Oncologists Value Survival Over Quality of Life, Study Finds

For oncologists, drugs that help cancer patients live longer are worth more than drugs that help patients live well, according to research from Duke University's Fuqua School of Business and several health-related centers.

On average, oncologists were willing to prescribe treatments that cost about $245,000 to prolong life for one year, but the cost threshold dropped to about $119,000 per year for treatments that improve quality of life without prolonging patients' lives.

"Oncologists are understandably focused on survival, but they need to pay equal attention to the quality of life people experience during and after treatment," said senior author Peter Ubel, M.D., the John O. Blackburn professor of business administration at Fuqua.

The researchers found a wide range in what cancer doctors considered reasonable treatment costs. The threshold varied from $10,000 to $5 million per quality adjusted life year (QALY), a standard for assessing the cost-effectiveness of medical interventions. The spending thresholds assessed in the study were also measured in QALYs.

The research can be found on Medical Decision Making's website: http://bit.ly/fBIYBP.

The results highlight a critical problem in the struggle to control health care costs, Ubel said. Increasingly, doctors are being asked to consider whether very expensive cancer drugs -- some of which offer only small gains in survival -- are worth prescribing. But according to Ubel, the data on cost-effectiveness comes without guidelines for determining appropriate financial value in cancer care.

"Currently, individual oncologists are left to decide whether the benefits of expensive new drugs justify their costs," said Ubel. "Cancer care spending is unlikely to drop when there is such a broad range in what oncologists consider reasonable."

"The fact that these highly trained, wonderful doctors are confused about the issue suggests we as a society should discuss the cost of cancer care more explicitly. With health care spending emptying patients' pocketbooks, and bankrupting state and federal governments, we need to decide how much we should spend for small improvements in the quantity or quality of patients' lives."

The study results are based on a survey sent to members of the American Society of Clinical Oncology. The 768 physicians who responded considered two hypothetical scenarios involving a patient with metastatic cancer and a year to live.

The first scenario asked the doctor how much benefit, in months of survival gained, a new drug would need to provide for them to prescribe it. The new drug cost $75,000 more than standard treatment. The second scenario asked the doctor to indicate the highest cost at which they would prescribe a medication to improve the quality of life without prolonging survival.

The respondents consistently chose to spend more on life-prolonging treatments than on quality-enhancing treatments.

Additional authors of the study include Michael A. Kozminski and Aleksandra Jankovic of the Center for Behavioral and Decision Sciences in Medicine, University of Michigan Medical School in Ann Arbor, Mich.; Peter J. Neuman of the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center in Boston; and Eric S. Nadler of the Charles Sammons Cancer Center, Baylor University Medical Center in Dallas.

The study was funded by grants from the California Healthcare Foundation and the Tufts Medical Center.

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FDA Approves New Indication for Tasigna

The U.S. Food and Drug Administration on June 17 approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

Tasigna is believed to work by blocking a signal that leads to leukemic cell development. The new indication expands the use of Tasigna to adult patients in earlier stages of the disease. The FDA originally approved Tasigna in October 2007 for the treatment of Ph+CP-CML in adult patients whose disease had progressed or who could not tolerate other therapies, including Gleevec (imatinib).

When Tasigna was originally approved in October 2007, the FDA identified that the therapy placed patients at risk of an abnormal heart rhythm called QT prolongation. In March 2010, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Tasigna to help patients and health care professionals to better understand this risk. The REMS includes an updated Medication Guide and a communication plan to help reduce medication errors involving drug-food interactions and incorrect dosing intervals.

“It’s important for companies to continue developing oncology drugs for earlier stages of the disease once they have demonstrated clinical effectiveness in resistant forms of cancer,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, part of the FDA’s Center for Drug Evaluation and Research. “This approach has the potential to increase the availability of an effective treatment to more patients.”

In CML, too many blood stem cells develop into a type of white blood cell called granulocytes. These granulocytes are abnormal and do not become healthy white blood cells. These cells can build up in the blood and bone marrow so there is less room for healthy white blood cells, red blood cells, and platelets. When this happens, infection, anemia, or unexpected bleeding may occur.

The FDA granted Tasigna a priority review for Ph+ CP-CML. The agency completed the review in six months. The new indication for Tasigna was approved under the FDA’s accelerated approval program, which allows FDA to approve a drug to treat serious diseases with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit. The company is required to collect additional long term efficacy and safety information data confirming the drug’s benefit. The accelerated approval program provides earlier patient access to promising new drugs while the confirmatory clinical trials are being conducted.

The safety and effectiveness of Tasigna were evaluated in a single clinical trial enrolling 846 patients with newly diagnosed Ph+ CP-CML. Patients received either Tasigna or Gleevec until the disease worsened, or until unacceptable side effects developed. The study was designed to measure a significant reduction in the surrogate endpoint of the number of CML cancer cells in the blood stream (i.e., major molecular response) at 12 months. About 44 percent of patients who received Tasigna experienced a major molecular response, compared with 22 percent of patients receiving Gleevec.

In patients with newly diagnosed CP-CML, the most commonly reported non-blood-related adverse drug reactions were rash, itching (pruritus), headache, nausea, fatigue, and muscle pain (myalgia). Serious blood-related drug reactions included decrease in bone marrow activity (myelosuppression), low level of platelets in the blood (thrombocytopenia), decrease in infection-fighting white blood cells (neutropenia), and anemia.

