The efficacy of paclitaxel and cisplatin combination chemotherapy for the treatment of metastatic or recurrent gastric cancer: a multicenter phase II study.
BACKGROUND
Although many treatments for advanced gastric cancer have been developed, only poor treatment results have generally been obtained. We performed a prospective study on the combination chemotherapy of paclitaxel and cisplatin (PC). The primary objectives of the study were elucidating the disease response and evaluating the drug regimen's safety.


METHODS
Patients with metastatic or recurrent gastric cancer received intravenous paclitaxel 175 mg/m2, and cisplatin 70 mg/m2 on day 1. This cycle was repeated every 3 weeks.


RESULTS
From January 2000 to March 2004, 37 patients from 3 different hospitals were enrolled in this study. A total of 135 treatment cycles (median: 3 cycles) were administered. The responses were evaluable in 34 patients; 24 patients received this regimen as their first-line treatment for metastatic cancer and the other patients received it as their second-line treatment for recurrent cancer. The objective response rate (RR) was 26.5% (95% CI: 11.7-41.3) with two complete responses, and stable disease was observed in 41.1% of the patients. Importantly, an RR of 33.3% (95% CI: 0.6-66.0) was achieved for the eight patients who received this regimen as a first-line treatment. The median follow up duration was 14 months for all the patients, and the median time to progression was 6 months (95% CI: 1.9-10.2). The overall survival time was 8.9 months (95% CI: 7.0-11.0) with a 1-year survival rate of 18.7% (95% CI: 5.6-31.8). The most common toxicity was neutropenia.


CONCLUSIONS
PC exhibited promising activity against gastric cancer for the previously untreated patients as a first-line treatment with an acceptable toxicity profile.
Shin
Sang Joon
SJ
Division of Oncology-Hematology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Chun
Sung Ho
SH
Kim
Kyeong Ok
KO
Kim
Min Kyoung
MK
Lee
Kyung Hee
KH
Hyun
Myung Soo
MS
Bae
Sung Hwa
SH
Ryoo
Hun Mo
HM
Do
Young Rok
YR
Kwon
Ki Young
KY
Song
Hong Suk
HS
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D002945:Cisplatin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000627:therapeutic use*; D011446:Prospective Studies; D012449:Safety; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel; D002945:Cisplatin