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A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer

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Abstract

Purpose

Trastuzumab-based chemotherapy is usually administered through either a peripherally inserted central catheter (PICC) or a totally implanted vascular access device (PORT). As the most effective type of access is unknown, a feasibility trial, prior to conducting a large pragmatic trial, was undertaken.

Methods

The trial methodology utilized the integrated consent model incorporating oral consent. Patients receiving trastuzumab-based neo/adjuvant chemotherapy for early-stage breast cancer were randomized to a PICC or PORT insertion. Feasibility was reflected through a combination of endpoints; however, the a priori definition of feasibility was > 25% of patients approached agreed to randomization and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis.

Results

During the study period, 4/15 (26.7%) medical oncologists approached patients about study participation. Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8%) were randomized to PICC and 27 (48.2%) to PORT access. Overall, 17.2% (5/29) and 14.8% (4/27) of patients had at least one line-associated complication in the PICC and PORT arms respectively. The study was terminated early due to slow accrual.

Conclusion

The study met its feasibility endpoints with respect to patient and physician engagement. However, the slow rate of accrual (56 patients in 2 years) means that conducting a large pragmatic trial would require additional strategies to make such a study possible.

Trial registration

ClinicalTrials.gov Identifier: NCT02632435

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References

  1. Lipitz-Snyderman A et al (2015) Complications associated with use of long-term central venous catheters among commercially insured women with breast cancer. J Oncol Pract 11(6):505–510

    Article  Google Scholar 

  2. Chopra V, Anand S, Hickner A, Buist M, Rogers MA, Saint S, Flanders SA (2013) Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis. Lancet 382(9889):311–325

    Article  Google Scholar 

  3. LeVasseur N, Stober C, Daigle K, Robinson A, McDiarmid S, Mazzarello S, Hutton B, Joy A, Fergusson D, Hilton J, McInnes M, Clemons M (2018) Optimizing vascular access for patients receiving intravenous systemic therapy for early-stage breast cancer-a survey of oncology nurses and physicians. Curr Oncol 25(4):e298–e304

    CAS  PubMed  PubMed Central  Google Scholar 

  4. LeVasseur N, Stober C, Ibrahim M, Gertler S, Hilton J, Robinson A, McDiarmid S, Fergusson D, Mazzarello S, Hutton B, Joy AA, McInnes M, Clemons M (2018) Perceptions of vascular access for intravenous systemic therapy and risk factors for lymphedema in early-stage breast cancer—a patient survey. Curr Oncol 25(4):e305–e310

    CAS  PubMed  PubMed Central  Google Scholar 

  5. Krein SL et al (2019) Patient-reported complications related to peripherally inserted central catheters: a multicentre prospective cohort study. BMJ Qual Saf 28(7):574–581

    Article  Google Scholar 

  6. Robinson A et al (2018) Optimal vascular access strategies for patients receiving chemotherapy for early-stage breast cancer: a systematic review. Breast Cancer Res Treat:1–14

  7. Robinson A et al (2019) A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy. Breast Cancer Res Treat

  8. Hilton J et al (2016) Novel methodology for comparing standard-of-care interventions in patients with cancer. J Oncol Pract 12(12):e1016–e1024

    Article  Google Scholar 

  9. Basulaiman B et al (2019) Creating a pragmatic trials program for breast cancer patients: Rethinking Clinical Trials (REaCT). Breast Cancer Res Treat

  10. ClinicalTrials.gov. Randomized trial standard of care vascular access strategies for (neo)adjuvant trastuzumab-based breast cancer treatment (OTT 15-06) NCT02632435. 2015 [cited 2018 August 1]; Available from: https://clinicaltrials.gov/ct2/show/NCT02632435

  11. Kim SY, Miller FG (2014) Informed consent for pragmatic trials--the integrated consent model. N Engl J Med 370(8):769–772

    Article  CAS  Google Scholar 

  12. Sugarman J, Califf RM (2014) Ethics and regulatory complexities for pragmatic clinical trials. JAMA 311(23):2381–2382

    Article  CAS  Google Scholar 

  13. Singh KR, Agarwal G, Nanda G, Chand G, Mishra A, Agarwal A, Verma AK, Mishra SK, Goyal P (2014) Morbidity of chemotherapy administration and satisfaction in breast cancer patients: a comparative study of totally implantable venous access device (TIVAD) versus peripheral venous access usage. World J Surg 38(5):1084–1092

