FDA begins process to remove breast cancer indication from Avastin label

The U.S. Food and Drug Administration announced today (December 16) that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

“After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Subsequent studies failed to confirm the benefit observed in the original trial. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”

Removing the breast cancer indication from the Avastin label will be a process. This is the first step. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

Oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

The agency has informed Genentech, Avastin’s manufacturer, of its proposal to withdraw marketing approval of the drug for breast cancer. Genentech has not agreed to remove the breast cancer indication voluntarily, so the agency has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination. The company has 15 days to request a hearing; if it does not do so, the hearing will be waived, and FDA will begin proceedings to remove the breast cancer indication.

Avastin, in combination with chemotherapy (paclitaxel), was approved in February 2008 under the FDA’s accelerated approval program, based on the results of a clinical trial known as “E2100,” which evaluated the drug in patients who had not received chemotherapy for their metastatic HER2-negative breast cancer. Under the accelerated approval program, a drug may be approved based on clinical data that suggest the drug has a meaningful clinical benefit, with more information being needed to confirm this. The program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.

After the accelerated approval of Avastin for breast cancer, Genentech completed additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on “progression-free survival” without evidence of an improvement in overall survival or a clinical benefit to patients sufficient to outweigh the risks. The small increase in “progression-free survival” reflects a small, temporary effect in slowing tumor growth.

Avastin has also been associated with several other serious and potentially life-threatening side effects including the risk of stroke, wound healing complications, organ damage or failure; and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.

On the basis of all available data relating to the use of Avastin to treat metastatic breast cancer, the agency has determined that the risks of the drug outweigh the benefits for this use.

FDA is open to working with Genentech on any proposals to conduct additional studies of Avastin in patients with metastatic breast cancer designed to identify a population of patients in which the drug’s benefits exceed the risks.

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Oncologists Value Survival Over Quality of Life, Study Finds

For oncologists, drugs that help cancer patients live longer are worth more than drugs that help patients live well, according to research from Duke University's Fuqua School of Business and several health-related centers.

On average, oncologists were willing to prescribe treatments that cost about $245,000 to prolong life for one year, but the cost threshold dropped to about $119,000 per year for treatments that improve quality of life without prolonging patients' lives.

"Oncologists are understandably focused on survival, but they need to pay equal attention to the quality of life people experience during and after treatment," said senior author Peter Ubel, M.D., the John O. Blackburn professor of business administration at Fuqua.

The researchers found a wide range in what cancer doctors considered reasonable treatment costs. The threshold varied from $10,000 to $5 million per quality adjusted life year (QALY), a standard for assessing the cost-effectiveness of medical interventions. The spending thresholds assessed in the study were also measured in QALYs.

The research can be found on Medical Decision Making's website: http://bit.ly/fBIYBP.

The results highlight a critical problem in the struggle to control health care costs, Ubel said. Increasingly, doctors are being asked to consider whether very expensive cancer drugs -- some of which offer only small gains in survival -- are worth prescribing. But according to Ubel, the data on cost-effectiveness comes without guidelines for determining appropriate financial value in cancer care.

"Currently, individual oncologists are left to decide whether the benefits of expensive new drugs justify their costs," said Ubel. "Cancer care spending is unlikely to drop when there is such a broad range in what oncologists consider reasonable."

"The fact that these highly trained, wonderful doctors are confused about the issue suggests we as a society should discuss the cost of cancer care more explicitly. With health care spending emptying patients' pocketbooks, and bankrupting state and federal governments, we need to decide how much we should spend for small improvements in the quantity or quality of patients' lives."

The study results are based on a survey sent to members of the American Society of Clinical Oncology. The 768 physicians who responded considered two hypothetical scenarios involving a patient with metastatic cancer and a year to live.

The first scenario asked the doctor how much benefit, in months of survival gained, a new drug would need to provide for them to prescribe it. The new drug cost $75,000 more than standard treatment. The second scenario asked the doctor to indicate the highest cost at which they would prescribe a medication to improve the quality of life without prolonging survival.

The respondents consistently chose to spend more on life-prolonging treatments than on quality-enhancing treatments.

Additional authors of the study include Michael A. Kozminski and Aleksandra Jankovic of the Center for Behavioral and Decision Sciences in Medicine, University of Michigan Medical School in Ann Arbor, Mich.; Peter J. Neuman of the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center in Boston; and Eric S. Nadler of the Charles Sammons Cancer Center, Baylor University Medical Center in Dallas.

