Editor’s note: This article discusses the results of a clinical trial—a research study with volunteer patients. The goal of the trial was to test a new breast cancer treatment called GP2. GP2 is a cancer vaccine that works by boosting a patient’s own immune system to keep cancer from returning after treatment (recurrence). In the trial, it was shown to be safe and effective. The researchers also found that women with HER2-positive breast cancer who had taken the drug trastuzumab before GP2 treatment experienced no recurrence.
“A new breast cancer vaccine candidate, (GP2), provides further evidence of the potential of immunotherapy in preventing disease recurrence. This is especially the case for high-risk patients when it is combined with a powerful immunotherapy drug. These findings are being presented by The University of Texas MD Anderson Cancer Center at the 2014 American Society of Clinical Oncology’s Breast Cancer Symposium in San Francisco.
“One of only a few vaccines of its kind in development, GP2 has been shown to be safe and effective for breast cancer patients, reducing recurrence rates by 57%. Further, women with the highest overexpression of HER2 (known as HER2 +3) had no cancer recurrences when they were administered the vaccine after completing trastuzumab (Herceptin), a type of immunotherapy drug known as a monoclonal antibody. HER2 is an oncoprotein that promotes tumor growth and is expressed to some extent in 75-80% of breast cancers…
“We believe many more patients will benefit in some way from immunotherapy,” says Mittendorf. “The challenge will be identifying the right immunotherapeutic approach for each individual patient. When doctors are able to do that, cancer therapy, and immunotherapy specifically, will follow a more personalized approach.””
Editor’s note: This story is about a clinical trial—a research study with volunteer patients. The goal of the trial was to test a post-surgery breast cancer treatment that combines the drugs lapatinib (Tykerb) and trastuzumab (Herceptin), and compare the combination to either drug on its own. All patients involved had early stage breast cancer that tested positive for HER2. The study found good tumor shrinkage rates for the combination treatment, but found no difference in overall survival time between patients who took the combo versus patients treated with a single drug.
“The phase III NeoALTTO trial showed a significantly improved pathologic complete response rate with lapatinib (Tykerb) plus trastuzumab (Herceptin) vs either alone in women with HER2-positive early breast cancer. As reported in The Lancet Oncology by de Azambuja et al, the combination was not associated with any benefit in the secondary endpoints of event-free survival or overall survival, although the investigators noted that the trial was not powered to detect survival differences. Significantly better event-free survival and overall survival were observed in patients with pathologic complete response, with the association in event-free survival being significant in the combination group…
“In this open-label trial, 455 patients were randomly assigned between January 2008 and May 2010 to receive oral lapatinib at 1,500 mg (n = 154), intravenous (IV) trastuzumab at a 4 mg/kg loading dose followed by 2 mg/kg (n = 149), or lapatinib at 1,000 mg plus trastuzumab (n = 152) for 6 weeks, followed by an additional 12 weeks of the assigned anti-HER2 therapy in combination with weekly paclitaxel 80 mg/m². Definitive surgery was performed at 4 weeks after the last dose of paclitaxel. After surgery, patients received three cycles of FEC (fluorouracil at 500 mg/m², epirubicin at 100 mg/m², cyclophosphamide at 500 mg/m²) given IV every 3 weeks followed by 34 weeks of the same assigned neoadjuvant anti-HER2 therapy.
“Pathologic complete response was observed in 51.3% of the combination recipients vs 29.5% of the trastuzumab recipients (P = .0001), and there was no difference in pathologic complete response between the trastuzumab group and the lapatinib group (24.7%, P = .34).”
The gist: A new drug called neratinib (aka PB272) has shown promising results in a clinical trial testing the drug in volunteer patients. The clinical trial involved patients with early-stage HER2-positive breast cancer. They were treated with the drug trastuzumab, and then received follow-up (“adjuvant“) treatment with neratinib. Adjuvant treatments are given to patients after primary treatment to prevent cancer from returning. Indeed, in this clinical trial, neratinib was shown to significantly lengthen the amount of time that passed without patients’ disease worsening.
“Puma Biotechnology Inc said its experimental breast cancer drug met its main goal in a late-stage trial.
“Shares of the company, which doesn’t have any drug in the market, tripled to $176.94 in extended trading.
“Puma said on Tuesday it plans to file for marketing approval of neratinib, code named PB272, in the first half of 2015.
“Adjuvant treatment with the drug showed a statistically significant improvement in disease-free survival of 33 percent versus patients on placebo, according to trial data.”
“Breast cancer awareness campaigns stress saving the breasts – but what about the heart? Breast cancer patients who are positive for the HER2 gene may be at increased risk for heart damage during chemotherapy, according to a new study. Cardio-oncology is a relatively new field of research, emerging as scientists and doctors understand the connections between cancer treatment and the heart.”
“Approximately 15% of patients with breast cancer have tumors that overexpress the HER2 protein and these patients can benefit from HER2-targeted therapies. The American Society of Clinical Oncology recently released a clinical practice guideline on systemic therapy for patients with advanced HER2-positive breast cancer, published in the Journal of Clinical Oncology. The rationale for the guideline is that several new agents have become available for treatment of metastatic HER2-positive breast cancer since the approval of trastuzumab (Herceptin).
“Up to half of all patients with HER2-positive metastatic breast cancer develop brain metastases over time. Recommendations for the management of brain metastases in patients with HER2-positive breast cancer are detailed in another recently released companion guideline.”
Editor’s note: Click through to the full article (arrow button to the right of the title) to see the recommendations.
“At a median follow-up of 8 years, patients receiving trastuzumab (Herceptin) sequentially after chemotherapy and radiotherapy in the Herceptin Adjuvant (HERA) trial had a low incidence of cardiac events and these were reversible in the vast majority of patients. This long-term assessment confirms and extends previous reports of cardiac safety.
“The three-arm HERA trial compared 2 years or 1 year of trastuzumab with observation in 5,102 patients with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. ‘This is the first time that results of the 2-year trastuzumab arm have been reported, and the follow-up time has doubled,’ researchers reported in the Journal of Clinical Oncology.
“Eligible patients had a left-ventricular ejection fraction of at least 55% following neoadjuvant chemotherapy with or without radiotherapy and cardiac function was closely monitored. Cardiac adverse events leading to discontinuation of trastuzumab occurred in 9.4% of the 1,673 patients receiving 2 years of trastuzumab and 5.2% of the 1,682 patients receiving 1 year of trastuzumab.”
Editor’s note: This story discusses the results of a study that investigated the effects of the drug trastuzumab (brand name Herceptin) on cardiac health. The study involved 5,102 patients with HER2-positive, early-stage breast cancer. All of the patients had been previously treated. Patients were given trastuzumab as an adjuvant therapy—a treatment given after the main treatment to keep cancer from returning. Researchers found a low incidence of adverse cardiac events for the patients. However, they say that each patient should still have a cardiac assessment before and while taking trastuzumab to ensure that any problems are detected early.