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Comparing patients’ and clinicians’ assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial)

  • Epidemiology
  • Published:
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Abstract

The RACS sentinel node biopsy versus axillary clearance (SNAC) trial compared sentinel-node-based management (SNBM) and axillary lymph-node dissection (ALND) for breast cancer. In this sub study, we sought to determine whether patient ratings of arm swelling, symptoms, function and disability or clinicians’ measurements were most efficient at detecting differences between randomized groups, and therefore, which of these outcome measures would minimise the required sample sizes in future clinical trials. 324 women randomised to SNBM and 319 randomised to ALND were included. The primary endpoint of the trial was percentage increase in arm volume calculated from clinicians’ measurements of arm circumference at 10 cm intervals. Secondary endpoints included reductions in range of motion and sensation (both measured by clinicians); and, patients’ ratings of arm swelling, symptoms and quality of life, using the European Organisation for Research and Treatment of Cancer Breast Cancer Module (EORTC QLM-BR23), the body image after breast cancer questionnaire (BIBC) and the SNAC study specific scales (SSSS). The relative efficiency (RE, the squared ratio of the test statistics, with 95% confidence intervals calculated by bootstrapping) was used to compare these measures in detecting differences between the treatment groups. Patients’ self-ratings of arm swelling were generally more efficient than clinicians’ measurements of arm volume in detecting differences between treatment groups. The SSSS arm symptoms scale was the most efficient (RE = 7.1) The entire SSSS was slightly less so (RE = 4.6). Patients’ ratings on single items were 3–5 times more efficient than clinicians’ measurements. Primary endpoints based on patient-rated outcome measures could reduce the required sample size in future surgical trials.

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Author information

Authors and Affiliations

  1. NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW, 1450, Australia

    Michaella J. Smith, Tatiana Sourjina, Val Gebski, Xanthi Coskinas, R. John Simes & Martin R. Stockler

  2. Breast, Endocrine and Surgical Oncology Unit, Royal Adelaide Hospital, Adelaide, SA, Australia

    P. Grantley Gill & James Kollias

  3. Wesley Hospital, Brisbane, QLD, Australia

    Neil Wetzig

  4. New South Wales Breast Cancer Institute, Westmead Hospital, University of Sydney, Sydney, Australia

    Owen Ung

  5. Waikato Hospital, Waikato, New Zealand

    Ian Campbell

  6. Breast Cancer Network, Camberwell, VIC, Australia

    Avis Macphee

  7. Consumer advisory panel, ANZ Breast Cancer Trials Group, New Castle, NSW, Australia

    Leonie Young

Authors
  1. Michaella J. Smith
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  2. P. Grantley Gill
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The Royal Australasian College of Surgeons SNAC Trial Group

Corresponding author

Correspondence to Michaella J. Smith.

Appendix

Appendix

Comparison of the relative efficiency of arm volume measurements with the SNAC study specific scales for those patients with complete data and those with incomplete data available.

 

Outcome measure

All patients

Patients with complete data

MWW, P-value for difference between groups

MWW, z-score for difference between groups

Relative efficiencya (95% CI)

Required sample size

MWW, P-value for difference between groups

MWW, z-score for difference between groups

Relative efficiencya (95% CI)

Required sample size

Rated by clinicians

    % Increase in arm vol

0.001

3.3

1

1,000

0.008

2.7

1

1,000

Rated by patients

    Arm disability subscale (3 items)

0.1

3.0

0.8 (0.2–4)

1,220

0.01

2.6

0.9 (0.1–7)

1,090

    Arm dysfunction subscale (4 items)

0.006

3.5

1.1 (0.3–5)

880

0.001

3.3

1.5 (0.3–10)

680

    SNAC study specific scales (15 items)

<0.0001

6.3

3.7 (1.4–15)

270

<0.0001

5.8

4.6 (2.0–28)

220

    Single arm swelling item “Arm swelling—how much has this aspect troubled you over the last 4 weeks”

<0.0001

6.6

4.0 (1.7–16)

250

<0.0001

6.0

5 (1.7–30)

200

    Arm symptoms subscale (7 items)

<0.0001

7.7

5.4 (2.3–22)

180

<0.0001

7.2

7.1 (2.6–46)

140

  1. aRelative efficiency compared with percentage increase in arm volume
  2. >1 = More efficient, <1 = Less efficient

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Smith, M.J., Gill, P.G., Wetzig, N. et al. Comparing patients’ and clinicians’ assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial). Breast Cancer Res Treat 117, 99–109 (2009). https://doi.org/10.1007/s10549-008-0202-3

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