Specialists question decision not to fund drugs for kidney cancer· Advisory body says treatment too expensive. (The Guardian-25/08/2008) 

Doctors say Nice has got its sums wrong Allegra Stratton, political correspondent
The government's drug advisory body has defended its methods of assessing what cancer treatments should be offered to patients after some of the country's most eminent cancer specialists told it to "get its sums right". The National Institute for Health and Clinical Excellence (Nice) issued a statement at the weekend explaining its methodology after 26 oncologists - including the directors of oncology at two of Britain's biggest cancer hospitals - wrote to the Sunday Times and called for "radical change" in the way Nice makes its decisions. The oncologists were reacting to a decision by Nice this month not to give the go-ahead to four drugs that slow the progress of kidney cancer but do not cure it. The oncologists said Nice assessed cancer treatment "poorly" and its economic formulas were "not suitable", with often traumatic effects. The letter said: "We have seen distraught patients remortgaging their houses, giving up pensions and selling their cars to buy drugs that are freely available to those using health services in countries of comparable wealth." The specialists challenged Nice to explain what they saw as a discrepancy between the UK and European countries that spend as much on healthcare but, on average, a third more on cancer drugs.

Reacting to the oncologists' attack, the chief executive of Nice, Andrew Dillon, said the oncologists were wrong and questioned the research their argument was based on. He said that in the last nine years Nice had appraised 56 anti-cancer drugs and given the go-ahead to 52. Nice said this month that it would not approve four drugs, Sutent, Avastin, Nexavar and Torisel, which help to delay the progress of renal cancer (pictured) by up to six months. Advanced renal cancer is diagnosed in around 3,600 people a year. Nice makes such decisions by measuring what it calls quality-adjusted life years (Qalys) - the cost of securing an extra year of healthy life by providing new medicine. Nice's clinical director, Professor Peter Littlejohns, ruled that the cost of the four drugs was, in terms of Qalys, six times too high. The normal NHS limit is about £30,000 a patient per quality-adjusted year.  In his letter to the oncologists, Dillon underscored what he thought to be the impartial nature of Nice's appraisal committee. He said: "The provisional conclusions on the use of drugs for treating renal cancer are those of an independent appraisal committee whose membership is largely drawn from NHS clinicians in active practice. They understand the issues at stake; they themselves are often involved with the care of patients with cancer; but they are also involved in the day-to-day care of patients with other conditions, many as distressing." Dillon challenged the cancer specialists to decide which other treatments should be sacrificed. He said: "To maintain the credibility of their argument, they need to explain which patients - with other diseases - should forgo cost effective care in order to meet the needs of those with renal cancer. 

"There is a finite pot of money for the NHS. If one group of patients is provided with cost ineffective care, other groups - lacking powerful lobbyists - will be denied cost effective care for miserable conditions like schizophrenia, Crohn's disease or cystic fibrosis." Kevin Barron, a Labour MP who chairs the Commons health select committee, defended Nice, saying the NHS was not a "bottomless pit" and someone had to make difficult decisions about the cost of drugs. He said: "Nice is doing it better than what we had 10 years ago which was clinicians making the decisions." He added that Nice even appeared to be forcing some pharmaceutical companies to look at their prices. "Two out of the five big pharmaceutical companies are allegedly looking into their pricing and if they are prepared to go back and look at the cost of their drugs - to make them more cost effective - then I welcome that." This week patients from the Kidney Cancer Support Network will stage a protest outside the London offices of Nice.

New drug prolongs survival of advanced kidney cancer (Reuters Health-23/07/2008)

Treatment with everolimus can significantly improve the progression-free survival of patients with advanced kidney cancer that has not responded to other treatments, according to a report in the online issue of The Lancet. This finding stems from a study of 410 patients with kidney cancer that had spread, or "metastasized," to other parts of the body, despite treatment with sunitinib, sorafenib or both drugs. The patients were randomly assigned to receive everolimus once a day or placebo, in addition to supportive care. Everolimus has already been approved by the U.S. Food and Drug Administration under the trade name Certican for preventing organ rejection after a heart transplant. Approval as a cancer drug would widely expand the use of this agent. Lead author Dr. Robert J. Motzer, from Sloan-Kettering Cancer Center in New York, and colleagues, initially planned to stop the study after 290 events occurred that indicated disease progression, but an interim analysis showed a clear advantage with everolimus therapy, so the trial was terminated after 191 events. Overall, the rate of cancer progression in the everolimus group was 37 percent compared with 65 percent in the placebo group, a statistically significant difference. The average progression-free survival time was 4.0 months for the everolimus group and 1.9 months for the placebo group.

Mouth sores, rash and fatigue were more common in the everolimus group than in the placebo group, but were usually of mild or moderate severity, the researchers note. Twenty-two patients (8 percent) in the everolimus group developed inflammation of the lung, which became moderately severe in eight patients. In a related editorial, Dr. Jennifer J. Knox, from the University of Toronto, comments that these study data support the choice of this treatment design for patients with advanced kidney cell cancer. "I would encourage international regulatory boards to accept these data as evidence of clinical benefit."

