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Saturday, March 01, 2008

Most NYC Hospitals Provide Uninsured Patients With Information On Financial Assistance

Most New York City hospitals are in compliance with a new state law that requires them to inform low-income, uninsured patients about financial assistance for medical treatment, according to an investigation by the New York City Council, the New York Times reports.

Under the law, which took effect in January, all New York hospitals must inform uninsured patients verbally, in writing or prominently placed signage, that they could be eligible for state financial aid from an $847 billion charity care hospital fund. Uninsured patients with incomes at or below the federal poverty level are eligible for lower health care costs, including a maximum payment of $150 for surgery and $15 for emergency department and clinic visits. Patients with higher incomes are eligible for medical care on a sliding fee scale set by each hospital.

For the survey, City Council personnel posed as patients or their relatives and made one call and one visit to 59 hospitals in the city. The investigation found that staff at 42 of the hospitals gave information about financial aid without prompting, while staff at nine hospitals did not offer the information even after being prompted. Staff at five of those nine hospitals said patients who were unable to pay would not receive medical attention. In addition, the investigation found that 63% of hospitals had posters about financial assistance in two or more locations, while 22% of hospitals had no signs posted.

Council Speaker Christine Quinn said, "We saw a significant amount of compliance, for this early in a law's existence," adding, "But the thing about a public health law is that if one person is forgotten, it creates the real possibility that that one person might not get the lifesaving information they need" (Kershaw, New York Times, 10/31).

Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


Expression Patterns of microRNAs Appear Altered in Colon Cancer
Preliminary research has found an association between certain microRNA expression patterns and poor survival and treatment outcomes for colon cancer, according to a study in the January 30 issue of JAMA.

Colon cancer is a major cause of cancer death worldwide. Colorectal cancer is the third most common and second leading cause of cancer death in the United States. "Even though 5-year mortality rates have modestly declined over the last 3 decades, there is still a need to identify new prognostic biomarkers and therapeutic targets for this disease," the authors write. They add that microRNAs have potential as diagnostic biomarkers and therapeutic targets in cancer.

MicroRNAs are 18 to 25 nucleotide, noncoding RNA (ribonucleic acid) molecules that have been found to regulate a variety of cellular processes and may also have a role in the development of cancer cells. The prognostic potential of microRNAs has been demonstrated for chronic lymphocytic leukemia, lung cancer and pancreatic cancer, according to background information in the article. No study has evaluated the association between microRNA expression patterns and colon cancer prognosis or therapeutic outcomes.

Aaron J. Schetter, Ph.D., M.P.H., and Curtis C. Harris, M.D., of the National Cancer Institute, National Institutes of Health, Bethesda, Md., and colleagues evaluated microRNA profiles of colon tumors and paired nontumorous tissue to study their potential role in tumor formation, diagnosis and therapeutic outcome in colon cancer. The study included 84 patients from Maryland; associations were validated in a second, independent group of 113 patients from Hong Kong.

Thirty-seven microRNAs were differentially expressed in tumor tissues by microRNA microarray analysis in the Maryland test cohort. Expression patterns of five tested microRNAs were validated in the Hong Kong cohort. "The discriminatory power of 5 microRNAs to differentiate between tumor and nontumorous tissue suggests that predictable and systematic changes of microRNA expression patterns may occur during tumorigenesis and may be representative of sporadic colon adenocarcinomas," the authors write.

"...we found systematic differences in microRNA expression patterns between colon tumors and paired nontumorous tissue. Tumors with high expression of miR-21 [a microRNA] was associated with poor survival outcome and poor response to adjuvant chemotherapy in 2 independent cohorts, independent of staging and other clinical covariates suggesting that miR-21 may be a useful diagnostic biomarker for colon adenocarcinomas and survival prognosis including response to therapy."

Nektar's Clinical Trial To Evaluate NKTR-102 Efficacy In Colorectal Cancer
Nektar Therapeutics starts Phase 2 clinical development program to evaluate NKTR-102 (PEG-irinotecan) as a potential treatment for colorectal cancer.

NKTR-102 is Nektar's lead oncolytic candidate using the company's innovative small molecule PEGylation technology platform.

"The start of the Phase 2 program for NKTR-102 in colorectal cancer is a major achievement for Nektar," said Howard W. Robin, Nektar President and Chief Executive Officer. "Our Phase 2 program has the potential to demonstrate Nektar's ability to generate innovative and important PEGylated small molecule therapeutics. Based on our positive Phase 1 study findings, we also plan to initiate Phase 2 studies this year to evaluate NKTR-102 in multiple solid tumor settings."

Results from the Phase 1 study for NKTR-102 are expected to be presented at major oncology conferences in 2008.

About the Phase 2 Clinical Development Program for NKTR-102 (PEG-irinotecan)

The Phase 2 program is designed to evaluate the safety and efficacy of NKTR-102 (PEG-irinotecan) for the treatment of patients with solid tumors. The first study in the program will investigate NKTR-102 in combination with cetuximab as a second-line colorectal cancer treatment in irinotecan-naive patients as compared to treatment with standard irinotecan in combination with cetuximab.

