User login
Research and Reviews for the Practicing Oncologist
FDA issues new rule on drug shortages
The Food and Drug Administration (FDA) has announced that it would require some manufacturers to give the agency early warning of an imminent drug shortage. The agency made the announcement on December 15, 2011, as a Senate committee held a hearing the continuing drug shortage problem. It issued an interim final rule in response to President Obama’s October 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services...
*For a PDF of the full article, click in the link to the left of this introduction.
The Food and Drug Administration (FDA) has announced that it would require some manufacturers to give the agency early warning of an imminent drug shortage. The agency made the announcement on December 15, 2011, as a Senate committee held a hearing the continuing drug shortage problem. It issued an interim final rule in response to President Obama’s October 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services...
*For a PDF of the full article, click in the link to the left of this introduction.
The Food and Drug Administration (FDA) has announced that it would require some manufacturers to give the agency early warning of an imminent drug shortage. The agency made the announcement on December 15, 2011, as a Senate committee held a hearing the continuing drug shortage problem. It issued an interim final rule in response to President Obama’s October 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services...
*For a PDF of the full article, click in the link to the left of this introduction.
Retrospective Study of Patients with Metastatic Triple-Negative Breast Cancer: Survival, Health Care Utilization, and Cost
Background: Triple-negative breast cancer (TNBC) is a subset of breast cancer. Health care cost and utilization data for TNBC are lacking.
Objective: We examined differences between metastatic TNBC and metastatic non-TNBC in survival and health care costs and utilization.
Methods: This retrospective analysis of metastatic TNBC (134 patients) and metastatic non-TNBC (445 patients) used a proprietary oncology registry, the Impact Intelligence Oncology Management registry database, linked with health insurance claims and social security mortality data.
Results: We found metastatic patients whose breast cancer is triple negative to be younger (56.49 vs 59.24 years), to be more likely to have recurrent disease (64.93 vs 45.39%), and to have greater mortality vs metastatic non-TNBC patients (67.16 vs 50.79%) (all P less than .05). Recurrent patients with metastatic TNBC have the highest risk of death (HR, 1.9; P less than .001), whereas survival was greatest for de novo metastatic non-TNBC. Patients with metastatic TNBC had more all-cause annual hospitalizations, more hospitalized days, and higher total costs vs metastatic non-TNBC. Annual payer’s total costs, annual payer’s inpatient costs, cancer-related hospitalizations, and cancer-related inpatient costs also were greater among patients with metastatic TNBC.
Limitations: While the study spans slightly more than 2 years, 5-10 years would have been preferable to achieve a full clinical profile of indexed patients. The database also omitted factors that potentially confound the results, such as race and socioeconomic status.
Conclusions: Metastatic TNBC is associated with significant burden of disease and higher health care utilization vs metastatic non-TNBC, which may be due in part to the aggressive clinical course of the disease...
* For a PDF of the full article, click in the link to the left of this introduction.
Background: Triple-negative breast cancer (TNBC) is a subset of breast cancer. Health care cost and utilization data for TNBC are lacking.
Objective: We examined differences between metastatic TNBC and metastatic non-TNBC in survival and health care costs and utilization.
Methods: This retrospective analysis of metastatic TNBC (134 patients) and metastatic non-TNBC (445 patients) used a proprietary oncology registry, the Impact Intelligence Oncology Management registry database, linked with health insurance claims and social security mortality data.
Results: We found metastatic patients whose breast cancer is triple negative to be younger (56.49 vs 59.24 years), to be more likely to have recurrent disease (64.93 vs 45.39%), and to have greater mortality vs metastatic non-TNBC patients (67.16 vs 50.79%) (all P less than .05). Recurrent patients with metastatic TNBC have the highest risk of death (HR, 1.9; P less than .001), whereas survival was greatest for de novo metastatic non-TNBC. Patients with metastatic TNBC had more all-cause annual hospitalizations, more hospitalized days, and higher total costs vs metastatic non-TNBC. Annual payer’s total costs, annual payer’s inpatient costs, cancer-related hospitalizations, and cancer-related inpatient costs also were greater among patients with metastatic TNBC.