Other FDA-approved drugs to treat CML include Gleevec in May 2001 and Sprycel (dasatinib) in June 2006. Tasigna and Gleevec are marketed by East Hanover, N.J.-based Novartis Pharmaceuticals. Sprycel is marketed by New York City-based Bristol-Myers Squibb.

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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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Prescription Drug Benefits for Medicare Patients with Cancer to Cost More in 2009

/PRNewswire-USNewswire/ -- People with cancer enrolled in Medicare Part D plans will spend more out-of-pocket for their Part D drugs and face increased restrictions on access to them in 2009, according to new research released today by Avalere Health and the American Cancer Society Cancer Action Network (ACS CAN).

The Avalere-ACS CAN research found that Medicare stand-alone prescription drug plans (PDPs) have been increasingly shifting name-brand oral cancer drugs to higher formulary tiers over the last four years, meaning that with each year, the products have cost more for consumers.

In 2009, the large majority of PDPs placed name-brand oral oncology products -- including Gleevec, Sutent, Tarceva, Thalomid, and Tykerb -- on specialty tiers that require cost sharing of 26 percent to 35 percent for each prescription. For example, 84 percent of PDP enrollees are in plans that put Gleevec -- a name-brand drug used to treat leukemia and other forms of cancer -- on their most expensive tiers (fourth or higher) in 2009, up from 39 percent in 2006.

"This pattern of shifting the costs of branded medications to patients needs to be scrutinized, especially in light of the economic difficulty being experienced by so many seniors," said Valerie Barton, a vice president at Avalere Health.

"Shifts in drug coverage can limit access to treatment for people with cancer, significantly reducing their treatment options or even requiring a stoppage of treatment," said Daniel E. Smith, president of ACS CAN. "We urge policymakers to pay close attention to how these changes impact people with cancer. At the same time, it is critical that people with cancer understand their health coverage and the potential hurdles that may impact their treatment."

In addition to changing tier placement, PDPs in 2009 are increasing their use of prior authorization to control access to branded cancer drugs. The Avalere-ACS CAN research found that Gleevec had the largest increase in the number of PDPs requiring prior authorization, with 70 percent of plans requiring it, up from 35 percent in 2006. Tarceva had the next highest increase, with 62 percent of plans requiring prior authorization in 2009, up from 35 percent in 2006. Thalomid was next, with 68 percent of plans requiring prior authorization in 2009, up from 43 percent in 2006.

Geography and plan choice influence how much a person with cancer will spend out-of-pocket in Medicare Part D. Avalere and ACS CAN modeled hypothetical drug regimens for women with breast cancer and found that total out-of-pocket costs for a woman enrolled in AARP MedicareRx Saver in Florida will be about $1,985, while total out-of-pocket costs for beneficiaries enrolled in Humana PDP Standard in California will average about $2,551.

ACS CAN and the American Cancer Society are closely monitoring these issues as part of their nationwide efforts to ensure access to quality, affordable health care for all Americans. The organizations believe that the health care system needs to be retooled with an emphasis on prevention and early detection; meaningful health insurance that is adequate, affordable, available and administratively simple; and reducing pain and suffering with an emphasis on quality of life.

Avalere continues to analyze Medicare drug benefit data. Since the inception of the Medicare drug program, Avalere has used its proprietary DataFrame(R) database to track trends in drug pricing, plan strategy and structure, and the beneficiary experience.

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PIEDMONT HOSPITAL URGES GEORGIA WOMEN TO GET SCREENED

In 2007, the American Cancer Society estimated there were 11,000 cases of cervical cancer diagnosed in the United States. While cervical cancer is at a four percent decrease overall, thousands of women are still dying as a result of it each year. January is Cervical Cancer Awareness and Screening Month and Piedmont Hospital is encouraging women throughout Georgia to get cervical cancer screenings.

The primary reason for the decline in the incidence and mortality rate of women with cervical cancer is due to the widespread use of the Papanicolaou (Pap) test to detect cervical abnormalities. A Pap test can detect cervical cancer before it spreads or even develops – dramatically improving the odds of surviving the disease, and it is the most important thing women can do to protect themselves from cervical cancer.

“Regular screenings for women are the first defense against cervical cancer,” said Alfred Jenkins, M.D., OBGYN at Piedmont Gynecology Oncology. "If more women were screened regularly, many unnecessary deaths from cervical cancer could be avoided."

The American Cancer Society recommends two ways to prevent cancer: Avoid the risk factors for pre-cancers, such as HPV, and get a regular Pap test. The Pap test can even detect HPV infection and pre-cancers. Treatment of these problems can stop cervical cancer before it develops fully into an invasive cancer.

“Since January is Cervical Cancer Awareness and Screening Month, it is the perfect time to encourage women to see their doctor to get screened for cervical cancer,” Dr. Jenkins said. “I also encourage them to ask their doctor about the HPV vaccine as another method to prevent cervical cancer.”

Dr. Jenkins has been a part of the Piedmont Healthcare family since early last year, working with Piedmont Gynecologic Oncology located on the Piedmont Hospital campus. He also holds part-time office hours at Piedmont Fayette Hospital in Fayetteville. Dr. Jenkins is board-certified in obstetrics and gynecology and gynecologic oncology. Prior to joining Piedmont Gynecologic Oncology, Dr. Jenkins served as director of the Division of Gynecologic Oncology at M.D. Anderson Cancer Center-Orlando. While there, he performed the first gynecologic robotics procedure in the state of Florida. He also performs fertility-sparing surgery for cervical cancer.