Novartis Takes Fight to Pfizer’s Ibrance with New Kisqali Data


“New data from Novartis’s breast cancer drug Kisqali underscored its effectiveness in pre-menopausal women, the Swiss drugmaker said, amid efforts to muscle in on turf dominated by rival Pfizer’s Ibrance.

“A late-stage trial showed Kisqali, in concert with hormonal therapies, halted the advance of hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer in pre-menopausal women for longer than in women getting hormonal therapy alone, Novartis said on Wednesday.”

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Aromasin Plus OFS May Reduce Risk of Recurrent Breast Ca (CME/CE)


“Premenopausal women with hormone receptor-positive, HER2-negative breast cancer may benefit from exemestane (Aromasin) plus ovarian function suppression (OFS) versus tamoxifen with or without OFS, analysis of recurrence-risk data from the TEXT and SOFT trials has indicated.

“Those with a high recurrence risk may experience a 10% to 15% improvement in the 5-year breast cancer-free interval (BCFI) with aromatase inhibitor (AI) exemestane plus OFS, while those at intermediate risk may experience an improvement of at least 5% with the same regimen, according to Meredith M. Regan, ScD, of Dana-Farber Cancer Institute in Boston, MA, and colleagues.

“Patients at lowest risk of recurrence had minimal benefit with exemestane plus OFS, the study showed, which is online in the Journal of Clinical Oncology.”

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EBCC-10 NEWS: Chemotherapy Every Two Weeks for Premenopausal Breast Cancer Patients Improves Survival and Does Not Increase Risk of Early Menopause

“Amsterdam, The Netherlands: Premenopausal women with breast cancer have a better chance of survival if they are given cycles of adjuvant chemotherapy closer together, every two weeks rather than every three weeks. Furthermore, this regimen, known as “dose-dense” adjuvant chemotherapy, does not seem to be associated with an increased risk of treatment induced early menopause.

“The findings will be presented today (Thursday) at the 10th European Breast Cancer Conference (EBCC-10) and the researchers say they are important for helping younger breast cancer patients and their doctors to make better-informed decisions about the choice of chemotherapy regimens that are given in addition to other treatments such as surgery, hormone therapy and radiotherapy.

“Dr Matteo Lambertini, MD, a medical oncologist at IRCCS AOU San Martino-IST, National Institute for Cancer Research, Genoa, Italy [1], and at the Institut Jules Bordet, Brussels, Belgium, will tell the conference: ‘Our results confirm the superiority of dose-dense chemotherapy as compared to standard interval regimens in premenopausal patients at higher risk of relapse, and its use should be implemented in Europe, as it is in the United States.’ ”

ASCO Recommends Ovarian Suppression for ER-Positive Breast Cancer

“An American Society of Clinical Oncology (ASCO) expert panel issued an updated guideline recommending that higher-risk premenopausal women with estrogen receptor (ER)-positive breast cancer receive ovarian suppression in addition to adjuvant endocrine therapy. Lower-risk patients, however, should not receive ovarian suppression.

“ ‘In the past year, randomized trials with robust methodological designs have analyzed the effect of ovarian suppression among premenopausal women with ER-positive breast cancers treated with tamoxifen,’ wrote the panel, led by ASCO expert Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Institute in Boston. In the past, studies of this therapy have suffered from problems such as selection criteria confounding.

“The guideline update is based on four randomized controlled trials. These include the Eastern Cooperative Oncology Group 3193 (E-3193) trial, the Suppression of Ovarian Function Trial (SOFT), the Tamoxifen and Exemestane Trial (TEXT), and the Austrian Breast Cancer Study Group (ABCSG)-12 trial. Overall, the studies did not find a significant difference with regard to overall survival between tamoxifen alone, tamoxifen plus ovarian suppression, or aromatase inhibitors (AIs) plus ovarian suppression. The guideline update was published in the Journal of Clinical Oncology.”

ESMO Asia 2015 News: Endocrine Therapy in Premenopausal Women: Selecting Patients, Treatments and Durations

“Prudence Francis, from the Peter MacCallum Cancer Centre in Melbourne, Victoria, Australia, discussed which endocrine therapy is best for young, premenopausal patients.

“She noted that the key differentiating factor in order to decide on a treatment option in this patient population is the risk of recurrence, and cited the findings of the Suppression of Ovarian Function Trial (SOFT) as well as those of a joint analysis of SOFT and the Tamoxifen and Exemestane Trial (TEXT).

“In the SOFT trial, patients were randomly assigned to receive one of three regimens for 5 years: tamoxifen alone; tamoxifen plus ovarian function suppression (OFS; via treatment with the gonadotropin-releasing-hormone agonist triptorelin, oophorectomy or irradiation); or tamoxifen with OFS and the aromatase inhibitor exemestane.”

Women with Luminal A Subtype of Breast Cancer Did Not Benefit from Adjuvant Chemotherapy

“Premenopausal women whose invasive breast cancers were of the luminal A subtype had comparable 10-year disease-free survival rates regardless of whether or not they received adjuvant chemotherapy, according to data from the phase III DBCG77B clinical trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8-12.

” ‘Luminal A is a relatively common subtype of breast cancer, and is defined by high expression of hormone receptors [estrogen receptor (ER) and progesterone receptor (PR)], and low expression of the cell-growth marker Ki67 and the oncoprotein HER2. It is the form of breast cancer with the best prognosis,’ said Torsten Nielsen, MD, PhD, professor of pathology at the University of British Columbia in Vancouver, Canada.

” ‘We wanted to address the clinical question of whether or not women with molecularly low-risk luminal A breast cancer actually benefit from chemotherapy,’ added Nielsen. ‘Instead of starting a new trial and waiting for 10 years to find answers, we used an older, completed trial that had saved tissue samples for future studies.’ “

Menopause Status, Screening Interval May Predict More Aggressive Breast Cancer Tumors

“Premenopausal women diagnosed with breast cancer following biennial mammograms appeared more likely to have larger and more advanced tumors than women screened annually, according to the results of a prospective study.

“However, the proportion of tumors with less favorable prognostic characteristics appeared similar among postmenopausal women with breast cancer not treated with hormone therapy who received biennial or annual mammograms.

“ ‘The frequency at which women should receive screening mammography remains controversial in the U.S.,’ Diana L. Miglioretti, PhD, professor of biostatics at University of California, Davis, and colleagues wrote. ‘However … mammography accuracy has improved, new breast cancer treatments have been developed, and interest in tailoring screening recommendations to individual risk to maximize the balance of benefits vs. harms has increased.’ “

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.’ ”

Higher Folate Intake Associated With Reduced Risk of Hormone Receptor–Negative Breast Cancer in Premenopausal Women

The gist: New research shows that premenopausal women who have more folate in their diet may be less likely to develop estrogen receptor (ER)–negative and progesterone receptor (PR)–negative breast cancer. This doesn’t necessarily mean that folate supplements can prevent cancer. It just shows a correlation between folate and cancer risk.

“In an analysis from the European Prospective Investigation Into Cancer and Nutrition (EPIC) reported in the Journal of the National Cancer Institute, de Batlle and colleagues found reduced risks of estrogen receptor–negative and progesterone receptor–negative breast cancer for highest vs lowest dietary folate intake among premenopausal women.

“The study involved EPIC data from 367,993 women aged 35 to 70 years in 10 European countries. During median follow-up of 11.5 years, 11,575 women developed breast cancer. Folate intake was estimated from country-specific questionnaires…

“The investigators concluded: ‘Higher dietary folate intake may be associated with a lower risk of sex hormone receptor–negative breast cancer in premenopausal women.’ ”