PALOMA-3 Demonstrates QoL Benefits With Palbociclib Plus Fulvestrant

Patient-reported outcomes for quality of life favour addition of palbociclib to fulvestrant for hormone receptor-positive, HER2-negative, metastatic breast cancer

medwireNews: Quality of life (QoL) results from the PALOMA-3 trial add further support for the use of the cyclin-dependent kinase inhibitor palbociclib in combination with the oestrogen receptor antagonist fulvestrant in women with hormone receptor-positive, HER2-negative, metastatic breast cancer.

“The observed PROs [patient-reported outcomes] support the concept that the greater efficacy and favorable safety profile of palbociclib plus fulvestrant translates to relatively better QoL compared with placebo plus fulvestrant”, the researchers report in the Annals of Oncology.

Trial participants were asked to complete the European Organisation for Research and Treatment of Cancer Quality-of-Life questionnaire (QLQ-C30) and its breast cancer module QLQ-BR23 on day 1 of cycles 1–4 of treatment, thereafter on day 1 of alternating cycles, and again at the end of treatment.

Over 95% of the 347 patients randomly assigned to receive palbociclib plus fulvestrant and the 174 patients given placebo plus fulvestrant completed at least one QLQ-C30 question for each cycle between baseline and cycle 14. And a similar proportion did so for the breast cancer module, say Nadia Harbeck, from the University of Munich in Germany, and co-authors.

Global QoL scores at baseline were comparable between the groups but the on-treatment global QoL score was significantly better for patients given palbociclib and fulvestrant than for those given placebo plus fulvestrant, at 66.1 vs 63.0.

The improved QoL score was accompanied by a significantly longer time to QoL deterioration for patients givenpalbociclibversus placebo plus fulvestrant (hazard ratio=0.64).

Analysis of QLQ-C30 functional scores also showed a significant difference between the treatment groups in favour of palbociclib plus fulvestrant in the change in emotional functioning from baseline (2.7 vs –1.9).

QLQ-C30 symptom scales indicated that palbociclib plus fulvestrant was associated with a significantly greater decrease from baseline in pain (–3.3 vs 2.0) and less worsening of nausea and vomiting (1.7 vs 4.2) than placebo plus fulvestrant.

And time to deterioration of pain was an estimated 8.0 months versus 2.8 months for the treatment group, with a significant hazard ratio of 0.64.

However, palbociclib plus fulvestrant was associated with a higher incidence of alopecia than placebo plus fulvestrant (14.8 vs 5.8%) and this translated to significantly greater deterioration in the symptom scale of the breast cancer QLQ-BR23 module with regard to upset by hair loss (2.9 vs –6.0).

Nevertheless, overall changes within the treatment groups indicated that palbociclib-treated patients experienced a significant improvement in breast symptoms, while patients in both study arms significantly benefitted with regard to arm symptoms but experienced a significant worsening of systemic side effects.

“Our results further support the positive risk-benefit profile of palbociclib in combination with fulvestrant and show that addition of palbociclib does not impose toxicities that interfere with patient QoL”, the researchers conclude.

“Pain has been shown to have a significant negative impact on QoL in advanced/[metastatic breast cancer] patients”, they add. “Consequently, reducing or delaying pain symptoms is likely to have a positive impact on overall patient functioning and QoL.”


Harbeck N, Iyer S, Turner N, et al. 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. Ann Oncol 2016; Advance online publication 30 March. doi: 10.1093/annonc/mdw139

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