Thursday, April 19, 2012
Emerging Therapies for Ovarian Cancer - Chemotherapy Advisor
Emerging Therapies for Ovarian Cancer - Chemotherapy Advisor
Bevacizumab
Other Antiangiogenesis Agents
Poly(ADP-ribose) Polymerase Inhibitors
Other Novel Agents in Ovarian Cancer
printer-friendly (view all on one page): link
Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer - Full Text View - ClinicalTrials.gov
Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer - Full Text View - ClinicalTrials.gov
Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
This study is currently recruiting participants.
Verified April 2012 by Stanford University
First Received on December 13, 2011.
Last Updated on April 18, 2012
History of Changes
| Sponsor: | Stanford University |
|---|---|
| Information provided by (Responsible Party): | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01494012 |
Purpose
This
phase I trial studies the side effects and the best dose of stereotactic
body radiation therapy (SBRT) in treating patients with metastatic or
recurrent ovarian cancer or primary peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
FDA (U.S.) Safety Alert > Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume
Safety Alerts for Human Medical Products > Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume
[Posted 04/18/2012]
AUDIENCE: Risk Manager, Pain Management
ISSUE: Customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume. Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.
BACKGROUND: The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 10830LL, with an expiration date of April 1, 2013. Morphine Sulfate Carpujects 4 mg/mL are packaged in Slim-Pak tamper detection packages with each box containing 10 Carpujects (NDC 0409-1258-30).
The affected lot was distributed in January 2012. It was initially distributed to wholesalers and a limited number of hospitals in Arizona, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas and Virginia.
RECOMMENDATION: Anyone with an existing inventory of affected product should stop use and distribution and quarantine the product immediately and call Stericycle at 1-888-912-7088 to arrange for the return of the product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
abstract + links/podcast: Prevention of Pegfilgrastim-Induced Bone Pain: A Phase III Double-Blind Placebo-Controlled Randomized Clinical Trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base
Prevention of Pegfilgrastim-Induced Bone Pain: A Phase III Double-Blind Placebo-Controlled Randomized Clinical Trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base
Conclusion
Our phase III randomized placebo-controlled clinical trial demonstrated that naproxen at a dose of 500 mg twice per day is
effective in reducing the incidence and severity of pegfilgrastim-induced bone pain.
Footnotes
-
See accompanying editorial doi: 10.1200/JCO.2011.41.3146 and article doi: 10.1200/JCO.2011.39.2381;
- listen to the podcast by Dr Von Hoenn at www.jco.org/podcasts
Seth's Blog: Bandits and philanthropists
Bandits and philanthropists:
The web is minting both, in quantity.
Bandits want something for nothing. They take. They take free content where they can find it. They fight for anonymity, for less community involvement. They want more than their fair share, and they walk past the busker, because they can hear him playing real good, for free.
The spammer is a bandit, stealing your attention because he can get away with it, and leaving nothing in return.
Philanthropists see a platform for giving. They support the tip jar. They argue for community standards and yes, for taxes that are more fair to the community. They support artists online, and when they can, they buy the book.
The artist who creates a video that touches you, or an infographic that informs you--she's giving more than she gets, leaving the community better than it was before she got there.
Both types have been around forever, of course. But the web magnifies the edges. It's easier than ever to be a free rider, to make your world smaller and to take. And easier than ever to be a big time contributor, even if you don't have any money. You can contribute your links or your attention or your energy...
The fascinating thing for me is how much more successful and happy the philanthropists are. It turns out that when you make the world smaller, you get to keep more of what you've got, but you end up earning a lot less (respect, connections, revenue) at the same time.
Bandits want something for nothing. They take. They take free content where they can find it. They fight for anonymity, for less community involvement. They want more than their fair share, and they walk past the busker, because they can hear him playing real good, for free.
The spammer is a bandit, stealing your attention because he can get away with it, and leaving nothing in return.
Philanthropists see a platform for giving. They support the tip jar. They argue for community standards and yes, for taxes that are more fair to the community. They support artists online, and when they can, they buy the book.
The artist who creates a video that touches you, or an infographic that informs you--she's giving more than she gets, leaving the community better than it was before she got there.
Both types have been around forever, of course. But the web magnifies the edges. It's easier than ever to be a free rider, to make your world smaller and to take. And easier than ever to be a big time contributor, even if you don't have any money. You can contribute your links or your attention or your energy...
The fascinating thing for me is how much more successful and happy the philanthropists are. It turns out that when you make the world smaller, you get to keep more of what you've got, but you end up earning a lot less (respect, connections, revenue) at the same time.
