Seeing opportunities in specialization, pharmacists are turning to oncology
National cancer conference highlights therapy advances, outcomes
Pharmacists seeking opportunities through specialized knowledge are discovering oncology, a field offering a vast patient population and a wide range of disease variations. When the Board of Pharmaceutical Specialties (BPS) in Washington, DC, offered its first examination in oncology pharmacy in 1998, 118 of 207 candidates successfully completed the certification process.
Coordinated under the umbrella of the American Pharmaceutical Association (APhA), BPS has been offering annual pharmacy specialty exams since 1976 in nuclear pharmacy, nutrition support pharmacy, pharmacotherapy, and psychiatric pharmacy, but never before had so many pharmacists pursued a new specialty certification. To date, nearly 3,000 pharmacists have been credentialed in all five areas now offered.
"[The oncology exam drew] the largest number of people to come out for a new specialty exam in our history, so there clearly is not only a great interest in oncology pharmacy practice at the specialist level, but I think recognition that this is going to be a valuable credential down the road," says Richard Bertin, BPS executive director.
The simple breadth of the field of oncology, in terms of the nearly two dozen different strains of cancer being fought, along with the large patient population and availability of research funding makes oncology an opportunistic pursuit for clinical pharmacists.
Consider these facts:
• The American Cancer Society says half of all American men and one-third of all women will develop some form of cancer in their lifetimes. To combat the disease, drug therapies, biotechnology, and research are ever-expanding.
• Last year, according to the Pharmaceutical Research and Manufac turers Association (Pharma) in Washington, DC, 316 new drugs went into development, 130 of which were aimed at breast, lung, and colon cancer. Pharma says $1.4 billion is spent annually by drug companies on cancer-fighting agents. Specifically, 59 new drugs went into devel opment for breast cancer, topped only by skin cancer research with 60 investigational drugs. Just over 30 drugs each were aimed at colon cancer, leukemia, lymphoma, prostate cancer, and solid tumors.
Other specialties are attracting their share of pharmacists, as well.
"We’re seeing considerable growth in all types of pharmacy specialties," says Bertin. "One reason is the requirement that patients be managed by general physicians, who depend more and more on specialist pharmacists to provide drug therapy information to them and their patients in clinics, but from there, if a pharmacist wants to be effective in the oncology area, you really do have to focus and get specialized within the field," he says of the many areas of cancer treatment, such as sarcomas, skin cancer, lymphoma, and cancers linked to specific organs or other tissues.
A national conference this year in Atlanta by the American Society of Clinical Oncology (ASCO) speaks to the considerable fine-tuning being discovered within the various avenues of drug therapy. Of the nearly 200 papers submitted, clinical trials included drug therapy aimed at tumor-growth enzymes, DNA formulations, proteins, stem cell therapy, vaccines, and chemotherapy sensitizer drugs. Also submitted were large numbers of studies taking new approaches to combination therapies pairing drugs on the market with those in Phase III trials.
University pharmacy departments also are taking notice of the opportunities in oncology. The University of Colorado School of Pharmacy, for example, is offering an oncology specialty residency to its PharmD students.
"Our major area of focus is adult medical oncology," says residency director Carol Balmer, PharmD. "The emphasis is on supportive care, the antineoplastic drugs and cancers treated with those drugs, prevention and management of antineoplastic toxicities, and investigational cancer therapies. Residents are also exposed to gynecologic oncology, surgical oncology, bone marrow transplantation, community oncology, and pediatric oncology," she says, adding that much of the hands-on work is done at the University of Colorado Cancer Center.
Balmer describes the typical duties of an oncology pharmacist as monitoring patient lab results based on drug therapy and recommending changes when necessary for those admitted to the hospital. As oncology team members, pharmacists also accompany physicians on patient rounds for drug therapy consultations and meet patients in cancer clinics to assess their responses to drug therapy.
The BPS recognizes residencies as part of its certification process, which also includes a 200-question exam, basic license and graduation requirements, and physician collaboration time spent constructing patient-specific drug therapies and drug use protocols.
Conference speaks to field’s breadth
If a theme emerged from the 35th annual ASCO meeting, it was that no experimental therapy is without merit and all should be pursued as researchers continue to look for novel ways of fighting cancer.
Presented at the conference were encouraging early trial results, including the use of anti-angiogenesis nose drops to treat Kaposi’s sarcoma, minute radioactive cones used to fight liver metastases, standard diabetes drugs to cause cancer cells to age, and efforts to make bone marrow cells resistant to chemotherapy.
Also discussed among a wide range of approaches was a novel ovarian cancer vaccine that uses synthetic antigens to mimic cancer-associated epitopes to trick the immune system into mounting an early response against the cancer.
