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Cancer patients with advanced disease should have access to palliative care early on in their illness, according to new guidelines from the American Society of Clinical Oncology.

That doesn’t mean oncologists are being encouraged to give up on extending the lives of those patients, says Thomas Smith, an author of the guidance and director of palliative care for Johns Hopkins Medicine and a professor of palliative care in the Hopkins School of Medicine’s oncology department.

Rather, the guidelines recommend combining palliative care — open and honest communication about the progress of the disease and the patient’s wishes, medical appropriate goal-setting and careful attention to symptom management — with standard oncology care, says Smith. (The “provisional clinical opinion” is published online by the Journal of Clinical Oncology.)

Practically, that would mean patients would still receive whatever treatments were likely to help fight their disease. But they’d also get help from a palliative care team trained in having tough conversations about prognosis, quality of life and death.

“It’s not hard for oncologists to tell who can be cured and who can’t,” says Smith. “But it’s hard to sit down and explain to people what will happen to them, and to have a discussion about how that person wants to spend their last weeks, months and years of life,” he says.

There aren’t a huge number of large randomized clinical trials on which to base recommendations for palliative care, says Smith; the area is not particularly well funded.

But one study that did get a lot of attention, published in the New England Journal of Medicine in 2010, found that advanced lung-cancer patients who were randomly assigned to receiving early palliative care in conjunction with standard care not only reported better quality of life, but lived a few months longer than patients receiving only standard care.

What comes through “loud and clear” from the available research is that there’s no harm in incorporating palliative care early on with patients with metastatic disease, says Smith. Patients tend to have their pain and symptoms better managed, to have a better understanding of their illness, and to receive more medically appropriate care, he says. Research also shows they and their family members are less likely to be depressed.

The statement from ASCO says that more research is necessary to figure out the best timing and venue for providing palliative care, to evaluate reimbursement models and to gauge the effectiveness of various components, among other things.

Bonus: ASCO: How to Talk About End-of-Life-Care With Cancer Patients

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“I wouldn’t hesitate to sue you.”

I’m sorry, what?

That is what I heard from the mother of one of my patients. I was evaluating a high school athlete who had recurrent stingers (nerve injury that affects an upper limb, usually resolves with time) and a possible episode of transient quadriparesis (affecting all limbs this time). I wasn’t on the sidelines for these injuries, so I had to go on the reports given to me by the athlete and the school’s athletic trainer.

Read the rest of The fear of malpractice will always be in the back of my mind on KevinMD.com.

Category: Physician | Tags: Malpractice | 5 comments

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The Food and Drug Administration questioned the clinical benefit of using Amgen’s bone drug Xgeva to prevent or delay the spread of prostate cancer to the bones.

Xgeva is currently approved to delay fractures and other bone injuries in patients whose cancers have already spread to the bones.

The company is seeking approval for use of Xgeva to prevent the spread of prostate cancer in a group of men that has not responded to other therapies.

Xgeva will be reviewed Wednesday by the FDA’s oncologic drugs advisory committee, which is made up of non-FDA medical experts. The FDA today posted a review of Xgeva in preparation for the meeting.

Amgen conducted a study of Xgeva in 1432 men with prostate cancer that had not responded to previous therapies, but had not spread to the bones. Many types of cancer spread to the bones and cause tumors to grow, destroying the bone around the tumor, causing fractures and other problems.

Half of the men were treated with Xgeva while the other half received a placebo. The study examined the time until men developed bone metastases or died, whichever occurred first. The study showed Xgeva prolonged median bone metastatis-free survival by 4.2 months compared to men in the placebo group.

While the FDA said the study met its primary objective, the agency said it was unclear whether the results were “clinically meaningful” given that there was no difference in overall survival between the two patient groups. The agency said the risk-benefit ratio of Xgeva must also take into account the overall toxicity of the drug. One of the side-effects includes a risk of developing osteonecrosis of the jaw, or ONJ, a rare jaw-decay problem.

Michael Severino, Amgen’s vice president of research and development, said today that the company believes Xgeva does provide a clinically meaningful benefit because it delays the spread of cancer to the bone, which causes significant pain and other problems such as incontinence.

Xgeva is also sold under the brand name Prolia as an osteoporosis treatment but is administered at a lower dose and less often than used to treat cancer-related bone complications. Xgeva and Prolia’s combined sales in 2011 topped $550 million. The drugs target a protein called RANK Ligand, which helps regulate cells called osteoclasts that break down bone.

(This post originally ran on Dow Jones Newswires.)

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