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Clinical Trial
. 2023 Jan;34(1):91-100.
doi: 10.1016/j.annonc.2022.09.161. Epub 2022 Oct 7.

Perioperative or only adjuvant gemcitabine plus nab-paclitaxel for resectable pancreatic cancer (NEONAX)-a randomized phase II trial of the AIO pancreatic cancer group

T Seufferlein  1 , W Uhl  2 , M Kornmann  3 , H Algül  4 , H Friess  5 , A König  6 , M Ghadimi  7 , E Gallmeier  8 , D K Bartsch  9 , M P Lutz  10 , R Metzger  11 , K Wille  12 , B Gerdes  13 , C C Schimanski  14 , F Graupe  15 , V Kunzmann  16 , I Klein  17 , M Geissler  18 , L Staib  19 , D Waldschmidt  20 , C Bruns  21 , U Wittel  22 , S Fichtner-Feigl  22 , S Daum  23 , A Hinke  24 , L Blome  25 , A Tannapfel  26 , A Kleger  27 , A W Berger  27 , A M R Kestler  27 , J S Schuhbaur  27 , L Perkhofer  27 , M Tempero  28 , A C Reinacher-Schick  29 , T J Ettrich  27
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Free article
Clinical Trial

Perioperative or only adjuvant gemcitabine plus nab-paclitaxel for resectable pancreatic cancer (NEONAX)-a randomized phase II trial of the AIO pancreatic cancer group

T Seufferlein et al. Ann Oncol. 2023 Jan.
Free article

Abstract

Background: Data on perioperative chemotherapy in resectable pancreatic ductal adenocarcinoma (rPDAC) are limited. NEONAX examined perioperative or adjuvant chemotherapy with gemcitabine plus nab-paclitaxel in rPDAC (National Comprehensive Cancer Network criteria).

Patients and methods: NEONAX is a prospective, randomized phase II trial with two independent experimental arms. One hundred twenty-seven rPDAC patients in 22 German centers were randomized 1 : 1 to perioperative (two pre-operative and four post-operative cycles, arm A) or adjuvant (six cycles, arm B) gemcitabine (1000 mg/m2) and nab-paclitaxel (125 mg/m2) on days 1, 8 and 15 of a 28-day cycle.

Results: The primary endpoint was disease-free survival (DFS) at 18 months in the modified intention-to-treat (ITT) population [R0/R1-resected patients who started neoadjuvant chemotherapy (CTX) (A) or adjuvant CTX (B)]. The pre-defined DFS rate of 55% at 18 months was not reached in both arms [A: 33.3% (95% confidence interval [CI] 18.5% to 48.1%), B: 41.4% (95% CI 20.7% to 62.0%)]. Ninety percent of patients in arm A completed neoadjuvant treatment, and 42% of patients in arm B started adjuvant chemotherapy. R0 resection rate was 88% (arm A) and 67% (arm B), respectively. Median overall survival (mOS) (ITT population) as a secondary endpoint was 25.5 months (95% CI 19.7-29.7 months) in arm A and 16.7 months (95% CI 11.6-22.2 months) in the upfront surgery arm. This difference corresponds to a median DFS (mDFS) (ITT) of 11.5 months (95% CI 8.8-14.5 months) in arm A and 5.9 months (95% CI 3.6-11.5 months) in arm B. Treatment was safe and well tolerable in both arms.

Conclusions: The primary endpoint, DFS rate of 55% at 18 months (mITT population), was not reached in either arm of the trial and numerically favored the upfront surgery arm B. mOS (ITT population), a secondary endpoint, numerically favored the neoadjuvant arm A [25.5 months (95% CI 19.7-29.7months); arm B 16.7 months (95% CI 11.6-22.2 months)]. There was a difference in chemotherapy exposure with 90% of patients in arm A completing pre-operative chemotherapy and 58% of patients starting adjuvant chemotherapy in arm B. Neoadjuvant/perioperative treatment is a novel option for patients with resectable PDAC. However, the optimal treatment regimen has yet to be defined. The trial is registered with ClinicalTrials.gov (NCT02047513) and the European Clinical Trials Database (EudraCT 2013-005559-34).

Keywords: gemcitabine plus nab-paclitaxel; neoadjuvant treatment; perioperative treatment; resectable pancreatic cancer.

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Conflict of interest statement

Disclosure Reported grants and personal fees: TS: Amgen, AstraZeneca, Bayer, BMS, Falk Foundation, Pierre Fabre, Servier, Boehringer Ingelheim, Cantargia AB, Sanofi, Merck Serono; Roche; HA: AstraZeneca, MSD, Servier, Seattle Genetics, Chugai Pharma; HF: Bayer, Merck, Pfizer, Mylan; AK: Ipsen, Pierre Fabre, Roche, CCS: Merck; MG: Amgen, Lilly, Merck; DW: AstraZeneca, Bayer, BMS, Eisai, Falk Pharma, Incyte, Roche, Ipsen; AT: Amgen, Falk Pharma, Merck, Pfizer; LP: AstraZeneca, Servier; MT: CPRIT, Novartis, Abbvie, Advance Medical/Teladoc Health, AstraZeneca, BMS, EcoR1 Capital, Eisai, Elicio Therapeutics, FibroGen, GlaxoSmithKline, Immunovia, Ipsen, Karyopharm Therapeutics, Merck, Pharmacyclics, Swedish Orphan Biovitrum, Ono Pharmaceutical, BIOPHARM, GlaxoSmithKline, Pharmacyte Biotech, Tocagen; ACR: Amgen, AstraZeneca, BMS, MCI Group, Merck Serono, MSD, Roche, Pierre Fabre, Roche, Alexion Pharmaceuticals, BioNTech, Rafael Pharmaceuticals, Servier; TJE: AstraZeneca, Bayer, BMS, Daiichi Sankyo, Eisai, Incyte, Ipsen, Lilly, Merck Serono, MSD, Pierre Fabre, Roche, Sanofi, Servier. All other authors have declared no conflicts of interest.

Comment in

  • The NEONAX study.
    Büchler MW, Neoptolemos JP. Büchler MW, et al. Ann Oncol. 2023 Apr;34(4):442-443. doi: 10.1016/j.annonc.2023.01.003. Epub 2023 Jan 19. Ann Oncol. 2023. PMID: 36681300 No abstract available.

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