Department of Hematology and Oncology, Tokai University School of Medicine, Kanagawa, Japan.
Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Aichi, Japan.
Blood Adv. 2021 Feb 23;5(4):984-993. doi: 10.1182/bloodadvances.2020002567.
Rituximab plus cyclophosphamide-doxorubicin-vincristine-prednisone (R-CHOP) is the standard of care for untreated diffuse large B-cell lymphoma (DLBCL). However, the schedule for rituximab administration has not been optimized. To compare standard R-CHOP with CHOP plus dose-dense weekly rituximab (RW-CHOP) in patients with untreated DLBCL, we conducted a phase 2/3 study (JCOG0601, jRCTs031180139). Patients were randomly assigned to R-CHOP (CHOP-21 with 8 doses of rituximab once every 3 weeks [375 mg/m2]) or RW-CHOP (CHOP-21 with 8 doses of weekly rituximab [375 mg/m2]) groups. The primary end point of the phase 2 component was percent complete response (%CR) of the RW-CHOP arm, whereas that of the phase 3 component was progression-free survival (PFS). Between December 2007 and December 2014, 421 untreated patients were randomly assigned to R-CHOP (213 patients) or RW-CHOP (208 patients). The %CR in the RW-CHOP arm was 85.3% and therefore met the prespecified decision criteria for the phase 2 component. With a median follow-up of 63.4 months, the 3-year PFS and overall survival were 79.2% and 88.7% in the R-CHOP arm and 80.3% and 90.4% in the RW-CHOP arm, respectively. There was no significant difference in PFS (hazard ratio, 0.95; 90.6% confidence interval, 0.68-1.31). Although the safety profile and efficacy of RW-CHOP was comparable with R-CHOP and its tolerability was acceptable, weekly rituximab in combination with CHOP during the early treatment period did not improve PFS in untreated patients with DLBCL. This trial was registered at jrct.niph.go.jp as #jRCTs031180139.
利妥昔单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松（R-CHOP）是未经治疗的弥漫性大 B 细胞淋巴瘤（DLBCL）的标准治疗方法。然而，利妥昔单抗的给药方案尚未得到优化。为了比较未经治疗的 DLBCL 患者中标准的 R-CHOP 与 CHOP 加密集每周利妥昔单抗（RW-CHOP），我们进行了一项 2/3 期研究（JCOG0601，jRCTs031180139）。患者被随机分配到 R-CHOP（CHOP-21 方案，每 3 周给予 8 剂利妥昔单抗，每次 375mg/m2）或 RW-CHOP（CHOP-21 方案，每周给予 8 剂利妥昔单抗，每次 375mg/m2）组。2 期部分的主要终点是 RW-CHOP 臂的完全缓解率（%CR），而 3 期部分的主要终点是无进展生存期（PFS）。2007 年 12 月至 2014 年 12 月，421 例未经治疗的患者被随机分配到 R-CHOP（213 例）或 RW-CHOP（208 例）组。RW-CHOP 臂的%CR 为 85.3%，因此达到了 2 期部分的预定决策标准。中位随访 63.4 个月后，R-CHOP 臂的 3 年 PFS 和总生存率分别为 79.2%和 88.7%，RW-CHOP 臂分别为 80.3%和 90.4%。PFS 无显著差异（风险比，0.95；90.6%置信区间，0.68-1.31）。尽管 RW-CHOP 的安全性和疗效与 R-CHOP 相当，且其耐受性可接受，但在早期治疗期间，每周利妥昔单抗联合 CHOP 并未改善未经治疗的 DLBCL 患者的 PFS。该试验在 jrct.niph.go.jp 注册，编号为#jRCTs031180139。
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