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Fifty-one patients (32 previously untreated, 19 previously treated) with advanced squamous cell carcinoma of the head and neck received a single course of combination chemotherapy consisting of high dose cis-platinum (DDP), bleomycin (Bleo), +/- high dose methotrexate (MTX). Thirty-three (65%) patients responded to therapy; 5 (10%) of these patients had a complete response. Previously untreated patients and those who received the three drugs (DDP, Bleo and MTX) had the highest response rates. The duration of response was 8 to 12 weeks. Seven (15%) patients showed a two-year survival rate. All nonresponders were dead of disease within two years. Three (56%) of the five complete-response patients and 4 (21%) of the partial-response patients survived for two years. The role of preoperative chemotherapy in head and neck cancer is yet to be conclusively defined.

To evaluate an effective, cell-cycle-specific combination chemotherapy which could be administered on an outpatient basis, COMB of Maryland (Cytoxan, Oncovin, methotrexate and bleomycin) was used in 20 patients with stage IV squamous cell carcinoma of head and neck origin. All patients had unresectable but measurable disease. Nine patients had distant metastases. Prior to this chemotherapy, 15 (75%) patients underwent radiation therapy, 12 (60%) had radical surgery, and 3 (15%) were administered other chemotherapeutic drugs. The distribution of the primary site of tumor was identical to the overall distribution of squamous cell carcinoma of head and neck found in this country. Drug dosages were: Cytoxan 100 mg/m2 p.o. days 1-14, Oncovin 1 mg/m2 IV days 1 and 8, methotrexate 25 mg/m2 IV days 1 and 8, and bleomycin 15 units/m2 IM days 1 and 8. This cycle was repeated every four weeks. Two (10%) patients had complete response and 7 (35%) had partial response, thus giving the total response rate of 9 (45%). Seven (35%) patients had static disease and 4 (20%) had progression of disease. Duration of response was from 8 to 26+ weeks with a median duration of 17+ weeks. Response rate was statistically related to performance status and previous chemotherapy. However, it was not related to age, sex, site of origin, previous radiation therapy, or differentiation of the tumor. Increased survival (P < 0.01) was seen in responders (median 16+ weeks) as compared to nonresponders (9 weeks). Hematologic toxicity was seen in 9 (45%) patients, resulting in one chemotherapy-related death. Overall, this chemotherapy has been well tolerated on an outpatient basis. Although 15 (75%) patients received prior radiation therapy, the results were comparable to those obtained by other, more toxic combination chemotherapeutic regimens.