Health-related quality of life of patients with metastatic melanoma treated with tumor-infiltrating lymphocytes compared with ipilimumab in a randomized phase III trial

BACKGROUND: This study aimed to assess health-related quality of life (HRQoL) in patients with metastatic melanoma treated with a tumor-infiltrating lymphocyte investigational medicinal product (TIL-IMP) or ipilimumab (IPI) after failure of first- or second-line treatment.

PATIENTS AND METHODS: In a multicenter, randomized, phase III trial, patients with metastatic melanoma (unresectable stage IIIC-IV) were randomized to TIL-IMP or IPI treatment (NCT02278887). HRQoL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL), EuroQol 5D-3L (EQ-5D), and the Impact of Event Scale (IES). HRQoL outcomes were evaluated using a generalized estimating equations model. Sensitivity analyses were carried out to assess dropout assumptions. Results were interpreted for statistically and clinically significant differences.

RESULTS: Of 168 patients randomized 1 : 1, n = 143 baseline HRQoL scores (85%) were calculated. Of these, 75 (89%) were in the TIL-IMP group and 73 (87%) in the IPI group. TIL-IMP-treated patients reported higher global health status scores at week 24 compared with IPI-treated patients (78.2 versus 73.9; P < 0.05) and higher emotional functioning (85.9 versus 77.9; P < 0.05) scores. Patients treated with TIL-IMP had significantly lower fatigue (25.0 versus 32.4; P < 0.05) and pain (13.7 versus 17.6; P < 0.05) scores at week 24, but marginally higher nausea and vomiting (7.5 versus 5.2; P < 0.05) symptom scores. EQ-5D scores were also higher in the TIL-IMP group (0.89 versus 0.83; P < 0.05). These statistically significant differences were not considered clinically meaningful. The hypothesized higher impact of the more intensive TIL-IMP treatment compared with IPI was not observed, according to IES scores (11.8 versus 17.4; P < 0.05 at 24 weeks). Sensitivity analyses showed similar results.

CONCLUSIONS: Patients with metastatic melanoma treated with TIL-IMP experienced similar HRQoL compared with IPI monotherapy, with indications of better HRQoL outcomes over time. Ongoing follow-up is essential to assess longer-term HRQoL and its generalizability to a larger patient population to help guide personalized treatment decisions.