U.S. cancer death rates continue drop

U.S. cancer death rates are falling, with big decreases in major killers such as colon and lung cancer, the American Cancer Society said on Wednesday.

The improvement was due a decline in smoking, better treatment and earlier detection, it said.

The group predicted 1,529,560 new cancer cases in the United States in 2010 and 569,490 deaths.

Death rates for all cancer types fell by 2 percent a year from 2001 to 2006 among men and 1.5 percent per year from 2002 to 2006 in women, it said.

New cases of colorectal cancer fell 3 percent a year in men and 2.2 percent a year for women from 1998 to 2006, while lung cancer rates have fallen in men by 1.8 percent each year since 1991 and finally started leveling off among women.

“We will build on our progress in the fight against cancer through laws and policies that increase access to cancer prevention, early detection, and treatment services, and with a sustained federal investment in research designed to find breakthroughs in the prevention and treatment of the most deadly forms of cancer,” John Seffrin, chief executive officer of the American Cancer Society, said in a statement.

FALLING MORTALITY RATE

The drops in mortality rates have meant 767,000 people who would have died prematurely from cancer over the past 20 years did not, the organization said.

The overall U.S. death rate from cancer in 2007 was 178.4 per 100,000 people, a 1.3 percent drop from 2006, when the rate was 180.7 per 100,000.

“In that time, mortality rates have decreased by 21 percent among men and by 12 percent among women, due primarily to declines in smoking, better treatments, and earlier detection of cancer,” the group said in a statement.

Lung cancer remains the No. 1 cancer killer of both men and women in the United States. Breast cancer comes in No. 2 for women, prostate cancer is the second most common killer of men, and colon cancer is the third leading cause of cancer death for both sexes.

On Tuesday, the U.S. Centers for Disease Control and Prevention said at least 10,000 people and possibly far more die in the United States each year because they have not been screened for colon or breast cancer.

The cancer society projects that 222,520 Americans will get lung cancer in 2010 and 157,300 will die. It says 102,900 will get colon cancer and 51,370 will die from it; 209,060 will get breast cancer and 40,230 will die; and 217,730 will get prostate cancer and 32,050 will die from it.

New Lung Cancer Treatment Approach Raises Hopes and Debate

A number of clinical trials have tried and failed to improve survival in patients who have advanced non-small cell lung cancer (NSCLC) by extending the duration of their initial treatment. The premise behind the approach, often called maintenance therapy, is simple: In patients whose tumors regress following their initial treatment, give the cancer another kick while it’s down, rather than waiting for it to regain steam before delivering further therapy.

Where past trials have failed, though, several recent phase III trials using more current agents have reported some success using maintenance therapy. To date, one trial has reported improved overall survival and a second, the SATURN trial, is slated to report improved overall survival next week at an international lung cancer conference. Several other trials have shown improvements in progression-free survival. Among patients with advanced disease, for whom survival can range from a few months to 1 or 2 years, any improvement is good news.

Positive Trials of Maintenance Therapy in NSCLC

Even with the positive data, though, leading lung cancer experts disagree on some important details about precisely how maintenance therapy fits into the current treatment mix for advanced NSCLC, which now includes numerous options for first-, second-, and third-line treatments, some of which are targeted therapies.

The debate over maintenance chemotherapy has taken on renewed importance in recent weeks, with the FDA’s approval of the first agent for use in this indication, pemetrexed (Alimta). Just how deeply this new treatment approach will reach into the clinic is unclear. According to Dr. Sherman Baker, Jr., of Virginia Commonwealth University’s Massey Cancer Center, it’s already being done on a limited basis and its use is now likely to expand.

“The question in my mind is, will we do it right?” he said. That is, will clinicians follow the approaches that clinical trials have shown offer a benefit? Dr. Baker also wonders if these trials will alter cancer specialists’ mindset. “Will these trials change how we view advanced NSCLC—not just as a disease that is always fatal but as something that we may be able to make more of a chronic disease, where 2-year survivals are more common?”

