Journal of Clinical Oncology, Vol 16, 3329-3334, Copyright © 1998 by American Society of Clinical Oncology

ARTICLES

Combination of irinotecan and etoposide for treatment of refractory or relapsed small-cell lung cancer

N Masuda, K Matsui, S Negoro, N Takifuji, K Takeda, T Yana, M Kobayashi, T Hirashima, Y Kusunoki, S Ushijima, I Kawase, T Tada, H Sawaguchi and M Fukuoka
Department of Internal Medicine, Osaka Prefectural Habikino Hospital, Japan.

PURPOSE: To determine the response rate, survival, and toxicity of irinotecan (CPT-11), a topoisomerase I inhibitor, combined with etoposide, a topoisomerase II inhibitor, in refractory or relapsed small-cell lung cancer (SCLC). PATIENTS AND METHODS: Twenty-five patients with refractory or relapsed SCLC were entered onto the trial. All 25 patients had been pretreated with some form of cisplatin-based combination chemotherapy and had also received previous etoposide- or anthracyclinecontaining chemotherapy. The median time off chemotherapy was 6.7 months (range, 0.9 to 23.5). Patients were treated at 4-week intervals using CPT-11 (a starting dose of 70 mg/m2 intravenously on days 1, 8, and 15) plus etoposide (80 mg/m2 intravenously on days 1 to 3), with a subsequent dose based on toxicity. In addition, recombinant human granulocyte colony-stimulating factor (rhG-CSF; 2 microg/kg/d) was given from day 4 to day 21, except on the days of CPT-11 administration. RESULTS: All patients were assessable for toxicity and survival. Twenty-four patients were assessable for response. There were 14 partial responses (PRs) and three complete responses (CRs), for an overall response rate of 71% (95% confidence interval, 53% to 89%). The median response duration was 4.6 months. Median survival was 271 days. Major toxicities were myelosuppression (predominantly leukopenia) and diarrhea. Grade 3 to 4 neutropenia and thrombocytopenia occurred in 56% and 20% of patients, respectively. Grade 3 to 4 diarrhea was observed in 4%. There was one treatment-related death due to severe myelosuppression. CONCLUSION: A combination of CPT-11 and etoposide with rhG-CSF support is an active therapy against refractory or relapsed SCLC and deserves to be studied more extensively in a phase III trial.

This article has been cited by other articles:

				G. R. Simon and A. Turrisi Management of Small Cell Lung Cancer: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition) Chest, September 1, 2007; 132(3_suppl): 324S - 339S. [Abstract] [Full Text] [PDF]

				Y. Ohe, S. Negoro, K. Matsui, K. Nakagawa, T. Sugiura, Y. Takada, Y. Nishiwaki, S. Yokota, M. Kawahara, N. Saijo, et al. Phase I-II study of amrubicin and cisplatin in previously untreated patients with extensive-stage small-cell lung cancer Ann. Onc., March 1, 2005; 16(3): 430 - 436. [Abstract] [Full Text] [PDF]

				G. R. Simon and H. Wagner Small Cell Lung Cancer Chest, January 1, 2003; 123(1_suppl): 259S - 271S. [Abstract] [Full Text] [PDF]

				K. Osterlind Chemotherapy in small cell lung cancer Eur. Respir. J., December 1, 2001; 18(6): 1026 - 1043. [Abstract] [Full Text] [PDF]

				M. L. Rothenberg Irinotecan (CPT-11): Recent Developments and Future Directions-Colorectal Cancer and Beyond Oncologist, February 1, 2001; 6(1): 66 - 80. [Abstract] [Full Text]