A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma: Long-Term Follow-Up.
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.
Program of Innovative Therapy in Oncology and Hematology, Department of Diagnostic, Clinical Medicine and Public Health, University of Modena and Reggio Emilia, Modena, Italy.
Alessia
A
Bari
Raffaella
R
Marcheselli
Luigi
L
Marcheselli
Isabel
I
Alvarez
Samantha
S
Pozzi
Paola
P
Ferri
Antonio
A
Lazzaro
Alberto
A
Fragasso
Santo
S
Neri
Luca
L
Baldini
Angelo Michele
AM
Carella
Francesco
F
Angrilli
Roberto
R
Guariglia
Gabriele
G
Buda
Caterina
C
Stelitano
Stefano
S
Sacchi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000069286:Bortezomib / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008224:Lymphoma, Follicular / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D009503:Neutropenia / Q000175:diagnosis / Q000209:etiology / Q000473:pathology; D010523:Peripheral Nervous System Diseases / Q000175:diagnosis / Q000209:etiology / Q000473:pathology; D012008:Recurrence; D000069283:Rituximab / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000175:diagnosis / Q000209:etiology / Q000473:pathology
D000069283:Rituximab; D000069286:Bortezomib