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Plain Language Summary of Publication

The Effects of Adding Palbociclib to Endocrine Therapy to Treat Advanced Breast Cancer: A Plain Language Summary of a Study Using the PALOMA-2 and PALOMA-3 Trial Results

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Pages 5-16 | Received 09 May 2023, Accepted 12 Jul 2023, Published online: 02 Nov 2023
 

Plain Language Summary

What is this summary about?

This is a summary of an article that reported results of a study using data from two phase 3 clinical trials called “PALOMA-2” and “PALOMA-3.” Both PALOMA-2 and PALOMA-3 trials included women with HR+/HER2− advanced breast cancer. HR+/HER2− breast cancer means the breast cancer cells of these women have receptors for female sex hormones and little or no HER2 receptors. Both PALOMA trials tested the effect of adding a medication called palbociclib (brand name, Ibrance®) to a hormone therapy. Hormone therapy, also known as endocrine therapy, is a treatment that blocks or removes hormones that cause cancer cells to grow and divide. In both trials, women took endocrine therapy with either palbociclib or a placebo.

What was the aim of this study?

The researchers aimed to see if the results from the PALOMA trials were similar for subgroups of women in the 2 trials. The subgroups in the study included women who shared certain features about their cancer or treatment history, for example, women whose cancer had spread to the liver. For each subgroup, the study compared the results from the 2 treatment groups: (1) women who took palbociclib plus endocrine therapy, and (2) women who took placebo plus endocrine therapy.

What were the results & what do they mean?

The same effect was found in all subgroups. Compared with those who took placebo, women who took palbociclib lived longer without their cancer getting worse (growing or spreading). Also, among women who had chemotherapy after stopping the trial treatment, those who took palbociclib started chemotherapy later than those who took placebo. Because palbociclib slows cancer growth and leads to tumor shrinkage, this may have played a part in starting chemotherapy later. These results show that palbociclib plus endocrine therapy is better at slowing the progression of advanced HR+/HER2− breast cancer than endocrine therapy alone. This can be said for women with different advanced HR+/HER2− breast cancer features and treatment history. Overall, the results support women taking palbociclib with an endocrine therapy if they have advanced HR+/HER2− breast cancer.

This is an abstract of the Plain Language Summary of Publication article.

To read the full Plain Language Summary of this article, click here to view the PDF .

Link to original article here

Link to original article here

Video Abstract

Acknowledgments

The authors would like to thank all the women who took part in the PALOMA-2 and PALOMA-3 trials.

Financial & competing interests disclosure

Hope S Rugo reports sponsored research to her institution from Pfizer Inc., Merck, Novartis, Eli Lilly, Roche-Genentech, Daiichi-Sankyo, Macrogenics, Sermonix, Astellas Pharma, GlaxoSmithKline, OBI Pharma, Pionyr Immunotherapeutics, Stemline Therapeutics, Taiho Oncology, Veru Inc. and Gilead, and honoraria from Puma Biotechnology, Napo Pharmaceuticals, Blueprint Medicines, Daiichi-Sankyo and Scorpion Therapeutics. Seock-Ah Im has received research funding from AstraZeneca, Daewoong Pharm, Eisai, Pfizer Inc. and Roche, and reports consulting fees for AstraZeneca, Daiichi-Sankyo, Eli Lilly, GlaxoSmithKline, Hanmi, Idience, MSD, Novartis, Pfizer Inc. and Roche. Sherene Loi has received research funding to her institution from Novartis, Bristol Myers Squibb, Merck, Puma Biotechnology, Eli Lilly, Nektar Therapeutics, AstraZeneca, Roche-Genentech and Seattle Genetics; consulting fees paid to her institution from Aduro Biotech, Novartis, GlaxoSmithKline, Roche-Genentech, AstraZeneca, Silverback Therapeutics, G1 Therapeutics, Puma Biotechnology, Pfizer Inc., Gilead Therapeutics, Seattle Genetics, Tallac Therapeutics and Bristol Meyers Squibb, is a Scientific Advisory Board Member of Akamara Therapeutics, has acted as a consultant (not compensated) to Seattle Genetics, Novartis, Bristol Meyers Squibb, Merck, AstraZeneca and Roche-Genentech, and is supported by the National Breast Cancer Foundation of Australia Endowed Chair and the Breast Cancer Research Foundation, New York. Anil A Joy reports consulting fees from Pfizer Inc., Novartis, Roche, Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, AbbVie, Amgen, Genomic Health, Puma Biotechnology and Teva, is an Advisory Board member of Pfizer Inc., and is a part of the National study Chair NCIC/CCTG MA 38. Eustratios Bananis, Xin Huang, Kathy Puyana Theall and Sindy Kim are employees of and stockholders in Pfizer Inc. Richard S. Finn reports consulting fees/honoraria from Pfizer Inc. and research grant/funding from Pfizer Inc., Eli Lilly and Novartis. Yaroslav Shparyk has no conflict of interest. Janice M Walshe reports consulting fees (e.g., advisory boards) from Roche, Genomic Health and Pfizer Inc., and reports fees for non-CME Services received directly from commercial interest or their agents (e.g., speakers’ bureaus) from Roche, Genomic Health and Pfizer Inc. Bethany Sleckman has no conflict of interest. Reshma Mahtani reports consulting fees from Agendia, Amgen, Biotheranostics, Daiichi-Sankyo, Eli Lilly, Genentech, Immunomedics, Merck, Pfizer Inc., Novartis, SeaGen, Genentech, AstraZeneca and Puma Biotechnology. Véronique Diéras reports consulting fees from Genentech, Eli Lilly, Pfizer Inc., AbbVie, Novartis Pharma KK, Roche-Peru, AstraZeneca and Daiichi-Sankyo, and reports fees for non-CME services received directly from commercial interest or their agents (e.g., speakers’ bureaus) from Pfizer Inc., Novartis Pharma KK, Roche-Peru and AstraZeneca.

Writing support was provided by Zoe Kelly, PhD, of Oxford PharmaGenesis Inc., Newtown, PA, USA, and was funded by Pfizer Inc.