Lymphoseek Approved for All Solid-Tumor Cancers

The gist: Oncologists sometimes remove lymph nodes near a patient’s tumor. If the cancer is spreading, these so-called sentinel lymph nodes are likely to contain cancer cells. Therefore, it is important that oncologists be able to accurately detect sentinel lymph nodes so they can be removed and analyzed. A new system for sentinel lymph node detection has now been approved by the U.S. Food and Drug Administration (FDA) for all solid-tumor cancers, including breast cancer and melanoma. The system is called Lymphoseek.

“Approval of the Lymphoseek system for detecting sentinel lymph nodes has been extended to cover all solid-tumor cancers, its manufacturer said Wednesday.

“The FDA is also permitting the radiolabeled tracer system to also now be used with or without lymphoscintigraphy, according to Navidea Biopharmaceuticals.

“Previously, Lymphoseek had been approved in conjunction with melanomas, breast cancers, and head and neck tumors.

“The product uses a technetium-99 labeled tracer to identify lymph nodes serving areas near primary tumors, allowing oncologists to select for excision and analysis those nodes most likely to harbor emigrating cancer cells. The tracer is called tilmanocept, and it binds to CD206 receptors in lymph nodes.”


Circulating Tumor Cells Provide Genomic Snapshot of Breast Cancer

“The genetic fingerprint of a metastatic cancer is constantly changing, which means that the therapy that may have stopped a patient’s cancer growth today, won’t necessarily work tomorrow. Although doctors can continue to biopsy the cancer during the course of the treatment and send samples for genomic analysis, not all patients can receive repeat biopsies. Taking biopsies from metastatic cancer patients is an invasive procedure that it is frequently impossible due to the lack of accessible lesions. Research published October 10th in the journal Breast Cancer Research suggest that tumor cells circulating in the blood of metastatic patients could give as accurate a genomic read-out as tumor biopsies.

“Counting the number of circulating (CTCs) can tell us whether a patient’s cancer is aggressive, or whether it is stable and responding to therapy,” says the article’s first author Sandra V. Fernandez, Ph.D., assistant professor of Medical Oncology at Thomas Jefferson University. “Our work suggests that these in the blood also accurately reflect the genetic status of the parent tumor or its metastases, potentially giving us a new and easy to source of genomic information to guide treatment.”


Osteoporosis Treatment May Also Benefit Breast Cancer Patients

“Treatment approaches to reduce the risk of bone complications (metastasis) associated with breast cancer may be one step closer to becoming a reality. According to a study led by a team at the Research Institute of the McGill University Health Centre (RI-MUHC), findings show that medication used to treat bone deterioration in post-menopausal women may also slow skeletal metastasis caused from breast cancer. This study, published in this month’s issue of the Journal of the National Cancer Institute (JNCI), is among the first to link bisphosphonate (a common osteoporosis medication) use with improved survival in women with breast cancer.

” ‘Skeletal metastases develop in up to 70 percent of women who die from breast cancer,’ says study co-lead author, Dr. Richard Kremer, director of the Bone and Mineral Unit at the MUHC and a professor in the Faculty of Medicine at McGill University. ‘This causes considerable suffering and is life-threatening. Preventing this could translate into saving a significant number of lives.’ “


Roche Breast Cancer Drug Perjeta Appears to Greatly Extend Patients’ Lives

“A drug used to treat advanced breast cancer has had what appears to be unprecedented success in prolonging lives in a clinical trial, researchers reported on Sunday.

“Patients who received the drug — Perjeta, from the Swiss drug maker Roche — had a median survival time nearly 16 months longer than those in the control group.

“That is the longest amount of time for a drug used as an initial treatment for metastatic breast cancer, the researchers said, and it may be one of the longest for the treatment of any cancer.

“Most cancer drugs prolong survival in patients with metastatic disease for a few months at most. Metastasis means the cancer has spread to other parts of the body.

“ ‘We’ve never seen anything like this before,’ said Dr. Sandra M. Swain of the MedStar Washington Hospital Center in Washington, the lead author of the study. ‘It’s really unprecedented to have this survival benefit.’ ”


Roche Says Avastin Prolongs Life in Breast Cancer Study

“Swiss drugmaker Roche said its cancer drug Avastin helped women with a common form of breast cancer live longer without their disease worsening, when used in combination with chemotherapy drug Xeloda.

“Results of a Phase III study involving 185 patients with HER2-negative metastatic breast cancer found those treated with both drugs saw an almost threefold improvement in how long they lived without their disease getting worse compared with those taking Avastin alone.

“A second late-stage trial with 494 patients who continued treatment with Avastin and standard chemotherapy after their disease had progressed showed patients lived significantly longer without the disease getting worse compared with those treated only with chemotherapy.”

Learn more about clinical trials—research studies with volunteer patients.


Eribulin Plus Trastuzumab Safe, Effective in HER-2–Positive Metastatic Breast Cancer

The gist: Researchers recently tested a breast cancer treatment in a clinical trial—a research study with volunteer patients. The treatment combines the drug trastuzumab (aka Herceptin) with a new drug called eribulin mesylate. The goal of the trial was to find out how well the combination might work for patients who had already been treated with trastuzumab. All patients who participated had HER-positive metastatic breast cancer. It was found that the treatment was safe and effective, regardless of whether patients had already taken trastuzumab.

