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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

Authors :
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)
Publication Year :
2023
Publisher :
BMJ Publishing Group, 2023.

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

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
13
Issue :
4
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.19a3f93622fa498a96c3eec56dc02310
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2022-071350