Japanese Journal of Clinical Oncology Advance Access published online on August 18, 2007
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hym076
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© 2007 Foundation for Promotion of Cancer Research
Neoadjuvant, Surgery and Adjuvant Chemotherapy without Radiation for Esophageal Cancer
1 Department of Surgical Oncology
2 Department of UMMG/UM Surgery
3 Department of Hematology/Oncology
4 Department of General Surgery
5 Division of Biostatistics
6 Department of Pathology, University of Miami
7 Sylvester Comprehensive Cancer Center, Division of Hematology and Oncology, Miami, Florida, USA
For reprints and all correspondence: Bach Ardalan, Sylvester Comprehensive Cancer Center, Division of Hematology and Oncology, Suite 3550, 1475 NW 12th Ave, Miami, FL 33136, USA. E-mail: bardalan{at}med.miami.edu
Received January 31, 2007; accepted April 19, 2007
Background: A phase II trial to evaluate neoadjuvant (NAD), surgery and adjuvant (AD) combination chemotherapy without radiation therapy (RT) for patients with esophageal adenocarcinoma staged with endoscopic ultrasound and CT as T3N1 was carried out.
Methods: Thirty-three eligible patients were enrolled. NAD therapy was administered in two 49-day cycles and included cisplatin, floxuridine, paclitaxel and leucovorin. Esophageal resection was performed followed by AD therapy.
Results: Thirty-three patients initiated NAD therapy; 10 experienced grade 3 and 4 toxicities, which included leucopenia, fatigue, nausea, diarrhea and stomatitis. Additionally, 16 patients experienced grade 1 and 2 hematologic and non-hematologic toxicities. Fifteen patients were down-staged, of whom five were T2, seven were T1, and three had nodal disease with no evidence of residual cancer in the esophageal bed. Fifteen patients remained T3, and two showed progressive disease. Thirty-two patients proceeded to surgery and 30 were resected. Although all resected patients were eligible for AD therapy, 15 did not receive it either because of patient refusal or surgeon recommendation. Fifteen patients received AD therapy: nine who had remained T3 and six who had down-staged. Three patients experienced grade 3 and 4 toxicities similar to those in NAD therapy. Six patients had grade 1 and 2 toxicities. Kaplan–Meier estimates of overall survival at 1, 3 and 5 years were 73% (95% CI: 58–88%), 52% (95% CI: 34–69%) and 29% (95% CI: 13–45%), respectively. Median survival was 42 months.
Conclusion: Deletion of RT may safely allow for more aggressive chemotherapy and increase chances of survival. The results need to be confirmed in a randomized phase II or larger phase III trial.
Key Words: GI-esophagus-med • chemo-phase I-II-III • GI-esophagus-surg • chemotherapy • esophageal cancer
This study has only been presented in part to American Society of Clinical Oncology. The content of this manuscript is original and does not directly or indirectly benefit financial interests of any of the authors.