Fotemustine-based therapy in combination with rituximab as a first-line induction chemotherapy followed by WBRT for newly diagnosed primary central nervous system lymphoma: a prospective phase II trial.

Abstract

OBJECTIVE:

This study aimed to evaluate the safety, efficacy, and feasibility of the rituximab, fotemustine, pemetrexed, and dexamethasone (R-FPD) regimen followed by whole-brain radiotherapy (WBRT) for patients with primary central nervous system lymphoma (PCNSL).

METHODS:

A prospective, single-center phase II clinical trial was conducted. Patients with PCNSL newly diagnosed at the First Affiliated Hospital of Zhengzhou University between July 2018 and July 2020 were studied. The R-FPD regimen consisted of rituximab (375 mg/m2 i.v. on D0), fotemustine (100 mg/m2 i.v. on D1), pemetrexed (600 mg/m2 i.v. on D1), and dexamethasone (40 mg i.v. on D1-5). Patients 60 years or younger who showed a complete response (CR) were treated with 23.4 Gy of WBRT after the end of chemotherapy; those older than 60 years with CR were treated with a wait-and-see approach; and those who did not show CR after the 4th cycle of chemotherapy were given salvage WBRT 30 Gy + local tumor field irradiation up to 45 Gy, regardless of age.

RESULTS:

A total of 30 patients were included. After 2 cycles, the objective response rate (ORR) was 96.5% (28/29, 1 CR, 27 PR, 0 SD, and 1 PD). After 4 cycles, the ORR was 73.1% (19/26, 11 CR, 8 PR, 4 SD, and 3 PD). After WBRT, the ORR was 90.9% (10/11, 7 CR, 3 PR, and 1 SD). The grade III and IV toxicity responses were mainly leukopenia (20.0%), thrombocytopenia (23.3%), and anemia (10.0%).

CONCLUSIONS:

Fotemustine-based therapy in combination with rituximab chemotherapy followed by WBRT can improve outcomes, providing ORR benefits and favorable tolerability in patients newly diagnosed with PCNSL.

• Authors: Jingjing Wu, Fenghua Gao, Wenhua Wang, Xudong Zhang, Meng Dong, Lei Zhang, Xin Li, Ling Li, Zhenchang Sun, Xinhua Wang, Xiaorui Fu, Linan Zhu, Mengjie Ding, Songtao Niu, Zhaoming Li, Yu Chang, Feifei Nan, Jiaqian Yan, Hui Yu, Xiaolong Wu, Zhiyuan Zhou, Jieming Zhang, Mingzhi Zhang
• Journal: Cancer biology & medicine (Cancer Biol Med) (Oct 12 2021) ISSN: 2095-3941 [Print] China
• PMID: 34633776 (Publication Type: Journal Article)
• Copyright: Copyright © 2021 Cancer Biology & Medicine.