Study Finds Ribociclib Improves Progression-Free Survival for Women with Metastatic Breast Cancer


“In a randomized, Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center, ribociclib, in combination with the aromatase inhibitor letrozole, dramatically improved progression-free survival (PFS) of post-menopausal women with hormone receptor-positive metastatic breast cancer, compared to the hormone therapy alone.

“The study found a 44 percent improvement in PFS with ribociclib, a CDK4/6 inhibitor, and letrozole as a front line therapy. Gabriel Hortobagyi, M.D., professor of Breast Medical Oncology, presented the findings at ESMO 2016 Congress, and is the corresponding author of the New England Journal of Medicine paper.”

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Two Generic Drugs Shown to Reduce Breast Cancer Deaths

“There’s new evidence that two inexpensive generic drugs can improve survival rates for women who develop breast cancer after menopause.

“In two large studies published Friday in The Lancet, a class of hormone-therapy drugs called aromatase inhibitors and bone-preserving drugs called bisphosphonates improved survival and recurrence rates in postmenopausal women with early breast cancer.

” ‘It may be that this is a first step in helping us figure out which patients are more likely benefit and which patients are not,’ Dr. Dawn L. Hershman, associate professor of medicine and director of the breast cancer program at the Herbert Irving Comprehensive Cancer Center at Columbia University, told CBS News. ‘We can strategize to give the medications that are going to give the most benefit and avoid the toxicity and the cost for patients with minimal benefits.’ “

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.”

Improved Prognosis for Patients With Estrogen Receptor–Positive Breast Cancer With Large Reductions in Mammographic Density After Tamoxifen Initiation

“Improved prognosis for women with estrogen receptor–positive breast cancer who experience a large reduction in mammographic density following the initiation of tamoxifen treatment extends to premenopausal as well as postmenopausal women, researchers reported in the Journal of the National Cancer Institute. While a previous analysis linked decline in mammographic density following initiation of tamoxifen with improved survival in postmenopausal women, this more recent evaluation of change also showed improved survival in premenopausal women ‘for whom tamoxifen is the primary anti-endocrine therapy,’ Nyante et al wrote.

“ ‘Mammographic density reflects the fibroglandular composition of the breast, and women with the highest levels have approximately four-fold higher breast cancer risk compared with women with the lowest density,’ the investigators noted. ‘Emerging evidence,’ they added, ‘indicates that density reductions specifically among tamoxifen users may predict treatment effectiveness in adjuvant and chemopreventative settings, which could have value for planning long-term treatment.’ ”

New Drug Combination for Advanced Breast Cancer Delays Disease Progression

The gist: A new treatment that combines the drugs bortezomib and fulvestrant has shown promise in treating post-menopausal women with metastatic hormone receptor-positive breast cancer whose disease worsened after being treated with drugs called aromatase inhibitors. The combo treatment was tested in 118 patients in a clinical trial. It doubled the number of patients still alive after 12 months, and it lowered the chance of patients’ cancer worsening. Further studies will continue to measure the effectiveness of the treatment.

“A new combination of cancer drugs delayed disease progression for patients with hormone-receptor-positive metastatic breast cancer, according to a multi-center phase II trial. The findings of the randomized study (S6-03) were presented at the 2014 San Antonio Breast Cancer Symposium, held Dec. 6-9, by Kerin Adelson, M.D., assistant professor of medical oncology at Yale Cancer Center and chief quality officer at Smilow Cancer Hospital at Yale-New Haven.

“The trial enrolled 118 post-menopausal women with metastatic hormone-receptor-positive breast cancer whose cancer continued to progress after being treated with an aromatase inhibitor. The study, based on work done by Doris Germain of Mt. Sinai Hospital, found that the combination of the drugs bortezomib and fulvestrant—versus fulvestrant alone—doubled the rate of survival at 12 months and reduced the chance of cancer progression overall.

“Bortezomib, used most commonly in treating multiple myeloma, is a proteasome inhibitor that prevents cancer cells from clearing toxic material. Fulvestrant causes clumping of the estrogen-receptor protein. When bortezomib blocks the ability of the cell to clear these protein clumps, they grow larger and become toxic to the cancer cells. This, in turn, amplifies the effectiveness of fulvestrant, a drug commonly used in this subset of patients.

“The drug combination doubled the number of patients whose cancer had not progressed after one year from 14% to 28%, according to Adelson.”