Canadian breast implant cohort: Extended follow-up of cancer incidence
Blogger's Note: prior Canadian patient-led lawsuits failed
~~~~~~~~~~~~~~~~~
Canadian breast implant cohort: Extended follow-up of cancer incidence:
Abstract
Cosmetic breast implants are not associated with increased breast cancer incidence, but variations of risk according to implant characteristics are still poorly understood. As well, the assessment of cancer risk for sites other than breast needs to be clarified. The purpose of this study was to fill these research gaps. This study presents an extended analysis of 10 more years of follow-up of a large Canadian cohort of women who received either cosmetic breast implants (n=24,558) or other cosmetic surgery (15,893). Over 70% of the implant cohort was followed for over 20 years. Cancer incidence among implant women was compared to those of controls using multivariate Poisson models and the general female population using the Standardized Incidence Ratios (SIRs). Women with breast implants had reduced rates of breast and endometrial cancers compared with other surgery women. Subglandular implants were associated to a reduced rate of breast cancer compared to submuscular implants (Incidence Rate Ratio (IRR) = 0.78, 95% CI= 0.63-0.96) and this reduction persisted over time. We observed a 7-fold increased rate (IRR = 7.36, 95% CI= 1.86-29.12) of breast cancer in the first five years after the date of surgery for polyurethane-coated subglandular implant women but this IRR decreased progressively over time (p value for trend = 0.02). We also observed no increased risk of rarer forms of cancer among augmented women. A reduction in breast cancer incidence was observed for women with subglandular implants relative to women with submuscular implants. Possible increase of breast cancer incidence shortly after breast augmentation with polyurethane implants needs to be verified.
FDA (U.S.) Press Announcements > U.S. Marshals seize ultrasound gel product at a New Jersey company
Press Announcements > U.S. Marshals seize ultrasound gel product at a New Jersey company
FDA NEWS RELEASE
For Immediate Release: April 18, 2012
Media Inquires: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
U.S. Marshals seize ultrasound gel product at a New Jersey companyProduct samples revealed bacterial contamination
JCO Editorial (re: Ontario/Pritchard et al) [18F]Fluorodeoxyglucose Positron Emission Tomography–Computed Tomography in Breast Cancer: When… and When Not?
[18F]Fluorodeoxyglucose Positron Emission Tomography–Computed Tomography in Breast Cancer: When… and When Not?
"....It has taken a relatively long time to generate the data needed to guide appropriate use of FDG PET/CT for breast cancer for all phases of the disease. The task is still not quite complete but is propelled by studies such as Pritchard et al.6 We hope that the approach for directing new imaging procedures into clinical practice will continue to improve and be ready when the next imaging breakthrough emerges."
"Diagnostic imaging plays an important role in the care of patients with breast cancer and is used for breast cancer detection, diagnosis, staging, and therapeutic response evaluation.1 Advances in imaging technology, especially relatively newer technologies such as magnetic resonance imaging (MRI) and positron emission tomography without or with integrated computed tomography (PET or PET/CT) provide powerful diagnostic tools, but also generate questions and controversy regarding where and when to use these new modalities. Early studies of new imaging approaches most often come from centers that are scientifically invested in the development of the technology. Typically, small and highly selected patient populations are evaluated, and these preliminary studies often indicate excellent diagnostic performance. Later on, when large multicenter trials are performed with more clinically representative patient populations, the new test invariably performs less well. Nevertheless, the excitement surrounding early results from a new imaging technology and the increasing public access to these early results fuel the desire by patients for access to new forms of diagnostic imaging. Physicians and patients share the wish for diagnostic certainty in excluding cancer spread at the time of diagnosis and may reason that a purely diagnostic procedure, even if untested, can do no harm. These factors, combined with the challenge and expense of carrying out larger scale diagnostic imaging trials, can lead to the early adoption of new imaging studies into clinical practice, often before their performance and optimal use have been fully determined. However, ......."
abstract: Prospective Study of 2-[18F]Fluorodeoxyglucose Positron Emission Tomography in the Assessment of Regional Nodal Spread of Disease in Patients With Breast Cancer: An Ontario Clinical Oncology Group Study
Prospective Study of 2-[18F]Fluorodeoxyglucose Positron Emission Tomography in the Assessment of Regional Nodal Spread of Disease in Patients With Breast Cancer: An Ontario Clinical Oncology Group Study
Purpose 2-[18F]fluorodeoxyglucose (FDG) positron emission tomography (PET) is potentially useful in assessing lymph nodes and detecting distant metastases in women with primary breast cancer.
Conclusion
FDG-PET is not sufficiently sensitive to detect positive axillary lymph nodes, nor is it sufficiently specific to appropriately identify distant metastases. However, the very high positive predictive value (96%) suggests that PET when positive is indicative of disease in axillary nodes, which may influence surgical care.
