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- Title
Assessing clinical benefit response in the treatment of gastric malignant ascites with non-measurable lesions: a multicenter phase II trial of paclitaxel for malignant ascites secondary to advanced/recurrent gastric cancer.
- Authors
Imamoto, Haruhiko; Oba, Koji; Sakamoto, Junichi; Iishi, Hiroyasu; Narahara, Hiroyuki; Yumiba, Takeyoshi; Morimoto, Takashi; Nakamura, Masaki; Oriuchi, Noboru; Kakutani, Chieko; Morita, Satoshi; Shiozaki, Hitoshi
- Abstract
Background: Paclitaxel has shown promise against advanced gastric cancer and associated malignant ascites with non-measurable lesions. In order to evaluate the therapeutic effect of paclitaxel against malignant gastric ascites, a prospective phase II clinical trial was designed according to our previously proposed criteria represented by the clinical benefit response in gastric cancer (CBR-GC) criteria and the five-point method (5PM). Methods: Patients with advanced gastric cancer with malignant ascites were treated with 1-h intravenous (i.v.) infusions of 80 mg/m of paclitaxel weekly over a 3-week cycle on days 1, 8, and 15, followed by 1 week of rest. Therapeutic responses were measured according to the CBR-GC criteria and the 5PM. Results: The CBR-GC criteria showed improved ascites volume and functional status in 39.1% of patients. A positive CBR-GC response in abdominal girth was seen in 31.3% of patients, and this was significantly correlated with the 5PM-estimated change in ascites volume ( p < 0.001). The median number of treatment cycles was 3 (range 1-12). The most common non-hematological toxicity was anorexia, in 22.2% of patients. Conclusion: Weekly i.v. paclitaxel is a safe and effective chemotherapeutic regimen based on validated CBR-CG criteria.
- Subjects
STOMACH cancer; CLINICAL trials; PACLITAXEL; CANCER treatment; ANTINEOPLASTIC agents
- Publication
Gastric Cancer, 2011, Vol 14, Issue 1, p81
- ISSN
1436-3291
- Publication type
Article
- DOI
10.1007/s10120-011-0016-6