High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study)
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High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). / Fritsch, K; Kasenda, B; Schorb, E; Hau, P; Bloehdorn, J; Möhle, R; Löw, S; Binder, M; Atta, J; Keller, U; Wolf, H-H; Krause, S W; Heß, G; Naumann, R; Sasse, S; Hirt, C; Lamprecht, M; Martens, U; Morgner, A; Panse, J; Frickhofen, N; Röth, A; Hader, C; Deckert, M; Fricker, H; Ihorst, G; Finke, J; Illerhaus, G.
In: LEUKEMIA, Vol. 31, No. 4, 04.2017, p. 846-852.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study)
AU - Fritsch, K
AU - Kasenda, B
AU - Schorb, E
AU - Hau, P
AU - Bloehdorn, J
AU - Möhle, R
AU - Löw, S
AU - Binder, M
AU - Atta, J
AU - Keller, U
AU - Wolf, H-H
AU - Krause, S W
AU - Heß, G
AU - Naumann, R
AU - Sasse, S
AU - Hirt, C
AU - Lamprecht, M
AU - Martens, U
AU - Morgner, A
AU - Panse, J
AU - Frickhofen, N
AU - Röth, A
AU - Hader, C
AU - Deckert, M
AU - Fricker, H
AU - Ihorst, G
AU - Finke, J
AU - Illerhaus, G
PY - 2017/4
Y1 - 2017/4
N2 - To investigate immuno-chemotherapy for elderly immuno-competent patients (⩾65 years) with newly diagnosed primary central nervous system lymphoma, we conducted a multicentre single-arm trial. One cycle consisted of rituximab (375 mg/m2, days 1, 15, 29), high-dose methotrexate (3 g/m2days 2, 16, 30), procarbazine (60 mg/m2days 2-11) and lomustine (110 mg/m2, day 2)-R-MPL protocol. Owing to infectious complications, we omitted lomustine during the study and consecutive patients were treated with the R-MP protocol. Three cycles were scheduled and repeated on day 43. Subsequently, patients commenced 4 weekly maintenance treatment with procarbazine (100 mg for 5 days). Primary end point was complete remission (CR) after 3 cycles. We included 107 patients (69 treated with R-MPL and 38 with R-MP). In all, 38/107 patients achieved CR (35.5%) and 15 (14.0%) achieved partial remission. R-MP was associated with a lower CR rate (31.6%) compared with R-MPL (37.7%), but respective 2-year progression-free survival (All 37.3%; R-MP 34.9%; R-MPL 38.8%) and overall survival (All 47.0%; R-MP 47.7%; R-MPL 46.0%) rates were similar. R-MP was associated with less ⩾grade 3 toxicities compared with R-MPL (71.1% vs 87.0%). R-MP is more feasible while still associated with similar efficacy compared with R-MPL and warrants further improvement in future studies.
AB - To investigate immuno-chemotherapy for elderly immuno-competent patients (⩾65 years) with newly diagnosed primary central nervous system lymphoma, we conducted a multicentre single-arm trial. One cycle consisted of rituximab (375 mg/m2, days 1, 15, 29), high-dose methotrexate (3 g/m2days 2, 16, 30), procarbazine (60 mg/m2days 2-11) and lomustine (110 mg/m2, day 2)-R-MPL protocol. Owing to infectious complications, we omitted lomustine during the study and consecutive patients were treated with the R-MP protocol. Three cycles were scheduled and repeated on day 43. Subsequently, patients commenced 4 weekly maintenance treatment with procarbazine (100 mg for 5 days). Primary end point was complete remission (CR) after 3 cycles. We included 107 patients (69 treated with R-MPL and 38 with R-MP). In all, 38/107 patients achieved CR (35.5%) and 15 (14.0%) achieved partial remission. R-MP was associated with a lower CR rate (31.6%) compared with R-MPL (37.7%), but respective 2-year progression-free survival (All 37.3%; R-MP 34.9%; R-MPL 38.8%) and overall survival (All 47.0%; R-MP 47.7%; R-MPL 46.0%) rates were similar. R-MP was associated with less ⩾grade 3 toxicities compared with R-MPL (71.1% vs 87.0%). R-MP is more feasible while still associated with similar efficacy compared with R-MPL and warrants further improvement in future studies.
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Central Nervous System Neoplasms
KW - Female
KW - Humans
KW - Immunologic Factors
KW - Lymphoma
KW - Male
KW - Methotrexate
KW - Neoplasm Staging
KW - Proportional Hazards Models
KW - Quality of Life
KW - Remission Induction
KW - Treatment Outcome
KW - Tumor Burden
KW - Clinical Trial, Phase II
KW - Journal Article
KW - Multicenter Study
U2 - 10.1038/leu.2016.334
DO - 10.1038/leu.2016.334
M3 - SCORING: Journal article
C2 - 27843136
VL - 31
SP - 846
EP - 852
JO - LEUKEMIA
JF - LEUKEMIA
SN - 0887-6924
IS - 4
ER -