JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.
THIS WEEK'S CONTENT
JAMA NEWS RELEASES
(Embargoed for Release: 3:00 p.m. CT, Tuesday, March 4, 2008)
JAMA NEWS RELEASES
WOMEN WHO HAVE STOPPED ESTROGEN PLUS PROGESTIN THERAPY MAY BE AT INCREASED RISK OF CANCER
NON-POLYPOID (FLAT) COLON LESIONS RELATIVELY COMMON AND ASSOCIATED WITH COLORECTAL CANCER
ADDING CHEMOTHERAPY TO CHEMORADIATION TREATMENT FOLLOWING SURGERY FOR PANCREATIC CANCER APPEARS TO HAVE LIMITED SURVIVAL BENEFIT
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
WOMEN REMAIN AT RISK FOR BREAST CANCER THREE YEARS AFTER STOPPING HORMONE THERAPY IN WOMEN’S HEALTH INITIATIVE TRIAL
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
SAVE THE DATE: JAMA will hold a media briefing on Tuesday, March 18, from 10 a.m. – 12:15 p.m., at the National Press Club in Washington, D.C., on Genetics and Genomics.
The program will highlight new research on the identification of genes related to several major diseases and conditions that affect millions of men and women, as well as genomic medicine applications for common chronic diseases. A group of international researchers will present their papers published in this special theme issue of JAMA and Editor-in-Chief Dr. Catherine DeAngelis will moderate the program.
To register, go to www.jamamedia.org and click on the Events tab, or call 312-464-JAMA.
TV Note: This week's JAMA Video News Report is on the health risks and benefits after stopping estrogen plus progestin hormone therapy. The report will be fed Tuesday, March 4, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 26 (formerly Intelsat America 6) C-Band, Transponder 14, downlink frequency: 3880 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, March 4, 2008
Media Advisory: To contact Gerardo Heiss, M.D., call Ramona DuBose at 919-966-7467.
WOMEN WHO HAVE STOPPED ESTROGEN PLUS PROGESTIN THERAPY MAY BE AT INCREASED RISK OF CANCER
CHICAGO—A follow-up study of women who stopped taking the hormone therapy of estrogen plus progestin after this intervention was discontinued as part of a clinical trial indicates that these women may have an increased risk of cancer, compared to women in the placebo group, according to a study in the March 5 issue of JAMA. Cardiovascular disease and fracture risks were similar between the two groups, but women who took hormone therapy had an overall higher global risk index reflecting the balance of risks and benefits from a number of endpoints combined, including deaths.
The Women’s Health Initiative (WHI) trial of estrogen plus progestin, which included 16,608 postmenopausal women, assessed whether conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) prevents heart disease and hip fractures and increases the risk of breast cancer. The trial was stopped in 2002 when data indicated an increased risk of breast cancer and a failure to demonstrate an overall health benefit of the therapy. Further analysis showed that women in the CEE plus MPA group had higher risks of cardiovascular disease (CVD), coronary heart disease (CHD), stroke and venous thromboembolism and lower risks of fracture and colorectal cancer.
Gerardo Heiss, M.D., of the University of North Carolina, Chapel Hill, N.C., and colleagues examined the risks and benefits experienced by 15,730 trial participants who had follow-up, from July 2002 to March 2005, after they stopped hormone therapy.
The researchers found that the annualized event rates for the outcome “all cancer” was higher during the postintervention follow-up for the CEE plus MPA group (1.56 percent per year [n = 281]) than the placebo group (1.26 percent per year [n = 218]). This reflects a greater risk of invasive breast cancer and other cancers in the CEE plus MPA group; the rates of colorectal cancer did not differ significantly between the two groups; rates of endometrial cancer were lower in the CEE plus MPA group. Though risk of breast cancer remained elevated during the follow-up, the risk was less than that experienced towards the end of the trial period.
The risk of cardiovascular events after the intervention were comparable, with an annualized rate of 1.97 percent in the CEE plus MPA (343 events) and 1.91 percent in the placebo group (323 events), meaning that the increased risks found during the trial period weakened after study drugs were stopped.
The risk of fractures during the postintervention follow-up was similar among women in both groups for each type of fracture considered: hip, vertebral and other osteoporotic fractures. “This reflects a greater increase in the annualized risk of fractures after the intervention in the women who had been assigned to CEE plus MPA compared with women assigned to placebo, particularly for hip and vertebral fractures. Thus, the protective effects of CEE plus MPA previously evident during the trial were not observed to carry over into the postintervention phase...,” the researchers write.
During the postintervention phase, the rate of death from all causes was higher by 15 percent in the group originally assigned to CEE plus MPA than in those assigned to placebo, but this difference was not statistically significant.
