BMC Cancer (Mar 2020)

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,
  • Faysal Dane,
  • Berna Oksuzoglu,
  • Nuriye Yildirim Ozdemir,
  • Abdurrahman Isikdogan,
  • Metin Ozkan,
  • Guzin Gonullu Demirag,
  • Hasan Senol Coskun,
  • Bulent Karabulut,
  • Turkkan Evrensel,
  • Mehmet Ali Ustaoglu,
  • Feyyaz Ozdemir,
  • Hande Turna,
  • Tugba Yavuzsen,
  • Faruk Aykan,
  • Alper Sevinc,
  • Hakan Akbulut,
  • Deniz Yuce,
  • Mutlu Hayran,
  • Saadettin Kilickap

DOI
https://doi.org/10.1186/s12885-020-06758-9
Journal volume & issue
Vol. 20, no. 1
pp. 1 – 7

Abstract

Read online

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