In appropriate doses, continuous infusion of paclitaxel and cisplatin along with radiation is safe and tolerable in patients with localized esophageal cancer, according to the results of a phase ! trial reported in the January 1st issue of the Journal of Clinical Oncology.
Dr. David P. Kelsen of Memorial Sloan-Kettering Cancer Center, New York and colleagues note that the most commonly used regimen for patients with esophageal cancer combines cisplatin and fluorouracil along with radiation. However, limited efficacy and substantial toxicity have led to study of other agents.To examine potentially suitable doses of paclitaxel and cisplatin in combination with radiotherapy, the researchers studied 34 patients with advanced esophageal cancer and 3 with local recurrence or positive resection margins.Chemotherapy consisted of weekly 96-hour infusions of paclitaxel. Dosage escalated from 10 to 80 mg per square meter over the course of the 6-week study. Cisplatin was given as a 30-mg per square meter weekly bolus. The patients also received radiation therapy.Toxicity requiring a treatment break of more than 2 weeks was seen in one patient on the maximum dose of paclitaxel. Other events requiring treatment interruption also occurred mostly at that dosage.At the 60-mg per square meter level, the researchers found that myelosuppression, mainly neutropenia, was relatively mild and transient. Other events such as esophagitis and peripheral neuropathy were uncommon.The team concludes that the recommended dose of paclitaxel in this regimen should be 60-mg per square meter per week.Follow-up, they add, showed “encouraging” anti-tumor efficacy. There was a pathological complete response rate of 24%, a 72% complete resection rate and a 43% 3-year survival.(Source: J Clin Oncol 2004;52:45-52: Reuters Health: January 22, 2004: Oncolink)