Three
Federal Agencies Embark Upon New Initiative
The National Cancer Institute (NCI), Food and Drug
Administration (FDA), and Centers for Medicare and Medicaid Services (CMS) recently announced a new initiative aimed at better understanding the
function of biomarkers in cancer research, diagnosis, and treatment. The Oncology Biomarker Qualification Initiative (OBQI) will bring these
three agencies together to collaborate and share resources to examine and identify the vital role that biomarkers - the biological indicators of
disease - play in a variety of cancers.
Biomarkers can be analyzed through a patient's blood,
tissue samples, or with imaging scans, potentially allowing researchers and physicians to individualize treatment based on a clearer understanding of
how those biomarkers impact a patient's cancer. For example, one well-known biomarker that affects approximately 25% of the women diagnosed with
breast cancer is the HER2 gene. Women whose cancer over–expresses this gene are considered "HER2 positive" and are given a therapy
specifically designed to counteract the over–expression of this biomarker. Ultimately, if the OBQI is successful, physicians will be
able to match other therapies to patients based on biomarker research, so that more patients are treated only with the therapies from which they are
likely to derive a significant benefit.
In order to achieve this goal, the OBQI will try to
determine whether particular biomarkers can help researchers:
- Evaluate whether a patient's tumor is responding to treatment, after just one
or two courses of therapy
- Demonstrate that a tumor is dying, even if it is not shrinking
- Indicate which patients are at higher risk for disease recurrence
- Predict whether a tumor will respond to a specific treatment
- Quickly determine whether an investigational therapy is effectively treating
the tumor
The first OBQI project will evaluate a scanning method called
Fluorodeoxyglucose-Positron Emission Tomography - or FDG-PET - which is used to detect non-Hodgkin's lymphoma. In this study, researchers will
use the FDG-PET scanning technology on patients currently being treated for non-Hodgkin's lymphoma to see if the FDG-PET can predict whether the
tumor will respond to the therapy.
According to officials at NCI, FDA and CMS, this and
other research produced by the initiative could help patients by reducing the time and resources needed to conduct clinical trials, which in turn
would speed drug development by honing in on effective tumor targets. Additionally, Medicare may be more willing to cover the cost of therapies
developed through biomarker research because there would be scientific evidence pointing to which patients are most likely to benefit from the
treatment.
While the OBQI research is promising for researchers, physicians,
and patients and their families, some advocates have voiced concern that the initiative may be perceived as negative by the drug industry.
Although these companies could benefit by shortened timelines for drug discovery, clinical research, and the FDA approval process, they may fear that
biomarker research will eventually narrow the population of patients using their treatments. And if the OBQI does help researchers link the
presence of certain biomarkers to specific therapies, it is likely that future treatments will be designed to benefit segments of the patient
population rather than treating patients with a "one size fits all" approach.
In spite of these concerns, the OBQI does have the
potential to bring about major change in the way that cancers are diagnosed and treated, which ultimately is good news for the entire cancer
community.
Gastrointestinal Cancers Symposium
News of Colorectal Cancer Treatments
This year the annual Gastrointestinal Cancers Symposium was held at
the end of January and was co-sponsored by the American Society of Clinical Oncology, The American Gastrointestinal Association, the Society of
Surgical Oncology and the American Society for Therapeutic Radiology and Oncology.
Addition of Oxaliplatin to Treatment Increases
Survival
For many years almost all colorectal cancer (CRC)
patients received 5-FU and leucovorin for chemotherapy treatment. When irinotecan was approved for use with CRC patients, it was paired with
5-FU and leucovorin and referred to as FOLFIRI. Somewhat later, when oxaliplatin was approved, it too was paired with 5-FU and leucovorin and
referred to as FOLFOX. FOLFOX and FOLFIRI became the mainstays of CRC chemotherapy treatment.
Doctors in the Gruppo Oncologico Nord Ovest (GONO) in
Italy reported on a phase III study that compared FOLFIRI (Arm A) to FOLFOXIRI (Arm B: 5-FU, leucovorin, irinotecan and oxaliplatin) as first
line treatment for patients with metastatic CRC. The 244 patients enrolled were well matched and treatment was received every two weeks.
The results for the primary endpoint, response rate, showed that overall RR (complete + partial) was significantly higher in the FOLFOXIRI (66% vs
41%, p=0.0002). Another result reported at a median follow-up of 14 months was that the average progression free survival was greater in the
FOLFOXIRI arm, 9.8 vs 6.9 months (p=0.0006). Overall survival at 30 months was 34% in the FOLFOXIRI arm vs 21% in the FOLFIRI arm (p=0.032)
The toxicities reported showed that all measures were
higher in the FOLFOXIRI arm but the most significant difference was in grade 2-3 peripheral neurotoxicity, which was (arm A/arm B) 0% vs 18%.
(See report below.)
Biweekly irinotecan, oxaliplatin, and infusional
5FU/LV (FOLFOXIRI) versus FOLFIRI as first-line treatment of metastatic colorectal cancer (MCRC): Results of a randomized, phase III trial by the
Gruppo Oncologico Nord Ovest (GONO).
For more info link here to ASCO's 2006 Gastrointestinal Cancers Symposium site.
|
Drugs for treating colon
cancer |
|
Generic Name
|
Brand Name
|
|
Fluorouracil (5FU) |
Adrucil |
|
Leucovorin |
Wellcovorin |
|
Irinotecan (CPT-11) |
Camptosar |
|
Capecitabine |
Xeloda |
|
Oxaliplatin |
Eloxatin |
|
Bevacizumab |
Avastin |
|
Cetuximab (C225) |
Erbitux
|
|
Combinations of drugs to treat colon
cancer |
|
FOLFIRI |
Infusional 5FU, Leucovorin, Irinotecan
|
|
FOLFOX |
5FU, Leucovorin, Oxaliplatin
|
|
IFL |
Irinotecan, bolus 5FU, Leucovorin
|
|
FOLFOXIRI |
Infusional 5FU, Leucovorin, Irinotecan,
Oxaliplatin |
|
XELIRI/CAPEIRI |
Xeloda, Irinotecan/Capecitabine, Irinotecan
|
|
XELOX/ CAPEOX |
Xeloda, Oxaliplatin/Capecitabine, Oxaliplatin
|
Neuroprotective Agent Shows Promise
When peripheral neuropathy becomes severe enough, doses
of oxaliplatin are reduced. However, a reduction in dose or delay in treatment often results in suboptimal outcomes. Therefore, preventing
side effects or reducing their severity is critical to optimal treatment delivery and improved long-term outcomes. Furthermore, peripheral
neuropathy may become a persistent condition, affecting the quality of life for long-term survivors.
Xaliproden (SR57746A), which is not FDA approved
for any indication, showed evidence of reducing dose-limiting neurotoxicity in patients being treated for metastatic CRC with oxaliplatin. Six
hundred forty nine patients receiving FOLFOX4 participated in a phase III randomized placebo controlled study conducted by researchers from Glasgow
University, Glasgow, Scotland. Xaliproden was given from the first day of chemotherapy until 15 days past the last FOLFOX cycle.
The primary endpoints were reduction in the risk of occurrence of
grade 3-4 peripheral sensory neuropathy (PSN) and non-inferiority in response rate (RR). Results reported showed a 39% (p=0.0203) reduction in the
risk of grade 3-4 PSN for patients receiving Xaliproden. In addition, Xaliproden showed no detrimental impact on outcomes in those patients
receiving the drug.
Xaliproden is an oral non-peptide compound which has shown to
exhibit a wide range of neurotrophic effects. Neurotrophic factors are substances that are responsible for the growth and survival of neurons
during development, and for maintaining adult neurons. Neurotrophic factors also are capable of making damaged neurons regrow their processes
in a test tube and in animal models.
Most recently Xaliproden has shown modest effects in
amyotrophic lateral sclerosis (ALS) and Alzheimer disease.
Randomized double blind (DB) placebo (Plcb) controlled phase
III study assessing the efficacy of Xaliproden (X) in reducing the cumulative peripheral sensory neuropathy (PSN) induced by the oxaliplatin (Ox) and
5-FU/LV combination (FOLFOX4) in first line treatment of patients (pts) with metastatic colorectal cancer (MCRC).
ADVOCATE
LECTURE SERIES ON GENOMICS, PHARMACOGENETICS AND TISSUE COLLECTION, STORAGE AND ACCESS
The Indiana University Department of Defense Breast
Cancer Center of Excellence and the Research Advocacy Network are co-sponsoring an Advocate Lecture Series in March. The lecture series is
to inform advocates about the importance of genomics, pharmacogenetics and biospecimen collection and storage in making targeted treatments available
to patients. The faculty is composed of the researchers who are part of the IU/DOD Breast Cancer Center of Excellence. The lecture series
will be conducted as webinar meetings where participants use a toll free conference number and view the slides on their computer screens. There
is no charge to the participants and it is not necessary to download additional software. The series will include three 1 hour presentations starting at 11 am Central, 12 noon
Eastern and 9 am Pacific.
-
On March 16th, George W. Sledge, Jr. MD, the Director of the
Center, will present an overview of the IU/DOD grant, the "omics" involved in the research, the desired outcomes and how advocates can support this
research.
-
On March 23rd, Jenny Chang, MD will give an overview of genomics in
cancer and David Flockhart, MD, PhD will provide an overview of pharmacogenetics.
-
On March 30th, Ann Thor, MD will discuss the operational issues in
collecting and storing biospecimens, especially in multi-centered, multi-country research.
If you are interested in participating, please visit http://www.linkconferencecall.com/reg/researchadvocacy/ to register. The sessions will be archived for later playback for those that are unable to attend the live sessions.
Funding for the lecture series was provided by the DOD Breast Cancer Center of Excellence and Eli Lilly and Company.
What It Means For Me™: Fact Sheets
Two fact sheets have been added to the "What it Means for Me" Fact Sheet Series. These fact sheet topics are on the
results of the Avastin and Herceptin studies in breast cancer. These are available for download on the
Research Advocacy Network Publications area of
the website.
Reporting on some of our activities:
Advocate Institute adds playbacks from "Research Into Practice" Lecture
Series
The Advocate Institute has added three session playbacks from the NCCN / RAN Advocate Lecture
Series on "Research Into Practice." This series is an excellent way for advocates to better understand the influencers and barriers to
advancing research results into clinical practice. The one hour sessions can be accessed at: http://www.researchadvocacy.org/advocateInstitute/
Research Advocacy Network Activities
- March 6-7 Data Sharing and Intellectual Capital Working Group
-
March 8-12 National Comprehensive Cancer Network 11th Annual Conference Roundtable panel "Oncology Practice Today" Quality
Evaluation, Coverage and Reimbursement"
-
March 16-Indiana University Dept of Defense (DoD) Breast Cancer Center of Excellence Advocate Lecture Series. Click here to
register
-
March 23-Indiana University Dept of Defense (DoD) Breast Cancer Center of Excellence Advocate Lecture Series Click here
to register
-
March 30 - Indiana University Dept of Defense (DoD) Breast Cancer Center of Excellence Advocate Lecture Series Click here to register
-
April 1-5 AACR Annual Meeting
-
April 9 - 11 caBIG Annual Meeting
-
April 10-13 NCCTG Spring Meeting
-
April 19-23 Tenth Intercultural Cancer Council Bienniel Symposium, Washington DC
-
May-June Focus on Research Webconferences
-
June 1 Women Against Lung Cancer Annual Meeting, Atlanta, GA
-
June 2-6 American Society of Clinical Oncology (ASCO) Annual Meeting, Atlanta, GA
| Awareness Events |
| January |
July |
| Cervical Cancer Screening Month |
August |
| February |
Multiple Myeloma Awareness Week |
| National Donor Day (14th) |
National Minority Donor Awareness Day(1st) |
| Wise Health Consumer Month |
National Lesbians Cancer Awareness Day (24th) |
| March |
September |
| Kidney Cancer Awareness Month |
Childhood Cancer Month |
| Lymphedema "D" Day (6th) |
Gynecological Cancer Awareness Month |
| National Colorectal Cancer Awareness Month |
Leukemia & Lymphoma Awareness Month |
| National Nutrition Month |
National Ovarian Cancer Awareness Month |
| April |
National Thyroid Cancer Awareness Month |
| Cancer Control Month |
Prostate Cancer Awareness Month |
| Cancer Detection & Early Awareness Month |
Pain Awareness Month |
| Cancer Fatigue Awareness Month |
October |
| Head & Neck Cancer Awareness Month |
National Breast Cancer Awareness Month |
| Lymphoma Awareness Month |
National Mammography Day(21st) |
| National Young Adult Cancer Awareness Week - April 3-9 |
November |
| Oral Cancer Awareness Week - April 11 – 17 |
Brain Tumor Awareness Day |
| Testicular Cancer Awareness Week - April 1-7 |
Lung Cancer Awareness Month |
| May |
National Hospice & Palliative Care Month |
| Brain Tumor Action Week - May 1-7 |
National Pancreatic Cancer Awareness Month |
| Cover the Uninsured Week – May 1-7 |
National Family Caregivers Month |
| Melanoma Monday(2nd) |
National Caregivers Month |
| National Melanoma/Skin Cancer Detection & Prevention Month |
National Bone Marrow Donor Awareness Month |
| Skin Cancer Awareness Month |
Smoking Cessation Awareness Month |
| June |
December |
| National Cancer Survivors Day (4th) |
National Aplastic Anemia Awareness Month |
| Sarcoma Awareness Month |
|
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