A summary of the risks and benefits, the global index, included outcomes for coronary heart disease, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture and death due to other causes. The researchers found that this measure was 12 percent higher in women randomly assigned to receive CEE plus MPA compared with placebo and did not materially change after the intervention was stopped.
“This analysis of delayed and sustained health benefits and risks following randomized allocation to CEE plus MPA vs. placebo adds new information to inform the optimal use of postmenopausal CEE plus MPA. Over the course of [an average of] 2.4 years from termination of intervention with CEE plus MPA, rapid changes in hormone therapy–related risks and benefits were observed, as well as trends that suggest that continued follow-up of the study participants of this trial will be informative as regards possible delayed effects of CEE plus MPA,” the authors write. “Following termination of use of CEE plus MPA of 3.5 to 8.5 years, clinical vigilance seems warranted with respect to a sustained higher risk of malignancies.”
(JAMA. 2008;299[9]:1036-1045. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, March 4, 2008
Media Advisory: To contact Roy M. Soetikno, M.D., M.S., call Kerri Childress at 650-858-3925. To contact editorial author David Lieberman, M.D., call Tamara Hargens Bradley at 503-494-8231.
NON-POLYPOID (FLAT) COLON LESIONS RELATIVELY COMMON AND ASSOCIATED WITH COLORECTAL CANCER
CHICAGO—Flat, non-polypoid colorectal neoplasms (NP-CRNs), which may be difficult to detect, appear to be relatively common and may have a greater association with cancer compared with the more routinely diagnosed type of colorectal polyps, according to a study in the March 5 issue of JAMA.
Colorectal cancer is the second leading cause of cancer death in the United States. Prevention has focused on the detection and removal of polypoid (resembling a polyp) neoplasms (a new and abnormal growth). Recent studies, however, have demonstrated that colorectal cancer can also arise from NP-CRNs. “Nonpolypoid colorectal neoplasms are more difficult to detect by colonoscopy or computed tomography colonography because the subtle findings can be difficult to distinguish from those of normal mucosa [membrane]. As compared with surrounding normal mucosa, NP-CRNs appear to be slightly elevated, completely flat, or slightly depressed,” the authors write. Data are limited on the significance of NP-CRNs.
Roy M. Soetikno, M.D., M.S., and colleagues with the Veterans Affairs Palo Alto Health Care System, Palo Alto, Calif., examined data from a group of 1,819 patients undergoing elective colonoscopy to estimate the prevalence of NP-CRNs and to characterize the association of NP-CRNs with colorectal cancer.
The overall prevalence of NP-CRNs was 9.35 percent (n = 170). The prevalence of NP-CRNs in the subpopulations for screening, surveillance, and symptoms was 5.84 percent, 15.44 percent, and 6.01 percent, respectively. The overall prevalence of NP-CRNs with cancer that had not spread or had spread in tissue beneath the mucous membrane was 0.82 percent; in the screening population, the prevalence was 0.32 percent. Overall, NP-CRNs were nearly 10 times more likely to contain cancerous tissue than polypoid lesions, irrespective of the size.
The positive size-adjusted association of NP-CRNs with cancer that had not spread or had spread in tissue beneath the mucous membrane was also observed in subpopulations for screening and surveillance. The depressed type of NP-CRNs had the highest risk (33 percent). Nonpolypoid colorectal neoplasms containing cancer were smaller in diameter as compared with the polypoid ones.
“In conclusion, in this population of patients at a single Veterans Affairs hospital, NP-CRNs were a relatively common finding during colonoscopy. They were more likely to contain carcinoma compared with polypoid neoplasms, independent of lesion size. Recent studies have pointed out differences in the genetic mechanisms underlying nonpolypoid and polypoid colorectal neoplasms. Future studies on NP-CRNs should further evaluate whether the diagnosis and removal of NP-CRNs has any effect on the prevention and mortality of colorectal cancer and particularly focus on their genetic and protein abnormalities,” the authors write.
(JAMA. 2008;299[9]:1027-1035. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: NONPOLYPOID COLORECTAL NEOPLASIA IN THE UNITED STATES
In an accompanying editorial, David Lieberman, M.D., of Oregon Health & Science University, Portland VA Medical Center, Portland, Ore., comments on the findings of Soetikno and colleagues.
“[Nonpolypoid colorectal neoplasms] may be biologically distinct from polypoid lesions and appear to be more likely to harbor malignant features. Detection and complete removal at colonoscopy may be challenging. The current study emphasizes the importance of quality in the performance of colonoscopy,” he writes. “The optimal methods for enhancing colonoscopic imaging of NP-CRNs are uncertain. … Additional studies are needed to determine whether imaging modalities such as computed tomography colonography will be able to detect NP-CRNs. Finally, longitudinal studies are needed to determine whether patients with NP-CRNs require more intensive colonoscopic surveillance compared with patients with polypoid lesions of similar size and histology.”
