A Multicenter, Phase II Study of R-THP-COP Therapy for Elderly Patients with Newly Diagnosed, Advanced-stage, Indolent B-cell Lymphoma

Overview

Journal J Clin Exp Hematop

Specialties Hematology
Pathology

Date 2021 Jul 1

PMID 34193755

Authors

Kazunori Ohnishi

Ken Ohmachi

Kiyoshi Ando

Kazuhito Yamamoto

Tatsuya Ito

Mitsune Tanimoto

Kaneyuki Ohbayashi

Kazuma Ohyashiki

Kunihiro Tsukasaki

Kensuke Naito

Takayo Suzuki

Takaaki Ono

Koichi Miyamura

Yoshitoyo Kagami

Tomohiro Kinoshita

Tomomitsu Hotta

Michinori Ogura

Affiliations

Soon will be listed here.

Abstract

The optimal combined chemotherapy regimen with rituximab has yet to be established for elderly patients with advanced-stage indolent B-cell lymphoma (B-NHL). A multicenter study was performed to evaluate the efficacy and toxicity of R-THP-COP therapy in elderly patients (aged 70-79 years) with newly diagnosed advanced-stage indolent B-NHL using the complete response rate (%CR) as the primary endpoint. Patients with newly diagnosed, clinical stage III/IV, indolent B-NHL, aged 70-79 years, with a performance status of 0-2 were eligible for this study. R-THP-COP consists of 375 mg/m of rituximab, 50 mg/m of pirarubicin, 750 mg/m of cyclophosphamide, 1.4 mg/m of vincristine, and 100 mg/day of oral prednisolone for 5 days. This study was discontinued due to poor accrual after the enrollment of 18 patients, although the planned sample size was 40 patients. The numbers of patients with follicular lymphoma, mucosa-associated lymphoid tissue lymphoma, and mantle cell lymphoma were 16, 1, and 1, respectively. The median age was 73 (range, 70 to 79) years. The %CR including unconfirmed CR was 45% (95% confidence interval: 25-66%) and the overall response rate was 72%. The estimated 5-year overall survival and progression-free survival rates were 55% and 28%, respectively. The major toxicity observed was grade 4 neutropenia (94%). Grade 4 non-hematological toxicities were not observed and no patients developed grade 3/4 cardiac toxicities. This phase II study provides useful information regarding the efficacy and toxicity of R-THP-COP therapy for patients aged 70 years or older with newly diagnosed, advanced-stage, indolent B-NHL, although the sample size was small.

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