    Article  Google Scholar 

  14. Di Carlo I et al (2001) Totally implantable venous access devices implanted surgically: a retrospective study on early and late complications. Arch Surg 136(9):1050–1053

    Article  Google Scholar 

  15. Ozyuvaci E, Kutlu F (2006) Totally implantable venous access devices via subclavian vein: a retrospective study of 368 oncology patients. Adv Ther 23(4):574–581

    Article  Google Scholar 

  16. Aw A, Carrier M, Koczerginski J, McDiarmid S, Tay J (2012) Incidence and predictive factors of symptomatic thrombosis related to peripherally inserted central catheters in chemotherapy patients. Thromb Res 130(3):323–326

    Article  CAS  Google Scholar 

  17. Vescia S, Baumgärtner AK, Jacobs VR, Kiechle-Bahat M, Rody A, Loibl S, Harbeck N (2008) Management of venous port systems in oncology: a review of current evidence. Ann Oncol 19(1):9–15

    Article  CAS  Google Scholar 

  18. Showalter SL, Brown JC, Cheville AL, Fisher CS, Sataloff D, Schmitz KH (2013) Lifestyle risk factors associated with arm swelling among women with breast cancer. Ann Surg Oncol 20(3):842–849

    Article  Google Scholar 

  19. Piran S, Ngo V, McDiarmid S, le Gal G, Petrcich W, Carrier M (2014) Incidence and risk factors of symptomatic venous thromboembolism related to implanted ports in cancer patients. Thromb Res 133(1):30–33

    Article  CAS  Google Scholar 

  20. Suleman A et al (2019) Implanted vascular access device related deep vein thrombosis in oncology patients: a prospective cohort study. Thromb Res 177:117–121

    Article  CAS  Google Scholar 

  21. McDiarmid S, Scrivens N, Carrier M, Sabri E, Toye B, Huebsch L, Fergusson D (2017) Outcomes in a nurse-led peripherally inserted central catheter program: a retrospective cohort study. CMAJ Open 5(3):E535–e539

    Article  Google Scholar 

  22. Tolaney SM et al (2015) Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med 372(2):134–141

    Article  Google Scholar 

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Funding

Funding of this study was through the Rethinking Clinical Trials (REaCT program).

Author information

Authors and Affiliations

  1. Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada

    Mark Clemons, Anne Kehoe, Arif Awan & Bassam Basulaiman

  2. Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada

    Mark Clemons, Carol Stober, Deanna Saunders, Lisa Vandermeer & Sasha Mazzarello

  3. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada

    Mark Clemons, Brian Hutton & Dean Fergusson

  4. Department of Nursing, Ottawa General Hospital, Ottawa, Canada

    Debbie Bedard, Fiona MacDonald & Marie-Claude Brunet

  5. Division of Medical Oncology, Cancer Centre of Southeastern Ontario, Kingston, Canada

    Andrew Robinson

  6. Department of Medicine, University of Ottawa, Ottawa, Canada

    Ranjeeta Mallick, Brian Hutton & Dean Fergusson

Authors
  1. Mark Clemons
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  2. Carol Stober
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  3. Anne Kehoe
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  4. Debbie Bedard
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  5. Fiona MacDonald
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  6. Marie-Claude Brunet
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  7. Deanna Saunders
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  8. Lisa Vandermeer
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  9. Sasha Mazzarello
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  10. Arif Awan
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  11. Bassam Basulaiman
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  12. Andrew Robinson
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  13. Ranjeeta Mallick
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  14. Brian Hutton
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  15. Dean Fergusson
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Corresponding author

Correspondence to Mark Clemons.

Ethics declarations

We declare that this study complies with ethical standards in Canada. The study was approved by the provincial Research Ethics Board (Ontario Research Ethics Board, OCREB) and local REBs.

Conflict of interest

Dr. Awan reports participating in the Novartis Canada Advisory Board on the use of Ribociclib. Dr. Hutton reports personal fees from Cornerstone Research, outside the submitted work. The remaining authors declare that they have no conflicts of interest (Clemons, Stober, Kehoe, Bedard, MacDonald, Brunet, Saunders, Vandermeer, Mazzarello, Basulaiman, Robinson, Mallick, and Fergusson).

Research involving human participants

The study was approved by the appropriate institutional research ethics committees and was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Clemons, M., Stober, C., Kehoe, A. et al. A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer. Support Care Cancer 28, 4891–4899 (2020). https://doi.org/10.1007/s00520-020-05326-y

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  • DOI: https://doi.org/10.1007/s00520-020-05326-y

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