Jung Sung-Hoon, Lee Je-Jung, Kim Won Seog, Lee Won-Sik, Do Young Rok, Oh Sung Yong, Kim Min Kyoung, Mun Yeung-Chul, Shin Ho-Jin, Kwak Jae-Yong, Kang Hye Jin, Won Jong Ho, Kwon Jung Hye, Park Eunkyung, Suh Cheolwon, Yang Deok-Hwan
Department of Hemato-Oncology, Chonnam National University Hwasun Hospital, Jeollanam-do, Korea.
Department of Hemato-Oncology, Samsung Medical Center, Seoul, Korea.
Eur J Haematol. 2015 Jun;94(6):504-10. doi: 10.1111/ejh.12459. Epub 2014 Nov 21.
This study aimed to determine the objective response, toxicity, and clinical outcome of weekly rituximab consolidation after four cycles of R-CHOP21 in very elderly patients with DLBCL. A prospective, multi-institutional phase II trial was conducted on patients with previously untreated CD20(+) DLBCL who were older than 70 yr. Patients were treated with four cycles of R-CHOP21 followed by weekly consolidation with rituximab (375 mg/m(2) , four times infusion) (NCT01181999). We also compared the clinical outcomes with an historical case-matched control group treated conventionally with six cycles of R-CHOP21. A total of 51 patients with newly diagnosed DLBCL were enrolled at 15 institutes between June 2010 and September 2013. The median age was 76 yr (range: 70-89). Forty-one of the 51 patients completed the planned rituximab consolidation (R-consolidation). The overall response rate was 78.4%, comprising 74.5% with a complete response and 3.9% with a partial response. After a median follow-up of 20.3 months, 2-yr progression-free survival and overall survival were 63.9% and 68.7%, respectively. No serious toxicities were reported during rituximab consolidation. Weekly rituximab consolidation following four cycles of R-CHOP21 resulted in an acceptable response with high tolerability and could be a good compromise between efficacy and safety for elderly patients with DLBCL.
本研究旨在确定在接受4个周期R-CHOP21治疗后的高龄弥漫性大B细胞淋巴瘤（DLBCL）患者中，每周使用利妥昔单抗巩固治疗的客观缓解率、毒性及临床结局。对年龄大于70岁、既往未经治疗的CD20(+) DLBCL患者进行了一项前瞻性、多机构的II期试验。患者接受4个周期的R-CHOP21治疗，随后每周使用利妥昔单抗（375 mg/m²，静脉滴注4次）进行巩固治疗（NCT01181999）。我们还将临床结局与接受6个周期R-CHOP21传统治疗的历史病例匹配对照组进行了比较。2010年6月至2013年9月期间，共有51例新诊断的DLBCL患者在15家机构入组。中位年龄为76岁（范围：70 - 89岁）。51例患者中有41例完成了计划的利妥昔单抗巩固治疗（R巩固治疗）。总缓解率为78.4%，其中完全缓解率为74.5%，部分缓解率为3.9%。中位随访20.3个月后，2年无进展生存率和总生存率分别为63.9%和68.7%。利妥昔单抗巩固治疗期间未报告严重毒性反应。4个周期R-CHOP21治疗后每周使用利妥昔单抗巩固治疗可获得可接受的缓解率，耐受性高，对于老年DLBCL患者而言，可能是疗效与安全性之间的良好折衷方案。
