A phase II trial of weekly fractionated irinotecan and cisplatin for advanced gastric cancer.
OBJECTIVE
This study was to evaluate the activity and the safety of a combination chemotherapy regimen of weekly fractionated irinotecan and cisplatin in advanced gastric cancer patients.


METHODS
Patients with advanced gastric adenocarcinoma with either chemotherapy-naive or only one prior chemotherapy regimen received irinotecan 50 mg/m2 followed by cisplatin 30 mg/m2. Both drugs were administered weekly for 3 consecutive weeks, followed by 1-week rest. Treatment was repeated until disease progression occurred. Response evaluation was performed according to the RECIST criteria.


RESULTS
Forty-seven patients (13 chemo-naive, 34 prior chemotherapy) were enrolled. Of 46 evaluable patients, overall response rate was 25.5% (95% CI, 12.9-39.3%) and disease control rate was 63.8% (95% CI, 50.9-79.5%) by intent-to-treat analysis. The time to progression and overall survival duration were 21 and 44 weeks, respectively. One-year survival rate was 41.6%. The most frequent grade 4 toxicity was neutropenia, which was the major cause of treatment delay. Non-hematological toxicities of grade 3-4 were rare with occurrence rate of 14.9% for anorexia and emesis.


CONCLUSIONS
Fractionated irinotecan combined with cisplatin with 3-week-on and 1-week-off schedule produced favorable clinical results for advanced gastric cancer. Because of the feasible efficacy and low non-hematologic toxicity, this treatment could be a promising salvage regimen in patients who have failed to taxanes.
Jeung
Hei-Cheul
HC
Cancer Metastasis Research Center, Yonsei Cancer Center, Yonsei University College of Medicine, 134, Shinchon-Dong, Seodaemun-Ku, CPO Box #8044, Seoul, 120-752, South Korea.
Rha
Sun Young
SY
Noh
Sung Hoon
SH
Roh
Jae Kyung
JK
Chung
Hyun Cheol
HC
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D016879:Salvage Therapy; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin