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

• DOI: 10.1007/s10120-011-0016-6
• Publication Date: 2011-02-16T20:51:45Z
• 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
• Keywords: Adult; Aged, 80 and over; Male; Paclitaxel; Ascites; Middle Aged; Antineoplastic Agents, Phytogenic; 3. Good health; Survival Rate; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Stomach Neoplasms; Disease Progression; Ascitic Fluid; Humans; Female; Treatment Failure; Neoplasm Recurrence, Local; Waist Circumference; Aged

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).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.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.Weekly i.v. paclitaxel is a safe and effective chemotherapeutic regimen based on validated CBR-CG criteria.