Chemotherapy May Not Be Necessary for Intermediate-Risk, Early-Stage Breast Cancer


“Women with early-stage breast cancer and an intermediate risk recurrence score from a 21-gene expression assay may be able to avoid chemotherapy, according to a retrospective study published in Cancer.

” ‘Through years of research discoveries, it became clear that we were overtreating many women with breast cancer, especially those with early-stage breast cancer,’ Carlos H. Barcenas, MD, assistant professor of breast medical oncology at The University of Texas MD Anderson Cancer Center, said in a press release. ‘In addition to chemotherapy’s obvious side effects, there were also long-term complications for these women as survivors.’ ”

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More Patients with Early-Stage Breast Cancer May Be Able to Avoid Chemotherapy in the Future


“Women with early-stage breast cancer who had an intermediate risk recurrence score (RS) from a 21-gene expression assay had similar outcomes, regardless of whether they received chemotherapy, a new study from The University of Texas MD Anderson Cancer finds.

“The encouraging research, published in the journal CANCER, still needs to be validated in an ongoing international trial. If verified, women with intermediate scores may one day be able to avoid chemotherapy as standard of care.”

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Enobosarm Meets Pre-Specified Primary Efficacy Endpoint in Ongoing Phase 2 Clinical Trial in ER+/AR+ Breast Cancer


“GTx, Inc. (Nasdaq: GTXI) today announced that enobosarm achieved the pre-specified primary efficacy endpoint in the 9 mg dose cohort from patients in both stage 1 and the ongoing stage 2 of its Phase 2 clinical trial in women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. The primary efficacy endpoint requires at least nine patients (out of a total of 44 evaluable patients) to achieve clinical benefit, defined as either a complete response, partial response or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment. In this ongoing trial, the efficacy endpoint was achieved in the first 22 confirmed evaluable patients, and the trial will continue enrolling and treating eligible patients with enobosarm until 44 evaluable patients have completed the trial. Enobosarm has been well tolerated among patients treated to date in the 9 mg dose cohort with the majority of adverse events being either grade 1 or 2.”

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Adjuvant Chemotherapy Improves Overall Survival in Patients With Stage IB Non-Small Cell Lung Cancer


“The use of adjuvant chemotherapy in early-stage non-small cell lung cancer (NSCLC) patients improves overall survival (OS) and 5-year OS in patients with tumor sizes ranging from 3 – 7 cm.

“Stage I , the earliest stage at which clinicians diagnose lung cancer, is identified in approximately 16% of all lung cancer cases in the U.S. For early-stage  with medically operable clinical NSCLC, surgery is the treatment of choice. Several studies have found that patients with stage II and III NSCLC that had adjuvant chemotherapy following complete surgical resection lived longer than those that had surgery without chemotherapy. However, in early-stage NSCLC patients there currently is not enough evidence to support the use of chemotherapy following complete resection, even though stage I lung cancer recurs either locally or at distant sites in roughly a third of early-stage patients. Exploratory analysis of the use of adjuvant chemotherapy in early-stage patients showed improved overall survival for patients whose tumors were ? 4 cm. Consequently, a thorough investigation of the clinical benefits and survival of the use of adjuvant chemotherapy in early-stage patients is warranted in order to improve the current treatment recommendations.”

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Neratinib Improves DFS in HER2-Positive Breast Cancer

“Treatment with the tyrosine kinase inhibitor neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% in patients with early-stage HER2-positive breast cancer, representing a 33% improvement compared with placebo, according to findings from the phase III ExteNET study published in The Lancet Oncology.

“In the phase III study, which was also presented at the 2015 ASCO Annual Meeting, the 2-year DFS rate with placebo was 91.6% (HR, 0.67; 95% CI, 0.50-0.91; P = .009). In patients with both HER2- and HR-positive disease, the 2-year DFS rate was 95.4% with neratinib and 91.2% with placebo, representing a 49% benefit (HR, 0.51; P = .001).”