Limitations: While the study spans slightly more than 2 years, 5-10 years would have been preferable to achieve a full clinical profile of indexed patients. The database also omitted factors that potentially confound the results, such as race and socioeconomic status.
Conclusions: Metastatic TNBC is associated with significant burden of disease and higher health care utilization vs metastatic non-TNBC, which may be due in part to the aggressive clinical course of the disease...
* For a PDF of the full article, click in the link to the left of this introduction.
Background: Triple-negative breast cancer (TNBC) is a subset of breast cancer. Health care cost and utilization data for TNBC are lacking.
Objective: We examined differences between metastatic TNBC and metastatic non-TNBC in survival and health care costs and utilization.
Methods: This retrospective analysis of metastatic TNBC (134 patients) and metastatic non-TNBC (445 patients) used a proprietary oncology registry, the Impact Intelligence Oncology Management registry database, linked with health insurance claims and social security mortality data.
Results: We found metastatic patients whose breast cancer is triple negative to be younger (56.49 vs 59.24 years), to be more likely to have recurrent disease (64.93 vs 45.39%), and to have greater mortality vs metastatic non-TNBC patients (67.16 vs 50.79%) (all P less than .05). Recurrent patients with metastatic TNBC have the highest risk of death (HR, 1.9; P less than .001), whereas survival was greatest for de novo metastatic non-TNBC. Patients with metastatic TNBC had more all-cause annual hospitalizations, more hospitalized days, and higher total costs vs metastatic non-TNBC. Annual payer’s total costs, annual payer’s inpatient costs, cancer-related hospitalizations, and cancer-related inpatient costs also were greater among patients with metastatic TNBC.
Limitations: While the study spans slightly more than 2 years, 5-10 years would have been preferable to achieve a full clinical profile of indexed patients. The database also omitted factors that potentially confound the results, such as race and socioeconomic status.
Conclusions: Metastatic TNBC is associated with significant burden of disease and higher health care utilization vs metastatic non-TNBC, which may be due in part to the aggressive clinical course of the disease...
* For a PDF of the full article, click in the link to the left of this introduction.
Community Oncology Podcast - Radiation in breast cancer
Dr. David H. Henry takes you on an audio tour of the December issue of Community Oncology, which includes a discussion and commentary on adding regional nodal irradiation to whole-breast irradiation to improve disease-free survival in breast cancer patient. Other podcast features includes highlights from the San Antonio Breast Cancer Symposium, the International Society of Geriatric Oncology and the Radiological Society of North America.
Dr. David H. Henry takes you on an audio tour of the December issue of Community Oncology, which includes a discussion and commentary on adding regional nodal irradiation to whole-breast irradiation to improve disease-free survival in breast cancer patient. Other podcast features includes highlights from the San Antonio Breast Cancer Symposium, the International Society of Geriatric Oncology and the Radiological Society of North America.
Dr. David H. Henry takes you on an audio tour of the December issue of Community Oncology, which includes a discussion and commentary on adding regional nodal irradiation to whole-breast irradiation to improve disease-free survival in breast cancer patient. Other podcast features includes highlights from the San Antonio Breast Cancer Symposium, the International Society of Geriatric Oncology and the Radiological Society of North America.
We Asked, They Answered: What Is Palliative Care?
At the 7th Annual Chicago Supportive Oncology Conference, we asked leaders and experts in supportive oncology to define "palliative care." This is what they had to say:
At the 7th Annual Chicago Supportive Oncology Conference, we asked leaders and experts in supportive oncology to define "palliative care." This is what they had to say:
At the 7th Annual Chicago Supportive Oncology Conference, we asked leaders and experts in supportive oncology to define "palliative care." This is what they had to say:
TECHNOLOGY Packing a punch into your PowerPoint presentations
Many PowerPoint presentations are mindnumbingly boring— and often useless— because some basic guidelines are overlooked during their preparation. As a result, the software ends up failing both the presenter and the audience. It doesn’t have to be that way, though. If you use PowerPoint properly, it can enhance your talk, amplify your ideas, and help you deliver your message with maximum impact to an audience that remains engaged—and awake.
