Three-Week Course of Breast Radiation May Be as Effective as Conventional Five to Seven Week Course for Early Breast Cancers, Says U.S. Study

/PRNewswire/ -- According to a study presented November 4, 2009, at the 51st Annual Meeting of the American Society for Radiation Oncology (ASTRO), a shortened, more intensive course of radiation given to the whole breast, along with an extra dose of radiation given to the surgical bed of the tumor (concomitant boost), has been shown to result in excellent local control at a median follow up of two years after treatment with no significant side effects.

"The observations to date suggest that a three-week course of radiation therapy with concomitant boost results in outcomes comparable to that of a five to seven week course for early stage-breast cancers. Additional studies with a larger body of data and longer follow-up period will help establish whether this type of radiation treatment should be routinely used," Manjeet Chadha, M.D., lead author of the study and a radiation oncologist at the Beth Israel Medical Center in New York, said.

This shorter treatment, called accelerated hypofractionated whole breast irradiation, is an especially attractive option because women can receive a full course of radiation therapy in half the time -- three weeks of daily treatments vs. five to seven weeks. In addition, the cost of this treatment is lower relative to the cost of the standard whole breast radiation and is also less expensive than other new approaches, such as partial breast irradiation (breast brachytherapy).

"Studies from Europe and Canada have used accelerated schedules for breast radiation therapy with favorable results reported on longer follow up. In the U.S., however, there is limited data on this topic," Dr. Chadha said. "Additionally, the radiation therapy technique used in our study is different from previously published experiences. For each patient, we developed a conformal, personalized plan using three-dimensional dosimetry data derived from the patient specific CT scan images. Radiation treatment was delivered to the whole breast using an accelerated hypofractionated schedule, with the simultaneous delivery of a boost dose given to the precise location from which the tumor was removed."

Many women with early-stage breast cancer undergo breast conserving therapy. Typically, this means they first have surgery to remove the visible cancer (a lumpectomy), and then receive a course of radiation therapy to kill any microscopic cancer cells that may remain. The standard whole breast radiation treatment takes 15 to 30 minutes every day, Monday through Friday, for five to seven weeks.

Beginning in June 2004, researchers studied 112 women with early-stage breast cancer who received accelerated hypofractionated whole breast irradiation plus concomitant boost. The results were reported on 105 patients who had completed therapy and had a minimum six-month follow up. The patient group had small breast tumors that had not spread to the lymph nodes. Women with early-stage breast cancer who received chemotherapy or underwent radiation to the lymph nodes were excluded from the study. Patients were followed at regular intervals after completion of treatment.

Findings show that the cancer did not return to the original site or to the surrounding region in these women. The median follow-up of the study was two years. Survival was greater than 95 percent for patients with five years of follow up. The study also shows there were no significant physical or cosmetic side effects from the radiation treatment.

In an era of personalized care, Dr. Chadha emphasizes, "Women with early-stage breast cancer interested in this shorter course should ask their radiation oncologists about this option to evaluate whether it is suitable for their individual case."

For more information on radiation therapy for breast cancer, visit www.rtanswers.org.

The abstract, "Results using 3-week Accelerated Whole Breast (WB) Radiation Therapy (RT) and Concomitant Boost for Early-stage Node Negative Breast Cancer," will be presented at a scientific session at 11:30 a.m. on Wednesday, November 4. To speak to the lead author of the study, Manjeet Chadha, M.D., please call Beth Bukata or Nicole Napoli November 1-4, 2009, in the ASTRO Press Room at McCormick Place West at 312-791-7005 or 312-791-7006. You may also e-mail them at bethb@astro.org or nicolen@astro.org.

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Cancer Community Alarmed at CMS Policy Lumping Life-Saving Cancer Therapy With Diagnostic Testing For Major Funding Cuts

/PRNewswire/ -- The following is being released by US Oncology:

Concerned members of the cancer community, including physicians, patient organizations and other care advocates, spoke out today in opposition to a proposed federal policy under consideration by the Centers for Medicare and Medicaid Services (CMS) that would lump life-saving radiation therapy in with diagnostic testing services in receiving major Medicare funding cuts. In support of their cause, a bipartisan letter led by Reps. Parker Griffith (D-AL), Sue Myrick (R-NC), Lois Capps (D-CA) and Mike Rogers (R-MI), was sent to Health and Human Services Secretary Kathleen Sebelius urging a reversal of this proposal.

"I am very alarmed at the prospect of these dangerous funding cuts being made to radiation therapy, which is a safe and effective treatment proven as a trusted tool in the fight against cancer," said Bernard W. Taylor, M.D., a radiation oncologist at Texas Oncology-Longview Cancer Center in Longview, Texas. "For vulnerable cancer patients like mine, this proposed policy would limit their access to vital radiation treatment through longer wait times and less time spent with their doctors. We must educate policymakers on the radical difference between life-saving, therapeutic radiation therapy and diagnostic testing, and the critical need to spare radiation therapy from these cuts."

