Impact of Pegfilgrastim Approval on Relative Dose Intensity and Outcomes of R-CHOP for Diffuse Large B-Cell Lymphoma
Abstract Maintaining the relative dose intensity (RDI) of chemotherapy with R-CHOP improves the prognosis of patients with diffuse large B-cell lymphoma (DLBCL). Pegfilgrastim was approved for use in Japan in November 2014 to prevent febrile neutropenia (FN) and maintain RDI. We herein reviewed 334 patients with DLBCL who received six or more courses of R-CHOP and retrospectively analyzed the difference in the RDI, overall survival (OS), and progression-free survival (PFS) between patients whose treatment started after November 2014 (the post-approval group) and those whose treatment started before October 2014 (the pre-approval group). The incidence of FN was lower (39.2% vs. 62.2%, P < 0.001) and the RDI of R-CHOP was higher (86.8% vs. 67.8%, P < 0.001) in the post-approval group. The RDI of patients aged < 70 years was maintained at a high level even if their RDI was predicted to be low based on the model derived from the pre-approval group. Pegfilgrastim was administered to many of these patients and was thought to have contributed to the high RDI maintenance in the post-approval group. The 5-year OS (85.7% and 69.9%, P = 0.009) and PFS (81.4% and 64.4%, P = 0.011) were superior in the post-approval group. In this group, improved survival outcomes were observed among patients with Ann Arbor stage 3/4 (5-year OS: 83.7% vs. 61.3%, P = 0.019) and high risk on the NCCN-IPI (5-year OS: 80.7% vs. 32.4%, P = 0.014). Maintenance of high RDI of R-CHOP and significant improvement in clinical outcomes, especially in high-risk groups, were observed after pegfilgrastim approval.