New Option for Preserving Fertility in Women Being Treated With Chemotherapy for Early-Stage Breast Cancer

“One of the most reported studies emanating from the 2014 ASCO Annual Meeting involves the use of the luteinizing hormone–releasing hormone (LHRH) agonist goserelin (Zoladex) to reduce the risk of ovarian failure among women being treated with chemotherapy for early-stage breast cancer, and to increase the likelihood of a successful pregnancy afterward (see page 22).1 Network and cable television, national and regional newspapers, and international news services covered the study and what it might mean to women concerned about preserving fertility after being treated for cancer.

“In an interview with The ASCO Post, the study’s lead author, Halle Moore, MD, said that she welcomed the media coverage because ‘the more the public is aware of fertility preservation options for patients receiving chemotherapy, the more likely it is that those patients will ask their doctors about [such measures].’ Dr. Moore is a Staff Physician and Chair of the Survivorship Program at the Cleveland Clinic. The study was funded by the National Institutes of Health, and Dr. Moore was hopeful that the extensive media coverage might also help the public see ‘where our dollars are going’ and understand the importance of federally funded research.”


ASCO Clinical Practice Guideline: Systemic Therapy for Patients With Advanced HER2-Positive Breast Cancer

“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.


Long-Term Follow-up Confirms Low Incidence of Cardiac Events Associated With Trastuzumab

“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.


FDA Grants Orphan Drug Designation for Anti-CD19 T-Cell Cancer Immunotherapy Product

“Kite Pharma, Inc, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company’s lead investigational therapy, an autologous engineered T-cell product that targets CD19 expression on B-cell malignancies, for the treatment of diffuse large B-cell lymphoma.

“Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States. The orphan drug designation also would entitle Kite Pharma to a 7-year period of marketing exclusivity in the United States.”

Editor’s note: When a newly developed drug for a rare (“orphan”) disease seems particularly promising for patients, the FDA may choose to grant it “orphan drug designation.” The designation removes certain barriers that might otherwise keep a drug company from being able to successfully develop and profit from an orphan drug. A new treatment for diffuse large B-cell lymphoma has now been granted orphan drug designation.


FDA Approves Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia

“The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.

The approval was based on the results of a multicenter, randomized, open-label trial comparing ofatumumab in combination with chlorambucil to single-agent chlorambucil.

Editor’s note: Once a newly developed drug has passed testing in clinical trials with volunteer patients, the U.S. Food and Drug Administration (FDA) decides whether to approve it, allowing doctors throughout the U.S. to prescribe it to patients with certain conditions. The FDA has now approved a new treatment for patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based treatment is not a good option. The new treatment combines a drug called ofatumumab (brand name Arzerra) with a drug called chlorambucil (Leukeran).