Health Canada warns of anemia in kidney cancer drug interaction (Yahoo NEws- 11/07/2008)

Health Canada is warning doctors and cancer patients about the use of Avastin in combination with another drug, Sutent (sunitinib malate), to treat kidney cancer. Hoffmann-LaRoche Ltd., makers of Avastin, has informed Health Canada of safety concerns over a rare type of anemia associated with the drug interaction. The drug-maker says about a third of the advanced kidney cancer patients taking both drugs in a U.S. study developed the anemia. Patients also experienced common side effects separately associated with each drug more often when the two were used in combination. Avastin is approved for use with other drugs to treat cancer of the bowel and rectum that has spread, but is not approved for use in kidney cancers or in conjunction with sunitinib malate. 

Kidney cancer vaccine falls short in clinical trial (Yahoo News-3/07/2008)

A new kidney cancer vaccine failed in last-phase clinical trials to improve the odds of avoiding remission after tumour-removing surgery, according to a study released Friday. A team of researchers led by Christopher Wood of the Anderson Cancer Center in Houston, Texas gave the vaccine, called vitespen, to 409 patients whose cancerous tumours had been removed. They then compared the relapse and survival rates to a second group that received no additional treatment. The difference in outcomes was statistically insignificant, reported the study, published in the British journal The Lancet. A large number of renal cancel patients relapse after surgery, earlier research has shown. When this happens, it is lethal -- there is no cure for metastatic kidney cancer. The new vaccine was designed to help prevent such remissions. There were more than 200,000 new cases of kidney cancer worldwide in 2004, and just over 100,000 deaths, according to the International Agency for Research on Cancer. Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for about 85 percent of all kidney tumours. The study also showed that a subset of patients with early stages of the disease who had been given vitespin fared marginally better than a control group, but said further trials were needed to verify these results. In a sharply-worded comment, also published in The Lancet, James Yang of the National Cancer Institute of Bethesda, Maryland chided vaccine manufacturers which "cannot accept the results of randomised trials" that do not meet their expectations. Selectively highlighting partial findings weakens the credibility of the nascent field of cancer immunotherapy, he said.

Kidney cancer in U.S. being caught earlier (Reuters Health-19/05/2008)

 Most cases of the commonest form of kidney cancer, renal cell carcinoma, in the US are now more likely than ever to be detected at stage I of the disease, an analysis of the National Cancer Data Base shows. "The study also reveals a small but significantly higher survival rate for recently diagnosed kidney cancers. This is good news for the more than 50,000 kidney cancer patients who will be identified this year," Dr. Christopher J. Kane, from UC San Diego Medical Center in California, said in a statement. Kane's team examined the patterns of cancer detection and outcomes among 205,963 patients who were diagnosed with renal cell carcinoma from 1993 to 2004. As the years progressed, a rise in cases of stage I disease was seen, while cases of stage II, III, and IV disease dropped off, according to the report in the medical journal Cancer. The average size of stage I tumors at the time of diagnosis also shrunk during the study. In 1993, the average tumor diameter was 4.1 centimeters, while in 2003, it was 3.6 centimeters. The researchers found that patients diagnosed in 1998 had a 3.3% increase in survival compared to those diagnosed in 1993. Kane chalks these trends up to increased use of medical imaging. "What we are seeing is that gynecologic or abdominal imaging to evaluate pain or other complaints is picking up other forms of disease such as kidney cancer," he explained. "The increased and widespread use of medical imaging in the United States is helping to diagnose cancer in its non-symptomatic stages when it is easier to treat successfully."

Everolimus drug may delay kidney cancer progression (Washington News-17/05/2008)

 A new study from Memorial Sloan-Kettering Cancer Centre suggests that experimental targeted therapy everolimus (RAD001) can considerably delay cancer progression in patients with metastatic kidney cancer. The study led by Dr Robert Motzer, an attending physician at Memorial Sloan-Kettering Cancer Centre (MSKCC) revealed that Everolimus, a once-daily oral therapy may inhibit cancer progression in kidney. "This study has given us a new and clearly useful tool for treating renal cell tumours, and everolimus is an important step forward in terms of disease management and quality of life for patients living with this disease," said Dr. Motzer.  The drug targets mTOR protein, which acts as a central regulator of tumour cell division, cell metabolism, and blood vessel growth.  The researchers conducted the study on more than 400 patients with the disease that had progressed with currently available targeted therapies sunitinib and/or sorafenib. They were randomly given everolimus or placebo. 

The findings revealed that after six months, 26 percent of patients in the everolimus group had disease that had not progressed, compared to only 2 percent of the placebo group. The average difference in progression free survival was four months for everolimus, compared to 1.9 months for the placebo group. "For almost 20 years, we made no headway in the management of advanced kidney cancer," said Dr. Motzer. "Recently, the identification of several new angiogenesis- targeted agents has provided us with new treatment options and an improved outlook for patients with advanced kidney cancer. "Based on the results of this trial, everolimus could become another tool in our armamentarium and, in the future, kidney cancer is likely to be managed as a chronic disease with these types of treatment advances," he added. The findings will be presented on May 31 at the annual meeting of the American Society for Clinical Oncology.