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 language | English |
|---|---|
| Pages (from-to) | 637-645 |
| Number of pages | 9 |
| Journal | International Journal of Clinical Oncology |
| Volume | 16 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Dec 2011 |
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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 journal › Article
}
TY - JOUR
T1 - A 4-week versus a 3-week schedule of gemcitabine monotherapy for advanced pancreatic cancer
T2 - A randomized phase II study to evaluate toxicity and dose intensity
AU - Hirao, Ken
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
AU - Ogawa, Tsuneyoshi
AU - Ishida, Etsuji
AU - Yamamoto, Kazuhide
PY - 2011/12
Y1 - 2011/12
N2 - 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
AB - 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
KW - 3-week schedule
KW - 4-week schedule
KW - Chemotherapy
KW - Dose intensity
KW - Gemcitabine
KW - Pancreatic cancer
UR - http://www.scopus.com/inward/record.url?scp=84855186532&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84855186532&partnerID=8YFLogxK
U2 - 10.1007/s10147-011-0237-z
DO - 10.1007/s10147-011-0237-z
M3 - Article
VL - 16
SP - 637
EP - 645
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
SN - 1341-9625
IS - 6
ER -