Safety and Efficacy of Radiation Therapy in Advanced Melanoma Patients Treated With Ipilimumab

Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):72-7. doi: 10.1016/j.ijrobp.2016.04.017. Epub 2016 Apr 21.


Purpose: 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.

Methods and materials: 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.

Results: 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.

Conclusions: 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.

MeSH terms

  • Antibodies, Monoclonal / administration & dosage*
  • Antineoplastic Agents / administration & dosage
  • Chemoradiotherapy / methods
  • Chemoradiotherapy / mortality*
  • Cohort Studies
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug-Related Side Effects and Adverse Reactions / mortality
  • Drug-Related Side Effects and Adverse Reactions / prevention & control
  • Female
  • Humans
  • Ipilimumab
  • Male
  • Melanoma / mortality
  • Melanoma / secondary*
  • Melanoma / therapy*
  • Middle Aged
  • Neoplasm Staging
  • North Carolina / epidemiology
  • Prevalence
  • Radiation Injuries / mortality
  • Radiation Injuries / prevention & control
  • Radiotherapy Dosage
  • Radiotherapy, Conformal / methods
  • Radiotherapy, Conformal / mortality*
  • Retrospective Studies
  • Risk Factors
  • Survival Rate
  • Treatment Outcome


  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • Ipilimumab