Table 2.
Key features of referenced trials investigating Health Related Quality of life in patients treated with immune-checkpoint inhibitors.
| First author | Study design | Study population and AJCC stage | Assessment of quality of life | Sample size | Response rate | Main conclusions on HRQOL |
|---|---|---|---|---|---|---|
| Revicki D. A. et al [33] |
Phase III MDX010-20 | Stage IIIc/IV pts. during treatment induction | EORTC QLQ-C30 at baseline and week 12 | 676 pts.: IPI + gp100: N=403 IPI alone: N=137 Gp alone: N=136 |
Baseline ≥ 95% Week 12: IPI + pg100: 62% IPI alone: 65 % Gp alone: 61% |
IPI with or without gp100 does not have significant negative impact on HRQOL during the induction phase compared to gp100 alone. |
|
| ||||||
| Petrella T. M. et al [50] | Phase III KEYNOTE-006 | Stage IIIc/IV pts. during treatment induction | EORTC QLQ-C30 EQ-5D at baseline and week 12 |
776 pts.: PEMBRO every 2 w.: N=270 PEMBRO every 3 w.: N=266 IPI 3 mg/kg: N=240 |
Baseline ≥ 98% Week 12: PEMBRO 2 w: 79% PEMBRO 3 w: 85% IPI: 74% |
HRQOL was better maintained with PEMBRO than with IPI in patients with IPI-naive advanced melanoma. |
|
| ||||||
| Schadendorf D. et al [35] | Phase III Checkmate-067 | Stage IIIc/IV pts. during first 12 months of treatment | EORTC QLQ-C30 EQ-5D at baseline there after resp. w. 1 and 5 of every 6 w. cycle during first 6 mos., and every 6 w. thereafter |
945 pts.: NIVO: N=316 NIVO + IPI: N=314 IPI: N=315 |
Baseline ≥ 89% Week 13: NIVO: 78% NIVO + IPI: 53% IPI: 63% |
Results of HRQOL data support the clinical benefit of NIVO monotherapy and NIVO plus IPI combination therapy in pts. with advanced melanoma. Differences in irAE between the 2 groups did not affect HRQOL. |
|
| ||||||
| Schadendorf D. et al [34] |
Phase III KEYNOTE-002 |
Stage IIIc/IV pts. during the first 12 weeks | EORTC QLQ-C30 | 520 pts.: PEMBRO 2 mg/kg: N=176 PEMBRO 10 mg/kg: N=177 Chemotherapy: N=167 |
Baseline: Week 12 ≥ 93% PEMBRO 2 mg/kg: 69% PEMBRO 10 mg/kg: 75% Chemotherapy: 65% |
HRQOL was better maintained with PEMBRO than with chemotherapy, supporting the use of PEMBRO in pts. with IPI-refractory melanoma |
gp100, glycoprotein 100 peptide vaccine; IPI, ipilimumab; NIVO, nivolumab; PEMBRO, pembrolizumab; yr., year; w., week; pts., patients; HRQOL: Health Related Quality of Life; SF-36, Short Form 36.