A phase II study of irinotecan and docetaxel combination chemotherapy for patients with previously treated metastatic or recurrent advanced gastric cancer.
OBJECTIVE
Irinotecan (I) and docetaxel (D), each of which has a unique mechanism of action, were recently introduced in the treatment of patients with advanced gastric cancer (AGC). We have evaluated the efficacy and safety of the ID combination for AGC patients after failure of fluoropyrimidine- or platinum-based chemotherapy.


METHODS
Patients with relapsed or progressive AGC after prior fluoropyrimidine- or platinum-based chemotherapy were treated with I (160 mg/m(2), 90 min) followed by D (65 mg/m(2), 1 h) every 3 weeks. Because of the unacceptable toxicity among the first ten patients, the doses were reduced for I (120 mg/m(2)) and D (50 mg/m(2)) every 3 weeks.


RESULTS
Forty-nine patients, of median age 53 years (range, 27-68 years), were treated with 170 cycles of chemotherapy (median, 2 cycles; range, 1-12 cycles). Three patients achieved complete response and seven achieved partial response, resulting in an overall response rate (ORR) of 20.4% [95% confidence interval (CI), 9.1-31.7%], with a median duration of 7.1 months (range: 2.1-69.1 months). ORR was 60% (95% CI, 29.6-90.3%) for the higher dose and 10.3% (95% CI, 0.7-19.8%) for the lower dose. Median time to progression for all patients was 2.7 months (95% CI, 1.7-3.8 months) and the median overall survival was 8.9 months (95% CI, 6.6-11.3 months). Grade 3/4 toxicities included neutropenia (90%), febrile neutropenia (50%), asthenia (40%), and diarrhea (10%) with the higher dose and neutropenia (71%), febrile neutropenia (11%), diarrhea (24%), and asthenia (24%) with the lower dose. There were two possible treatment-related deaths.


CONCLUSIONS
The combination of irinotecan and docetaxel, once every three weeks shows anti-tumor activity but is not feasible as a second-line treatment for AGC patients after failure of fluoropyrimidine- or platinum-based chemotherapy due to the high rate of toxicities.
Sym
Sun Jin
SJ
Department of Medicine, Division of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Songpa Gu, Seoul, South Korea.
Chang
Heung Moon
HM
Kang
Hye Jin
HJ
Lee
Sung Sook
SS
Ryu
Min-Hee
MH
Lee
Jae-Lyun
JL
Kim
Tae-Won
TW
Yook
Jeong Hwan
JH
Oh
Sung Tae
ST
Kim
Byung Sik
BS
Kang
Yoon-Koo
YK
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001247:Asthenia / Q000139:chemically induced; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin