Moving on, fighting on

last of six chapters Patients sustained by hope

doctor readies next study of cancer vaccine

October 17, 2008|By Articles by Stephanie Desmon | Articles by Stephanie Desmon,stephanie.desmon@baltsun.com and chiaki.kawajiri@baltsun.com

Dr. Leisha Emens dreads the calls she has been getting lately. The news is rarely good. "A lot of people are dying right now. It's to be expected. These people have an incurable disease," Emens says in late August, as she wraps up her early work running clinical trials of an experimental breast cancer vaccine.

Anita, who received the vaccine last year, has just died. Two more women whose breast cancer seemed to disappear after receiving the vaccine have had their disease return. No one would blame Emens if she felt like what she has worked for is slipping away.

But then the Johns Hopkins oncologist remembers all she has learned, all of the data she has collected, all of the blood she has tested, all of the apparent victories. Her vaccine, designed to train the immune system to attack breast cancer, is safe for humans. It has elicited immune responses in more than one-third of the women who have received it.

And, even though she can't prove the vaccine is responsible, many of the women have experienced a quality of life they might not have had otherwise with Stage IV breast cancer, a disease that often spells death within a year or two of diagnosis.

"What's that worth? It's worth a lot actually," Emens says. "You have to redefine what your idea of success is. It's making a difference one person at a time. There's a lot to be said for that."

For the doctor, who doesn't promise a cure, these trials are just the first step in a process that may take years or even decades to complete. Every step must be taken deliberately, each one building upon the last.

For the patients it may be the one slim chance left for a cure. They don't have years or decades.

Yet it is time for Emens to shift some of her attention, even as her patients grapple with the present. She is writing a paper to explain what she learned from her first 28 patients. She is still recruiting women for her second trial. There is still so much more to learn and each step in the process takes so long.

By November, she hopes to have the approvals she needs from Hopkins and the Food and Drug Administration to start recruiting volunteers for the next stage of her science. If all goes according to plan, Emens will enroll not only women with advanced cancer, as she did in the first two trials, but also women with an aggressive early-stage breast cancer, adding a vaccine to standard treatment in hopes it will keep the disease from returning. She is also writing grant proposals and protocols for a fourth trial. It cannot be done unless she finds the money.

Meanwhile, in a freezer not far from her laboratory sit the many vials and syringes of blood she has collected from the participants in the first two trials. Perhaps she and her staff will discover unknown breast cancer proteins in there, something that could lead to new targets to attack with new drugs.In the four years since Emens began her first trial, there have been some apparent victories, women who have not only lived beyond the typical one to two years, but have lived well. Often, metastatic cancer patients don't. Their days can be marked by chemotherapy that makes them too sick to enjoy their remaining time, or by severe pain treated with medications that cloud their minds.

True believer in the vaccine

Susan Kristoff got her first vaccination in January 2007. When she met Emens, Kristoff could barely walk because of the cancer in her hip. Soon the South Florida woman was getting around without pain. Then, scans showed she no longer had active cancer.

But, in late August, the cancer was back.

She is still a true believer in the vaccine. She thinks the women in the trials just need a booster shot to keep the immune system revved up. Boosters are not part of the trial. Emens says she is not ready to research a booster until she knows more about how the vaccine has worked.

"In my gut and my heart, I know that I would be fine indefinitely if I got the booster, " said the 46-year-old Kristoff. "I had a really, really fast reaction to the vaccine. I'm 100 percent confident in the vaccine."

She has been taking a combination of anti-cancer medications in recent weeks and is showing some improvement. Her next move is to find another vaccine trial. Already comfortable in the role of pioneer, she is ready to do it again.

Doing better?

Annie Siple spent months traveling from her Orlando-area home to Baltimore hoping the vaccine would save her life. After she was told in July that the vaccine had failed to contain her cancer, she went into crisis mode. In the following weeks, she flew to Houston, to Philadelphia, to Boca Raton, Fla., running up thousands of dollars on her credit cards in search of a doctor who would appeal to her determination to live through alternative therapy.

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