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.
This article originally appeared on ONA