In this month’s issue:

Fox Chase Study looks at effectiveness of treatment for ovarian cancer

Philadelphia -- An international clinical study to evaluate new treatments for women with ovarian cancer is now open in the U.S., with plans for activation in the United Kingdom, Italy, Scandinavia, Australia, New Zealand, and other countries. This randomized study will compare the overall effectiveness of the standard treatment (a combination of paclitaxel and carboplatin) for ovarian cancer with recently developed chemotherapy combinations incorporating newer drugs. Michael A. Bookman, M.D., a medical oncologist at Fox Chase Cancer Center, a member of Philadelphia International Medicine, is the lead investigator for this treatment study. It was developed by the Gynecologic Oncology Group, an organization dedicated to clinical research in gynecologic cancer, in collaboration with an international panel of experts and with assistance from the pharmaceutical industry. The National Cancer Institute (NCI) sponsors the study.

In the United States during 2000, it is estimated that 23,100 women will be diagnosed with ovarian cancer and 14,000 women will die of the disease. In North America, Western Europe, and Scandinavia, ovarian cancer accounts for approximately five percent of overall cancer deaths in women and is the most common cause of death among gynecologic tumors.

Currently, there are no effective screening methods for the early detection of ovarian cancer, and the majority of women with the disease are diagnosed with advanced cancer that has already spread within the peritoneal cavity (abdomen). Despite improvements in overall survival using the standard combination of paclitaxel and carboplatin, the five-year survival rate for women with advanced disease remains less than 30 percent.

The primary objective of the international study is to compare overall survival and progression-free survival of each of the four experimental arms with the standard chemotherapy treatment of paclitaxel and carboplatin.

"Currently, surgery and chemotherapy for ovarian cancer is effective, but long-term cure is uncommon," said Bookman. "In this study, we hope to determine if adding any one of three promising drugs to the standard treatment will improve the effectiveness."

The drugs that will be studied are topotecan, gemcitabine, and liposomal doxorubicin (Doxil). "Each of these drugs has the ability to directly enhance the activity of carboplatin, which remains the single best drug available to treat ovarian cancer," Bookman added. "In addition, these drugs are already used individually to treat recurrent ovarian cancer, and have good activity in that setting."

As many as 4,000 women are expected to participate in this study, depending on the effectiveness of the different treatment regimens. "

An international study was proposed by the National Cancer Institute because of the large number of patients required to complete a valid study in a reasonable period of time," Bookman explained. "This study will allow us to get the answers we need sooner so that we can identify more effective treatments for this devastating disease, while designing more novel treatments for the next generation of clinical trials."

This chemotherapy study is divided into "doublets" (two drugs) or "triplets" (three drugs). Each of the treatment arms includes a total of eight courses. Each course will be repeated every 3 to 4 weeks. The possible treatments are 1) carboplatin and paclitaxel (standard therapy treatment), 2) carboplatin, paclitaxel, and gemcitabine, 3) carboplatin and gemcitabine followed by carboplatin and paclitaxel, 4) carboplatin and topotecan followed by carboplatin and paclitaxel, or 5) carboplatin, paclitaxel, and Doxil. "

Although the trial has five different treatment arms, the basic approach was to take the current standard treatment and add the three new drugs using doses and schedules that are safe and tolerable," Bookman said.

Some common side effects include low blood counts with increased risk of infection or bleeding, decreased appetite, hair loss, and fatigue. Other uncommon side effects include allergic reactions, muscle weakness or sores in the mouth.

The second purpose of the study is to determine whether response to chemotherapy and survival are different in patients with mutations in the BRCA1 and BRCA2 genes compared to patients without mutations in these genes.

In addition, researchers want to determine whether there is a survival difference in women with and without a family history of ovarian cancer. BRCA1 and BRCA2 mutations may be present in as many as 10-15 percent of women with ovarian cancer. Women with these mutations have an increased risk of developing breast or ovarian cancer, as do some of their close family members.

Penn Study shows new treatment for whiplash helps patients cope

Millions of dollars each year are spent to cope with headaches. Many of those headaches are linked to whiplash in car accidents, sudden falls or head trauma. In 1994 alone, a million drivers in the United States were rear-ended and 500,000 were injured.

