Safety and efficacy of nivolumab in older patients (pts) with renal cell carcinoma: Results of a sub-group analysis of the GETUG-AFU 26 NIVOREN multicenter phase II study.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 331-331
Author(s):  
Loic Mourey ◽  
Cécile Dalban ◽  
Sylvie Negrier ◽  
Christine Chevreau ◽  
Gwenaelle Gravis ◽  
...  
Keyword(s):  
Real World ◽  
Older Patients ◽  
Kinase Inhibitors ◽  
Group Analysis ◽  
Age Groups ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Primary Objective ◽  
Safety And Efficacy ◽  
Real World Setting

331 Background: NIVOREN GETUG AFU 26 study, is a french multicenter prospective study to evaluate safety and efficacy of Nivolumab (N) in a broad “real world setting” in mRCC after failure of 1 or 2 tyrosine kinase inhibitors. Methods: Between February 2016 and July 2017, 729 pts were enrolled across 27 institutions. Primary objective of the trial was safety assessed by grade ≥ 3 treatment related adverse event (TRAE). We report here results of older patients above 70 years old ([70;75[; [75;80[; ≥ 80) compared with their younger counterparts. Results: Overall, 720 patients were treated (median age 64 (22;90)). Among them 205 pts were ≥ 70 (28.5%) divided as follow: [70-75[:107 (14.9%) / [75-80[: 68 (9,4%) / ≥ 80: 30 (4,2%). Patients’ characteristics (Table) were similar in younger and older patients except for IMDC risk groups (IMDC) classification with less poor prognostic in pts ≥ 75 and fewer brain metastasis in pts ≥ 70. Treatment duration was similar across age groups despite a rate of discontinuation for TRAE increasing with age. Regarding efficacy, there was a non-significant trend toward improved response rate and progression free survival and lower specific survival with increasing age. Conclusions: In this large “real world” setting study a significant number of old pts were included. Prognostic profile appears better in older pts included. There is no signal for an excess of toxicity in this population and efficacy is comparable to younger patients. Age alone should not prevent prescribing N in mRCC. Clinical trial information: NCT03013335 . [Table: see text]

Safety and efficacy of nivolumab in metastatic renal cell carcinoma (mRCC): Final analysis from the NIVOREN GETUG AFU 26 study.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 542-542 ◽  
Author(s):  
Laurence Albiges ◽  
Sylvie Negrier ◽  
Cécile Dalban ◽  
Christine Chevreau ◽  
Gwenaelle Gravis ◽  
...  
Keyword(s):  
Prospective Study ◽  
Real World ◽  
Kinase Inhibitors ◽  
Objective Response ◽  
Final Analysis ◽  
Primary Objective ◽  
Duration Of Treatment ◽  
Safety And Efficacy ◽  
Real World Setting ◽  
Grade 3

542 Background: NIVOREN GETUG AFU 26 study, is a French multicenter prospective study to evaluate safety and efficacy of Nivolumab (N) in a broad “real world setting” in mRCC after failure of 1 or 2 tyrosine kinase inhibitors. Methods: Between February 2016 and June 2017, 729 pts have been enrolled across 27 institutions. Primary objective of the trial was safety assessed by grade ≥ 3 treatment related adverse event (TRAE). Results: Overall, 720 patients treated with N were included in this final analysis. All pts had clear cell mRCC. Median age was 64 years old, 77.4% were male, 84.7% had prior nephrectomy. ECOG PS was >1 in 15.0%, 21.3% pts had received prior everolimus, 22.4% pts had received more than 2 previous lines, IMDC risk groups were 18.3%/56.2%/25.5% for good/intermediate and poor risk respectively. Brain Metastasis at screening was noted in 83 (12.3%) pts. With a median follow up of 20.9 months (mo), median duration of treatment was 5.2 mo (0.5; 28.1) with 15% of pts still on therapy. Median PFS was 3.2 IC 95% [2.9; 4.6] mo. At the time of this analysis, 316 pts have died and 12 mo OS rate was 69% IC 95% [66; 73]. Objective response rate was 20.8% (1.2% CR, 19.6%PR). Stable disease was seen in 31.6% and PD in 47.6%. Noteworthy, 46.1% of pts were treated beyond progression. Overall, 123 pts (17.1%) have presented at least one grade ≥ 3 TRAE, including asthenia (2.4%), metabolic disorders (2.1%), gastro-intestinal disorders (1 .9%), musculoskeletal (1.7%), renal disorders (1.3%), hematologic (1.3%). 6 patients have developed grade 5 toxicity (2 cardiac failure, 1 macrophage activation syndrom, 1 Cerebral hemorrhage, 1 unknown). Treatment discontinuation due to any grade TRAE occurred in 54 pts (7.5%). Interestingly, pts with grade ≥ 3 TRAE had longer PFS than pts without grade ≥ 3 TRAE (HR 0.69 [0.55-0.87]). Conclusions: We report the primary objective analysis of the largest prospective real world setting study of N in mRCC. NIVOREN study demonstrates that N safety and efficacy in a “real world” prospective study are similar to the pivotal study. Grade ≥ 3 TRAE was associated with longer PFS. Clinical trial information: NCT03013335.

Safety and efficacy of nivolumab in metastatic renal cell carcinoma (mRCC): Results from the NIVOREN GETUG-AFU 26 study.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 577-577 ◽  
Author(s):  
Laurence Albiges ◽  
Sylvie Negrier ◽  
Cécile Dalban ◽  
Gwenaelle Gravis ◽  
Christine Chevreau ◽  
...  
Keyword(s):  
Prospective Study ◽  
Real World ◽  
Kinase Inhibitors ◽  
Clear Cell ◽  
Univariate Analysis ◽  
Primary Objective ◽  
Duration Of Treatment ◽  
Safety And Efficacy ◽  
Real World Setting ◽  
Ecog Ps

577 Background: Nivolumab (N) has been approved for the treatment of mRCC after failure of 1 or 2 tyrosine kinase inhibitors (TKI) based on the results of Checkmate 025 study. Right after approval, we initiated the NIVOREN GETUG-AFU 26 study (NCT03013335), a French multicenter prospective study to evaluate safety and efficacy of N in a “real world setting”. Methods: Patients (pts) with clear cell mRCC could be enrolled if they had received at least one TKI. Compared with the pivotal trial, inclusion criteria allowed patients with more than 2 previous lines of treatment, including previous mTOR inhibitors, ECOG PS 2, asymptomatic brain metastases (BM) or impaired renal function. The primary objective of the study was the safety of N, efficacy being the main secondary objective. Between February 2016 and June 2017, 729 pts have been enrolled. We report the results from the first 528 pts. Results: All pts had clear cell mRCC, median age was 64, 77.2% were male. ECOG PS was > 1 in 73 pts (14.7%), 27.5% pts had received prior everolimus, 29.7% pts had received more than 2 previous lines, IMDC risk groups were 19%/54.9%/26.1% for good/intermediate and poor risk respectively; 69 (14%) pts had BM at screening. With a median follow up of 13.1 months, median duration of treatment was 4.1 months [0-15.6], with 31.4% of pts still on therapy. Treatment discontinuation due to adverse event (AE) occurred in (48) 13.3% pts . 64 serious related AE have been reported in 52 pts (9.9%) including 7 renal failures and 6 pneumonitis. Median PFS was 4.4 months 95%CI[3;4.6] . At the time of this analysis, 170 pts have died and 12 months OS rate was 66.4% 95%CI[ 61.7; 70.7]. In subgroups analysis, ECOG-PS > 1 (Hazard Ratio (HR) = 2.450 [1.704;3.523]), more than 2 previous lines (HR = 1.442 [1.059;1.963]) and prior use of everolimus (HR = 1.704 [1.250;2.322]) were associated with reduced OS in univariate analysis. Conclusions: We report the first analysis of the largest prospective real world setting study of N in mRCC. NIVOREN study demonstrates that N safety and efficacy in a “real world” prospective study are comparable to the pivotal study. Clinical trial information: NCT03013335.

scholarly journals Selpercatinib in RET fusion-positive non-small-cell lung cancer (SIREN): a retrospective analysis of patients treated through an access program

2021 ◽  
Vol 13 ◽  
pp. 175883592110196
Author(s):  
Oliver Illini ◽  
Maximilian Johannes Hochmair ◽  
Hannah Fabikan ◽  
Christoph Weinlinger ◽  
Amanda Tufman ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Objective Response ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Real World Setting ◽  
Access Program

Introduction: Rearranged during transfection (RET) gene fusions are rare genetic drivers in non-small cell lung cancer (NSCLC). Selective RET-inhibitors such as selpercatinib have shown therapeutic activity in early clinical trials; however, their efficacy in the real-world setting is unknown. Methods: A retrospective efficacy and safety analysis was performed on data from RET fusion-positive NSCLC patients who participated in a selpercatinib access program (named patient protocol) between August 2019 and January 2021. Results: Data from 50 patients with RET fusion-positive advanced NSCLC treated with selpercatinib at 27 centers in 12 countries was analyzed. Most patients were Non-Asian (90%), female (60%), never-smokers (74%), with a median age of 65 years (range, 38–89). 32% of the patients had known brain metastasis at the time of selpercatinib treatment. Overall, 13 patients were treatment-naïve, while 37 were pretreated with a median of three lines of therapy (range, 1–8). The objective response rate (ORR) was 68% [95% confidence interval (CI), 53–81] in the overall population. The disease control rate was 92%. The median progression-free survival was 15.6 months (95% CI, 8.8–22.4) after a median follow-up of 9 months. In patients with measurable brain metastases ( n = 8) intracranial ORR reached 100%. In total, 88% of patients experienced treatment-related adverse events (TRAEs), a large majority of them being grade 1 or 2. The most common grade ⩾ 3 TRAEs were increased liver enzyme levels (in 10% of patients), prolonged QTc time (4%), abdominal pain (4%), hypertension (4%), and fatigue/asthenia (4%). None of patients discontinued selpercatinib treatment for safety reasons. No new safety concerns were observed, nor where there any treatment-related death. Conclusions: In this real-world setting, the selective RET-inhibitor selpercatinib demonstrated durable systemic and intracranial antitumor activity in RET fusion-positive NSCLC and was well tolerated.

Impact of Age in the Outcome of Patients with Chronic Myeloid Leukemia in Late Chronic Phase: Clinical and Molecular Results of a Phase II Study of the GIMEMA CML Working Party.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4805-4805
Author(s):  
Giovanni Martinelli ◽  
Francesca Palandri ◽  
Ilaria Iacobucci ◽  
Simona Bassi ◽  
Fausto Castagnetti ◽  
...  
Keyword(s):  
Phase Ii ◽  
Older Patients ◽  
Age Groups ◽  
Chronic Phase ◽  
Working Party ◽  
Progression Free Survival ◽  
Observation Time ◽  
Molecular Response ◽  
Term Outcome ◽  
Long Term Outcome

Abstract To assess the effect of age on response and compliance we performed a sub-analysis within a phase II trial of the GIMEMA CMLWorking Party (CML/002/STI571). Since the WHO cut-off age to define an older patient is 65 years, we identified: 226/284 (80%) younger patients (below 65 years) and 58/284 (20%) older patients (above 65 years) before starting imatinib. Responses (hematologic and cytogenetic) were lower in older age group but progression free survival and overall survival probabilities (median observation time 3 years) were the same. Moreover, among complete cytogenetic responders, no differences were found in the level of molecular response between the 2 age groups. As probably expected, older patients experienced more adverse events (AEs), both hematologic and non-hematologic: this worsen compliance, however, did not prevent a long term outcome similar to younger ones. CML

Prevalence of angiomyolipoma among patients with tuberous sclerosis complex: A U.S. Healthcare Claims Database study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e12042-e12042
Author(s):  
Zhimei Liu ◽  
Peter Sun ◽  
Michael Kohrman ◽  
John Bissler
Keyword(s):  
Tuberous Sclerosis ◽  
Incidence Rate ◽  
Tuberous Sclerosis Complex ◽  
Real World ◽  
Age Groups ◽  
Benign Neoplasm ◽  
Chi Square ◽  
Claims Database ◽  
Real World Setting ◽  
The Relationship

e12042 Background: Angiomyolipoma (AML) are common benign neoplasm in the kidney, and are associated with tuberous sclerosis complex (TSC). The objectives of this study were to examine AML prevalence among TSC patients in a real world setting, and to explore the relationship between AML prevalence and ages, genders, or residential regions. Methods: A retrospective cohort study was conducted based on a large US commercial healthcare claims database. Patients with a TSC claim between 2000 and 2009 and with continuous 12-month enrollment after their first TSC claim were selected for the study. AML patients were identified based on ICD-9CM code (223.0X). Patients’ genders, residential regions, and age on their first TSC/or AML claim (if they had AML) were derived respectively from enrollment files and healthcare claims. Two-sample t tests and Chi-square tests were used to explore the relationships between AML prevalence, genders, residential regions and the age groups. Results: The study included 2,767 TSC patients with a mean age of 28.5 years on their first TSC claims, and 55.3% were female. AML prevalence among TSC patients was 7.8% in their first observed post-TSC year, and could be 78% at the end of the 10th observed post-TSC year if AML incidence rate (701.1 per 10,000 TSC patient years) remains constant. Associations between AML prevalence and age groups, genders, or residential regions were statistically significant (all p<0.05); and variations of AML prevalence by genders (Male: 5.6 vs. Female: 9.7%), residential regions (6.2-9.4%) and age groups at the first TSC claim (3.9% for age<1 year, 5.2% for age 1-5 years, 10.6% for 6-10 years, 8.4% for age 11-18 years, 13.6% for age 19-25 years, and 6.9% for age 26 years or more) were observed. Conclusions: In a real world setting AML occurred in 7.8% TSC patients in the first post-TSC year, and could increase to 78% within 10 years if the incidence rate remained at 701.1 per 10,000 TSC patient years. AML prevalence was associated with age, gender and residential regions, and varied significantly by ages, genders and residential regions. Further research is needed to explore the factors that resulted into these associations.

Understanding real-world outcomes in patients with NSCLC who progress on 1st-/2nd-generation EGFR TKIs.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20589-e20589
Author(s):  
Ancilla Fernandes ◽  
Karen E Skinner ◽  
Mark Stephen Walker ◽  
Melissa Pavilack ◽  
Ari M. Vanderwalde
Keyword(s):  
Treatment Period ◽  
Real World ◽  
Kinase Inhibitors ◽  
Growth Factor Receptor ◽  
Retrospective Chart Review ◽  
Progression Free Survival ◽  
2Nd Generation ◽  
Egfr Tyrosine Kinase Inhibitors ◽  
Tki Treatment ◽  
Egfr Tkis

e20589 Background: Epidermal growth factor receptor (EGFR)tyrosine kinase inhibitors (TKIs) are recommended for patients (pts) with EGFR mutation ( EGFRm) positive non-small cell lung cancer (NSCLC). Limited data are available for real-world outcomes in pts who experience progression on 1st-/2nd-generation EGFR TKIs, which was the focus of this study. Methods: A retrospective chart review of pts with advanced NSCLC (stage IIIb/IV) from 10 US community oncology practices was conducted. Patients were included if they were diagnosed 1/1/2008—1/1/2015, were treated with erlotinib or afatinib (TKIs) either first line (1L) or second line (2L), and had disease progression (per clinician’s assessment) prior to 10/31/2015. Pts were classified into cohorts based on TKI initiation (1L or 2L) and EGFRm status. Progression-free survival (PFS) and overall survival (OS) were evaluated for the TKI treatment period and the post-progression period. Results: The study included 364 pts: 77.7% white, 17.3% African American; mean (SD) age 66.3 (11.3) years. PFS and OS were longer for 1L and EGFRm+ pt cohorts during the TKI treatment period. After progression, 25.3% (80/316) pts continued TKI, while around half received chemotherapy (56.3%; 178/316). The effects of other variables evaluated as predictors of PFS and OS were largely nonsignificant. Conclusions: Outcomes were worse after progression irrespective of EGFRm status and whether TKI was initiated 1L or 2L. This finding highlights the need for therapeutic options that improve outcomes in pts after progression on a 1st-/2nd-generation EGFR TKI. [Table: see text]

Abiraterone acetate (AA) with or without cabazitaxel (CBZ) in treatment of chemotherapy naive metastatic castration-resistant prostate cancer (mCRPC).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 84-84
Author(s):  
Susan F. Slovin ◽  
Karen E. Knudsen ◽  
Susan Halabi ◽  
Mark T. Fleming ◽  
Ana M. Molina ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gene Networks ◽  
Radiographic Progression ◽  
Performance Status ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Primary Objective ◽  
Castration Resistant Prostate Cancer ◽  
Ecog Performance Status ◽  
Castration Resistant

84 Background: Loss of retinoblastoma tumor suppressor (RB) function has been shown to lead to CRPC and is strongly associated with poor outcome. RB functions as a transcriptional repressor; as such, loss of RB causes de-repression of pro-tumorigenic gene networks, including deregulation of the androgen receptor (AR) locus, excessive AR production, and castration-resistant (ligand independent) AR activity that can bypass hormone therapy. Our hypothesis is that leveraging RB status can direct treatment decisions. The primary objective of the trial (NCT02218606) was to determine the radiographic progression free survival (rPFS) of AA/prednisone (AAP) with and without CBZ in mCRPC patients (pts) that have progressed on primary androgen deprivation therapy and no prior AR directed therapy or chemotherapy. Methods: This is a multicenter non-comparative randomized phase 2 trial. Pts were randomized 1:1 to AAP with crossover to CBZ upon AAP failure (Arm 1), or the combination of AAP + CBZ (Arm 2). Randomization was stratified by the CALGB 90401 prognostic risk groups. The primary endpoint was rPFS (time from randomization to radiographic progression or death, whichever occurs first). Arms were analyzed separately. Results: Between October 2014 and March 2019, 93 pts were accrued; 81 were randomized. Median age was 68 years and ECOG performance status was 0 or 1. Endpoints are shown in Table. Therapies were well tolerated. Conclusions: Results of AAP + CBZ (Arm 2) in chemotherapy naïve pts suggest that men may derive benefit from the earlier use of CBZ with acceptable toxicity, supporting further study of this combination in mCRPC pts. Circulating Tumor Cells are being analyzed for changes in RB/AR expression. Managed by: Prostate Cancer Clinical Trials Consortium; Funding: Sanofi US; Support: Prostate Cancer Foundation. Clinical trial information: NCT02218606. [Table: see text]

Long-term safety and efficacy of nevirapine, stavudine and lamivudine in a real-world setting

AIDS ◽  
2001 ◽  
Vol 15 (6) ◽  
pp. 804-805 ◽  
Author(s):  
Peter Shalit ◽  
Pat Farrell ◽  
Pamela Lindgren
Keyword(s):  
Real World ◽  
Safety And Efficacy ◽  
Real World Setting

Predicting complete cytogenetic response and subsequent progression-free survival in 2060 patients with CML on imatinib treatment: the EUTOS score

Blood ◽  
2011 ◽  
Vol 118 (3) ◽  
pp. 686-692 ◽  
Author(s):  
Joerg Hasford ◽  
Michele Baccarani ◽  
Verena Hoffmann ◽  
Joelle Guilhot ◽  
Susanne Saussele ◽  
...  
Keyword(s):  
High Risk ◽  
Kinase Inhibitors ◽  
Prognostic Score ◽  
Progression Free Survival ◽  
Risk Groups ◽  
High Risk Group ◽  
Prognostic Scores ◽  
Imatinib Treatment ◽  
Free Survival ◽  
Eutos Score

AbstractThe outcome of chronic myeloid leukemia (CML) has been profoundly changed by the introduction of tyrosine kinase inhibitors into therapy, but the prognosis of patients with CML is still evaluated using prognostic scores developed in the chemotherapy and interferon era. The present work describes a new prognostic score that is superior to the Sokal and Euro scores both in its prognostic ability and in its simplicity. The predictive power of the score was developed and tested on a group of patients selected from a registry of 2060 patients enrolled in studies of first-line treatment with imatinib-based regimes. The EUTOS score using the percentage of basophils and spleen size best discriminated between high-risk and low-risk groups of patients, with a positive predictive value of not reaching a CCgR of 34%. Five-year progression-free survival was significantly better in the low- than in the high-risk group (90% vs 82%, P = .006). These results were confirmed in the validation sample. The score can be used to identify CML patients with significantly lower probabilities of responding to therapy and survival, thus alerting physicians to those patients who require closer observation and early intervention.

Sign in / Sign up

Export Citation Format

Share Document