A randomized phase III study of cisplatin with or without methotrexate for recurrent squamous cell carcinoma of the head and neck. A Northern California oncology group study

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Abstract

Eighty patients with recurrent squamous cell cancer of the head and neck were randomized to cisplatin (80 mg/m2) every 3 weeks or cisplatin plus weekly methotrexate (250 mg/m2) with leucovorin. The overall response rate to cisplatin was 18%, with 10% complete responses. The overall response to the combination was 33% with 18% complete responses (P = 0.11). There was no difference in response duration, time to progression, or survival. There was no difference in renal toxicity between the 2 arms (creatinine > 2 mg/dl in 6% of the patients). There was significantly more leukopenia (64%), thrombocytopenia (18%), anemia (18%), and mucositis (33%) in the combination arm. This combination of two of the best agents for head and neck cancer did not improve response, but resulted in added toxicity. Copyright © 1983 American Cancer Society

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Jacobs, C., Meyers, F., Hendrickson, C., Kohler, M., & Carter, S. (1983). A randomized phase III study of cisplatin with or without methotrexate for recurrent squamous cell carcinoma of the head and neck. A Northern California oncology group study. Cancer, 52(9), 1563–1569. https://doi.org/10.1002/1097-0142(19831101)52:9<1563::AID-CNCR2820520904>3.0.CO;2-R

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