scholarly journals Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network

2019 ◽  
Vol 8 (6) ◽  
pp. 877 ◽  
Author(s):  
Concetta Conticello ◽  
Alessandra Romano ◽  
Vittorio Del Fabro ◽  
Enrica Antonia Martino ◽  
Valeria Calafiore ◽  
...  
Keyword(s):  
Real Life ◽  
Previous Treatment ◽  
Complete Response ◽  
Median Number ◽  
Maximum Tolerated Dose ◽  
Considerable Proportion ◽  
Duration Of Treatment ◽  
Full Dosage

Background: The ASPIRE (NCT01080391) phase 3 trial showed the efficacy of carfilzomib, lenalidomide and dexamethasone (KRd) triplet for relapse and refractory multiple myeloma (RRMM). However, little is known about safety and efficacy of KRd outside a clinical trial context. Methods: Herein we report real life results of KRd given to 130 RRMM patients from 12 Sicilian Centers. Results: Median age was 62 years; patients had received a median of two previous lines of treatment (range 1–10) and 52% were refractory to previous treatment. Median number of KRd cycles was 12 (2–29), with a mean duration of treatment of 12 months; 21 patients had received at least 18 cycles. Overall response rate was 61%, including 18% complete response. Median PFS was 22.9 months, median OS was not reached. Creatinine clearance >30 mL/min, quality of the best achieved response and standard Fluorescence In Situ Hybridization (FISH) risk were independent predictors of favorable outcome. Patients who received the full-dosage of carfilzomib in the first two cycles had a better outcome. Conclusions: KRd was effective and well tolerated and in a considerable proportion of patients, therapy continued beyond the 18th cycle. The finding of a better outcome in patients with the higher cumulative dose of carfilzomib in the first two cycle encourages to maintain the maximum tolerated dose.

scholarly journals Chlorosulfuric acid-assisted production of functional 2D materials

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Mohsen Moazzami Gudarzi ◽  
Maryana Asaad ◽  
Boyang Mao ◽  
Gergo Pinter ◽  
Jianqiang Guo ◽  
...  
Keyword(s):  
Hexagonal Boron Nitride ◽  
2D Materials ◽  
Real Life ◽  
Large Area ◽  
Polar Solvents ◽  
Aspect Ratios ◽  
Two Dimensional Materials ◽  
Liquid Phase Exfoliation

AbstractThe use of two-dimensional materials in bulk functional applications requires the ability to fabricate defect-free 2D sheets with large aspect ratios. Despite huge research efforts, current bulk exfoliation methods require a compromise between the quality of the final flakes and their lateral size, restricting the effectiveness of the product. In this work, we describe an intercalation-assisted exfoliation route, which allows the production of high-quality graphene, hexagonal boron nitride, and molybdenum disulfide 2D sheets with average aspect ratios 30 times larger than that obtained via conventional liquid-phase exfoliation. The combination of chlorosulfuric acid intercalation with in situ pyrene sulfonate functionalisation produces a suspension of thin large-area flakes, which are stable in various polar solvents. The described method is simple and requires no special laboratory conditions. We demonstrate that these suspensions can be used for fabrication of laminates and coatings with electrical properties suitable for a number of real-life applications.

Complete responses to two different anti-PD1 agents in a metastatic melanoma patient

2019 ◽  
Vol 26 (2) ◽  
pp. 496-499 ◽  
Author(s):  
Saadettin Kilickap ◽  
Deniz C Guven ◽  
Oktay H Aktepe ◽  
Burak Y Aktas ◽  
Omer Dizdar
Keyword(s):  
Metastatic Melanoma ◽  
Checkpoint Inhibitors ◽  
Real Life ◽  
Complete Response ◽  
Duration Of Treatment ◽  
Treatment Protocols ◽  
Real Life Data ◽  
Heavily Pretreated ◽  
Drug Free

In the last decade, immune checkpoint inhibitors changed the landscape of metastatic melanoma. However, the optimal duration of treatment and treatment cessation in responders is largely unknown. Herein, we represent a heavily pretreated metastatic melanoma case who had a complete response to pembrolizumab and also a complete response with nivolumab after progression during drug-free follow-up. We think that reinduction with a different anti-PD1 antibody may be used in patients with metastatic melanoma responders. Clinical trials with prespecified sequential treatment protocols and large real-life data can further delineate this subject.

