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

作者：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^*

来源：Cancer Biology & Medicine, 2022, 19(07): 1089-1099.

DOI：10.20892/j.issn.2095-3941.2021.0026

• Rituximab
• primary central nervous system lymphoma
• pemetrexed
• fotemustine
• WBRT

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.

• 单位
  郑州大学