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Weekly Irinotecan and Cisplatin in Advanced Non-Small Cell Lung Cancer: A Multicenter Phase II Study

Vanderbilt University, Nashville, Tennessee 37232 [M. H. J., D. H. J., Y. S., D. P. C., R. F. D.]; Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111 [C. J. L.]; Methodist- LeBonheur Health Care, Memphis, Tennessee 38105 [F. Y.]; West Virginia University, Morgantown, West Virginia 26506 [J. S. R.]; Erlanger Medical Center, Chattanooga, Tennessee 37403 [L. L. S.]; and Saint Thomas Hospital, Nashville, Tennessee 37205 [A. G. C.]

The combination of weekly irinotecan (CPT-11) and monthly cisplatin has shown promising activity in advanced non-small cell lung cancer (NSCLC) in previous Phase I and II studies. However, same-day administration of these agents may better exploit their therapeutic synergy and minimize toxicities. This multicenter Phase II study was undertaken to evaluate the efficacy and safety of a combination of weekly CPT-11 and weekly cisplatin in patients with advanced NSCLC. Patients with chemotherapy-naive stage IIIB or IV NSCLC were treated with repeated cycles of therapy comprising weekly treatment with both cisplatin and CPT-11 for 4 weeks, followed by a 2-week rest. The starting doses of CPT-11 and cisplatin were 65 and 30 mg/m², respectively. Treatment was continued until the occurrence of disease progression, unacceptable toxicity, or a maximum of six cycles. Fifty patients were enrolled. The median age was 59 years (range, 44–79 years). Eastern Cooperative Oncology Group performance status was 0 in 22 patients, 1 in 19 patients, and 2 in 9 patients. Seven and 43 patients had stages IIIB and IV disease, respectively. Five patients had brain metastasis. Patients received a median of three 6-week cycles (range, 1–6). The objective response rate was 36% (18 of 50; 95% confidence interval, 24–54%) and included 18 partial responses. Median time to tumor progression was 6.9 months (range, 0.6–15.2). The median survival was 11.6 months (range, 0.16–21.9 months), and the 1-year survival rate was 46%. Grade 3/4 nonhematological toxicities included vomiting (12%) and diarrhea (26%). Grade 3/4 hematological toxicities included anemia (14%), neutropenia (26%), and thrombocytopenia (14%). Relative dose intensities for CPT-11 and cisplatin were 89 and 62%, respectively. Weekly combined administration of CPT-11 and cisplatin achieved a promising overall response rate, median time to tumor progression, and median survival in patients with stage IIIB/IV NSCLC. The regimen was well tolerated, and the planned dose intensity was well maintained. Further evaluation of this combination in NSCLC is warranted.

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				Y. Xu and M. A. Villalona-Calero Irinotecan: mechanisms of tumor resistance and novel strategies for modulating its activity Ann. Onc., December 1, 2002; 13(12): 1841 - 1851. [Abstract] [Full Text] [PDF]