Phase II study of bortezomib in combination with rituximab, cyclophosphamide and prednisone with or without doxorubicin followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma

Michael Craig, Wahid Hanna, Fernando Cabanillas, Chien Shing Chen, Dixie Lee Esseltine, Rachel Neuwirth, Owen A. O'Connor

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

This non-comparative phase II study (ClinicalTrials.gov: NCT00715208) evaluated bortezomib in place of vincristine in established rituximab-chemotherapy regimens in relapsed/refractory follicular (FL) or marginal zone lymphoma (MZL). Patients were allocated (physician/patient preference) to receive six 21-d cycles of: bortezomib 1·6 mg/m2 (days 1, 8), rituximab 375 mg/m2 (day 1), cyclophosphamide 1000 mg/m2 (day 1) and prednisone 100 mg (days 1-5; VR-CP; 47 FL, 1 MZL patients); or bortezomib, rituximab, prednisone per VR-CP, cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 (day 1; VR-CAP; 4 FL, 2 MZL, 1 chronic lymphocytic leukaemia patients). With VR-CP, the response rate was 77%, with a 27% complete response rate. After a median follow-up of 10·9 months, 40% of patients had relapsed/progressed or died. Median duration of response and progression-free survival was 21·9 and 14·9 months, respectively. Common drug-related grade ≥3 adverse events were neutropenia (25%), thrombocytopenia (6%) and lymphopenia (6%). Thirteen (27%) patients reported peripheral neuropathy (one grade 3). With VR-CAP, one FL patient achieved complete response and three FL and two MZL patients achieved partial responses. Three patients reported drug-related grade 1/2 peripheral neuropathy. Weekly bortezomib and rituximab represents an active, feasible treatment platform in FL. VR-CP was active and well tolerated in patients with relapsed/refractory FL.

Original languageEnglish (US)
Pages (from-to)920-928
Number of pages9
JournalBritish Journal of Haematology
Volume166
Issue number6
DOIs
StatePublished - Jan 1 2014

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Follicular Lymphoma
Prednisone
Doxorubicin
Cyclophosphamide
Maintenance
Lymphoma
Peripheral Nervous System Diseases
Rituximab
Bortezomib
Lymphopenia
Patient Preference
Vincristine
B-Cell Chronic Lymphocytic Leukemia
Neutropenia
Thrombocytopenia
Pharmaceutical Preparations
Disease-Free Survival
Physicians
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Phase II study of bortezomib in combination with rituximab, cyclophosphamide and prednisone with or without doxorubicin followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma. / Craig, Michael; Hanna, Wahid; Cabanillas, Fernando; Chen, Chien Shing; Esseltine, Dixie Lee; Neuwirth, Rachel; O'Connor, Owen A.

In: British Journal of Haematology, Vol. 166, No. 6, 01.01.2014, p. 920-928.

Research output: Contribution to journalArticle

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abstract = "This non-comparative phase II study (ClinicalTrials.gov: NCT00715208) evaluated bortezomib in place of vincristine in established rituximab-chemotherapy regimens in relapsed/refractory follicular (FL) or marginal zone lymphoma (MZL). Patients were allocated (physician/patient preference) to receive six 21-d cycles of: bortezomib 1·6 mg/m2 (days 1, 8), rituximab 375 mg/m2 (day 1), cyclophosphamide 1000 mg/m2 (day 1) and prednisone 100 mg (days 1-5; VR-CP; 47 FL, 1 MZL patients); or bortezomib, rituximab, prednisone per VR-CP, cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 (day 1; VR-CAP; 4 FL, 2 MZL, 1 chronic lymphocytic leukaemia patients). With VR-CP, the response rate was 77{\%}, with a 27{\%} complete response rate. After a median follow-up of 10·9 months, 40{\%} of patients had relapsed/progressed or died. Median duration of response and progression-free survival was 21·9 and 14·9 months, respectively. Common drug-related grade ≥3 adverse events were neutropenia (25{\%}), thrombocytopenia (6{\%}) and lymphopenia (6{\%}). Thirteen (27{\%}) patients reported peripheral neuropathy (one grade 3). With VR-CAP, one FL patient achieved complete response and three FL and two MZL patients achieved partial responses. Three patients reported drug-related grade 1/2 peripheral neuropathy. Weekly bortezomib and rituximab represents an active, feasible treatment platform in FL. VR-CP was active and well tolerated in patients with relapsed/refractory FL.",
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