ASCO LOS ANGELES--A phase II study of gemcitabine, a novel nucleoside
analog, plus 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,
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.