title: Safety and Efficacy of Radiation Therapy in Advanced Melanoma Patients Treated With Ipilimumab.
abstract: Ipilimumab and radiation therapy (RT) are standard treatments for advanced melanoma; preclinical models suggest the potential for synergy. However, limited clinical information exists regarding safety and optimal timing of the combination.
  
  
  
  We reviewed the records of consecutive patients with unresectable stage 3 or 4 melanoma treated with ipilimumab. Patients were categorized as having received RT or not. Differences were estimated between these 2 cohorts.
  
  
  
  We identified 88 patients treated with ipilimumab. At baseline, the ipilimumab-plus-RT group (n=44) had more unfavorable characteristics. Despite this, overall survival, progression-free survival, and both immune-related and non-immune-related toxicity were not statistically different (P=.67). Patients who received ipilimumab before RT had an increased duration of irradiated tumor response compared with patients receiving ipilimumab after RT (74.7% vs 44.8% at 12 months; P=.01, log-rank test). In addition, patients receiving ablative RT had non-statistically significantly improved median overall survival (19.6 vs 10.2 months), as well as 6-month (95.1% vs 72.7%) and 12-month (79.7% vs 48.5%) survival rates, compared with those treated with conventionally fractionated RT.
  
  
  
  We found that both ablative and conventionally fractionated RT can be safely administered with ipilimumab without a clinically apparent increase in toxicity. Patients who received ipilimumab before RT had an increased duration of irradiated tumor response.
authors.affiliation: School of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Rosie
authors.initials: R
authors.lastname: Qin
authors.affiliation: Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Adam
authors.initials: A
authors.lastname: Olson
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Bhavana
authors.initials: B
authors.lastname: Singh
authors.affiliation: Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.
authors.forename: Samantha
authors.initials: S
authors.lastname: Thomas
authors.affiliation: Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.
authors.forename: Steven
authors.initials: S
authors.lastname: Wolf
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Nrupen A
authors.initials: NA
authors.lastname: Bhavsar
authors.affiliation: Division of Medical Oncology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Brent A
authors.initials: BA
authors.lastname: Hanks
authors.affiliation: Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Joseph K
authors.initials: JK
authors.lastname: Salama
authors.affiliation: Division of Medical Oncology, Duke University Medical Center, Durham, North Carolina. Electronic address: april.salama@duke.edu.
authors.forename: April K S
authors.initials: AK
authors.lastname: Salama
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D059248:Chemoradiotherapy / Q000379:methods / Q000401:mortality*; D015331:Cohort Studies; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions / Q000401:mortality / Q000517:prevention & control; D005260:Female; D006801:Humans; D000074324:Ipilimumab; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000556:secondary* / Q000628:therapy*; D008875:Middle Aged; D009367:Neoplasm Staging; D009657:North Carolina / Q000453:epidemiology; D015995:Prevalence; D011832:Radiation Injuries / Q000401:mortality / Q000517:prevention & control; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000379:methods / Q000401:mortality*; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000074324:Ipilimumab