The DOI matches its Crossref record; 7 of the 7 references it cites were found in a registry or an index.
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
Open accessAbstract
BACKGROUND: In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, 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 i.m. 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-effect analyses were carried out 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 versus 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 to -1.5 versus 2.0, 95% CI -0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 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: NCT01942135.
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Metadata
- Authors
- Harbeck, N., Iyer, S., Turner, N., Cristofanilli, M., Ro, J., André, F., Loi, S., Verma, S., Iwata, H., Bhattacharyya, H., Puyana Theall, K., Bartlett, C. H., & Loibl, S.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2016-06
- Volume
- 27
- Issue
- 6
- Pages
- 1047-1054
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2313479654
- Cited by
- 176
- References
- 7
- FWCI
- 19.86
- Type
- journal article
- Language
- en
- Open access
- hybrid
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- creativecommons.org/licenses/by-nc/4.0/ (vor, 1254 d)
- Funders
- Pfizer Inc.
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- Harbeck, N., Iyer, S., Turner, N., Cristofanilli, M., Ro, J., André, F., Loi, S., Verma, S., Iwata, H., Bhattacharyya, H., Puyana Theall, K., Bartlett, C. H., & Loibl, S. (2016). 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. Annals of Oncology. https://doi.org/10.1093/annonc/mdw139
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