Buechler M, Mukherji B, Chasin W, Nathanson L
Cancer. 1979 Mar;43(3):1095-100. doi: 10.1002/1097-0142(197903)43:3<1095::aid-cncr2820430347>3.0.co;2-p.
Twenty-three patients with advanced recurrent head and neck carcinoma were randomized to receive either high dose methotrexate with calcium leucovorin rescue (HDMTX) or HDMTX in combination with bacilli Calmette Guerin (HDMTX/BCG). An additional eight patients were treated with escalating doses of HDMTX ranging from 1 to 7 g of methotrexate. Of 12 patients receiving HDMTX, one complete response and two partial responses were noted. Of 11 patients in the HDMTX/BCG group, one complete response and two partial responses were observed. Only one partial response was noted in eight patients receiving escalating doses of the drug. Responses were brief and no significant difference in response duration was seen in any particular group. Toxicities in all groups were tolerable. BCG did not improve response rate, median duration of response, or median survival in these patients. Reported experiences with high dose methotrexate have been reviewed and again, responses to "high dose methotrexate" were found to be of brief duration. Despite acceptable toxicity, the brief duration of response and cost of such therapy raises serious question on the usefulness of chemoimmunotherapy utilizing high dose methotrexate with leucovorin rescue and BCG in the management of advanced recurrent carcinomas of the head and neck region.
23例晚期复发性头颈癌患者被随机分为两组，一组接受大剂量甲氨蝶呤联合亚叶酸钙解救治疗（HDMTX），另一组接受大剂量甲氨蝶呤联合卡介苗治疗（HDMTX/BCG）。另外8例患者接受剂量递增的HDMTX治疗，甲氨蝶呤剂量从1克至7克不等。在接受HDMTX治疗的12例患者中，观察到1例完全缓解和2例部分缓解。在HDMTX/BCG组的11例患者中，观察到1例完全缓解和2例部分缓解。在接受剂量递增的该药物治疗的8例患者中，仅观察到1例部分缓解。缓解期短暂，在任何特定组中均未观察到缓解持续时间的显著差异。所有组的毒性均可耐受。卡介苗并未提高这些患者的缓解率、中位缓解持续时间或中位生存期。已对已报道的大剂量甲氨蝶呤治疗经验进行了回顾，再次发现对“大剂量甲氨蝶呤”的反应持续时间短暂。尽管毒性可接受，但缓解期短暂以及该治疗的费用对在头颈区域晚期复发性癌的治疗中使用大剂量甲氨蝶呤联合亚叶酸钙解救和卡介苗进行化学免疫治疗的有效性提出了严重质疑。