This diagram of stage IIIA non-small cell lung cancer shows cancer in the lymph nodes, left main bronchus, pleura, diaphragm, and chest wall.

Getting to this Moment

Although there is some disagreement on the role of maintenance therapy, there is no question about the duration of first-line chemotherapy in patients with advanced NSCLC—four to six cycles (most often four)—or that first-line chemotherapy should consist of a combination of agents that include a platinum chemotherapy drug such as cisplatin or carboplatin. Numerous trials have shown that these platinum-based “doublets” are highly effective, but that going beyond six cycles simply piles on toxicity without any added clinical benefit.

Maintenance therapy—as practiced in the phase III clinical trials that have reported positive results (see sidebar)—comes into play in patients whose tumors have responded to first-line therapy. These patients then immediately begin treatment with maintenance agents until their disease shows signs of progressing.

In the international phase III trial that garnered pemetrexed’s FDA approval for this new indication, patients with advanced NSCLC of the nonsquamous type had a median overall survival of 15.5 months with pemetrexed maintenance therapy, compared with 10.3 months for those who received best supportive care. Progression-free survival also improved significantly. Patients with squamous cell carcinoma did not benefit from the maintenance therapy regimen.

Dr. Chandra P. Belani, the trial’s principal investigator, believes the trial results establish maintenance therapy as a new standard of care for nonsquamous NSCLC. “Such a survival benefit with maintenance therapy has not been seen before,” he said. Given the low rate of less-severe side effects seen with pemetrexed, he added, the potential survival benefits warrant its use.

“Whenever there is something new, there are going to be those who are reluctant to use it,” Dr. Belani said. “But now that it is approved [by the FDA] based on the trial results, how can you deny it to patients?”

Dr. Nasser Hanna, from Indiana University’s Simon Cancer Center, remains skeptical of maintenance chemotherapy for most patients with advanced NSCLC. The survival benefit in the pemetrexed trial, he argued, is not quite what it seems because many patients in the trial’s non-maintenance arm did not receive the study drug or any approved second-line therapy once their disease progressed. And even low-grade toxicities, he added, “are not trivial,” particularly in this patient population.

Similar results, Dr. Hanna continued, can be achieved in many patients even if they get a “holiday” from treatment—referring to the practice of giving patients time to recover from the duress of first-line treatment—or even if, as current guidelines recommend, the next round of treatment is not initiated until there are signs of progression.

In another positive maintenance therapy trial that used the chemotherapy drug docetaxel (Taxotere), published earlier this year, a significant percentage of patients in the non-maintenance arm did not receive docetaxel upon disease progression. However, patients who did had the same survival as those who received it immediately.

“I don’t see these trials as demonstrating that maintenance therapy is necessary for the majority of patients,” Dr. Hanna said. “But they do underscore the value of these agents in metastatic disease and the importance of not losing the opportunity to treat patients with these drugs.”

That limited window of opportunity, argued Dr. Belani, is exactly why immediate administration of therapy is so important. “There is no way to predict which patient will benefit from a treatment holiday,” he said. “After a treatment holiday, a third of patients can’t go on to [receive the next] treatment. They either have a declining performance status, their cancer progresses, or they die.”

No Longer “One and Done”

A key point to take away from the recent positive maintenance therapy trials is that they all involved FDA-approved second- and third-line treatments, said Dr. Mark Socinski from the University of North Carolina’s Lineberger Comprehensive Cancer Center. This is a big change from earlier in this decade, he noted, when there were fewer effective first-line therapies for NSCLC, let alone anything beyond that.

“These trials are telling us that it’s important for patients to get drugs known to improve survival,” he said. “A maintenance strategy is one way to do that.” Regardless of the strategy that’s chosen, Dr. Socinski continued, the available data indicate that oncologists need to more closely consider the next line of therapy and educate their patients about it.

“We need to tell them, if your cough gets worse, if the pain gets worse, don’t wait for your next appointment. Don’t ignore your symptoms,” he said. “Patients need to hear that something like that means their disease might be getting worse, and they need to know that getting active agents can help.”

—Carmen Phillips

Rosetta Genomics Now Processing Fine-Needle Aspirate Cell Block Samples for Lung Cancer Subclassification Molecular test that helps determine treatment can now be performed before the tumor is surgically resected

REHOVOT, Israel & PHILADELPHIA, Apr 05, 2010 Uses highly accurate microRNA-based technology of miRview(TM) squamous test on Fine-Needle Aspirate (FNA) cell block samples to subclassify non-small cell lung cancer (NSCLC) into squamous or non-squamous

–Subclassification of NSCLC using preoperative FNA samples currently presents a challenge to physicians, with an estimated 30%-40% of cases remaining unclassified or being misclassified

–In a recent study,(1 )Johns Hopkins University researchers demonstrated that miRview squamous correctly subclassified 95% of FNA cell block specimens and small biopsies originally diagnosed as poorly differentiated NSCLC

Rosetta Genomics, Ltd. /quotes/comstock/15*!rosg/quotes/nls/rosg (ROSG 2.22, -0.06, -2.63%) , a leading developer and provider of microRNA-based molecular diagnostics, announced today that starting April 1, 2010 physicians are able to send FNA cell block samples to Rosetta Genomics’ CLIA-certified and CAP-accredited laboratory in Philadelphia for analysis using Rosetta’s miRview squamous test. FNA is a less invasive method to obtain tumor cells compared with tumor resections or biopsies. This breakthrough will enable patients and physicians to benefit from a highly accurate diagnostic assay without having to undergo a more invasive procedure.

miRview squamous is a molecular diagnostic test that measures the expression level of a single microRNA to accurately differentiate squamous from non-squamous NSCLC. The test offers patients and physicians a highly accurate diagnostic tool that produces standardized and reproducible results.

“Enabling physicians to subclassify NSCLC tumors with miRview squamous based on FNA cell blocks, without the need for more invasive procedures, brings significant value to lung cancer patient management,” noted Dr. Tina Edmonston, Director of Rosetta Genomics’ CLIA-certified laboratory. “As pathologists, we are often faced with challenges especially when trying to subclassify poorly differentiated NSCLCs. However, correct subclassification is crucial to determine the treatment of the patient. We believe this new capability will help physicians better address this issue.”

Lung cancer is the leading cause of cancer mortality in the U.S., killing more than 160,000 Americans annually. In over 60,000 of these patients with NSCLC, identification of the squamous sub-type has significant clinical implications. Squamous lung cancer carries increased risk of severe or fatal bleeding for certain targeted biological therapies, including bevacizumab (Avastin(TM)) and other drugs under development.(2) Other approved therapies, such as pemetrexed (Alimta(TM)) are indicated for non-squamous NSCLC only.(3)

“This improvement is an excellent example of how by adapting our proprietary miRNA-based technologies to be used on FNA cell block specimens, our highly accurate miRview squamous assay can be made available to more patients suffering from lung cancer,” stated Ken Berlin, President and CEO of Rosetta Genomics.

In a recently published study in Clinical Cancer Research, Johns Hopkins University researchers demonstrated that miRview squamous correctly subclassified 95% of FNA cell block specimens and small biopsies originally diagnosed as poorly differentiated NSCLC into squamous and non-squamous cell carcinoma.

About microRNAs

MicroRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. MicroRNAs’ unique advantage as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle aspirate (FNA) cell blocks. It has been suggested that their small size (19-21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced. To learn more about microRNAs, please visit www.rosettagenomics.com.

About miRview(TM) Products

miRview(TM) are a series of microRNA-based diagnostic tests developed by Rosetta Genomics. miRview(TM) mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary. miRview(TM) squamous accurately identifies the squamous subtype of NSCLC, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain targeted therapies. miRview(TM) meso distinguishes mesothelioma, a cancer connected to asbestos exposure, from other malignancies in the lung and pleura. miRview(TM) tests are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, over 100,000 patients a year may benefit from the miRview(TM) mets test, 60,000 from miRview(TM) squamous, and 60,000 from miRview(TM) meso, with similar numbers of patients outside the U.S. The company’s tests are now being offered through distributors around the globe. For more information, please visit www.mirviewdx.com.