The study was funded by grants from the California Healthcare Foundation and the Tufts Medical Center.

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Patients with Stage II and Stage III Colon Cancer Treated with 5-FU-Based Adjuvant Therapy after 1995 Have Improved Overall Survival

(BUSINESS WIRE)--ASCO Abstract Number: 3616 - Patients with stage III colon cancer treated with 5-FU-based chemotherapy after complete surgical removal of their tumor after 1995 had improved overall survival with no change in time to recurrence compared to patients treated before 1995. In contrast, patients with stage II colon cancer treated after 1995 had longer time to recurrence and time from recurrence to death compared to those patients treated prior to 1995, according to Mayo Clinic and Gr Hospitalier Pitie-Salpetriere, Paris, researchers. They will present the study’s findings on June 4-8, 2010, at the 2010 American Society of Clinical Oncology Annual Meeting in Chicago.

“By combining information from 21 cancer treatment trials for patients with stage II and stage III colon cancer, our analysis determined that those patients treated after 1995 had improved overall survival,” says Dan Sargent, Ph.D., Mayo Clinic biostatistician, North Central Cancer Treatment Group (NCCTG) statistician and senior author on the study.

The analysis compared patient data from more than 18,000 patients with stage II and stage III colon cancer treated with 5-FU-based chemotherapy after their primary tumor had been surgically removed for the time period 1978-1995 versus 1996-2007.

“Patients with stage II colon cancer treated after 1995 had had longer time to recurrence, possibly due to improvements in surgery and pathology” says Dr. Sargent. “In addition, after 1995, both stage II and stage III colon cancer patients treated after surgery with the same 5-FU-based chemotherapy after surgery had improved overall survival. This finding provides evidence to support previous findings that access to new medical therapies introduced in the mid-1990s as well as the expanded use of surgery for patients recurrent disease have meaningfully improving overall survival for patients treated in this setting.”

The findings arise from analysis of combined data collected within an expanded database by the Adjuvant Colon Cancer End Points (ACCENT) Group, a consortium of scientists. The ACCENT database includes data from more than 33,500 patients from the United States, Canada, Australia and Europe. ACCENT, chaired by Dr. Sargent, is supported by the North Central Cancer Treatment Group.

Dr. Sargent conducted the analysis on the expanded database in concert with an international team of scientists participating in ACCENT including Qian Shi, Ph.D. and Brian Bot, from Mayo Clinic; Thierry Andre, M.D., Gr Hospitalier Pitie-Salpetriere; Greg Yothers, M.D., NSABP Statistical Center, Pittsburgh; Daniel Haller, M.D., Abramson Cancer Center, University of Pittsburgh; Eric Van Cutsem, M.D., Ph.D., University Hospital Gasthuisberg/Leuven; James Cassidy, M.D., Glasgow University; Jacqueline Benedetti, Ph.D., Fred Hutchinson Cancer Research Center, Seattle; and Michael O’Connell, M.D., National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, NSABP Operations Center, Pittsburgh.

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Pediatric Cancer Survivors at Risk for Chronic Illnesses that May Cause Heart Disease

Survivors of pediatric cancer are at greater risk for high cholesterol, diabetes and high blood pressure, all of which predispose them to heart disease.

These risk factors for heart disease are being found at an earlier age than in the general population, according to research published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

Lillian R. Meacham, MD, professor of pediatrics at Emory University and medical director of the Aflac Cancer Center of Children's Healthcare of Atlanta Cancer Survivor Program, used data from the Childhood Cancer Survivor Study, which included 8,599 cancer survivors and 2,936 of their siblings.

"In data previously published from the Childhood Cancer Survivor Study, pediatric cancer survivors were found to be at almost 10-fold greater risk for cardiovascular disease than their non-survivor counterparts," says Meacham. "In this study we identified whether the predisposing risk factors for cardiovascular disease - obesity, hypertension, hyperlipidemea and diabetes - were present at higher rates compared to siblings. If the risk factors could be recognized and treated early it is hoped some of the long-term cardiac side effects could be averted."

Meacham found that cancer survivors were nearly twice as likely as their siblings to take medication for high blood pressure, 60 percent more likely to take cholesterol medication and 70 percent more likely to have diabetes.

Radiation treatment may be playing a role in the development of risk factors for cardiovascular disease, Meacham says. Total body irradiation was linked with a 5.5-fold increased risk and chest and abdomen radiation a 2.2-fold increased risk of cardiovascular risk factor clustering, which when present is associated with subsequent cardiovascular disease.

