Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study.
The therapeutic landscape for advanced melanoma has recently been transformed by several novel agents (immune checkpoint inhibitors and molecular-targeted agents). The prospective, multi-site, observational study IMAGE (ipilimumab: management of advanced melanoma in real practice) included a retrospective cohort to describe real-world treatment prior to approval of the immune checkpoint inhibitor ipilimumab. This retrospective cohort of patients, who started second-line/subsequent treatment (index therapy) for advanced melanoma within 3 years before ipilimumab approval, was selected randomly by chart review. Collected data included treatment history, patient outcomes, and healthcare resource utilization. All patients had ≥1 year of follow-up data. This analysis included 177 patients from Europe (69%) and North America (31%). The most common index therapies (used alone or in combination) were fotemustine (23%), dacarbazine (21%), temozolomide (14%), and platinum-based chemotherapy (14%). Most patients (89%) discontinued index treatment during the study period; the most common reason was disease progression (59%). Among patients with tumor assessment (153/177; 86%), 2% had complete response, 5% had partial response, and 12% had stable disease on last tumor assessment. At 1-year study follow-up, median progression-free survival was 2.6 months (95% confidence interval [CI], 2.1-2.9) and median overall survival was 8.8 months (95% CI, 6.5-9.7). During follow-up, 95% of the patients had healthcare visits for advanced melanoma, 74% of whom were hospitalized or admitted to a hospice facility. These results provide insights into patient care with advanced melanoma in the era before ipilimumab and may serve as a benchmark for new agents in future real-world studies.
National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom.
Mark R
MR
Middleton
Centre Hospitalier Lyon-Sud, Lyon, France.
Stéphane
S
Dalle
Centre Hospitalier Universitaire de Québec, Quebec City, Canada.
Joel
J
Claveau
Hospital Son Llatzer, Illes Balears, Spain.
Pilar
P
Mut
Oncology Specialists SC, Park Ridge, Illinois.
Sigrun
S
Hallmeyer
Hôpital Laënnec, Quimper, France.
Patrice
P
Plantin
Plymouth Oncology Centre, Derriford Hospital, Plymouth, United Kingdom.
Martin
M
Highley
Bristol-Myers Squibb, Princeton, New Jersey.
Srividya
S
Kotapati
Bristol-Myers Squibb, Princeton, New Jersey.
Trong Kim
TK
Le
Bristol-Myers Squibb, Princeton, New Jersey.
Jane
J
Brokaw
Duke Clinical Research Institute, Durham, North Carolina.
Amy P
AP
Abernethy
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D005260:Female; D006801:Humans; D000074324:Ipilimumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008875:Middle Aged; D058990:Molecular Targeted Therapy; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D019233:Retreatment; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents; D000074324:Ipilimumab
Advanced melanoma; ipilimumab; observational study; real-world treatment practice; retrospective