Today the Lance Armstrong Foundation (LAF) announced outstanding new commitments to cancer control from European nations including Belgium, England, Germany, Ireland and Italy as part of the LIVESTRONG Global Cancer Campaign, an initiative to address the global cancer burden. The European commitments feature ambitious goals ranging from creating a national cancer plan to addressing disparities in treatment for cancer survivors to establishing an academy devoted entirely to cancer to improvements for breast health services, among others.

Across Europe there will be more than 3.4 million cases of cancer diagnosed in 2009 and more than 1.8 million deaths. Lung cancer is the most common cancer in men followed by prostate and colorectal cancer. Breast cancer is the most common cancer in women with approximately 450,000 new cases a year and the number one cause of cancer-related death in European women claiming approximately 150,000 lives.

“The commitments being made to cancer control in Europe are awe inspiring,” said Doug Ulman, LAF President and CEO. “They are great examples of the progress we can accomplish when innovative ideas are well executed with the right support and resources.”

Alexander Eggermont, President of the European CanCer Organization (ECCO) headquartered in Brussels, Belgium, is committing to create a stronger, more unified approach to cancer health and research policy by establishing a European Academy of Cancer Sciences in September, 2009. Twenty-five years ago, ECCO was founded on the vision that tackling cancer requires a coordinated effort, a new concept at the time which is now broadly accepted. ECCO supports taking a wider approach to oncology - one that will bring together major players in cancer research, treatment and care in order to create awareness of survivors’ wishes and needs; encourage progressive thinking in cancer policy, education and training; and will continue to promote European cancer research.

Jon Spiers, an employee at Cancer Research UK in London, England, the largest funder of cancer research in Europe, says the goals his organization has created will link its vision to the progress being made and the impact it hopes to have in the next 10 years and beyond. Cancer Research UK, which receives nearly all its funding from the general public, allowing it to study more than 1 million cancer patients and support more than 100 clinical trials, is tackling major initiatives with outcomes expected to have significant impact on cancer control in the UK. Those initiatives will: make 75 percent of the UK public aware of lifestyle choices that reduce their risk of cancer; reduce the number of smokers by four million adults, preventing thousands of new diagnoses each year; lead to early diagnosis among two-thirds of all cancer cases, increasing chances for successful treatment; provide a detailed understanding of the causes and changes in the body in two-thirds of all cancer cases; reduce the disparities in mortality rates between the rich and poor by half, and give nine out of ten survivors the access to critical information they need at the time of diagnosis and during treatment.

Jan Geissler, CEO of the European Cancer Patient Coalition (ECPC) headquartered in Riemerling, Germany, outlines ECPC’s commitment aims to protect and promote the fundamental rights of European cancer patients: increase cancer survivors’ influence over the policies that affect them on a daily basis; demand timely access to appropriate prevention, screening and treatment; and promote the advancement of cancer research. ECPC’s ultimate goal is to empower patients to become true partners in the healthcare system.

“Each year there are more than 2.2 million new cases and more than 1.1 million cancer deaths in the EU 25,” Geissler said. “There is a lot to do to make sure all citizens can access appropriate prevention, early detection, diagnosis, treatment and care across the EU.”

Christine Murphy-Whyte, board member of Europa Donna Ireland (EDI) in Dublin, Ireland, explained her organization is committed to raising the voice of the breast cancer survivors, patients and their affected family and friends through several initiatives. They plan to launch two campaigns - one a breast health media campaign that highlights behaviours to avoid in order to reduce rates of breast cancer, and another for health policy changes, with a focus on the need for specialized breast health centres that provide screenings, treatment and care. In addition, they will connect women in disadvantaged areas of Ireland to breast health services and will host the second annual Breast Health Day on October 15, 2009, with this year’s focus on the importance of exercise.

Murphy-Whyte said, “”The voices of women in Ireland have been instrumental in pushing for change, including the voices of women, sadly no longer with us, who fell victim to outmoded practices and failure to benefit from the best that medical science has to offer.”

Francesco De Lorenzo, founder of the Federation of Volunteer-Based Cancer Organizations (FAVO) in Rome, Italy, outlined the goals of his commitment, which include ensuring the approval of the National Cancer Plan by winter 2009; addressing the rehabilitation inequalities given to cancer survivors, especially among the poorer, southern populations; increasing up to 90% of people who have access to breast, colon and cervix cancer screenings and improve the impact cancer survivors have on health policy at the national and European level.

