M, Hebbar M, Flynn P, Milchar B, Atkins J, et al. A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer. Annals of Oncology 2015;26:1194-200. - PMC - PubMed
Ducreux 2002 {published data only}
    1. Ducreux M, Rougier P, Pignon JP, Douillard JY, Seitz JF, Bugat R, et al. A randomised trial comparing 5-FU with 5-FU plus cisplatin in advanced pancreatic carcinoma. Annals of Oncology 2002;13(8):1185-91. - PubMed
Ducreux 2018 {published data only}
    1. Ducreux MP, Desgrippes R, Texier M, Di Fiore F, Vanelslander P, Capitain O, et al. PRODIGE 29-UCGI 26 (NEOPAN): a randomised trial of chemotherapy with folfirinox or gemcitabine in locally advanced pancreatic carcinoma (PC). Annals of Oncology 2018;29(Suppl 8):viii266-viii267. [DOI: 10.1093/annonc/mdy282.164] - DOI - PubMed
Ducreux 2022 {published data only}
    1. Ducreux MP, Desgrippes R, Rinaldi Y, Fiore F, Guimbaud R, Follana P, et al. 1296MO PRODIGE 29-UCGI 26(NEOPAN): A phase III randomised trial comparing chemotherapy with folfirinox or gemcitabine in locally advanced pancreatic carcinoma (LAPC). Annals of Oncology 2022;33:S1136. - PubMed
    1. Ducreux MP, Desgrippes R, Texier M, Di Fiore F, Vanelslander P, Capitain O, et al. PRODIGE 29-UCGI 26(NEOPAN): a randomised trial of chemotherapy with folfirinox or gemcitabine in locally advanced pancreatic carcinoma (PC). Annals of Oncology 2018;29:viii266. - PubMed
Duffy 2015 {published data only}
    1. Duffy AG, Beg MS, Greten TF, Beatson MA, Mavroukakis S, Patel SP, et al. A multicenter randomized phase II study of NPC-1C(N) in combination with gemcitabine (G) and nab-paclitaxel (A) versus G and A alone in patients with metastatic or locally advanced pancreatic cancer (PC) previously treated with folfirinox (F). Journal of Clinical Oncology 2015;33(Suppl 3):TPS499.
El‐Khoueiry 2012 {published data only}
    1. El-Khoueiry AB, Ramanathan RK, Yang DY, Zhang W, Shibata S, Wright JJ, et al. A randomized phase II of gemcitabine and sorafenib versus sorafenib alone in patients with metastatic pancreatic cancer. Investigational New Drugs 2012;30(3):1175-83. - PMC - PubMed
Evans 2014 {published data only}
    1. Evans J, Moore M, Van Cutsem E, Rock E, Strauss L, ODwyer P. Phase 2 Double-blind, placebo-controlled trial of dasatinib added to gemcitabine for subjects with locally-advanced pancreatic cancer (LAPC). Annals of Oncology 2014;25:ii105. - PubMed
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    1. Friess H, Langrehr JM, Oettle H, Raedle J, Niedergethmann M, Dittrich C, et al. A randomized multi-center phase II trial of the angiogenesis inhibitor Cilengitide (EMD 121974) and gemcitabine compared with gemcitabine alone in advanced unresectable pancreatic cancer. BioMed Central Cancer 2006;6:285. - PMC - PubMed
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    1. Fuchs CS, Azevedo A, Okusaka T, Van Laethem JL, Lipton LR, Riess H, et al. A phase 3 randomized, double-blind, placebo-controlledtrial of ganitumab or placebo in combination withgemcitabine as first-line therapy for metastaticadenocarcinoma of the pancreas: the GAMMA trial. Annals of Oncology 2015;26:921-7. - PMC - PubMed
Fukutomi 2015 {published data only}
    1. Fukutomi A, Mizusawa J, Katayama H, Nakamura S, Ito Y, Hiraoka N, et al. Randomized phase II study of S-1 and concurrent radiotherapy with versus without induction chemotherapy of gemcitabine for locally advanced pancreatic cancer (JCOG 1106). Journal of Clinical Oncology 2015;33:4116.
Furuse 2017 {published data only}
    1. Furuse J. Clinical trials in progress of chemotherapy for unresectable pancreatic cancer in Japan. Pancreatology 2017;17(4 Suppl 1):S11.
