Baseline and early change of systemic inflammation index (bSII and ΔSII) as prognostic factors in metastatic renal cell carcinoma (mRCC) patients treated with Nivolumab: Final results of the Meet-URO 15 (I-BIO-REC) study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5072-5072
Author(s):  
Sara Elena Rebuzzi ◽  
Francesco Atzori ◽  
Marilena Di Napoli ◽  
Marco Stellato ◽  
Marco Messina ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Overall Response Rate ◽  
Complete Blood Count ◽  
Progression Free Survival ◽  
Free Survival ◽  
Secondary Analyses ◽  
The Difference ◽  
Line Of Therapy ◽  
Metastatic Sites

5072 Background: Biomarkers to select mRCC patients most likely to benefit to immunotherapy are still needed. The retrospective multicentre Meet-URO-15 study evaluated the prognostic role of peripheral blood cells in mRCC patients treated with Nivolumab. Methods: Complete blood count was collected at the first four cycles of Nivolumab. The primary endpoint was median overall survival (mOS) according to baseline neutrophil-to-lymphocyte ratio. Secondary analyses included bSII defined as platelet x NLR (cutoff = 1375) and ΔSII defined as the difference between SII at 2ndcycle and bSII (median used as cutoff = 383). Results: From October 2015 to October 2019, 470 patients started Nivolumab as 2nd(67%), 3rd(22%) and > 3rd(11%) line. Median age was 66 years, 71% were male and 83% had clear cell histology. Baseline IMDC group was favorable in 25%, intermediate in 63% and poor in 12%. Lymph-nodes, visceral and bone metastases were present in 54%, 91% and 36%. mOS and progression-free survival (PFS) were 34.8 and 7.5 months. Overall response rate (ORR) and disease control rate (DCR) were 30% and 61%. SII was available in 404 patients: SII < 1375 (82%) correlated with statistically significant improvement of PFS [10.2 vs 4.1 months, HR 2.06 (1.54-2.76), p< 0.001], OS [46.2 vs 9.5 months, HR 3.16 (2.23-4.49), p< 0.001], ORR (35% vs 21%, p= 0.035) and DCR (67% vs 40%, p< 0.001). ΔSII was available in 360 patients: ΔSII < 383 (75%) correlated with statistically significant improvement of PFS [11.3 vs 4.7 months; HR 1.64 (1.23-2.18), p= 0.001] and OS [NR vs 21.1 months; HR 1.76 (1.21-2.56), p= 0.003], ORR (37% vs 24%, p= 0.023) and DCR (68% vs 53%, p= 0.01). Multivariate analyses adjusted for IMDC group, line of therapy and metastatic sites, confirmed the statistically significant correlation of bSII and ΔSII with OS, PFS and DCR. Conclusions: Our study showed the statistically significant correlation of lower bSII and early ΔSII with longer OS, PFS and higher DCR in mRCC patients treated with Nivolumab.

Baseline and early change of neutrophil to lymphocyte ratio (bNLR and ΔNLR) as prognostic factors in metastatic renal cell carcinoma (mRCC) treated with Nivolumab: Final results of the Meet-URO 15 (I-BIO-REC) study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17081-e17081
Author(s):  
Sara Elena Rebuzzi ◽  
Sebastiano Buti ◽  
Marco Maruzzo ◽  
Ugo De Giorgi ◽  
Andrea Sbrana ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Overall Response Rate ◽  
Clear Cell ◽  
Complete Blood Count ◽  
Progression Free Survival ◽  
Free Survival ◽  
The Difference ◽  
Line Of Therapy ◽  
Metastatic Sites

e17081 Background: Biomarkers to select mRCC patients most likely to benefit to immunotherapy are needed. The retrospective multicentre Meet-URO-15 study evaluated the prognostic role of peripheral blood cells in mRCC patients treated with Nivolumab. Methods: Complete blood count was assessed at the first four cycles of Nivolumab. The primary endpoint was median overall survival (mOS) according to bNLR. NLR was defined as neutrophil / lymphocyte (cutoff = 3) and ΔNLR the difference between NLR at 2nd cycle and bNLR (median as cutoff = 1.1). Results: From October 2015 to October 2019, 470 patients started Nivolumab as 2nd (67%), 3rd (22%) and > 3rd (11%) line. Median age was 66 years, 71% were male and 83% had clear cell histology. Baseline IMDC group was favorable in 25%, intermediate in 63% and poor in 12%. Lymph-nodes, visceral and bone metastases were present in 54%, 91% and 36%. mOS and progression-free survival (PFS) were 34.8 and 7.5 months. Overall response rate (ORR) and disease control rate (DCR) were 30% and 61%. bNLR was available in 404 patients: bNLR < 3 (54%) correlated with statistically significant longer PFS [11.4 vs 5.4 months; HR 1.69 (1.33-2.15)] and OS [46.2 vs 17.2 months; HR 2.37 (1.72-3.26)] (both p< 0.001), with similar ORR (35% vs 30%, p= 0.28) but higher DCR (71% vs 52%, p< 0.001). ΔNLR was available in 360 patients: ΔNLR < 1.1 (73%) correlated with a statistically significant improvement of PFS [11.2 vs 4.9 months; HR 1.53 (1.16-2.03), p= 0.03], OS [Not Reached vs 19.7 months; HR 1.83 (1.28-2.61), p= 0.001], ORR (37% vs 23%, p= 0.011) and DCR (68% vs 53%, p= 0.008). Multivariate analyses adjusted for IMDC group, line of therapy and metastatic sites, confirmed the statistically significant correlation of bNLR and ΔNLR with OS, PFS and DCR. Conclusions: Our study showed the statistically significant correlation of lower bNLR and early ΔNLR with longer OS, PFS and higher DCR in mRCC patients treated with Nivolumab.

Baseline and early change of neutrophil to lymphocyte ratio (bNLR and ΔNLR) as prognostic factors in metastatic renal cell carcinoma (mRCC) patients treated with nivolumab: Preliminary results of the Meet-URO 15 (I-BIO-REC) study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 752-752
Author(s):  
Sara Elena Rebuzzi ◽  
Sebastiano Buti ◽  
Luca Galli ◽  
Giuseppe Procopio ◽  
Ugo De Giorgi ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Complete Blood Count ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Prognostic Role ◽  
Free Survival ◽  
The Difference ◽  
Line Of Therapy ◽  
Metastatic Sites

752 Background: Biomarkers to select mRCC patients most likely to benefit to immune-checkpoint inhibitors are still needed. The ongoing retrospective multicentre Meet-URO 15 (I-BIO-REC) study evaluates the prognostic role of peripheral blood cells in mRCC patients treated with nivolumab. Methods:The primary endpoint of the study was median overall survival (mOS) according to bNLR. Complete blood count was collected at the first four cycles of nivolumab. NLR was defined as the ratio of neutrophil to lymphocyte (cutoff = 3) and ΔNLR the difference between NLR at 2nd cycle and bNLR (median used as cutoff = 0.3). Here we reported preliminary analyses on bNLR and DNLR. Results: From May 2016 to January 2019 189 patients started nivolumab as 2nd (62%), 3rd (25%) and > 3rd (13%) line. Median age was 69 years, 67% were male and 87% had clear cell histology. Baseline IMDC group was favorable in 26%, intermediate in 63% and poor in 11%. Lymph-nodes, visceral and bone metastases were present in 55%, 92% and 37%. mOS and progression-free survival (PFS) were 30.5 months and 9.5 months. Overall response rate (ORR) and disease control rate (DCR) were 28% and 57%. bNLR was available in 162 patients: bNLR < 3 (52%) correlated with statistically significant longer PFS [11.5 vs 5.6 months; HR 1.61 (1.09-2.39), p = 0.017] and OS [NR vs 22.4 months; HR 2.61 (1.53-4.46), p < 0.001], with similar ORR (32% vs 32%) but higher DCR (66% vs 55%) compared to NLR ≥ 3. ΔNLR was available in 136 patients: ΔNLR < 0.3 (50%) correlated with statistically significant longer PFS [17.1 vs 8.5 months; HR 1.57 (1.02-2.43) p = 0.04] and OS [medians not reached; HR 1.91 (1.04-3.51) p = 0.038], with similar ORR (39% vs 32%) but higher DCR (73% vs 56%) compared to ΔNLR ≥ 0.3. Univariate and multivariate analyses adjusted for IMDC group, line of therapy and metastatic sites, confirmed the statistically significant correlation between ΔNLR with PFS and OS and NLR with OS but not with PFS. Conclusions: Preliminary analyses of our study showed a prognostic role of bNLR and early ΔNLR in mRCC patients treated with nivolumab.