"Each of these examples illustrates the use of a different biochemical or biological target to treat cancer patients," says Derek Raghaven, MD, chief of medical oncology at the University of Southern California Norris Comprehensive Cancer Center. Raghaven acted as moderator of a panel on the next generation of cancer therapies.
"These types of trials represent a paradigm shift away from traditional therapy and toward approaches tailored to individual cancers, all of which has been made possible by translational research, moving promising concepts from the lab directly to clinical trials," he says.
One of the more anticipated sets of trials at the conference, though, had disappointing results. Five studies were submitted on the combined use of stem cell support therapy — as peripheral blood stem cell support or bone marrow transplant — with high-dose chemotherapy primarily to treat metastatic breast cancer patients as well as those with high-risk primary breast cancer.
Based on the success of earlier Phase II trials, the Phase III results were expected to further the gains of stem cell support, but instead they proved inconclusive in four of five independent studies just as the use of stem cell support has been increasing as an adjuvant treatment for high-risk primary breast cancer patients.
The studies showed that high-dose chemotherapy treatment with stem cell support was not better than conventional chemotherapy. The Ameri - can Cancer Society subsequently has deemed the results inconclusive and is backing further study, which the National Cancer Institute has begun through clinical trials.
Tamoxifen studies encouraging
More encouraging in the field of breast cancer were studies showing the much-publicized drug tamoxifen, approved last year as a prevention drug for patients showing a high or increased risk of contracting breast cancer, is doing the job it was approved to do.
"The research presented confirms that tamoxifen has tremendous potential in reducing the risk of breast cancer for increased-risk women," Lori Goldstein, MD, associate director of the Fox Chase Cancer Center in Philadelphia, told assembled ASCO members. "The additional data is also encouraging, demonstrating that the drug can also prevent pre-cancerous lesions from becoming cancerous, but [tamoxifen] is not without side effects. Data still indicate that women on tamoxifen are at increased risk of developing endometrial cancer and blood clots, but the incidence of these events is low," she said.
Other studies presented at the conference include the following:
1. The combination of injectable topotecan hydrochloride with paclitaxel as a positive approach to first-line treatment of extensive small cell lung cancer. Study results showed median survival rates of one year or more for topotecan hydrochloride vs. the average of eight to 10 months with standard chemotherapy. Topotecan hydrochloride is in the class of drugs known as topoisomerase I inhibitors, which attack cancer cells by inhibiting the topoisomerase I enzyme needed to replicate the DNA of cells inflicted with cancer. The drug is available on the market as Hycamtin by Smith Kline Beecham, but it has not been approved for first-line treatment. It is approved for use against ovarian metastatic carcinoma following the failure of chemotherapy or for use as a secondary therapy in small cell lung cancer following chemotherapy failure.
2. Paclitaxel in combination therapy with carboplatin in the treatment of advanced ovarian cancer vs. the chemotherapy drug cisplatin based on the decreased toxicity found with the paclitaxel-carboplatin match. Patients given the new combination experienced less gastrointestinal, genitourinary, and metabolic disorders such as kidney damage during trials, which randomized 800 patients to one or the other com bination. The study also reports a successful three-hour infusion for the combination, vs. the standard 24-hour infusion used for paclitaxel and cisplatin.
3. An advance in the restoration of tumor sensitivity to chemotherapy in cases of soft-tissue sarcoma using a combination of the investigational drug biricodar dicitrate (Incel, Vertex Pharmaceuticals) with standard doxorubicin. The combination is effective through Incel’s ability to enhance the activity of doxorubicin against resistance. The drug works by blocking enzymes that decrease the sensitivity of tumors to chemotherapy.
4. A colorectal combination therapy that adds the investigational drug trimetrexate glucuronate (NeuTrexin, U.S. Bioscience) with traditional therapies leucovorin and 5-fluorouracil (5-FU) as a triple combination. The combination increased median survival from 10.1 to 12.9 months when trimetrexate was added. Research ers believe the drug works by increasing the activity of 5-FU by stimulating the body’s naturally occurring compound phosphoribosylpyrophosphate, which converts 5-FU into metabolites that inhibit cancer cell replication.
These and other studies point out another growing approach to oncology: Along with finding drugs that fight cancer, finding drugs that help other drugs fight cancer is becoming equally important. For oncology pharmacists, determining protocols or interactions within these new para digms of therapy is becoming a clinical niche.
[For more details, contact: Board of Pharmaceutical Specialties, 2215 Constitution Ave. N.W., Washing ton, DC 20037. Telephone: (202) 429-7591. Web site: http://www.bpsweb.org. American Society of Clinical Oncology, 225 Reinekers Lane, Suite 650, Alexandria, VA 22314. Telephone: (703) 299-0150. Web site: www.asco.org.]
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