García Santos 2018 {published data only}
    1. García Santos E, Padilla Valverde D, Villarejo Campos P, Sanchez Garcia S, Martin Fernandez J. HIPEC with gemcitabine as an adjuvant locoregional treatment after radical surgery in pancreatic cancer. Presentation of the clinical trial N-2016-004298-41. Pleura and Peritoneum 2018;3:SA206.
García Santos 2020 {published data only}
    1. García Santos EP, Padilla-Valverde D, Sánchez-García S, Manzanares-Campillo MC, Puerto-Puerto A, Rodríguez-Martínez M, et al. Hyperthermic intra-abdominal chemotherapy with gemcitabine as an adjuvant locoregional treatment after radical surgery in pancreatic cancer. Surgical Case Reports 2020;7(16):[no pagination]. [DOI: 10.31487/j.SCR.2020.07.16] - DOI
Gill 2014 {published data only}
    1. Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind SK, Zulfiqar M, et al. PANCREOX: A randomized phase 3 study of 5FU/LV with or without oxaliplatin for second-line advanced pancreatic cancer (APC) in patients (pts) who have received gemcitabine (GEM)-based chemotherapy (CT). Journal of Clinical Oncology 2014;32:5s. - PubMed
Gilliam 2012 {published data only}
    1. Gilliam AD, Broome P, Topuzov EG, Garin AM, Pulay I, Humphreys J, et al. An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas 2012;41(3):374-9. - PubMed
GISTG 1985 (radiotherapy) {published data only}
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GITSG 1979 {published data only}
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GITSG 1985 {published data only}
    1. Gastrointestinal Trials Study Group. Phase II trials of maytansine, low-dose chlorozotocin, and high-dose chlorozotocin as single agents against advanced measurable adenocarcinoma of the pancreas. Gastrointestinal Tumor Study Group. Cancer Treatment Reports 1985;69(4):417-20. - PubMed
GITSG 1988 {published data only}
    1. Group Gastrointestinal Tumor Study. Treatment of locally unresectable carcinoma of the pancreas: comparison of combined-modality therapy (chemotherapy plus radiotherapy) to chemotherapy alone. Journal of the National Cancer Institute 1988;80(10):751-5. - PubMed
Golan 2020 {published data only}
    1. Golan T, Barenboim A, Lubezky N. ASO author reflections: pancreatic cancer patients with germline brca mutations benefit from early introduction of platinum-based chemotherapy. Annals of Surgical Oncology 2020;27(10):3971-2. - PubMed
Gonçalves 2012 {published data only}
    1. Gonçalves A, Gilabert M, François E, Dahan L, Perrier H, Lamy R, et al. BAYPAN study: a double-blind phase III randomized trial comparing gemcitabine plus sorafenib and gemcitabine plus placebo in patients with advanced pancreatic cancer. Annals of Oncology 2012;23(11):2799-805. - PubMed
Gong 2007 {published data only}
    1. Gong JF, Zhang XD, Li J, Di LJ, Jin ML, Shen L. Efficacy of gemcitabine-based chemotherapy on advanced pancreatic cancer. Ai Zheng [Chinese Journal of Cancer] 2007;26(8):890-4. - PubMed
Haas 2015 {published data only}
    1. Haas M, Boeck SH, Waldschmidt D, Reinacher-Schick A, Freiberg-Richter J, Seufferlein T, et al. ACCEPT: Afatinib as cancer therapy for exocrine pancreatic tumors-An explorative randomized phase II trial. Journal of Clinical Oncology 2015;33:TPS4150.
Hall 2019 {published data only}
    1. Hall W, Tsai S, Banerjee A, George B, Ritch PS, Thomas JP, et al. A randomized, phase II clinical trial of preoperative stereotactic body radiation therapy versus conventionally fractionated chemoradiation for resectable, borderline-resectable, or locally advanced type A pancreatic adenocarcinoma. Journal of Clinical Oncology: American Society of Clinical Oncology 2019;37(15 Suppl 1):..