(JAMA. 2008;299[9]:1068-1069. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, March 4, 2008
Media Advisory: To contact William F. Regine, M.D., call Ellen Beth Levitt at 410-328-8919. To contact editorial author James L. Abbruzzese, M.D., call Laura Sussman at 713-745-2457.
ADDING CHEMOTHERAPY TO CHEMORADIATION TREATMENT FOLLOWING SURGERY FOR PANCREATIC CANCER APPEARS TO HAVE LIMITED SURVIVAL BENEFIT
CHICAGO—The addition of the drug gemcitabine with chemoradiation for the treatment of patients who had surgery for pancreatic cancer was associated with a survival benefit, although this improvement was not statistically significant, according to a study in the March 5 issue of JAMA.
Despite the potential benefits of surgically removing cancer involving the pancreas, there is a 50 percent to 85 percent rate of local relapse associated with liver and intra-abdominal failure and a 5-year survival of less than 20 percent, according to background information in the article. The frequency and pattern of failure makes the combination of added postoperative chemotherapy and radiation an important consideration. The drug gemcitabine has been shown to improve outcomes compared with the drug fluorouracil.
William F. Regine, M.D., of the University of Maryland Medical Center, Baltimore, and colleagues conducted a study to assess if the addition of gemcitabine to the supplemental treatment of fluorouracil chemoradiation (chemotherapy plus radiation) improved survival for patients who had a portion of their pancreas removed as a treatment for pancreatic cancer (surgical resection). The randomized controlled phase 3 trial included 451 patients enrolled between July 1998 and July 2002 at 164 U.S. and Canadian institutions, with follow-up through August 2006. Patients received chemotherapy with either fluorouracil (n = 230) or gemcitabine (n = 221) for three weeks prior to chemoradiation therapy and for 12 weeks after chemoradiation therapy (with fluorouracil).
The researchers found that patients with pancreatic head (a part of the pancreas) tumors (n = 388) had a median (midpoint) survival of 20.5 months and 3-year survival of 31 percent in the gemcitabine group vs. 16.9 months and 22 percent in the fluorouracil group. A certain level of hematologic (involving abnormalities in the blood cell counts) toxicity (grade 4) was 1 percent in the fluorouracil group and 14 percent in the gemcitabine group without a difference in neutropenia (a blood disorder) or infection. There were no differences in the ability to complete chemotherapy or radiation therapy.
“The addition of gemcitabine to [supplemental] fluorouracil-based chemoradiation was associated with a survival benefit for patients with resected pancreatic cancer, although this improvement was not statistically significant,” the authors write.
Patients in the study had the lowest rate of cancer recurring in its original location than in other previous studies. The tumor came back in the same area in 23 percent of the patients, compared to 40 percent to 60 percent of patients in other studies. At least 70 percent of the patients in this study experienced spread of their cancer to other parts of the body, a process that is known as systemic metastasis.
“Laboratory correlative studies from [this trial] are ongoing and are evaluating molecular genetic alterations that promote local and systemic relapse. Future trials should emphasize novel systemic treatments to reduce systemic metastases and modern image-guided radiation to prevent local recurrence while reducing radiation-related toxic effects.”
(JAMA. 2008;299[9]:1019-1026. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: ADJUVANT THERAPY FOR SURGICALLY RESECTED PANCREATIC ADENOCARCINOMA
In an accompanying editorial, James L. Abbruzzese, M.D., of the University of Texas M. D. Anderson Cancer Center, Houston, offers suggestions on how to improve outcomes for pancreatic cancer patients with surgical resection.
“First, the lessons regarding the optimal selection of patients for surgical resection need to be exported more effectively into the high-surgical volume setting. … Second, further work is needed to determine which patients are most likely to benefit from chemoradiation and, if this modality is going to evolve, further emphasis should be placed on the development of more effective radiation sensitizers.”
“Third, based on interindividual differences in drug metabolism and DNA repair, it appears that patients who are more likely to benefit from current chemotherapy and chemoradiation strategies can be defined prospectively. These individualized approaches should be examined in prospective clinical trials. Finally, and most importantly, efforts must be redoubled to develop a new generation of promising therapeutics, and the commitment must be increased to understand and test them in prospectively defined patient subsets—not the means to detect marginal or incremental improvements in clinical trials of large numbers of unselected patients.”
