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J. O. Irwin (1935)
Test of Significance for Differences Between Percentages Based on Small Numbers, 12
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Gisplatin and Bleomycin Adjuvant Chemotherapy in Head and Neck Cancer: Results of the Head and Neck Contracts Program, 43
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(1986)
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M. Merlano, R. Rosso, M. R. Sertoli (1988)
Sequential Versus Alternating Chemotherapy and Radiotherapy in Stage III and IV Squamous Cell Carcinoma of the Head and Neck: A Phase III Study, 6
Between August 1983 and December 1986, 116 previously untreated patients with squamous cell carcinoma of the head and neck were randomized to receive induction chemotherapy followed by radiotherapy given in conventional fractions (55 patients, arm A) or an alternating chemotherapy and radiotherapy (3 courses of 20 Gy, 10 daily fractions each; 61 patients, arm B). The same chemotherapy was used in both arms: 6 mg/m2 vinblastine sulfate, hour 0; 30 mg bleomycin, hour 6; 200 mg methotrexate, hours 24 to 26; 45 mg leucovorin, hour 48. Forty‐five patients had stage III disease and 71 had stage IV disease. All patients were evaluated for survival, 112 for toxicity, and 105 for analyses of response and time from the start of treatment until progression of disease. At the end of the combined treatment, we observed an overall response rate of 52% in arm A and an overall response rate of 64.9% in arm B. The incidence of mucositis was more relevant in arm B compared to arm A (P >.00004). The difference in complete response, progression‐free survival, and survival was statistically significant, with an advantage for arm B (P >.03, P >.02, and P >.03, respectively). The analysis at a median follow‐up of 36 months (range = 19 to 59) demonstrates a higher effectiveness for the alternating program.
The Laryngoscope – Wiley
Published: Jan 1, 1990
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