1. Gefitinib in definitive management of esophageal or gastroesophageal junction cancer: a retrospective analysis of two clinical trials.
- Author
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Sohal, D. P. S., Rice, T. W., Rybicki, L. A., Rodriguez, C. P., Videtic, G. M. M., Saxton, J. P., Murthy, S. C., Mason, D. P., Phillips, B. E., Tubbs, R. R., Plesec, T., McNamara, M. J., Ives, D. I., Bodmann, J. W., and Adelstein, D. J.
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ESOPHAGOGASTRIC junction cancer , *ADENOCARCINOMA , *GEFITINIB , *EPIDERMAL growth factor receptors , *CANCER radiotherapy , *CANCER chemotherapy , *RETROSPECTIVE studies , *CLINICAL trials , *CANCER treatment , *THERAPEUTICS - Abstract
The role of epidermal growth factor receptor inhibition in resectable esophageal/gastroesophageal junction ( E/GEJ) cancer is uncertain. Results from two Cleveland Clinic trials of concurrent chemoradiotherapy ( CCRT) and surgery are updated and retrospectively compared, the second study differing only by the addition of gefitinib ( G) to the treatment regimen. Eligibility required a diagnosis of E/GEJ squamous cell or adenocarcinoma, with an endoscopic ultrasound stage of at least T3, N1, or M1a ( American Joint Committee on Cancer 6th). Patients in both trials received 5-fluorouracil (1000 mg/m2/day) and cisplatin (20 mg/m2/day) as continuous infusions over days 1-4 along with 30 Gy radiation at 1.5 Gy bid. Surgery followed in 4-6 weeks; identical CCRT was given 6-10 weeks later. The second trial added G, 250 mg/day, on day 1 for 4 weeks, and again with postoperative CCRT for 2 years. Preliminary results and comparisons have been previously published. Clinical characteristics were similar between the 80 patients on the G trial (2003-2006) and the 93 patients on the no- G trial (1999-2003). Minimum follow-up for all patients was 5 years. Multivariable analyses comparing the G versus no- G patients and adjusting for statistically significant covariates demonstrated improved overall survival (hazard ratio [ HR] 0.64, 95% confidence interval [ CI] = 0.45-0.91, P = 0.012), recurrence-free survival ( HR 0.61, 95% CI = 0.43-0.86, P = 0.006), and distant recurrence ( HR 0.68, 95% CI = 0.45-1.00, P = 0.05), but not locoregional recurrence. Although this retrospective comparison can only be considered exploratory, it suggests that G may improve clinical outcomes when combined with CCRT and surgery in the definitive treatment of E/GEJ cancer. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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