Periop-01: A randomized controlled trial of extended perioperative tinzaparin to improve disease-free survival in patients with resectable colorectal cancer.-Reference-Cited by-同舟云学术

Periop-01: A randomized controlled trial of extended perioperative tinzaparin to improve disease-free survival in patients with resectable colorectal cancer.

Published:2022-02-01 Issue:4_suppl Volume:40 Page:124-124
ISSN:0732-183X
Container-title:Journal of Clinical Oncology
language:en
Short-container-title:JCO

Author:

Auer Rebecca Ann C¹,Karanicolas Paul Jack²,Ott Michael³,Brackstone Muriel⁴,Ashamalla Shady²,Asmis Timothy R.⁵,Boutros Marylise⁶,Caycedo Marulanda Antonio⁷,Jayaraman Shiva⁸,Jonker Derek J.¹,Moloo Husein⁹,Patel Sunil⁷,Spadafora Silvana¹⁰,MacLellan Steven¹¹,Mallick Ranjeeta¹²,Stotland Peter¹³,Tagalakis Vicky⁶,Trottier Daniel C.¹⁴,Weaver Joel¹⁵,Carrier Marc¹⁶

Affiliation:

1. Ottawa Hospital Research Institute, University Of Ottawa, Ottawa, ON, Canada;

2. Sunnybrook Health Sciences Centre, Odette Cancer Centre, University of Toronto, Toronto, ON, Canada;

3. Schulich School of Medicine, London Health Sciences Center, University of Western Ontario, London, ON, Canada;

4. Schulich School of Medicine, London Health Sciences Centre, University of Western Ontario, London, ON, Canada;

5. The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada;

6. Jewish General Hospital, McGill University, Montréal, QC, Canada;

7. Kingston Health Sciences Center, Queen's University, Kingston, ON, Canada;

8. St. Joseph's Health Center, University of Toronto, Toronto, ON, Canada;

9. The Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada;

10. Group Health Centre and Algoma Regional Cancer Program, Sault Ste. Marie, ON, Canada;

11. Humber River Hospital, University of Toronto, Toronto, ON, Canada;

12. Ottawa Hospital Research Institute, Ottawa, ON, Canada;

13. North York General Hospital, University of Toronto, Toronto, ON, Canada;

14. Montfort Hospital, Ottawa, ON, Canada;

15. Queensway Carleton Hospital, Ottawa, ON, Canada;

16. Ottawa Health Research Institute, University of Ottawa, Ottawa, ON, Canada;

Abstract

124 Background: Cancer patients undergoing surgical resection of their tumor are hypercoagulable beyond the period of hospitalization. Preclinical studies demonstrate that the postoperative hypercoagulable state promotes metastases, an effect that is abrogated by administration of perioperative low molecular-weight heparin (LMWH). Methods: We conducted a randomized, open label clinical trial to determine if extended duration thromboprophylaxis using subcutaneous LMWH (tinzaparin 4,500 IU daily), beginning at decision to operate and continuing for 56 days postoperatively, compared to inpatient postoperative thromboprophylaxis only, increased the 3-year disease-free survival (DSF) in patients undergoing resection for colorectal cancer. Secondary outcomes included 5-year overall survival (OS), postoperative bleeding and venous thromboembolism (VTE). Results: Trial recruitment was stopped prematurely after 614 of the planned 1075 patients were registered, following a pre-defined interim analysis for futility. The intention-to-treat analysis included 602 patients with demographics in the table. The 3-year DFS was 78.9% (63/299 recurrences) in the tinzaparin group and 80.5% (59/303 recurrences) in the control group (hazard ratio (HR) 1.09; [95% CI 0.91,1.31; p=0.3]). The 5-year OS was 91.3% in the tinzaparin group and 92.4% in the control group (HR 1.08; [95% CI 0.66,1.79; p=0.1]). The incidence of postoperative VTE was 1.7% and 1.3% in the tinzaparin and control groups, respectively (HR 1.3; [95% CI 0.30,5.69; p=0.7]. The incidence of major bleeding in the first postoperative week was 0.3% and 2% in the tinzaparin and control groups, respectively (HR 0.16; [95% CI 0.02,1.15; p=0.07]. Conclusions: Extended duration perioperative anticoagulation with tinzaparin did not improve DFS or OS in colorectal cancer patients undergoing surgical resection. The incidences of postoperative bleeding and VTE were low. Funded by Canadian Institute of Health Research and Leo Pharma Clinical trial information: NCT01455831. [Table: see text]

Funder

Canadian Institute of Health Research

Pharmaceutical/Biotech Company.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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