一项关于多发性骨髓瘤自体骨髓移植与化疗的前瞻性随机试验。法国骨髓瘤研究组。

A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Français du Myélome.

作者信息

Attal M, Harousseau J L, Stoppa A M, Sotto J J, Fuzibet J G, Rossi J F, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R

机构信息

Department of Hematology, Hôpital Purpan, Toulouse, France.

出版信息

N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.

DOI:10.1056/NEJM199607113350204

PMID:8649495

Abstract

BACKGROUND

The median survival of patients with myeloma after conventional chemotherapy is three years or less. Promising results have been reported with high-dose therapy supported by autologous bone marrow transplantation. We conducted a randomized study comparing conventional chemotherapy and high-dose therapy.

METHODS

Two hundred previously untreated patients under the age of 65 years who had myeloma were randomly assigned at the time of diagnosis to receive either conventional chemotherapy or high-dose therapy and autologous bone marrow transplantation.

RESULTS

The response rate among the patients who received high-dose therapy was 81 percent (including complete responses in 22 percent and very good partial responses in 16 percent), whereas it was 57 percent (complete responses in 5 percent and very good partial responses in 9 percent) in the group treated with conventional chemotherapy (P < 0.001). The probability of event-free survival for five years was 28 percent in the high-dose group and 10 percent in the conventional-dose group (P = 0.01); the overall estimated rate of survival for five years was 52 percent in the high-dose group and 12 percent in the conventional-dose group (P = 0.03). Treatment-related mortality was similar in the two groups.

CONCLUSIONS

High-dose therapy combined with transplantation improves the response rate, eventfree survival, and overall survival in patients with myeloma.

摘要

背景

骨髓瘤患者经传统化疗后的中位生存期为三年或更短。有报道称自体骨髓移植支持的大剂量疗法取得了有前景的结果。我们进行了一项随机研究，比较传统化疗和大剂量疗法。

方法

200名年龄在65岁以下、此前未接受过治疗的骨髓瘤患者在确诊时被随机分配接受传统化疗或大剂量疗法及自体骨髓移植。

结果

接受大剂量疗法的患者的缓解率为81%（包括22%的完全缓解和16%的非常好的部分缓解），而接受传统化疗的组的缓解率为57%（5%的完全缓解和9%的非常好的部分缓解）（P<0.001）。大剂量组五年无事件生存率为28%，传统剂量组为10%（P=0.01）；大剂量组五年总体估计生存率为52%，传统剂量组为12%（P=0.03）。两组的治疗相关死亡率相似。