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Erasmus Medisch Centrum, Rotterdam Academisch Medisch Centrum, Amsterdam

Effect of preoperative concurrent chemoradiotherapy on survival of patients with resectable esophageal or esophagogastric junction cancer: Results from a multicenter randomized phase III study.

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Erasmus Medisch Centrum, Rotterdam Academisch Medisch Centrum, Amsterdam

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  1. Effect of preoperative concurrent chemoradiotherapy on survival of patients with resectable esophageal or esophagogastric junction cancer: Results from a multicenter randomized phase III study. A. van der Gaast, P. van Hagen, M. Hulshof, M.I. van Berge Henegouwen, G.A. Nieuwenhuijzen, J.T. Plukker, J.J. Bonenkamp, E.W. Steyerberg, H.W. Tilanus. CROSS study group

  2. Erasmus Medisch Centrum, Rotterdam Academisch Medisch Centrum, Amsterdam Catharina Ziekenhuis, Eindhoven UMC St. Radboudt, Nijmegen Universitair Medisch Centrum Groningen VU Medisch Centrum, Amsterdam Rijnstate Ziekenhuis, Arnhem CROSS study

  3. Background • The incidence of esophageal (adenocarcinomas) cancer increases • Despite careful preoperative staging in 20% - 30% an irradical resection is performed • A radical resection is a strong prognostic factor • Preoperative chemoradiotherapy may increase the number of radical resection and therefore the prognosis of these patients CROSS study

  4. Objectives Primary endpoints To compare median survival rates between patients treated for resectable esophageal adenocarcinoma or squamous cell carcinoma To compare quality of life before, during and after treatment Secondary endpoints To compare pathological responses To compare progression free survival To compare the number of R0 resections To compare treatment toxicity To compare costs CROSS study

  5. Eligibility criteria Major Inclusion criteria: Esophageal SCC or AC (cT1N1, T2-3Nx, M0) Adequate hematologic, renal, hepatic and pulmonary functions WHO 0, 1 or 2 Written informed consent Major exclusion criteria: T1N0 or M+ Tumor length > 8 cm Weight loss > 10% CROSS study

  6. Statification and statistical considerations • Stratification parameters • WHO performance • N- stage • Tumor type • Hospital • Sample size calculation • 16 versus 22 months median survival • 175 patients per treatment-arm CROSS study

  7. Accrual CROSS study

  8. Chemoradiotherapy treatment regimen • Chemoradiotherapy regimen: • Paclitaxel 50mg/m2 + Carboplatin AUC=2 on days 1, 8, 15, 22 and 29 • Concurrent radiotherapy of 41.4 Gy in 23 fractions of 1.8 Gy • Surgery within 6 weeks after completion of chemoradiotherapy (THE/TTE) CROSS study

  9. Baseline characteristics (1) CROSS study

  10. Baseline characteristics (2) CROSS study

  11. Baseline uTN-stage Number of patients TN-Stage CROSS study

  12. Delivery of treatment % • Number of courses: • 1 course = 175 pts • 2 courses = 172 pts • 3 courses = 172 pts • 4 courses = 167 pts • 5 courses = 163 pts • Number of operated patients: • CRT arm: 166/175 (95%) • Surgery arm: 184/188 (98%) CROSS study

  13. Toxicity of treatment (chemoradiotherapy) • Major toxicities (grade 3-5 CTC 3.0) • Hematologic: n=12 (6.8%) • Grade 3: n=12 • Grade 4: n=0 • Grade 5: n=0 • Non-hematologic: n=28 (16%) • Grade 3: n=26 • Grade 4: n=1 • Grade 5: n=1 CROSS study

  14. Resection rate and resection margins Resection rate of all randomised patients Surgery alone CRT + surgery 162/188 (86%) 157/175 (90%) Resection margins Surgery alone CRT + surgery R0 110 (67%) 145 (92.3%) p<0.002 R1 52 (33%) 12 (7.6%) R0 = no tumor within 1 mm of the resection margins CROSS study

  15. Pathology after CRT Pathologic complete response rate 32% in primary tumors (in 145 revised resection specimens of 158 in total) Number of patients TGR1: No vital cells (pCR) TGR2: <10% vital cells TGR3: 10-50% vital cells TGR4: >50% vital cells Tumor Regression Grade CROSS study

  16. Morbidity and Mortality (postoperative) Surgery alone CRT + Surgery Pulmonary complications 66% 69% Cardiac complications 24% 23% Chylothorax 8% 11% Mediastinitis 6% 4% Anastomotic leakage 25% 22% In-hospital mortality 7 (3.8%) 6 (3.4%) CROSS study

  17. Follow-up and survival • Median follow-up 32 months Surgery alone CRT + Surgery • 1 year survival rate 70% 82% • 2 year survival rate 52% 67% • 3 year survival rate 48% 59% • Median survival 26 months 49 months CROSS study

  18. Overall survival CRTx Surgery HR 0.67 95% CI (.49 - .91) P=0.012 HR 0.67 95% CI (0.49 - 0.91) No’s at risk Surgery alone CRT + surgery CROSS study

  19. HR’s (95% CI) for death according to baseline variables 0.67 (0.49 – 0.91) 0.49 (0.27 – 0.90) 0.72 (0.50 – 1.04) 0.62 (0.44 – 0.87) 0.92 (0.45 – 1.89) 0.82 (0.58 – 1.16) 0.34 (0.17 – 0.68) 0.67 (0.49 – 0.94) 0.67 (0.32 – 1.41) Favors preoperative CRT Favors surgery alone CROSS study

  20. CONCLUSION Neoadjuvant chemoradiotherapy with weekly administrations of carboplatin and paclitaxel and concurrent radiotherapy followed by surgery improves survival compared to surgery alone In this study we observed no increase in postoperative complications or postoperative mortality with preoperative chemoradiotherapy CROSS study

  21. We want to thank all our patients and families Acknowledgements CROSS study

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