Intermittent Extended Letrozole Fails in Postmenopausal Breast Cancer

Excerpt:

“An intermittent dosing schedule with extended adjuvant letrozole did not improve disease-free survival (DFS) over continuous treatment with the agent in postmenopausal women with hormone receptor–positive breast cancer, according to the randomized phase III SOLE trial.

” ‘The magnitude of the beneficial effect of 5 years of extended letrozole use in postmenopausal women who have previously received an aromatase inhibitor for 5 years is low,’ wrote study authors led by Marco Colleoni, MD, of the European Institute of Oncology in Milan, Italy. That small effect may be partially due to acquired resistance, and animal studies suggest that such resistance can be reversed by discontinuing treatment.”

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FDA Aims to Expand Early-Approval Program for Promising Drugs

Excerpt:

“The Food and Drug Administration wants to help patients get faster access to promising cancer treatments.

“The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.

“Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.”

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Study Questions Exclusion of Cancer Survivors from Trials

Excerpt:

“A quarter of newly diagnosed cancer patients 65 or older are survivors who had a prior cancer — often preventing them from participating in clinical trials, researchers from UT Southwestern’s Simmons Cancer Center have found.

“The UT Southwestern scientists found that 11 percent of individuals ages 20-64 had a history of a prior cancer, and 25 percent of individuals 65 or older had a history of a prior cancer.

“As the number of cancer survivors grows, more individuals are being excluded from cancer clinical trials that could benefit them when diagnosed with a second cancer.”

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EU, US Approvals for Faslodex Combinations

Excerpt:

“AstraZeneca’s Faslodex has been cleared on both sides of the Atlantic for use in combination with a CDK4/6 inhibitor.

“In the EU, the drug’s use has been approved for use alongside the CDK4/6 inhibitor palbociclib to treat a certain form of breast cancer, in the US it can be prescribed in combination with the CDK4/6 inhibitor abemaciclib.

“Both the European Commission and US Food and Drug Administration have approved the combination for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.”

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Breast Cancer May Return Even 20 Years Later, Study Finds

Excerpt:

“Breast cancer can ‘smolder’ and return even 20 years later unless patients keep taking drugs to suppress it, researchers reported Wednesday.

“They were looking for evidence that at least some breast cancer survivors might be able to skip the pills that reduce the risk of the breast tumors coming back, but found that even women with ‘low-risk’ cancers had a small rate of recurrence 15 and 20 years later.”

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

Excerpt:

“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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New SERM Shows Promise in Advanced Breast Cancer

Excerpt:

“In women with estrogen receptor-positive, hormone-refractory metastatic breast cancer, oral Z-endoxifen hydrochloride, the potent metabolite of tamoxifen, provided substantial drug exposure regardless of CYP2D6 genotype, acceptable toxicity, and promising antitumor activity, researchers reported.

“Results from a phase I study in 38 patients with metastatic breast cancer demonstrated a clinical benefit rate (stable disease ≥ 6 months) of 26.3%. including a partial response by RECIST criteria in three patients who experienced progression during prior tamoxifen therapy, according to Matthew P. Goetz, MD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.”

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Breast Cancer Patients Forego Post-Surgery Treatment Due to Mistrust, Study Suggests

Excerpt:

“Nearly one-third of women with breast cancer went against their doctor’s advice and chose not to begin or complete the recommended adjuvant anti-cancer therapy to kill residual tumor cells following surgery, according to a study led by a Johns Hopkins Bloomberg School of Public Health researcher.

“A survey that included 2,754 breast cancer patients in Florida and Pennsylvania during a two-year period found that this ‘treatment discordance’ – not following a doctor’s recommended treatment plan in its entirety – was more likely among patients who reported a general distrust of medical institutions and insurers. The patients’ trust or distrust of their own doctors did not seem to be a factor.”

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Expert Raises QoL Concerns With Adjuvant Hormonal Therapy in ER+ Breast Cancer

Excerpt:

“As research of early-stage estrogen receptor (ER)-positive breast cancer continues, experts are relying more on extended adjuvant hormonal therapy with aromatase inhibitors, but are concerned about patient quality of life (QoL) with such treatment.

” ‘My passion is to really try to figure out how to make the side effects of these therapies more tolerable and how to help women be able to actually have reasonably good and normal QoL while they’re taking these therapies, so that we can increase compliance,’ said Michelle E. Melisko, MD.”

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