有棘細胞癌および悪性黒色腫に対する塩酸イリノテカン (CPT-11) の後期第II相臨床試験

A late phase II study of CPT-11 was conducted to evaluate for antitumor activity and safety in patient with squamous cell carcinoma of skin (SCC) and malignant melanoma (MM) by 22 multi-institutional study group in Japan. Forty-two patients in SCC and 38 in MM were enrolled from June 1990 to November 1992. Patients were administered at a dose of 100 mg/m2 weekly by intravenous infusion.The characteristics of 41 eligible patients with SCC were median age: 67 yr. (43-86), male/female: 31/10, P.S. 0-1/2-3: 35/6, no prior therapy: 27. Thirteen patients including 2 complete responses (CRs) responded to CPT-11. The response rate was 39.4% (13/33) . Two CRs were confirmed histologically. Out of 11 partial responses (PRs) 7 was able to resect completely tumor site after the treatment. Antitumor activity was observed not only in primary site but also in distant metastases such as lungs and lymph nodes.The characteristics of 35 eligible patients with MM were median age: 55yr. (29-81), male/female: 20/15, P.S. 0-1/2-3: 32/3, prior therapy: 30 (chemotherapy 26) . Three patients were achieved PR for a response rate of 9.4% (3/32) . Out of them 2 were recurrence patients with lung metastases, having received prior chemotherapy, DAV.Major adverse reactions were nausea/vomiting, diarrhea, anorexia, leukopenia and anemia for the incidence (≥ grade 2) of 47.4% (36/76), 36.8% (28/76) and 52.6% (40/76), 56.6% (43/76) and 26.3% (20/76), respectively. These adverse reactions were well tolerable and reversible. It was thought that CPT-11 should be given carefully after confirming laboratory data and patients conditions.Inconclusion, CPT-11 is very effective against SCC, but less effective against MM in this study. Further clinical studies of CPT-11 combined with other agents are warranted.