De Lorenzo said, “The approval of the National Cancer Plan will improve prevention, care and treatments, as well as rehabilitation of all cancer patients all over the country.”

These advocates will join 250 attendees representing more than 60 countries around the world in an unprecedented show of solidarity against the global cancer epidemic at the LIVESTRONG Global Cancer Summit in Dublin, Ireland, August 24 - 26. The Summit will make the case for urgent action to address the global cancer burden and introduce new commitments for cancer control by bringing together key stakeholders from all parts of the world. The LIVESTRONG Global Cancer Summit will ignite a unified global movement while providing attendees the opportunity to connect with other advocates, network, gain media exposure and access tools and resources to help them mobilize in their own communities. Speakers include honorary Summit chair and former Irish President Mary Robinson, Irish Cancer Chief Professor Tom Keane, CNN chief medical correspondent Dr. Sanjay Gupta, as well as representatives from the World Health Organization and other global bodies.

In September 2008, Lance Armstrong, LAF founder and chairman, cancer survivor and champion cyclist, announced the Foundation’s commitment to making cancer a global priority at the Clinton Global Initiative Annual Meeting in New York. The LAF made this commitment after its worldwide research, conducted over 18 months, revealed widespread misconceptions, stigma and lack of awareness associated with cancer. In response, the LAF established the LIVESTRONG Global Cancer Campaign to urgently address the burden of cancer worldwide and support the 28 million people living with cancer around the globe. Cancer kills more people every year than AIDS, tuberculosis and malaria combined. It is estimated that cancer will be the leading cause of death worldwide by 2010. With such staggering statistics, the LAF recognized that a global challenge like cancer required a global movement. And so it began urging world leaders, leading cancer organizations and cancer survivors to join together by making commitments to take action in their communities to reduce the burden of cancer.

Source
The LIVESTRONG Global Cancer Campaign
Lance Armstrong Foundation

RIDGEWOOD, N.J., June 29 — Patients with early-stage colon cancer who develop recurrences after primary surgery can derive similar benefits from intensive postoperative surveillance — including improved survival — as patients with late-stage disease, a new study found.

• Explain to interested patients that close follow-up and frequent postoperative testing can improve their survival, regardless of whether their colon cancer is early or late stage.
• Also explain that many patients who develop recurrences continue to do well if they have a second surgery.
• Note that carcinoembryonic antigen testing was the most effective surveillance approach in this study.

Analysis of data from the Clinical Outcomes of Surgical Therapy (COST) trial, in which postoperative surveillance after colon cancer surgery was more intensive than is recommended by current guidelines, found that overall salvage rates following recurrence were equivalent for patients with early- and late-stage disease, at 35.9% and 37%, respectively (P=0.9), Vassiliki L. Tsikitis, MD, of the Mayo Clinic, Rochester, and colleagues reported online in the Journal of Clinical Oncology.

Follow-up in COST, which was a randomized trial comparing laparoscopic colectomy with open colectomy, included one of three surveillance modalities: carcinoembryonic antigen (CEA) testing every three months for the first year and then every six months for five years, chest radiography every six months for two years and then annually, and colonoscopy or colon radiography after one year and then every three years.

A Cochrane analysis had previously determined that colon cancer recurrence rates were not affected by intensity of follow-up, but that postrecurrence survival was superior among patients followed more intensively — presumably because of earlier detection and higher rates of second surgery.

But the Cochrane analysis did not address concerns such as which tests to use for surveillance, how often testing should be done, and, in particular, how best to treat postsurgical patients who had had early-stage disease.

So Dr. Tsikitis and colleagues undertook a secondary analysis comparing these aspects of follow-up and treatment in 537 patients with early-stage (I and IIA) colon cancer and 254 with late-stage (IIB and III) disease.

They found that during five years of follow-up, recurrences developed in 55 patients with early-stage disease and in 91 patients with late-stage disease.

The cumulative incidence of recurrence among early-stage patients was 6% (95% CI 4% to 8%) at two years and 9.5% at five years (95% CI 7% to 12%, P<0.0001).

Among late-stage patients the cumulative incidence at those time points was 23.7% (95% CI 18.7% to 29.3%) and 35.7% (95% CI 29.9% to 42.1%, P<0.0001).

Median time to recurrence was 1.8 years in early-stage patients and 1.4 years in those with late-stage disease.

