ASCO LOS ANGELES--A phase II study of gemcitabine(Drug information on gemcitabine), a novel nucleoside analog, plus cisplatin(Drug information on cisplatin) (Platinol) in patients with stage III or IV non-small-cell lung cancer (NSCLC) showed an encouraging 42% response rate and 8-month median survival.
"The median survival is similar to other active combinations, and, given the favorable toxicity profile of this predominantly outpatient regimen, we feel it should be further assessed in a randomized phase III study," said W.P. Steward, MD, of the Canadian National Cancer Institute and Queens University, Kingston, Ontario.
Dr. Steward reported the results of the multicenter study, involving researchers in the United Kingdom and France, at a scientific session of the American Society of Clinical Oncology (ASCO) meeting.
At the same session, Italian researchers presented data from their phase II trial using the same drug doses in a slightly different schedule. They achieved an even more impressive response rate (54%), and described their regimen as well tolerated on an outpatient basis despite a considerable incidence of thrombocytopenia.
Gemcitabine (Gemzar from Eli Lilly and Company) is currently available in the United States for patients with advanced pancreatic cancer through a treatment investigational new drug (IND) program.
Rationale for the Combination
Dr. Steward said that the rationale for combining the two drugs stems from their known activity in the disease (gemcitabine produces response rates on the order of 24% when given as a single agent), their largely nonoverlapping toxicity profiles, and encouraging preclinical data suggesting synergy between the two agents in a variety of tumor models, including adenocarcinoma lines.