Rituximab, pirarubicin, cyclophosphamide, vincristine, and prednisolone (R-THP-COP) leads to noninferior response and safety outcomes compared with rituximab, doxorubicin, cyclophosphamide, vincristine, and prednisolone (R-CHOP), and may be a therapeutic alternative for patients with diffuse large B cell lymphoma (DLBCL), according to a study published in Hematologic Oncology.
A previous single-arm phase 2 study reported that R-THP-COP leads to favorable outcomes in this patient population with a reduced incidence of cardiovascular adverse events — a commonly observed toxicity with R-CHOP, the current standard of care — but due to study design could not establish a comparative benefit.
For this prospective, noninferiority phase 3 study, researchers randomly assigned 81 previously untreated patients younger than 70 years with DLBCL to receive R-THP-COP or R-CHOP. Baseline characteristics were well balanced between the 2 study groups.
Results showed that the overall response rate (ORR) was 88% among patients who received R-CHOP and 90% among those treated with R-THP-COP; both treatment groups achieved complete response (CR) rates of 85%. Differences in response rates were not significant, and therefore established the noninferiority of R-THP-COP.
After a median follow up of 75.2 months, the 5-year overall survival (OS) was 87% and 82% in the R-CHOP and R-THP-COP groups, respectively, (P=.82), and the 5-year progression-free survival (PFS) was 74% and 79%, respectively.
An analysis of adverse effects showed that there were no significant differences in the rates of hematologic toxicities, including grade 3 or 4 anemia, neutropenia, and thrombocytopenia. No grade 3 cardiac adverse effects were observed in either study arm, and no serious late adverse effects were reported. One patient experienced treatment-related acute myeloid leukemia in the R-THP-COP group.
The authors concluded that “the results of our phase 3 clinical trial showed noninferiority of R‐THP‐COP to R‐CHOP, suggesting that R‐THP‐COP may be an important alternative for the initial treatment of patients with DLBCL.”
Hara T, Yoshikawa T, Goto H, et al. R‐THP‐COP versus R‐CHOP in patients younger than 70 years with untreated diffuse large B cell lymphoma: a randomized, open‐label, noninferiority phase 3 trial[published online June 8, 2018]. Hematol Oncol. doi: 10.1002/hon.2524.