1 / 15

Michael Stahl on behalf of the German Oesophageal Cancer Study Group

Abstract No 4530, Poster No 18. Long term results of a phase III study investigating chemoradiation with and without surgery in locally advanced squamous cell carcinoma of the esophagus. Michael Stahl on behalf of the German Oesophageal Cancer Study Group.

ronald
Download Presentation

Michael Stahl on behalf of the German Oesophageal Cancer Study Group

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Abstract No 4530, Poster No 18 Long term results of a phase III study investigating chemoradiation with and without surgery in locally advanced squamous cell carcinoma of the esophagus Michael Stahl on behalf of the German Oesophageal Cancer Study Group

  2. Participating CentersGerman Oesophageal Cancer Study Group • Essen (KEM, AKK, University, EKK) • Düsseldorf (University) • Tübingen (University) • Marburg (University) • Duisburg (St.J., Städt.) • Trier (KB) • Berlin (RRK) • Göttingen (University) • Mönchengladbach (Franz.)

  3. Eligibility Criteria • SCC of the intrathoracic esophagus • Stage T3-4 N0-1 M0 according to CT und EUS • Medically fit for surgery, PS 0-1 • Age up to 70 years • Written informed consent

  4. Flow Diagram of Patients included Excluded (not meeting inclusion criteria) n = 5 Assessed for eligibility n = 189 Refused randomisation n = 12 Treated A n = 7 Treated B n = 5 Randomised n = 172 Allocated to Arm A n = 86 Allocated to Arm B n = 86 Stahl M, et al JCO 23:2310-7, 2005 Treated n = 86 Treated n = 85

  5. Stratification Criteria • Center • Gender • Weight loss (up to vs. above 10% of BW) • Complete EUS • Stage (T3N0 vs. T3N+ vs. T4)

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

  7. Statistical design • Test for equivalence between arms Id<15%I - H0: 35% 2y-survival in Arm A; >20% Arm B • N= 175 , power of 80%, a=0.05

  8. Results at Surgery • Surgery 62 patients • Resection 55 / 62 (89%) • R0 51 / 62 (82%) ypT0 N0 M0 18 / 51 (35%) ypT1-3 N0 M0 17 / 51 (33%) ypT1-3 N1 M0 9 / 51 (18%) ypT1-3 N0-1 M1 7 / 51 (14%)

  9. Surgical Procedures • Exploration 7 /62 • Resection 55/62 (89%) • TTE 49/55 (89%) • THE 4/55 • Other 1/55 • Unknown 1/55

  10. Treatment Related Mortality CTX CRTX Surgery Arm A 2/86(2.2%) 0 7/57(12.3%) Arm B 2/85(2.3%) 0 0/5 all 4/171(2.3%) 0 7/62(11.3%) Overall 8.2%, including 3 pts. with late toxicity

  11. Patterns of Failure(treatment according to protocol) Arm A* Arm B* Any failure 31/56 (55%) 57/83 (69%) Local+regional 14/31 (45%) 41/57 (72%) Distant (only) 16/31 (52%) 14/57 (25%) Unknown 1/31 ( 3%) 2/57 ( 3%) * Arm A: CRTX (at least 36 Gy) + Resection, Arm B: CRTX (at least 59 Gy)

  12. Overall Survival (JCO 2005) Log-rank for equivalence p = 0.04 2-YSR 38.8% vs. 35.4%

  13. Overall Survival (December 2007) 5-YSR 27.9% vs. 17.0% Calculated 10-YSR 19.2% vs 12.2% Logrank p=0.36 HR 1.15 (0.82-1.61) • CRTX with Surgery • CRTX alone

  14. Survival as treated (no crossover) 5-YSR 28.0% vs. 17.0% Calculated 10-YSR 19.8% vs 12.9% Logrank p=0.48 HR 1.13 (0.79-1.61)

  15. Cox Regression Analysis Progn. Factor HR (95%CI) p-value CTX-Response (y/n) 0.30 0.19-0.48 <0.0001 Treatment group (A/B) 1.19 0.80-1.76 0.39 Gender (m/f) 1.06 0.65-1.73 0.82 EUS complete (y/n) 0.91 0.61-1.35 0.64 Weight loss (</>10%) 1.19 0.76-1.85 0.45 Stage (T3N1/T3N0) 1.02 0.61-1.70 0.94 Stage (T4NX/T3N0) 1.01 0.52-1.97 0.97

More Related