Fra THE LANCET: Although an objective response rate of 3·9–77% has been reported with methotrexate, dependent on the dose and treatment line, methotrexate has not been compared with best supportive ca
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Fra THE LANCET: Although an objective response rate of 3·9–77% has been reported with methotrexate, dependent on the dose and treatment line, methotrexate has not been compared with best supportive care in a randomised trial to study the effects on overall survival in recurrent squamous-cell carcinoma of the head and neck.[10], [26] and [27] In a phase 3 trial comparing methotrexate with platinum-based chemotherapy, overall survival did not differ between treatment groups, supporting activity of methotrexate in advanced disease.28 Additionally, Stewart and colleagues' phase 3 trial10 assessing two dose levels of gefitinib against methotrexate suggested no overall difference between the treatment groups but reported that patients with squamous-cell carcinoma of the head and neck who received methotrexate had a better overall survival than was expected, which is very similar to what we noted. This outcome was not expected at the initiation of the trial, and possibly resulted in more widespread use of methotrexate. Our trial was designed on the basis of the assumption that controls (ie, best supportive care with optional methotrexate) would have a poor median overall survival of 4 months and that those treated with zalutumumab monotherapy (ie, without methotrexate) plus best supportive care would have a longer median overall survival of 6 months (hazard ratio 0·67). Thus, the significance of any overall survival benefit of zalutumumab we could report in this study might have been diminished by the use of methotrexate in most patients in the control group and led to an underestimation of the sample size. Furthermore, after progressive disease, chemotherapy drugs other than methotrexate were more frequently given in the control group (27 [28%] of 95 patients) than in the zalutumumab group (27 [14%] of 191 patients), and these drugs were introduced earlier in the control group (median 79 days vs 170 days).
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