Hamada 2017 {published data only}
    1. Hamada C, Okusaka T, Ikari T, Isayama H, Furuse J, Ishii H, et al. Efficacy and safety of gemcitabine plus S-1 in pancreatic cancer: a pooled analysis of individual patient data. British Journal of Cancer 2017;116(12):1544-50. - PMC - PubMed
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    1. Hammel P, Huguet F, Van Laethem JL, Goldstein D, Glimelius B, Artru P, et al. Comparison of chemoradiotherapy (CRT) and chemotherapy (CT) in patients with a locally advanced pancreatic cancer (LAPC) controlled after 4 months of gemcitabine with or without erlotinib: final results of the international phase III LAP 07 study. Journal of Clinical Oncology 2013;31:LBA4003.
Hammel 2020 {published data only}
    1. Hammel P, Bachet JB, El-Hariry I, Portales F, Mineur L, Metges JP, et al. A phase IIb of eryaspase in combination with gemcitabine or FOLFOX as second-line therapy in patients with metastatic pancreatic adenocarcinoma (NCT02195180). Journal of Clinical Oncology: American Society of Clinical Oncology 2017;35(15 Suppl 1):[no pagination].
    1. Hammel P, Fabienne P, Mineur L, Metges JP, Andre T, La Fouchardiere C, et al. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: an open-label, randomized phase IIb trial. European Journal of Cancer 2020;124:91-101. - PubMed
Han 2006 {published data only}
    1. Han GH, Yin ZX, Meng XJ, He CY, Zhang HB, Sun AH, et al. Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma. Chinese Journal of Digestive Diseases 2006;7(1):45-8. - PubMed
Hazel 1981 {published data only}
    1. Hazel JJ, Thirlwell MP, Huggins M, Maksymiuk A, MacFarlane JK. Multi-drug chemotherapy with and without radiation for carcinoma of the stomach and pancreas: a prospective randomized trial. Journal of the Canadian Association of Radiologists 1981;32(3):164-5. - PubMed
Heinemann 2013 {published data only}
    1. Heinemann V, Ebert MP, Laubender RP, Bevan P, Mala C, Boeck S. Phase II randomised proof-of-concept study of the urokinase inhibitor upamostat (WX-671) in combination with gemcitabine compared with gemcitabine alone in patients with non-resectable, locally advanced pancreatic cancer. British Journal of Cancer 2013;108(4):766-70. - PMC - PubMed
Heinemann 2013 (GUT) {published data only}
    1. Heinemann V, Vehling-Kaiser U, Waldschmidt D, Kettner E, Marten A, Winkelmann C, et al. Gemcitabine plus erlotinib followed by capecitabine versus capecitabine plus erlotinib followed by gemcitabine in advanced pancreatic cancer: final results of a randomised phase 3 trial of the 'Arbeitsgemeinschaft Internistische Onkologie' (AIO-PK0104). Gut 2013;62(5):751-9. - PMC - PubMed
Herman 2013 {published data only}
    1. Herman JM, Wild AT, Wang H, Tran PT, Chang KJ, Taylor GE, et al. Randomized phase III multi-institutional study of TNFerade biologic with fluorouracil and radiotherapy for locally advanced pancreatic cancer: final results. Journal of Clinical Oncology 2013;31(7):886. - PMC - PubMed
Hingorani 2015 {published data only}
    1. Hingorani SR, Proctor Harris W, Hendifar AE, Bullock AJ, Wu XW, Huang Y, et al. High response rate and PFS with PEGPH20 added to nab-paclitaxel/gemcitabine in stage IV previously untreated pancreatic cancer patients with high-HA tumors: Interim results of a randomized phase II study. Journal of Clinical Oncology 2015;33:4006.
Horton 1981 {published data only}
    1. Horton J, Gelber R D, Engstrom P, Falkson G, Moertel C, Brodovsky H, et al. Trials of single-agent and combination chemotherapy for advanced cancer of the pancreas. Cancer Treatment Reports 1981;65(1-2):65-8. - PubMed
Hurwitz 2015 {published data only}
    1. Hurwitz HI, Uppal N, Wagner SA, Bendell JC, Beck T, Wade SM 3rd, et al. Randomized, double-blind, phase II study of ruxolitinib or placebo in combination with capecitabine in patients with metastatic pancreatic cancer for whom therapy with gemcitabine has failed. Journal of Clinical Oncology 2015;33(34):4039-47. [DOI: 10.1200/JCO.2015.61.4578.] - DOI - PMC - PubMed
Hurwitz 2015 (JANUS 1) {published data only}
    1. Hurwitz H, Garrett WM, Clark J, Brill KJ, Dawkins FW, Hidalgo M, et al. JANUS 1: A phase 3, placebo-controlled study of ruxolitinib plus capecitabine in patients with advanced or metastatic pancreatic cancer (MPC) after failure or intolerance of first-line chemotherapy. Journal of Clinical Oncology 2015;33:TPS4147.
