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Michael Stahl on behalf of the German Oesophageal Cancer Study Group

P re O perative Chemotherapy or Radiochemotherapy in E sophago-gastric Adenocarcinoma T rial POET. Michael Stahl on behalf of the German Oesophageal Cancer Study Group. German Oesophageal Cancer Study Group (GOeCSG). Kliniken Essen-Mitte University Clinic of Marburg

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Michael Stahl on behalf of the German Oesophageal Cancer Study Group

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  1. PreOperative Chemotherapy or Radiochemotherapy in Esophago-gastric Adenocarcinoma TrialPOET Michael Stahl on behalf of the German Oesophageal Cancer Study Group

  2. German Oesophageal Cancer Study Group(GOeCSG) • Kliniken Essen-Mitte • University Clinic of Marburg • University Clinic of Tuebingen • University Clinic of Dresden • Alfried Krupp Krankenhaus Essen • University Clinic of Duesseldorf • University Clinic of Essen • Städt. Klinikum Krefeld • University Clinic of Bonn • Krankenhaus St. Georg, Leipzig • Kaiserswerther Diakonie Düsseldorf • Marienhospital Düsseldorf • Klinikum Nürnberg Nord • Klinikum Kassel • Klinikum Oldenburg • Katholische Kliniken im Kreis Kleve • Knappschaft-Krankenhaus Bottrop • Phillippus-Stift Essen • Asklepios-Kliniken Bad Oldesloh

  3. POET GOeCSG Eligibility Criteria • Adenocarcinoma of the esophago-gastric junction (type I – III according to the Siewert classification) • Locally advanced stage uT3-T4 NX M0 (CT and EUS mandatory, diagnostic laparoscopy to detect peritoneal carcinosis, no PET)

  4. POET GOeCSG Rationale • Preoperative CTX will be a standard of care • Additional radiotherapy may increase rate of R0-resection, rate of pN0, and rate of major histologic response (phase II trial of the group) • This may increase the number of long term survivors

  5. POET GOeCSG Statistics • Additional radiotherapy will increase 3-year survival from 25% to 35% • 177 evaluable patients per arm needed (alpha level 5%, power 80%) • Stratification was done for center, type of AC, uT-stage, weight loss, and gender

  6. POET GOeCSG Endpoints • Primary endpoint • Overall survival • Secondary endpoints • Rate of R0-Resection • Rate of PCR • Postoperative Mortality • Local tumor control

  7. POET GOeCSG Recruitment • Opened to accrual December 2000 • Planned interim analysis October 2005 • Closed due to poor accrual December 2005 • 126 pts. randomized after stratification • 119 pts. eligible and evaluated • Arm A (CTX + S) 59 pts. • Arm B (CTX + CRTX + S) 60 pts.

  8. POET GOeCSG Treatment Arm A Week Arm B PLF II PLF III (3 weeks) PLF I Surgery 1 6 7 1314 17 20-21 15 x 2 Gy in 3 weeks Surgery PLF I PLF II PE (1 week) PLF: Cisplatin 50mg/m2, 1h, d 1,15,29. Leukovorin/5-FU 500mg/m2 2h / 2g/m2 24h, d 1,8,15,22,29,36 PE: Cisplatin 50 mg/m2, 1h, d 2+8. Etoposide 80 mg/m2, 1h, d 3-5

  9. POET GOeCSG Typical Radiation Field in EGJ-Cancer Type I

  10. POET GOeCSG Patient Characteristics Arm A Arm B (N=59) (N=60) uT3 / T4 54 / 5 55 / 5 AEG I / II-III 32 / 27 33 / 27 Weight loss </>10% 43 / 16 44 /16 Male / female 54 / 5 54 / 6 WHO PS 0 / 1 38 / 17 # 33 / 24 # Age (years) 56.0 60.6 * * Mann-Whitney p = 0.005 # unknown in 7 pts.

  11. POET GOeCSG Compliance to Treatment Arm A Arm B Started treatment (n) 59 59 Completed part 1 73% 70% Completed part 2 66% 70% Underwent surgery 88% 83%

  12. POET GOeCSG Results at Surgery Arm A Arm B (n=59) (n=60) • Patients with S 88.1% 81.7% • R0-Resection 69.5% 71.7% • R1/R2 13.6% 3.3% • Exploration (n) 3 4 peritoneal mets 2 peritoneal mets 3 unresect. 1 hepatic mets 1

  13. POET GOeCSG Pathohistologic Results Arm A Arm B p (n=49) (n=45) T0N0M0 2.0% 15.6% 0.03 T1-4N0M0 34.7% 48.9% T0-4N0M0 36.7% 64.4% 0.01 T0-4N+M0 55.1 % 31.1% T1-4N+M1 8.2% 4.4%

  14. POET GOeCSG Mortality after Surgery Arm A Arm B (n=52) (n=49) Hospital mortality 2 (3.8%) 5 (10.2%)* Pneumonia 1 2 Anastom. leakage 1 2 Kardiac shock 0 1 * Fisher´s exact p = 0.26

  15. POET GOeCSG Overall Survival Logrank p = 0.07 HR Arm B vs. A 0.67 (0.41-1.07) Arm B 47.4% Arm A 27.7% Follow-up 45.6 mo

  16. Freedom from Local Tumor Progression Arm B 76.5% Logrank p = 0.06 HR Arm B vs. A 0.45 (0.19 -1.05) 59.0% Arm A POET GOeCSG

  17. POET GOeCSG Survival Arm A Arm B Difference 2 year survival 43.1% 61.9% 18.8% 3 year survival 27.7% 47.4% 19.7% (14.7-42.3) (32.8-60.7) Median survival 21.1 mo 33.1 mo 12 mo Median follow-up 45.2 mo 46.2 mo 1 mo

  18. POET GOeCSG POET - Conclusions • There is a strong trend for improved survival by adding radiotherapy to preoperative chemotherapy • Statistical significance was not reached in our trial due to low number of patients randomized • These results are in line with other published phase II-III trials investigating perioperative chemoradiation in EG-junction cancer

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