Osby E, Beksac M, Reizenstein P
Anticancer Res. 1986 Sep-Oct;6(5):1145-7.
Sixty-seven patients with stage II and III myeloma were subjected to 3 consecutive prospective phase II studies. Nineteen patients had received melphalan - prednisolone (melphalan group), 17 cyclophosphamide - vincristine - prednisolone (cyclophosphamide group) and 22 alternating combinations of 7 cytostatics and prednisolone (alternating group). Nine patients were unevaluable. The median time until response was achieved was 5, 5 and 3 months respectively. The purpose of the study was to see if combination or alternating combination chemotherapy can delay the appearance of refractoriness. Patients were regarded as refractory after progression, which was defined as advance from stage II to stage III, and, in stage III as an increase of the monoclonal serum protein of more than 25% and/or the monoclonal urine protein of more than 100% despite continued treatment. Refractoriness was not delayed by alternating combination treatment. Thirty per cent of the patients became refractory after 10 months of response in the melphalan group and after 11 months in the cyclophosphamide and the alternating chemotherapy groups. The results remained after stratification for stage.
67例II期和III期骨髓瘤患者接受了3项连续的前瞻性II期研究。19例患者接受了美法仑-泼尼松（美法仑组），17例接受了环磷酰胺-长春新碱-泼尼松（环磷酰胺组），22例接受了7种细胞抑制剂与泼尼松的交替联合方案（交替组）。9例患者无法评估。达到缓解的中位时间分别为5个月、5个月和3个月。本研究的目的是观察联合化疗或交替联合化疗是否能延缓难治性的出现。患者病情进展后被视为难治性，病情进展定义为从II期进展到III期，在III期时，尽管持续治疗，单克隆血清蛋白增加超过25%和/或单克隆尿蛋白增加超过100%。交替联合治疗并未延缓难治性的出现。美法仑组30%的患者在缓解10个月后出现难治性，环磷酰胺组和交替化疗组在缓解11个月后出现难治性。按分期分层后结果依然如此。
