Dr. Diane Yamada

A Look at Issues Facing Gynecologic Oncologists

The Society of Gynecologic Oncologists (SGO) recently held its 42^nd Annual Meeting on Women’s Cancer exploring the latest breakthroughs in research and barriers that threaten optimal care.

Held in March in Orlando, Fla., the meeting featured 278 scientific presentations plus lectures, workshops, symposia and post-graduate courses focused on emerging science, clinical trials and treatment advances for those involved in the comprehensive management and prevention of women’s cancers including cervical, ovarian, vulvar, uterine and vaginal cancers.

Getting Aggressive with Ovarian Cancer

“We’re doing better, but we’re still not there, yet,” Diane Yamada, MD, a professor in the Department of Obstetrics and Gynecology and section chief for Gynecologic Oncology at the University of Chicago, stated of the fight against ovarian cancer. The SGO spokesperson said taking an aggressive stance against this quiet killer has helped improve the average survivability after diagnosis from 12-18 months in the 1970s to five years today.

“The fact of the matter is that the vast majority of the time, we find patients with ovarian cancer at an advanced stage,” she continued. “We don’t have any reliable early detection tools as of yet,” Yamada noted, adding a number of avenues are being explored to improve diagnostics. Often by the time the cancer is discovered, it has already spread. “When we talk about ‘ovarian cancer,’ we are really referring to ovarian and fallopian tube cancer and primary peritoneal cancer, also.”

The connected cancers, however, do offer some clues for innovative research lines. “The different cell types from which these cancers arise have some similarities,” Yamada said. “We know some people are genetically at greater risk to develop these cancers, but we don’t really understand yet what is the key inciting event that triggers cancer in these patients.”

What gynecologic and medical oncologists do know, however, is that they have to get tough when fighting the disease. Yamada said research has shown patients fare better with a more aggressive surgical stance, which is a different concept than treating many other types of cancers. The first step is aggressive tumor debulking to remove as much of the visible cancer as possible followed by chemotherapy, to which ovarian cancer is usually very sensitive. When patients can tolerate the assertive treatment regimen, they tend to go into remission for longer periods of time.

“How you get the chemotherapy matters, too,” Yamada continued. She said several studies that have come out over the last few years suggest receiving weekly doses of chemotherapy is preferable to the more standard dosing of once every three weeks. Researchers, she continued, have found that intraperitoneal chemotherapy also improves outcomes. However, Yamada was quick to add, in both cases, side effects increase so quality of life issues must be balanced against any incremental treatment gains.

A third area of improvement has come in the form of targeted therapies, particularly Avastin (bevacizumab). “I think we know bevacizumab works and can prolong a patient’s time to progression,” she said of introducing the drug after first using a standard mix of Taxol (paclitaxel) and carboplatin or cisplatin. “I think the jury is still out about how much benefit Avastin is going to have in up front therapy, but certainly Avastin has activity in ovarian cancer.”

Yamada said she thinks personalized medicine holds promise for ovarian cancer patients and noted there are some very innovative clinical trials underway. Already, targeted molecular therapies give oncologists options for sequentially treating patients to slow tumor growth and push back survivability.

With 26,000 new cases diagnosed annually, Yamada said she recognizes ovarian cancer doesn’t approach the scale of breast cancer. Gaining critical mass in terms of research numbers, however, is key to extending survival rates. To that end, Yamada said the Gynecologic Oncology Group was created specifically as a cooperative clinical trials group for gynecologic cancers and has been instrumental in advancing the outcomes for patients with gynecologic cancers. For more information on open trials for patients, go online to www.clinicaltrials.gov.

Primary Prevention Key to Stopping Cervical Cancer

“As a gynecologic oncologist, I would be very happy to not take care of another cervical cancer patient again and to not have to watch a woman suffer from what is essentially a preventable disease,” stated Mark Einstein, MD, MS, associate professor in the Division of Gynecologic Oncology in the Department of Obstetrics & Gynecology and Women’s Health at Albert Einstein College of Medicine in New York City.

Unfortunately, this cervical cancer expert is well aware that day is still somewhere off in the future. Screening numbers still have room for improvement. For some, access is still an issue, particularly in remote areas of the country. Einstein said cultural hindrances also keep some ethnic minorities from pursuing screening.

Even when an appointment is made, Einstein noted, “Screening is good, but screening isn’t perfect.” However, he added, a lesion too small to be detected by standard cytology screening was often caught over an interval of time while effective treatment protocols could still be employed. “It’s a very slow progression, which is why we have lots of opportunities to catch it early,” he said.

