A phase II study of a combined biweekly irinotecan and monthly cisplatin treatment for metastatic or recurrent gastric cancer.
BACKGROUND
There is no universally confirmed standard chemotherapeutic regimen for advanced gastric cancer (AGC). The aim of this study was to investigate the efficacy and safety of combined biweekly irinotecan and monthly cisplatin treatments of patients with AGC. The primary end point was progression-free survival.


METHODS
AGC patients with or without measurable lesions received 70 mg/m2 irinotecan on days 1 and 15, and 80 mg/m2 cisplatin on day 1 every 4 weeks.


RESULTS
Of 40 enrolled patients, 21 patients had measurable disease. With a median follow-up duration of 35 weeks, the median progression-free survival and overall survival were 2.2 months and 8.0 months, respectively. The progression-free survival rate at 6 months was 30.0%. The most common adverse event of grade 3 to 4 was neutropenia (32.5%). Grade 3 diarrhea was observed in 2 patients (5.0%). There was no treatment-related death.


CONCLUSIONS
Current combined biweekly irinotecan and monthly cisplatin treatment did not show activity comparable with other active regimens in AGC.
Im
Chong Kun
CK
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Rha
Sun Young
SY
Jeung
Hei-Cheul
HC
Ahn
Joong Bae
JB
Shin
Sang Joon
SJ
Noh
Sung Hoon
SH
Roh
Jae Kyung
JK
Chung
Hyun Cheol
HC
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin