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Veterans Administration Hospital, West Haven, Connecticut 06516 [R. P., L. R. S.], and Yale University School of Medicine, New Haven, Conne ticut 06510 [R. P., D. R. M., S. R., L. R. S., R. L. C.]
Thirty-eight patients with advanced, inoperable squamous cell carcinoma of the head and neck were randomized to receive methotrexate alone or methotrexate with Bacillus Calmette-Guérin. The response rates with methotrexate (3 of 19) and methotrexate plus B. Calmette-Guérin (4 of 16) were similar, as was the duration of response and survival of the two groups. The results of in vitro immunological studies of lymphocytes were assessed. Marked weight loss, poor performance status, and distant metastases were the most important prognostic factors. The presence of anergy was significantly correlated with weight loss. This study also indicated that a large tumor burden is a frequent occurrence in advanced head and neck cancer and may account for the lack of efficacy of B. Calmette-Guérin.
1 This work was supported in part by National Cancer Institute Grants 54583 and CA-09200 and by the Veterans Administration.
2 Postdoctoral Fellow in Oncology.
3 Present address: Saint Francis Hospital, 900 Hyde St., San Francisco, Calif. 94109.
4 Present address: University of North Carolina, Chapel Hill, N. C. 27514.
Received 5/10/78. Accepted 6/27/78.
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