Effect of Paclitaxol, Cisplatin, and 5-Flurouracil Chemotherapy in Advanced Stomach Cancer

Kim, Yeul Hong; Shin, Sang Won; Kim, Byung Soo; Kim, Jin Ho; Kim, Jong Kuk; Mok, Young Jae; Kim, Jong Suk; Song, Chi Wook; Ryu, Ho Sang; Kim, Jun Suk; Hyun, Jin Hai

Abstract

PURPOSE: Paclitaxel has not been used widely in gastrointestinal cancers. However, a recent phase II report of paclitaxel in patients with esophageal adenocarcinoma has suggested a possible role of paclitaxel for the treatment of advanced gastric carcinoma. A phase II trial was initiated to determine the clinical utility of a 3 drug combination (paclitaxel, cisplatin, and 5-fluorouracil) in patients with advanced gastric carcinoma.
MATERIALS AND METHODS
Eligibility included biopsy-proven inoperable or relapsed adenocarcinoma of the stomach with adequate bone marrow, hepatic, and renal function. Patients received paclitaxel at 175 mg/m2 (3 hour infusion) on day 1 followed by cisplatin at 20 mg/m2/day infusion and 5-fluorouracil at 750 mg/m2/day continuous infusion for 5 days. Treatment has been repeated in every 4 weeks. Total 31 patients were enrolled; 7 had relapsed disease after resection and 5-fluorouracil based adjuvant chemotherapy, 5 had previous chemotherapy. Twenty-one patients had measurable disease and 9 were evaluable. Demographics included; median age, 47 years (range, 27~64 years); male: female, 21: 10; median performance status 2 (range, 0~4).
RESULTS
Major responses occurred in 16/30 (53%; 95% confidence interval, 35~71%) patients (2 complete responses, 14 partial responses); 13 of 21 (61.9%) patients with measurable disease and 3 of 9 (33%) evaluable patients. Median response duration was 17 weeks (range, 8~44+ weeks) and median time to progression was 20 weeks (range, 8~51+ weeks). Median survival was 27 weeks (range, 8~72+ weeks). WHO grade 3~4 toxicities included: neutropenia (61.9%), nausea/vomiting (23.8%), mucositis (19%), and diarrhea (9.5%). Grade 2~3 neurotoxicity, fluid retention syndrome, hypersensitive reaction had occurred in 6, 2, and 1 patients, respectively. There was 1 instance of treatment-related death due to sepsis.
CONCLUSION
This regimen was highly active in advanced gastric carcinoma and had moderate toxicity. However, the response duration was short like other regimens. Considering poor performance status of our patients, this regimen may have strong potential in the neoadjuvant setting.