Fulvestrant Prolongs PFS for Women with Hormone Receptor– Positive Advanced Breast Cancer


“Fulvestrant prolonged PFS compared with anastrozole among women with hormone receptor– positive locally advanced or metastatic breast cancer who have not received previous endocrine therapy, according to a phase 3, randomized, double blind trial published in The Lancet.

” ‘The primary endpoint of this phase 3 study was met, with patients receiving fulvestrant having a significantly longer PFS than patients receiving anastrozole,’ John F.R. Robertson, MD, a professor at University of Nottingham Medical School and Royal Derby Hospital Centre in Derby, United Kingdom, and colleagues wrote. ‘This represents a meaningful and relevant finding for which clinical data are limited.’ ”

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Neoadjuvant Abemaciclib Active in HR+/HER2- Breast Cancer


“A neoadjuvant regimen combining the CDK4/6 inhibitor abemaciclib with anastrozole induced a response rate of 54.7% in patients with HR+/HER2-negative early-stage breast cancer, according to findings from the phase II neoMONARCH trial presented at the 2016 San Antonio Breast Cancer Symposium.

“The study also met its primary endpoint of reduction in Ki67 expression level at week 2. The abemaciclib combination yielded a geometric mean change in Ki67 from baseline to day 15 of -92.6%.”

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Fulvestrant Bests Anastrozole in Phase III Breast Cancer Study


“First-line treatment with fulvestrant (Faslodex) led to significantly better progression-free survival (PFS) compared with anastrozole for patients with hormone receptor (HR)-positive advanced breast cancer, according to findings from the phase III FALCON trial reported at the 2016 ESMO Congress.

“Confirming results of an earlier phase II study, the FALCON trial yielded a median PFS of 16.6 months with fulvestrant versus 13.8 months with anastrozole. Moreover, a consistent advantage favoring fulvestrant emerged from a subgroup analysis. The overall advantage appeared to be driven by a substantial difference in PFS among patients without visceral metastases treated with fulvestrant.”

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Abemaciclib Effective for Ki67 Reduction in Certain Postmenopausal Women with Breast Cancer


“Neoadjuvant abemaciclib with or without anastrozole led to significantly greater reductions in tissue Ki67 after 2 weeks of treatment than anastrozole alone among postmenopausal women with hormone receptor–positive, HER-2–negative breast cancer, according to interim phase 2 study results presented at the European Society for Medical Oncology Congress.”

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Two Drugs Equal For Early Breast Cancer

“Postmenopausal women who have an early, noninvasive form of breast cancer had similar recurrence rates of disease whether they took the drug tamoxifen or the aromatase inhibitor anastrozole after surgery, new research shows.

“However, the side effects of the two medications differed greatly, said study author Jack Cuzick, director of the Wolfson Institute of Preventive Medicine at Queen Mary University of London, England.

“His team looked at nearly 3,000 women, all past menopause, who had hormone-receptor positive ductal carcinoma in situ (DCIS) breast cancer and underwent surgery to excise it. With DCIS, the cells that line the milk ducts have changed but not spread into the surrounding breast tissue.”

Study Finds Safer Drug to Prevent Return of Breast Cancer

“Women diagnosed with a common type of breast cancer now have a more effective, safer drug for follow-up care intended to prevent the disease from returning or spreading, according to a national study that involved Pittsburgh doctors and patients.

“The study, released Saturday, found that anastrozole was more effective than tamoxifen, the medication of choice for the past 10 or 15 years, to prevent additional episodes of cancer in post-menopausal women already treated for the ductal cancer known as DCIS. The study was described as the first to compare the medications’ use in patients with DCIS.

“ ‘The bottom line is that this changes the way we treat’ DCIS, said Adam Brufsky, a study co-author and co-director of UPMC’s Comprehensive Breast Cancer Center.

“The study ‘has tremendous merit,’ said Thomas Julian, division director of breast surgical oncology for the Allegheny Health Network, noting as many as 50,000 women are diagnosed with DCIS each year. The drug especially benefited women younger than 60, he said.”

Anastrozole Beneficial for Postmenopausal Women with Lobular Breast Cancer

The gist: A clinical trial compared postmenopausal breast cancer patients who took tamoxifen after surgery with patients who took tamoxifen plus the drug anastrozole. They researchers found that, after three years, more women with lobular breast cancer who took anastrozole were alive than those who took only tamoxifen. These results suggest that anastrozole may benefit postmenopausal women with lobular breast cancer.

