Milpied Noel, Deconinck Eric, Gaillard Fanny, Delwail Vincent, Foussard Charles, Berthou Christian, Gressin Remy, Lucas Virginie, Colombat Philippe, Harousseau Jean-Luc
University Hospital of Nantes, Nantes, France.
N Engl J Med. 2004 Mar 25;350(13):1287-95. doi: 10.1056/NEJMoa031770.
The efficacy of first-line intensive chemotherapy plus transplantation of autologous hematopoietic stem cells in adults with disseminated aggressive lymphoma is unknown.
We compared high-dose therapy plus autologous stem-cell support with the standard regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in a randomized trial. The patients were 15 to 60 years of age, had untreated aggressive lymphoma, and were at low, low intermediate, or high intermediate risk of death (i.e., a maximum of two adverse prognostic factors) according to the age-adjusted International Prognostic Index. The primary outcome was event-free survival at five years.
Of 207 consecutive patients, 197 underwent randomization; 99 were assigned to receive CHOP, and 98 to receive high-dose chemotherapy plus stem-cell transplantation. Overall, 78 percent of the patients completed the assigned treatment; the median follow-up was four years. The estimated event-free survival rate (+/-SD) at five years was significantly higher among patients who received high-dose therapy than among patients who received CHOP (55+/-5 percent vs. 37+/-5 percent, P=0.037). Among patients with a high intermediate risk of death, according to the age-adjusted International Prognostic Index, the five-year survival rate was significantly higher after high-dose therapy than after CHOP (74+/-6 percent vs. 44+/-7 percent, P=0.001).
High-dose chemotherapy with autologous stem-cell support is superior to CHOP in adults with disseminated aggressive lymphoma.
一线强化化疗联合自体造血干细胞移植治疗成人播散性侵袭性淋巴瘤的疗效尚不清楚。
在一项随机试验中，我们比较了高剂量疗法联合自体干细胞支持与环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP）标准方案的疗效。患者年龄在15至60岁之间，患有未经治疗的侵袭性淋巴瘤，根据年龄调整后的国际预后指数，其死亡风险为低、低中或高中（即最多两个不良预后因素）。主要结局是五年无事件生存率。
在207例连续患者中，197例接受了随机分组；99例被分配接受CHOP治疗，98例接受高剂量化疗联合干细胞移植。总体而言，78%的患者完成了指定治疗；中位随访时间为四年。接受高剂量治疗的患者五年无事件生存率（±标准差）显著高于接受CHOP治疗的患者（55±5%对37±5%，P=0.037）。根据年龄调整后的国际预后指数，在死亡高中风险患者中，高剂量治疗后的五年生存率显著高于CHOP治疗后（74±6%对44±7%，P=0.001）。
对于成人播散性侵袭性淋巴瘤患者，高剂量化疗联合自体干细胞支持优于CHOP方案。