How can you make PowerPoint your friend? Here are five guidelines to keep in mind the next time you prepare to use this presentation software program. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Many PowerPoint presentations are mindnumbingly boring— and often useless— because some basic guidelines are overlooked during their preparation. As a result, the software ends up failing both the presenter and the audience. It doesn’t have to be that way, though. If you use PowerPoint properly, it can enhance your talk, amplify your ideas, and help you deliver your message with maximum impact to an audience that remains engaged—and awake.
How can you make PowerPoint your friend? Here are five guidelines to keep in mind the next time you prepare to use this presentation software program. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Many PowerPoint presentations are mindnumbingly boring— and often useless— because some basic guidelines are overlooked during their preparation. As a result, the software ends up failing both the presenter and the audience. It doesn’t have to be that way, though. If you use PowerPoint properly, it can enhance your talk, amplify your ideas, and help you deliver your message with maximum impact to an audience that remains engaged—and awake.
How can you make PowerPoint your friend? Here are five guidelines to keep in mind the next time you prepare to use this presentation software program. ...
* For a PDF of the full article, click in the link to the left of this introduction.
2011 Annual Meeting of the Radiological Society of North America: Advances in imaging aid detection of cancer
Family history data support annual mammograms in 40s
Women aged 40–49 years with and without a family history of breast cancer had almost the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.
The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, NY. Dr. Destounis presented the results of her study in a press briefing.
A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.
Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the US Preventive Services Task Force. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Family history data support annual mammograms in 40s
Women aged 40–49 years with and without a family history of breast cancer had almost the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.
The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, NY. Dr. Destounis presented the results of her study in a press briefing.
A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.
Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the US Preventive Services Task Force. ...
* For a PDF of the full article, click in the link to the left of this introduction.
Family history data support annual mammograms in 40s
Women aged 40–49 years with and without a family history of breast cancer had almost the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.
The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, NY. Dr. Destounis presented the results of her study in a press briefing.
A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.
Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the US Preventive Services Task Force. ...
* For a PDF of the full article, click in the link to the left of this introduction.
2011 San Antonio Breast Cancer Symposium: New therapies, genetic assays translate into early detection of recurrence, encouraging outcomes
Bevacizumab improves survival in HER2-positive metastatic disease
Bevacizumab (Avastin) improved progression-free survival (PFS) when added to standard treatment in a study of more than 400 women with human epidermal growth factor receptor 2 (HER2)–positive locally recurrent or metastatic breast cancer.
That finding, which emerged from the AVEREL trial, adds another wrinkle in the ongoing controversy regarding use of bevacizumab in breast cancer treatment.
For the primary endpoint of investigator- assessed PFS, conducted at a median follow-up of 26 months, the addition of bevacizumab resulted in a hazard ratio (HR) of 0.82 (P = 0.0775), compared with treatment with trastuzumab (Herceptin) and docetaxel alone. This difference was not statistically significant. Median investigator-assessed PFS was 16.5 months with bevacizumab versus 13.7 months without it.
In an assessment by an independent review committee (IRC), however, a significant improvement in PFS was seen with the addition of bevacizumab (hazard ratio, 0.72; P = 0.0162). Median IRC-assessed PFS was 16.8 months with bevacizumab, compared with 13.9 months without the drug.
* For a PDF of the full article, click in the link to the left of this introduction.
Bevacizumab improves survival in HER2-positive metastatic disease
Bevacizumab (Avastin) improved progression-free survival (PFS) when added to standard treatment in a study of more than 400 women with human epidermal growth factor receptor 2 (HER2)–positive locally recurrent or metastatic breast cancer.