Ibraimi 2017 {published data only}
    1. Ibraimi Z, Moesinger R, Kurtishi I, Murtezani A. Comparison of clinical effectiveness of folfirinox versus gemcitabine on quality of life in patients with pancreatic cancer stage IV. Asian Journal of Pharmaceutics 2017;11(3 Suppl 1):S609-15.
Infante 2013 {published data only}
    1. Infante JR, Somer BG, Park JO, Li CP, Scheulen ME, Kasubhai SM, et al. A randomized, double-blind, placebo-controlled trial of trametinib, a MEK inhibitor, in combination with gemcitabine for patients with untreated metastatic adenocarcinoma of the pancreas. Journal of Clinical Oncology 2013;31(4 Suppl):291. - PubMed
Ioka 2009 {published data only}
    1. Ioka T, Takakura R, Nakaizumi A, Tanaka S, Iishi H, Nakamura S, et al. A multicenter randomized phase II study of full-dose gemcitabine and concurrent radiotherapy comparing gemcitabine alone for the unresectable locally advanced pancreatic adenocarcinoma. Journal of Clinical Oncology 2009;27:e15512.
Ioka 2013 {published data only}
    1. Ioka T, Katayama K, Ishida N, Takada R, Yamai T, Fukutake N, et al. Randomized phase II study of best available fluoropyrimidine compared with continuation of gemcitabine (Gem) monotherapy in patients with Gem-refractory pancreatic cancer. Journal of Clinical Oncology 2013;31:287.
Ioka 2017 {published data only}
    1. Ioka T, Komatsu Y, Mizuno N, Tsuji A, Ohkawa S, Tanaka M, et al. Randomised phase II trial of irinotecan plus S-1 in patients with gemcitabine-refractory pancreatic cancer. British Journal of Cancer 2017;116(4):464-71. - PMC - PubMed
Ioka 2019a {published data only}
    1. Ioka T, Nakamori S, Sugimori K, Kanai M, Ikeda M, Ozaka M, et al. Liposomal irinotecan (nal-IRI) plus 5-fluorouracil/levoleucovorin (5 FU/ LV) vs 5-FU/LV in Japanese patients (pts) with gemcitabine-refractory metastatic pancreatic cancer (mPAC). Annals of Oncology 2019;30:IX47-8.
Ioka 2019b {published data only}
    1. Ioka T, Ueno M, Ueno H, Okusaka T, Park JO, Chang HM, et al. TAS-118 (S-1 plus leucovorin) versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer: a randomised, open-label, phase 3 study (GRAPE trial). European Journal of Cancer 2019;106:78-88. - PubMed
Ioka 2021 {published data only}
    1. Ioka T, Furuse J, Okano N, Fukutomi A, Todaka A, Mizusawa J, et al. Randomized phase II study of chemoradiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer: Japan Clinical Oncology Group trial, JCOG1106. Japanese Journal of Clinical Oncology 2021;51(2):235-43. - PubMed
Ishikawa 2019 {published data only}
    1. Ishikawa T, Kawashima H, Ohno E, Matsubara H, Sasaki Y, Achiwa K, et al. Randomized phase II study of consecutive-day versus alternate-day treatment with S-1 as second-line chemotherapy in advanced pancreatic cancer. Oncology 2019;96(1):1-7. - PubMed
Jacobs 2004 {published data only}
    1. A Jacobs. Full survival data not available. Email to V Chin 5 September 2014.
    1. Jacobs AD, Burris HA, Rivkin S, Ritch PS, Eisenberg PD, Mettinger KL. A randomized phase III study of rubitecan (ORA) vs. best choice (BC) in 409 patients with refractory pancreatic cancer report from a North-American multi-center study. Journal of Clinical Oncology 2004;22:4013.
Javle 2011 {published data only}
    1. Javle MM, Varadhachary GR, Fogelman DR, Shroff RT, Overman MJ, Ukegbu L, et al. Randomized phase II study of gemcitabine (G) plus anti-IGF-1R antibody MK-0646, G plus erlotinib (E) plus MK-0646 and G plus E for advanced pancreatic cancer. Journal of Clinical Oncology 2011;29:4026.
Johnson 2001 {published data only}
    1. Johnson CD, Puntis M, Davidson N, Todd S, Bryce R. Randomized, dose-finding phase III study of lithium gamolenate in patients with advanced pancreatic adenocarcinoma. British Journal of Surgery 2001;88(5):662-8. - PubMed
Jonas 2021 {published data only}
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Kayahan 2021 {published data only}
    1. Kayahan N, Karaca M, Satis H, Yapar D, Özet A. FOLFIRINOX versus gemcitabine-cisplatin combination as first-line therapy in treatment of pancreaticobiliary cancer. Turkish Journal of Medical Sciences 2021;51(4):1727-32. - PMC - PubMed
Kim 2011 {published data only}
    1. Kim GP, Foster NR, Salim M, Flynn PJ, Moore DF, Zon R, et al. Randomized phase II trial of panitumumab (P), erlotinib (E), and gemcitabine (G) versus erlotinib-gemcitabine in patients with untreated, metastatic pancreatic adenocarcinoma. Journal of Clinical Oncology 2011;29:238.
Kindler 2008 {published data only}
    1. Kindler HL, Gangadhar T, Karrison T, Hochster HS, Moore MJ, Micetich K, et al. Final analysis of a randomized phase II study of bevacizumab (B) and gemcitabine (G) plus cetuximab (C) or erlotinib (E) in patients (pts) with advanced pancreatic cancer (PC). Journal of Clinical Oncology 2008;26:4502.
Kindler 2010 {published data only}
    1. Kindler HL, Niedzwiecki D, Hollis D, Sutherland S, Schrag D, Hurwitz H, et al. Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303). Journal of Clinical Oncology 2010;28(22):3617-22. - PMC - PubMed
Kindler 2011 {published data only}
    1. Kindler HL, Ioka T, Richel DJ, Bennouna J, Letourneau R, Okusaka T, et al. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncology 2011;12(3):256-62. - PubMed
Kindler 2012 {published data only}
    1. Kindler HL, Richards DA, Garbo LE, Garon EB, Stephenson JJ Jr, Rocha-Lima CM, et al. A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer. Annals of Oncology 2012;23(11):2384-42. - PubMed
Kindler 2015 {published data only}
    1. Kindler HL, Locker GY, Mann H, Golan T. POLO: A randomized phase III trial of olaparib tablets in patients with metastatic pancreatic cancer (mPC) and a germline BRCA1/2 mutation (gBRCAm) who have not progressed following first-line chemotherapy. In: Journal of Clinical Oncology. Vol. 33. 2015.
Klaassen 1985 {published data only}
    1. Klaassen DJ, MacIntyre JM, Catton GE, Engstrom PF, Moertel CG. Treatment of locally unresectable cancer of the stomach and pancreas: a randomized comparison of 5-fluorouracil alone with radiation plus concurrent and maintenance 5-fluorouracil--an Eastern Cooperative Oncology Group study. Journal of Clinical Oncology 1985;3(3):373-8. - PubMed
Ko 2012 {published data only}
    1. Ko AH, Youssoufian H, Gurtler J, Dicke K, Kayaleh O, Lenz H J, et al. A phase II randomized study of cetuximab and bevacizumab alone or in combination with gemcitabine as first-line therapy for metastatic pancreatic adenocarcinoma. Investigational New Drugs 2012;30(4):1597-606. - PubMed
Ko 2016 {published data only}
    1. Ko AH, Murphy PB, Peyton JD, Shipley D, Al-Hazzouri A, Rodrigeuz FA, et al. RAINIER: A randomized, double-blinded, placebo-controlled phase II trial of gemcitabine (gem) plus nab-paclitaxel (nab-P) combined with apatorsen (A) or placebo (Pl) in patients (pts) with metastatic pancreatic cancer (mPC). Journal of Clinical Oncology 2016;34(4 Suppl):419.
