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 vaccineSusan 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.
She is now on leave from her very physical job as a waitress at a restaurant at Walt Disney World's Animal Kingdom and living on a dairy-free, meat-free diet. Every three weeks she flies to Chicago for chemotherapy at the Block Institute for Integrative Cancer Care. The medication is given at specific times of the day based on "when DNA is most active," she explained. The goal, according to the center, is to cut down on the toxic side effects of chemotherapy.
At home, Siple spends up to six hours a day using several contraptions she believes will make her well. One looks like a pair of sun lamps. She says it uses audio frequencies to detoxify her body and open its energy pathways. Another looks like a giant lightbulb that Siple holds over her liver. She says it restores energy that the frequencies take away. A third machine operates on even higher frequencies. She uses it while sitting with each foot in a metal lasagna pan filled with water. It is all to make her body an inhospitable place for cancer to hide.
Siple, 43, has four tumors in her liver. In July a spot was found on a lymph node near her spine. But in late September she got a different kind of news - the good kind. The tumor markers in her blood, which had been over 3,000, were down to 400. Tests of liver function, which had been at dangerously low levels, were nearing normal. And this month, scans showed her tumors have started to shrink.
"When I visualize," she said yesterday, "I think of the vaccine still working in my body."
Still fightingPeggy Murphy's chemotherapy treatments began in July, but the port that was implanted to make the process easier never worked correctly. Surgeons had to remove it in August after it became infected. Murphy, whose longtime companion, Alan R. Craig, regularly drives her to Hopkins from her home near Lancaster, Pa., spent much of the summer in and out of hospital emergency rooms complaining of horrible pain, at times spitting up bile. She's taking large doses of Oxycodone. She's often emotional and forgetful.
In September, Murphy's doctors told her the chemo wasn't doing the job. Her entire spine was showing signs of cancer. She switched to a chemotherapy drug administered in pill form, which left her unable to keep anything down. She lost 15 pounds. Doctors recently adjusted the dosage to reduce the side effects.
The pain in her side that sometimes leaves her unable to sleep turned out to be from cracks in ribs weakened by the cancer. When those heal, she hopes to be in less pain. Meanwhile, her son is helping her search for a new clinical trial.
She is not done fighting.
No concernsAfter hearing from Emens that her scans looked good, 38-year-old Darby Steadman took off on vacation with her two elementary-school-age children and her high-school-sweetheart husband. She visited friends in Atlanta, went to Boca Raton, Fla., and stayed in a beach house on St. Simons Island in Georgia that belongs to another woman in the trial. Steadman still must get the cancer drug Herceptin intravenously every three weeks to tackle the cancer remaining in her lymph nodes and spine. But she earned a two-month reprieve from Hopkins. Her fourth round of vaccine injections is scheduled for Oct. 28.
As the school year began, Steadman relished her new role as simply a mom and not a cancer patient. But over Labor Day weekend, while at a Christian family camp, Steadman fell off a zip-line. She broke her right ankle, which required surgery to repair. She can't drive. She can't go for walks in the neighborhood with her friends. She became a patient once again.
Emens' phone rang in late August. It was Susan Marangi, whose cancer had been in check even longer than Kristoff's. Marangi had been admitted to Mercy Medical Center after her back went out and the pain became too much to bear.
Because of her medical history, doctors ordered bone scans. The good news: the pain was from a compressed disc and some arthritis, not the cancer. The bad news: her bones were lighting up.
The cancer, they told her, had returned.
She tried to hide how she felt, but she was devastated. "We all knew this was an experiment," she said the day after she got the report. "It will work in somebody. I'm not throwing in the towel right now."
Emens found a way to squeeze Marangi into her schedule. The doctor wanted to see the scans herself.
Marangi's cancer has always been a slow-growing sort. She is, after all, alive 20 years after her diagnosis. But Emens agreed with the Mercy doctors. The cancer was back, she said, if only in a few small spots on the spine. It would also turn out Marangi's back pain was related to the cancer. The disease had weakened the bones and caused one of her vertebrae to fracture.
Emens changed Marangi's medicine and told her they would have to watch her more closely. But, the doctor told her patient, "There's nothing to be concerned about."
Those reassuring words are the ones Marangi heard the loudest. She was ecstatic. Those weeks of grieving for herself, of mentally preparing for an imminent end, seemed over.
"Do I need to give my dogs away and put my house on the market?" she asked Emens.
"Sue," the doctor replied, "you're not going anywhere."
more on the seriesOnline at baltimoresun.com/vaccine:
Watch a video of Annie Siple discussing her personal approach to the vaccine and breast cancer, and find more photos, videos and previous installments of the series at baltimoresun.com/vaccine