Among the 55 early-stage patients who experienced a recurrence, 20 (36%) had a second surgery and a median survival of 51.2 months, compared with a median survival of 8.8 months for those who did not have a second surgery (P=0.0002).

Among the 91 late-stage patients who had a recurrence, 32 (35.2%) had a second surgery, and median survival for these patients was 35.8 months compared with 11.3 months for those who did not have a second surgery (P<0.0001).

“Our analysis of the COST trial database confirms . . . [that] roughly one third of patients who experience recurrences after primary colon cancer resection can be treated with secondary curative-intent surgery when followed intensively after primary surgery,” the investigators said.

There were no significant differences in sites of single first recurrence between early- and late-stage patients, with the liver and lung being the most common, but patients with early-stage disease were less likely to have multiple sites of recurrence (3.6%) compared with those who had late-stage disease (28.6%, P<0.001).

Method of detection of the recurrences did not differ between early- and late-stage patients, respectively:

• Carcinoembryonic antigen, 29.1% (early-stage) versus 37.4% (late-stage)
• CT scan, 23.6% versus 26.4%
• Chest x-ray, 7.3% versus 12.1%
• Colonoscopy, 12.7% versus 8.8%

A subset analysis of detection methods found that “CEA was the single most important diagnostic test to detect early recurrences and the maximum number of recurrences,” particularly during the second year, the investigators wrote.

During the second year, CEA alone identified 26 recurrences, while combined CT scan, chest x-ray, and colonoscopy detected 24.

Their analysis, the investigators said, supports the frequent use of CEA testing as a monitoring tool.

“We would encourage the three-month testing interval for at least one year, if not for two years, and agree with twice yearly values until year five of follow-up.”

Guidelines from the American College of Clinical Oncology recommend CEA testing every three months for three years, while the National Comprehensive Cancer Network advises CEA testing every three to six months for two years and then every six months to five years.

With the lung imaging approach used in COST — twice yearly chest radiography — 23.6% of lung recurrences were identified, which was greater than the 10% usually cited in the literature.

“Given that patients with isolated lung metastases often experience excellent 5-year survival rates (27% to 41%), we would recommend that patients undergo some manner of chest imaging as part of their postoperative surveillance approach,” they said.

Whether this should be radiography or CT remains uncertain and “cannot be resolved at this juncture,” they said.

The failure to determine the role of CT in surveillance is a shortcoming of the study, according to the investigators.

Another limitation of the study is the fact that the COST database was not designed to evaluate best practices for postoperative surveillance.

“Societal and economic questions” also remain regarding intensive postoperative surveillance, but “there can be little doubt that finding recurrences early brings benefit for patients of either stage,” they concluded.

COST was supported by the National Cancer Institute. The authors disclosed no conflicts of interest.

Primary source: Journal of Clinical Oncology

Source reference:

Tsikitis V, et al “Postoperative surveillance recommendations for early stage colon cancer based on results from the clinical outcomes of surgical therapy trial” J Clin Oncol 2009; DOI: 10.1200/JCO.2008.20.7050.

WHEELING, W.Va., June 29 — Studies of cancer drugs that are expected to find survival advantages of two months or less should be undertaken only if the treatment costs less than $20,000, two NIH researchers recommended.

Otherwise, the research community will waste valuable resources pursuing therapies that the healthcare system can’t afford to provide, according to Tito Fojo, MD, PhD, of the National Cancer Institute’s medical oncology division, and Christine Grady, PhD, of the NIH’s bioethics department.

“If we allow a survival advantage of 1.2 months to be worth $80,000 . . . we would need $440 billion annually — an amount nearly 100 times the budget of the National Cancer Institute — to extend by one year the life of the 550,000 Americans who die of cancer annually,” they wrote in a strongly worded commentary online in the Journal of the National Cancer Institute.

“And no one would be cured,” they added.

Drs. Fojo and Grady were addressing the conundrum posed by new drugs that provide small but genuine survival benefits but which come with staggering price tags.

They cited the example of cetuximab (Erbitux) and a 2008 study that found that one course of the drug, costing $80,000, prolonged overall survival in patients with non-small cell lung cancer by 1.2 months when added to standard chemotherapies. (See: ASCO: Cetuximab (Erbitux) Gives Extra Time to Advanced Lung Cancer Patients)

The lead investigator on that study enthused that the study established a “new standard for first-line treatment of patients with NSCLC.”

