Journal of Clinical Oncology, Vol 15, 251-260, Copyright © 1997 by American Society of Clinical Oncology

ARTICLES

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

P Rougier, R Bugat, JY Douillard, S Culine, E Suc, P Brunet, Y Becouarn, M Ychou, M Marty, JM Extra, J Bonneterre, A Adenis, JF Seitz, G Ganem, M Namer, T Conroy, S Negrier, Y Merrouche, F Burki, M Mousseau, P Herait and M Mahjoubi
Institut Gustave Roussy, Villejuif, France.

PURPOSE: To assess the efficacy of irinotecan (CPT-11) in the treatment of advanced colorectal cancer in both chemotherapy-naive and pretreated patients. PATIENTS AND METHODS: Two hundred thirteen patients (aged 18 to 75 years) with metastatic colorectal cancer, World Health Organization (WHO) performance status < or = 2, and life expectancy > or = 3 months were treated with CPT-11 350 mg/m2 every 3 weeks. All 178 patients eligible for efficacy analysis had not received more than one prior fluorouracil (5-FU)-based chemotherapy regimen (adjuvant or palliative) and had adequate hematologic, renal, and hepatic function. RESULTS: Primary tumor sites were the colon (71%) and rectum (28%). Sixty-six percent of the patients had > or = two metastatic sites. Ninety-eight percent of the patients had undergone previous surgery, and 77.5% had received prior chemotherapy. Thirty-two of 178 eligible patients achieved on objective response (four complete responses [CRs] and 28 partial responses [PRs]; response rate, 18%; 95% confidence interval, 12.6% to 24.4%), 65 were stable, and 59 progressed. The response rate was 17.7% in the pretreated group and 18.8% in the chemotherapy-naive group. Within the former subgroup, response rates of 16.1% were reported in patients who were progressive on prior 5-FU chemotherapy and 19.1% in patients who were progressive off such treatment. The median duration of objective response (9.1 months) and median time to achievement of a response (9.3 weeks) did not differ between chemotherapy-naive and pretreated patients. The most frequent adverse events were neutropenia, which developed in 80% of the patients, delayed diarrhea (87%), alopecia (88%), fatigue (81%), and nausea/vomiting (77%). All these adverse events were manageable. Severe (WHO grade 3 or 4) neutropenia was only observed in 18% of the cycles, leukopenia in 11%, delayed diarrhea in 11%, and nausea and vomiting in 3%. Development of simultaneous grade 3 or 4 neutropenia and delayed diarrhea during 4% of the cycles was the safety issue of greatest concern. CONCLUSION: CPT-11 has definite activity in the treatment of advanced metastatic colorectal cancer both in chemotherapy-naive and in pretreated patients who experienced disease progression on 5-FU, which suggests a lack of cross-resistance between CPT-11 and 5-FU. Diarrhea and neutropenia, the major toxicities of CPT-11, contribute to the risk to develop febrile neutropenic sepsis.
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				W. Scheithauer, G. V. Kornek, M. Raderer, J. Valencak, G. Weinlander, M. Hejna, K. Haider, W. Kwasny, and D. Depisch Combined Irinotecan and Oxaliplatin Plus Granulocyte Colony-Stimulating Factor in Patients With Advanced Fluoropyrimidine/Leucovorin-Pretreated Colorectal Cancer J. Clin. Oncol., March 1, 1999; 17(3): 902 - 902. [Abstract] [Full Text] [PDF]

				U. Vanhoefer, A. Harstrick, C.-H. Kohne, W. Achterrath, Y. M. Rustum, S. Seeber, and H. Wilke Phase I Study of a Weekly Schedule of Irinotecan, High-Dose Leucovorin, and Infusional Fluorouracil as First-Line Chemotherapy in Patients With Advanced Colorectal Cancer J. Clin. Oncol., March 1, 1999; 17(3): 907 - 907. [Abstract] [Full Text] [PDF]

				C. M. Whitacre, E. Zborowska, J. K. V. Willson, and N. A. Berger Detection of Poly(ADP-ribose) Polymerase Cleavage in Response to Treatment with Topoisomerase I Inhibitors: A Potential Surrogate End Point to Assess Treatment Effectiveness Clin. Cancer Res., March 1, 1999; 5(3): 665 - 672. [Abstract] [Full Text] [PDF]

				J. A. Skirvin and V. Relias Review : Topoisomerase I inhibitors: 2. Irinotecan Journal of Oncology Pharmacy Practice, June 1, 1998; 4(2): 103 - 116. [Abstract] [PDF]

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