Long-term real-world experience with ...
Type de document :
Compte-rendu et recension critique d'ouvrage
PMID :
Titre :
Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study
Auteur(s) :
Dalle, Stéphane [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Mortier, Laurent [Auteur]
Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189 [ONCO-THAI]
Corrie, Pippa [Auteur]
Cambridge University Hospitals - NHS [CUH]
Lotem, Michal [Auteur]
Hadassah Hebrew University Medical Center [Jerusalem]
Board, Ruth [Auteur]
Arance, Ana [Auteur]
Meiss, Frank [Auteur]
University of Freiburg [Freiburg]
Terheyden, Patrick [Auteur]
Universität zu Lübeck = University of Lübeck [Lübeck]
Gutzmer, Ralf [Auteur]
Medizinische Hochschule Hannover = Hannover Medical School [MHH]
Buysse, Brian [Auteur]
Oh, Kelly [Auteur]
Brokaw, Jane [Auteur]
Bristol-Myers Squibb [Princeton]
Le, T Kim [Auteur]
Bristol-Myers Squibb [Princeton]
Mathias, Susan [Auteur]
Scotto, Julie [Auteur]
Bristol-Myers Squibb [Princeton]
Lord-Bessen, Jennifer [Auteur]
Bristol-Myers Squibb [Princeton]
Moshyk, Andriy [Auteur]
Bristol-Myers Squibb [Princeton]
Kotapati, Srividya [Auteur]
Bristol-Myers Squibb [Princeton]
Middleton, Mark [Auteur]
Churchill Hospital [Breast Care Unit]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Mortier, Laurent [Auteur]
Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189 [ONCO-THAI]
Corrie, Pippa [Auteur]
Cambridge University Hospitals - NHS [CUH]
Lotem, Michal [Auteur]
Hadassah Hebrew University Medical Center [Jerusalem]
Board, Ruth [Auteur]
Arance, Ana [Auteur]
Meiss, Frank [Auteur]
University of Freiburg [Freiburg]
Terheyden, Patrick [Auteur]
Universität zu Lübeck = University of Lübeck [Lübeck]
Gutzmer, Ralf [Auteur]
Medizinische Hochschule Hannover = Hannover Medical School [MHH]
Buysse, Brian [Auteur]
Oh, Kelly [Auteur]
Brokaw, Jane [Auteur]
Bristol-Myers Squibb [Princeton]
Le, T Kim [Auteur]
Bristol-Myers Squibb [Princeton]
Mathias, Susan [Auteur]
Scotto, Julie [Auteur]
Bristol-Myers Squibb [Princeton]
Lord-Bessen, Jennifer [Auteur]
Bristol-Myers Squibb [Princeton]
Moshyk, Andriy [Auteur]
Bristol-Myers Squibb [Princeton]
Kotapati, Srividya [Auteur]
Bristol-Myers Squibb [Princeton]
Middleton, Mark [Auteur]
Churchill Hospital [Breast Care Unit]
Titre de la revue :
BMC Cancer
Pagination :
642
Éditeur :
BioMed Central
Date de publication :
2021-05-29
ISSN :
1471-2407
Mot(s)-clé(s) en anglais :
Advanced melanoma
Ipilimumab
Overall survival
Quality of life
Real-world
Subsequent therapy
Ipilimumab
Overall survival
Quality of life
Real-world
Subsequent therapy
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Background: Ipilimumab has shown long-term overall survival (OS) in patients with advanced melanoma in clinical trials, but robust real-world evidence is lacking. We present long-term outcomes from the IMAGE study (NCT01511913) ...
