SERIOUS SIDE EFFECTS MORE LIKELY WITH NEW CANCER DRUGS

NEW YORK (Reuters Health) Jul 19 - Many new cancer drugs may come at a price -- including a higher risk of diarrhea, skin problems, and hypertension, according to an analysis of randomized controlled trials used for drug registration.

Canadian researchers used reports on 38 cancer drugs reviewed and approved by the U.S. Food and Drug Administration between 2000 and 2010. Those included medications to treat colon, breast, and lung cancers.

The study showed the newer cancer drugs caused significantly more side effects, and more treatment-related deaths, than their older counterparts.

"You've got to consider both efficacy and toxicity in the picture," said Dr. Susan Ellenberg, from the University of Pennsylvania's Perelman School of Medicine in Philadelphia.

"People are willing to accept a certain amount of excess toxicity if they think it's going to increase the chance of having their cancer cured," Dr. Ellenberg, who wasn't involved in the new study, told Reuters Health. "But that's not always true -- it really depends on what the toxicity is."

Dr. Eitan Amir from Princess Margaret Hospital in Toronto and his colleagues consulted toxicity information from new drug labels and clinical trials.

Those drugs included bevacizumab, docetaxel, and sunitinib. Studies had between 266 and 1,725 cancer patients each.

The researchers found cancer patients who were randomly assigned to the newer drugs were 40% more likely to die from a side effect than those in comparison groups, who were typically treated with the current standard of care at the time or a placebo.

Still, less than 1% had a treatment-related death.

The number of patients who stopped taking a drug because of side effects ranged from less than 1% to 7%.

Patients in the newer treatment groups were 52% more likely to have a range of severe to possibly life-threatening side effects, from nerve damage to heart problems.

And ten out of 12 of the drug-related problems Dr. Amir's team tracked were more common among people treated with the drugs under examination, according to findings published July 16 in the Journal of Clinical Oncology.

"Overall, at least we can say from clinical trial patients that the benefit (of these drugs) is more than the risks," said Dr. Shenhong Wu, an oncologist from Stony Brook University School of Medicine in New York, who wasn't involved in the new study.

But, "In the real world, patients are complicated; they have all kinds of issues. So the benefits and risks may be different," Dr. Wu said.

Dr. Amir told Reuters Health that when patients and their doctors are discussing starting a new treatment, doctors should take into account a patient's overall health, and not just the cancer.

"These are all drugs which improve outcomes, certainly of cancer, and overall survival," he said. "The only thing we're trying to highlight is, it's not as if you're getting anything for free."

SOURCE: http://bit.ly/NkT4K3

J Clin Oncol, 2012.