At issue is a 19 percent funding cut in Medicare reimbursement to the radiation oncology specialty contained within the CY 2010 Physician Fee Schedule Proposed Rule, equating to cuts of up to 44 percent for certain codes critical to the provision of radiation therapy treatments. Of particular concern in the rule is a proposed policy that raises the utilization rate for medical equipment costing over one million dollars from 50 to 90 percent. The lawmakers and other experts in the industry warn that cuts of this size will result in the closing of many freestanding and community-based cancer centers, particularly in rural areas, harming patient access to care.

"As a radiation oncologist who practiced in the community setting, I am aware of how these severe cuts would limit access to life-saving radiation therapy for cancer patients," said Rep. Griffith. "I am proud to be working on healthcare reform to expand access to high quality, effective care for cancer patients and all Americans, and I look forward to working with both parties as well as the administration to find a solution that averts these cuts and protects patient access to care."

The Congressional letter submitted to Secretary Sebelius, signed by more than 60 Members of Congress, asked CMS to refrain from finalizing the proposed reductions in Medicare payment for radiation oncology services, and to refrain from applying a higher assumed equipment utilization rate to radiation oncology equipment. The letter states:

"We are writing you today to emphasize a clear distinction: Radiation therapy is not diagnostic imaging. . . The therapeutic use of radiation to treat cancer should not be the target of those concerned with volume growth in the area of diagnostic imaging."

The proposal to reduce rates for diagnostic imaging was made by the Medicare Payment Advisory Commission (MedPAC) in their March 2009 report. MedPAC has subsequently stated that it never intended to include radiation therapy in any Medicare reimbursement cuts and yet CMS proposed to extend the cuts to radiation oncology anyway.

According to the National Cancer Institute (NCI), radiation therapy has been found to be under-utilized, with a variety of barriers, including travel time to care, cited as standing between patients and treatment. Following a review of relevant literature, the Agency for Health Care Research and Quality (AHRQ) found evidence of disparities in radiation therapy use among older patients; women; and African Americans, with the exception of care provided in the Veterans' Administration system. In another study of more than 11,000 women in Florida who had undergone breast conserving surgery, the odds of receiving post-surgical radiation therapy decreased by 3 percent for every 5-mile increase in the distance to the nearest radiation therapy facility.

"We support using data to ensure that payment rates for medical procedure are appropriate," said Leonard Kalman, M.D., Chairman of US Oncology's Public Policy Steering Committee. "However, making cuts of this size to radiation therapy - a treatment modality that more than 1 million cancer patients rely upon each year for both curative intent and palliative treatment - without an expressed rationale backed by supporting data is unsound and frankly quite frightening. On behalf of our country's cancer patients, many of whom will rely on radiation therapy at some point in their illness, we must ensure that these cuts are not applied."

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Chemotherapy and Radiation After Surgery Prolongs Life for Pancreatic Cancer Patients

Pancreatic cancer patients treated with a combination of chemotherapy and radiation after surgery survive approximately six months longer than those receiving surgery alone, Johns Hopkins Kimmel Cancer Center scientists report.

Previous clinical trials conducted in the 1980s and 90s in the United States established the benefit of postoperative chemotherapy and radiation. However, experts still disagree on whether to administer the treatments because results from European studies suggest the opposite effect — a decrease in survival.

“Some physicians might avoid chemotherapy and radiation if a benefit in survival is uncertain. However, without proof, I believe it is a disservice to these patients if we eliminate chemotherapy and radiation,” says radiation oncologist Joseph Herman, M.D., who led the study.

Herman and his team sought to put the issue to rest by reviewing records of 616 Johns Hopkins patients whose pancreatic cancers were surgically removed between Aug. 30, 1993, and Feb. 28, 2005. The researchers compared the survival of 345 of the patients who had only surgery with 271 who were then treated with 5-fluorouracil (FU)-based chemotherapy agents and modern types of radiation.

Patients receiving the combined chemotherapy and radiation experienced an improved median survival when compared with patients who did not (21.2 vs. 14.4 months). Two-year survival also improved (43.9 percent vs. 31.9 percent), as did five-year survival (20.1 percent vs. 15.4 percent). Results were published in the July 20 issue of the Journal of Clinical Oncology.

“The take-home message of this study is that patients who received combined chemotherapy and radiation appeared to have better survival than patients who have surgery alone, suggesting that it is safe and beneficial if it’s done carefully and properly,” says Herman, assistant professor in the Department of Radiation Oncology and Molecular Radiation Sciences.