“The survival benefit postmenopausal patients with breast cancer derive from anastrozole vs. tamoxifen varies considerably by histology, according to an analysis of phase 3 study results presented at the San Antonio Breast Cancer Symposium.

“Researchers suggested the finding may help refine adjuvant endocrine treatment decisions.

“Several prior studies showed aromatase inhibitors improved outcomes among postmenopausal patients with breast cancer compared with tamoxifen monotherapy. A meta-analysis by Forbes and colleagues, which included data on 11,798 patients included in randomized trials that compared 5 years of tamoxifen vs. a sequence of tamoxifen followed by aromatase inhibitors, showed patients assigned aromatase inhibitors demonstrated a significant reduction in recurrence (RR=0.84; 95% CI, 0.73-0.97). Researchers also observed significantly fewer deaths in the aromatase inhibitor group (RR=0.84; 0.73-0.97)…

“ ‘In summary, among all patients with lobular cancer, anastrozole was associated with a significant reduction in OS events compared to tamoxifen,’ Knauer said. ‘However, anastrozole efficacy was strongly depending on histology and intrinsic subtype of breast cancer.’ ”

Adding Pictilisib to Anastrozole Treatment Might Improve Responses for Patients with Early-Stage, ER+, HER2-, Luminal B Breast Cancer

The gist: The drug pictilisib might improve response to treatment with the drug anastrozole for patients with early-stage, ER-positive, HER2-negative, luminal B breast cancer. In a clinical trial, patients who took pictilisib with anastrozole had better responses than patients who took anastrozole alone.

“The addition of pictilisib to anastrozole improved anti-proliferative response through the reduction of Ki67 in patients with early-stage breast cancer and particularly among those with luminal B tumors, according to study results presented at the San Antonio Breast Cancer Symposium…

“Schmid and colleagues evaluated data from 73 post-menopausal women with newly diagnosed breast cancer. All women had ER-positive, HER-2–negative disease. Fifty-three percent of the women had luminal A tumors, and 47% had luminal B tumors.

“Researchers randomly assigned patients 2:1 to the PI3K inhibitor pictilisib (GCD-0941, Genentech) plus 1 mg anastrozole (n=50) or anastrozole alone (n=23) for 2 weeks prior to surgery. The dose of pictilisib was reduced from 340 mg to 260 mg due to a concern for side effects demonstrated on other studies…

“ ‘The data presented show that the addition of the PI3 kinase inhibitor pictilisib significantly increases the anti-proliferative response of anastrozole in ER-positive breast cancer,’ Schmid said. ‘Subsequent analyses suggest increased benefit of pictilisib for patients with luminal B and highly proliferative tumors.’ ”

Treatment with Fulvestrant Improved Survival Over Anastrozole in Untreated, Advanced, HR+ Breast Cancer

The gist: A clinical trial with volunteer patients found that a drug called fulvestrant outperformed the drug anastrozole for women with advanced, hormone receptor-positive breast cancer. None of the women had received any other treatment for their cancer. “Patients assigned fulvestrant survived a median of 54.1 months compared with 48.4 months for anastrozole.”

“Fulvestrant 500 mg significantly improved overall survival compared with anastrozole, among women with treatment-naive, advanced, hormone receptor-positive breast cancer, according to data from the phase II FIRST trial presented at the 2014 San Antonio Breast Cancer Symposium (SABCS).

“ ‘This is now the second randomized controlled trial where fulvestrant 500 mg has shown a time-to-progression and survival advantage over the control arm,” said study presenter John Robertson, MD, professor of surgery, University of Nottingham, Royal Derby Hospital, United Kingdom.

“The phase III CONFIRM study found fulvestrant 500 mg to have a survival advantage over anastrozole in the second-line setting.

“According to Robertson, fulvestrant was originally developed in a 250 mg dosage. However, early trials of fulvestrant 250 mg in the first and second line showed only equivalence to anastrozole and similarity to tamoxifen. However, when it was decided to double the dose, and the CONFIRM study showed a survival advantage for fulvestrant 500 mg, the researchers decided to also look at outcomes with the higher dose in the first-line setting.”