But Drs. Fojo and Grady argued that health professionals and researchers cannot ignore costs in setting treatment standards.

“What counts as a benefit in cancer treatment? How much should cost factor into deliberations? Who should decide? As oncologists, we cannot go on without answering these questions,” they wrote.

Their commentary noted that a string of studies had found only “marginal benefits” for cetuximab in colorectal cancer as well, and that other costly drugs have also shown only small survival gains.

Bevacizumab (Avastin), for example, gained FDA approval for non-small cell lung cancer on the basis of a two-month improvement in overall survival — at a cost of $90,000 for a course of treatment.

Even smaller advantages have been found for some nonbiologic targeted therapies. A course of treatment with erlotinib (Tarceva) cost nearly $16,000, but extended median survival in pancreatic cancer by just 10 days in one study.

“We must ask ourselves if the additional 10 days are a benefit,” Drs. Fojo and Grady said.

“We naturally avoid confronting the tension between not wanting to put a value on a life and having limited resources. But the spiraling cost of cancer care in particular makes this dilemma inescapable.”

They continued, “We must stop deluding ourselves into thinking that prescribing cetuximab, bevacizumab, erlotinib, or any of the other expensive chemotherapies and tests is an aberration, a temporary deviation from an otherwise reasonable cost trajectory.”

More than 90% of all new anticancer drugs receiving FDA approval in the past four years cost more than $20,000 for a 12-week course of treatment, they said.

Drs. Fojo and Grady rejected the argument that cost-benefit ratios will improve through identification of patient subgroups who are more or less likely than average to respond to a given drug.

They recommended that the insurers, pharmaceutical companies, the FDA, and other government agencies should put more emphasis on clinically rather than statistically significant benefits from new treatments.

They said the drug development and approval system should discourage large trials powered to detect tiny survival improvements, unless the associated cost is strictly limited.

The authors put the primary responsibility for devising a sensible approach on the oncologist community.

The authors called on the American Society of Clinical Oncology (ASCO) to “lead the way in engaging oncologists and the public in dialogue about what should count as a benefit.”

In recent years, they said, ASCO’s meetings have given great prominence to some studies showing marginal survival benefits, in plenary presentations and press briefings.

Such treatment suggests that ASCO endorses such small survival benefits as important and even practice-changing, Drs. Fojo and Grady argued.

In response, ASCO issued a statement saying “it will take a collective effort from all sectors to produce affordable, high-quality healthcare for all patients. ASCO recognizes the urgency of the situation, and is committed to doing its part.”

In the statement, attributed to ASCO president Douglas Blayney, MD, the organization agreed that cancer care costs are rising at unsustainable rates.

The statement also contended that “ASCO has taken a leadership role” in balancing clinical progress with affordability through such means as evidence-based practice guidelines, care-quality programs, and establishing a task force on costs of care.

“Earlier this year, we published a guide to help patients talk with their doctors about the cost of their treatments,” the statement said.

Drs. Fojo and Grady said clinicians must have the freedom to recommend against ultra-expensive therapies likely to extend life for just a few weeks.

“Oncologists should feel supported if they decide that for a given patient or group of patients, the marginal benefit is not worth the cost,” they wrote.

As part of that approach, Drs. Fojo and Grady recommended a series of policies for the oncology community, some of which go against long-standing practices:

• Anticipated treatment costs should be coupled to trial designs, such that the endpoint benefit should cost no more for a quality-adjusted life-year than renal dialysis — currently $129,000.
• Drugs that work for a particular patient subset “should be advocated, approved, and prescribed for that subset only.”
• Clinicians should not prescribe beyond FDA-approved indications — such as giving treatment-resistant or refractory patients a drug approved only as first-line therapy.
• “The all too common practice of administering a new, marginally beneficial drug to a patient with advanced cancer should be strongly discouraged. In cases where there are no further treatment options, emphasis should be first on quality of life and then cost.”
• Toxicities should receive extra scrutiny for drugs with marginal benefits.

“The current situation cannot continue,” the authors concluded. “We cannot ignore the cumulative costs of the tests and treatments we recommend and prescribe.”

The authors reported no external funding or conflicts of interest.

Primary source: Journal of the National Cancer Institute

Source reference:
Fojo T, et al “How much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question” J Natl Cancer Inst 2009; DOI: 10.1093/jnci/djp177.

Related Article(s):

• ASCO: Cetuximab (Erbitux) Gives Extra Time to Advanced Lung Cancer Patients