학술논문
Multidrug chemotherapy, whole-brain radiation and cytarabine therapy for primary central nervous system lymphoma in elderly patients with dose modification based on geriatric assessment: study protocol for a phase II, multicentre, non-randomised study
Document Type
article
Author
Kenji Yoshida; Tomoyuki Akita; Kosuke Katayama; Kiyohide Kakuta; Takafumi Nishizaki; Fumiyuki Yamasaki; Hirotaka Fudaba; Kenichiro Asano; Takashi Sasayama; Manabu Natsumeda; Taichi Shimabukuro; Kotaro Taguchi; Shinichiro Koizumi; Noriyuki Nakayama; Kentaro Fujii; Ikuno Nishibuchi; Kazuhiko Sugiyama; Ushio Yonezawa; Momii Yasutomo; Yukari Kawasaki; Kazuhiro Tanaka; Hiroaki Nagashima; Yoshihiro Tsukamoto; Makoto Ideguchi; Kazuhiko Kurozumi; Tomohiro Hosoya; Atsushi Kambe
Source
BMJ Open, Vol 13, Iss 4 (2023)
Subject
Language
English
ISSN
2044-6055
Abstract
Introduction Multidrug chemoimmunotherapy with rituximab, high-dose methotrexate, procarbazine and vincristine (R-MPV) is a standard therapy for younger patients with primary central nervous system lymphoma (PCNSL); however, prospective data regarding its use in elderly patients are lacking. This multi-institutional, non-randomised, phase II trial will assess the efficacy and safety of R-MPV and high-dose cytarabine (HD-AraC) for geriatric patients with newly diagnosed PCNSL.Methods and analysis Forty-five elderly patients will be included. If R-MPV does not achieve complete response, the patients will undergo reduced-dose, whole-brain radiotherapy comprising 23.4 Gy/13 fractions, followed by local boost radiotherapy comprising 21.6 Gy/12 fractions. After achieving complete response using R-MPV with or without radiotherapy, the patients will undergo two courses of HD-AraC. All patients will undergo baseline geriatric 8 (G8) assessment before HD-AraC and after three, five and seven R-MPV courses. Patients with screening scores of ≥14 points that decrease to