A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Français du Myélome.
A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Français du Myélome.
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1996
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通讯作者：
M. Attal;J. Harousseau;A. Stoppa;J. Sotto;J. Fuzibet;J. Rossi;P. Casassus;H. Maisonneuve;T. Facon;N. Ifrah;C. Payen;R. Bataille
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作者：
M. Attal;J. Harousseau;A. Stoppa;J. Sotto;J. Fuzibet;J. Rossi;P. Casassus;H. Maisonneuve;T. Facon;N. Ifrah;C. Payen;R. Bataille
背景骨髓瘤患者经常规化疗后的中位生存期为三年或更短。据报道，自体骨髓移植支持的大剂量治疗取得了令人振奋的结果。我们进行了一项随机研究，比较了常规化疗和大剂量治疗。方法将200例初治的65岁以下骨髓瘤患者在确诊时随机分为常规化疗组和大剂量化疗加自体骨髓移植组。结果大剂量组有效率为81%(完全缓解22%，部分缓解16%)，而常规化疗组57%(完全缓解5%，部分缓解9%)(P<；0.001)。大剂量组5年无事件生存概率为28%，常规剂量组为10%(P=0.01)；总的5年生存率估计为52%，常规剂量组为12%(P=0.03)。两组与治疗相关的死亡率相似。结论大剂量联合移植可提高骨髓瘤患者的有效率、无事件存活率和总存活率。
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.