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 Katou, Naoko Kurihara, Osamu Mizuno, Tsuneyoshi Ogawa, Etsuji Ishida, Kazuhide Yamamoto

Research output: Contribution to journalArticle

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

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

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gemcitabine
Pancreatic Neoplasms
Appointments and Schedules
Neutropenia
Platelet Count
Thrombocytopenia
Disease-Free Survival
Survival

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Surgery
  • Hematology

Cite this

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

In: International Journal of Clinical Oncology, Vol. 16, No. 6, 12.2011, p. 637-645.

Research output: Contribution to journalArticle

Hirao, K, Kawamoto, H, Sakakihara, I, Noma, Y, Yamamoto, N, Harada, R, Tsutsumi, K, Fujii, M, Katou, 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, vol. 16, no. 6, pp. 637-645. https://doi.org/10.1007/s10147-011-0237-z
Hirao, Ken ; Kawamoto, Hirofumi ; Sakakihara, Ichiro ; Noma, Yasuhiro ; Yamamoto, Naoki ; Harada, Ryo ; Tsutsumi, Koichiro ; Fujii, Masakuni ; Katou, Hironari ; Kurihara, Naoko ; Mizuno, Osamu ; Ogawa, Tsuneyoshi ; Ishida, Etsuji ; Yamamoto, Kazuhide. / 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. In: International Journal of Clinical Oncology. 2011 ; Vol. 16, No. 6. pp. 637-645.
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AU - Kawamoto, Hirofumi

AU - Sakakihara, Ichiro

AU - Noma, Yasuhiro

AU - Yamamoto, Naoki

AU - Harada, Ryo

AU - Tsutsumi, Koichiro

AU - Fujii, Masakuni

AU - Katou, Hironari

AU - Kurihara, Naoko

AU - Mizuno, Osamu

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