Lire la suite >Background: Ipilimumab has shown long-term overall survival (OS) in patients with advanced melanoma in clinical trials, but robust real-world evidence is lacking. We present long-term outcomes from the IMAGE study (NCT01511913) in patients receiving ipilimumab and/or non-ipilimumab (any approved treatment other than ipilimumab) systemic therapies.Methods: IMAGE was a multinational, prospective, observational study assessing adult patients with advanced melanoma treated with ipilimumab or non-ipilimumab systemic therapies between June 2012 and March 2015 with ≥3 years of follow-up. Adjusted OS curves based on multivariate Cox regression models included covariate effects. Safety and patient-reported outcomes were assessed.Results: Among 1356 patients, 1094 (81%) received ipilimumab and 262 (19%) received non-ipilimumab index therapy (systemic therapy [chemotherapy, anti-programmed death 1 antibodies, or BRAF ± MEK inhibitors], radiotherapy, and radiosurgery). In the overall population, median age was 64 years, 60% were male, 78% were from Europe, and 78% had received previous treatment for advanced melanoma. In the ipilimumab-treated cohort, 780 (71%) patients did not receive subsequent therapy (IPI-noOther) and 314 (29%) received subsequent non-ipilimumab therapy (IPI-Other) on study. In the non-ipilimumab-treated cohort, 205 (78%) patients remained on or received other subsequent non-ipilimumab therapy (Other-Other) and 57 (22%) received subsequent ipilimumab therapy (Other-IPI) on study. Among 1151 patients who received ipilimumab at any time during the study (IPI-noOther, IPI-Other, and Other-IPI), 296 (26%) reported CTCAE grade ≥ 3 treatment-related adverse events, most occurring in year 1. Ipilimumab-treated and non-ipilimumab-treated patients who switched therapy (IPI-Other and Other-IPI) had longer OS than those who did not switch (IPI-noOther and Other-Other). Patients with prior therapy who did not switch therapy (IPI-noOther and Other-Other) showed similar OS. In treatment-naive patients, those in the IPI-noOther group tended to have longer OS than those in the Other-Other group. Patient-reported outcomes were similar between treatment cohorts.Conclusions: With long-term follow-up (≥ 3 years), safety and OS in this real-world population of patients treated with ipilimumab 3 mg/kg were consistent with those reported in clinical trials. Patient-reported quality of life was maintained over the study period. OS analysis across both pretreated and treatment-naive patients suggested a beneficial role of ipilimumab early in treatment.Trial registration: ClinicalTrials.gov , NCT01511913. Registered January 19, 2012 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01511913.Lire moins >
Lire la suite >Background: Ipilimumab has shown long-term overall survival (OS) in patients with advanced melanoma in clinical trials, but robust real-world evidence is lacking. We present long-term outcomes from the IMAGE study (NCT01511913) in patients receiving ipilimumab and/or non-ipilimumab (any approved treatment other than ipilimumab) systemic therapies.Methods: IMAGE was a multinational, prospective, observational study assessing adult patients with advanced melanoma treated with ipilimumab or non-ipilimumab systemic therapies between June 2012 and March 2015 with ≥3 years of follow-up. Adjusted OS curves based on multivariate Cox regression models included covariate effects. Safety and patient-reported outcomes were assessed.Results: Among 1356 patients, 1094 (81%) received ipilimumab and 262 (19%) received non-ipilimumab index therapy (systemic therapy [chemotherapy, anti-programmed death 1 antibodies, or BRAF ± MEK inhibitors], radiotherapy, and radiosurgery). In the overall population, median age was 64 years, 60% were male, 78% were from Europe, and 78% had received previous treatment for advanced melanoma. In the ipilimumab-treated cohort, 780 (71%) patients did not receive subsequent therapy (IPI-noOther) and 314 (29%) received subsequent non-ipilimumab therapy (IPI-Other) on study. In the non-ipilimumab-treated cohort, 205 (78%) patients remained on or received other subsequent non-ipilimumab therapy (Other-Other) and 57 (22%) received subsequent ipilimumab therapy (Other-IPI) on study. Among 1151 patients who received ipilimumab at any time during the study (IPI-noOther, IPI-Other, and Other-IPI), 296 (26%) reported CTCAE grade ≥ 3 treatment-related adverse events, most occurring in year 1. Ipilimumab-treated and non-ipilimumab-treated patients who switched therapy (IPI-Other and Other-IPI) had longer OS than those who did not switch (IPI-noOther and Other-Other). Patients with prior therapy who did not switch therapy (IPI-noOther and Other-Other) showed similar OS. In treatment-naive patients, those in the IPI-noOther group tended to have longer OS than those in the Other-Other group. Patient-reported outcomes were similar between treatment cohorts.Conclusions: With long-term follow-up (≥ 3 years), safety and OS in this real-world population of patients treated with ipilimumab 3 mg/kg were consistent with those reported in clinical trials. Patient-reported quality of life was maintained over the study period. OS analysis across both pretreated and treatment-naive patients suggested a beneficial role of ipilimumab early in treatment.Trial registration: ClinicalTrials.gov , NCT01511913. Registered January 19, 2012 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01511913.Lire moins >
Langue :
Anglais
Vulgarisation :
Non
Source :
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