Risedronate Reduces Anastrozole-Related Bone Loss in Osteopenic/Osteoporotic Postmenopausal Women

The gist: Postmenopausal women who take the drug anastrazole to prevent breast cancer often suffer from bone loss. Now, a clinical trial with volunteer patients has shown that a drug called risedronate might reduce anastrozole-associated bone loss.

“In a substudy of the IBIS-II trial reported in The Lancet Oncology, Sestak et al found that risedronate treatment reduced anastrozole-related bone loss over 3 years in postmenopausal women at increased risk for breast cancer…

“The study involved assessment of bone mineral density changes among a subgroup of women in the IBIS-II trial. Patients were stratified according to T score: stratum I = ≥−1.0; stratum II (osteopenic) = ≥ −2.5 and < −1.0; and stratum III (osteoporotic) = < −2.5 and > −4.0. All patients were randomly assigned to anastrozole 1 mg/d or placebo, those in stratum II were randomly assigned to risedronate 35 mg/week vs placebo, and all patients in stratum III received risedronate…

“The investigators concluded: ‘Risedronate counterbalances the effect of anastrozole-induced bone loss in osteopenic and osteoporotic women and might be offered in combination with anastrozole treatment to provide an improved risk–benefit profile.’ ”

Pfizer Submits NDA For Breast Cancer Drug Palbociclib Combined With Letrozole

Editor’s note: Before a new cancer treatment can be prescribed by doctors in the U.S., it must be approved by the U.S. Food and Drug Administration (FDA). Recently, the drug company Pfizer submitted an application to the FDA in the hopes that its new breast cancer treatment might be approved. The treatment combines two drugs called palbociclib and letrozole. It is specifically meant for treating advanced or metastatic breast cancer in post-menopausal women whose tumors have tested ER+ and HER2-. In addition, the women must not have already taken any other cancer treatments that travel through the bloodstream. The new treatment has performed well in a clinical trial with volunteer patients.

“Pharma giant Pfizer, Inc. ( PFE ) announced Monday that it submitted a New Drug Application or NDA, to the U.S. Food and Drug Administration or FDA, for palbociclib, in combination with letrozole, as first-line systemic treatment advanced or metastatic breast cancer in post-menopausal women.

” ‘Today’s submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer,’ said Garry Nicholson, President, Pfizer Oncology.

” is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases 4 and 6 to regain cell cycle control and block tumor cell proliferation.

“The NDA seeks approval for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.”

Over-the-Counter Pain Reliever May Slow Recurrence in Breast Cancer Patients

With promising new information on the risks of obesity and the benefits of anti-inflammatories, researchers at the Cancer Therapy & Research Center have launched a new study on aspirin and fish oil open to postmenopausal women who are cancer-free.

“It’s based on their own findings published today in the journal Cancer Research, which reveal that some postmenopausal overweight breast cancer patients who use common anti-inflammatory drugs like aspirin or ibuprofen have significantly lower breast cancer recurrence rates.

“Researchers from the CTRC at The University of Texas Health Science Center at San Antonio and The University of Texas at Austin began that study by examining blood serum from CTRC breast cancer patients, said CTRC oncologist Andrew Brenner, M.D., Ph.D.”

Postmenopausal Breast Cancer Risk Decreases Rapidly After Starting Reg. Physical Activity

“Postmenopausal women who in the past four years had undertaken regular physical activity equivalent to at least four hours of walking per week had a lower risk for invasive breast cancer compared with women who exercised less during those four years, according to data published in Cancer Epidemiology, Biomarkers Prevention, a journal of the American Association for Cancer Research.

” ‘Twelve MET-h [metabolic equivalent task-hours] per week corresponds to walking four hours per week or cycling or engaging in other sports two hours per week and it is consistent with the World Cancer Research Fund recommendations of walking at least 30 minutes daily,’ said Agnès Fournier, PhD, a researcher in the Centre for Research in Epidemiology and Population Health at the Institut Gustave Roussy in Villejuif, France. ‘So, our study shows that it is not necessary to engage in vigorous or very frequent activities; even 30 minutes per day is beneficial.’

“Postmenopausal women who in the previous four years had undertaken 12 or more MET-h of physical activity each week had a 10 percent decreased risk of invasive breast cancer compared with women who were less active. Women who undertook this level of physical activity between five and nine years earlier but were less active in the four years prior to the final collection did not have a decreased risk for invasive breast cancer.”