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 language | English |
|---|---|
| Pages (from-to) | 7-14 |
| Number of pages | 8 |
| Journal | Acta Haematologica |
| Volume | 137 |
| Issue number | 1 |
| DOIs | |
| Publication status | E-pub ahead of print - Nov 4 2016 |
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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
Cite this
A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma : Long-Term Follow-Up. / Bari, Alessia; Marcheselli, Raffaella; Marcheselli, Luigi; Alvarez De Celis, Maria Isabel; Pozzi, Samantha; Ferri, Paola; Lazzaro, Antonio; Fragasso, Alberto; Neri, Santo; Baldini, Luca; Carella, Angelo Michele; Angrilli, Francesco; Guariglia, Roberto; Buda, Gabriele; Stelitano, Caterina; Sacchi, Stefano; Gruppo Italiano Studio Linfomi (GISL).
In: Acta Haematologica, Vol. 137, No. 1, 04.11.2016, p. 7-14.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma
T2 - Long-Term Follow-Up
AU - Bari, Alessia
AU - Marcheselli, Raffaella
AU - Marcheselli, Luigi
AU - Alvarez De Celis, Maria Isabel
AU - Pozzi, Samantha
AU - Ferri, Paola
AU - Lazzaro, Antonio
AU - Fragasso, Alberto
AU - Neri, Santo
AU - Baldini, Luca
AU - Carella, Angelo Michele
AU - Angrilli, Francesco
AU - Guariglia, Roberto
AU - Buda, Gabriele
AU - Stelitano, Caterina
AU - Sacchi, Stefano
AU - Gruppo Italiano Studio Linfomi (GISL)
N1 - © 2016 S. Karger AG, Basel.
PY - 2016/11/4
Y1 - 2016/11/4
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Bortezomib
KW - Drug Administration Schedule
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Lymphoma, Follicular
KW - Male
KW - Middle Aged
KW - Neoplasm Grading
KW - Neoplasm Staging
KW - Neutropenia
KW - Peripheral Nervous System Diseases
KW - Recurrence
KW - Rituximab
KW - Survival Analysis
KW - Thrombocytopenia
KW - Clinical Trial, Phase II
KW - Journal Article
KW - Multicenter Study
U2 - 10.1159/000449052
DO - 10.1159/000449052
M3 - Article
C2 - 27820922
VL - 137
SP - 7
EP - 14
JO - Acta Haematologica
JF - Acta Haematologica
SN - 0001-5792
IS - 1
ER -