He cautions that this is a retrospective study and that selection bias was possible as they may have selected out those patients who are healthy enough to receive the chemotherapy and radiation. “Regardless, it is still encouraging to say that many of these patients had very aggressive cancer and a lot of them are still alive several years after they received this combination therapy,” says Herman.

Because data to assess treatment toxicity were unavailable, Herman and his study team focused on survival instead. He says the majority of patients were able to complete the therapy, suggesting that they tolerated it well.

The study also identified risk factors to determine those patients most likely to benefit from combined chemotherapy and radiation. Patients who clearly benefited included those with lymph-node-positive disease and those with tumors larger than 3 centimeters (about 1.2 inches). Patients with aggressive tumors also benefited, as did those with margin-positive disease, where the surgeon was unable to remove most of the tumor.

Groups were similar with respect to tumor size, nodal status and margin status, but those receiving combined chemotherapy and radiation were younger (median 64 vs. 70 years) and less likely to present with another serious disease.

“The survival benefit is still seen regardless of high-risk tumor characteristics and after controlling for age, other concurrent diseases and surgical complications,” Herman says.

Patients in this study received about five and a half weeks of combined chemotherapy and radiation, which is referred to as concurrent therapy. The therapy begins about four to eight weeks after surgery.

Most patients also received continuous-infusion 5-FU chemotherapy. This is a form of chemotherapy that enhances the ability of radiation to damage DNA, the building block of the rapidly dividing cancer cells. Patients take four weeks off at the conclusion of their initial therapy, and then may receive maintenance chemotherapy, as prescribed, in the weeks and months ahead.

Pancreatic cancer strikes about five out of 100,000 people each year in the United States. Because pancreatic cancer often has no symptoms in its early stages, cancerous tumors often go unnoticed until the cancer advances and individuals become ill. Prognosis is poor for long-term survival, with only about 5 percent of pancreatic cancer patients surviving five years after their diagnosis.

The most aggressive and effective form of treatment for pancreatic cancer is a complicated surgery commonly known as the Whipple procedure (used in this study), in which the gallbladder, common bile duct, part of the duodenum, and the head of the pancreas are generally removed. Johns Hopkins Hospital has performed more than 3,000 Whipple surgeries over the past 25 years.

The study was funded by the Johns Hopkins Department of Radiation Oncology and Molecular Radiation Sciences.

Michael Swartz, Charles Hsu, Jordan Winter, Timothy Pawlik, Elizabeth Sugar, Ray Robinson, Daniel Laheru, Elizabeth Jaffee, Ralph Hruban, Kurtis Campbell, Christopher Wolfgang, Fariba Asrari, Ross Donehower, Manuel Hidalgo, Luis Diaz, Charles Yeo, John Cameron, Richard Schulick and Ross Abrams, also from Johns Hopkins, assisted with this study.

One-Day Breast Cancer Treatment Saves Lives in Less Time

(ARA) – For many patients, a cancer diagnosis is no longer a fatal one. However, the comfort that a patient’s condition is treatable is often accompanied by dread of the grueling treatment that will be needed to save his or her life. But a new therapy holds hope for treating some cancers in just a single day, rather than through months of harsh radiation therapy.

Arleen Sharwell, 65, a New York resident and mother of two, was among the millions of women who received a diagnosis of breast cancer last year. After the initial shock of the diagnosis, Sharwell discussed her treatment options with her breast surgeon on Long Island. They settled on a lumpectomy surgery followed by five to six weeks of traditional radiation therapy.

Through a family connection, Sharwell learned of a procedure that can eliminate weeks of costly, physically demanding post-operative radiation treatment. The procedure, known as intraoperative electron beam radiation therapy, uses a device called the Mobetron, from IntraOp Medical (www.intraopmedical.com), to deliver a single dose of radiation at the time of surgery. Because the procedure applies the radiation directly to the cancer-affected area, treatment times are shorter, recovery is faster, side effects are fewer and cosmetic results are better than those often experience by patients who go through traditional radiation treatment.

Recent clinical studies, including one from renowned breast surgeon Dr. Umberto Veronesi of Milan’s European Institute of Oncology, have shown that a single dose of radiation at the time of surgery could be equivalent to a full six-week course of traditional post-operative radiation treatment. This treatment is being widely adopted in many international health centers, as it provides a cost-effective way to treat breast cancer, while offering patients better quality of life.

After researching the Mobetron and the single dose treatment, Sharwell passed the information to her doctor. She assumed her doctor would take an active role in helping her to connect with a hospital that offered the treatment, but Arleen’s doctor was uninterested in hearing about the Mobetron. More than that, he openly questioned its effectiveness. “Arleen,” he said, “We have better things here.”

