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Updated survival analysis of two sequential prospective trials of R‐MACLO‐IVAM followed by maintenance for newly diagnosed mantle cell lymphoma
Author(s) -
Hosein Peter J.,
SandovalSus Jose D.,
Goodman Deborah,
Arteaga Alexandra Gomez,
Reis Isildinha,
Hoffman James,
Stefanovic Alexandra,
Rosenblatt Joseph D.,
Lossos Izidore S.
Publication year - 2015
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.23996
Subject(s) - medicine , mantle cell lymphoma , thalidomide , rituximab , chemotherapy , maintenance therapy , surgery , chemotherapy regimen , progression free survival , phases of clinical research , neutropenia , lenalidomide , gastroenterology , lymphoma , oncology , multiple myeloma
A phase II trial of R‐MACLO‐IVAM followed by thalidomide maintenance for mantle cell lymphoma (MCL) demonstrated promising progression‐free survival (PFS) and overall survival (OS) rates. Thalidomide maintenance was associated with significant toxicity and was subsequently modified to rituximab maintenance. Herein, we present updated results and follow‐up. Two sequential phase II trials included chemotherapy‐naïve patients with MCL up to 75 years old. Four cycles of R‐MACLO‐IVAM chemotherapy were delivered as previously described. Patients who achieved complete responses (CR) were eligible for thalidomide or rituximab maintenance therapy. Among 36 patients enrolled, the MCL International Prognostic Index (MIPI) was low in 53%, intermediate in 36% and high in 11%. Thirty‐five patients completed at least 2 cycles of chemotherapy; 34 (94%) achieved a CR. After a median follow‐up of 74.4 months, the 5‐year PFS was 51% (95% CI 33–68%) and the 5‐year OS was 85% (95% CI 73–97%). Two deaths occurred during the chemotherapy phase due to disease progression and neutropenic sepsis, respectively. One patient developed secondary acute myeloid leukemia after 7 years. R‐MACLO‐IVAM chemotherapy is effective for patients with newly diagnosed MCL. Am. J. Hematol. 90:E111–E116, 2015. © 2015 Wiley Periodicals, Inc.