Raje N, Powles R, Kulkarni S, Milan S, Middleton G, Singhal S, Mehta J, Millar B, Viner C, Raymond J, Treleaven J, Cunningham D, Gore M
Myeloma Unit, Royal Marsden NHS Trust, Sutton, Surrey.
Br J Haematol. 1997 Apr;97(1):153-60. doi: 10.1046/j.1365-2141.1997.d01-2122.x.
In a sequential nonrandomized study, 204 consecutive unselected patients aged < 70 years received induction chemotherapy with infusional vincristine and adriamycin with oral methyl prednisolone (VAMP: n = 75) or with additional cyclophosphamide, C-VAMP (n = 129). 38/129 C-VAMP patients also received verapamil during induction as part of a controlled trial with the aim to overcome drug resistance. A median of five courses (range 1-11) of chemotherapy were required before maximal response was attained and this was similar in both groups. An over-all response rate of 71% was noted at the end of induction. The complete remission (CR) rate with C-VAMP was 24%, which was significantly higher (P = 0.04) than the CR rate with VAMP alone (8%). The addition of verapamil did not alter the response rate of C-VAMP. Compliance to VAMP was overall 83% and not affected by the addition of cyclophosphamide. The proportion of patients going on to receive high-dose chemotherapy and an autograft was the same for VAMP and C-VAMP treated patients (71%). The median overall survival (OS) and progression-free survival (PFS) for the whole group were 4.4 years and 2.0 years and no difference in outcome was observed between the different treatment groups. Therefore the addition of weekly cyclophosphamide to VAMP induction therapy has significantly improved the response rates of previously untreated myeloma patients. C-VAMP was not more toxic and did not compromise the chances of receiving an autograft. Verapamil was without influence on any parameters in this study.
在一项序贯非随机研究中,204例年龄小于70岁的连续入选患者接受了诱导化疗,其中75例患者接受了静脉输注长春新碱、阿霉素联合口服甲基泼尼松龙(VAMP方案:n = 75),129例患者接受了VAMP方案加用环磷酰胺的C-VAMP方案(n = 129)。129例C-VAMP方案治疗的患者中有38例在诱导化疗期间还接受了维拉帕米,这是一项旨在克服耐药性的对照试验的一部分。在达到最大缓解之前,两组患者所需的化疗疗程中位数均为5个疗程(范围1 - 11个疗程)。诱导化疗结束时总体缓解率为71%。C-VAMP方案的完全缓解(CR)率为24%,显著高于单纯VAMP方案的CR率(8%,P = 0.04)。维拉帕米的加入并未改变C-VAMP方案的缓解率。VAMP方案的总体依从率为83%,不受环磷酰胺加入的影响。接受大剂量化疗和自体移植的VAMP方案和C-VAMP方案治疗患者的比例相同(71%)。整个研究组的中位总生存期(OS)和无进展生存期(PFS)分别为4.4年和2.0年,不同治疗组之间未观察到结局差异。因此,在VAMP诱导治疗中加入每周一次的环磷酰胺显著提高了初治骨髓瘤患者的缓解率。C-VAMP方案毒性并未增加,也未影响接受自体移植的机会。在本研究中,维拉帕米对任何参数均无影响。