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, 05/03/2011
Clinical Article
Hirao K et al. – 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.
Methods- Patients with advanced pancreatic cancer 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 3-week schedule (gemcitabine at 1000 mg/m² as 30-min infusion weekly for 2 consecutive weeks every 3 weeks)
- Primary endpoint was compliance rate during first 8 weeks between 2 groups
- 90 patients were enrolled.
- Compliance rate during the first 8 weeks was the same (53.3%)
- For 4- and 3-week schedules, tumor response rates 14.2 and 17.1%, median PFS 112 and 114 days, and median OS was 206 and 250 days
- Grade 3–4 neutropenia was major AE in both schedules: 37.7 and 35.5%
- Thrombocytopenia (platelet count <70000/mm³) significantly higher for 4-week schedule: 26.6 and 4.4%
- Mean received dose intensity equal: 588 and 550 mg/m 2 /week
