Results from a Phase II study - which will be published in the August 10, 2007 issue of the Journal of Clinical Oncology (JCO) and are now available as an Early Release Article at jco - demonstrate that ixabepilone, a Bristol-Myers Squibb Company (NYSE: BMY) investigational compound, has activity in patients with metastatic breast cancer whose tumors were resistant to three types of standard chemotherapy (anthracycline, taxane, and capecitabine). Currently, there are few proven treatment options available to patients with breast cancer whose disease has rapidly progressed through or whose disease is not responding to prior treatment with approved chemotherapies. This study was one of five Phase II ixabepilone studies published in this issue of JCO, including three additional studies in metastatic breast cancer and one in non-small cell lung cancer.
"Drug resistance is a major concern in treating patients with advanced disease," said Renzo Canetta, vice president, Oncology Global Clinical Research, Bristol-Myers Squibb. "The results of this study are important as they provide valuable information about this investigational compound and its potential in patients with advanced breast cancer that is no longer responding to any of the current U.S. approved chemotherapy treatments."
The 126 patients enrolled in the single-arm Phase II study (CA163081) had heavily pretreated, advanced metastatic breast cancer, which had progressed through three prior therapies (anthracycline, taxane and capecitabine). The primary endpoint was objective response rate, which is an assessment of the response to treatment as determined by the independent radiology facility (IRF). Secondary efficacy endpoints included duration of response, time to response, progression-free survival (PFS), and overall survival (OS), and with the exception of OS, analyses were based on IRF data. Response-evaluable patients were defined as patients with measurable disease, as determined by the IRF, which met the resistance criteria for anthracyclines, taxanes, and capecitabine. Results of the 113 response-evaluable patients were assessed by the IRF, as well as independently by investigators at the study site, and showed:
-- Objective response rate was achieved in 11.5% of patients as determined
by the IRF and 18.6% as determined by the investigators.
-- Median duration of response of 5.7 months.
-- Median time to response of 6.1 weeks.
-- Median progression-free survival of 3.1 months.
-- Median overall survival of 8.6 months.
Overall treatment-related non-hematological adverse events greater than or equal to 20% included: peripheral sensory neuropathy 60% (Grade 3/4: 14%); fatigue/asthenia 50% (Grade 3/4: 14%); myalgia/arthralgia 49% (Grade 3/4: 8%); alopecia 48% (Grade 3/4: 0%); nausea 42% (Grade 3/4: 2%); stomatitis/mucositis 29% (Grade 3/4: 7%); vomiting 29% (Grade 3/4: 1%); diarrhea 22% (Grade 3/4: 1%); and musculoskeletal pain 20% (Grade 3/4: 3%). Treatment-related hematological adverse events greater than or equal to 20% included: leukopenia 90% (Grade 3/4: 49%); anemia 84% (Grade 3/4: 8%); neutropenia 79% (Grade 3/4: 54%); and thrombocytopenia 44% (Grade 3/4: 8%).
About Ixabepilone
Ixabepilone is an investigational compound, a semisynthetic analog of epothilone B, designed to inhibit or prevent the growth or development of cancer cells. Epothilones are a potential new class of antineoplastic (or chemotherapy) agents. For information on ixabepilone clinical trials, log on to clinicaltrials.
On June 19, 2007 the company announced that the U.S. Food and Drug Administration has accepted, for filing and granted priority review of, these data as part of the New Drug Application for ixabepilone. The target action date is in late October. The proposed indications for ixabepilone are as a monotherapy to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine and in combination with capecitabine to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane. The company also plans to submit these data as part of a registrational dossier in the European Union, and other countries this year.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the application submitted to the FDA will be approved, that an application will be submitted or approved in any other country, or, if approved, that the product will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2006 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Bristol-Myers Squibb
Bristol-Myers Squibb
четверг, 27 октября 2011 г.
четверг, 20 октября 2011 г.
Being Called At Home About Work Bothers Women More Than Men
Women are more psychologically distressed when receiving emails or phone calls about work while they are at home than men are, researchers from the University of Toronto wrote in Journal of Health and Social Behavior. The results of their findings surprised some people who thought women would welcome the flexibility between home and work duties offered by modern technology.
The researchers gathered data from a national survey of US workers. They asked participants how often they received communications by text messages, emails and telephone calls about work-related matters during their free time. They found that females who were contacted often by colleagues, clients or their own bosses reported elevated levels of psychological distress. Males, on the other hand, exposed to similar levels of communications appeared to be less affected.
Lead author Paul Glavin, said:
"Initially, we thought women were more distressed by frequent work contact because it interfered with their family responsibilities more so than men. However, this wasn't the case. We found that women are able to juggle their work and family lives just as well as men, but they feel more guilty as a result of being contacted. This guilt seems to be at the heart of their distress."
