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Prescription Cancer Drugs
Europeans Inflate Survival Gain from Cancer Screening (CME/CE)
Posted by: admin in Prescription Cancer Drugs on August 19th, 2009
- Explain that 92% of European women overestimated the mortality reduction from breast cancer screening by at least an order of magnitude, or reported they didn’t know the reduction, while 89% of men overestimated the mortality reduction from prostate cancer screening in a similar fashion.
- Note that the study was not designed to assess whether or not overestimation resulted in more participation in screening.
European men and women overestimate the benefits of breast and prostate cancer screening, researchers have found.
A total of 92% of women overestimated or didn’t know the mortality reduction from mammography screening while 89% of men did the same for prostate-specific antigen (PSA) testing, according to Gerd Gigerenzer, PhD, of the Max Planck Institute for Human Development in Berlin.
“Information about the benefits of mammography and PSA screening has not reached the general public in nine European countries, including the age tested by screening programs,” the researchers reported online in the Journal of the National Cancer Institute.
The absolute risk reduction in mortality associated with screening for breast cancer is on the order of one in 1,000, the researchers said.
There’s a similar risk reduction for men with PSA testing — though it can be much smaller, with estimates ranging between zero and one in 1,000.
In fact, after reviewing the evidence, the U.S. Preventive Services Task Force said it’s unclear whether increased detection of prostate cancer from screening would reduce morbidity and mortality.
So, to assess perceptions of cancer-specific mortality reduction associated with the screening methods, the researchers conducted interviews with 10,228 patients in Europe between September and December 2006.
They found that only 1.5% of women chose the correct estimate for reduction in mortality due to breast cancer screening.
Four times as many women answered that the benefit was zero, while 92.1% overestimated the benefit by at least one order of magnitude or said they didn’t know.
The greatest overestimation occurred in France, the Netherlands, and the U.K. — countries that have high participation rates in mammography screening, the researchers said.
In their survey, researchers also found that 89.3% of men either overestimated mortality reduction from prostate cancer screening or reported they didn’t know.
The greatest overestimation occurred in France, followed by Austria, the Netherlands, Spain, and the U.K.
The researchers also found that men and women ages 50 to 69 — the targets of screening programs — weren’t better informed about the benefits of mammography and PSA screening than the rest of the population.
Frequently consulting a physician and reading informational pamphlets tended to increase overestimation of the benefit, rather than reduce it, the researchers said.
They noted that previous studies have shown physicians, too, lack knowledge about the benefits of screening, and some have conflicts of interest that support the “possibility that these professionals contribute to overestimation.”
Knowing the benefit of a treatment is necessary for rational decision-making, the researchers said. However, currently available information sources are “not designed to communicate benefits clearly. As a consequence, preconditions for informed decisions about participation in screening are largely nonexistent in Europe.”
The study did not attempt to assess whether overestimation was associated with more screening. The study also may be limited because the results may not be generalizable to populations outside of Europe.
In an accompanying editorial, Steve Woloshin, MD, of Dartmouth, and Lisa Schwartz, MD, of the VA Outcomes Group in White River Junction, Vt., said the method for assessing perception of risk was biased towards overestimation. That should not, however, diminish the study’s findings, they said.
“Whether people overestimate the benefit of screening — or have no idea — the problem is the same,” they wrote. “Without an accurate sense of how well screening works, people cannot begin to make informed decisions. We need to move from selling screening to helping people realize that screening is a genuine choice.”
Primary source: Journal of the National Cancer Institute
Source reference:
Additional source: Journal of the National Cancer Institute
Source reference:
Woloshin S, Schwartz LM “Numbers needed to decide” J Natl Cancer Inst 2009; 101: 1163-1165.
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Equal Care Erases Race Disparities For Some Cancers, Not All (CME/CE, with audio)
Posted by: admin in Prescription Cancer Drugs on July 15th, 2009
SAN FRANCISCO, July 9 — African-Americans are more likely to die from breast, prostate, and ovarian cancers than other races — even when they get identical medical care and after controlling for other socioeconomic factors, researchers found.
But no other major cancers produced the persistent racial disparity with equal treatment, and after adjustment for tumor prognostic factors, demographics, and socioeconomics, Kathy S. Albain, MD, of Loyola University Chicago in Maywood, Ill., and colleagues reported.
Their analysis of Southwest Oncology Group trials suggested that access to care, later stage diagnosis, and poverty — widely blamed for cancer disparities — don’t tell the whole story, they wrote online in the Journal of the National Cancer Institute.
