Ji Dongmei, Li Qiu, Cao Junning, Guo Ye, Lv Fangfang, Liu Xiaojian, Wang Biyun, Wang Leiping, Luo Zhiguo, Chang Jianhua, Wu Xianghua, Hong Xiaonan
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, P.R. China.
Department of Medical Oncology, West China Hospital of Medicine, Sichuan University, Chengdu 610041, P.R. China.
Oncotarget. 2016 May 31;7(22):33331-9. doi: 10.18632/oncotarget.8973.
Cyclophosphamide, doxorubicin, vincristine, and prednisolone plus rituximab (R-CHOP) is the standard treatment for patients with diffuse large B cell lymphoma (DLBCL). However, rituximab cannot be popularly applied in a considerable number of patients with DLBCL because of economic reasons. To develop a new regimen to improve the outcome of these patients is extremely important. In our study, sixty five patients with DLBCL were randomly assigned to thalidomide plus CHOP group (n=32) or to CHOP alone group (n=33). Objective response rates (ORR) and complete remission rates (CRR) were 96.7% and 80.6% in T-CHOP group versus 78.9 % and 57.8 % in CHOP group, respectively (P <0.05). At a median follow-up of 96 months, median PFS for T-CHOP group was still not reached yet, and in CHOP group it was 22.9 months (95% CI [0-50.4]). (P=0.163). Median overall survival (OS) for T-CHOP group was also not reached, and the estimated median OS for CHOP group was 83.5 months, the difference of OS between the two groups is not significant (p=0.263). But, in patients with Bcl-2 positive and Bcl-6 negative, the median PFS in T-CHOP group was longer than that in CHOP group (111.0 vs 8.5 months (P=0.017). In addition, thalidomide did not significantly increase the grade 3/4 toxicity of CHOP. We concluded that the addition of thalidomide to the CHOP regimen significantly improved the CRR and showed a trend of improving clinical outcome in patients with DLBCL, especially for patients with Bcl-2 positive and Bcl-6 negative B-cell phenotype, without increased toxicity.
环磷酰胺、多柔比星、长春新碱、泼尼松龙联合利妥昔单抗（R-CHOP）是弥漫性大B细胞淋巴瘤（DLBCL）患者的标准治疗方案。然而，由于经济原因，利妥昔单抗在相当数量的DLBCL患者中无法广泛应用。开发一种新的治疗方案以改善这些患者的治疗效果极为重要。在我们的研究中，65例DLBCL患者被随机分为沙利度胺联合CHOP组（n = 32）或单纯CHOP组（n = 33）。T-CHOP组的客观缓解率（ORR）和完全缓解率（CRR）分别为96.7%和80.6%，而CHOP组分别为78.9%和57.8%（P <0.05）。在中位随访96个月时，T-CHOP组的中位无进展生存期（PFS）仍未达到，CHOP组为22.9个月（95%CI[0 - 50.4]）（P = 0.163）。T-CHOP组的中位总生存期（OS）也未达到，CHOP组的估计中位OS为83.5个月，两组之间的OS差异不显著（p = 0.263）。但是，在Bcl-2阳性且Bcl-6阴性的患者中，T-CHOP组的中位PFS长于CHOP组（111.0对8.5个月，P = 0.017）。此外，沙利度胺并未显著增加CHOP方案的3/4级毒性。我们得出结论，在CHOP方案中添加沙利度胺可显著提高CRR，并显示出改善DLBCL患者临床结局的趋势，尤其是对于Bcl-2阳性且Bcl-6阴性B细胞表型的患者，且未增加毒性。
