Drugs offer hope for chronic disease
SmithKline Beecham in Philadelphia recently reported new developments for three drugs designed to treat chronic illness: Kytril and Hycamtin for cancer patients and Novastan for heart patients. The company recently received clearance from the U.S. Food and Drug Admin-istration in Rockville, MD, for a once-daily dosage of its antiemetic, Kytril, which helps prevent the nausea and vomiting associated with chemotherapy.
Previously, cancer patients received a 1 mg Kytril tablet within one hour of chemotherapy and a second 1 mg tablet 12 hours after the first. With this newest approval, cancer patients can take a single 2 mg Kytril tablet any time within one hour before chemotherapy.
Promising study results
"A majority of cancer patients who undergo chemotherapy without antiemetics experience nausea and vomiting that can seriously affect their ability to maintain normal daily functioning," says Paul Hesketh, MD, co-director of the division of hematology-oncology and chief of the section of medical oncology at St. Elizabeth’s Medical Center in Boston. "Oral antiemetics such as Kytril have been revolutionizing the way we manage chemotherapy-induced nausea and vomiting. Now, patients can take Kytril right before chemotherapy in their physician’s office, without having to take an additional dose when they return home."
Researchers conducted a double-blind multicenter trial of 697 patients randomly selected to receive either a single 2 mg dose of Kytril or one 1 mg Kytril dose prior to chemotherapy and a second 1 mg dose 12 hours after the first. Of patients receiving a single 2 mg dose, 64% achieved a complete response, defined as no incidence of vomiting, no moderate or severe nausea, and no use of rescue medication. Of patients receiving two 1 mg doses of Kytril, 69% achieved a complete response rate.
Researchers from Loyola University in Chicago recently announced promising results from a study of an investigational SmithKline Beecham anticoagulant called Novastan (argatroban). The drug can replace heparin in heparin-induced thrombocytopenia (HIT) patients undergoing balloon angioplasty, they announced at the American Heart Association’s 70th Annual Scientific Session held recently in Orlando.
HIT is an immune disorder caused by the development of antibodies to the complex of heparin and a blood protein called platelet factor 4 (PF4). Up to 30% of heparin-treated patients have the antibody to the heparin PF4 complex and are predisposed to developing HIT.
Within 30 days of developing HIT, 52.8% of HIT patients develop heparin-induced thrombo-cytopenia-thrombotic syndrome (HITTS) which is associated with complications such as pulmonary embolism, stroke, skin necrosis, and limb gangrene, says Bruce Lewis, MD, associate professor of medicine at Loyola University and chief of cardiology at Catholic Health Partners in Chicago. "About 7.5% of the population that receives prolonged heparin develops a positive test for HIT and a portion of those will have catastrophic thrombosis," he says.
Argatroban is a much safer alternative to heparin for patients with HIT because it provides effective anticoagulation with fewer complications, Lewis notes: "In our study, bleeding complications occurred in only one in 50 patients." Although the study did not focus on medical costs, argatroban appears to shorten the average length of stay for HITTS and should therefore lead to lower medical costs, he adds.
Viable treatment for lung cancer
The study found that 98% of the argatroban-treated HIT patients had favorable outcomes from balloon angioplasty procedures, compared with 94% of patients treated with heparin in a historical control group. The study included 50 patients with a history of HIT. Patients received argatroban at a dose of 350 ug/kg bolus followed by continuous infusion. Researchers compared the study results with more than 5,000 previous non-HIT patients treated with heparin during balloon angioplasty. Aside from the presence or absence of HIT, other patient characteristics were similar.
Researchers from Johns Hopkins Oncology Center in Baltimore recently reported that a new injection drug, Hycamtin, offers a viable treatment option for patients with small-cell lung cancer. They reviewed findings from five separate clinical trials of the drug, which is currently only available for patients with recurrent metastatic ovarian cancer.
"Since survival rates of patients with small- cell lung cancer have traditionally been poor, and results with many other drugs have been very disappointing, it is critical that we identify new agents that can be used as either first- or second-line therapy," says David S. Ettinger, MD, professor of oncology and medicine and associate director for clinical affairs at Johns Hopkins Oncology Center, who presented the research findings at the 15th annual meeting of the Chemotherapy Foundation in New York City.
"Results from several studies suggest that Hycamtin, either alone or in combination with other agents, may be a promising treatment option for this patient population," Ettinger says.
Results of the five separate clinical trials include the following:
• Patients who received a combination of Hycamtin/paclitaxel with granulocyte-colony stimulating factor (G-CSF) achieved response rates consistent with those observed with currently used first-line chemotherapies.
Patients with previously untreated small- cell lung cancer received Hycamtin 1mg/m2 as a 30-minute infusion over the course of three weeks.
The overall response rate was 92%, with two patients receiving complete response, or disappearance of signs and symptoms of cancer. The one-year survival rate was 50%.
• Patients with previously untreated extensive disease small-cell lung cancer received an infusion of Hycamtin 2.0 mg/m2 as a single agent on days one through five every three weeks. Patients also received G-CSF.
Roughly 40% of patients had a partial response. The median duration was 4.8 months, overall median survival time was 10 months, and one year survival rate was 39%.
• Patients with small-cell lung cancer were randomized to receive Hycamtin 1.5mg/m2 as a 30-minute infusion once daily for five days or cyclophosphamide, doxorubican, and vincristine (CAV) by infusion on day one every three weeks. Patients treated with Hycamtin alone achieved a 25% response rate, compared with a 15% response rate for CAV patients.
Survival duration is longer
"The results are encouraging, because most small-cell lung cancer patients will eventually relapse and become very difficult to treat," says Ettinger. "Studies with Hycamtin as a single-agent therapy have shown responses in patients who have already received first-line chemotherapy. In addition, patients who respond to Hycamtin have demonstrated longer than expected durations of response and survival."
For more information, contact: SmithKline Beecham’s Prescription Drug Patient Assistance Program at (800) 546-0420, or visit the company’s World Wide Web site. The address is: www.sb.com.
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