That sudden jolt from behind whips heads back and forth and puts excess pressure on the neck's 14 joints that connect the skull to the spine. One of those joints near the base of the skull is called C2-3. Every year about 30,000 people in car accidents and other whiplash traumas end up with damaged C2-3 joints. Some have unrelenting head pain and quit work, completely disabled.

Now a team of doctors at the University of Pennsylvania's Department of Rehabilitation Medicine, a member of Philadelphia International Medicine, lead by Curtis W. Slipman, MD, head of Penn's Spine Center, has demonstrated a new and successful treatment for headaches linked to C2-3 joint injury.

In a retrospective study focused on 18 patients who had daily pain, a steroid was injected through a small needle directly into the neck joint's synovial cavity lining to reduce inflammation. The result was "almost miraculous for 11 percent of patients who were completely free of pain afterward," said Dr. Slipman. Another 61 percent had fewer than three headaches a week that were relieved by common oral pain medicine.

"That means we were able to help about 75 percent of those patients who had coped with unrelenting head pain 24 hours a day," continued Slipman. They woke up with pain and went to sleep with pain for an average of three years. And whatever medication they took, it did nothing. I'm talking about narcotics, aspirin, ibuprofen, percocet, darvocet, morphine - no impact on the headaches at all. We took these individuals and injected their C2-3 joint on an average of two times and had superior success."

Since migraine headache and joint C2-3 symptoms are similar - pain behind the eye, in the forehead and severe nausea - Slipman does a test injection of a local anesthetic in the joint to see if headache is relieved. When joint damage is the cause, the headache will usually subside in a few minutes.

"There are a lot of people out there who are experiencing disabling headaches and think they have migraines or concussion pain, but in fact are treatable. I work closely with physicians who take care of head trauma. For them, it's an eye opening experience when some headaches disappear after we treat the C2-3 joint."

The Penn research was published in the March, 2001 American Journal of Physical Medicine and Rehabilitation, Vol. 80, No. 3, Pages 182-188. "Therapeutic Zygapophyscal Joint Injections for Headaches Emanating from the C2-3 joint."

Temple Physician Presented "Distinguished Surgeon Award"

 The director of Gynecology, Urogynecology, Pelvic Reconstructive Surgery at Temple University Hospital, a member of Philadelphia International Medicine, received the Distinguished Surgeon Award of the Society of Gynecologic Surgeons this month. Dr. Marvin H. Grody, an internationally renowned surgeon who has been at Temple University Hospital and School of Medicine for 12 years, was presented the award on behalf of his esteemed career.

Dr. Gody has been featured in a variety of professional and media forums. He has presented at major gynecologic conferences, scientific meetings and Grand Round programs at teaching institutions around the world. He has appeared on the NBC Network "Today" show to speak about gynecological corrective operations that improve quality of life for women with pelvic organ prolapse.

Magee Rehab and Philadelphia 76ers team up for wheelchair basketball

 The Philadelphia 76ers, one of 16 NBA teams sponsoring wheelchair basketball teams in their franchise area, have partnered with Magee Rehabilitation Hospital, a member of Philadelphia International Medicine, to help support the Sixers Spokemen. The Spokemen have received warm-up suits and uniform jerseys from the 76ers, whose support has helped the Spokemen grow into two separate squads.

Magee is a leading provider of wheelchair sports programs that allows participants to compete against physical equals and at the same time improve overall health and fitness. Wheelchair basketball demands speed, strength, stamina and key skills. It is increasingly popular as a recreational and competitive option for people using wheelchairs, and is drawing a growing number of fans and spectators. Magee Rehabilitation Hospital, a founding member of the Jefferson Health System, and part of the Regional Spinal Cord Injury Center of Delaware Valley, is the Philadelphia region's original provider of physical and cognitive rehabilitation. The not-for-profit health organization provides lifetime rehabilitation and wellness programs for persons with spinal cord injury, brain injury, stroke, amputation, orthopedic injury, joint replacement, geriatric illnesses and work injury.

Philadelphia International Medicine is an organization that provides medical and patient support services to international patients. It also provides continuing medical education and health care training and education to international physicians, administrators and other practitioners. As the international department of several Philadelphia-area hospitals, international patients gain access to physicians and hospitals rated among the best in the world through one telephone call to PIM. You can reach PIM by calling 1-215-735-3575; fax, 1-215-790-1267; or e-mail, physicians@philadelphiamedicine.com. You can find out more about PIM through its Website at www.philadelphiamedicine.com.

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