For patients with metastatic colorectal cancer, the Food and Drug Administration (FDA) has approved a new use of Avastin® (bevacizumab): It can be continued as part of ‘second-line’ combination therapy, even if it was used in first-line therapy.

When stage IV cancer progresses despite use of Avastin plus either FOLFOX (5FU plus Eloxatin® or oxalyplatin) or FOLFIRI (5FU plus Camptosar® or irinotecan)-based chemotherapy, the FDA has now approved continued use of Avastin when second-line treatment switches to the other chemotherapy.

Avastin is a monoclonal antibody (a “targeted drug”) that helps prevent a cancer from stimulating growth of new blood-vessels that then help the tumor get bigger.

The FDA’s approval is based on a large, randomized Phase III trial which showed that median overall survival was 11.2 months when patients continued Avastin along with the second-line chemotherapy, compared to a 9.8-month median survival with just the second-line chemotherapy without Avastin. Participants in the trial averaged about 63 years old, and were able to carry out normal activities or at least housework or office work (i.e., ECOG performance status of 0-1).

There was no significant increase in adverse events (such as worse side effects) in those continuing Avastin, versus those who stopped the drug for second-line treatment.

FDA approval for the new use clears the way for insurers to cover the drug’s use, which averages roughly $5,100 a month.

Sources: Jan. 25, 2013 FDA press release; “Avastin Wins New Colorectal Cancer Indication,” Jan. 24 2013 MedPage Today ; “Genentech’s Avastin approved for wider use in colorectal cancer,” Jan. 24 San Francisco Business Times.

Disclosure: Fight Colorectal Cancer accepts  unrestricted educational grants and charitable donations from Genentech, the manufacturers of Avastin. Fight Colorectal Cancer has ultimate control over website content.

The Centers for Disease Control is urging doctors to prescribe antiviral medications to high-risk patients suspected of having the flu, even without a positive test. When given within 48 hours of symptoms appearing, antivirals like Tamiflu or Relenza can ease symptoms, shorten illness, and prevent serious complications.

Clinicians are not prescribing antiviral medications as often as in previous years, even though the 2013 flu season is causing more hospitalizations and deaths according to government figures. Complications from this year’s predominant flu strain are especially high among the elderly, causing half of hospitalizations and 90% of deaths so far.

With a sharp increase in both hospitalizations and deaths in the 2^nd week of January, the Centers for Disease Control (CDC) issued a physician advisory urging use of antivirals for more people–especially those at high risk–as soon as flu symptoms appear.

“When given promptly, they work,” CDC Director Thomas Frieden, MD, told a Jan. 18^th press briefing. “They can reduce symptoms, shorten the duration of illness, and prevent serious complications including hospitalization and death.”

Frieden also advised clinicians not to wait for test results or a positive ‘rapid flu test’ when probably flu appears in people at high risk for complications: anyone over age 65 or under age 2, or having any ongoing serious illness (including cancer survivors no longer in treatment).

Only halfway through the flu season

The number of influenza-related hospitalizations and deaths will rise in the coming weeks even as the  national average of new cases begins to slow, Frieden warned, partly because there is a lag time between when flu hits and when complications like pneumonia appear.

And even though flu rates are leveling out in much of the east and south, the outbreak is just beginning in California, Arizona, Hawaii, and Nevada. “Folks out West, you still have most of the flu season yet to come,” Frieden said.

What this means for you:

• Experts are still strongly recommending that anyone over 2 years old should get a flu shot for protection—of you and others—over the next several months.
• Even if you got vaccinated, you can still get a strain of influenza.
• If you begin to have flu symptoms and are “high-risk” or have contact with high-risk people, you should get antiviral medication with 48 hours. (High risk includes cancer survivors, even if you’re no longer in treatment. Even if it’s later than 2 days, you might still benefit, so call your doctor.)
• Flu symptoms include fever, cough, sore throat, body aches.
• You are contagious to anyone within 6 feet until you have been without a fever for 24 hours.  Stay home.

Sources:

• “CDC Urges Tamiflu RX to Curb Flu Death Rate,” Jan. 18 2013 Medscape
• Jan. 15 2013 CDC Health Advisory: Summary of CDC Recommendations for Influenza Antiviral Medications

Provided by Kaiser Health News

Experts were surprised this week when the latest government survey showed that consumers actually paid a slightly smaller share of the nation’s total health bill in 2011, even though more people now pay higher deductibles.

Total U.S. spending on health care grew 3.9% in 2011 (including all medical goods and services, public health, cost of health insurance, investments, and government costs). That equals 17.9% of Gross Domestic Product (the same as 2009 and 2010) or about $8,680 per person in the nation.

Consumers paid just over one-quarter (28%) of total costs. Meanwhile, federal government health spending has risen more than three times as fast as consumer health spending since 2007, largely due to increased Medicare and Medicaid services for seniors and the disabled.

But many households hit hard by high deductibles

Even though the federal government is paying more of the nation’s total bill, individuals and families are paying a higher percentage of their personal income on health care. Household medical expenses are rising faster than the families’ income, according to government statistician Micah Hartman.