NEPA as antiemetic prophylaxis after failure of 5HT3-RA plus dexamethasone in patients receiving carboplatin and gemcitabine chemotherapy: A monocentric real-life experience

2020 ◽  
pp. 107815522092940
Author(s):  
Maria Rosaria Valerio ◽  
Vittorio Gebbia ◽  
Nicolò Borsellino ◽  
Maria La Vecchia ◽  
Vincenzo Serretta ◽  
...  
Keyword(s):  
Combination Chemotherapy ◽  
Rescue Medication ◽  
Life Experience ◽  
Real Life ◽  
Complete Response ◽  
Antiemetic Prophylaxis ◽  
Phase 0 ◽  
Subsequent Cycle ◽  
Delayed Cinv

Introduction Chemotherapy-induced nausea and vomiting (CINV) may affect adherence to planned chemotherapy treatments and compromise patients’ quality of life during the therapy. NEPA is an oral fixed combination of netupitant, a highly-selective NK1-RA and palonosetron, a 5HT3-RA, approved for the prevention of acute and delayed CINV. The aim of this study was to evaluate the efficacy and safety of NEPA with dexamethasone for CINV prophylaxis in the challenging setting of carboplatin and gemcitabine combination chemotherapy, after failure of prophylaxis with 5HT3 receptor antagonist. Methods Eligible patients were undergoing carboplatin and gemcitabine combination chemotherapy for metastatic non-small cell lung cancer (NSCLC), ovarian cancer or urothelial cancer and experienced nausea and/or vomiting after the first cycle of chemotherapy, despite an antiemetic prophylaxis with a 5HT3-RA and dexamethasone. Primary efficacy endpoint was complete response (CR: no emesis, no rescue medication) obtained with NEPA, during the overall phase (0–120 h), after the start of chemotherapy. Results During the first cycle of chemotherapy, 15 out of 30 (50%) patients did not properly control CINV with a 5HT3-RA plus dexamethasone used as primary antiemetic prophylaxis and then were switched to NEPA from the subsequent cycle. During NEPA administration, 13 out of 15 patients (86.7%) achieved an overall CR (no emesis, no rescue medication). Antiemetic treatment with NEPA was very well tolerated with only two patients (13.3%) that experienced a grade 1 TEAE. Conclusions Our experience showed that NEPA has proven to be very effective and well tolerated in the prophylaxis of CINV induced by carboplatin-based chemotherapy.

5-Azacytidine in 82 Low/Intermediate-1 IPSS Risk Myelodysplastic Syndromes: Results from the Italian Patient Named Program

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2680-2680
Author(s):  
Pellegrino Musto ◽  
Luca Maurillo ◽  
Alessandra Spagnoli ◽  
Antonella Gozzini ◽  
Flavia Rivellini ◽  
...  
Keyword(s):  
Overall Survival ◽  
Myelodysplastic Syndromes ◽  
Response Rate ◽  
Previous Treatment ◽  
Response Duration ◽  
Complete Response ◽  
Median Number ◽  
Phase Iii ◽  
Fixed Dose ◽  
Female Ratio

