A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer.

• DOI: 10.1200/jco.1992.10.1.16
• Publication Date: 2017-02-23T16:25:09Z
• Authors: M Fukuoka; H Niitani; A Suzuki; M Motomiya; K Hasegawa; Y Nishiwaki; T Kuriyama; Y Ariyoshi; S Negoro; N Masuda
• Keywords: Leukopenia; Camptothecin; Performance status

PURPOSE Camptothecin-11 (CPT-11) is a new semisynthetic derivative of CPT, and has been shown to inhibit DNA topoisomerase I have strong antitumor activity with low toxicity in murine tumors. To evaluate the effectiveness CPT-11 patients non-small-cell lung cancer (NSCLC), phase II study was conducted between April 1989 February 1990. PATIENTS AND METHODS Seventy-three were entered onto study. All had no previous therapy measurable disease. Their median age 67 years (range, 34 75 years). Fifty-four performance status (PS) 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale, 19 PS 2. given at dose 100 mg/m2 by intravenous 90-minute infusion once week. The modified based WBC count obtained day drug administration. RESULTS Of 72 assessable patients, 23 (31.9%) showed partial response (95% confidence interval, 20.2% 43.6%). 40 stage IV disease, 13 (32.5%) responded. Response rates for those 2 did not differ (34.0% 26.3%, respectively). duration showing PR 15 weeks. survival time all 42 major toxicities leukopenia diarrhea. Grade 3 4 diarrhea occurred 18 (25%) (21%), respectively. These unpredictable. Other greater than equal grade included nausea/vomiting (22%), anemia (15%), alopecia (4%) pneumonitis (3%). One patient died pulmonary (interstitial pneumonitis). CONCLUSIONS very active agent NSCLC acceptable toxicities. Further trials combination other agents this disease are warranted.