"Mechanistically, we are not yet sure why this is, but the association is definitely there," says Meacham.

Researchers examined the presence of cardiovascular risk factors and found that physical inactivity among cancer survivors was linked with a 70 percent increased risk for cardiovascular risk factor clustering. Older age at the time of the study was linked to a 8.2-fold increased risk for cardiovascular risk factor clustering among survivors compared with children who had never had cancer.

"These risk factors are manifesting at about age 32, which is much younger than a non-cancer survivor would exhibit signs of cardiovascular risk factors," says Meacham. "Some have suggested that when you are a cancer survivor there are parts of you that wear out early, so we need to be vigilant about our follow-up of these patients in order to find these late effects early and intervene."

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UGA Study finds significantly worse outcomes in cancer patients with cognitive impairment

A new study published by researchers from the University of Georgia and the Moffitt Cancer Center in Tampa, Fla., has found that cancer patients with dementia have a dramatically lower survival rate than patients with cancer alone, even after controlling for factors such as age, tumor type and tumor stage.

But the study, published in the early online edition of the journal Critical Reviews in Oncology/Hematology, also argues that a diagnosis of dementia shouldn’t discourage the use of cancer screenings and appropriate cancer treatments.

“As the population ages and as treatments improve, we’re going to see more patients with both dementia and cancer,” said lead author Claire Robb, assistant professor in the UGA College of Public Health. “And right now there are no guidelines for oncologists as to how to treat these patients.”

Robb and her co-authors in the Senior Adult Oncology Program at Moffitt compared the outcomes of 86 cancer patients with cognitive impairment to a control group of 172 patients with cancer alone. They found that cancer patients with dementia survived an average of four fewer years.

Robb, who is also a researcher in the UGA Cancer Center, said that the reason for the disparity is unclear. She notes that the patients in both groups received similar treatment and that the survival gap persists even after controlling for age, tumor type and tumor stage.

But Robb pointed out that within the cognitively impaired group, there was a dramatic difference in survival time between those with mild cognitive impairment and those with moderate to severe impairment. People with mild cognitive impairment often have problems with thinking and memory yet can still live independently; those with moderate to severe dementia forget details about current events, lose awareness and have difficulty with basic tasks such as preparing meals or choosing proper clothing. The researchers found that while patients with moderate to severe dementia had an average survival time of eight months, those with mild dementia had an average survival time of nearly four and a half years.

“Some people would argue against treating patients with mild cognitive impairment because they’re going to have a shorter survival,” Robb said. “But, you know, 53 months—almost 4 and a half years—is a pretty significant amount of time to live.”

The patients in the UGA/Moffitt study generally received the same treatment regardless of cognitive status, but other studies have found that patients with dementia often receive fewer cancer screenings and undergo less aggressive treatment. One study found that physicians were significantly less likely to recommend a mammogram for a woman with dementia than without, while another found that patients with dementia were twice as likely to have colon cancer reported only after death. Another study of breast cancer patients found that those with dementia were 52 percent less likely to have the tumor removed surgically, 41 percent less likely to undergo radiation therapy, 39 percent less likely to undergo chemotherapy and nearly three times more likely to receive no treatment.

“The fact that cognitively impaired patients seen in our Senior Adult Oncology Program received treatments similar to unimpaired patients while epidemiologic data show a marked difference in treatment provides food for thought,” said study co-author Dr. Martine Extermann, associate faculty member at Moffitt. “Although this might reflect a referral bias in which those who volunteered to participate in the study are different from the general population, it might also indicate that such patients benefit from a specialized evaluation and management in a geriatric oncology program.”

Robb emphasized that she does not advocate overly aggressive treatment for patients who are in the late stages of dementia, but urges the creation of guidelines to help ensure that cognitively impaired cancer patients receive appropriate treatment.

“People have thought about the impact of the aging population on rates of cancer and dementia, but not much attention has been paid to what happens when the diseases coincide,” Robb said. “We’re going to be seeing more cases like these, and, if anything, I hope our research raises awareness of this situation.”

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Rep. Lewis Commends Kidney Care Partners' Health Care Campaign to Improve Survival Rates of First-Year Dialysis Patients in Georgia

/PRNewswire / -- Kidney Care Partners announced the launch of a voluntary quality improvement campaign pledging to reduce mortality among first-year dialysis patients - those at the greatest risk - in Georgia and across the country by 20 percent by the end of 2012.

