ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation

Excerpt:

“ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.”

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Small Benefit Seen in Adding Radiation to DCIS Plan for Breast Cancer

Excerpt:

“Patients with ductal carcinoma in situ (DCIS) are often treated with radiation after lumpectomy, although it has remained unclear whether this can reduce the risk of dying from this noninvasive form of breast cancer. A new study published Friday said that the combination of the 2 treatments was associated with a small benefit in reduced risk of breast cancer death compared with lumpectomy or mastectomy alone.”

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Dana-Farber Researcher Sees Biomarker Potential in ESR1 Mutations

Excerpt:

“As a medical oncologist and investigator, Rinath M. Jeselsohn, MD, focuses on the detection and clinical implications of ESR1 mutations in estrogen receptor–positive breast cancer. She is a member of the research team in the lab of Myles A. Brown, MD, at Dana-Farber Cancer Institute in Boston, Massachusetts, where investigators are seeking to elucidate the factors underlying the mechanisms of hormone responsiveness, particularly steroid hormone receptors, in human cancers.

“Jeselsohn, who has led numerous studies into ESR1 mutations, discussed the field in an interview with OncologyLive®.”

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Atezolizumab Plus Chemotherapy Improves PFS for Triple-Negative Breast Cancer

Excerpt:

“First-line atezolizumab plus nab-paclitaxel improved PFS compared with placebo among patients with metastatic or unresectable locally advanced triple-negative breast cancer, according to interim results from the IMpassion130 trial released by the manufacturer.

“Researchers observed prolonged PFS in both the intention-to-treat population and the PD-L1-positive population.”

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Long-Term Results of Adjuvant Endocrine Therapy in Premenopausal Breast Cancer

Excerpt:

“In an analysis of long-term outcomes in the SOFT and TEXT trials reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine, Francis et al found that the addition of ovarian suppression to adjuvant tamoxifen significantly improved 8-year rates of disease-free and overall survival vs tamoxifen alone among premenopausal women with breast cancer; risk of recurrence was further reduced with exemestane plus ovarian suppression.

“Initial reports showed that 5-year rates of recurrence were significantly lower among premenopausal women who received the aromatase inhibitor exemestane plus ovarian suppression vs tamoxifen plus ovarian suppression, with the addition of ovarian suppression to tamoxifen not significantly improving recurrence risk vs tamoxifen alone.”

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Neratinib/T-DM1 Combo Shows Promise in HER2-Positive Breast Cancer

Excerpt:

“The combination of neratinib (Nerlynx) and T-DM1 (ado-trastuzumab emtansine; Kadcyla) induced an overall response rate of 60% in previously-treated women with HER2-positive metastatic breast cancer, according to results from the phase Ib NSABP FB-10 study presented at the 2018 ASCO Annual Meeting.

“Among 12 of 20 evaluable patients with objective responses, 3 had a complete response and 9 had a partial response. An additional 2 patients had stable disease, and 6 patients had progressive disease.”

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Tucatinib Active in Heavily Pretreated HER2+ Breast Cancer

Excerpt:

“Tucatinib used in combination with capecitabine, trastuzumab (Herceptin), or both agents showed promising antitumor activity in heavily pretreated women with HER2-positive breast cancer with or without brain metastases, according to findings published in The Lancet Oncology.

“In phase Ib results from a nonrandomized, open-label study, 83% (5/6) of patients with measurable disease treated with tucatinib/capecitabine had an objective response, as did 40% (6/15) of patients receiving tucatinib/trastuzumab. Sixty-one percent (14/23) of patients treated with the combination of all 3 drugs had an objective response.”

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Early Detection and Intervention Reduce Breast Cancer–Related Lymphedema

Excerpt:

“A new study has found that early detection along with a simple intervention can be highly effective in preventing breast cancer–related lymphedema for at-risk women. According to data presented at the 2018 Annual Meeting of the American Society of Breast Surgeons, 82% of women identified at an early stage of lymphatic impairment returned to their normal pretreatment measurements following patient-administered therapies that combined compression sleeve garments and self-directed massage. The researchers, who used bioimpedance spectroscopy to measure extracellular fluid, emphasized that early screening of lymphatic function is crucial to address subtle lymphatic changes before they become permanent. ”

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Talazoparib Granted Priority Review by FDA for BRCA+ Metastatic Breast Cancer

Excerpt:

“A new drug application (NDA) for the PARP inhibitor talazoparib has been granted a priority review by the FDA for the treatment of patients with germline BRCA mutation–positive, HER2-negative locally advanced or metastatic breast cancer, according to Pfizer, the manufacturer of the agent.

“In results from the phase III EMBRACA trial, on which the application is based, talazoparib reduced risk of disease progression or death by 46% compared with chemotherapy in patients with BRCA-positive advanced breast cancer. At a median follow-up of 11.2 months, the Median progression-free survival (PFS) at the median follow-up of 11.2 months was 8.6 months (95% CI, 7.2-9.3) with talazoparib versus 5.6 months (95% CI, 4.2-6.7) with physician’s choice of therapy (HR, 0.54; 95% CI, 0.41-0.71; P <.0001). The objective response rate (ORR) was 62.6% (95% CI, 55.8-69.0) compared with 27.2% (95% CI, 19.3-36.3), respectively (odds ratio, 4.99; 95% CI, 2.9-8.8; 2-sided P value <.0001).”

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