Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy.

作者: P Rougier , R Bugat , J Y Douillard , S Culine , E Suc

DOI: 10.1200/JCO.1997.15.1.251

关键词: FluorouracilColorectal cancerIrinotecanPerformance statusInternal medicineChemotherapyGastroenterologyPhases of clinical researchMetastasisChemotherapy regimenMedicine

摘要: PURPOSETo assess the efficacy of irinotecan (CPT-11) in treatment advanced colorectal cancer both chemotherapy-naive and pretreated patients.PATIENTS AND METHODSTwo hundred thirteen patients (aged 18 to 75 years) with metastatic cancer, World Health Organization (WHO) performance status or = 3 months were treated CPT-11 350 mg/m2 every weeks. All 178 eligible for analysis had not received more than one prior fluorouracil (5-FU)-based chemotherapy regimen (adjuvant palliative) adequate hematologic, renal, hepatic function.RESULTSPrimary tumor sites colon (71%) rectum (28%). Sixty-six percent > two sites. Ninety-eight undergone previous surgery, 77.5% chemotherapy. Thirty-two achieved on objective response (four complete responses [CRs] 28 partial [PRs]; rate, 18%; 95% c...

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