A 4-week versus a 3-week schedule of gemcitabine monotherapy for advanced pancreatic cancer: A randomized phase II study to evaluate toxicity and dose intensity

Ken Hirao, Hirofumi Kawamoto, Ichiro Sakakihara, Yasuhiro Noma, Naoki Yamamoto, Ryo Harada, Koichiro Tsutsumi, Masakuni Fujii, Hironari Kato, Naoko Kurihara, Osamu Mizuno, Tsuneyoshi Ogawa, Etsuji Ishida, Kazuhide Yamamoto

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6 Citations (Scopus)

Abstract

Background: This randomized phase II study compared the efficacy and toxicity between 4-week and 3-week schedules of gemcitabine monotherapy in advanced pancreatic cancer. Methods: Patients with advanced pancreatic cancer were randomly assigned to either a 4-week schedule (gemcitabine at 1000 mg/m2 as a 30-min infusion weekly for 3 consecutive weeks every 4 weeks) or a 3-week schedule (gemcitabine at 1000 mg/m2 as a 30-min infusion weekly for 2 consecutive weeks every 3 weeks). The primary endpoint was the compliance rate during the first 8 weeks between the two groups. Results: A total of 90 patients were enrolled. The compliance rate during the first 8 weeks was the same (53.3%). For the 4- and 3-week schedules, the tumor response rates were 14.2 and 17.1% (p = 0.92), median progression free survival was 112 and 114 days (p = 0.82), and median overall survival was 206 and 250 days (p = 0.84), respectively. Grade 3-4 neutropenia was the major adverse event in both schedules: 37.7 and 35.5% (p = 0.82). In contrast, thrombocytopenia (platelet count <70000/mm3) was significantly higher for the 4-week schedule: 26.6 and 4.4% (p = 0.008). The mean received dose intensity was equal: 588 and 550 mg/m2/week (p = 0.14). Conclusions: The 3-week schedule of gemcitabine did not improve the compliance rate during 8 weeks compared with the 4-week schedule, but it attained a comparable efficacy with lower toxicity. Further investigation will be needed to introduce it into daily practice. Clinical trial registration number: UMIN ID 974.

Original languageEnglish
Pages (from-to)637-645
Number of pages9
JournalInternational Journal of Clinical Oncology
Volume16
Issue number6
DOIs
Publication statusPublished - Dec 2011

Keywords

  • 3-week schedule
  • 4-week schedule
  • Chemotherapy
  • Dose intensity
  • Gemcitabine
  • Pancreatic cancer

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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    Hirao, K., Kawamoto, H., Sakakihara, I., Noma, Y., Yamamoto, N., Harada, R., Tsutsumi, K., Fujii, M., Kato, H., Kurihara, N., Mizuno, O., Ogawa, T., Ishida, E., & Yamamoto, K. (2011). A 4-week versus a 3-week schedule of gemcitabine monotherapy for advanced pancreatic cancer: A randomized phase II study to evaluate toxicity and dose intensity. International Journal of Clinical Oncology, 16(6), 637-645. https://doi.org/10.1007/s10147-011-0237-z