The "Performance Excellence and Accountability in Kidney Care" or PEAK Campaign (www.kidneycarequality.org) to reduce mortality in the first year will focus on patient education and key clinical care activities to achieve its goal.

Led by Kidney Care Partners, with support from research partners at Brown University and Quality Partners of Rhode Island as well as experts in the kidney community, the PEAK Campaign will:

-- Equip health care providers with tools to help first-year dialysis
patients better transition;
-- Improve the health and survival of first-year dialysis patients;
-- Result in reduced hospitalizations, thus resulting in Medicare
savings.


The PEAK campaign has garnered support not only from a broad cross-section of the kidney community but also from policymakers. "This Congress is deeply committed to resolving the fundamental challenges of health care delivery in this country, but we cannot do it alone," said Rep. John Lewis (D-GA), sponsor of the Kidney Care Quality and Education Act of 2007, which included patient-centered education programs and linked reimbursement with quality care - provisions which were ultimately passed as part of the Medicare legislation of 2008. "We need organizations like KCP to target specific problem areas in the community and find ways to respond. Saving lives is the goal that motivates us all."

Kidney disease affects more than 26 million people nationwide. Approximately 400,000 Americans suffer from kidney failure and require dialysis or kidney transplantation to survive. Transplants are limited due to the shortage of donor organs, so most patients undergo dialysis for three to four hours, three times a week. The number of Americans with kidney disease is rising steadily due to risk factors including diabetes, hypertension, obesity and high blood pressure.

African Americans, Hispanics and other minority groups are most at-risk for developing kidney failure. And while African Americans make up just 12 percent of the general population, they account for 30 percent of people with kidney failure.

There were 3,790 new dialysis patients in 2007 in Georgia alone, a 15 percent increase since 2003, and a total of 14,086 patients on dialysis in 2007 in Georgia, a more than 20 percent increase since 2003, according to the Southeastern Kidney Council.

All too often, the onset of chronic kidney disease (CKD) is gradual and undetected, leaving patients especially vulnerable when the disease is recognized. Helping patients to understand their disease and to manage it appropriately is an essential ingredient to high quality care for newly diagnosed patients and a central component of the PEAK Campaign.

"The kidney care community has achieved considerable and measurable quality improvements in the last decade. The goal of the PEAK Campaign is to help us achieve comparable results in the next decade," said Kent Thiry, KCP Chair. "Our Campaign focuses on patients who are new to dialysis, because these patients are particularly vulnerable. One challenge is to help these patients understand and effectively manage their disease. We also will start a systematic community-wide process of identifying and sharing 'breakthrough' practices that will improve survival rates."

While the survival rate of end-stage renal disease (ESRD) patients has improved, mortality in the first year of dialysis has remained stable during the last decade. The kidney care community has recognized the need to improve the first-year mortality rate as compared to other industrialized nations.

With recommendations from our research partners, KCP will encourage providers to further improve outcomes for first-year dialysis patients in an effort to extend, even save, 10,000 lives.

"Dialysis providers already have robust quality improvement programs in place to ensure consistent delivery of high quality care. The kidney care community looks forward to undertaking this voluntary effort to take quality improvement to the next level," KCP's Thiry added.

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Kidney Transplant Survival can be Long-Term for People with HIV

A Johns Hopkins study finds that HIV-positive kidney transplant recipients could have the same one-year survival rates for themselves and their donor organs as those without HIV, provided certain risk factors for transplant failure are recognized and tightly managed.

“Kidney transplantation is a viable and necessary option for HIV-positive patients with chronic kidney disease, especially since kidney disease is taking such a large toll on this group,” says Jayme Locke, M.D., a resident in the Department of Surgery at Johns Hopkins University School of Medicine, and lead researcher of the study described in the January issue of the Archives of Surgery.

Traditionally, HIV patients were not considered transplant candidates because survival rates after transplantation were thought to be greatly compromised by the disease, which cripples the body’s immune system. Transplant patients also take drugs that suppress their immune systems in order to prevent organ rejection, a regimen thought to further threaten their already fragile immune systems.

Locke says their study results are in part a reflection of newer antiretroviral therapies that have reduced HIV death rates by 80 percent. Indeed, people with HIV now die like most other people, of chronic diseases, rather than from the opportunistic infections that once took a grave toll. Kidney disease, for example, accounts for more than 10 percent of HIV-related deaths.

