Miller T P, Dahlberg S, Cassady J R, Adelstein D J, Spier C M, Grogan T M, LeBlanc M, Carlin S, Chase E, Fisher R I
Arizona Cancer Center, University of Arizona, Tucson, USA.
N Engl J Med. 1998 Jul 2;339(1):21-6. doi: 10.1056/NEJM199807023390104.
Patients with clinically localized, intermediate- or high-grade non-Hodgkin's lymphoma usually receive initial treatment with a doxorubicin-containing regimen such as cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Pilot studies suggest that eight cycles of CHOP alone or three cycles of CHOP followed by involved-field radiotherapy are effective in such patients.
We compared these two approaches in a prospective, randomized, multi-institutional study. The end points were progression-free survival, overall survival, and life-threatening or fatal toxic effects. Two hundred eligible patients were randomly assigned to receive CHOP plus radiotherapy, and 201 received CHOP alone.
Patients treated with three cycles of CHOP plus radiotherapy had significantly better progression-free survival (P=0.03) and overall survival (P=0.02) than patients treated with CHOP alone. The five-year estimates of progression-free survival for patients receiving CHOP plus radiotherapy and for patients receiving CHOP alone were 77 percent and 64 percent, respectively. The five-year estimates of overall survival for patients receiving CHOP plus radiotherapy and for patients receiving CHOP alone were 82 percent and 72 percent, respectively. The adverse effects included one death in each treatment group. Life-threatening toxic effects of any type were seen in 61 of 200 patients treated with CHOP plus radiotherapy and in 80 of 201 patients treated with CHOP alone (P=0.06). The left ventricular function was decreased in seven patients who received CHOP alone, whereas no cardiac events were recorded in the group receiving CHOP plus radiotherapy (P=0.02).
Three cycles of CHOP followed by involved-field radiotherapy are superior to eight cycles of CHOP alone for the treatment of localized intermediate- and high-grade non-Hodgkin's lymphoma.
临床局限性中、高度非霍奇金淋巴瘤患者通常接受含多柔比星的方案进行初始治疗，如环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP方案）。初步研究表明，单纯CHOP方案8个周期或CHOP方案3个周期后行受累野放疗对这类患者有效。
我们在一项前瞻性、随机、多机构研究中比较了这两种方法。终点指标为无进展生存期、总生存期以及危及生命或致命的毒性作用。200例符合条件的患者被随机分配接受CHOP方案加放疗，201例接受单纯CHOP方案。
接受3个周期CHOP方案加放疗的患者，其无进展生存期（P=0.03）和总生存期（P=0.02）显著优于单纯接受CHOP方案的患者。接受CHOP方案加放疗和单纯接受CHOP方案患者的5年无进展生存期估计分别为77%和64%。接受CHOP方案加放疗和单纯接受CHOP方案患者的5年总生存期估计分别为82%和72%。不良反应包括每个治疗组各有1例死亡。接受CHOP方案加放疗的200例患者中有61例出现任何类型的危及生命的毒性作用，接受单纯CHOP方案的201例患者中有80例出现（P=0.06）。单纯接受CHOP方案的7例患者左心室功能下降，而接受CHOP方案加放疗的组未记录到心脏事件（P=0.02）。
对于局限性中、高度非霍奇金淋巴瘤的治疗，3个周期CHOP方案后行受累野放疗优于单纯8个周期CHOP方案。