“Eribulin mesylate plus trastuzumab demonstrated activity in patients with HER-2–positive metastatic breast cancer regardless of prior treatment with trastuzumab, according to phase 2 study results presented at the Breast Cancer Symposium.

“Joyce O’Shaughnessy, MD, of the Texas Oncology Baylor Charles A. Sammons Cancer Center, and colleagues sought to evaluate whether prior trastuzumab (Herceptin, Genentech) affected the efficacy of eribulin mesylate (Halaven, Eisai) plus trastuzumab. Previous data indicated the combination conferred a 71% objective response rate as a first-line treatment.

“The analysis included 52 patients (median age, 59.5 years) who had not undergone prior chemotherapy for metastatic breast cancer. Twenty-one patients had previously received trastuzumab and 31 had not. A median of 23 months had passed since previous treatment.

“Patients received 1.4 mg/m2 IV eribulin mesylate on days 1 and 8 of a 21-day cycle. They also received an initial trastuzumab dose of 8 mg/kg, followed by 6-mg/kg doses on day 1 of each cycle. Median treatment duration was approximately 30 weeks.

“Researchers reported similar rates of objective clinical response (62% vs. 77%) and clinical benefit (81% vs. 87%) between patients who had received prior trastuzumab and those who had not.”


Sarah Cannon Research UK and BioMarin Collaborate on EMBRACA Clinical Study in Hereditary Breast Cancer With BRCA Mutation

The gist: Researchers are conducting a clinical trial with volunteer patients to test a new breast cancer treatment called BMN673. BMN673 is a “PARP inhibitor” drug that may benefit patients who have hereditary mutations in the BRCA genes. Patients involved in the trial must have locally advanced and/or metastatic breast cancer, and must have undergone no more than two prior chemotherapy treatments for metastatic disease.

” ‘We are excited to collaborate with BioMarin on this landmark trial to increase the treatment opportunities for patients with BRCA related breast cancer,’ said Dr Alison Jones, Consultant Medical Oncologist and Principal Investigator for the EMBRACA Phase 3 trial at Sarah Cannon Research Institute UK.

” ‘This study is an important milestone for both organizations to foster future collaborations,’ highlighted Dr Hendrik-Tobias Arkenau, FRCP, PhD, Medical Oncologist and Medical Director at Sarah Cannon Research Institute UK.

” ‘Sarah Cannon Research UK has a long history of pioneering significant advances in medical therapy, and we are thrilled to commence enrollment outside of the United States to evaluate the safety and efficacy of BMN 673 in patients with hereditary breast cancer,’ said Hank Fuchs, M.D., Chief Medical Officer of BioMarin. ‘Breast cancer patients with germline BRCA-associated tumors have no targeted treatment options. There is an unmet need for therapies that target specific molecular defects in tumors, and PARP inhibitors offer that potential in BRCA-related breast cancer.’

“The EMBRACA Phse 3 study began in the United states in the fall of 2013 and has expanded internationally. BioMarin plans to enroll patients from sites around the world and to work with partners outside of the United States. The EMBRACA Phase 3 study is an open-label, randomized, parallel, two-arm, multi-center study of BMN 673 versus physician’s choice in approximately 430 germline BRCA mutation patients with locally advanced and/or metastatic breast cancer, who have received no more than two prior chemotherapy regimens for metastatic disease. The primary objective of the study is to measure progression free survival (PFS). Secondary objectives include evaluating the objective response rate (ORR) and the overall survival (OS).”


Cultured CTCs Reveal Genetic Profile, Potential Drug Susceptibility of Breast Cancer Cells

Editor’s note: Oncologists can look for cells that have broken off of a primary or metastatic tumor in the blood of a cancer patient to figure out specific characteristics of the patient’s disease. New research shows that routine blood tests for these cells (known as “circulating tumor cells,” or “CTCs”) could help an oncologist track a patient’s cancer over time, revealing information about which treatments might work best.

“Circulating tumor cells captured with a microchip-based device developed at the Massachusetts General Hospital (MGH) Center for Engineering in Medicine and the MGH Cancer Center can be cultured to establish cell lines for genetic analysis and drug testing. In the July 11 issue of Science, an MGH research team reports that the cultured cells accurately reflect a tumor’s genetic mutation over time and changing susceptibility to therapeutic drugs.

” ‘We now can culture cells from the blood that represent those present in metastatic deposits, which allows testing for drug susceptibility as the tumor evolves and acquires new mutations,’ says Shyamala Maheswaran, PhD, of the MGH Cancer Center, co-senior author of the Science paper. ‘We need to improve culture techniques before this is ready for clinical use, and we are working on doing that right now.’ “


Adjuvant Paclitaxel Not Equivalent to Doxorubicin/Cyclophosphamide in Breast Cancer With 0 to 3 Positive Axillary Nodes

“In the phase III Cancer and Leukemia Group B (CALGB) 40101/Alliance trial reported in the Journal of Clinical Oncology, Shulman et al found that noninferiority of adjuvant single-agent paclitaxel was not established vs doxorubicin/cyclophosphamide for relapse-free survival in women with operable breast cancer with 0 to 3 positive nodes. Paclitaxel was less toxic than doxorubicin/cyclophosphamide.”

Editor’s note: A recent study found that treatment with the drug paclitaxel was no better than a combination of doxorubicin and cyclophosphamide for breast cancer patients who had 0-3 positive axillary nodes (i.e. cancer cells were found in 0-3 lymph nodes; cancer cells in lymph nodes can be used to predict the risk of metastatic breast cancer).