JCO: Palliative Sedation: When and How? Commentary including references
Blogger's Note:
“Not everything that can be counted counts and not everything that counts can be counted.” Albert Einstein
~~~~~~~~~~~~~~
Commentary (on Maltoni et al): Palliative Sedation: When and How?
REFERENCES
abstract: Postoperative venous thromboembolism predicts survival in cancer patients
Postoperative venous thromboembolism predicts survi... [Ann Surg. 2012]
OBJECTIVES:
To determine whether a postoperative venous thromboembolism (VTE) is associated with a worse prognosis and/or a more advanced cancer stage and to evaluate the association between a postoperative VTE and cancer-specific survival when known prognostic factors, such as age, stage, cancer type, and type of surgery, are controlled.CONCLUSIONS:
Postoperative VTE in oncology patients with limited disease and a complete surgical resection is associated with an inferior cancer survival. A postoperative VTE remains a poor prognostic factor, even when controlling for age, stage, cancer type, and surgical procedure further supporting an independent link between hypercoagulability and cancer survival.
JNCI J Natl Cancer Inst - audio/podcast - JNCI PODCAST News Summaries for Issue 9 The Efficacy of Cancer Vaccines - Dr. Jeffrey Schlom talks about therapeutic cancer vaccines
Blogger's Note: comments in interview include references to prostate, FAP (genetics/colorectal cancer) & high risk ovarian/breast; note also comments regarding the use of cancer vaccines in early stage cancers
JNCI PODCAST
The Efficacy of Cancer Vaccines- Dr. Jeffrey Schlom talks about therapeutic cancer vaccines
abstract: If patient-reported outcome measures are considered key health-care quality indicators, who is excluded from participation? - Health Expectations
If patient-reported outcome measures are considered key health-care quality indicators, who is excluded from participation? - Health Expectations
Abstract
Patient-reported
outcome measures have received increasing attention with regard to
ensuring quality improvement across the health service. However, there
is a risk that people with disabilities and low literacy are
systematically excluded from the development of these measures as well
as their application in clinical practice. This editorial highlights
some of these risks and the potential consequences of exclusion for
these groups.
Wednesday, April 18, 2012
A Evaluation of Metformin, Targeting Cancer Stem Cells for the Prevention of Relapse in Patients With Stage IIC/III/IV Ovarian, Fallopian Tube, and Primary Peritoneal Cancer - Full Text View - ClinicalTrials.gov
A Evaluation of Metformin, Targeting Cancer Stem Cells for the Prevention of Relapse in Patients With Stage IIC/III/IV Ovarian, Fallopian Tube, and Primary Peritoneal Cancer - Full Text View - ClinicalTrials.gov
A Evaluation of Metformin, Targeting Cancer Stem Cells for the Prevention of Relapse in Patients With Stage IIC/III/IV Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
This study is currently recruiting participants.
Verified March 2012 by University of Michigan Cancer Center
First Received on March 30, 2012.
Last Updated on April 16, 2012
History of Changes
| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Information provided by (Responsible Party): | Ronald Buckanovich, University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01579812 |
Purpose
The
primary objective of this study is to determine if metformin
administered as the time of traditional adjuvant chemotherapy to women
with advanced ovarian, primary peritoneal or fallopian tube cancer will improve recurrence-free survival at 18 months compared to controls.
Acetyl-L-Carnitine Hydrochloride in Preventing Peripheral Neuropathy in Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavi - GOGty Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy - Full Text View - ClinicalTrials.gov
WebMd: ACETYL - L - CARNITINE (including other names)
~~~~~~~~~~~~~~~~~~~~
This study is not yet open for participant recruitment.
Verified April 2012 by National Cancer Institute (NCI)
First Received on December 14, 2011.
Last Updated on April 17, 2012
History of Changes
Acetyl-L-Carnitine Hydrochloride in Preventing Peripheral Neuropathy in Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy - Full Text View - ClinicalTrials.gov
Purpose
RATIONALE:
Acetyl-L-carnitine hydrochloride may prevent or lessen peripheral
neuropathy caused by chemotherapy. It is not yet known whether
acetyl-L-carnitine hydrochloride is more effective compared to a placebo
in preventing peripheral neuropathy caused by chemotherapy.
PURPOSE: This randomized
phase III trial studies how well acetyl-L-carnitine hydrochloride works
compared to a placebo in preventing peripheral neuropathy in patients
with recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer undergoing chemotherapy.
Does “Cancer” – The Word – Properly Explain “Cancer” – the Disease?