Abstract 5-azacytidine (AZA) significantly prolonged overall survival in higher-risk patients with myelodysplastic syndromes (MDS) in a large, international, randomized, phase III trial (AZA-001). However, data about efficacy and safety of AZA in lower risk MDS are less consistent and only few small studies have addressed this topic. Among a total of 246 MDS treated with AZA in 31 different Italian Institutions since 2005 within to a national patient named program, we evaluated 82 patients scored as low/int-1 IPSS risk MDS. Median age was 68 years (range 34–85), male/female ratio 50/32. According to WHO classification, there were 21 RA/RARS, 4 5q-syndromes, 20 RCMD, 24 RAEB-1, 5 RAEB-2, 4 CMMoL, and 4 MDS unclassified. Median time from diagnosis was 27 months (range 1–132). Sixty-eight patients (82.9%) were transfusion-dependent, sixty (74%) had received a prior treatment, mostly with erythropoiesis stimulating agents. AZA was administered as single drug in 61 patients (74.4%), while in the remaining subjects it was variously combined with growth factors, valproic acid or other agents. Forty-eight patients (58.5%) received a “standard” AZA dose of 75 mg/sqm/d s.c., thirty-four (41.5%) a fixed dose of 100 mg/d s.c. Single cycle treatment duration was 7 days in 45 patients (54.9%), < 7 days in 32 patients (39%), > 7 days in 3 patients (3.7%), unknown in 2 patients (2.4%). The median number of monthly cycles was 6 (range 1–21), and 63 patients (76.8%) completed at least 4 cycles. The most relevant toxicities observed (grade 3–4) were represented by myelosuppression (22%) and infections (6%). According to 2006-updated IWG criteria, overall response rate was 39% (47.5% in patients who had completed at least 4 cycles). In particular, complete response, partial response and hematological improvement occurred in 12.2%, 8.5% and 18.3% of patients (15.8%, 11.1% and 20.6% in those who were treated with at least 4 cycles), respectively. Stable or progressive disease was observed in 29.3%/25.6% and 30.2%/22.2% of patients receiving less than or at least 4 cycles, respectively. Response duration ranged from 1 to +21 months. There were no significant differences in response rate according to dose and schedule employed, although a slight trend in favour of 75 mg/sqm vs 100 mg fixed dose was seen (45.8% vs 29.4%, respectively). There was also no difference in the percentages of response according to age, previous treatment and transfusion dependence. Overall survival at 2 years was 62%. A survival benefit emerged for responding patients, compared to non responders (82% vs 57%) (p=0.015). A favourable trend was also observed for transfusion-independent patients, while age, pre-treatment and AZA dose did not influence survival. These data indicate that AZA may be safe and effective for a subset of patients with low/int-1 IPSS risk MDS, resistant or not suitable for alternative treatments. The efficacy may improve if at least 4 cycles are administered.

Clinical Efficacy of VEL-CTD (Bortezomib, Cyclophosphamide, Thalidomide, and Dexamethasone) Regimen in Patients with Relapsed or Refractory Multiple Myeloma: A Phase II Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3693-3693
Author(s):  
Yeo-Kyeoung Kim ◽  
Je-Jung Lee ◽  
Sang-Kyun Sohn ◽  
Ho-Jin Shin ◽  
Joo-Seop Chung ◽  
...  
Keyword(s):  
Sensory Neuropathy ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Chemotherapeutic Agents ◽  
Significant Activity ◽  
Treatment Regimens ◽  
Highly Active ◽  
Therapeutic Responses

Abstract BACKGROUND: Recent studies demonstrates that the combination of bortezomib and several chemotherapeutic agents may have significant activity in myeloma. In this study, we assessed the efficacy and safety of the combination with bortezomib, cyclophosphamide, thalidomide, and dexamethasone (vel-CTD) for the patients with relapsed/refractory myeloma. METHODS: Fifty-three patients who had received at least four cycles of treatment were enrolled. Bortezomib was given at 1.3 mg/m2 on D1, 4, 8, 11, thalidomide 50 mg/day, daily, cyclophosphamide 150 mg/m2 P.O. on D1–4, and dexamethasone 20 mg/m2 I.V. or P.O. on D1, 4, 8, 11. RESULTS: There were 26 males (49.1%) and 27 females (50.9%). The median age of patients was 67 years (range, 40–78 years). Median number of the previous treatment regimens was two (range, 1~5). Of total 53 patients, forty-nine patients (92.5%) achieved at least a partial response (PR) including 28 (52.8%) with complete response (CR) and 21 (42.9%) with PR as their best response. Median progression-free survival (PFS) was 14.7 months (range; 12.3–17.1 months) and median overall survival (OS), from the onset of vel-CTD was 31.6 months (range; 23.3–39.9 months). Patients who achieved a good response at least a PR after four cycles of vel-CTD showed longer PFS than those with poor therapeutic responses (2yr PFS, 28±8.7% vs. 0%, p=0.03). Further, patients who achieved a good therapeutic responses also showed significantly longer OS than those with poor responses (2yr OS, 72.3±8.3% vs. 33.3±15.7%, p=0.009). Grade 3–4 toxicities included thrombocytopenia (30.2%), neutropenia (11.3%), peripheral sensory neuropathy (32.1%), and thrombosis (3.8%). There was no treatment-related death. CONCLUSIONS: Vel-CTD is a highly active salvage therapy in patients with relapsed/refractory myeloma. However, frequent side effects such as peripheral neuropathy should be considered. Furthermore, trials evaluating novel treatment approaches after bortezomib should be offered to reduce the rate of disease progression, particularly in patients who fail to show a good response at least PR after four cycles of therapy.