Baseline lymphocyte to monocyte ratio (LMR) and systemic inflammation index (SII) as prognostic factors in metastatic renal cell carcinoma (mRCC) patients treated with nivolumab: Preliminary results of the Meet-URO 15 (I-BIO-REC) study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 751-751 ◽  
Author(s):  
Sara Elena Rebuzzi ◽  
Sebastiano Buti ◽  
Andrea Sbrana ◽  
Giuseppe Procopio ◽  
Ugo De Giorgi ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Prognostic Role ◽  
Free Survival ◽  
Lymphocyte To Monocyte Ratio ◽  
Secondary Endpoints ◽  
Line Of Therapy ◽  
Metastatic Sites

751 Background: Biomarkers to select mRCC patients most likely to benefit to immune-checkpoint inhibitors are still needed. The ongoing retrospective multicentre Meet-URO 15 (I-BIO-REC) study evaluates the prognostic role of peripheral blood cells in mRCC patients treated with nivolumab. Methods:The primary endpoint of the study was median overall survival (mOS) according to baseline neutrophil to lymphocyte ratio (NLR), but here preliminary analyses on baseline LMR and SII (secondary endpoints) are reported. LMR was defined as the ratio of lymphocyte to monocyte (cutoff = 3) and SII as platelet x neutrophil/lymphocyte (cutoff = 1375). Results: From May 2016 to January 2019 189 patients started nivolumab as 2nd (62%), 3rd (25%) and > 3rd (13%) line. Median age was 69 years, 67% were male and 87% had clear cell histology. Baseline IMDC group was favorable in 26%, intermediate in 63% and poor in 11%. Lymph-nodes, visceral and bone metastases were present in 55%, 92% and 37%. mOS and progression-free survival (PFS) were 30.5 months and 9.5 months. Overall response rate (ORR) and disease control rate (DCR) were 28% and 57%. LMR was available in 150 patients: LMR ≥ 3 (44%) correlated with statistically significant longer OS [NR vs 26.8 months, HR 0.50 (0.29-0.88); p = 0.016] but not PFS (10.3 vs 9.9 months, HR 0.87 (0.58-1.31); p = 0.5) with similar ORR (34% vs 33%) and DCR (60% vs 63%) compared to LMR < 3. SII was available in 162 patients. SII < 1375 (82%) correlated with statistically significant longer PFS [11.5 vs 3.4 months; HR 2.16 (1.36-3.43), p = 0.001] and OS [NR vs 9.5 months; HR 3.87 (2.21-6.78), p < 0.001] with higher ORR (35% vs 20%) and DCR (65% vs 40%) compared to SII ≥ 1375. Univariate and multivariate analyses adjusted for IMDC group, line of therapy and metastatic sites, confirmed the statistically significant correlation between SII with PFS and OS, but not for LMR. Conclusions: Preliminary analyses of our study showed a prognostic role of baseline SII, while it is uncertain for LMR in mRCC patients treated with nivolumab.

scholarly journals OS14 - 208 The prognostic role of pre-operative complete blood count (CBC) in progression-free survival in patients with meningioma