In 2012, one worker in three had medical insurance with a deductible of $1000 or more, meaning they must pay $1000 “out of pocket” before most expenses are covered. (In 2006, only one in 10 workers had a high-deductible plan.)

At the moment, the cost of higher deductibles is being partly offset by lower average prescription costs, as low-cost generics become more available for common medicines.

But more and more employers—as well as insurers under the new “health exchange” insurance marketplaces coordinated by the Affordable Care Act—will offer only high-deductible plans with pretax health savings accounts in the near future, according to employer and insurer surveys.

Fight Colorectal Cancer Answer Line and Upcoming Webinar Both Offer Advice

Public health officials worry that high deductibles may keep patients from getting needed screening or early treatment.

“One of the most common calls to our Answer Line right now is from people due for a colonoscopy, or unable to pay treatment copays, because they can’t afford their high deductible,” says Tavia Gilchrist, one of the friendly voices of Fight Colorectal Cancer’s Answer Line.

People may not have enough cash to pay a plan’s high deductible; or they’ve been laid off and lost all insurance; or they’re in a ‘grandfathered’ plan that isn’t yet required to offer free screenings. Gilchrist helps people define exactly what issue they’re facing, whether it’s insurance or Medicare rules, confusion about what a doctor is ordering, or a lack of local screening programs. “Every state – even areas within a state – is different,” she notes. Her job is to get callers started in the right direction to find answers to their specific question.

Webinar features expert on handling cancer finances

Speaking of questions, you can listen to plenty of answers in the live webinar “Addressing the Financial Burden of Cancer” on Wednesday, Jan. 16 from 8 to 9:30 pm EST. It features Elaine Martinez, a case manager with the Colorectal CareLine at the Patient Advocate Foundation.

Elaine serves as a liaison between colorectal cancer patients and their insurers, employers and/or creditors to resolve insurance, job, and/or debt problems. She helps investigate reimbursement levels for prescribed treatments, researches available clinical trials, and helps people enroll in resource programs for both uninsured and underinsured patients.

If you can’t listen in on Wednesday, the webinar will be archived for later listening, too.

Either way, you can’t afford to miss it.

Sources:

• “Who Knew? Patients’ Share of Health Spending Is Shrinking,” Jan. 14 Kaiser Health News;
• “Employer Health Benefits: 2012 Summary of Findings,” Kaiser Family Foundation and Health Research & Education Trust;
• 2011 National Health Expenditures report, Centers for Medicare & Medicaid Services;

• Fight Colorectal Answer Line: 1-877-427-2111

• Webinar: “Addressing the Financial Burden of Cancer”

Life-altering fatigue will affect 80% of people getting chemotherapy or radiation therapy, plus most people who have metastatic cancer, and even many survivors long after treatment is done.

Yet fatigue in cancer patients has been under-reported, under-diagnosed, and under-treated, according to an expert panel convened by the National Comprehensive Cancer Network (NCCN) a decade ago to recommend cancer-related fatigue treatment guidelines.

Some good news: A recent Dutch study published in the Journal of Clinical Oncology found that advanced cancer patients can get significant relief from serious fatigue, when their fatigue and other symptoms are regularly monitored and treated according to guidelines.

Some less good news: A small U.S. study published in Support Care Cancer found that even at an excellent cancer center, most metastatic cancer patients did not get any of the recommended treatments for even severe fatigue. Read the rest of this entry »

This past year has brought remarkable scientific advances in the understanding of colorectal cancer (CRC), and—as usual with science—opened up even more questions to be answered in 2013 and beyond. Here are just a few highlights:

Your BODY: Peering inside cells

In 2012, scientists penetrated deeper inside cells to better understand why and how normal cells become cancerous and spread (metastasize) through the body.

(1)   For the first time ever, 150 researchers with the Cancer Genome Atlas Project—a collaboration of dozens of U.S. institutions–mapped the entire genome for each of 250 different colorectal cancers. Instead of just looking for specific mutated genes, they mapped literally the entire DNA package of 3.5 billion pairs of the 4-letter genetic “alphabet” contained in each cancer sample.

1. One surprise was that colon and rectal cancer are genetically virtually indistinguishable, putting to rest a long-held theory that rectal and colon cancers are somehow different.
2. By comparing cancer cell genomes to normal cells, they identified 24 separate genes involved with colorectal cancer—including 3 new genes. They also identified two other “over-active” genes directing cell proliferation, as well as changes in three different “signaling pathways” that turn genes on or off during cell growth.

(2)   A month later, a 9-year international collaboration called ENCODE (the Encyclopedia of DNA Elements) simultaneously published a blizzard of 30 journal articles, summarizing their findings about how at least four million gene switches can flick genes on and off, or, like an electric outlet dimmer, work together to turn genes up or down. Previously, scientists have only understood about how approximately 3% of DNA matter is normally active in directing cell functions. By analyzing data from 1,600 sets of standardized experiments using the equivalent of 300 years of lightning-fast computer analyses on more than 15 trillion bytes of raw data, scientists took a giant leap forward in understanding how the other 97% of the human genome (previously nicknamed DNA “dark matter”) might explain why many diseases appear.

