title: Irinotecan plus cisplatin combination against metastatic gastric cancer: phase II study.
abstract: In this phase II study, we aimed to detect efficacy and toxicity of the combination of CPT-11 and cisplatin administered to patients with metastatic gastric carcinoma. On d 1, CPT-11, 100 mg/m2, was administered by intravenous infusion for 90 min, followed by a 2 h infusion of cisplatin, at 70 mg/m2 every 3 wk. Forty-one patients were enrolled into the study. Twenty-eight patients were chemotherapy naive. The total number of chemotherapy cycles administered was 165, and the median number of cycles received was 4 (range, 1-8 cycles). The median follow-up time was 12 mo (range, 4-34 mo). There were 4 complete responses (9.7%) and 14 partial responses (34.2%), which result in a response rate of 43.9% (18 of 41 patients). The median time to progression was 8.0 +/- 0.8 mo with 56% and 13% of patients progression free at 6 and 12 mo, respectively. The median overall survival was 9.0 +/- 1.1 mo, with 68 % and 32% of patients alive at 6 and 12 mo, respectively. Grade 3-4 nausea and vomiting was observed in five patients (12%) and grade 3-4 neutropenia in five patients (12%). Grade 3 infection was observed in only one patient (2%). Grade 2 transient liver dysfunction related to chemotherapy was observed in one patient (2%). Chemotherapy was stopped due to nephrotoxicity in one patient (2%). There was no treatment-related death. In conclusion, administration of CPT-11 and cisplatin in this particular dose every 3 wk is effective and well-tolerated treatment regimen.
authors.affiliation: Medical Oncology, Erciyes University Medical Faculty, Kayseri, Turkey. er@erciyes.edu.tr
authors.forename: Mustafa
authors.initials: M
authors.lastname: Altinbas
authors.forename: Ozlem
authors.initials: O
authors.lastname: Er
authors.forename: Metin
authors.initials: M
authors.lastname: Ozkan
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Solak
authors.forename: H Senol
authors.initials: HS
authors.lastname: Coskun
authors.forename: Can
authors.initials: C
authors.lastname: Kucuk
authors.forename: Sebnem
authors.initials: S
authors.lastname: Gursoy
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin