10 results on '"Pérol, M"'
Search Results
2. First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLC.
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Zhou C, Solomon B, Loong HH, Park K, Pérol M, Arriola E, Novello S, Han B, Zhou J, Ardizzoni A, Mak MP, Santini FC, Elamin YY, Drilon A, Wolf J, Payakachat N, Uh MK, Rajakumar D, Han H, Puri T, Soldatenkova V, Lin AB, Lin BK, and Goto K
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- Humans, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung genetics, Lung Neoplasms drug therapy, Lung Neoplasms genetics, Proto-Oncogene Proteins c-ret antagonists & inhibitors
- Abstract
Background: Selpercatinib, a highly selective potent and brain-penetrant RET inhibitor, was shown to have efficacy in patients with advanced RET fusion-positive non-small-cell lung cancer (NSCLC) in a nonrandomized phase 1-2 study., Methods: In a randomized phase 3 trial, we evaluated the efficacy and safety of first-line selpercatinib as compared with control treatment that consisted of platinum-based chemotherapy with or without pembrolizumab at the investigator's discretion. The primary end point was progression-free survival assessed by blinded independent central review in both the intention-to-treat-pembrolizumab population (i.e., patients whose physicians had planned to treat them with pembrolizumab in the event that they were assigned to the control group) and the overall intention-to-treat population. Crossover from the control group to the selpercatinib group was allowed if disease progression as assessed by blinded independent central review occurred during receipt of control treatment., Results: In total, 212 patients underwent randomization in the intention-to-treat-pembrolizumab population. At the time of the preplanned interim efficacy analysis, median progression-free survival was 24.8 months (95% confidence interval [CI], 16.9 to not estimable) with selpercatinib and 11.2 months (95% CI, 8.8 to 16.8) with control treatment (hazard ratio for progression or death, 0.46; 95% CI, 0.31 to 0.70; P<0.001). The percentage of patients with an objective response was 84% (95% CI, 76 to 90) with selpercatinib and 65% (95% CI, 54 to 75) with control treatment. The cause-specific hazard ratio for the time to progression affecting the central nervous system was 0.28 (95% CI, 0.12 to 0.68). Efficacy results in the overall intention-to-treat population (261 patients) were similar to those in the intention-to-treat-pembrolizumab population. The adverse events that occurred with selpercatinib and control treatment were consistent with those previously reported., Conclusions: Treatment with selpercatinib led to significantly longer progression-free survival than platinum-based chemotherapy with or without pembrolizumab among patients with advanced RET fusion-positive NSCLC. (Funded by Eli Lilly and others; ClinicalTrials.gov number, NCT04194944.)., (Copyright © 2023 Massachusetts Medical Society.)
- Published
- 2023
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3. First-line pembrolizumab with or without platinum doublet chemotherapy in non-small-cell lung cancer patients with PD-L1 expression ≥50.
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Descourt R, Chouaid C, Pérol M, Besse B, Greillier L, Bylicki O, Ricordel C, Guisier F, Gervais R, Schott R, Auliac JB, Robinet G, and Decroisette C
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- Adult, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, B7-H1 Antigen analysis, B7-H1 Antigen antagonists & inhibitors, B7-H1 Antigen metabolism, Carcinoma, Non-Small-Cell Lung immunology, Carcinoma, Non-Small-Cell Lung mortality, Carcinoma, Non-Small-Cell Lung pathology, Clinical Trials, Phase III as Topic, Disease Progression, Female, Follow-Up Studies, Humans, Lung immunology, Lung pathology, Lung Neoplasms immunology, Lung Neoplasms mortality, Lung Neoplasms pathology, Male, Middle Aged, Multicenter Studies as Topic, Progression-Free Survival, Prospective Studies, Randomized Controlled Trials as Topic, Response Evaluation Criteria in Solid Tumors, Antibodies, Monoclonal, Humanized administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy
- Abstract
Pembrolizumab plus chemotherapy is currently used in the first-line treatment of advanced non-small-cell lung cancer without EGFR mutations or ALK rearrangements, regardless of PD-L1 expression status. A study comparing chemotherapy plus pembrolizumab versus pembrolizumab alone has never been performed in patients with PD-L1 ≥50%. The aim of this trial is to perform such a comparison as first-line treatment in patients not eligible for locally advanced treatment who have expression of PD-L1 on ≥50% of tumor cells. The expected results are a reduction in the risk of early progression. A higher objective tumor response is also expected with the combination of chemotherapy and pembrolizumab compared with pembrolizumab alone. The study will allow a direct comparison of the proportion of patients who derive long-term benefit from the treatment. Clinical trial number: EudraCT (2020-002626-86); ClinicalTrials.gov (NCT04547504).
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- 2021
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4. Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer.
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Solomon BJ, Zhou CC, Drilon A, Park K, Wolf J, Elamin Y, Davis HM, Soldatenkova V, Sashegyi A, Lin AB, Lin BK, F Loong HH, Novello S, Arriola E, Pérol M, Goto K, and Santini FC
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- Adult, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carboplatin administration & dosage, Carboplatin adverse effects, Carcinoma, Non-Small-Cell Lung genetics, Carcinoma, Non-Small-Cell Lung mortality, Cisplatin administration & dosage, Cisplatin adverse effects, Clinical Trials, Phase III as Topic, Cross-Over Studies, Female, Humans, Lung Neoplasms genetics, Lung Neoplasms mortality, Male, Middle Aged, Multicenter Studies as Topic, Mutation, Oncogene Proteins, Fusion genetics, Pemetrexed administration & dosage, Pemetrexed adverse effects, Progression-Free Survival, Proto-Oncogene Proteins c-ret genetics, Pyrazoles adverse effects, Pyridines adverse effects, Randomized Controlled Trials as Topic, Antibodies, Monoclonal, Humanized administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy, Pyrazoles administration & dosage, Pyridines administration & dosage
- Abstract
Selpercatinib, a novel, highly selective and potent, inhibitor of RET , demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive RET fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial. LIBRETTO-431 (NCT04194944) is a randomized, global, multicenter, open-label, Phase III trial, evaluating selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab in treatment-naive patients with locally advanced/metastatic RET fusion-positive nonsquamous non-small-cell lung cancer. The primary end point is progression-free survival by independent review. Key secondary end points include overall survival, response rate, duration of response and progression-free survival. Clinical trial registration: NCT04194944 (ClinicalTrials.gov).
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- 2021
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5. Healthcare resource utilization in advanced non-small-cell lung cancer: post hoc analysis of the randomized phase 3 REVEL study.
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Garon EB, Winfree KB, Molife C, Cui ZL, Arriola E, Levy B, Mekhail T, and Pérol M
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- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Non-Small-Cell Lung pathology, Clinical Trials, Phase III as Topic, Disease Progression, Female, Granulocyte Colony-Stimulating Factor therapeutic use, Humans, Lung Neoplasms pathology, Male, Middle Aged, Neoplasm Staging, Platinum therapeutic use, Taxoids therapeutic use, Ramucirumab, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Docetaxel therapeutic use, Lung Neoplasms drug therapy, Patient Acceptance of Health Care statistics & numerical data
- Abstract
Purpose: In REVEL, patients with advanced non-small-cell lung cancer (aNSCLC) and patients with increased tumor aggressiveness (rapid disease progression (RDP), platinum-refractory disease (PRD), and high symptom burden (HSB)) benefited from second-line treatment with ramucirumab plus docetaxel over placebo plus docetaxel. This post hoc analysis describes healthcare resource utilization (HCRU) associated with the treatment., Methods: aNSCLC patients who had progressed during or after first-line platinum-based chemotherapy were randomized to receive docetaxel and either ramucirumab or placebo until disease progression, unacceptable toxicity, withdrawal, or death. HCRU included hospitalizations, transfusions, and concomitant medications. Categorical variables (counts and percentages) were compared using Fisher's exact test. Continuous variables (mean, standard deviation (SD), median, minimum, and maximum) were compared using the Wilcoxon rank sum test., Results: Patient characteristics were largely similar between treatment arms. Within the intent-to-treat (ITT) population (n = 1253), the mean treatment duration was 19.7 and 16.9 weeks in the ramucirumab and control arms, respectively; 51.0% versus 54.9% of patients received subsequent anticancer therapy, respectively. Hospitalization rates were 41.9% versus 42.6% (p = 0.863), mean length of hospital stay was 14.5 days versus 11.3 days (p = 0.066), transfusion rates were 9.9% versus 12.3% (p = 0.206), and use of granulocyte colony-stimulating factors was 41.8% versus 36.6% (p = 0.063), respectively. No significant difference was observed in HCRU between treatment arms in both ITT population and in aggressive disease subgroups including RDP (n = 209), PRD (n = 360), and HSB (n = 497)., Conclusion: In REVEL, the addition of ramucirumab to docetaxel did not increase HCRU among patients with aggressive aNSCLC disease. These results may help inform economic evaluation of treatment for patients with aNSCLC.
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- 2021
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6. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy.
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Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, and Pérol M
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- Antibodies, Monoclonal, Humanized pharmacology, Antineoplastic Combined Chemotherapy Protocols pharmacology, Disease Progression, Docetaxel pharmacology, Female, Humans, Neoplasm Staging, Ramucirumab, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Docetaxel therapeutic use, Lung Neoplasms drug therapy, Platinum therapeutic use
- Abstract
Introduction: Non-small-cell lung cancer (NSCLC) is a heterogeneous disease. Front-line therapy may affect responses to subsequent treatment regimens, thus influencing second-line therapy decision making. In the randomised phase 3 REVEL study, second-line ramucirumab plus docetaxel (ram+doc) versus docetaxel (doc) improved survival of patients with metastatic NSCLC. We explore efficacy, safety and quality-of-life (QoL) in REVEL based on front-line therapy., Methods: Patients were grouped by specific front-line therapy received. Overall survival (OS), progression-free survival (PFS), objective response rate, safety and QoL were assessed descriptively. Kaplan-Meier estimation and Cox proportional hazards modelling were used; frequencies reported in percentages., Results: Baseline characteristics of 1253 patients were generally well balanced between treatment arms within each front-line therapy subgroup. For patients with non-squamous disease (n=912), induction therapies included platinum-based chemotherapy plus a taxane (n=227; 25%) or pemetrexed (n=449; 49%), with (n=172; 19%) or without bevacizumab. For patients with squamous disease (n=328), induction therapies included platinum-based chemotherapy plus gemcitabine (n=176; 54%) or a taxane (n=69; 21%). A highly selected subgroup (n=127; 14%) received pemetrexed continuation maintenance therapy. Ram+doc improved median OS and PFS versus doc across front-line therapy subgroups, as reflected by HRs ranging from 0.78 to 0.91 and 0.66 to 0.92, respectively, similar to results in the overall intention-to-treat cohort (HRs: 0.86 and 0.76, respectively). High-grade treatment-emergent adverse events of special interest (including neutropenia, febrile neutropenia, leucopenia and hypertension) were generally higher in ram+doc-treated patients relative to doc-treated patients regardless of front-line therapy. No clear differences in safety or QoL were seen across front-line therapy subgroups; outcomes were consistent with those reported in the overall intention-to-treat cohort., Conclusions: Results of this exploratory analysis suggest that second-line ram+doc may be effective regardless of prior treatment with platinum-based chemotherapy plus a taxane, pemetrexed, gemcitabine or bevacizumab. Overall, ram+doc is clinically beneficial across a wide range of patients with metastatic NSCLC who have progressed after various front-line therapies., Trial Registration Number: NCT01168973., Competing Interests: Competing interests: The following authors declared conflicts of interests. GCC, AHZ, ABO, PL, KW, and VJS are full-time employees and stockowners of Eli Lilly and Company. EA is a former employee and stockowner of Eli Lilly and Company. EBG has received honoraria from Dracen and EMD Serono, and his institution has received research funding from AstraZeneca, Bristol Myers Squibb, Merck, Eli Lilly and Company, Novartis, Genentech, Dynavax, Iovance, Mirati, and Neon. GVS has received honoraria from Eli Lilly and Company, AstraZeneca, Clovis Oncology, Regeneron, Novartis, Merck Sharp and Dohme, Pfizer, and Roche and has served on the speaker’s bureaus of Eli Lilly and Company, AstraZeneca, Merck Sharp and Dohme, and Novartis. MR has received honoraria for lectures from and functions in an advisory/consulting role for Eli Lilly and Company, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Hoffman-La Roche, Merck, Novartis, and Pfizer. MT has received Advisory Board honoraria from AbbVie, Bristol Myers Squibb, Boehringer, Celgene, Eli Lilly and Company, Merck Sharp and Dohme, Novartis, Roche, Takeda; speaker’s honoraria from Eli Lilly and Company, Merck Sharp and Dohme, Takeda; research funding from AstraZeneca, Bristol Myers Squibb, Celgene, Roche; and travel grants from Bristol Myers Squibb, Boehringer, Merck Sharp and Dohme, and Novartis. HK has received reimbursement for meeting expenses and/or has functioned in an advisory/consultancy role for Eli Lilly and Company, Genesis Pharma, GlaxoSmithKline, Merck, Novartis, Pfizer, and Roche and has received reimbursement for meeting expenses from Enorasis. J-HK serves in an advisory/consultancy role for and his institution has received grant funding for clinical trials from Eli Lilly and Company, including during the conduct of this study, and from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and Roche. OTB has received honoraria from Eli Lilly and Company, AstraZeneca, Boehringer Ingelheim (for research funding and advisory/consultancy role), GlaxoSmithKline (for research funding), Merck (for advisory/consultancy role), Novartis, Pfizer, and Roche (for research funding). MP has received honoraria for speaking, advisory and consultancy roles for Eli Lilly and Company., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)
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- 2020
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7. Association of baseline symptom burden with efficacy outcomes: Exploratory analysis from the randomized phase III REVEL study in advanced non-small-cell lung cancer.
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Pérol M, Winfree KB, Cuyun Carter G, Lin Cui Z, Bowman L, and Garon EB
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- Adolescent, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung mortality, Female, Humans, Lung Neoplasms mortality, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Survival Analysis, Treatment Outcome, Young Adult, Ramucirumab, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Docetaxel therapeutic use, Lung Neoplasms drug therapy
- Abstract
Objectives: The REVEL study demonstrated improved efficacy with ramucirumab plus docetaxel versus placebo plus docetaxel for previously treated advanced/metastatic non-small-cell lung cancer (NSCLC) without further detriment to patient quality of life, symptoms, or functioning. This post hoc analysis explored the association between baseline Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI) and efficacy., Materials and Methods: Baseline ASBI scores were the average of the 6 LCSS symptom components. Low and high symptom burden (LSB ≤ median, HSB > median) were analyzed across and by treatment arms for effects on overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) using the Kaplan-Meier method and Cox proportional hazards model., Results: Baseline LCSS compliance was approximately 78% in both REVEL treatment arms. Patients with LSB versus HSB had fewer poor prognostic factors. The HSB patient population significantly overlapped with previously identified aggressive disease subgroups (rapidly progressing disease or refractory to first-line treatment). Patients with LSB versus HSB had significantly improved OS (P < 0.0001), PFS (P < 0.0001), and ORR (P = 0.0003) regardless of treatment, with superior ORR and PFS but not OS in the ramucirumab plus docetaxel arm. Patients with HSB treated with ramucirumab plus docetaxel versus docetaxel had improved OS (median, 7.39 vs. 5.95 months; HR 0.749 [95% CI 0.610-0.920]; P = 0.0308), PFS (median, 4.01 vs. 2.63 months; HR 0.749 [0.619-0.907]; P = 0.0202), and ORR (18% vs. 11%; P = 0.0458). Of patients with rapidly progressing disease, 57% (92/162) also had HSB., Conclusions: Baseline ASBI may be an independent prognostic factor in this large second-line cohort of patients with advanced NSCLC. The preservation of improved PFS and OS in the HSB cohort suggests that the addition of ramucirumab to docetaxel provides benefit in patients with greater symptom burden, consistent with previous data on REVEL patients with aggressive disease., (Copyright © 2019 Elsevier B.V. All rights reserved.)
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- 2019
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8. Anti-PD1-induced psoriasis: a study of 21 patients.
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Bonigen J, Raynaud-Donzel C, Hureaux J, Kramkimel N, Blom A, Jeudy G, Breton AL, Hubiche T, Bedane C, Legoupil D, Pham-Ledard A, Charles J, Pérol M, Gérard E, Combemale P, Bonnet D, Sigal ML, and Mahé E
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- Aged, Aged, 80 and over, Disease Progression, Female, Humans, Male, Middle Aged, Psoriasis diagnosis, Psoriasis metabolism, Adaptive Immunity, Antibodies, Monoclonal, Humanized immunology, Programmed Cell Death 1 Receptor immunology, Psoriasis immunology
- Published
- 2017
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9. Outcomes in patients with aggressive or refractory disease from REVEL: A randomized phase III study of docetaxel with ramucirumab or placebo for second-line treatment of stage IV non-small-cell lung cancer
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Martin Reck, Denis Moro-Sibilot, Paolo Bidoli, Annamaria Zimmermann, Michael Thomas, Melissa Lynne Johnson, Luis Paz-Ares, Pablo Lee, Robert M. Jotte, Anne Tsao, Nathan A. Pennell, Faye W. Chan-Diehl, Ekaterine Alexandris, Federico Cappuzzo, Maurice Pérol, Frances A. Shepherd, Hossein Borghaei, Gebra Cuyun Carter, Andreas Sashegyi, Shaker R. Dakhil, Reck, M, Paz-Ares, L, Bidoli, P, Cappuzzo, F, Dakhil, S, Moro-Sibilot, D, Borghaei, H, Johnson, M, Jotte, R, Pennell, N, Shepherd, F, Tsao, A, Thomas, M, Carter, G, Chan-Diehl, F, Alexandris, E, Lee, P, Zimmermann, A, Sashegyi, A, Perol, M, and Pérol, M
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0301 basic medicine ,Oncology ,Refractory patient ,Male ,Cancer Research ,Lung Neoplasms ,Phases of clinical research ,non-small cell lung cancer (NSCLC) ,Docetaxel ,Kaplan-Meier Estimate ,0302 clinical medicine ,Phase 3 clinical trial ,Refractory patients ,Carcinoma, Non-Small-Cell Lung ,Antineoplastic Combined Chemotherapy Protocols ,Aged, 80 and over ,education.field_of_study ,Antibodies, Monoclonal ,Middle Aged ,Clinical trial ,Angiogenesi ,Treatment Outcome ,030220 oncology & carcinogenesis ,Retreatment ,Disease Progression ,Female ,Taxoids ,medicine.drug ,Pulmonary and Respiratory Medicine ,Adult ,medicine.medical_specialty ,Histology ,Population ,Non-small cell lung cancer (NSCLC) ,Antibodies, Monoclonal, Humanized ,Ramucirumab ,03 medical and health sciences ,Young Adult ,Refractory ,Internal medicine ,medicine ,Humans ,education ,Lung cancer ,non-small cell lung cancer ,Aged ,Neoplasm Staging ,business.industry ,Vascular endothelial growth factor (VEGF) ,medicine.disease ,Human monoclonal antibody ,030104 developmental biology ,Drug Resistance, Neoplasm ,Quality of Life ,Angiogenesis ,Vascular endothelial growth factor ,business ,Progressive disease - Abstract
Objectives The REVEL study demonstrated improved efficacy for patients with advanced non-small cell lung cancer treated with ramucirumab plus docetaxel, independent of histology. This exploratory analysis characterized the treatment effect in REVEL patients who were refractory to prior first-line treatment. Materials and methods Refractory patients had a best response of progressive disease to first-line treatment. Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and safety. Kaplan-Meier and Cox proportional hazards regression were performed for OS and PFS, and Cochran-Mantel-Haenszel test was used for response. QoL was assessed with the Lung Cancer Symptom Scale. Sensitivity analyses were performed on subgroups of the intent-to-treat population with limited time on first-line therapy. Results Of 1253 randomized patients in REVEL, 360 (29%) were refractory to first-line treatment. Baseline characteristics were largely balanced between treatment arms. In the control arm, median OS for refractory patients was 6.3 versus 10.3 months for patients not meeting this criterion, demonstrating the poor prognosis of refractory patients. Median OS (8.3 vs. 6.3 months; HR, 0.86; 95% CI, 0.68–1.08), median PFS (4.0 vs. 2.5 months; HR, 0.71; 95% CI, 0.57–0.88), and ORR (22.5% vs. 12.6%) were improved in refractory patients treated with ramucirumab compared to placebo, without new safety concerns or further deteriorating patient QoL. Conclusions The effect of ramucirumab in refractory patients is similar to that in the intent-to-treat population. The benefit/risk profile for refractory patients suggests that ramucirumab plus docetaxel is an appropriate treatment option even in this difficult-to-treat population.
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- 2017
10. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): A multicentre, double-blind, randomised phase 3 trial
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Shaker R. Dakhil, Paolo Bidoli, Kumar Prabhash, Joanna Pikiel, Keunchil Park, Sergey Orlov, Ekaterine Alexandris, Michael Thomas, Sergey Yurasov, Maurice Pérol, Steven J.M. Gans, Oscar Arrieta, Federico Cappuzzo, Grzegorz Czyzewicz, Konstantinos N. Syrigos, Tuncay Göksel, Tudor Ciuleanu, Andreas Sashegyi, Alexandru Grigorescu, Conrad R. Lewanski, Martin Reck, Nina Karaseva, Vera Gorbunova, Edward B. Garon, Ruben Dario Kowalyszyn, Joo Hang Kim, Garon, E, Ciuleanu, T, Arrieta, O, Prabhash, K, Syrigos, K, Goksel, T, Park, K, Gorbunova, V, Kowalyszyn, R, Pikiel, J, Czyzewicz, G, Orlov, S, Lewanski, C, Thomas, M, Bidoli, P, Dakhil, S, Gans, S, Kim, J, Grigorescu, A, Karaseva, N, Reck, M, Cappuzzo, F, Alexandris, E, Sashegyi, A, Yurasov, S, and Pérol, M
- Subjects
Adult ,Male ,medicine.medical_specialty ,Lung Neoplasms ,Docetaxel ,Placebo ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Ramucirumab ,Placebos ,Maintenance therapy ,Double-Blind Method ,Internal medicine ,Carcinoma, Non-Small-Cell Lung ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Clinical endpoint ,Humans ,Survival rate ,Aged ,Neoplasm Staging ,Platinum ,Performance status ,business.industry ,Antibodies, Monoclonal ,General Medicine ,Middle Aged ,medicine.disease ,Surgery ,Survival Rate ,Disease Progression ,Quality of Life ,Female ,Taxoids ,business ,Febrile neutropenia ,medicine.drug - Abstract
Background Ramucirumab is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR-2. We aimed to assess efficacy and safety of treatment with docetaxel plus ramucirumab or placebo as second-line treatment for patients with stage IV non-small-cell-lung cancer (NSCLC) after platinum-based therapy. Methods In this multicentre, double-blind, randomised phase 3 trial (REVEL), we enrolled patients with squamous or non-squamous NSCLC who had progressed during or after a first-line platinum-based chemotherapy regimen. Patients were randomly allocated (1:1) with a centralised, interactive voice-response system (stratified by sex, region, performance status, and previous maintenance therapy [yes vs no]) to receive docetaxel 75 mg/m 2 and either ramucirumab (10 mg/kg) or placebo on day 1 of a 21 day cycle until disease progression, unacceptable toxicity, withdrawal, or death. The primary endpoint was overall survival in all patients allocated to treatment. We assessed adverse events according to treatment received. This study is registered with ClinicalTrials.gov, number NCT01168973. Findings Between Dec 3, 2010, and Jan 24, 2013, we screened 1825 patients, of whom 1253 patients were randomly allocated to treatment. Median overall survival was 10·5 months (IQR 5·1-21·2) for 628 patients allocated ramucirumab plus docetaxel and 9·1 months (4·2-18·0) for 625 patients who received placebo plus docetaxel (hazard ratio 0·86, 95% CI 0·75-0·98; p=0·023). Median progression-free survival was 4·5 months (IQR 2·3-8·3) for the ramucirumab group compared with 3·0 months (1·4-6·9) for the control group (0·76, 0·68-0·86; p
- Published
- 2014
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