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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:Haruhiko Imamoto  Koji Oba  Junichi Sakamoto  Hiroyasu Iishi  Hiroyuki Narahara  Takeyoshi Yumiba  Takashi Morimoto  Masaki Nakamura  Noboru Oriuchi  Chieko Kakutani  Satoshi Morita  Hitoshi Shiozaki
Affiliation:1. Department of Surgery, Kinki University, Osaka, Japan
2. Translational Research and Clinical Trial Center Hokkaido University Hospital, Hokkaido University, Sapporo, Japan
3. Young Leaders?? Program in Health-Care Administration, Department of Social-Life Science, Nagoya University Graduate School of Medicine, 65 Tsurumaicho, Showaku, Nagoya, 466-8550, Japan
4. Department of Internal Medicine, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
5. Department of Clinical Oncology, Hiroshima University, Hiroshima, Japan
6. Department of Surgery, Osaka Kousei Nenkin Hospital, Osaka, Japan
7. Department of Surgery, Yao City Hospital, Yao, Japan
8. Department of Surgery, Wakayama Medical University, Wakayama, Japan
9. Department of Diagnostic Radiology and Nuclear Medicine, Gunma University, Maebashi, Japan
10. EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan
11. Department of Biostatistics, Yokohama City University, Yokohama, Japan
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/m2 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?Conclusion Weekly i.v. paclitaxel is a safe and effective chemotherapeutic regimen based on validated CBR-CG criteria.
Keywords:
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