Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, Sonneveld P, Gisselbrecht C, Cahn J Y, Harousseau J L
Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
N Engl J Med. 1995 Dec 7;333(23):1540-5. doi: 10.1056/NEJM199512073332305.
High-dose chemotherapy followed by autologous bone marrow transplantation is a therapeutic option for patients with chemotherapy-sensitive non-Hodgkin's lymphoma who have relapses. In this report we describe a prospective randomized study of such treatment.
A total of 215 patients with relapses of non-Hodgkin's lymphoma were treated between July 1987 and June 1994. All patients received two courses of conventional chemotherapy. The 109 patients who had a response to chemotherapy were randomly assigned to receive four courses of chemotherapy plus radiotherapy (54 patients) or radiotherapy plus intensive chemotherapy and autologous bone marrow transplantation (55 patients).
The overall rate of response to conventional chemotherapy was 58 percent; among patients with relapses after chemotherapy, the response rate was 64 percent, and among those with relapses during chemotherapy, the response rate was 21 percent. There were three deaths from toxic effects among the patients in the transplantation group, and none among those in the group receiving chemotherapy without transplantation. The two groups did not differ in terms of prognostic factors. The median follow-up time was 63 months. The response rate was 84 percent after bone marrow transplantation and 44 percent after chemotherapy without transplantation. At five years, the rate of event-free survival was 46 percent in the transplantation group and 12 percent in the group receiving chemotherapy without transplantation (P = 0.001), and the rate of overall survival was 53 and 32 percent, respectively (P = 0.038).
As compared with conventional chemotherapy, treatment with high-dose chemotherapy and autologous bone marrow transplantation increases event-free and overall survival in patients with chemotherapy-sensitive non-Hodgkin's lymphoma in relapse.
大剂量化疗后进行自体骨髓移植是化疗敏感的复发性非霍奇金淋巴瘤患者的一种治疗选择。在本报告中,我们描述了一项关于这种治疗的前瞻性随机研究。
1987年7月至1994年6月期间,共治疗了215例复发性非霍奇金淋巴瘤患者。所有患者均接受了两个疗程的传统化疗。对化疗有反应的109例患者被随机分配接受四个疗程的化疗加放疗(54例患者)或放疗加强化化疗及自体骨髓移植(55例患者)。
传统化疗的总体缓解率为58%;化疗后复发的患者中,缓解率为64%,化疗期间复发的患者中,缓解率为21%。移植组有3例患者死于毒性作用,未进行移植的化疗组无死亡病例。两组在预后因素方面无差异。中位随访时间为63个月。骨髓移植后的缓解率为84%,未进行移植的化疗后的缓解率为44%。五年时,移植组的无事件生存率为46%,未进行移植的化疗组为12%(P = 0.001),总生存率分别为53%和32%(P = 0.038)。
与传统化疗相比,大剂量化疗及自体骨髓移植治疗可提高化疗敏感的复发性非霍奇金淋巴瘤患者的无事件生存率和总生存率。