2016 ◽  
Vol 43 (S4) ◽  
pp. S6-S6
Author(s):  
S. Karimi ◽  
P.D. Tonge ◽  
L. Gonen ◽  
R. Tabasinejad ◽  
G. Zadeh ◽  
...  
Keyword(s):  
Complete Blood Count ◽  
Tumor Resection ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Tumor Grade ◽  
Prognostic Information ◽  
Free Survival ◽  
Univariate Analyses

Factors which might influence outcome in patients with meningioma are not well-understood. Previous studies have examined associations of laboratory blood values including hemoglobin levels with patient outcomes in cancer. We hypothesized those changes in CBC before tumor resection can be used as one of the prognostic factors for tumor recurrence/progression in meningioma. To address this, we gathered the clinical and pre-operative CBC results for final analysis from 226 patients (64 males and 162 females) who underwent craniotomy for primary meningioma (grades: 157 WHO GI, 59 GII, 10 GIII) at our institution between 2001 and 2015.Individual parameters were analyzed for correlation with progression-free survival. The median recurrence free survival (RFS) was not reached and follow-up ranged 0.3-14 years. Fifty-six patients (25%) had anemia and 30% of the patients showed leukocytosis using standard cut-offs. On univariate analyses, low hemoglobin (Hb) level, as well as high leukocytes (Lkc), neutrophil (Neutro) and monocyte counts correlated with worse RFS. As expected, tumor grade was correlated with RFS. Low Hb level, high Lkc and Neutro counts were all significantly associated with RFS after adjusting for grade. Strikingly, 32% of patients with pre-operative anemia experienced a recurrence at 5 years, compared with only 11% of non-anemic patients. Conclusion: In this exploratory study, we find that pre-operative CBC data, which is readily available, may contain prognostic information relevant to subsequent risk of recurrence or progression in meningioma. While the biological mechanism for these associations is not clear, they represent hypotheses for further investigation.

scholarly journals Multicenter Phase II Study of a New Effective S-1 and Irinotecan Combination Schedule in Patients with Unresectable Metastatic or Recurrent Colorectal Cancer

2013 ◽  
Vol 7 ◽  
pp. CMO.S10769 ◽  
Author(s):  
◽  
Yutaka Ogata ◽  
Takaho Tanaka ◽  
Yoshito Akagi ◽  
Nobuya Ishibashi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Median Overall Survival ◽  
Overall Response Rate ◽  
Phase Ii Study ◽  
Progression Free Survival ◽  
Recurrent Colorectal Cancer ◽  
Free Survival ◽  
Multicenter Phase ◽  
Grade 3

Introduction This multicenter phase II study determined the efficacy and safety of new daily oral S-1 and weekly irinotecan (CPT-11) combination schedule in patients with previously untreated advanced or recurrent colorectal cancer. Patients and Methods Patients received first-line chemotherapy comprising S-1 80 mg/m2/day given on days 3 to 7, 10 to 14, and 17 to 21 and 60 mg/m2 CPT-11 administered intravenously on days 1, 8, and 15 of a 28-day cycle. Results A total of 45 eligible patients were enrolled in this study. The overall response rate was 48.9%. Median progression-free survival and median overall survival was 8.1 months and 20.9 months, respectively. The rates of grade 3 or 4 toxicity were as follows: neutropenia, 8.9%; anemia, 4.4%; anorexia, 6.7%; and diarrhea, 6.7%. Conclusions This new S-1 and irinotecan combination schedule appeared to be an effective, well-tolerated, and convenient regimen in patients with advanced colorectal cancer as compared with conventional regimens such as FOLFIRI and IRIS.

Advanced chondrosarcomas: Role of chemotherapy and survival.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10023-10023
Author(s):  
Binh Bui Nguyen ◽  
Angela Cioffi ◽  
Sophie Piperno-Neumann ◽  
Loic Chaigneau ◽  
François Bertucci ◽  
...  
Keyword(s):  
Performance Status ◽  
Objective Response ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Best Supportive Care ◽  
Progression Rate ◽  
Free Survival ◽  
Investigational Drugs ◽  
Metastatic Sites

10023 Background: There are no data about the role of chemotherapy in patients with advanced chondrosarcomas. Methods: From 2000 to 2011, 98 patients with a confirmed diagnosis of advanced chondrosarcomas were referred to one of the 8 participating institutions, and their medical records reviewed. Results: Median age was 46 years (range 16-82). The most frequent histological subtype was conventional chondrosarcoma (n=60, 61%). 83 patients (85%) had metastatic disease ( lung n=71, bone n=23, liver n=6) and 15 patients (15%) had locoregional unresectable disease. 30 patients (31%) had ≥ 2 metastatic sites. 63 patients (64%) received 1st-line combination agent chemotherapy. 70 patients (71%) received a 1st-line anthracycline-containing regimen (doxorubicin + cisplatin +/- ifosfamide: n=30, doxorubicin or pegylated liposomal doxorubicin: n=18, doxorubicin + ifosfamide +/- dacarbazine: n=16, others= 6). RECIST objective response was observed in 14 patients (14%), all but two treated with anthracyclines. 30 patients (31%) had stable disease > 6 months. Median progression-free survival (PFS) and overall survival (OS) were 5.3 months (95% CI: 2.8-7.7) and 19 months (95% CI: 14-24) respectively. Performance status (PS) ≥ 2 was the sole factor significantly associated with OS. Conclusions: Chemotherapy is associated with a 6-month non-progression rate of about 45% in patients with advanced chondrosarcoma. Best supportive care should be considered in patients with poor PS. These data should be used as a reference for response and outcome in the assessment of investigational drugs in advanced chondrosarcoma.

Efficacy of chemotherapy for patients with unresectable or recurrent pancreatic adenosquamous carcinoma: A multicenter retrospective analysis.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 647-647 ◽  
Author(s):  
Yukio Yoshida ◽  
Akira Fukutomi ◽  
Makoto Ueno ◽  
Keita Mori ◽  
Kazuo Watanabe ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Adenosquamous Carcinoma ◽  
Treatment Options ◽  
Objective Response ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Ductal Adenocarcinoma ◽  
Poor Survival ◽  
Free Survival ◽  
Metastatic Sites

647 Background: Pancreatic adenosquamous carcinoma (PASC) is a rare variant of pancreatic ductal adenocarcinoma (PDAC). Although unresectable or recurrent PASC is usually treated by systemic chemotherapy, there are few reports which show the efficacy of chemotherapy. The aim of this study was to evaluate the efficacy of chemotherapy for patients (pts) with unresectable or recurrent PASC. Methods: We collected data retrospectively from 24 Japanese institutions. The selection criteria were as follows: 1) histologically or cytologically proven PASC (non-surgical specimens were eligible if squamous cell carcinoma (SCC) was detected), 2) unresectable or recurrent disease treated with 1st line chemotherapy between April 2001 and December 2017. Results: This study included 138 pts with median age of 66 years (range: 36-85). About 60% of pts were diagnosed with biopsy and only SCC was detected in 13.0% of pts. Median overall survival (mOS) was 6.7 months (M), median progression free survival (mPFS) was 2.8 M, and the 1-year survival rate (1YSR) was 26.7%. For the 102 metastatic or distal recurrent pts with PS of 0-1, patient characteristics were as follows: ≥76 years old, 9 (8.8%); PS of 0, 39 (38.2%); number of metastatic sites ≥2, 25 (24.5%). The treatment efficacies (The objective response rates(%)/mPFS(M)/mOS(M)/1YSR(%)) of the 5 major regimens were Gemcitabine(GEM) (n=45, 4.4%/2.2M/4.8M/28.1%), GEM+nab-PTX (n=24, 29.2%/2.9M/7.6M/23.1%), GEM+S-1 (n=9, 11.1%/5.1M/9.9M/25.4%), FOLFIRINOX (n=7, 14.3%/2.5M/7.5M/14.3%), and S-1 (n=7; 28.6%/2.6M/5.0M/28.6%), respectively. One patient with liver metastasis underwent conversion surgery after GEM+nab-PTX and achieved long survival. CRP ≥3.0mg/dl, CA19-9 ≥1000 U/ml, residual primary site, and monotherapy had a significant correlation with poor survival in multivariate analysis. Conclusions: Although combination chemotherapy regimens such as FOLFIRINOX and GEM+nab-PTX are now available, the prognosis of metastatic PASC remains poor. Development of more effective treatment options is required.