Long-term toxicity profile of trastuzumab emtansine (T-DM1): A multicenter real-life study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12507-e12507
Author(s):  
Giuseppe Buono ◽  
Alessandra Fabi ◽  
Lucia Del Mastro ◽  
Katia Cannita ◽  
Nicla Maria La Verde ◽  
...  
Keyword(s):  
Side Effects ◽  
Liver Toxicity ◽  
Real Life ◽  
Metastatic Breast ◽  
Complete Response ◽  
Median Number ◽  
Her2 Positive ◽  
Life Study ◽  
Safety Issues

e12507 Background: T-DM1 is widely used in HER2 positive metastatic breast cancer (MBC) patients (pts), often for many cycles until progression. However, little is known about its long term toxicity. The aim of this study was to evaluate the safety profile of T-DM1 when delivered for ≥12 cycles. Methods: HER2 positive MBC pts who had received ≥12 cycles of T-DM1 across 18 Italian cancer centers were enrolled from January 2017 to September 2018. The 12 cycles cut-off was chosen based on the EMILIA trial median PFS (9.6 months), to identify a patient population treated with T-DM1 for longer time. Tumor and clinical characteristics were collected. Standard haematological tests, blood chemistries and side effects (nausea, vomiting, diarrhea, stomatitis, asthenia) were recorded cycle by cycle, according CTCAE criteria version 4. Haematological and laboratory toxicities were available for 86 patients, while other toxicities for all 115 patients. Results: Overall, 115 pts were enrolled. Median age was 54.5 (range 29.6–81.9); median time from diagnosis of metastatic disease to first T-DM1 cycle was 32.5 months. T-DM1 was administered as 2nd line and 3rd line of treatment in 45.2% and 27.8% of pts, respectively. Median number of cycles was 18 (range 12-59). Complete response, partial response and stable disease rates were 11.4%, 43% and 45.6%, respectively. Treatment related side effects are shown in table 1. Interestingly, no increased liver toxicity was observed in pts with liver metastases. Analysis of mean CTCAE grade by cycle showed that no relevant incremental toxicity was observed during long term T-DM1 therapy. Conclusions: T-DM1 is safe and well tolerated in these long responding pts. We found no relevant cumulative toxicity. Patients should be treated with T-DM1 as long as their tumor responds, as no safety issues are related to its long term use. [Table: see text]

Nivolumab in renal cancer: French evaluation of use, current practices and medico economic approach.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16093-e16093
Author(s):  
Francoise Grude ◽  
Gildas Appéré ◽  
Fanny Marhuenda ◽  
Delphine Deniel Lagadec ◽  
Elouen Boughalem ◽  
...  
Keyword(s):  
Survival Data ◽  
Renal Carcinoma ◽  
Real Life ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Real Life Setting ◽  
Medico Economic ◽  
Ecog Ps ◽  
Grade Iii

e16093 Background: Since April 2016 (EMA approval), Nivolumab could be prescribed in advanced renal carcinoma after prior treatment. The Brittany and Pays de la Loire Cancer Observatory has collected data on their real-life indications, current management, safety, efficacy and medico-economics. Methods: All non opposing adult patients with renal carcinoma initiated nivolumab (3 mg/kg q2w) in 2016 and 2017 were included. Minimum follow-up for survival was 12 months. Sex, age, performans status PS ECOG, toxicities, response rate, Progression Free Survival (PFS) and Overall Survival (OS) have been studied. Results: 141 pts were treated by nivolumab in 2016 and 2017 with a median age of 68 years old [39-94] and with 26% aged at least 75 years. The median number of courses was 7 [1-47]. 68 pts (48%) had 1 to 6 courses, 16 pts (11%) 7 to 12 courses, 25 pts (18%) 13 to 24 courses and 32 pts (23%) more than 25 courses. 81 (58%) pts were treated in 2nd line, 34 (24%) in 3rd line, and 25 (18%) in further lines. All lines combined, Complete Response (CR) was observed for 3 pts (2%), Partial Response (PR) for 26 pts (18%), Stable Disease (SD) for 36 pts (26%) (disease control DC : 46%) and disease progression for 51 pts (36%). For 25 pts (18%), nivolumab treatment has been stopped before first medical imaging. PS ECOG was 0-1 for 88 pts (62%), 2 for 21pts (15%), 3-4 for 8 pts (6%) and unknown for 24 pts. Median OS and PFS were 18.2 months and 3.2 months, respectively. No difference on survival has been noticed according to gender, treatment line, age (cut-off 70 or 75 yo) and grade III/IV toxicity. However, OS and PFS were significantly influenced by general health (p < 0.0001). PFS for PS 0-1 pts was 6.5 months, for PS2 2.3 months and for PS3-4 0.8 months. OS was not reached for PS0-1 pts, 3.8 months for PS2 pts and 0.8 months for PS3-4 pts. OS for patients with DC (RC+RP+SD) has not reached and PFS was 14.9 months respectively. 17% of patients presented grade III/IV toxicities. Nivolumab courses during the 2 years costed 5.1 millions of euros (drug, hospitalisation and transportation). 80% of this costs were dedicated to pts who experienced DC. Conclusions: In real life setting, survival outcomes and toxicities with nivolumab in advanced renal carcinoma are comparable to literature’s data. ECOG PS≥2 pts presented shorter survival than PS0-1 pts. Interestingly, 80% of the cost incurred for these treatments benefited to pts with DC. Updated survival data will be available be shown at the meeting.