ASCO Issues New Guideline on Use of Biomarkers to Guide Early Breast Cancer Therapy Decisions

“The American Society of Clinical Oncology (ASCO) today issued a new clinical practice guideline for women with early-stage invasive breast cancer and known hormone receptor and human epidermal growth factor 2 (HER2) receptor status. The guideline includes evidence-based recommendations on the appropriate use of breast tumor biomarker tests to guide decisions on adjuvant systemic therapy.

” ‘In the era of precision medicine, the role of biomarkers in guiding clinical care is greater than in the past. An extensive number of new tests have come out in the last 5-10 years, but not all have sufficient evidence of clinical utility,’ said Lyndsay N. Harris, MD, co-chair of the ASCO expert panel that developed the guideline. ‘These latest recommendations truly inform physicians about which tests need to be performed. But this is not all that goes into patient care—doctors need to continue discussions with patients to develop individualized treatment plans.’ “

Recommendation to Omit Radiation Therapy After Lumpectomy Is Not Frequently Implemented

“Nearly two thirds of U.S. women age 70 or older with stage I breast cancer who undergo lumpectomy and are eligible to safely omit subsequent radiation therapy (RT) according to national cancer guidelines still receive this treatment, according to new study results. The researchers looked at more than 205,000 cases of breast cancer nationwide, and their study is published as an ‘article in press’ on the Journal of the American College of Surgeons website in advance of print publication.

“After a lumpectomy, also called a breast-sparing or breast-conserving operation, radiation usually is given to the breast to reduce the chance of the cancer returning. However, treatment recommendations changed in 2004 for a select group of elderly breast cancer patients after research found that postoperative RT did not significantly prolong their survival over five years compared with women who received no RT.”

Sequential Anthracycline-Cyclophosphamide, Taxane Regimen 'Most Effective' Adjuvant Therapy for Early-Stage Breast Cancer

“Sequential anthracycline-cyclophosphamide and taxane may serve as the best available adjuvant therapy regimen for early-stage breast cancer regardless of hormone receptor status, according to the results of a systemic review and network meta-analysis.

“Many different adjuvant chemotherapy regimens exist for early-stage breast cancer; however, a conventional meta-analysis would not allow for comparison of all of these regimens, according to researchers.

“ ‘It is well established that adjuvant chemotherapy plays an important role in reducing the risk for recurrence and improving the survival of patients with breast cancer,’ Naoto T. Ueno, MD, PhD, chief of the section of translational breast cancer research at The University of Texas MD Anderson Cancer Center, and colleagues wrote. ‘The National Comprehensive Cancer Network guidelines for the treatment of breast cancer describe numerous recommended adjuvant chemotherapy regimens … of them, sequential anthracycline-cyclophosphamide and taxane (AC-T) is the most commonly accepted standard regimen. However, two types of regimens without anthracyclines may have efficacy similar to or greater than that of sequential AC-T.’ “

Early Stage Breast Cancer May Not Require Chemo

“Researchers report in the New England Journal of Medicine (NEJM) the strongest evidence yet that some women with early stage breast tumors may not need chemotherapy to effectively treat their cancer. For some women, hormone-based anti-tumor drugs may be all they need to enjoy 98% survival at five years and a 93.8% chance of being free of invasive breast cancer in that time as well.

“The key to identifying these women lies with a gene-based test called Oncotype Dx, which scans 21 genes in the tumor to create a dossier of the tumor’s strengths and weaknesses. The information helps doctors to determine how potentially aggressive, or not, a tumor might be. Allowed on the market as a clinical laboratory test in 2004, it produces a recurrence score from 0 to 100 and helps doctors determine whether women should be treated with chemotherapy. Lower scores generally indicate that hormone-based drug therapies are enough, while higher recurrence scores push physicians to consider chemotherapy to lower the risk of the cancer returning.”