|
| 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 |
|
