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| |  ASCO: Doxil (Liposomal Doxorubicin) and Hycamtin (Topotecan) Similar in Ovarian Tumor Shrinkage NEW ORLEANS, LA -- May 23, 2000 -- A major new study of two leading chemotherapy drugs used to treat recurrent ovarian cancer demonstrated that Doxil® (liposomal doxorubicin HCl) and Hycamtin® (topotecan HCl) have similar results in terms of tumor shrinkage, as presented Saturday (May 20) at the 36th Annual American Society of Clinical Oncology meeting in New Orleans. The study also found that the side effects were markedly different for the two drugs. Doxil patients experienced fewer serious complications including blood cell deficiencies associated with bone marrow suppression, and less need for follow up treatments such as transfusions or medications to increase blood cell count. The study also found an improved survival rate for a subset of patients who were termed "platinum-sensitive." These findings were described in an oral presentation by Alan Gordon, M.D., Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center in Dallas, and Director of Gynecologic Research for US Oncology, who was an investigator for the trial. A significant finding of the study was that Doxil patients who were platinum-sensitive (those who responded to their initial therapy and maintained this response for at least six months following treatment) had a median 23-week survival advantage over platinum-sensitive patients receiving topotecan. In general, platinum-sensitive patients did better than platinum-refractory patients on both drugs in terms of response and survival. (Refractory disease is defined as disease that has progressed while on treatment or within 6 months of completing treatment.) Dr. Gordon explained that, "platinum-refractory patients tend to have disease that is also resistant to other agents and may not respond as well to treatment." "This study and the results are significant since this Phase III clinical trial was one of the largest randomized studies in recurrent ovarian cancer to directly compare two agents," according to Dr. Gordon. "While we've known for some time that Doxil's once-a-month administration schedule is convenient in terms of patients' ability to maintain their lives as normally as possible, Doxil appears to offer equivalent efficacy to topotecan, while also reducing the incidence of complications that can adversely impact patients' health and require additional treatment that affects quality of life." Patients battling recurrent disease can be treated with only six infusions of Doxil over a six-month period, rather than making 40+ trips to the doctor for administration of topotecan. In Dr. Gordon's presentation, the data showed that patients treated with Doxil experienced fewer incidences of several hematologic (blood cell) toxicities, including anemia (lowered red blood cell count), neutropenia (lowered white blood cell count) and thrombocytopenia (platelet deficiency). With Doxil, patients' ability to fight infections appeared to be less compromised. Subjects experienced a lower incidence of death from sepsis, a potentially life-threatening infection. "Moreover, patients had less need for blood transfusions and other treatments which certainly enhances their ability to maintain a more normal lifestyle during treatment," Dr. Gordon continued. The trial involved 474 patients who were randomly assigned to receive Doxil as a one-hour infusion, or topotecan administered for 5 days every three weeks as a 30-minute intravenous infusion. The median time to disease progression, the study's primary endpoint, was similar in both groups: 18.4 weeks for Doxil patients and 18.3 weeks for the topotecan group. Median overall survival in both groups was also similar -- 53.4 weeks for Doxil patients and 51.1 for topotecan patients. Similarly, about the same percentage of patients who received Doxil and topotecan experienced at least a confirmed 50 percent reduction in tumor size (20 percent and 17 percent, respectively). Furthermore, hematologic (blood cell) toxicities were seen less frequently in the patients receiving Doxil. The incidence of dangerously low levels of infection-fighting white blood cells (12 versus 77 percent), oxygen-carrying red blood cells (six versus 28 percent), and clot-forming platelets (one versus 34 percent) were all significantly less in the patients receiving Doxil. Patients receiving Doxil required much less supportive care for these toxicities. Overall, there were three deaths due to infection reported in the patients receiving topotecan. Additionally, patients receiving Doxil experienced a higher incidence of skin toxicities (PPE -- 49 percent versus one) and mouth sores (40 percent vs. 15 percent) than those receiving topotecan. "The Ovarian Cancer National Alliance is pleased to learn that the results of the recently completed clinical trial on Doxil which we have reviewed today confirm that this therapy offers another option for women with recurrent ovarian cancer," stated Susan Butler, a member of the board of the Ovarian Cancer National Alliance. "For a disease that has too few treatments and takes the lives of 14,000 women each year, additional options are welcome news." Doxil is manufactured and marketed by ALZA Corporation, who sponsored this research. Hycamtin is manufactured and marketed by SmithKline Beecham. Baylor-Charles A. Sammons Cancer Center in Dallas, opened in 1976, treats all forms of cancer and participates in major national clinical trials offering patients access to the latest forms of cancer treatment. Sammons Cancer Center is located at Baylor University Medical Center, flagship hospital of Baylor Health Care System. Baylor University Medical Center operates as one of the nation's largest not-for-profit medical centers, caring for more than 400,000 people each year, and serves as a major patient care, teaching and research center for the Southwest. Related Links: Doxil (liposomal doxorubicin HCl), ALZA Corporation, Hycamtin (topotecan HCl) and SmithKline Beecham.
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