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Irinotecan/Cisplatin Studied as Initial and as Second-Line Treatment in Upper GI Cancers

Irinotecan/Cisplatin Studied as Initial and as Second-Line Treatment in Upper GI Cancers

HOUSTON—Irinotecan (Camptosar)/cisplatin (Platinol) is being studied as
induction therapy for carcinoma of the esophagus and in a separate trial as
second-line therapy of advanced gastric carcinoma. Jaffer A. Ajani, MD,
professor of medicine at the University of Texas M. D. Anderson Cancer Center
in Houston, Texas, presented information on the two trials.

Induction Therapy

"In the first trial we adopted a strategy of treating patients who have
localized carcinoma of the esophagus with induction chemotherapy followed by
chemoradiation and then surgery," Dr. Ajani explained. "Patients
accrued in this study are patients with adenocarcinoma or squamous cell
carcinoma and local-regional disease. Every patient has an endoscopic
ultrasonography for staging. Patients with T-1, N0, or T4 disease were not
eligible. Patients with any M-1 disease were not eligible. T2, N0 patients were
eligible because their natural history is extremely poor."

Induction chemotherapy included irinotecan at 70 mg/m² and cisplatin at 20
mg/m², each given 1 day per week for 2 weeks followed by 1 week off. "One
complete cycle equals 6 weeks. Patients get four doses of this combination.
Patients that have any evidence of improvement get the second cycle, so
induction chemotherapy in some patients can be as long as 12 weeks," Dr.
Ajani said.

When this trial was conceived, phase I data on irinotecan chemoradiation
were not available, so radiation was combined with 5-fluorouracil (5-FU) at 300
mg/m² for 5 days, Monday through Friday, and 5 doses of paclitaxel at 50
mg/m²,
usually on Mondays. Patients are restaged 5 weeks after end of chemoradiation
and then taken to surgery.

Dr. Ajani reported that this study has been completed, and data are being
analyzed. "We registered 43 patients, mostly men and mostly with
adenocarcinoma of the distal esophagus. Only 3 patients had mid-esophageal
lesions. Most patients (84%) had T-3 lesions, and most had N positive disease.
We are starting to biopsy all lymph nodes, so I expect this number to rise in
future studies. Five-millimeter lymph nodes are often designated as negative,
but our endoscopists are now able to biopsy celiac nodes or para-aortic nodes,
so I think the staging procedure is going to get better," Dr. Ajani said.

Strategy Is Feasible

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