The colorectal study is comprised of two sequential stages. The Phase 2a is an open-label, dose-finding trial in multiple solid tumor types that are refractory to standard curative or palliative therapies. The Phase 2b is an open-label, randomized, double-arm study in patients with second-line metastatic colorectal cancer and study participants will be randomized in one of two arms of the trial (1:1), to receive either NKTR-102 and cetuximab or standard irinotecan and cetuximab. The Phase 2b stage is expected to begin in mid-year 2008 and will be conducted in over 40 centers worldwide. The primary endpoint of the Phase 2b trial is progression-free survival. Secondary endpoints include response rate, response duration, overall survival, standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.

Genomic Health Identifies Genes Associated With Colon Cancer Recurrence
Genomic Health announced results of studies that have identified genes that could help predict the likelihood of recurrence and chemotherapy benefit for early-stage (stage II and III) colon cancer. The company is conducting detailed analyses of these studies to select a final gene set for a clinical assay to quantify the risk of recurrence and likelihood of chemotherapy benefit, which will be evaluated in an independent validation study.

Results of the studies were presented January 26, 2008 at ASCO GI, the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium, in Orlando, Florida.

"These results allow us to conclude that quantitative gene expression using methods developed by Genomic Health can identify genes that may predict the likelihood of colon cancer recurrence and chemotherapy benefit," said Steven Shak, M.D., chief medical officer of Genomic Health. "This marks an important step in our effort to develop a test to personalize treatment decisions for early-stage colon cancer patients using the same rigorous clinical development and validation process as we did with Oncotype DX for breast cancer."

Both study reports used Genomic Health's quantitative RT-PCR to analyze RNA expression for 375 cancer-related and reference genes from colon tumors of patients who were treated with surgery alone or with surgery and adjuvant 5-fluorouracil/leucovorin (5-FU/LV) chemotherapy.

The first report evaluated colon cancers from patients treated with surgery alone, including 270 patients from the National Surgical Adjuvant Breast & Bowel Project (NSABP) C-01/C-02 study and 765 patients who were treated at the Cleveland Clinic. Researchers identified 65 genes significantly associated with colon cancer recurrence across both patient populations. The range of individual gene expression was associated with an up to 11-fold difference in risk of disease recurrence.

The second report analyzed colon cancers from an additional 508 patients who were treated with surgery plus 5-FU/LV chemotherapy in NSABP study C-06. Of the 375 genes, the researchers identified 56 that were significantly associated with disease prognosis for stage II and III colon cancer in this study as well as in patients treated with surgery alone in NSABP C-01/C-02 and at the Cleveland Clinic. Furthermore, the collaborators used 15 of the 56 genes as a preliminary model to stratify patients into recurrence risk categories.

Genomic Health has completed four independent studies involving 1,851 colon cancer patients to evaluate a total of 761 genes. These data will support the selection of the final gene set, which will undergo clinical validation of its utility in guiding treatment decisions with adjuvant 5-FU/LV chemotherapy.



If You Are 50 And Over, Get Screened For Colorectal Cancer

As a new year approaches, the American Society for Gastrointestinal Endoscopy (ASGE) encourages all men and women age 50 and over to add getting screened for colorectal cancer to their list of New Year's resolutions for 2008. Recent studies have confirmed that a majority of Americans who should be screened for colorectal cancer are not. Colorectal cancer is a preventable and treatable disease when caught in its early stages. If you are age 50 or over, talk to your doctor about the colorectal cancer screening method that is best for you.

Colorectal cancer almost always develops from abnormal growths, called polyps, in the colon or rectum. Screening through colonoscopy saves lives by detecting and removing the precancerous polyps before they become cancerous.

Colorectal cancer is the third most commonly diagnosed cancer in men and women and the second leading cause of cancer-related deaths in the United States, killing nearly 56,000 people each year. Many of those deaths could be prevented with earlier detection. The five-year relative survival rate for people whose colorectal cancer is treated in an early stage is greater than 90 percent. Unfortunately, only 39 percent of colorectal cancers are found at that early stage. Once the cancer has spread to nearby organs or lymph nodes, the five-year relative survival rate decreases dramatically.

ASGE screening guidelines recommend that, beginning at age 50, men and women at average risk for developing colorectal cancer should begin colorectal cancer screening. People with risk factors, such as a family history of colorectal cancer, should begin at an earlier age. Patients are advised to discuss their risk factors with their physician to determine when to begin routine colorectal cancer screening and how often they should be screened. Colonoscopy is a procedure which looks at the entire colon and plays a very important role in colorectal cancer prevention because it is the only method that is both diagnostic and therapeutic. Not only does colonoscopy view the entire colon, but it also removes polyps before they turn into cancer.

Colorectal cancer can be present in people without symptoms, known family history, or predisposing conditions, such as inflammatory bowel disease.

While common in other benign conditions, the following symptoms might indicate colorectal cancer:

-- Unexplained change in bowel habits

-- Unexplained weight loss

-- Blood in the stool

-- Unexplained anemia