Posts Tagged ‘standard’

Novel immunotherapy vaccine decreases recurrence in HER2 positive breast cancer patients

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.

“This is an important and different avenue in immunotherapy research, in that we are investigating ways to prevent cancer recurrence by stimulating the immune system to treat cancer,” says principal investigator Elizabeth Mittendorf, M.D., Ph.D., associate professor of Surgical Oncology. “The ultimate goal is to develop a preventative tool that will minimize the risk of recurrence in women who have already had breast cancer and for whom standard therapies have failed.”

The findings are the result of a phase II randomized trial that paired the GP2 vaccine, designed to stimulate the CD8+ cells, commonly known as “killer” or “toxic” T cells, with an immune stimulant known as granulocyte/macrophage colony stimulating factor (GM-CSF). The trial included 190 patients with varying levels of HER2; 89 women received the GP2 vaccine with a GM-CSF adjuvant and a control group of 91 patients received GM-CSF alone. Eight patients experienced early recurrence or developed a second malignancy and did not complete the vaccine trial. The vaccine is injected subcutaneously and the initial series consisted of monthly inoculations for six months, followed by four cycles of booster shots administered every six months thereafter. The patients were monitored for nearly three years.

For all 190 patients, including those who did not complete the trial, the disease-free survival (DFS) rate was 88% among those who received the vaccine and 81% in the control group — representing a 37% reduction in recurrence. Excluding the patients who did not complete the vaccine series, the results are higher — 94% DFS rate versus 85% who did not get GP2 — a 57% risk reduction.

Women with HER2 +3 who were administered trastuzumab as part of the standard of care prior to receiving the vaccine experienced no cases of cancer recurrence. According to Mittendorf, trastuzumab may act like a primer for the vaccine. Trastuzumab stimulates CD4+ T cells to release substances that fight cancer cells and initiates an antibody response. Thus, it may prepare the immune system, making the vaccine even more effective. MD Anderson is now testing this combination of immunotherapies in other clinical trials.

Personalized Immunotherapy

The GP2 study supports previous MD Anderson research on similar breast cancer vaccines, such as AE37, which showed a significant immune response and improved recurrence rates in triple-negative breast cancer patients. Another candidate, E75, known as NeuVax or nelipepimut-S, showed a 50% recurrence decrease in high-risk patients. Currently, NeuVax is being tested internationally in a phase III clinical trial.

“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.”

source : http://www.sciencedaily.com/releases/2014/09/140905122717.htm

Breast radiation trial provides more convenience, better compliance, lowered cost and patient outcomes on par with current treatment

These interim results of the 5-year Phase II clinical trial using the experimental regimen are being presented at the Breast Cancer Symposium 2014 in San Francisco by Anthony E. Dragun, M.D., vice chair and associate professor of radiation oncology at the University of Louisville.

Dragun, a radiation oncologist with University of Louisville Physicians, launched the trial three years ago at UofL’s James Graham Brown Cancer Center, a part of KentuckyOne Health and the only site offering the experimental regimen in the United States. A second KentuckyOne Health site is being planned, he said, and is expected to begin enrolling patients this autumn.

Reviewing data from Europe — the United Kingdom in particular — Dragun found an alternative to the currently standard daily radiation treatments prescribed to patients after a lumpectomy. Physicians in the U.K. and other European countries were reporting excellent results with a regimen of radiation administered once-weekly.

“Instead of daily treatments for 25-30 days, five to six treatments administered once each week were being used,” he said. “I thought this regimen would give our patients here in Kentucky a great deal of access and choice, so we developed the trial and launched it in 2011.”

Approximately 150 female patients have been enrolled in the trial thus far, he said. Patients undergoing a lumpectomy following diagnosis of breast cancer are given a choice of the current standard of daily radiation treatments or the option to enroll in the trial and receive treatment one time per week.

The radiation dosing has been calibrated to compensate for the change in how the treatments are administered, but no adverse effects have been seen, Dragun said. “The outcomes with once-weekly treatments are absolutely in line with what we see in daily breast irradiation,” he said. “The standard of care is maintained.”

Giving women the choice of how their treatment is administered means more women complete their treatment, he said. “Finding time for daily treatments for 6 weeks or more just isn’t possible for many women,” Dragun said. “Scheduling once-weekly treatments is much easier to fit into the busy lives our patients lead.

“We also see many patients who depend on public transportation or live in rural areas that are 30 miles or more from our center, and they have told us that they would not have been able to complete a traditional course of daily radiation treatment. Their only alternative would be a mastectomy,” he said.

Because radiation treatment is reimbursed on a per-treatment basis, Dragun said the overall cost is lowered. “We have reduced the number of treatments to about one-fourth to one-third of what the current daily treatment regimen is,” he said. “Medicare reimburses radiation costs on a per-treatment basis, and most private insurers do likewise.

“This means we’ve been able to reduce the cost by 50 to 60 percent without jeopardizing the quality of care.”

Dragun plans to enroll another 50 patients at the Louisville site and 30 at the future trial site. After the completion of this trial, he intends to expand into a multi-center Phase III trial at facilities in other states.

“We believe the once-weekly regimen such as this will become a standard option in the next decade,” he said.

source : http://www.sciencedaily.com/releases/2014/09/140904121041.htm

Surgery associated with better survival for patients with advanced laryngeal cancer

Approximately 11,000 to 13,000 cases of laryngeal cancer are diagnosed each year and squamous cell carcinoma accounts for the vast majority of these tumors. Prior to 1991, total surgical removal of the larynx with postoperative radiation was the standard of care for advanced cancer. Since then, chemoradiation has become increasingly popular treatment because it can preserve the larynx.

The authors evaluated survival outcomes for surgical vs. nonsurgical treatment for advanced laryngeal cancer. The authors used data from the Surveillance, Epidemiology and End Results (SEER) database for their study of 5,394 patients diagnosed with stage III or IV laryngeal squamous cell carcinoma between 1992 and 2009.

Patients who had surgery had better 2-year and 5-year disease-specific survival (70 percent vs. 64 percent and 55 percent vs. 51 percent, respectively) and 2-year and 5-year overall survival (64 percent vs. 57 percent and 44 percent vs. 39 percent, respectively) than patients who did not under surgery. The use of nonsurgical treatment increased over time: 32 percent in the 1992 to 1997 patient group, 45 percent in the 1998 to 2003 group and 62 percent in the 2004 to 2009 group. The gap in survival between the two groups consistently narrowed over subsequent years. Patients who were diagnosed between 2004 and 2009 had better survival than those diagnosed earlier and this may be due to improvements in radiation and chemotherapy strategies.

“Patients need to be made aware of the modest but significant survival disadvantage associated with nonsurgical therapy as part of the shared decision-making process during treatment selection,” researchers noted.

source : http://www.sciencedaily.com/releases/2014/08/140821161353.htm