To Type or to Print? Oncotype DX and Mamma/BluePrint Tests for Breast Cancer


Women diagnosed with localized breast cancer face difficult decisions with their doctors. What kind of neoadjuvant (before surgery) treatment to choose? Should chemotherapy follow surgery? Based on the subtype of breast cancer, should specific chemotherapy drugs be used? Continue reading…


Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for Yervoy (ipilimumab) as Adjuvant Treatment for Fully Resected Stage III Melanoma

Bristol-Myers Squibb Company BMY, -0.27% today announced that the U.S. Food and Drug Administration (FDA) has approved Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy. This approval is based on clinical data from a pivotal Phase 3 trial, CA184-029 (EORTC 18071), which demonstrated Yervoy 10 mg/kg significantly improved recurrence-free survival (RFS) vs. placebo in this setting, with a 25 percent reduction in the risk of recurrence or death. The median RFS was 26 months (95% ci:19)(95% ci:39) for Yervoy vs. 17 months (95% ci:13)(95% ci:22) for placebo (hazard ratio [HR]=0.75; 95% CI: 0.64, 0.90; p<0.002). Yervoy is the first and only FDA-approved immune checkpoint inhibitor in the adjuvant treatment for fully resected Stage III melanoma (lymph node >1 mm).”


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.’ “


Postprostatectomy Radiation Therapy Yields Low Toxicity and Favorable Patient-Reported Quality of Life

“A prospective study of guideline-based, postoperative, image-guided intensity-modulated radiation therapy in patients with prostate cancer found low toxicity profiles and favorable patient-reported quality of life following treatment, with researchers concluding that toxicity and health-related quality of life should not impact the recommendation of radiation therapy following prostatectomy. The research was published by Berlin et al in Practical Radiation Oncology.

“Postprostatectomy radiation therapy has been reported as underutilized, with randomized trials showing the benefit of adjuvant radiation therapy, but only about 10% of patients receiving the treatment. One potential reason for underutilization could be concern over side effects or a negative impact on health-related quality of life.”


NSCLC Survival Not Improved By Adjuvant Bevacizumab

“When bevacizumab (Avastin) was added to adjuvant chemotherapy, overall survival (OS) did not improve in patients with surgically resected early-stage non-small cell lung cancer (NSCLC), according to findings of the phase III E1505 trial presented during a press conference at the 2015 World Conference on Lung Cancer.

“The phase III trial randomized 1501 patients with NSCLC in a 1:1 ratio to chemotherapy with bevacizumab (n = 752) or without (n = 749). Data revealed that OS did not differ between the two arms (hazard ratio [HR], 0.99; 95% CI, 0.81-1.21; P = .93); median OS was more than 72 months in both cohorts. Similar data was reported with disease-free survival, a secondary endpoint, between the two arms (HR, 0.98; 95% CI, 0.84-1.14; P = .75).”


Will Adjuvant Pembrolizumab Improve Recurrence-Free Survival for Patients with High-Risk Stage III Melanoma?

“A recently opened double- blind phase III EORTC trial 1325 will prospectively assess whether post-operative adjuvant therapy with pembrolizumab, an anti-PD-1 monoclonal antibody, improves recurrence-free survival as compared to placebo in patients with high-risk stage III melanoma.

“A unique feature of the study is that in case of relapse all patients will have guaranteed access to pembrolizumab. This allows the study to assess a second question: is there a difference in benefit between early or late access to pembrolizumab.”


Cardiac Toxicity Low Among Patients Treated with Adjuvant Trastuzumab

“Incidence of cardiac toxicity appeared low among patients with early HER-2–positive breast cancer who received adjuvant treatment with trastuzumab, according to results of the randomized phase 3 PHARE trial.

“Most cardiac events appeared reversible after discontinuation of trastuzumab (Herceptin, Genentech), researchers wrote.

“Trastuzumab improves outcomes for women with early HER-2–positive breast cancer, but prior studies have shown cardiotoxicity rates between 2% and 7%.

“The French National Cancer Institute sponsored the PHARE trial, which included 3,380 patients with early HER-2–positive breast cancer randomly assigned 1:1 to the standard 12-month trastuzumab regimen or a 6-month regimen.”


Adjuvant Chemo-Immunotherapy May Improve NSCLC Survival

“Postsurgical chemo-immunotherapy offers improved survival rates for patients with non–small-cell lung cancer (NSCLC), compared to adjuvant chemotherapy alone, according to the final analysis and long-term results from a small randomized, controlled phase III study in Japan. The findings were presented at the 2015 World Conference on Lung Cancer in Denver, Colorado (abstract 04.01).

“Immunotherapy in the trial consisted of adoptive transfer of autologous activated killer T cells and dendritic cells from patients’ regional lymph nodes, explained lead study author Hideki Kimura, MD, PhD, of Saiseikai Narashino Hospital in Narashino City, Japan.

“ ‘The final results of the statistical and immunological analysis of the study confirmed the efficacy of immunotherapy in adjuvant treatment of lung cancer patients,’ reported Dr. Kimura. A large-scale multi-institutional randomized controlled trial is needed and ‘inevitable’ for the study’s findings to see clinical application, he said.”


Genetic Test Impacts Chemo Choices In Surprising Ways

“In the new era of personalized medicine, having more information on hand is considered the ideal situation for making more customized, and ideally, effective decisions about medical care.

“And in a new study of breast cancer patients, researchers show that a relatively new genetic test for evaluating tumors is doing just that. It’s just that the test isn’t necessarily leading to the decisions that experts expected.

“The Oncotype DX Breast Cancer Assay is a test approved by the U.S. Food and Drug Administration to help women decide how likely their breast cancer is to recur. The score, from zero to 100, is for women with breast tumors that have not spread to the lymph nodes. It places women on a scale of probability, based on an analysis of 21 genes in her tumor. Most doctors and patients use the score to decide, in part, whether the woman should receive chemotherapy following surgery.”