A phase II study of paclitaxel, carboplatin, and radiation with or without surgery for esophageal cancer.

BACKGROUND

Cisplatin-based chemoradiotherapy (CRT) has been a standard treatment for patients with locally advanced esophageal cancer. However, cisplatin is associated with significant toxicity. We conducted a phase II clinical trial of concurrent paclitaxel, carboplatin, and radiation with or without surgery as an alternative to the standard cisplatin-based CRT for localized and metastatic esophageal cancer.

METHODS

Fifty patients with esophageal cancer were enrolled: 16 patients with stage II, eight patients with stage III, and 26 patients with stage IV disease. Two thirds (67%) of patients had adenocarcinoma and one third (33%) with squamous histology. Patients with resectable disease were treated with paclitaxel 30 mg/m, twice weekly for 10 doses, carboplatin AUC (area under the curve) 1.5 weekly for five doses; and concurrent radiation, 1.8 Gy/day, for a total of 45 Gy, followed by esophagectomy. Without surgery, patients received an additional dose each of paclitaxel and carboplatin with concurrent radiation for a total of 50.4 Gy, followed by two consolidation cycles of paclitaxel (200 mg/m) and carboplatin (AUC 6).

RESULTS

During CRT, common stage III/IV toxicities included nausea/emesis (19%), esophagitis (9%), and neutropenia (4%). For consolidation chemotherapy, neutropenia (23%), neuropathy (8%) and nausea/emesis (4%) were the most common stage III/IV side effects. After CRT, 26% had a complete response, 17% had a partial response, and 41% had stable disease. Ninety-one percent of patients had clinical improvement of dysphagia. With a median follow-up of 32 months, the median survival was 12 months for patients with metastatic disease, 44 months for localized disease treated with esophagectomy, and >44 months for localized disease treated with definitive CRT.

CONCLUSIONS

The regimen of paclitaxel, carboplatin, and radiation with or without surgery is well tolerated with promising efficacy for patients with esophageal cancer.