FCCC LOGO Faculty Publications
Berger AC , Winter K , Hoffman JP , Regine WF , Abrams RA , Safran H , Freedman GM , Benson AB , MacDonald J , Willett CG
Five Year Results of US Intergroup/RTOG 9704 With Postoperative CA 19-9 <= 90 U/mL and Comparison to the CONKO-001 Trial
International Journal of Radiation Oncology Biology Physics. 2012 Nov;84(3) :E291-E297
PMID: WOS:000309560600005   
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Purpose: Radiation Therapy Oncology Group (RTOG) trial 9704 was the largest randomized trial to use adjuvant chemoradiation therapy for patients with pancreatic cancer. This report analyzes 5-year survival by serum level of tumor marker CA 19-9 of <= 90 vs >90 U/mL and compares results to the those of the CONKO-001 trial. Methods and Materials: CA 19-9 expression was analyzed as a dichotomized variable (<= 90 vs >90 U/mL). Cox proportional hazard models were used to identify the impact of the CA 19-9 value on overall survival (OS). Actuarial estimates of OS were calculated using the Kaplan-Meier method. Results: Both univariate (hazard ratio [HR] = 3.2; 95% confidence interval [CI], 2.3-4.3, P<.0001) and multivariate (HR = 3.1; 95% CI, 2.2-4.2, P<.0001) analyses demonstrated a statistically significant decrease in OS for CA 19-9 serum level of >= 90 U/mL. For patients in the gemcitabine (Gem) treatment arm with CA 19-9 <90 U/mL, median survival was 21 months. For patients with CA 19-9 >= 90 U/mL, this number dropped to 10 months. In patients with pancreatic head tumors in the Gem treatment arm with RT quality assurance per protocol and CA 19-9 of <90 U/mL, median survival and 5-year rate were 24 months and 34%. In comparison, the median survival and 5-year OS rate for patients in the Gem arm of the CONKO trial were 22 months and 21%. Conclusions: This analysis demonstrates that patients with postresection CA 19-9 values >= 90 U/mL had a significantly worse survival. Patients with pancreatic head tumors treated with Gem with CA 19-9 serum level of <90 U/ mL and per protocol RT had favorable survival compared to that seen in the CONKO trial. CA 19-9 is a stratification factor for the current RTOG adjuvant pancreas trial (0848). (c) 2012 Elsevier Inc.
Berger, Adam C. Winter, Kathryn Hoffman, John P. Regine, William F. Abrams, Ross A. Safran, Howard Freedman, Gary M. Benson, Alan B., III MacDonald, John Willett, Christopher G. 21 Elsevier science inc New york 017ai Retta e, 1987, cancer, v60, p2428