Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma

Peter Hosein, Jose D. Sandoval-Sus, Deborah Goodman, Alexandra Gomez Arteaga, Isildinha Reis, James E Hoffman, Alexandra Stefanovic, Joseph D Rosenblatt, Izidore Lossos

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)E111-E116
JournalAmerican Journal of Hematology
Volume90
Issue number6
DOIs
StatePublished - Jun 1 2015

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Mantle-Cell Lymphoma
Survival Analysis
Maintenance
Thalidomide
Drug Therapy
Disease-Free Survival
Acute Myeloid Leukemia
Disease Progression
Sepsis
Survival Rate
Survival

ASJC Scopus subject areas

  • Hematology

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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. / Hosein, Peter; Sandoval-Sus, Jose D.; Goodman, Deborah; Arteaga, Alexandra Gomez; Reis, Isildinha; Hoffman, James E; Stefanovic, Alexandra; Rosenblatt, Joseph D; Lossos, Izidore.

In: American Journal of Hematology, Vol. 90, No. 6, 01.06.2015, p. E111-E116.

Research output: Contribution to journalArticle

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abstract = "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-na{\"i}ve 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.",
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