Quality of Life With Palbociclib Plus Fulvestrant in Previously Treated Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer: Patient-Reported Outcomes From the PALOMA-3 Trial
Menée dans le cadre de l'essai PALOMA-3 ayant inclus 521 patientes atteintes d'un cancer métastatique du sein HR+/HER2-, cette étude évalue la qualité de vie des patientes en fonction du traitement reçu (fulvestrant seul ou en combinaison avec le palbociclib)
Background In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in HR+/HER2– endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient reported outcomes (PROs) between the two treatment groups. Patients and methods Patients were randomized 2:1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n=347) plus fulvestrant (500 mg intramuscularly per standard of care) or placebo plus fulvestrant (n=174). PROs were assessed on Day 1 of Cycles 1–4 and of every other subsequent cycle starting with Cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0−100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated measures mixed-effects analyses were performed to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model. Results Questionnaire completion rates were high at baseline and during treatment (from baseline to Cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group (66.1, 95% confidence interval [CI]: 64.5, 67.7 vs 63.0, 95% CI: 60.6, 65.3; P=0.0313). Significantly greater improvement from baseline in pain was also observed in this group (–3.3, 95% CI: –5.1,–1.5 vs 2.0, 95% CI:–0.6, 4.6; P=0.0011). No significant differences were observed for other QLQ-BR 23 functioning domains, breast, or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P<0.025) and pain (P <0.001) compared with fulvestrant alone. Conclusion Palbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression. Clinical Trial Registration ClinicalTrials.gov identifier NCT01942135