LINKOPING, SwedenSwedish researchers found that gemcitabine (Gemzar)
plus carboplatin (Paraplatin) improved response rates and survival in patients
with advanced non-small-cell lung cancer during a phase III trial, according
to a presentation by C. Sederholm, MD, on behalf of the Swedish Lung Cancer
Study Group. Dr. Sederholm is with the department of pulmonary medicine at
University Hospital, Linkoping (ASCO abstract 1162).
"Combination gemcitabine plus carboplatin increased survival without
complicating toxicities or detriment to quality of life compared with
gemcitabine alone," Dr. Sederholm said.
Researchers enrolled 334 patients at 17 centers from October 1998 through
January 2001. Eligibility criteria included histologically/cytologically
confirmed stage IIIB or IV disease and performance status of 0 to 2. There was
no upper age limit. Patients with known central nervous system metastatic
disease were excluded.
The primary study endpoint was survival. Secondary endpoints were quality of
life, safety, time to progression, and response rate.
Patients were randomized into two treatment arms. In the first, 170 patients
received an intravenous infusion of gemcitabine, 1,250 mg/m², on days 1 and 8,
every 21 days. The 164 patients in the second arm were given the same regimen
of gemcitabine plus carboplatin, AUC of 5, on day 1, every 21 days.
A maximum of six cycles were planned. Doses were adjusted downward according
to hematologic toxicity. The median number of cycles given was five in the
gemcitabine arm and six in the combination arm. The dose intensity was
excellent in both treatment groups.