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NO Bassel F. El-Rayes 1 Basic Principles Clinical practice - PowerPoint PPT Presentation

Apr 05, 2024 •252 likes •476 views

Role of radiation in resectable and locally advanced pancreatic cancer? NO Bassel F. El-Rayes 1 Basic Principles Clinical practice should be Clinical practice should not be based on data showing benefit based on absence of data of

  1. Role of radiation in resectable and locally advanced pancreatic cancer? NO Bassel F. El-Rayes 1

  2. Basic Principles • Clinical practice should be • Clinical practice should not be based on data showing benefit based on absence of data of an intervention showing futility • The only time we should add treatment modality B to A is when the data clearly confirms A+B is better than A alone Winship Cancer Institute | Emory University 2

  3. Adjuvant Therapy 3

  4. CONKO 001: Gemcitabine vs. Observation in Patients w ith Resected Pancreatic Cancer Oettle H, et al. JAMA . 2013;310(14):1473-1481. Winship Cancer Institute | Emory University 4

  5. CONKO-001 Randomized Trial Median DFS 13.4 months (95% CI, 11.6-15.3 months) gemcitabine Median OS 22.8 months (95% CI, 18.5-27.2 months) 6.7 months (95% CI, 6.0-7.5 months) observation 20.2 months (95% CI, 17.7-22.8 months) hazard ratio, 0.55 [95% CI, 0.44-0.69] hazard ratio, 0.76 [95% CI, 0.61-0.95] Oettle H, et al. JAMA . 2013;310(14):1473-1481. Winship Cancer Institute | Emory University 5

  6. Oettle H, et al. JAMA . 2013;310(14):1473-1481. Winship Cancer Institute | Emory University 6

  7. ESPAC-1: A Randomized Trial of Chemoradiotherapy and Chemotherapy after Resection of Pancreatic Cancer The Two-by-Two Randomization Procedure Used for Both Chemoradiotherapy and Chemotherapy. Neoptolemos JP, et al. N Engl J Med. 2004;350(12):1200-1210. Winship Cancer Institute | Emory University 7

  8. Overall Survival ESPAC-1 Trial Neoptolemos JP, et al. N Engl J Med. 2004;350(12):1200-1210.

  9. ESPAC 4: Gemcitabine vs Gemcitabine Capecitabine in Resected Pancreatic Cancer Neoptolemos JP, et al. Lancet. 2017;389(10073):1011-1024. Winship Cancer Institute | Emory University 9

  10. Survival by Treatment Neoptolemos JP, et al. Lancet. 2017;389(10073):1011-1024. Winship Cancer Institute | Emory University 10

  11. Survival by treatment ESPAC-4 Neoptolemos JP, et al. Lancet. 2017;389(10073):1011-1024. Winship Cancer Institute | Emory University 11

  12. EORTC 40891 ESPAC-1 GITSG 91-73 Study Kalser MH, et al. Arch Surg. 1986;121(9):1045. Smeenk HG, et al. Ann Surg. 2007;246(5):734-740. Neoptolemos JP, et al. N Engl J Med. 2004;350(12):1200-1210. Winship Cancer Institute | Emory University 12

  13. Local Recurrence RTOG 9704 ESPAC-4 Regine WF, et al. JAMA. 2008;299(9):1019-1026. Neoptolemos JP, et al. Lancet. 2017;389(10073):1011-1024. Winship Cancer Institute | Emory University 13

  14. Survival Adjuvant Trials Chemotherapy Chemoradiotherapy • CONKO-1 • ESPAC-1 • 22.8 months (Gem) • 15.9 months (5FU XRT) • ESPAC-1 • RTOG 9704 (HOP) • 20 months (5FU) • 20.5 months (Gem XRT) • 17.1 months (5FU XRT) • ESPAC-3 • 23 months (5FU) • 23.6 months (Gem) • ESPAC-4 • 25.5 moths (Gem) • 28.0 months (Gem Cap) Winship Cancer Institute | Emory University 14

  15. RTOG 0848 5 cycles 1 cycle D R R I Gemcitabine A A Gemcitabine S R +/- Erlotinib N N E E A D D S S O O T E M A M G I I F Gemcitabine Gemcitabine E R Z Z FP/XRT Erlotinib +/- Erlotinib E E E E Winship Cancer Institute | Emory University 15

  16. Locally advanced disease 16

  17. FFCD-SFRO ECOG LAP-07 Median OS- 8.6 months Median OS- 11.1 months Median OS- 15.2 months Gem ChemoRT Chauffert B, et al. Ann Oncol. 2008;19(9):1592-1599. Loehrer P, et al. J Clin Oncol. 2011;29(31):4105-4112. Hammel P, et al. JAMA . 2016;315(17):1844-1853. Winship Cancer Institute | Emory University 17

  18. FOLFIRINOX for Locally Advanced Pancreatic Cancer Suker M, et al. Lancet Oncol. 2016;17(6):801-810. Winship Cancer Institute | Emory University 18

  19. FOLFIRINOX for locally advanced pancreatic cancer • Median OS 24.2 months • Median PFS 15.0 months Suker M, et al. Lancet Oncol. 2016;17(6):801-810. Winship Cancer Institute | Emory University 19

  20. Winship Cancer Institute | Emory University 20

  21. Basic Principles • Clinical practice should be • Clinical practice should not be based on data showing benefit based on absence of data of an intervention showing futility • The only time we should add treatment modality B to A is when the data clearly confirms A+B is better than A alone Winship Cancer Institute | Emory University 21

  22. Conclusion • Chemotherapy is an established treatment in the adjuvant setting in pancreas cancer • Multiple randomized trials showing benefit with advantage for gemcitabine and capecitabine • NO well-designed and adequately powered randomized trial has shown benefit for adjuvant radiation therapy • Chemoradiotherapy in locally advanced disease results are mixed with NO clear advantage shown over chemotherapy • Intensification of chemotherapy appears to be a promising approach in this setting Winship Cancer Institute | Emory University 22

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