According to their findings, a significant number of women have feelings of guilt when having to deal with work-related matters at home, even when their family lives are not directly affected. Males in similar circumstances do not seem to experience the same degree of guilt.
The authors suggest that expectations regarding the boundaries that separate work and private life are different between males and females, which lead to unique emotional consequences.
Co-author, Scott Schieman, said:
"Guilt seems to play a pivotal role in distinguishing women's work-family experiences from men's. While women have increasingly taken on a central role as economic providers in today's dual-earner households, strong cultural norms may still shape ideas about family responsibilities. These forces may lead some women to question or negatively evaluate their family role performance when they're trying to navigate work issues at home."
"Boundary-Spanning Work Demands and Their Consequences for Guilt and Psychological Distress"
Paul Glavin, Scott Schieman, Sarah Reid
Journal of Health and Social Behavior February 28, 2011 vol. 52 no. 1 43-57
doi: 10.1177/0022146510395023
The researchers gathered data from a national survey of US workers. They asked participants how often they received communications by text messages, emails and telephone calls about work-related matters during their free time. They found that females who were contacted often by colleagues, clients or their own bosses reported elevated levels of psychological distress. Males, on the other hand, exposed to similar levels of communications appeared to be less affected.
Lead author Paul Glavin, said:
"Initially, we thought women were more distressed by frequent work contact because it interfered with their family responsibilities more so than men. However, this wasn't the case. We found that women are able to juggle their work and family lives just as well as men, but they feel more guilty as a result of being contacted. This guilt seems to be at the heart of their distress."
According to their findings, a significant number of women have feelings of guilt when having to deal with work-related matters at home, even when their family lives are not directly affected. Males in similar circumstances do not seem to experience the same degree of guilt.
The authors suggest that expectations regarding the boundaries that separate work and private life are different between males and females, which lead to unique emotional consequences.
Co-author, Scott Schieman, said:
"Guilt seems to play a pivotal role in distinguishing women's work-family experiences from men's. While women have increasingly taken on a central role as economic providers in today's dual-earner households, strong cultural norms may still shape ideas about family responsibilities. These forces may lead some women to question or negatively evaluate their family role performance when they're trying to navigate work issues at home."
"Boundary-Spanning Work Demands and Their Consequences for Guilt and Psychological Distress"
Paul Glavin, Scott Schieman, Sarah Reid
Journal of Health and Social Behavior February 28, 2011 vol. 52 no. 1 43-57
doi: 10.1177/0022146510395023
четверг, 13 октября 2011 г.
HPV Home Tests Could Improve Cervical Screening Uptake
Home tests for the human papillomavirus (HPV) could help increase the take-up of cervical screening among women who do not respond to screening invitations, new research shows today.
Despite publicity surrounding Jade Goody who died from cervical cancer at the age of 27, a worrying number of women ignore the opportunity to be screened.
The study,* published in the British Journal of Cancer,** looked at 3000 women from the Westminster Primary Care Trust who had not responded to at least two screening invitations.
Self-sample HPV test kits were sent to half the women, while the other half were sent another invitation for cervical screening.
Around 10 per cent of women in the first group responded to receiving kits. This was made up of 96 women (6.4 per cent) doing the self-sample and in addition, 57 (3.8 per cent) booking an appointment to be screened in the usual way.
In the other group, 68 women (4.5 per cent) went for a smear test after receiving a third invitation.
Dr Anne Szarewski , lead author of the study and a Cancer Research UK cervical cancer expert, said: "Women who don't go for cervical screening face a higher risk of cervical cancer so it's important to encourage these women to take part. HPV self-sampling could be an effective way of getting women to be screened.
"Home testing for HPV is as accurate as samples taken by doctors and can help address some of the reasons, like finding time or being embarrassed, that women often give as reasons for not attending screening."
Screening for cervical cancer - the most common form of cancer in women under 35 - can prevent cases of the disease.
But over the last ten years the coverage rate - the proportion of women aged 25-64 in England who have had a cervical screening test at least once in the previous five years - has been edging lower and is now 78.9 per cent, just below the government's target of 80 per cent.
A one per cent fall in the coverage rate accounts for around 165,000 women.
The authors say the study should be repeated in other areas to find out if the level of response seen in Westminster is likely to be representative of the rest of the country.
In the HPV home test group eight women tested positive for HPV - two had high grade stages of abnormal cells and one had an invasive cancer. Dr Szarewski said this showed that self-sampling had the potential to pick up even more women with abnormalities.
While most women infected with HPV do not develop cervical cancer, the virus is the major cause of the disease.
Sara Hiom, director of health information at Cancer Research UK, said: "Although we saw a surge in the number of women going for smear tests immediately after the sad experience of Jade Goody, we know a significant proportion of women are not going for screening.
