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Combination chemotherapy with THP, CDDP and 5-FU for squamous cell carcinoma of the head and neck was conducted in 13 institutions in Hyogo Prefecture as a multi-institutional cooperative study. In the initial study (Nov. 1990-Nov. 1993), THP was administered intravenously at 20 mg/m2 on day 1, CDDP at 80 mg/m2 on day 2, and 5-FU at 1,000 mg/body/day in a continuous drip infusion for 120 hours from day 2 to day 6. In the second study (May, 1996-Mar. 1998), THP was administered at 20 mg/m2 on day 1, 5-FU at 10 mg/kg/day from day 1 to day 5, and CDDP at 70 mg/m2 on day 6 in the same way as the initial study. Forty-nine patients (Stage I in 3, Stage II in 12 including 2 recurrent cases, Stage III in 6, Stage IV in 28 including 3 recurrent cases; 1 course chemotherapy in 13 and 2 or more courses in 36) were subjected as complete cases in the initial study, and 36 patients (Stage I in 5 including one recurrent case, Stage II in 11 including 1 recurrent case, Stage III in 9 including 2 recurrent cases, Stage IV in 11 including one recurrent case; 1 course in 18 and 2 or more courses in 18) in the second. The overall response rate was 65.3% (CR in 3 cases) in the initial study and 63.9% (CR in 5 cases) in the second. Primary cases showed a response rate of 65.9% (29/44) in the initial study and 71.0% (22/31) in the second, whereas recurrent cases showed a 60.0% (3/5) response rate in the initial study and a 20.0% (1/5) rate in the second. Treatment-naive patients showed a response rate of 72.7% (24/33) in the initial study and 71.0% (22/31) in the second, whereas previously treated patients showed a 50.0% (8/16) response rate in the initial study and a 20.0% (1/5) rate in the second. Adverse reactions of more than Grade 3 in the initial study were leukopenia in 18.4%, thrombocytopenia in 8.2%, decrease of hemoglobin in 6.1%, loss of hair in 6.1%, anorexia in 36.7%, nausea and vomiting in 26.5%, and diarrhea in 4.1%, whereas those of Grade 3 in the second study were decrease of hemoglobin in 2.8%, anorexia in 22.2% and nausea and vomiting in 8.3%. From these results, it is suggested that the regimen in the second study was more useful than that in the initial study.

The treatment methods and prognosis were discussed in 12 patients of oral melanoma who were treated at Dept. of Oral and Maxillofacial Surgery, Kobe Univ. School of Medicine from 1975 to 1989, with a review of 96 cases published in the Japanese literature between 1984 and 1988, and the following findings were obtained. 1. Eleven our 12 cases were acral lentiginous melanoma (ALM), and one case was nodular melanoma (NM). 2. The early two cases were died of distant metastasis. Of the recent ten cases which were underwent surgical excision combined with adjuvant immunochemotherapy with DTIC, ACNU, VCR and OK-432, nine cases had good prognosis, and one case was died of local recurrence. 3. The prognosis of the reported cases was poor because of local recurrence and distant metastasis.

Eight cases of malignant tumors of the head and neck were treated with NK 631 on a dosage schedule of 10 mg at a time 3 times weekly, by intravenous one-shot injection or intravenous drip infusion, to observe its therapeutic effects and adverse reactions. The treatment was assessed markedly effective in 3, moderately effective in 1 and ineffective in 4 of them. The treatment was also assessed moderately or markedly effective in 3 and ineffective in 2 out of squamous cell carcinoma cases. Hematologic findings, serum electrolytes and enzymologic findings were normal, but the pulmonary function examinations revealed a tendency for PaO2 to decrease slightly. In 1 case where frequent cough was observed, the cough was mitigated on withdrawal of the treatment. The adverse reactions that evolved included fever, alopecia, eruptions, nausea and vomiting, and pigmentation of the nail. To summarize these findings, the authors were impressed with NK 631 and that the agent would exert an excellent antitumor effect, compared with bleomycin, and that its effect would evolve at the early stage of its treatment. Fixed drug eruption was observed as an adverse reaction of this drug in 1 case; however, the adverse reactions of this bleomycin analog appear similar to those of its parent compound, bleomycin.