Kunzmann 2021 {published data only}
    1. Hartlapp I, Algul H, Gokkurt E, Siegler G, Martens U, Waldschmidt D, et al. Induction chemotherapy in locally advanced pancreatic cancer (LAPC)-final results of a multicenter randomized phase 2 AIO trial (NEOLAP). Oncology Research and Treatment 2020;43:63. 24073857
    1. Kunzmann V, Algül H, Goekkurt E, Siegler GM, Martens UM, Waldschmidt D, et al. Conversion rate in locally advanced pancreatic cancer (LAPC) after nab-paclitaxel/gemcitabine- or FOLFIRINOX-based induction chemotherapy (NEOLAP): final results of a multicenter randomised phase II AIO trial. Annals of Oncology 2019;30:v253. 24073883
    1. Kunzmann V, Martens UM, Alguel H, Siveke JT, Goekkurt E, Pelzer U, et al. Secondary resectability in locally advanced pancreatic cancer (LAPC) after nab-paclitaxel/gemcitabine- versus FOLFIRINOX-based induction chemotherapy: Interim results of a randomized phase II AIO trial (NEOLAP). Journal of Clinical Oncology 2018;36(4 Suppl):348. 24073881
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Kwon 2017 {published data only}
    1. Kwon W, Jang JY, Han Y, Kim SW, Heo J, Park JS, et al. Multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreatic cancer. Journal of Hepato-Biliary-Pancreatic Sciences 2017;24 Suppl 1:A122.
Lasalvia‐Prisco 2012 {published data only}
    1. Lasalvia-Prisco E, Goldschmidt P, Galmarini F, Cucchi S, Vazquez J, Aghazarian M, et al. Addition of an induction regimen of antiangiogenesis and antitumor immunity to standard chemotherapy improves survival in advanced malignancies. Medical Oncology 2012;29(5):3626-33. - PMC - PubMed
Le (Ipilimumab) 2013 {published data only}
    1. Le DT, Lutz E, Uram JN, Sugar EA, Onners B, Solt S, et al. Evaluation of ipilimumab in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in previously treated pancreatic cancer. Journal of Immunotherapy 2013;36(7):382-9. - PMC - PubMed
Le 2013 {published data only}
    1. Le DT, Wang-Gillam A, Picozzi VJ, Greten TF, Crocenzi TS, Springett GM, et al. Interim safety and efficacy analysis of a phase II, randomized study of GVAX pancreas and CRS-207 immunotherapy in patients with metastatic pancreatic cancer. Journal of Clinical Oncology 2013;31:4040.
Le 2015 {published data only}
    1. Le DT, Crocenzi TS, Uram JN, Lutz ER, Laheru DA, Sugar EA, et al. Randomized phase II study of the safety, efficacy, and immune response of GVAX pancreas vaccine (with cyclophophamide) and CRS-207 with or without nivolumab in patients with previously treated metastatic pancreatic adenocarcinomas (STELLAR). Journal for Immunotherapy of Cancer 2015;3(Suppl 2):155.
Li 2003 {published data only}
    1. Li CP, Chao Y, Chi KH, Chan WK, Teng HC, Lee RC, et al. Concurrent chemoradiotherapy treatment of locally advanced pancreatic cancer: gemcitabine versus 5-fluorouracil, a randomized controlled study. International Journal of Radiation Oncology, Biology, Physics 2003;57(1):98-104. - PubMed
Li 2016 {published data only}
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Linstadt 1988 {published data only}
    1. Linstadt D, Quivey JM, Castro JR, Andejeski Y, Phillips TL, Hannigan J, et al. Comparison of helium-ion radiation therapy and split-course megavoltage irradiation for unresectable adenocarcinoma of the pancreas. Final report of a Northern California Oncology Group randomized prospective clinical trial. Radiology 1988;168(1):261-4. - PubMed
Loehrer 2011 {published data only}
    1. Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, et al. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. Journal of Clinical Oncology 2011;29(31):4105-12. - PMC - PubMed
Lokich 1979 {published data only}
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Lowery 2017 {published data only}
    1. Lowery MA, Harding JJ, Yu KH, Kelsen DP, Bomalaski JS, Glassman DC, et al. Phase IB trial of ADI-PEG 20 (A) plus nab-paclitaxel (nab-P) and gemcitabine (gem) in patients with advanced pancreatic cancer (PC). Journal of Clinical Oncology: American Society of Clinical Oncology 2017;35(4 Suppl 1):295. - PubMed
Lygidakis 1995 {published data only}
    1. Lygidakis NJ, Ziras FA, Kyparidou E, Parissis J, Papadopoulou P, Venetsanou B. Combined immunopharmaceutical therapy of patients with unresectable pancreatic carcinoma. Hepato-gastroenterology 1995;42(6):1039-52. - PubMed
Ma 2019 {published data only}
    1. Ma T, Liang T, Bai X. Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage ii pancreatic cancer: a prospective, randomized, open-label, single center trial. HPB: The Official Journal of the International Hepato Pancreato Biliary Association 2019;21 Suppl 2:S316-7.