"Cervical cancer is one of the few cancers that can be prevented through screening by picking up early changes in the cells which can lead to the disease. So finding a way to screen women who do not go for smear tests could be very valuable.
"HPV home tests could help overcome some of the barriers women face, especially those from deprived backgrounds or ethnic minorities where cultural barriers play a role.
"More research is needed to see if the response to self-sampling around the country would be generally higher but this study suggests it may have the potential to prevent even more cases of cervical cancer along with the current screening programme."
References
**Szarewski, A et al., HPV self-sampling as an alternative in non-attenders for cervical screening - a randomised controlled trial, British Journal of Cancer (2011) DOI:10.1038/bjc.2011.48
Notes
*funded by a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme grant
Source:
Cancer Research UK
Despite publicity surrounding Jade Goody who died from cervical cancer at the age of 27, a worrying number of women ignore the opportunity to be screened.
The study,* published in the British Journal of Cancer,** looked at 3000 women from the Westminster Primary Care Trust who had not responded to at least two screening invitations.
Self-sample HPV test kits were sent to half the women, while the other half were sent another invitation for cervical screening.
Around 10 per cent of women in the first group responded to receiving kits. This was made up of 96 women (6.4 per cent) doing the self-sample and in addition, 57 (3.8 per cent) booking an appointment to be screened in the usual way.
In the other group, 68 women (4.5 per cent) went for a smear test after receiving a third invitation.
Dr Anne Szarewski , lead author of the study and a Cancer Research UK cervical cancer expert, said: "Women who don't go for cervical screening face a higher risk of cervical cancer so it's important to encourage these women to take part. HPV self-sampling could be an effective way of getting women to be screened.
"Home testing for HPV is as accurate as samples taken by doctors and can help address some of the reasons, like finding time or being embarrassed, that women often give as reasons for not attending screening."
Screening for cervical cancer - the most common form of cancer in women under 35 - can prevent cases of the disease.
But over the last ten years the coverage rate - the proportion of women aged 25-64 in England who have had a cervical screening test at least once in the previous five years - has been edging lower and is now 78.9 per cent, just below the government's target of 80 per cent.
A one per cent fall in the coverage rate accounts for around 165,000 women.
The authors say the study should be repeated in other areas to find out if the level of response seen in Westminster is likely to be representative of the rest of the country.
In the HPV home test group eight women tested positive for HPV - two had high grade stages of abnormal cells and one had an invasive cancer. Dr Szarewski said this showed that self-sampling had the potential to pick up even more women with abnormalities.
While most women infected with HPV do not develop cervical cancer, the virus is the major cause of the disease.
Sara Hiom, director of health information at Cancer Research UK, said: "Although we saw a surge in the number of women going for smear tests immediately after the sad experience of Jade Goody, we know a significant proportion of women are not going for screening.
"Cervical cancer is one of the few cancers that can be prevented through screening by picking up early changes in the cells which can lead to the disease. So finding a way to screen women who do not go for smear tests could be very valuable.
"HPV home tests could help overcome some of the barriers women face, especially those from deprived backgrounds or ethnic minorities where cultural barriers play a role.
"More research is needed to see if the response to self-sampling around the country would be generally higher but this study suggests it may have the potential to prevent even more cases of cervical cancer along with the current screening programme."
References
**Szarewski, A et al., HPV self-sampling as an alternative in non-attenders for cervical screening - a randomised controlled trial, British Journal of Cancer (2011) DOI:10.1038/bjc.2011.48
Notes
*funded by a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme grant
Source:
Cancer Research UK
четверг, 6 октября 2011 г.
NPR's 'Weekend Edition Saturday' Profiles Prenatal Care Program at Bedford Hills Correctional Facility in New York
NPR's "Weekend Edition Saturday" profiled the prenatal care program for female inmates at Bedford Hills Correctional Facility in Westchester County, N.Y. The state sends all of its pregnant inmates to Bedford Hills, a maximum security prison, where they receive prenatal care and parenting classes and are permitted to keep their infants at an in-house nursery for up to 18 months after birth. The program is meant to foster relationships between women and their newborns, which provides the infants a "better start" and incentives for women to "stay straight," according to NPR. Mary Byrne of Columbia University, who is evaluating the success of the nursery program, said the infants at Bedford Hills "do as well as babies in any other setting" and are "not challenged at all in any negative way." Her research is expected to be completed in 2007. Critics of the program say it is "soft on crime" and that inmates should lose their parental rights, NPR reports. The U.S. is one of four countries that routinely takes infants away from their incarcerated mothers (Wertheimer, "Weekend Edition Saturday," NPR, 11/5).
The complete segment is available online in RealPlayer.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
The complete segment is available online in RealPlayer.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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