HOUSTONIrinotecan (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.
"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(Drug information on irinotecan) at 70 mg/m² and cisplatin(Drug information on 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(Drug information on 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