For the sex-specific cancers, biologic and genetic factors are likely to play a role, they said.
- Explain to interested patients that clinical trial settings provide a “level playing field” with equal treatment, disease stage, and other factors.
- Note that the study could not determine reasons for the persistent racial disparities in survival of breast, ovarian, and prostate cancers, although biologic and genetic factors have been postulated to play a role.
In an accompanying editorial, Otis W. Brawley, MD, chief medical officer of the American Cancer Society, emphasized that race is not a scientific categorization and is rejected by many anthropologists.
Rather, it is “a surrogate for area of geographic origin, socioeconomic status, and culture, all of which can have correlations with disease risk,” he noted.
Dr. Brawley added, “Perhaps advances in our understanding of biology will lead us away from concerns about race and we will better define high-risk populations using pathological markers of disease.”
Dr. Albain’s group pooled findings from 35 Southwest Oncology Group randomized, phase III trials in which a total of 19,457 adult cancer patients (11.9% African American) got uniform treatment by protocol and met similar entry criteria, including disease stage.
After adjustment for each cancer’s prognostic factors, such as tumor size, the researchers found no significant association between African-American race and overall survival in the following:
- Acute myelogenous leukemia (P=0.12)
- Limited-stage small cell lung cancer (P=0.29)
- Advanced-stage non-small cell lung cancer (P=0.20)
- Multiple myeloma (P=0.34)
- Early-stage colon cancer (P=0.87)
- Advanced-stage non-Hodgkin lymphoma (P=0.10)
“Good care in good hands gives the same outcome for all patients for the most part,” Dr. Albain said.
But compared with all other racial and ethnic groups combined, African-Americans had significantly poorer adjusted overall survival for sex-specific cancers. The 20-year survival estimates were:
- 68% versus 77% for early-stage premenopausal breast cancer (HR for death 1.41, P=0.007)
- 52% versus 62% for early-stage postmenopausal breast cancer (HR for death 1.49, P<0.001)
- 13% versus 17% for advanced-stage ovarian cancer (HR for death 1.61, P=0.002)
- 6% versus 9% for advanced-stage prostate cancer (HR for death 1.21, P=0.001)
Adding income and education to these analyses did not substantially impact the associations of race with overall survival.
Nor did comparing cause-specific mortality or comparing African-American patients to whites with other groups excluded.
Notably, an analysis of breast cancer by histology showed elevated overall mortality after full adjustment in African-Americans, compared with other groups for both hormone receptor-positive and hormone receptor-negative tumors.
This suggested that “the triple-negative biology theory cannot be the sole explanation for the difference in breast cancer outcomes by race,” the researchers said.
They cautioned that the studies did not control how patients were diagnosed, making it possible that non-African American patients were more likely to be screen detected, resulting in lead-time bias.
But cause-specific mortality analysis showed this did not explain the findings, they noted.
Since population-based studies have shown significant racial disparities in survival of cancers beyond just breast, ovarian, and prostate cancers, Dr. Brawley said the findings provide further evidence that real-world care is not equal.
“Blacks are less likely to have their disease detected early, and when it is detected, they are less likely to receive adequate treatment,” he concluded.
| The individual studies in the analysis were funded by the National Institutes of Health. The researchers reported no conflicts of interest.
Dr. Brawley provided no information on conflicts of interest. |
Primary source: Journal of the National Cancer Institute
Source reference:
Additional source: Journal of the National Cancer Institute
Source reference:
Cancer Therapies: How Much Is Life Worth? The $440 Billion Question
Posted by: admin in Prescription Cancer Drugs on July 01st, 2009
The decision to use expensive cancer therapies that typically produce only a relatively short extension of survival is a serious ethical dilemma in the U.S. that needs to be addressed by the oncology community, according to a commentary published online June 29 in the Journal of the National Cancer Institute.
Tito Fojo, M.D., Ph.D., of the Medical Oncology Branch, Center of Cancer Research at the National Cancer Institute, in Bethesda, Md., and Christine Grady, Ph.D., of the Department of Bioethics, the Clinical Center at the National Institutes of Health, tackle the controversy concerning the life-extending benefits of certain cancer drugs and the extent to which their cost should factor in deliberations.
The authors illustrate cost-benefit relationships for several cancer drugs, including cetuximab for treatment of non-small cell lung cancer, touted as “practice changing” and new standards of care by professional societies, including the American Society of Clinical Oncology.
They ask, “Is an additional 1.7 months [the additional overall survival for colorectal cancer patients treated with cetuximab] a benefit regardless of costs and side effects?”