Macarulla 2018a {published data only}
    1. Macarulla Mercade T, Bodoky G, Siveke J, Lee KH, Chen J, Mirakhur B, et al. 733P - NAPOLI-1 phase III trial outcomes by prior surgery, and disease stage, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Annals of Oncology 2018;29 Suppl 8:VIII249-250.
Macarulla 2018b {published data only}
    1. Macarulla Mercadé T, Lee K, Lakatos G, Wang-Gillam A, Chen L, Mirakhur B, et al. Selected subgroup analyses of liposomal irinotecan (nal-IRI) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in the global NAPOLI-1 phase III trial. Annals of Oncology 2018;29 Suppl 5:V101.
Macarulla 2020 {published data only}
    1. Macarulla Mercade T, Chen LT, Li CP, Siveke JT, Cunningham D, Bodoky G, et al. Liposomal Irinotecan + 5-FU/LV in Metastatic Pancreatic Cancer: Subgroup Analyses of Patient, Tumor, and Previous Treatment Characteristics in the Pivotal NAPOLI-1 Trial. Pancreas 2020;49(1):62-75. - PMC - PubMed
Maemura 2017 {published data only}
    1. Maemura K, Mataki Y, Kurahara H, Kawasaki Y, Iino S, Sakoda M, et al. Comparison of proton beam radiotherapy and hyper-fractionated accelerated chemoradiotherapy for locally advanced pancreatic cancer. Pancreatology 2017;17(5):833-8. - PubMed
Mallinson 1980 {published data only}
    1. Mallinson CN, Rake MO, Cocking JB, Fox CA, Cwynarski MT, Diffey BL, et al. Chemotherapy in pancreatic cancer: results of a controlled, prospective, randomised, multicentre trial. British Medical Journal 1980;281(6255):1589-91. - PMC - PubMed
Matsumoto 2022 {published data only}
    1. Matsumoto K, Miyamoto A, Kawase T, Murai T, Shibamoto Y. Concurrent high-dose intensity-modulated radiotherapy and chemotherapy for unresectable locally advanced and metastatic pancreatic cancer: a pilot study. Journal of Radiotherapy in Practice 2022;21(2):239-244.
Meyer 2008 {published data only}
    1. Meyer T, Caplin M, Palmer D, Valle JW, Larvin M, Waters J, et al. A phase IB/IIA, multicentre, randomised, double-blind placebo controlled study to evaluate the safety and pharmacokinetics of Z-360 in subjects with unresectable advanced pancreatic cancer in combination with gemcitabine. Journal of Clinical Oncology 2008;26:4636.
Middleton 2014 {published data only}
    1. Middleton G, Silcocks P, Cox T, Valle J, Wadsley J, Propper D, et al. Gemcitabine and capecitabine with or without telomerase peptide vaccine GV1001 in patients with locally advanced or metastatic pancreatic cancer (TeloVac): an open-label, randomised, phase 3 trial. Lancet Oncology 2014;15(8):829-40. - PubMed
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    1. Mizuno N, Yamao K, Komatsu Y, Munakata M, Ishiguro A, Yamaguchi, T, et al. Randomized phase II trial of S-1 versus S-1 plus irinotecan (IRIS) in patients with gemcitabine-refractory pancreatic cancer. Journal of Clinical Oncology 2013;31:263.
Modiano 2012 {published data only}
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Moertel 1981 {published data only}
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Moore 2003 {published data only}
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NCT04571489 {published data only}
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References to ongoing studies

Palmer 2018 {published data only}
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