About Rosetta Genomics

Rosetta Genomics is a leading developer of microRNA-based molecular diagnostics. Founded in 2000, the company’s integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic tools. The company’s first three microRNA-based tests, miRview(TM) squamous, miRview(TM) mets and miRview(TM) meso, are performed at the company’s Philadelphia-based, CLIA-certified and CAP accredited lab. Rosetta Genomics is the 2008 winner of the Wall Street Journal’s Technology Innovation Awards in the medical/biotech category. To learn more, please visit www.rosettagenomics.com.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to the role of microRNAs in human physiology and disease, and the potential of microRNAs in the diagnosis and treatment of disease, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Rosetta’s approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta’s ability to obtain, maintain and protect its intellectual property; Rosetta’s ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta’s need and ability to obtain additional funding to support its business activities; Rosetta’s dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta’s ability to successfully develop its products and services; Rosetta’s ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta’s technology; competition from others using technology similar to Rosetta’s and others developing products for similar uses; Rosetta’s dependence on collaborators; and Rosetta’s short operating history; as well as those risks more fully discussed in the “Risk Factors” section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2009 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

(1) Justin A. Bishop, Hila Benjamin, Hila Cholakh, Ayelet Chajut, Douglas P. Clark, William Westra. Accurate classification of non-small cell lung carcinoma using a novel microRNA-based approach. Clinical Cancer Research, 2010, 16(2) 610-619.

(2) Johnson et al, Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22:2184-91, 2004

(3) Alimta website at www.alimta.com

SOURCE: Rosetta Genomics, Ltd.

New Radiation Lung Cancer Treatment Therapy Shows Promise

Aiming powerful beams of radiation precisely at tumors helped control their growth and helped people with early stage but inoperable lung cancer live longer, U.S. researchers said according to recent press reports.

They said intensive radiation therapy — done in one to five treatments instead of the conventional 20 to 30 — provided more than double the rate of primary tumor control than seen in prior studies of conventional radiation therapy.

The findings suggest stereotactic body radiation therapy could “provide a significant step forward in the battle against this type of lung cancer,” Dr. Robert Timmerman of the University of Texas Southwestern Medical Center in Dallas, whose study was published in the Journal of the American Medical Association, said in a statement.

“The primary finding and perhaps most exciting aspect to this prospective study was the high rate of primary tumor control,” he said, noting that the treatment controlled tumor growth for three years in 97.6 percent of patients.

“Primary tumor control is an essential requirement for the cure of lung cancer,” Timmerman said.

Patients with early stage lung cancer generally get conventional radiation treatment, or no treatment at all, leaving the cancer to progress and kill about 60 percent of patients within two years.

For the study, the team followed 55 patients with non-small cell lung tumors whose medical conditions would not allow surgery. Radiation treatment lasted between 1.5 and two weeks.

Three years after treatment, 48.3 percent were still disease-free, and more than half — 55.8 percent — of those who got the treatment survived for three years. Overall, 20 percent of the patients died of lung cancer.

While the treatment helped control tumors in the lungs, 22 percent of patients developed tumors elsewhere in the body.

The researchers, who called these results “disappointing,” said the tumors may have been undetected during the initial screening, suggesting the need for better screening and possibly dual treatment with other cancer drugs to eliminate as much disease as possible.

Even so, Timmerman said the therapy offers “a new option that produces better outcomes and may represent an updated, and ultimately more successful, approach to the treatment of patients with early stage inoperable lung cancer.”

The study was funded by the U.S. National Institutes of Health and the Department of Defense.

Timmerman also reported receiving technology development grants from radiation device makers Varian Medical Systems of Palo Alto, California, and Elekta Instrument of Stockholm, Sweden.

Lung cancer kills around 1.2 million people a year and is the top cause of cancer death globally.