That finding, which emerged from the AVEREL trial, adds another wrinkle in the ongoing controversy regarding use of bevacizumab in breast cancer treatment.
For the primary endpoint of investigator- assessed PFS, conducted at a median follow-up of 26 months, the addition of bevacizumab resulted in a hazard ratio (HR) of 0.82 (P = 0.0775), compared with treatment with trastuzumab (Herceptin) and docetaxel alone. This difference was not statistically significant. Median investigator-assessed PFS was 16.5 months with bevacizumab versus 13.7 months without it.
In an assessment by an independent review committee (IRC), however, a significant improvement in PFS was seen with the addition of bevacizumab (hazard ratio, 0.72; P = 0.0162). Median IRC-assessed PFS was 16.8 months with bevacizumab, compared with 13.9 months without the drug.
* For a PDF of the full article, click in the link to the left of this introduction.
Bevacizumab improves survival in HER2-positive metastatic disease
Bevacizumab (Avastin) improved progression-free survival (PFS) when added to standard treatment in a study of more than 400 women with human epidermal growth factor receptor 2 (HER2)–positive locally recurrent or metastatic breast cancer.
That finding, which emerged from the AVEREL trial, adds another wrinkle in the ongoing controversy regarding use of bevacizumab in breast cancer treatment.
For the primary endpoint of investigator- assessed PFS, conducted at a median follow-up of 26 months, the addition of bevacizumab resulted in a hazard ratio (HR) of 0.82 (P = 0.0775), compared with treatment with trastuzumab (Herceptin) and docetaxel alone. This difference was not statistically significant. Median investigator-assessed PFS was 16.5 months with bevacizumab versus 13.7 months without it.
In an assessment by an independent review committee (IRC), however, a significant improvement in PFS was seen with the addition of bevacizumab (hazard ratio, 0.72; P = 0.0162). Median IRC-assessed PFS was 16.8 months with bevacizumab, compared with 13.9 months without the drug.
* For a PDF of the full article, click in the link to the left of this introduction.
Regional nodal irradiation cuts breast cancer recurrence
Whole-breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly improved disease-free survival, but not overall survival, in a randomized, multicenter phase III trial of women with node-positive or high-risk node-negative disease who were treated with breast-conserving surgery and adjuvant therapy. An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months (between March 2000 and March 2007), WBI plus RNI significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (hazard ratio [HR], 0.58; P = 0.02) and distant recurrence from 13.0% to 7.6% (HR, 0.64; P = 0.002), according to the lead investigator, Dr. Timothy Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ontario, Canada.
As a result, disease-free survival rate improved from 84.0% for WBI to 89.7% for WBI plus RNI (HR, 0.67; P = 0.003). Overall survival in the intergroup trial was 90.7% with WBI, compared with 92.3% with the combined radiation regimen, but the difference did not reach statistical significance (HR, 0.76; P = 0.07). In view of the positive findings from the National Cancer Institute of Canada Clinical Trials Group MA.20 study, the data safety monitoring committee recommended that the results be released. The data were presented by Dr. Whelan at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO).1
Report prepared by Matt Stenger, MS
* For a PDF of the complete article, click on the link to the left of this introduction.
Whole-breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly improved disease-free survival, but not overall survival, in a randomized, multicenter phase III trial of women with node-positive or high-risk node-negative disease who were treated with breast-conserving surgery and adjuvant therapy. An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months (between March 2000 and March 2007), WBI plus RNI significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (hazard ratio [HR], 0.58; P = 0.02) and distant recurrence from 13.0% to 7.6% (HR, 0.64; P = 0.002), according to the lead investigator, Dr. Timothy Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ontario, Canada.
