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Two drug studies presented recently at the annual meeting of the American Society of Clinical Oncology show promising results for cancer patients. One study showed that Hycamtin may offer a new treatment option for patients suffering from non-small cell lung cancer, one of the most common and lethal cancers. The other study found that Kytril tablets are as effective as the commonly given intravenous medication in preventing nausea and vomiting after chemotherapy.
Each year, 135,000 people most of them current or former smokers are diagnosed with non-small cell lung cancer. No standard treatment exists for the disease, which is extremely resistant to chemotherapy, and few single-agent therapies have achieved response rates greater than 15%, says Roman Perez-Soler, MD, lead investigator and deputy chairman of the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas’ M.D. Anderson Cancer Center. "It is critical that we identify new drugs that can be used in the first-line treatment of this disease," he says. "Results of first-line studies with other drugs have been disappointing in terms of prolonging survival, either as single agents or in combination with other therapies."
Hycamtin, however, caused 23% of patients in the study to go into partial remission, defined as having tumor shrinkage of more than 50%. The non-comparative Phase II trial involved 30 patients with advanced squamous cell lung cancer, none of whom had received prior chemotherapy. They were treated with Hycamtin 1.5 mg/m2 for five days every 21 days. The drug was generally well-tolerated, with the main side effect being suppression of white blood cells produced in the bone marrow, a common side effect of many chemotherapy agents. Some patients also reported nausea and fatigue.
Hycamtin (topotecan hydrochloride for injection), marketed by SmithKline Beecham, is currently indicated for use in the treatment of recurrent, metastatic ovarian cancer. Last year, it became the first topoisomerase I inhibitor to be cleared for marketing by the U.S. Food and Drug Administration. This new class of drugs kills cancer cells by inhibiting the enzyme topoisomerase I, which is essential in the replication of DNA in cancer cells.
Cancer patients undergoing chemotherapy with a high potential to cause nausea and vomiting can look to oral Kytril tablets as an alternative to the standard intravenous antiemetic, ondansetron, according to two studies done by the Oschner Cancer Institute in New Orleans and the Mayo Clinic in Jacksonville. The tablets are just as effective, and they require less time, are more convenient, and cost less than the intravenous drug, researchers say.
The two separate double-blind, randomized multicenter studies compared the effectiveness of giving a 1 mg Kytril tablet one hour before chemotherapy and 12 hours after with a 15-minute intravenous dose of 32 mg of ondansetron 30 minutes before chemotherapy. In the first study, where 1,054 patients received a course of cisplatin as chemotherapy, 55% of those who took Kytril reported no nausea 24 hours after treatment, while 58% had no nausea with ondansetron. In the second study, where 1,085 patients received either cyclophosphamide or carboplatin chemotherapy, 59% of those who took Kytril reported no nausea after 24 hours, and 58% had no nausea with ondansetron.
Commonly reported side effects, which occurred equally with Kytril and ondansetron, were headache, asthenia, and constipation. Kytril (granisetron hydrochloride), marketed by SmithKline Beecham, is indicated for the prevention of nausea and vomiting associated with a broad range of initial and repeat courses of moderate and highly emetogenic chemotherapies.
[For additional information on Hycamtin or Kytril, contact SmithKline Beecham at (800) 366-8900, Ext. 5231.]