“Vemurafenib offered numerical improvement in disease-free survival in a study of patients with completely resected stage IIC to IIIC BRAF V600 mutation–positive melanoma, but the results did not reach statistical significance. The benefit was bigger in those with stage IIC to IIIB disease, but this should be considered exploratory at this point.
” ‘Despite full resection, patients with stage IIC to III melanoma remain at high risk for disease recurrence and death,’ wrote study authors led by Michele Maio, MD, of University Hospital of Siena in Italy. ‘This situation warrants the use of adjuvant approaches to improve clinical outcomes.’ ”
“Adjuvant therapy with gefitinib (Iressa), an epidermal growth factor receptor (EGFR)-targeted agent, was more successful at preventing recurrence than standard-of-care chemotherapy, in a phase III study of patients with EGFR-positive non–small cell lung cancer (NSCLC). Gefitinib extended recurrence-free survival by about 10 months in patients with stage II–IIIA NSCLC. These findings were presented at the 2017 ASCO Annual Meeting.”
“The targeted therapy gefitinib appears more effective in preventing recurrence after lung cancer surgery than the standard of care, chemotherapy. In a phase III clinical trial, patients with epidermal growth factor receptor (EGFR)-positive, stage II-IIIA non-small cell lung cancer (NSCLC) who received gefitinib went about 10 months longer without recurrence than patients who received chemotherapy. The study will be presented at the upcoming 2017 ASCO Annual Meeting in Chicago.
” ‘Adjuvant gefitinib may ultimately be considered as an important option for stage II-IIIA lung cancer patients with an active EGFR mutation, and we may consider routine EGFR testing in this earlier stage of lung cancer,’ said lead study author Yi-Long Wu, MD, a director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. ‘We intend to follow these patients until we can fully measure overall survival as opposed to disease-free survival, which just measures disease recurrence.’ ”
“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.’ ”
“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.”
“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.”
“An innovative set of clinical trials have identified two drugs that could provide a fighting chance for women with advanced breast cancer.
“The drugs, neratinib and veliparib, both appear effective in helping women diagnosed with stage 2 or 3 breast cancer, researchers report.
“These are the first two drugs to come out of the I-SPY clinical trials, a research effort intended to streamline drug testing by better guiding treatments to those who would most benefit from them, said one of the study authors, Dr. Laura Esserman. She is director of breast cancer care at the University of California, San Francisco’s Comprehensive Cancer Center.”
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“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).”
“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.’ “