Phase II Randomized Study of Two Regimens of Sequentially Administered Mitomycin C and Irinotecan in Patients with Unresectable Esophageal and Gastroesophageal Adenocarcinoma
| Autor: | Abbas Abbas, Barbara McCracken-Bussa, Maryam B. Lustberg, Miguel A. Villalona-Calero, Tanios Bekaii-Saab, Mark E. Lustberg, Gregory A. Otterson, William E. Burak, Donn C. Young |
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| Rok vydání: | 2010 |
| Předmět: |
Male
Lung Neoplasms Esophageal Neoplasms Gastroesophageal Junction Adenocarcinoma Gastroenterology law.invention 0302 clinical medicine Randomized controlled trial law Mitomycin C Antineoplastic Combined Chemotherapy Protocols Stage (cooking) 0303 health sciences Liver Neoplasms Middle Aged Esophageal cancer 3. Good health Topoisomerase I Survival Rate Treatment Outcome Oncology Lymphatic Metastasis 030220 oncology & carcinogenesis Carcinoma Squamous Cell Female Esophagogastric Junction medicine.drug Pulmonary and Respiratory Medicine medicine.medical_specialty Mitomycin Bone Neoplasms Adenocarcinoma Irinotecan Article 03 medical and health sciences Stomach Neoplasms Internal medicine Gastroesophageal adenocarcinoma medicine Carcinoma Humans Survival rate Neoplasm Staging 030304 developmental biology business.industry medicine.disease Surgery Camptothecin business |
| Zdroj: | Journal of Thoracic Oncology. 5(5):713-718 |
| ISSN: | 1556-0864 |
| DOI: | 10.1097/jto.0b013e3181d7776d |
| Popis: | Background Based on the observation of topoisomerase-1, upregulation by mitomycin C (MMC), and the phase I antitumor activity of sequential MMC/irinotecan in esophageal cancer, we conducted a phase II evaluation of two schedules of this combination in previously untreated stage III/IV esophageal/gastroesophageal junction adenocarcinomas. Patients and Methods Patients ( n = 76) were randomized to either 6 mg/m 2 MMC on day 1 and 125 mg/m 2 irinotecan on days 2 and 9 (arm A) or 3 mg/m 2 MMC on days 1 and 8 and 125 mg/m 2 irinotecan on days 2 and 9 (arm B). Each cycle was repeated every 28 days. Restaging was planned after two cycles, and resections were performed whenever possible. A two-stage Simon minimax design was used for each arm, with a "pick-the-winner" approach based on efficacy. Results The response rate (complete response + partial response) in 73 evaluable patients was 52% (21 of 40 patients) for arm A and 33% (11/33) for arm B. Moderate or severe toxicity was similar. Twenty-seven patients were resected (20:7, arm A:B). There was one complete pathologic response; five others were node negative. Conclusion Irinotecan/MMC is feasible in esophageal/gastroesophageal junction adenocarcinoma. MMC (6 mg/m 2 ) every 28 days for up to six cycles is the recommended modulatory dose for irinotecan in future trials. |
| Databáze: | OpenAIRE |
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