Prognostic impact of RDI of vincristine in patients with DLBCL receiving R-CHOP: a supplementary analysis of JCOG0601

Blood Neoplasia Pub Date : 2025-02-16 DOI:10.1016/j.bneo.2025.100077

Takahiro Nakashima , Tomotaka Suzuki , Ryunosuke Machida , Kazuyuki Shimada , Tsutomu Kobayashi , Dai Maruyama , Wataru Munakata , Shinsuke Iida , Ken Ohmachi , Tomohiro Kinoshita , Kiyoshi Ando , Hirokazu Nagai

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Abstract

R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine [VCR], and prednisolone) is the standard of care for previously untreated patients with diffuse large B-cell lymphoma (DLBCL). However, some DLBCL survivors experience long-lasting VCR-related peripheral neuropathy (PN). VCR dose is usually reduced based on PN severity, but inconsistent results have been reported regarding the effect of VCR dose reduction on the prognosis of patients with DLBCL. To evaluate the clinical impact of the relative dose intensity (RDI) of VCR (RDI_O), we conducted a supplementary analysis of JCOG0601, a randomized phase 2/3 trial in which R-CHOP and CHOP with 8 doses of weekly rituximab were compared for progression-free survival (PFS). Among 422 patients enrolled in JCOG0601, 401 who had received at least 6 courses of protocol treatment were eligible. PFS was not significantly different between patients with low RDI_O (<95% [n = 161]) and high RDI_O (≥95% [n = 240]; P = .0679), although those with low RDI_O tended to have poor PFS (3-year PFS, 83.7% vs 78.2%). Multivariable analysis revealed that the presence of B symptoms and high-intermediate or high International Prognostic Index (IPI) risk, but not RDI_O, were associated with poor PFS. To our knowledge, this is the first study revealing VCR dose reduction may not be associated with poor PFS as much as the presence of B symptoms and high-intermediate or high IPI risk, using data from a prospective trial with rituximab plus 21-day cycles of CHOP. If the patients with DLBCL can complete rituximab plus CHOP treatment, VCR dose reduction due to toxicity may not significantly impair treatment efficacy. JCOG0601 was registered at www.jcog.jp/en/trials as #jRCTs031180139.

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长春新碱RDI对接受R-CHOP的DLBCL患者预后的影响：JCOG0601的补充分析

tr - chop（利妥昔单抗、环磷酰胺、阿霉素、长春新碱[VCR]和泼尼松龙）是先前未经治疗的弥漫性大b细胞淋巴瘤（DLBCL）患者的标准治疗方案。然而，一些DLBCL幸存者经历了长期的vcr相关周围神经病变（PN）。通常根据PN严重程度减少VCR剂量，但关于VCR剂量减少对DLBCL患者预后的影响，报道的结果不一致。为了评估VCR （RDIO）的相对剂量强度（RDI）的临床影响，我们对JCOG0601进行了补充分析，这是一项随机的2/3期试验，在该试验中，我们比较了R-CHOP和CHOP联合每周8剂量的美罗华治疗的无进展生存期（PFS）。在JCOG0601纳入的422名患者中，401名接受过至少6个疗程方案治疗的患者符合条件。低RDIO （<95% [n = 161]）和高RDIO（≥95% [n = 240]）患者的PFS无显著差异；P = .0679)，尽管低RDIO患者的PFS较差（3年PFS， 83.7% vs 78.2%）。多变量分析显示，B症状和高、中、高国际预后指数（IPI）风险与不良PFS相关，但与RDIO无关。据我们所知，这是第一个使用利妥昔单抗加21天周期CHOP的前瞻性试验数据，揭示VCR剂量减少可能与不良PFS的相关性不如与B症状和高、中、高IPI风险的相关性大。如果DLBCL患者能够完成利妥昔单抗联合CHOP治疗，由于毒性导致的VCR剂量减少可能不会明显影响治疗效果。JCOG0601在www.jcog.jp/en/trials上注册为#jRCTs031180139。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Blood Neoplasia

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