For the study, Locke and her team looked at the one-year kidney survival rates and one-year patient survival rates of 36,492 HIV-negative and 100 HIV-positive kidney transplant recipients listed on the United Organ Sharing Network (UNOS) list who received transplants between January 2004 and June 2006. They excluded those under 18 and anyone who had multi-organ transplantation.

The chances of survival were the same in both groups. However, kidney survival rates in these two groups showed that HIV-negative recipients had a 94.6 percent survival rate, compared to 87.9 percent in people with HIV. (People can survive on dialysis even if their transplanted kidney fails.)

However, when the investigators broke down the results into subgroups, they learned that some of the kidneys transplanted into HIV-positive recipients were relatively late getting to full function. This so-called delayed graft function (DGF) reduced kidney survival by 30 percent. When this group was removed from the rate comparison, both HIV-positive and HIV-negative groups had equal kidney and patient survival rates, says Locke.

According to Locke, this is significant because DGF can be avoided by controlling certain negative risk factors such as advanced organ donor age, deceased-donor kidneys (vs. live-donor kidneys) and long cold ischemic times (the time the kidney is without blood flow before transplant).

Other researchers who contributed to this study from Johns Hopkins University School of Medicine include Robert Montgomery, M.D., Ph.D.; Daniel S. Warren, Ph.D.; and Dorry Segev, M.D., of the Department of Surgery; and Aruna Subramanian, M.D., of the Department of Medicine.

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Study Shows Machine Perfusion Significantly Improves Transplant Results

/PRNewswire/ -- A landmark study published December 31 in the New England Journal of Medicine (NEJM) demonstrates that use of a specially-designed machine to store kidneys for transplantation offers significant benefits in kidney survival and function when compared to those stored in a traditional "ice box", or cold storage. Unlike the icebox, the LifePort(R) Kidney Transporter monitors the temperature and vascular performance of the organ in real time, while preserving it by pumping the kidney continuously with a cold solution, even while the organ is being transported to its intended recipient.

"This important study confirms the critical role that transportable machine perfusion can play in improving kidney transplant outcomes," said David Kravitz, Chief Executive Officer of Organ Recovery Systems, the manufacturer of LifePort. "It also demonstrates that LifePort should have a central place in all transplantation programs, to help ensure the best possible patient outcomes."

The international trial enrolled kidney pairs from 336 consecutive deceased donors in Europe and randomly assigned one kidney to machine perfusion and the other to static storage. Results showed that the odds of a delay in kidney function post transplant were reduced by almost half when machine perfusion was used compared with static cold storage. Delay in kidney function, or DGF, is a factor that is known to adversely affect the long-term outcome of kidney transplantation. The study also showed that the LifePort kidneys were 48 percent less likely to fail within the first year post-transplant compared to those kidneys stored in the traditional box of ice prior to transplantation. This is the first randomized, prospective study to directly compare the two methods of storing and transporting organs for transplantation.

"For the first time in the United States, the number of those waiting for a life-saving transplant has passed 100,000," said Joseph Vassalotti, MD, Chief Medical Officer of the National Kidney Foundation. "Any new method like the one demonstrated in this study, that will help maximize the available organs and potentially reduce the need for re-transplantation, is vitally important for patients and the professionals who care for them."

More than 1.5 million people worldwide suffer from end stage renal disease, for which a kidney transplant is the preferred treatment option. With a continuing global shortage of organs for transplantation, it is important to find ways of increasing not just the number of kidneys available but also the quality of organs for transplantation to improve the long-term outcome for recipients. By improving the quantity and quality of organs for transplant, both improvements in clinical outcomes and cost savings to health systems are likely to occur.

The LifePort provides a sealed, sterile, protected environment where a physiologic solution is gently pumped through the kidney at cold temperatures to minimize damage while the organ is outside the body. The LifePort is lightweight and portable allowing organs to be perfused and evaluated from the time of recovery until transplant. It can travel unaccompanied by land or air, safely transporting the kidneys across town or between states.

About the Machine Preservation Trial

The Machine Preservation Trial was an investigator-driven study, run by an independent Scientific Steering Committee across The Netherlands, Belgium and Germany, with Eurotransplant (an international organ exchange organization) collaborating as study coordinators. The Machine Preservation trial was sponsored by Organ Recovery Systems of Chicago, USA, manufacturers of the LifePort Kidney Transporter.

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