Breast cancer patients who are not responding to endocrine therapy may benefit from combination palbociclib and pulvestrant therapy, new research suggests.
Patients with hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer (n = 521) were randomly assigned to receive palbociclib plus fulvestrant or placebo plus fulvestrant.
Interesting / a little surprising to see negative overall survival results in PALOMA-3 (palbo/fulvestrant in MBC) for the complete trial population – had to splice out smaller groups for positive results. @NEJM https://t.co/YibBhw2IKP
— Ryan Huey, MD, MS (@ryanhuey) October 22, 2018
In the palbociclib plus fulvestrant group, median overall survival was 34.9 months (95% confidence interval [CI], 28.8 to 40.0), compared with 28.0 months (95% CI, 23.6 to 34.6) in the placebo plus fulvestrant group (hazard ratio [HR] for death, 0.81; 95% CI, 0.64 to 1.03; P = 0.09; absolute difference, 6.9 months). Patients with endocrine therapy sensitivity (n = 410) receiving palbociclib had a mean overall survival of 39.7 months (95% CI, 34.8 to 45.7), compared with 29.7 months (95% CI, 23.8 to 37.9) in placebo patients with endocrine therapy sensitivity (HR, 0.72; 95% CI, 0.55 to 0.94; absolute difference, 10.0 months). Palbociclib patients’ median time to the receipt of chemotherapy was 17.6 months, compared with 8.8 months in the placebo cohort (HR, 0.58; 95% CI, 0.47 to 0.73; P < 0.001).
PALOMA-3 demonstrated an approximately 7-month clinical meaningful improvement in OS for patients who received palbociclib. Also, use of CDK4/6 inhibitor was associated with delayed time to chemotherapy. #ESMO18#MOCnaESMO@MOCBrasil pic.twitter.com/OxFb4uN49D
— Debora Gagliato (@DGagliato) October 20, 2018
“The results of the study show that it is possible to improve and prolong the life of patients with hormone receptor-positive metastatic breast cancer. We now have solid data to suggest that this treatment should be the new standard of care,” said study author Dr. Massimo Cristofanilli.
On Saturday we published news of a major clinical trial which showed that the targeted drug #palbociclib extends #BreastCancer survival.
Watch study lead, Professor Nick Turner, discuss the findings from this trial in this video: https://t.co/bUI739VVLI#ESMO18
— The ICR (@ICR_London) October 23, 2018
Study author Nicholas Turner, a molecular oncology professor at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, called the treatment’s development “one of the biggest advances in treatment for women with advanced breast cancer in the last two decades.”
Original Article: Overall Survival with Palbociclib and Fulvestrant in Advanced #BreastCancer (PALOMA-3) https://t.co/PoifcpQnQc
Visit the @NEJMGroup booth (Hall B1, booth P-109) for a copy of this study and other papers released at #ESMO18.
— NEJM (@NEJM) October 20, 2018
“It’s incredibly rewarding that the benefits we had previously seen for palbociclib are now translating into such significant extensions in survival,” said Turner. “This drug can offer women more precious time with their loved ones and because it is a targeted treatment it is much kinder than chemotherapy, and enables many women to carry on with their lives normally.”
Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer | NEJM https://t.co/GYwvEcjXdo Thought that the attached figure, although exploratory, was notable pic.twitter.com/9wDnoY7q4M
— Robert S Miller, MD, FACP, FASCO, FAMIA-he/him (@rsm2800) October 21, 2018
Dr. Cristofanilli, a hematology/oncology professor at Northwestern University Feinberg School of Medicine and a Northwestern Medicine physician, said, “Typically, treatments for estrogen-positive metastatic breast cancer delay the progression of cancer but almost never prolong the life of patients. This treatment is the first of its kind to show such an important benefit.”
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Sources: NEJM, Medical Xpress, Northwestern Medicine
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