A phase 1 study of OSI-930 in combination with erlotinib in patients with advanced solid tumours

ScienceDirect.com - European Journal of Cancer - A phase 1 study of OSI-930 in combination with erlotinib in patients with advanced solid tumours

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Abstract

Aim

To determine the maximum tolerated dose (MTD) of OSI-930 that can be combined with erlotinib, and establish recommended phase 2 doses when both agents are administered daily in patients with advanced solid tumours.

Patients and methods

Eligible patients with advanced solid tumours were enrolled into this standard “three + three” dose escalation study. Study treatment commenced on day 1 with OSI-930, and erlotinib was introduced on day 8. PK profiles of OSI-930, erlotinib and its active metabolite, OSI-420, were determined. Changes in sVEGFR2 as a pharmacodynamic biomarker of OSI-930 activity were assessed.

Results

Twenty one patients were enrolled to 1 of 3 cohorts: 200 mg OSI-930 BID + 100 mg erlotinib QD; 200 mg OSI-930 BID + 150 mg erlotinib QD; 300 mg OSI-930 BID + 150 mg erlotinib QD. The most common adverse events were anorexia (85%), diarrhoea (75%), rash (70%) and lethargy (65%). The MTD was not reached but the onset of cumulative toxicity necessitating dose modification after the 28-d DLT assessment period was common at the highest dose level. A PK interaction was identified with co-administration of both agents resulting in a two-fold increase in OSI-930 exposure. Pharmacodynamic activity was observed with a decline in sVEGFR levels detected in all patients. Ten patients had disease stabilization (median duration 119 d).

Conclusions

200 mg OSI-930 BID + 150 mg erlotinib QD were the recommended doses for further evaluation of this combination.

Canadian-made therapeutic cancer vaccine (DPX-0907) showing promise - breast/ovarian - media

Canadian-made therapeutic cancer vaccine showing promise | CTV News

Reply to D.C. Currow et al: Hospital Can Be the Actively Chosen Place for Death

Blogger's Note:  what has not been discussed is the patient's medical condition which may alter their decision/s

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Reply to D.C. Currow et al

Currow et al¹ are correct that a death at home is not necessarily a marker of high-quality care. On the contrary, many patients choose to spend their final days in other settings. Family concerns, the presence of young children in the home, the absence of adequate caregiving resources, and fears about symptoms may all influence the choices that patients make. Indeed, it was for this reason that we did not rely on a patient's site of death as the main outcome.

Instead, we used patients' preferences by asking, “Where would you prefer to live out the rest of your life?”^2(p2784) We acknowledge that there is always the potential that questions could be interpreted in a variety of ways. However, in this case, we are confident that our wording makes it clear to patients that the question refers to their future care, not to their present situation. We also note that it would be interesting to examine determinants of whether preferences were met for death in other settings (eg, in the hospital). This was outside the scope of the current study but is a focus of ongoing work.

a must read - JCO: Letter -Hospital Can Be the Actively Chosen Place for Death

 Blogger's Note: this is the first article  (in my memory) which actually does true justice to meeting the needs of the patients/families when being asked where they wish to die; most if not all research ever explores the issue of:  is it possible to die at home and under what circumstances; surveys (typically hospital initiated) have obviously their own bias which is covered in this letter

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Hospital Can Be the Actively Chosen Place for Death

To the Editor:

Jeurkar et al¹ are to be congratulated on their retrospective cohort study exploring where people die in relation to their stated choice at the time of referral to hospice services. Sadly, the article does not present whether people “die in the setting of their choice,” as promised in the title. One cannot derive from the data presented the number of people who actively chose to die in hospital (and were able to do so) .or were not able to, despite this being their stated choice.  There are the continued assumptions that home is the better place to die, and that dying in an institution (a hospital, aged care facility, or inpatient hospice) is a failure of the system to support patients and their families at the end of life. However, a home death can be an equally unwanted outcome for patients, caregivers, or both.² Hospital can be the active choice for the place to die.

Is the desire for being in hospital at the time of death “biologically plausible?”

2nd article: Study Drug (Selumetinib) Is First to Help Patients with Recurrent Low-Grade Ovarian Cancer

Study Drug Is First to Help Patients with Recurrent Low-Grade Ovarian Cancer

Study drug (Selumetinib) is first to help patients with recurrent low-grade ovarian cancer

Study drug is first to help patients with recurrent low-grade ovarian cancer

index: Patient Education and Counseling Vol 90, Iss 3, March, 2013

 Blogger's Note: variety of abstracts

 eg;  What patients want;  Communicating shared decision-making: Cancer patient perspectives;  Sighing no longer an option: Healthcare professionals and patients help each other in a unique learning environment

Patient Education and Counseling | Vol 90, Iss 3, Pgs 287-420, (March, 2013)

Confirmed: MammaPrint Predicts Treatment in Breast Cancer (MammaPrint/Oncotype DX)

Confirmed: MammaPrint Predicts Treatment in Breast Cancer

Information Update - Health Canada suspends all medical device licences associated with IND Diagnostic

Information Update - Health Canada suspends all medical device licences associated with IND Diagnostic

"The devices include test kits used in pregnancy and ovulation, screening for blood in stool, urinary tract infections, infectious disease and illicit drugs. Some of the tests were sold in retail outlets, including discount/dollar stores for home use, while others were only sold for use by health professionals or laboratories.....PR Newswire (http://s.tt/1zyN7)

Feasibility of Trials in Ovarian Cancer by Line of Therapy and Platinum Sensitivity

Abstract

Background: To rapidly evaluate the significant numbers of novel therapies entering clinical development requires maximization of clinical trial capacity. To enable this, we evaluated the profile of patients with epithelial ovarian cancer (EOC) in clinical practice, compared with those targeted in clinical trials.

Methods: Patients with EOC treated between March-September 2009 (cohort A, n = 115 patients) and January-July 2012 (cohort B, n = 109 patients), in the North West London Cancer Network with a catchment of 1.2 million, were identified. Patient characteristics were compared with phase II/III EOC studies identified using clinicaltrials.gov (85 trials; 54,603 patients).

Results: In cohort A, comparing the proportion of patients in clinical practice with those in trials, 40% versus 55% (P = 0.0006) were chemotherapy-naive, 20% versus 9% (P < 0.0001) had platinum-resistant disease (platinum-free interval, <6 months), 16.2% versus 39% (P < 0.0001) were receiving second line, and 43.8% versus 5% (P < 0.0001) third-line chemotherapy or greater, respectively. Ninety-eight percent of treated patients had a performance status of 2 or less. These results were validated in cohort B, UK National Cancer Research Network and US Gynecologic Oncology Group trial databases.

Conclusions: These results provide the data to enable EOC trial portfolios to be balanced to clinical practice and suggest an increase in emphasis on trials for patients with platinum-resistant disease and third-line chemotherapy or greater, to address an area of clinical need and maximize recruitment.

Ovarian Cancer and Us: most read articles from Feb 7th /8th, 2013

The failure of cancer medicine? : The Lancet
Laparoscopic Gyn Surgery: Fasting Better Than Bowe...
Retooling Pap test to spot more kinds of cancer - ...
Ovarian Surface Epithelial Neoplasms in the Pediat...
paywalled: The impact

Annie Appleseed Project - Evidence-Based Complementary & Alternative Cancer Therapies Conference Live Video Broadcast

Click on logo above for The Annie Appleseed Project website

 
Evidence-Based Complementary & Alternative Cancer Therapies Conference Live Video Broadcast
  
The Conference Registration for the in person Annie Appleseed Project Evidence-Based Complementary and Alternative Cancer Therapies Conference is now OPEN: It's happening in West Palm Beach, FL Thursday, February 28 - Saturday, March 2, 2013

If you can’t be there for the ‘ Live In Person Conference’ please join us for the Live Video Streaming Broadcast of the Conference, happening simultaneously from the Conference Hall. We will be Live Video Streaming from the Conference, Thursday, Friday and Saturday.  Register today and before the Conference begins  you will be sent a password with easy viewing instructions to join us ‘virtually’.

Join us Online for 2 and a half days of content rich Live Video Streaming

Feb 28th – March 1 – March 2.

(With free bonus of optional 30 day On Demand viewing after the Event.)

Order here

Only $99.00

 

advisory panel applications now open - PCORI Advisory Panels | Patient-Centered Outcomes Research Institute

PCORI Advisory Panels | Patient-Centered Outcomes Research Institute

Advisory Panel Timeline

Application Period Opens:
January 29, 2013
Application Period Closes:
March 4, 2013, 5pm ET
Board Approval of Advisory Panel Members:
March 26, 2013
Applicants Notified of Status and Next Steps:
March 27, 2013 to April 5, 2013
Advisory Panel Kickoff and Training in Washington, DC:
April 19, 2013 to April 20, 2013

Consumers Union: Policy and Action from Consumer Reports

Consumers Union: Policy and Action from Consumer Reports

 Your skills can improve health research!

