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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
Author(s) -
Craig Michael,
Hanna Wahid T.,
Cabanillas Fernando,
Chen ChienShing,
Esseltine DixieLee,
Neuwirth Rachel,
O'Connor Owen A.
Publication year - 2014
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.12991
Subject(s) - medicine , rituximab , bortezomib , prednisone , gastroenterology , cyclophosphamide , vincristine , neutropenia , adverse effect , follicular lymphoma , surgery , chemotherapy , lymphoma , multiple myeloma
Summary This non‐comparative phase II study ( C linical T rials.gov: NCT 00715208) 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/m 2 (days 1, 8), rituximab 375 mg/m 2 (day 1), cyclophosphamide 1000 mg/m 2 (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/m 2 and doxorubicin 50 mg/m 2 (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 .