Retrospective study to identify clinical factors related to a high benefit of axitinib in mRCC: Results from AXILONG Spanish real-world study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 650-650
Author(s):  
Alvaro Pinto ◽  
Clara Iglesias Gomez ◽  
Miguel Ángel Climent ◽  
Enrique Gallardo Diaz ◽  
Xavier Garcia del Muro ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Median Overall Survival ◽  
Overall Response Rate ◽  
Progression Free Survival ◽  
Clinical Factors ◽  
Free Survival ◽  
Best Response ◽  
Extreme Response ◽  
High Benefit ◽  
Clinical Trial Information

650 Background: AXILONG is a Pfizer observational multi-institutional retrospective study, evaluating clinical factors which could be related with a higher benefit of axitinib in pretreated mRCC patients in two pre-specified subgroups with extreme response to axitinib. Methods: Medical records from 157 patients treated in 40 Spanish hospitals with axitinib under clinical practice were retrospectively reviewed and included in the study. Of note, patients had to had an extreme response with axitinib, which means being a long responder (LR) to axitinib, defined as those patients who achieved a median Progression Free Survival (mPFS) of 9 months or longer, or refractory patients (RP) those who achieved a Progression Disease (PD) as best response. Results: In this analysis, we describe the results of a subgroup of patients who received axitinib in second-line after sunitinib, which represents the 68,2% (n=107) of the patients included in the whole study. The 55,1% (n=59) of this subgroup were LR and the 44,9% (n=48) were RP. In this sub-group of patients, the mPFS in LR was 18,7 months (95%CI; 12,9-24,4) and the overall response rate (ORR) was 43,9% (3,5% CR). Median overall survival (mOS) since the start of axitinib was 28,2 months for both sub-groups included, being 44,8 months in the LR patients and 7,3 months in the RP (95% CI, 12.79–34.65; p <0,001). In this population the 1st line mPSF was 27,2 months in LR and 10,9 months in RP (95%CI; 12,97-20,15; p ≤0,001). Conclusions: Despite the limitations of the AXILONG study there were a subgroup of patients who can be considered long responders o axitinib in whom we can obtain a high benefit in terms of efficacy, when treating with the sequence sunitinib-axitinib. Clinical trial information: NCT03538717 .[Table: see text]

Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial

Blood ◽  
2006 ◽  
Vol 108 (10) ◽  
pp. 3295-3301 ◽  
Author(s):  
Marinus H. J. van Oers ◽  
Richard Klasa ◽  
Robert E. Marcus ◽  
Max Wolf ◽  
Eva Kimby ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Progression Free Survival ◽  
Remission Induction ◽  
Phase 3 ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Rituximab Maintenance ◽  
Non Hodgkin Lymphoma