You have expressed an interest and willingness to provide advice to Consumer Reports Health Rating Center. For that reason, we would like to introduce you to a project being developed by Brigham Women's Hospital.
Consumer Reports Health is helping Brigham and Women's Hospital recruit 12 consumers with strong analytical skills to help guide their drug research towards more patient centered outcomes – an objective we strongly support. Fill out the simple application below......

Big Consequences for Doctors Importing Prescription Drugs | Physicians Practice

Big Consequences for Doctors Importing Prescription Drugs | Physicians Practice
 

Blog | February 06, 2013 | Career, Law & Malpractice, Patient Relations

By Ericka L. Adler

Over the past year, I have received several calls from clients who received unexpected visits from FDA agents seeking information concerning the purchase of prescription drugs. In each case, the client had acquired expensive medications from a U.S. business at a fraction of the cost. The medications appeared identical in every way and there were no observed issues with any patients in the use of the medications. Sounds like an ideal way to cut costs, right?.....

Peer review matters to the public - A new guide to peer review is launched today to help the public make sense of research claims

Peer review matters to the public

A new guide to peer review is launched today to help the public make sense of research claims

People are bombarded with claims in newspapers and on the internet that are based on scientific studies. When faced with a headline that suggests an Alzheimer's drug increases the risk of heart attack or that watching TV is bad for children's mental health, or that pesticides are causing a decline in bee populations, people have to work out what to believe. Which claims should be taken seriously? Which are 'scares'?
I Don't Know What to Believe: Making Sense of Science Stories... explains the peer review process – the system researchers use to assess the validity, significance and originality of papers. It captures experiences and insights from editors and scientists and encourages people to ask "Is it peer reviewed?" when reading science stories.
A similar publication launched in the UK is now used by health workers, librarians, public-health officials, policy-makers, technology companies, safety bodies, popular writers, educators, parenting groups and local government. These are the people who are speaking directly with the public everyday and answering their questions.

Understanding peer review and asking about the status of claims is important to society because it helps people make decisions.

Download the guide: http://www.senseaboutscience.org/resources.php/116/Embargoed_until_00.01Feb8th2013_IDKWTB_web.pdf

Ovarian Cancer and Us blog - top 5 most read items this week

Exploring Diagnostic Accuracy In Cancer: A Nationwide Survey of 400 Leading Cancer Specialists   Fruit and Vegetable Intake and Risk of Breast Cancer by Hormone Receptor Status
A non-synonymous polymorphism in IRS1 modifies risk of developing breast and ovarian cancers in BRCA1 and ovarian cancer in BRCA2 mutation carriers
Prevalence and healthcare actions of women in a large health system with a family history meeting the 2005 USPSTF recommendation for BRCA genetic counseling referral
open access: International Cancer of the Pancreas Screening (CAPS) Consortium summit on the management of patients with increased risk for familial pancreatic cancer (+Lynch Syndrome/BRCA2...)

fulll text: Pegylated liposomal doxorubicin/carboplatin combination in ovarian cancer, progressing on single-agent pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin/carboplatin combination in ovarian cancer, progressing on single-agent pegylated liposomal doxorubicin

 World J Clin Oncol. 2012 October 10; 3(10): 137–141.

Published online 2012 October 10. doi:  10.5306/wjco.v3.i10.137

Journal of Ovarian Research - Pegylated liposomal doxorubicin in ovarian cancer treatment: A mono-institutional retrospective analysis. Do we still need it?

Journal of Ovarian Research | Abstract | Pegylated liposomal doxorubicin in ovarian cancer treatment: A mono-institutional retrospective analysis. Do we still need it?

 Conclusions

No evidence of superiority if PLD was compared to alternative agents was found in this analysis, particularly in the platinum-refractory setting. Our findings indicate a modest therapeutic activity of PLD in OC. Analysis of cost/benefit of PLD in OC is eagerly awaited.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

Amgen Announces Call For Nominations For 2013 Breakaway From Cancer® Champions -- THOUSAND OAKS, Calif., Feb. 8, 2013 /PRNewswire/ --

Amgen Announces Call For Nominations For 2013 Breakaway From Cancer® Champions -- THOUSAND OAKS, Calif., Feb. 8, 2013 /PRNewswire/ --

 From Feb. 5 through Feb. 25, nominations will be accepted online to recognize a cancer survivor, patient, caregiver or advocate for those impacted by cancer. Four individuals – one from each of the 2013 Amgen Tour of California communities of Escondido, Santa Clarita, Santa Barbara and Livermore – will ultimately be selected as the Breakaway from Cancer Champions.....

A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus - clinical trial Phase II biomarker validation study

A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus

 Verified by: University of South Alabama, February 2013
First Received: February 6, 2013 | Last Updated: February 6, 2013

"There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is a constant flow of mucus which has only one exit through the cervix and out the vagina. Proteins that are generated within the entire female reproductive system are trapped into this viscous fluid and eventually released as waste. When a routine PAP test is performed, a sample of this mucus is collected along with any cells, and preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile showing of the status of the cells in the female reproductive system.....

Ego-Based Medicine - Corrected Proof short abstract/pay-per-view

Ego-Based Medicine - Corrected Proof:
"This article about the tough multidisciplinary decisions we make as radiation oncologists highlights the importance of mutual respect throughout the different specialties and the importance of informed patient consent."

Ovarian Surface Epithelial Neoplasms in the Pediatric Population: Incidence, Histologic Subtype, and Natural History

Abstract

Surface epithelial neoplasms account for a small but significant proportion of pediatric ovarian tumors. The overall incidence, prevalence of histologic subtypes, and natural history of these neoplasms has not been thoroughly evaluated. A retrospective review of the pathology archives of Stanford University School of Medicine yielded 69 surface epithelial ovarian tumors in 64 pediatric patients 18 years of age or younger from 1974 to 2010. Tumors comprised benign (57.8%), borderline/low malignant potential (LMP) (37.5%), and malignant (4.7%) subgroups and exhibited serous, mucinous, and mixed histology; there were no clear cell, pure endometrioid, or transitional (Brenner) tumors. In addition, no high-grade carcinomas were identified. Clinical follow-up data were available in a subset of patients (maximum follow-up, 22 y). Similar numbers of recurrences were found in each of the 3 subgroups. However, overall survival was 100% for benign and borderline/LMP tumors and 50% for carcinomas. The type of surgical management and the use of chemotherapy varied; 2 patients with borderline/LMP tumors were treated by sterilizing procedures and/or chemotherapy. These data suggest that surface epithelial neoplasms comprise a small but significant proportion of ovarian tumors in the pediatric population, and they exhibit a marked preponderance for benign, borderline, and low-grade malignant subgroups. In contrast to their adult counterpart, high-grade serous carcinoma in children is extraordinarily rare and not seen in this series. Given this difference, uniform treatment modalities with consideration for ovarian conservation and fertility preservation should be rigorously adopted in any pediatric patient with a suspected ovarian surface epithelial neoplasm.

Talking to cancer patients about complementary therapies: An Update - Cancer Knowledge Network

Talking to cancer patients about complementary therapies: An Update - Cancer Knowledge Network

Retooling Pap test to spot more kinds of cancer - media

Retooling Pap test to spot more kinds of cancer - media

WASHINGTON — For years, doctors have lamented that there's no Pap test for deadly ovarian cancer. Wednesday, scientists reported encouraging signs that one day, there might be.

Researchers are trying to retool the Pap, a test for cervical cancer that millions of women get, so that it could spot early signs of other gynecologic cancers, too.........This is very early-stage research, and women shouldn't expect any change in their routine Paps. It will take years of additional testing to prove if the so-called PapGene technique really could work as a screening tool, used to spot cancer in women who thought they were healthy.........

How? It turns out that cells can flake off of tumors in the ovaries or the lining of the uterus, and float down to rest in the cervix, where Pap tests are performed. These cells are too rare to recognize under the microscope. But researchers from Johns Hopkins University used some sophisticated DNA testing on the Pap samples to uncover the evidence — gene mutations that show cancer is present.

In a pilot study, they analyzed Pap smears from 46 women who already were diagnosed with either ovarian or endometrial cancer. The new technique found all the endometrial cancers and 41 percent of the ovarian tumors, the team reported Wednesday in the journal Science Translational Medicine....