Phase II Trial of 96-Hour Paclitaxel in Previously Treated Patients with Advanced Esophageal Cancer

• Published in: Cancer investigation 2003, Vol.21 (4), p.512-516
• Main Authors: Anderson, Sibyl E., O'Reilly, Eileen M., Kelsen, David P., Ilson, David H.
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Adult; Aged; Antineoplastic agents; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Agents, Phytogenic - adverse effects; Antineoplastic Agents, Phytogenic - pharmacology; Biological and medical sciences; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Chemotherapy; Disease Progression; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - pathology; Female; Humans; Infusions, Intravenous; Male; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Paclitaxel - pharmacology; Pharmacology. Drug treatments; Treatment Outcome
• ISSN: 0735-7907; 1532-4192
• DOI: 10.1081/CNV-120022360

Background. A 96-hour infusion schedule of paclitaxel demonstrates tolerability and antitumor activity in lung cancer and breast cancer refractory to short-duration infusion paclitaxel. Given the activity of paclitaxel in esophageal cancer, a phase II trial of 96-hour infusion paclitaxel in esophageal cancer was undertaken. Methods. Both adenocarcinoma and squamous cell histology were included. Paclitaxel was administered at 140 mg m2 over 96 hours every 21 days. Patients who had metastatic disease to the liver and transaminases greater than two times normal value received 120 mg m2. Response to treatment was evaluated after the first two cycles and subsequently every third cycle. Results. Ten men and four women were entered. All were eligible for response and had stage IV disease. Thirteen patients were previously treated. All 13 received prior short-duration paclitaxel-containing chemotherapy regimens. Eleven patients had adenocarcinoma and three squamous cell cancer. Patients completed a mean of two cycles (range one to eight) prior to disease progression. No major responses were observed. Toxicity was minimal and included grade 3 4 neutropenia in 14% of patients. One patient with adenocarcinoma demonstrated stable disease for 28 weeks. Conclusion. No major activity was observed in a population of previously treated patients. Ninety-six-hour paclitaxel in metastatic esophageal cancer is generally well tolerated with minimal toxicity; however, it is ineffective in previously treated patients. Further evaluation of this schedule of paclitaxel in combination with concurrent radiotherapy, where its radiosensitizing potential may be useful, is ongoing in locally advanced esophageal cancer.