Both major advances will not only help researchers find new treatments and tests for individual cancers, but they also might begin to explain how non-genetic factors like diet or exercise could affect whether cancer begins, recurs, or spreads.

Your LIFESTYLE: Population studies reveal roles of diet, exercise, aspirin,

While some scientists peered deep into cells, others looked at patterns in whole populations of people who have and don’t have colorectal cancer.

1. More than half of all cancers could be prevented, a researcher told the International Cancer Control (UICC) World Cancer Congress 2012 , if only people actually followed the lifestyle recommendations and screening or other interventions that we already know prevent cancer, including and perhaps especially colorectal cancer.
2. Researchers from Dana-Farber Cancer Institute found that those who consistently ate a high-carbohydrate, sugar-laden diet appeared to have markedly higher recurrence rates  of their disease than patients whose diets were more varied and contained less-sugar.
3. More studies in 2012 strengthened the evidence that daily exercise is closely related to a better quality of life for those having and recovering from CRC, and start regular, moderate exercise is associated with a significantly lower risk of recurrence.
4. In 2012, studies showed people who take low-dose aspirin—especially those with Lynch syndrome—show lower rates of having colorectal cancer recur.

Your TREATMENT: Two new drugs for metastatic CRC, and a cost challenge

For the first time since 2006, two new drugs—Zaltrap (ziv-aflibercept)  and Stivarga (regorafenib) were approved by the FDA to treat metastatic colorectal cancer which has progressed despite other chemotherapy.

The oncology world was a bit stunned in September 2012, when leaders of the world-renowned Sloan-Kettering Cancer Center in New York City publicly announced they would not use the latest new drug (Zaltrap) because it was no more effective but priced twice as high as Stivarga. The makers of Zaltrap subsequently announced a 50% discount in the price . However, that discount may not immediately apply to patients themselves, so Fight Colorectal Cancer staff remain closely involved in discussions with the FDA and others.

Your COSTS: Drug shortages, grey-markets, fake Avastin, screening coverage

1. Fight Colorectal Cancer’s Kate Murphy closely followed crucial shortages in CRC treatment drugs in early 2012, as well as a developing “grey market” where those drugs were sold for exorbitant prices, and even the appearance of fake Avastin in the U.S. briefly during the spring of 2012. Leucovorin remains on the FDA’s list of drugs in short supply as 2012 ends.
2. Also in 2012, Fight Colorectal Cancer worked with Kaiser Family Foundation and other cancer organizations to provide a detailed report to Congress  investigating the problem of patients being billed unexpectedly for costs of screening colonoscopies when polyps are removed.

We at Fight Colorectal Cancer know—and our advocates continually tell their families, communities, and legislators—that the very best way to stop colorectal cancer in its tracks is to never let it get started.

Our Future: The greatest hope of all is prevention and early detection

• In March 2012, Kate Murphy reported on the first definitive study to prove that colonoscopy and polyp removal reduce deaths from colorectal cancer : In a large followup of the National Polyp Study, people who had adenomas removed—the risky kind of polyps—were half as likely to die from colon or rectal cancer than  the general US population.
• In its annual summary and budget discussion for 2012-2013, the National Cancer Institute wrote, “Through molecular, epidemiologic, and mathematical studies of colorectal cancer… we now know that…a death from colorectal cancer today will most likely occur because the cancer or its precursor adenoma was not detected during the preceding 27 years.”

Forward into 2013

Science will drive us forward in 2013. Facts show that African Americans get colorectal cancer, and die from it, more often than other groups: We need to reach those populations with better screening. We know that the majority of people at risk for having Lynch syndrome—with its multiple cancers—don’t know they’re at risk, and we must help find and educate those families.

Even as we celebrate the enormous scientific strides forward in 2012, we could lose all momentum and years of invaluable work if we allow cancer research funding to dry up.  And so we keep fighting:

1. Fight Colorectal Cancer has given its first-ever two-year Lisa Fund grant to a young researcher whose laboratory is using a whole new method of quickly testing different treatments for metastatic colorectal cancer.
2.  We are training, as we speak, a whole new class of Research Advocates to take the patient’s voice and perspective to the decision-makers in research programs and funding. These 20 new advocates will be stepping into the shoes of two deeply respected advocates whom we lost in 2012: Pat Steer and also Kate Murphy, the founder of this Research News blog.

Here’s part of what Kate wrote last New Year’s Eve. Her words still ring as true as ever:

* Come to Call-on Congress and make sure that programs and funding for colorectal cancer prevention and research are strong and growing.

* Do one last, very important thing: Make a gift to Fight Colorectal Cancer and ensure that our programs and research grants continue until we end suffering and death from colon and rectal cancer.

Here’s to “Another year, full of hope and promises.”