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

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

Apr 05, 2024 252 likes •478 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

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1

Role of radiation in resectable and locally advanced pancreatic cancer?

NO

Bassel F. El-Rayes

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2 Winship Cancer Institute | Emory University

Basic Principles

  • Clinical practice should be

based on data showing benefit

  • f an intervention
  • The only time we should add

treatment modality B to A is when the data clearly confirms A+B is better than A alone

  • Clinical practice should not be

based on absence of data showing futility

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Adjuvant Therapy

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4 Winship Cancer Institute | Emory University

Oettle H, et al. JAMA. 2013;310(14):1473-1481.

CONKO 001: Gemcitabine vs. Observation in Patients w ith Resected Pancreatic Cancer

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5 Winship Cancer Institute | Emory University

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.

CONKO-001 Randomized Trial

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6 Winship Cancer Institute | Emory University

Oettle H, et al. JAMA. 2013;310(14):1473-1481.

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7 Winship Cancer Institute | Emory University

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.

ESPAC-1: A Randomized Trial of Chemoradiotherapy and Chemotherapy after Resection of Pancreatic Cancer

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Neoptolemos JP, et al. N Engl J Med.2004;350(12):1200-1210.

Overall Survival ESPAC-1 Trial

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9 Winship Cancer Institute | Emory University

Neoptolemos JP, et al. Lancet. 2017;389(10073):1011-1024.

ESPAC 4: Gemcitabine vs Gemcitabine Capecitabine in Resected Pancreatic Cancer

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10 Winship Cancer Institute | Emory University

Survival by Treatment

Neoptolemos JP, et al. Lancet. 2017;389(10073):1011-1024.

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11 Winship Cancer Institute | Emory University

Survival by treatment ESPAC-4

Neoptolemos JP, et al. Lancet. 2017;389(10073):1011-1024.

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12 Winship Cancer Institute | Emory University

GITSG 91-73 Study EORTC 40891 ESPAC-1

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.

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13 Winship Cancer Institute | Emory University

RTOG 9704 ESPAC-4

Local Recurrence

Regine WF, et al. JAMA. 2008;299(9):1019-1026. Neoptolemos JP, et al. Lancet. 2017;389(10073):1011-1024.

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14 Winship Cancer Institute | Emory University

Survival Adjuvant Trials

Chemotherapy

  • CONKO-1
  • 22.8 months (Gem)
  • ESPAC-1
  • 20 months (5FU)
  • ESPAC-3
  • 23 months (5FU)
  • 23.6 months (Gem)
  • ESPAC-4
  • 25.5 moths (Gem)
  • 28.0 months (Gem Cap)

Chemoradiotherapy

  • ESPAC-1
  • 15.9 months (5FU XRT)
  • RTOG 9704 (HOP)
  • 20.5 months (Gem XRT)
  • 17.1 months (5FU XRT)
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15 Winship Cancer Institute | Emory University

R A N D O M I Z E R A N D O M I Z E R

E S T A G E

Gemcitabine Gemcitabine Erlotinib D I S E A S E F R E E Gemcitabine +/- Erlotinib Gemcitabine +/- Erlotinib

FP/XRT 5 cycles

RTOG 0848

1 cycle

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Locally advanced disease

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17 Winship Cancer Institute | Emory University

FFCD-SFRO Median OS- 8.6 months ECOG LAP-07 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.

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18 Winship Cancer Institute | Emory University

Suker M, et al. Lancet Oncol. 2016;17(6):801-810.

FOLFIRINOX for Locally Advanced Pancreatic Cancer

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19 Winship Cancer Institute | Emory University

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.

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20 Winship Cancer Institute | Emory University

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21 Winship Cancer Institute | Emory University

Basic Principles

  • Clinical practice should be

based on data showing benefit

  • f an intervention
  • The only time we should add

treatment modality B to A is when the data clearly confirms A+B is better than A alone

  • Clinical practice should not be

based on absence of data showing futility

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22 Winship Cancer Institute | Emory University

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