Does “Cancer” – The Word – Properly Explain “Cancer” – the Disease?:
by Jonathan Klein, MDOften times, after explaining a diagnosis and treatment plan to a patient, physicians hear some variation on “my brother/sister/parent/friend/co-worker had cancer and received radiation/surgery/phase I clinical trial medication. Why am I not receiving this?” The answer may revolve around the idea that different cancers, even different cancers arising from the same part of the body, can be wildly different in biology, treatment, and prognosis. We obviously want to ensure that patients understand their options so that they can make informed decisions about their own care, but couldn’t the medical community do a better job of conveying this concept to the public even before people end up in our clinics?
We use the catch-all term “cancer” to refer to diseases within the body arising from uncontrollably dividing cells. It is a term familiar to everyone, and a diagnosis of cancer is a useful shorthand – it’s concise, easy to understand, and conveys a sense of seriousness around what lies ahead. But beyond that initial purpose, it’s largely insufficient.
Potentially Dangerous Complementary and Alternative Medicine (CAM) Use by Ovarian Cancer Patients | Abstract
Potentially Dangerous Complementary and Alternative Medicine (CAM) Use by Ovarian Cancer Patients
Abstract
Objective:
The use of complementary or alternative medicine (CAM) has increased
greatly over the last decade. Although many CAM activities are unlikely
to increase a patient's risk for adverse events with conventional
treatment for cancer, this is not necessarily true of ingestible CAM
treatments such as herbal remedies, teas, and other supplements. This
study surveyed women with ovarian cancer in order to evaluate the use of
herbs and supplements that might place them at increased risk at the
time of their surgery for ovarian cancer.
Methods:
A total
of 219 women with ovarian cancer, who had received care from one of two
participating oncology practices, were surveyed.
Results:
Of the women who reported having had surgery to treat their ovarian cancer (n=209),
65 (31%) reporting using one or more herbs or supplements that have
been hypothesized to increase their risk for adverse outcomes. In almost
all cases the risks associated with these substances were elevated
risks for excessive bleeding.
Conclusions:
The use of
herbs and supplements that might increase risks associated with
excessive bleeding during gynecologic cancer surgery is common. Further
research is needed to better understand the risks associated with use of
herbs and supplements among women approaching surgery
. (J GYNECOL SURG
28:1)
Medscape: New Map of Breast Cancer Identifies 10 Disease Subtypes
Blogger's Note: references Oncotype DX and MammaPrint
New Map of Breast Cancer Identifies 10 Disease Subtypes
Oncofertility Education Modules: A presentation by Dr. Hananel Holzer
Oncofertility Education Modules: A presentation by Dr. Hananel Holzer:
Resident Module – Fertility#1
Resident Module – Fertility#2a
Resident Module – Fertility#2b
Resident Module – Fertility#3
by Monisha Sudarshan, MD
As one walks into Dr.Holzer’s office, his passion and love for helping patients with fertility issues is clear. Among the many honors and thank you notes, sits a small decorative baby carriage with the words engraved “Doctors are known to heal, you are known to create miracles”. Dr. Holzer is the Medical Director of the MUHC (McGill University Health Centre) Reproductive Centre and one of the pioneers in oncofertility. In fertility management, he describes every couple as a “new story” however, oncofertility presents its own unique challenges and complexities for the patient and physician population. Dr.Holzer advises his patients that the first and foremost importance is to fight the cancer; fertility represents an important aspect but is not the primary priority. One of his goals is also to educate and bring awareness to cancer physicians and residents about the options of fertility preservation for the younger oncology population and is working on creating easy, timely access for referral of these patients to expert centers. Continuing his educational endeavour, he has designed expert teaching modules targeted for resident education in oncology and fertility and to spark interest in this interesting and rapidly growing field. Modules begin with basic physiological changes with chemotherapy and radiotherapy, progress to current options in fertility preservation and the experience at the McGill University Health Center. Continue to stay tuned for more knowledge on this important and stimulating topic within oncology.
Where the Oldest Die Now - NYTimes.com
Where the Oldest Die Now - NYTimes.com
".... But if people are being shuttled from home to hospital to nursing home (and possibly around again) during their last days and weeks, that’s nothing to celebrate. “Site-of-death data only tells you where you are at time of death, but nothing about the transitions leading to that point,” Dr. Teno said....."
Opinion: Data to Knowledge to Action (pizza? lost friend? genomics.....)
Opinion: Data to Knowledge to Action:
Pizza on Tuesday within 2 miles of home? There is a search for that. Find a long lost high school friend or an out of print book? There are searches for that. Correlating genomic information with proteomics data, patient information, and drug trial results? You’re on your own. It is ironic and lamentable that internet queries can get you information on so many things, yet the scientific data that are crucial to finding cures for numerous diseases are often buried in an unusable format on a hard drive in somebody’s garage.
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