Subcutaneous alemtuzumab in patients with refractory/relapsed B-CLL after a fludarabine-based regimen

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6600-6600
Author(s):  
R. Bezares ◽  
G. Stemmelin ◽  
D. Argentieri ◽  
E. Lanari ◽  
E. Guy-Garay ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Residual Disease ◽  
Single Agent ◽  
Complete Response ◽  
Median Number ◽  
Duration Of Treatment ◽  
Barr Virus ◽  
Epstein Barr ◽  
Grade 3 ◽  
Cmv Disease

6600 Background: Alemtuzumab is the only immunotherapy that is effective as a single agent in patients with B-CLL who are refractory to, or who have relapsed after, fludarabine therapy. The optimized schedule for alemtuzumab that achieves maximal efficacy with manageable toxicity is still being explored. We report the first interim analysis of a new, less intensive schedule of alemtuzumab SC to patients with refractory/relapsed B-CLL. Methods: Alemtuzumab was dose escalated from 10 to 20 mg during the first week, 30 mg bid during the second and third weeks, and 30 mg once weekly during weeks 4, 6, 8, 10, 12, 16, 20, 24, 28, 34, and 40. Antiviral prophylaxis included TMP/SMX bid 3 times a week and acyclovir 200 mg tid. Results: Patients (N = 36) with refractory (19%) or relapsed (81%) B-CLL had a median age of 67 years (range, 43–86 years), 28 were male, 61%/39% had Binet stage B/C disease, and 2 had B-cell prolymphocytic transformation. The median number of prior therapies was 1 (range, 1–4). The median duration of treatment was 7 weeks (range, 2–24 weeks), with a median cumulative alemtuzumab dose of 412 mg (range, 150–1,080 mg). Thirty-two patients were evaluable for response. The overall response rate of 93%: complete response (CR), 34%; unconfirmed CR, 6%; partial response (PR), 53%. Two patients (7%) did not respond to therapy. Of the 7 refractory patients, 5 had a PR, 1 did not respond, and 1 was not yet evaluable. Median overall survival was 10 months, which correlated with response and pretreatment status. Minimal residual disease (MRD) was measured by flow cytometry in 5 patients who achieved a CR: 3 patients had <0.5% of CD5/CD19/CD23+ cells, 1 patient had <5% of CLL cells, and 1 patient had <10% CLL cells. According to WHO toxicity criteria, 5 patients experienced grade 3/4 infection; 2 patients had grade 3 granulocytopenia/thrombocytopenia; 1 patient had cytomegalovirus (CMV) reactivation without CMV disease; and 1 patient developed Epstein-Barr Virus with prolonged bone marrow hypoplasia. Conclusions: Results of this interim analysis suggest that a less intense regimen of alemtuzumab is feasible, effective, and safe for patients with refractory/relapse B-CLL after fludarabine therapy. No significant financial relationships to disclose.

Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 7518-7518
Author(s):  
Christopher Fegan ◽  
Alexey Valeryevich Danilov ◽  
Daniel Hodson ◽  
Gilles A. Salles ◽  
Alexander Starodub ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tyrosine Kinase ◽  
B Cell ◽  
Progressive Disease ◽  
Median Number ◽  
Maximum Tolerated Dose ◽  
Duration Of Treatment ◽  
B Cell Malignancies ◽  
Grade 3 ◽  
Clinical Trial Information

7518 Background: GS-4059 (ONO-4059) selectively and irreversibly inhibits Bruton’s tyrosine kinase (BTK) and entospletinib selectively inhibits spleen tyrosine kinase (SYK). Methods: This ongoing phase 1b study is evaluating the safety and tolerability of GS-4059 combined with entospletinib in patients with previously treated CLL, FL, SLL, MCL, MZL, WM, or non-GCB DLBCL. The study design uses 3+3 dose escalation (Table) withexpansion cohorts at potential phase 2 doses. Results: With a median duration of treatment of 22 weeks (range 3-56), 26/32 enrolled patients continue on treatment. The median age was 70 (43–85) years and 59% were men. Patients had the following diseases: CLL (n = 9), non-GCB DLBCL (7), FL (6), WM (5), MCL (2), SLL (2), and MZL (1). The median number of prior therapies was 2 (1–5). Five patients discontinued all study treatment, 4 due to disease progression (DLBCL x 2, MCL, MZL) and one due to withdrawal of consent. There has been 1 death on study due to progressive disease. The maximum tolerated dose was not reached. 90% of patients treated reported a treatment-emergent AE (TEAE) of which 48% were grade ≥3. Grade ≥3 TEAEs that were present in more than 1 patient were neutropenia (4), anemia, thrombocytopenia, pneumonia and AST/ALT elevation (2 each). The TEAEs present in >10% of patients were fatigue (7), petechiae (5), asthenia, constipation, contusion, dyspepsia, neutropenia and rash (4 each). No patients discontinued treatment due to AEs and all 5 patients with interruption of treatment for an AE successfully re-initiated therapy. 17 patients were evaluable for best overall response with the results as follows: 11 with partial responses (2 each with CLL, DLBCL, FL, SLL, WM, 1 with MCL); 4 with stable disease; 2 with progressive disease. Conclusions: GS-4059 at up to 160 mg in combination with entospletinib up to 400 mg daily was safe and well tolerated, supporting the continued clinical evaluation of the combination for the treatment of B-cell malignancies. Clinical trial information: NCT02457598 Clinical trial information: NCT02457598. [Table: see text]

Bortezomib, Bendamustine, and Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma: The Phase II VERTICAL Study

2011 ◽  
Vol 29 (25) ◽  
pp. 3389-3395 ◽  
Author(s):  
Nathan Fowler ◽  
Brad S. Kahl ◽  
Peter Lee ◽  
Jeffrey V. Matous ◽  
Amanda F. Cashen ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Response Rate ◽  
International Workshop ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Complete Response ◽  
Maximum Tolerated Dose ◽  
Free Survival ◽  
Highly Active ◽  
Grade 3

Purpose The aims of this multicenter study were to evaluate the response rate, progression-free survival, and toxicity of the combination of bortezomib, bendamustine, and rituximab in patients with follicular lymphoma whose disease was relapsed or refractory to prior treatment. Patients and Methods Patients received five 35-day cycles of bortezomib, bendamustine, and rituximab: bortezomib administered intravenously (IV) at a dose of 1.6 mg/m2 on days 1, 8, 15, and 22, cycles one to five; bendamustine 50, 70, or 90 mg/m2 IV over a 60-minute infusion on days 1 and 2, cycles one to five; and rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle one and day 1 of subsequent cycles. Patients were assessed using the International Workshop Response Criteria, with the primary end point of 60% complete response rate. Results Seventy-three patients were enrolled. During the dose-escalation phase, the maximum-tolerated dose for bendamustine was not reached; the 90 mg/m2 dose level was expanded for the efficacy assessment, and a total of 63 patients received bendamustine 90 mg/m2. In these 63 patients, the overall response rate was 88% (including 53% complete response). Median duration of response was 11.7 months (95% CI, 9.2 to 13.3). Median progression-free survival was 14.9 months (95% CI, 11.1 to 23.7). Toxicities were manageable; myelosuppression was the main toxicity (25% and 14% of patients experienced grade 3 to 4 neutropenia and grade 3 to 4 thrombocytopenia, respectively). Transient grade 3 to 4 neuropathy occurred in 11% of patients. Conclusion The combination of bortezomib, bendamustine, and rituximab is highly active in patients with follicular lymphoma who have received previous treatment.

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