Low absolute lymphocyte count is a poor prognostic factor for untreated advanced follicular lymphoma treated with rituximab plus bendamustine: results of the prospective phase 2 CONVERT trial.

Publisher: Springer Japan Country of Publication: Japan NLM ID: 9111627 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1865-3774 (Electronic) Linking ISSN: 09255710 NLM ISO Abbreviation: Int J Hematol Subsets: MEDLINE

Publication: 2008- : Tokyo : Springer Japan
Original Publication: Amsterdam : Elsevier Science Publishers, c1991-

Lymphocyte Count*; Lymphoma, Follicular/*blood ; Lymphoma, Follicular/*mortality; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bendamustine Hydrochloride/administration & dosage ; Biomarkers ; Clinical Trials, Phase II as Topic ; Disease Management ; Female ; Humans ; Kaplan-Meier Estimate ; Lymphoma, Follicular/diagnosis ; Lymphoma, Follicular/therapy ; Male ; Middle Aged ; Neoplasm Staging ; Prognosis ; Rituximab/administration & dosage ; Young Adult

The aim of this trial is to evaluate the utility of rituximab-bendamustine (R-B) for untreated advanced follicular lymphoma (FL) showing non-optimal response (nOR) to R-CHOP, and to identify clinical prognostic factors for FL patients receiving R-B. Patients who failed to achieve complete response/complete response unconfirmed (CR/CRu) [nOR-group] after 2 cycles of R-CHOP subsequently received 6 cycles of R-B. The primary endpoint was the 3-year progression-free survival (PFS) rate. Secondary endpoints included determination of prognostic factors. Fifty-six patients initially received R-CHOP, 43/56 patients (76.8%) were judged as nOR, and 33/43 patients (76.7%) completed 6 cycles of R-B. At a median follow-up of 50.6 months in the nOR-group, the 3-year PFS rate was 69.0%, and the 3-year overall survival (OS) rate was 92.7%. The most common toxicities associated with R-B were grade 3-4 lymphopenia (93.0%) and neutropenia (74.4%), both of which were manageable. A multivariate analysis including dose intensity, serum soluble interleukin-2 receptor, and FL international prognostic index-2 revealed low absolute lymphocyte count (<  869/μL) at diagnosis was an independent poor prognostic factor for both PFS and OS in the R-B-treated nOR-group. This result was further confirmed in validation cohorts including R-B-treated de novo (n = 40) and relapsed (n = 49) FL patients.
(© 2021. Japanese Society of Hematology.)

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Keywords: Absolute lymphocyte count; Bendamustine; Follicular lymphoma; Lymphopenia; Rituximab

0 (Biomarkers)
4F4X42SYQ6 (Rituximab)
981Y8SX18M (Bendamustine Hydrochloride)

Date Created: 20210417 Date Completed: 20210809 Latest Revision: 20210809

20240104

10.1007/s12185-021-03148-0

33864623