As a result, disease-free survival rate improved from 84.0% for WBI to 89.7% for WBI plus RNI (HR, 0.67; P = 0.003). Overall survival in the intergroup trial was 90.7% with WBI, compared with 92.3% with the combined radiation regimen, but the difference did not reach statistical significance (HR, 0.76; P = 0.07). In view of the positive findings from the National Cancer Institute of Canada Clinical Trials Group MA.20 study, the data safety monitoring committee recommended that the results be released. The data were presented by Dr. Whelan at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO).1
Report prepared by Matt Stenger, MS
* For a PDF of the complete article, click on the link to the left of this introduction.
Whole-breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly improved disease-free survival, but not overall survival, in a randomized, multicenter phase III trial of women with node-positive or high-risk node-negative disease who were treated with breast-conserving surgery and adjuvant therapy. An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months (between March 2000 and March 2007), WBI plus RNI significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (hazard ratio [HR], 0.58; P = 0.02) and distant recurrence from 13.0% to 7.6% (HR, 0.64; P = 0.002), according to the lead investigator, Dr. Timothy Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ontario, Canada.
As a result, disease-free survival rate improved from 84.0% for WBI to 89.7% for WBI plus RNI (HR, 0.67; P = 0.003). Overall survival in the intergroup trial was 90.7% with WBI, compared with 92.3% with the combined radiation regimen, but the difference did not reach statistical significance (HR, 0.76; P = 0.07). In view of the positive findings from the National Cancer Institute of Canada Clinical Trials Group MA.20 study, the data safety monitoring committee recommended that the results be released. The data were presented by Dr. Whelan at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO).1
Report prepared by Matt Stenger, MS
* For a PDF of the complete article, click on the link to the left of this introduction.
Community Oncology Podcast: Everolimus in ER-positive breast cancer
Dr. David Henry is your audio tour guide to the November 2011 issue of Community Oncology. Issue highlights include Community Translations, which addresses the role of everolimus in treating hormone-resistant ER-positive breast cancer; a review of guidelines for screening cancer patients for distress by Amy E. Lowery and Jimmie C. Holland; and original research on the impact of bone metastases and skeletal-related events on healthcare costs in prostate cancer patients on hormonal therapy by May Hagiwara, et.al. Also, reports from recent oncology meetings and regulatory news from Congress and the FDA.
Dr. David Henry is your audio tour guide to the November 2011 issue of Community Oncology. Issue highlights include Community Translations, which addresses the role of everolimus in treating hormone-resistant ER-positive breast cancer; a review of guidelines for screening cancer patients for distress by Amy E. Lowery and Jimmie C. Holland; and original research on the impact of bone metastases and skeletal-related events on healthcare costs in prostate cancer patients on hormonal therapy by May Hagiwara, et.al. Also, reports from recent oncology meetings and regulatory news from Congress and the FDA.
Dr. David Henry is your audio tour guide to the November 2011 issue of Community Oncology. Issue highlights include Community Translations, which addresses the role of everolimus in treating hormone-resistant ER-positive breast cancer; a review of guidelines for screening cancer patients for distress by Amy E. Lowery and Jimmie C. Holland; and original research on the impact of bone metastases and skeletal-related events on healthcare costs in prostate cancer patients on hormonal therapy by May Hagiwara, et.al. Also, reports from recent oncology meetings and regulatory news from Congress and the FDA.
Predicting Response to Placebos in Oncology
What is the role of placebos in oncology? What works and what doesn't? And could placebos be more than just controls and be used as an intervention? And if so, which patients would respond to placebos? A panel of experts discuss these questions during a gathering at the 7th annual Chicago Supportive Oncology Conference.
What is the role of placebos in oncology? What works and what doesn't? And could placebos be more than just controls and be used as an intervention? And if so, which patients would respond to placebos? A panel of experts discuss these questions during a gathering at the 7th annual Chicago Supportive Oncology Conference.
What is the role of placebos in oncology? What works and what doesn't? And could placebos be more than just controls and be used as an intervention? And if so, which patients would respond to placebos? A panel of experts discuss these questions during a gathering at the 7th annual Chicago Supportive Oncology Conference.