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Poster display session

3257 - High thromboembolic event rate in patients with locally advanced esophageal cancer during perioperative therapy. A pre-planned analysis of the intergroup phase III trial SAKK 75/08.

Date

09 Sep 2017

Session

Poster display session

Topics

Oesophageal Cancer

Presenters

Martin Fehr

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

M. Fehr1, H. Hawle2, S. Hayoz2, P. Thuss-Patience3, S. Schacher4, J. Riera Knorrenschild5, D. Dürr6, W.T. Knoefel7, H. Rumpold8, M. Bitzer9, M. Zweifel10, P. Samaras11, U. Mey12, R. Winterhalden13, M. Kueng14, W. Eisterer15, V. Hess16, M. Gerard2, M. Stahl17, T. Ruhstaller1

Author affiliations

  • 1 Oncology/haematology, Cantonal Hospital St. Gallen, 9007 - St. Gallen/CH
  • 2 Coordinating Center, Swiss Group for Clinical Cancer Research (SAKK), 3008 - Bern/CH
  • 3 Medical Clinic Of Hematology, Oncology And Tumor Immunology, Charite University Medicine Berlin, 13353 - Berlin/DE
  • 4 Medical Oncology, Cantonal Hospital Winterthur, Winterthur/CH
  • 5 Haematology, Oncology And Immunology, University Clinic Giessen and Marburg, Marburg/DE
  • 6 Medical Oncology, Stadtspital Triemli, Zürich/CH
  • 7 Surgery, University Hospital Duesseldorf, 40225 - Duesseldorf/DE
  • 8 Medical Oncology, Krankenhaus der Barmherzigen Schwestern Linz (bhslinz), 4040 - Linz/AT
  • 9 Department Of Internal Medicine I Gastroenterology, Hepatology, Infectious Diseases, University Hospital Tuebingen, 72076 - Tübingen/DE
  • 10 Medical Oncology, Inselspital - Universitätsspital Bern, 3010 - Bern/CH
  • 11 Onkologie, University Clinic Zürich, Zürich/CH
  • 12 Hämatologie/onkologie, Cantonal Hospital Grisons, 7000 - Chur/CH
  • 13 Medical Oncology, Cantonal Hospital Lucerne, Luzern/CH
  • 14 Oncology-haematology, HFR Fribourg - Hopital Cantonal, 1700 - Fribourg/CH
  • 15 Haematology And Onkology, University Clinic Innsbruck, 6020 - Innsbruck/AT
  • 16 Medical Oncology, University Hospital Basel, 4031 - Basel/CH
  • 17 Clinic For Medical Oncology/haematology, Kliniken Essen Mitte, 45136 - Essen/DE
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Resources

Abstract 3257

Background

High rates of venous thromboembolic events (VTE) are reported for patients (pts) with upper GI-cancers (stomach, pancreas) and treatment with Cisplatin (Cis), but mainly in retrospective analyses and in advanced disease. A prospective analysis of VTE in pts with resectable esophageal cancer is warranted.

Methods

Pre-planned analysis of VTE in a multicenter phase III trial according to reported AEs and SAEs from start of preoperative treatment until 6 months postoperatively. Pts with resectable esophageal cancer (T2N1-3; T3-4aNx) received 2 cycles of induction chemotherapy (CT) with Docetaxel (Doc) 75mg/m2, Cis 75 mg/m2 followed by chemoradiation (CRT) with 45 Gy, Doc 20 mg/m2 and Cis 25 mg/m2 weekly and then surgery or were randomly assigned to the same treatment with addition of neoadjuvant and adjuvant cetuximab.

Results

Of 300 pts 29 VTE were reported in 26 pts with an incidence rate (IR) of 8.7%. 3 pts had 2 VTE. 72% (21/29) of all VTE occurred preoperatively. No significant difference between treatment arms was found, odds ratio (OR) 0.8 [95%CI 0.4-1.9], p = 0.7. Grades (G) of VTE according to CTCAE v4.0: 3% (1/29) G1, 41% (12/29) G2, 45% (13/29) G3 and 10% (3/29) G5. In a multivariable logistic regression including baseline hemoglobin, platelets, neutrophils, BMI, treatment arm and histology, only adenocarcinoma (IR 11.1%, 21/189) compared to squamous cell cancer (IR 4.5%, 5/111) was significantly associated with VTE-risk during treatment, OR 2.9 [95%CI 1.02;8.4], p = 0.046. Baseline Khorana risk score (KRS) for VTE was 0 in 73% (19/26), 1-2 in 23% (6/26) of pts and 3 in one patient with VTE (≥ 3 equal to high-risk and recommendation for prophylaxis). Median PFS in pts with VTE was 2.1 yrs vs. 2.5 yrs for pts without VTE.

Conclusions

This first prospective analysis of VTE in resectable esophageal cancer pts reveals a high IR during perioperative therapy of almost 9% comparable to high-risk pts according to KRS. Only one of these pts would have been identified by KRS as high-risk. Prophylactic anticoagulation balanced against individual bleeding risks could be considered in esophageal cancer pts treated with neoadjuvant Cis-based CT and RCT, especially in adenocarcinoma.

Clinical trial identification

NCT 01107639 (release date: April 20, 2010)

Legal entity responsible for the study

Swiss Group for clinical Cancer research (SAKK)

Funding

Merck KGaA, Darmstadt, Germany

Disclosure

P. Thuss-Patience: Advisory boards: Roche, BMS, Nordic, MSD, Pfizer, Lilly. Research funding: Novartis. M. Bitzer: Consulting/advisory boards: Bayer Healthcare, BMS. W. Eisterer: Advisory boards: Roche, Merck, Amgen, Lilly, Celgene. M. Stahl: Advisory board: MSD, Amgen, Sanofi, Servier. T. Ruhstaller: Advisory boards: Novartis, Roche, Astra-Zeneca. All other authors have declared no conflicts of interest.

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