randomized multicenter phase II study of advanced pancreatic carcinoma by the
European Organization for Research and Treatment of Cancer (EORTC)
Gastrointestinal Cancer Group, the combination of docetaxel (Taxotere) and
gemcitabine (Gemzar) was "promising" relative to docetaxel/cisplatin (Platinol),
Manfred P. Lutz, MD, of University Hospital, Ulm, Germany, said at the 38th
Annual Meeting of the American Society of Clinical Oncology (abstract 498).
"Both combinations are active in advanced pancreatic cancer,
and both have acceptable toxicities," Dr. Lutz said.
Although gemcitabine is widely used for the treatment of
advanced pancreatic cancer, he said, response rates when used as a single agent
are less than 10%, and median survival is less than 6 months. Both docetaxel
and cisplatin also have proven clinical activity in this disease and are
synergistic with gemcitabine in peclinical models.
The trial enrolled 96 patients at 17 centers. Patients
received gemcitabine 800 mg/m2
on days l and 8 and docetaxel 85 mg/m2
on day 8, every 21 days, or docetaxel 75 mg/m2
on day 1 and cisplatin 75 mg/m2
on day 1, every 21 days.
The most important toxicity was neutropenia, which occurred
in approximately 30% of patients. Febrile neutropenia was seen in 17% of
patients on docetaxel/cisplatin and 7% on docetaxel/gemcitabine. There was more
neuropathy and vomiting in the docetaxel/cisplatin arm.
Partial responses were confirmed in 6 of 38 evaluable
patients in the docetaxel/gemcitabine arm (15.8%) and in 5 of 31 evaluable
patients in the docetaxel/cisplatin arm (16.1%). Progression-free survival was
3.6 months with gemcitabine and 2.8 months with cisplatin. Median survival
(intent to treat) was 7.4 months and 6.3 months, respectively. "One-year
survival is roughly 30% for gemcitabine/docetaxel," Dr. Lutz said.
He noted that toxicity in both arms is predictable and manageable.
"However," he said, "gemcitabine/docetaxel seems to have the favorable toxicity
profile." The docetaxel/gemcitabine combination will be tested against
gemcitabine alone in a randomized phase III trial.