Sharwell turned to Dr. David Ollila from the University of North Carolina in Chapel Hill. She met with Ollila, associate professor and surgical director for the multi-disciplinary breast and multidisciplinary melanoma programs at UNC, and Dr. Joel Tepper, professor and former chair of radiation oncology, to see if she was a candidate for the device. They were quickly able to confirm that she was a candidate, and the doctors scheduled her surgery to be conducted just a few days after the initial meeting.

The day of her operation, Arleen arrived at the hospital at 7 a.m. and finished her surgery and two-minute single dose of radiation from the Mobetron that same day. Dr. Tepper delivered a single dose of radiation to the tumor bed, pinpointing the exact area that required radiation so that healthy tissue was left unharmed. Dr. Ollila then safely removed the lump from Sharwell’s breast.

Sharwell never imagined that she would be treated as an outpatient for breast cancer. “The next day my family came in for lunch and I was shopping in Chapel Hill. I felt fine,” she says.

“The Mobetron made what seemed to be a dreadful situation something that I could overcome,” Sharwell says. “I’ve been trying to get the word out so that other patients can benefit from this fast and remarkable treatment.” She is also impressed with the way her breast has healed since the surgery. “I couldn’t imagine going to a plastic surgeon and having it look any better.”

Sharwell says cancer patients should never just accept what their doctor tells them. They must conduct their own research -- and always get a second opinion.

Courtesy of ARAcontent

Solid Tumor Cells Not Killed by Radiation and Chemotherapy Become Stronger

Because of the way solid tumors adapt the body's machinery to bring themselves more oxygen, chemotherapy and radiation may actually make these tumors stronger.

"In a sense, these therapies can make the tumor healthier," said Mark W. Dewhirst, D.V.M., Ph.D., professor of radiation oncology at Duke University Medical Center. "Unless the treatment is very effective in killing many if not most tumor cells, you are shooting yourself in the foot."

Dewhirst and colleagues Yiting Cao, M.D., Ph.D., of Duke Pathology, and Benjamin Moeller, M.D., Ph.D. have introduced this counter-intuitive idea at recent conferences and in a review article featured in the June issue of Nature Reviews Cancer.

Radiation and chemotherapy do kill most solid tumor cells, but in the cells that survive, the therapies drive an increase in a regulatory factor called HIF1 (hypoxia-inducible factor 1), which cells use to get the oxygen they need by increasing blood vessel growth into the tumor. Solid tumors generally have low supplies of oxygen, Dewhirst explained and HIF1 helps them get the oxygen they need.

The review article concludes that blocking (HIF1) would provide a clear mechanism for killing solid-tumor cells, particularly cells that are proving resistant to radiation or chemotherapy treatments.

As a part of this work, Dewhirst's team has been studying the phenomenon of rising and falling oxygen levels in tumors, called cycling hypoxia. Oxygen levels have been found to naturally cycle up and down in individual blood vessels as well as large tumor regions. This instability in the tumor's oxygen levels can increase HIF-1 production and cause radiation therapy to fail, Dewhirst said.

"It is my opinion that the whole tumor grows more aggressively because of this pulsation of oxygen at low levels," Dewhirst said. "Most people thought cycling hypoxia was caused by temporary stoppage of blood flow in single blood vessel in tumors. In fact, however, oxygen levels cycle up and down virtually everywhere in the tumor, which is caused by fluctuations in blood flow rate. It has been a challenge to convince people of this."

Dewhirst and colleagues have made movies of oxygen transport in a tumor of a living animal that show the oxygen levels cycle up and down significantly, pulsing in waves seen as color changes in the movies.

The Duke team argues that blocking HIF1 is the consistent answer to tumor growth problems. Blocking HIF1 activity interferes with the tumor's ability to undergo glycolysis (energy production) in low-oxygen conditions, which blocks tumor growth, the authors wrote. Exactly how to accomplish chemotherapy or radiation treatment in the safest, most effective ways, in combination with HIF1 blockade, is still open for exploration, Dewhirst said.

For example, targeting HIF1 in the early stages of tumor growth, especially in very early cancer spread, may help, Dewhirst said. "For a woman who has had a primary breast tumor removed, and who is at high risk for cancer spread, this might be a situation in which you'd target HIF1," he explained. "Blocking HIF1 makes sense during the early stages of angiogenesis, which is the accelerated phase of blood vessel formation. In this way, you could keep the early metastasis sites inactive and prevent them from growing."

The Duke team has completed a phase I trial with a HIF1 inhibitor. "We are actively pursuing this clinically and will be moving this study into Phase 2," Dewhirst said. "We are interested in other applications of HIF-1 inhibition in combination with radiation and chemotherapy for different diseases."