According to Fojo and Grady, in the U.S., 18 weeks of cetuximab treatment for non-small cell lung cancer, which was found to extend life by 1.2 months, costs an average of $80,000, which translates into an expenditure of $800,000 to prolong the life of one patient by 1 year. At this rate, it would cost $440 billion annually, an amount 100 times NCI’s budget, to extend the lives of 550,000 Americans who die of cancer annually by 1 year.
To address the issue, the commentators recommend that studies powered to detect a survival advantage of two months or less should test only interventions that can be marketed at a cost of less than $20,000 for a course of treatment.
Every life is of infinite value, the authors say, but spiraling costs of cancer care makes this dilemma inescapable.
“The current situation cannot continue. We cannot ignore the cumulative costs of the tests and treatments we recommend and prescribe. As the agents of change, professional societies, including their academic and practicing oncologist members, must lead the way,” the authors write. “The time to start is now.”
Citation: Fojo T. and Grady C. How Much Is Life Worth: Cetuximab, Non - Small Cell Lung Cancer, and the $440 Billion Question J Natl Cancer Inst 2009, 101: 1-5.
Source:
Steve Graff
Journal of the National Cancer Institute
Quality of Life Might Help Decide Between Prostate Cancer Therapies (CME/CE)
Posted by: admin in Prescription Cancer Drugs on June 17th, 2009
LITTLE FALLS, N.J., June 9 — Although the major treatments for early-stage prostate cancer yield similar survival rates, their effects on quality of life vary, researchers said.
- Explain to interested patients that, without a clear survival advantage for any of the prostate cancer treatments, side effects and how they affect quality of life may guide clinical decision-making.
Men who underwent treatment for prostate cancer with radical prostatectomy, brachytherapy, or external beam radiation had different issues related to quality of life through four years of recovery, John Gore, M.D., of the University of California Los Angeles, and colleagues reported online in the Journal of the National Cancer Institute.
“Because no treatment has proven superiority in prostate cancer control, treatment side-effect profiles often determine treatment choices,” the researchers said. “These results may guide decision-making for . . . clinical management of patients with health-related quality-of-life impairments after treatment for localized prostate cancer.”
Other studies evaluating quality of life following prostate cancer treatment have looked at periods of up to two years, which the researchers said “marked a period of convalescence.”
To assess longer-term outcomes and the differential effects of the therapies, they followed 475 men who were treated for early-stage disease for four years.
Most (307) had had radical prostatectomy, 90 underwent brachytherapy, and 78 received external beam radiation.
The participants completed a questionnaire before treatment and several times through follow-up.
Overall, mental and physical quality of life measures were “largely unaffected” by prostate cancer treatment, the researchers said, but there were some significant differences between the therapies.
Urinary incontinence occurred more frequently in patients who underwent prostatectomy than in those who underwent one of the radiation therapies (P<0.001 for both).
Following prostatectomy, the likelihood of recovering any degree of continence was low after 30 months, a finding that “may guide clinical decision making regarding the optimal timing of secondary therapies,” the researchers said.
Voiding and urinary storage problems were more common after brachytherapy than after prostatectomy (P<0.001). However, the probability of getting back to baseline urinary function after brachytherapy improved through four years.
Conversely, patients who underwent external beam radiation therapy had a progressive reduction in the likelihood of regaining baseline urinary function.
All three treatments were associated with sexual dysfunction, but patients who underwent prostatectomy were significantly less likely than men receiving radiation therapy to regain baseline sexual function (P<0.001).
“Thus,” Dr. Gore and colleagues said, “a clinician may advise patients considering surgery that although they may be sexually functional, they almost certainly will not function exactly as they did before surgery.”
Treatment with external beam radiation was associated with a progressive decline in sexual function through the four-year study, whereas there was a slight improvement over time following brachytherapy.
Bowel dysfunction occurred more frequently following either form of radiation therapy compared with prostatectomy.
The authors acknowledged some limitations of the study, including the fact that patients might have undergone treatments that worsened pre-existing conditions.
In addition, they said, patients who had a recurrence of cancer were not analyzed separately.
| The study was funded by the California Department of Health Services.
The authors reported that they had no conflicts of interest. |
Primary source: Journal of the National Cancer Institute
Source reference:
Gore J, et al “Survivorship beyond convalescence: 48-month quality-of-life outcomes after treatment for localized prostate cancer” J Natl Cancer Inst 2009; 101: 888-92.
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