https://orcid.org/0009-0002-4188-7368
Key Point
VCR dose reduction was not significantly associated with poor PFS in patients with DLBCL treated with R-CHOP, based on data from JCOG0601.
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, and 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 (RDIO), we conducted a supplementary analysis of JCOG0601, a randomized phase II/III trial wherein R-CHOP and CHOP with eight doses of weekly rituximab were compared for progression-free survival (PFS). Among 422 patients enrolled in JCOG0601, 401 who had received at least six courses of protocol treatment were eligible. PFS was not significantly different between patients with low RDIO (<95% [n=161]) and high RDIO (≥95% [n=240]) (p=0.0679), although patients with low RDIO 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 RDIO, were associated with poor PFS. In conclusion, this study is the first to show that 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 DLBCL patients can complete rituximab plus CHOP treatment, VCR dose reduction due to toxicity may not significantly impair treatment efficacy. (Trial number: jRCTs031180139)
Author notes
Data sharing statement:
Individual participant data that underlie the results reported in this article will not be shared because the follow-up of the patients was continued until December 2022. After the publication using data as of December 2022, individual participant data that underlie the results after deidentification will be shared if investigators whose proposed use of the data has been approved by the investigators from Lymphoma Study Group of JCOG identified for this purpose. Proposals should be directed to komachi@tokai.ac.jp. The data will be available for achieving aims in the approved proposal.