Once caught, precancerous lesions are typically cut off or frozen with minimal discomfort and little-to-no recovery time. “Ninety percent of the women treated for a precancerous lesion won’t get one again,” Einstein pointed out. For women who have progressed past the precancerous stage, he continued, “Most cervical cancers are surgically amenable.” Whereas cervical cancer used to be the leading cause of cancer death among U.S. women, CDC statistics show death rates have decreased dramatically over the past four decades. Einstein said a radical hysterectomy would often take care of the cancer but at a heavy cost, particularly to women of childbearing age. “We could do a lot more with diverting that from happening by preventing it first.”

Einstein said the cause of cervical cancer is now well known and a preventive solution is available. “The association between HPV and cervical cancer is higher than that between smoking and lung cancer,” he stated. Today, an HPV vaccine exists and is broadly covered for pre-teens and teens to receive the three-shot series. However, the vaccine, which is controversial among some groups, does not enjoy a school mandate — with the exception of Virginia and Washington, D.C., which both have easy ‘opt out’ rules — so it is essentially viewed as optional by many parents and providers.

“As of September of last year, as per the CDC, only about 44 percent of 13-18 year-olds have received at least one dose of the three-dose vaccine, and less than 10 percent have received all three doses,” said Einstein. “In the United States, our HPV vaccination rates are dismal, particularly in comparison to the single payer systems,” he continued, adding that in the U.K., Australia and Scandinavia, three-dose compliance rates among 12 year-olds are as high as 80 percent.

“We have a primary prevention with the HPV vaccine and a secondary prevention with regular screening. Early vaccination with regular Pap tests can prevent cervical cancer,” Einstein unequivocally stated … and yet, each day more women will learn they have the disease.

The Impact of Reform & Budget Constraints on Women’s Health

For all the progress that has been made in improving the standard of care for women’s cancers, a looming concern over the unintended consequences of changing the healthcare delivery system coupled with the threat of decreased access to research funds has many gynecologic oncologists worried.

Patrick Timmins, MD, a private practitioner with Women’s Care Cancer Associates in Albany, N.Y. and vice chair of the SGO Government Relations committee, is among those anxiously awaiting clarification on how reform will play out when it moves out of Washington, D.C. and into communities across the country.

“Accountable care organizations are the major unknown,” he said. “They have a nice name and a nice theory, but no one knows how they’ll work. By law, an ACO has to have all specialties and subspecialties represented, but it doesn’t say how that’s supposed to happen,” Timmins noted.

“The service we provide is small in number but critical in provision,” he continued. “We basically take care of the sickest patients … all of them with potentially life-threatening diseases.” The relatively small number of gynecologic oncologists across the country is one area of concern when it comes to forming ACOs. Timmins explained a minimum of 5,000 Medicare lives are required to be covered by an ACO. In the case of smaller cities, he wondered, what happens if there are two or three ACOs, but there is only one gynecologic oncologist in town. Do patients, he questioned, who have enjoyed care suddenly lose access? Much of it will depend on the setup … whether ACOs play out as employment models, contractual models or some type of hybrid.

Getting patients into the hands of either gynecologic oncologists or medical oncologists specializing in gynecologic cancers has a direct impact on outcomes, Timmins said. He pointed to research data showing statistically significant differences in terms of long-term survival for patients who have access to a specialist. “This data mirrors all the other data you see in other specialties. In any surgical specialty, when you go to people who do a lot, you get better outcomes,” he continued of the benefits of volume and experience.

Access to care isn’t the only threat on the horizon, however. Timmins said SGO is equally worried about continued access to the research funding that has made so many breakthroughs in women’s cancer care possible. “The major issue for us is that the House has passed a bill that cuts NIH funding by 5 percent,” he said. Timmins noted this doesn’t only affect basic science funding; “but from a clinical research standpoint, we may have to stop accruing patients to clinical trials … and that’s a real world impact.” And of course, he continued, clinical research is founded on basic research.

“We’re winning the war on cancer, and you want to quit! What? We just don’t understand the thinking. This would be the time to increase research funding. We have made such tremendous strides, and survival continues to improve.”

The field could also feel the effects of a Senate proposal to strip all research funding from the Department of Defense budget unless it’s directly related to traditional defense issues. Right now, DOD is funding peer-reviewed research on ovarian cancer that is focused on translational research. It’s going through DOD because of the heavy use of technology. Timmins said that just a few weeks ago, a researcher from the University of Washington had identified several new genes showing a familial link to ovarian cancer from a DOD-funded project. “Our contention is it (the DOD research program) was created by Congress for the technology component, and we think some of this research may actually be used by Defense in the future, such as in areas of bioterrorism detection.”

The bottom line, Timmins concluded, is maintaining access to care and access to research funding so that patients have the best shot at optimal outcomes. “Each family expects and deserves that their loved one will have the greatest chance at long-term survival with the least morbidity. We strive to provide that every single day.”

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