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| |  Gemzar Findings From Phase II Lung Cancer Study Are Reported INDIANAPOLIS--(HealthWire)--Jan. 16, 1997--A study published in the January issue of the Journal of Clinical Oncology (JCO) reports that 54 percent of patients in a Phase II trial of the chemotherapy combination Gemzar(R) plus cisplatin in patients with non-small cell lung cancer (NSCLC) showed a partial or complete response to the treatment during the study period. According to the American Cancer Society, non-small cell lung cancer accounts for 75 percent of all lung cancer cases, or approximately 127,000 new cases in the United States annually. It is a disease that may not manifest symptoms until the cancer has progressed to an advanced stage. The five-year survival rate for advanced NSCLC is less than 10 percent. The patients who participated in the multicenter study cited in JCO were diagnosed with stage IIIB-IV NSCLC and had not received previous treatment. Stages IIIB and IV NSCLC are the most advanced stages of the disease. The median age of patients was 60 years and performance status was 0 or 1. Patients were administered Gemzar weekly for three weeks, followed by one week of rest from Gemzar administration. They received cisplatin on the second day of the 28-day treatment cycle. Doses were withheld or reduced depending on toxicities observed in individual patients. Survival time and response rates The one year survival probability reported in the study was approximately 60 percent. The median survival duration for all 48 patients was 61.5 weeks (95 percent confidence interval, 40-71 weeks). Patients who responded to the treatment had an median survival time of 71 weeks, while patients who did not respond had a median survival time of 38.5 weeks. Of the 48 patients studied, 25 achieved a partial response, while one patient had a complete response for an overall response rate of 54 percent (95 percent confidence interval, 40-68 percent response rate). Partial response was defined as a reduction of 50 percent or more in the size of the tumor lesions. Complete response was defined as the complete disappearance of all tumor lesions, lasting at least four weeks. The median duration of response, or how long the response effect was observed, was 45.5 weeks, with 10 patients showing a response effect in excess of 60 weeks. Responses were submitted for validation to an independent review board. Twenty-four of the 26 responses submitted were validated. Symptom improvement In addition to survival time and response rate, a secondary endpoint of the study evaluated whether patients experienced relief of five disease-related symptoms during treatment: pain, dyspnea (shortness of breath), cough, hemoptysis (the coughing up of blood) and pleural effusion (accumulation of fluid in the membranes lining the lungs and the chest cavity). Symptom improvement lasting more than 4 weeks was documented in a majority of the patients. Of 27 patients complaining of pain when they entered the study, 52 percent experienced a reduction in their level of pain and in the amount of pain medication they used. Forty-two percent of the patients experienced improvement in breathing. Fifty percent had a reduction in cough and 63 percent reported a reduction in hemoptysis. Of nine patients with pleural effusion when the study began, eight showed improvement during the study. No confidence intervals were reported. Safety Information Doses of therapy were most often reduced or withheld for patients in the study due to toxicity related to blood cells. A severe reduction of the number of platelets produced by the body, described as WHO grade 3 or 4 thrombocytopenia, was observed in 52 percent of patients and caused the omission of the third Gemzar dose in 50 percent of the chemotherapy courses. The overall incidence of any thrombocytopenia was 72 percent. Thirty-six percent of patients experienced WHO grade 3 or 4 neutropenia, a decrease in infection-fighting white blood cells. Sixteen patients (33 percent) required a blood tranfusion due to anemia, a condition in which the concentration of hemoglobin in the blood has dropped below normal. Eighty-one percent of patients overall experienced some degree of nausea and/or vomiting, which were the most frequent adverse events. Ongoing studies Gemzar is cleared for marketing in the United States for the treatment of advanced or metastatic pancreatic cancer only. The study published in JCO must be validated by large randomized trials comparing Gemzar plus cisplatin with a standard treatment for NSCLC. Currently underway in the United States is a 2,500 patient clinical trial sponsored by the Eastern Cooperative Oncology Group evaluating the Gemzar plus cisplatin regimen against three other treatment regimens for NSCLC. Regulatory bodies in 17 countries have cleared Gemzar for the treatment of non-small cell lung cancer either as a single agent or in combination therapy with cisplatin, depending on the country. Studies of Gemzar for the treatment of NSCLC are ongoing around the world. Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering innovative pharmaceutical-based health care solutions that enable people to live longer, healthier and more active lives.
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