(JAMA. 2008;299[9]:1066-1067. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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JAMA REPORTS
VIDEO: Windows Media | Quicktime
WOMEN REMAIN AT RISK FOR BREAST CANCER THREE YEARS AFTER STOPPING HORMONE THERAPY IN WOMEN’S HEALTH INITIATIVE TRIAL
INTRO:
The Women’s Health Initiative was a major federally funded study. In 2002 researchers suspended one phase of the study after noticing women who took estrogen and progestin had increased health risks. Now a new study that followed those women for three years after the trial was halted indicates they were still at a higher risk for some conditions even after they stopped taking hormones. Jennifer Mitchell explains in this week’s JAMA Report.
VIDEO:
Woman at desk
Hormone pills
AUDIO:
GERRYE BOGGS IS ONE OF THOUSANDS OF WOMEN WHO PARTICIPATED IN THE WOMEN’S HEALTH INITIATIVE. LIKE MANY, SHE TOOK AN ESTROGEN – PROGESTIN COMBINATION PILL FOR AN AVERAGE OF ABOUT FIVE YEARS.
VIDEO:
SOT/FULL
@ :12
Gerrye Boggs
Study Participant
Runs :05
AUDIO:
“In my lifetime it was supposed to be the miracle drug for women.”
VIDEO:
B-ROLL
Researcher doing work looking at papers
FULL SCREEN GRAPHIC:
HEALTH RISKS AFTER STOPPING HORMONES
Cardiovascular Risks Diminish
Breast Cancer Risk Continues
AUDIO:
DR ROBERT WALLACE, PROFESSOR OF EPIDEMIOLOGY AT THE UNIVERSITY OF IOWA IS PART OF A TEAM OF RESEARCHERS WHO FOLLOWED STUDY PARTICIPANTS FROM 2002 THROUGH 2005 AFTER THEY STOPPED TAKING HORMONE THERAPY. THEY FOUND CARDIOVASCULAR RISKS SUCH AS CORONARY HEART DISEASE, BLOOD CLOTS, AND STROKE BEGAN TO DIMINISH RIGHT AWAY. BUT THE RISK OF BREAST CANCER, WHICH WAS TWENTY-FIVE PERCENT HIGHER DURING THE TRIAL FOR THOSE TAKING HORMONE THERAPY, CONTINUED TO PERSIST EVEN AFTER THE DRUGS WERE STOPPED.
VIDEO:
SOT/FULL
@ :46
Super: Robert Wallace, M.D.
University of Iowa
Runs :09
AUDIO:
“This is a randomized trial, it’s an experiment and that gives us a fair degree of certainty that this was related to the drug.”
VIDEO:
B-ROLL
Woman talking to healthcare worker
Hormone pills
AUDIO:
PROTECTION FROM COLON CANCER IDENTIFIED DURING THE TRIAL DISAPPEARED IN THE THREE YEAR FOLLOW UP. THERE WAS ALSO A SMALL INCREASED RISK OF LUNG CANCER AND AN INCREASE IN THE OVERALL DEATH RATE.
VIDEO:
SOT/FULL
Robert Wallace, M.D.
University of Iowa
Runs :07
AUDIO:
“There was about a fifteen percent increase in mortality among women on the drug after the drug was stopped.”
VIDEO:
B-ROLL
GFX/ JAMA COVER
Woman getting blood pressure taken by health care worker
AUDIO:
THE STUDY APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. GERRYE BOGGS SAYS BECAUSE OF THESE RISKS SHE IS SCREENED REGULARLY FOR BREAST AND COLON CANCER.
VIDEO:
SOT/FULL
Gerrye Boggs
Study Participant
Runs: 05
AUDIO:
“I will not take hormones not necessarily because of the risk but because I don’t think I need them.”
VIDEO:
B-ROLL
counting hormone pills
AUDIO:
SO DO THE OVERALL RISKS OF HORMONE THERAPY STILL OUT-WEIGH THE BENEFITS?
VIDEO:
SOT/FULL
Robert Wallace, M.D.
University of Iowa
Runs: 04
AUDIO:
“It continues to be overall unfavorable but that doesn’t mean the risks occur in every woman”
VIDEO:
B-ROLL
Woman getting mammogram
Hormone pills
Woman talking to doctor
AUDIO:
RESEARCHERS EMPHASIZE THE IMPORTANCE OF CARDIOVASCULAR AND CANCER SCREENINGS ESPECIALLY FOR WOMEN WHO ARE POST MENOPAUSE. WOMEN WHO FEEL THEY NEED HORMONE THERAPY SHOULD TALK TO THEIR DOCTOR ABOUT THE RISKS AND BENEFITS TO DETERMINE WHAT’S BEST.
JENNIFER MITCHELL, THE JAMA REPORT.
TAG:
Researchers say the most important thing for women to do is to continue to get annual health screenings and to take appropriate preventive measures for their age even if they are no longer taking hormones. Study participants will continue to be monitored at least through 2010. For more information visit www.jama.com.
