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Clinical Trial
. 2020 Mar 30;20(1):259.
doi: 10.1186/s12885-020-06758-9.

Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study

Suayib Yalcin  1   2 , Faysal Dane  3 , Berna Oksuzoglu  4 , Nuriye Yildirim Ozdemir  5 , Abdurrahman Isikdogan  6 , Metin Ozkan  7 , Guzin Gonullu Demirag  8 , Hasan Senol Coskun  9 , Bulent Karabulut  10 , Turkkan Evrensel  11 , Mehmet Ali Ustaoglu  12 , Feyyaz Ozdemir  13 , Hande Turna  14 , Tugba Yavuzsen  15 , Faruk Aykan  16 , Alper Sevinc  17 , Hakan Akbulut  18 , Deniz Yuce  19 , Mutlu Hayran  19 , Saadettin Kilickap  19
Affiliations
Clinical Trial

Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study

Suayib Yalcin et al. BMC Cancer. .

Abstract

Background: Combination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown.

Methods: A total of 125 patients were randomized to combination therapy (1000 mg/m2 gemcitabine + 125 mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000 mg/m2) arms to take treatment weekly for 7 of 8 weeks, and following 3 of 4 weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL.

Results: Overall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p = 0.018). These proportions were 27.3 and 36.6% in 6th month assessments, respectively (p = 0.357). Median overall survivals in combination and single-agent arms were 9.92 months and 5.95 months, respectively (HR: 0.64, 95% CI: 0.42-0.86, p = 0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22 months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p = 0.008). Median time-to-deterioration were 5.36 vs 3.68 months, and objective response rates were 37.1% vs 23.7% (p = 0.009), respectively in combination and single-agent arms.

Conclusions: Combination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer.

Trial registration: This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).

Keywords: Gemcitabine; Metastatic; Nab-paclitaxel; Pancreatic cancer; Quality of life.

PubMed Disclaimer

Conflict of interest statement

SY: Honorarium due to advisory board activity, speaker, bureau activity from Roche, Novartis, Amgen, Gen Ilac, Merck Serono, Pfizer, Lilly, Sanofi, MSD, BMS, Teva, Celgene Abbott, and Bayer.

Figures

Fig. 1
Fig. 1
Overall and progression-free survival
See this image and copyright information in PMC

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