Abstract We evaluated the role of rituximab (R) both in remission induction and maintenance treatment of relapsed/resistant follicular lymphoma (FL). A total of 465 patients were randomized to induction with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (every 3 weeks) or R-CHOP (R: 375 mg/m2 intravenously, day 1). Those in complete remission (CR) or partial remission (PR) were randomized to maintenance with R (375 mg/m2 intravenously once every 3 months for a maximum of 2 years) or observation. R-CHOP induction yielded an increased overall response rate (CHOP, 72.3%; R-CHOP, 85.1%; P < .001) and CR rate (CHOP, 15.6%; R-CHOP, 29.5%; P < .001). Median progression-free survival (PFS) from first randomization was 20.2 months after CHOP versus 33.1 months after R-CHOP (hazard ratio [HR], 0.65; P < .001). Rituximab maintenance yielded a median PFS from second randomization of 51.5 months versus 14.9 months with observation (HR, 0.40; P < .001). Improved PFS was found both after induction with CHOP (HR, 0.30; P < .001) and R-CHOP (HR, 0.54; P = .004). R maintenance also improved overall survival from second randomization: 85% at 3 years versus 77% with observation (HR, 0.52; P = .011). This is the first trial showing that in relapsed/resistant FL rituximab maintenance considerably improves PFS not only after CHOP but also after R-CHOP induction.

Bendamustine, bortezomib, and dexamethasone (BVD) in elderly patients with relapsed/refractory multiple myeloma (RRMM): The Intergroupe Francophone du Myélome (IFM) 2009-01 protocol.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8014-8014 ◽  
Author(s):  
Philippe Rodon ◽  
Cyrille Hulin ◽  
Brigitte Pegourie ◽  
Mourad Tiab ◽  
Bruno Anglaret ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Maintenance Phase ◽  
Progression Free Survival ◽  
Free Survival ◽  
Prior Therapy ◽  
Phase 2 Trial ◽  
Small Series ◽  
Grade 3 ◽  
D 20 ◽  
Line Of Therapy

8014 Background: Bortezomib (V) plus dexamethasone (D) is a treatment of choice of RRMM. In small series, the addition of an alkylator was beneficial. Bendamustine (B) showed a high activity in advanced MM. The IFM 2009-01 trial evaluates the combination of B, V and D in elderly pts with MM progressive on or after 1st line therapy. Methods: We conducted a phase 2 trial combining B 70 mg/m2 D1-8, V 1.3 mg/m2 D1-8-15-22 and D 20 mg D1-8-15-22 every 28 days. 4 cycles were administered. In responders (PR or better), 2 additional cycles were provided followed by a maintenance phase with 6 cycles given every 2 months. Inclusion criteria were progression on or after 1 prior line of therapy, measurable disease, PS ECOG <3, ANC > 1.5x109/l, platelets > 100x109/l, creatinine < 250 mcmol/l, AST and ALT < 3xULN. Pts with prior exposure to bortezomib were excluded. Response was evaluated according to IMWG criteria. Primary end point was response at end of cycle 4, secondary objectives overall response rate (ORR), progression-free survival (PFS), overall survival (OS) and toxicity. Results: The present analysis was restricted to the first 4 cycles. From 03/2010 to 07/2011, 73 pts were included, median age 75.8 years (range 66-86). Median time from diagnosis to inclusion was 29 months. All pts received only 1 prior therapy: MP in 12, MP-thalidomide in 44, lenalidomide-dexamethasone (LD) in 14, other in 3. 42 pts (57.5%) were responders at end of cycle 4 [CR: 8 (10.9%), VGPR: 9 (12.3%), PR: 25 (34.2%), SD: 10 (13.6%), progression: 11 (15%), early discontinuation: 10 (13.6%)]. 6pts/10 were in PR and 1pt/10 in VGPR at time of discontinuation. ORR was 67.1% (49/73 pts). 11 pts died (MM: 6, sepsis: 4, renal failure: 1). Adverse events grade 3-4 were neutropenia: 16 pts, thrombocytopenia: 7 pts, sepsis: 12 pts, gastro-intestinal: 8 pts, anaphylaxis: 1 pt. 2 pts had DVT. Peripheral neuropathy grade>1 occurred in 9 pts, all grade 2. Treatment was stopped in 20 pts (lack of efficacy: 11, toxicity: 9). Conclusions: These results compare favorably with those achieved with VD or LD. The triplet BVD combination is very effective and tolerable in elderly pts with MM in 1st progression.

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