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

AbstractBACKGROUND:
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.
AuthorsHenry Wang, Janice Ryu, David Gandara, Richard J Bold, Shiro Urayama, Michael Tanaka, Zelanna Goldberg, David Follette, Samir Narayan, Derick Lau
JournalJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 2 Issue 2 Pg. 153-7 (Feb 2007) ISSN: 1556-1380 [Electronic] United States
PMID17410032 (Publication Type: Clinical Trial, Phase II, Journal Article)
Chemical References
  • Carboplatin
  • Paclitaxel
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
  • Carboplatin (administration & dosage)
  • Combined Modality Therapy
  • Esophageal Neoplasms (drug therapy, radiotherapy, surgery)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel (administration & dosage)

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