A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma: Long-Term Follow-Up

Alessia Bari, Raffaella Marcheselli, Luigi Marcheselli, Maria Isabel Alvarez De Celis, Samantha Pozzi, Paola Ferri, Antonio Lazzaro, Alberto Fragasso, Santo Neri, Luca Baldini, Angelo Michele Carella, Francesco Angrilli, Roberto Guariglia, Gabriele Buda, Caterina Stelitano, Stefano Sacchi, Gruppo Italiano Studio Linfomi (GISL)

Research output: Contribution to journalArticlepeer-review

Abstract

Single-agent bortezomib (B) has shown activity in heavily pretreated patients with relapsed/refractory indolent lymphoma. On the basis of these findings, we performed a phase II study of B combined with rituximab (R) in patients with relapsed follicular lymphoma (FL). Forty-five patients with fairly good prognostic profiles were enrolled from 2007 to 2011 and received a total of 6 cycles of the B+R combination. The endpoints were the overall response rate (ORR), progression-free survival (PFS), duration of remission (DoR), overall survival (OS), and toxicity evaluation. When considering all the enrolled patients the ORR was 64%. At 5 years, the estimated PFS, DoR, and OS were 34, 49, and 70%, respectively. After excluding the 7 R-naïve patients, the ORR was 58%, with a PFS of 19 months. The most common grade >2 toxicities were thrombocytopenia (18%), peripheral neuropathy (13%), and neutropenia (2%). Our study shows the feasibility, long-term efficacy, and excellent tolerability of the B+R combination. We are aware that our study has specific limitations, such as the small sample size consisting of patients with a relatively good prognostic profile. However, because FL patients will be treated with subsequent chemotherapy regimens, a well-tolerated and effective chemotherapy-free therapy could be considered an additional tool for long-term disease control.

Original languageEnglish
Pages (from-to)7-14
Number of pages8
JournalActa Haematologica
Volume137
Issue number1
DOIs
Publication statusE-pub ahead of print - Nov 4 2016

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols
  • Bortezomib
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Lymphoma, Follicular
  • Male
  • Middle Aged
  • Neoplasm Grading
  • Neoplasm Staging
  • Neutropenia
  • Peripheral Nervous System Diseases
  • Recurrence
  • Rituximab
  • Survival Analysis
  • Thrombocytopenia
  • Clinical Trial, Phase II
  • Journal Article
  • Multicenter Study

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