Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: First results of International Breast Cancer Study Group trial 10-93

Carl Magnus Rudenstam, David Zahrieh, John F. Forbes, Diana Crivellari, Stig B. Holmberg, Piercarlo Rey, David Dent, Ian Campbell, Jürg Bernhard, Karen N. Price, Monica Castiglione-Gertsch, Aron Goldhirsch, Richard D. Gelber, Alan S. Coates

Research output: Contribution to journalArticle

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Abstract

Purpose: Axillary clearance in early breast cancer aims to improve locoregional control and provide staging information but is associated with undesirable morbidity. We therefore investigated whether avoiding axillary surgery in older women would result in improved quality of life (QL) with similar disease-free survival (DFS) and overall survival (OS). Patients and Methods: Between 1993 and 2002, women ≥ 60 years old with clinically node-negative operable breast cancer in whom adjuvant tamoxifen was considered indicated regardless of pathologic nodal status were randomly assigned to primary surgery plus axillary clearance (Sx + Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam for 5 consecutive years. The primary end point was QL reported by the patient and by physician assessment. Results: A total of 473 patients (234 to Sx + Ax, 239 to Sx) were randomly assigned. The median age was 74 years; 80% had estrogen receptor-positive disease. In both the patients' subjective assessment of their QL and the physicians' perception of the patients' QL, the largest adverse QL effects of Ax were observed from baseline to the first postoperative assessment, but the differences tended to disappear in 6 to 12 months. At a median follow-up of 6.6 years, results for Sx + Ax and Sx yielded similar DFS (6-year DFS, 67% v 66%; hazard ratio [HR] Sx + Ax/Sx, 1.06; 95% CI, 0.79 to 1.42; P = .69) and OS (6-year OS, 75% v 73%; HR Sx + Ax/Sx, 1.05; 95% CI, 0.76 to 1.46; P = .77). Conclusion: Avoiding axillary clearance for women ≥ 60 years old who have clinically node-negative disease and receive Tam for endocrine-responsive disease yields similar efficacy with better early QL.

Original languageEnglish (US)
Pages (from-to)337-344
Number of pages8
JournalJournal of Clinical Oncology
Volume24
Issue number3
DOIs
StatePublished - Jan 20 2006
Externally publishedYes

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Quality of Life
Tamoxifen
Breast Neoplasms
Disease-Free Survival
Survival
Physicians
Endocrine System Diseases
Estrogen Receptors
Morbidity

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer : First results of International Breast Cancer Study Group trial 10-93. / Rudenstam, Carl Magnus; Zahrieh, David; Forbes, John F.; Crivellari, Diana; Holmberg, Stig B.; Rey, Piercarlo; Dent, David; Campbell, Ian; Bernhard, Jürg; Price, Karen N.; Castiglione-Gertsch, Monica; Goldhirsch, Aron; Gelber, Richard D.; Coates, Alan S.

In: Journal of Clinical Oncology, Vol. 24, No. 3, 20.01.2006, p. 337-344.

Research output: Contribution to journalArticle

Rudenstam, CM, Zahrieh, D, Forbes, JF, Crivellari, D, Holmberg, SB, Rey, P, Dent, D, Campbell, I, Bernhard, J, Price, KN, Castiglione-Gertsch, M, Goldhirsch, A, Gelber, RD & Coates, AS 2006, 'Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: First results of International Breast Cancer Study Group trial 10-93', Journal of Clinical Oncology, vol. 24, no. 3, pp. 337-344. https://doi.org/10.1200/JCO.2005.01.5784
Rudenstam, Carl Magnus ; Zahrieh, David ; Forbes, John F. ; Crivellari, Diana ; Holmberg, Stig B. ; Rey, Piercarlo ; Dent, David ; Campbell, Ian ; Bernhard, Jürg ; Price, Karen N. ; Castiglione-Gertsch, Monica ; Goldhirsch, Aron ; Gelber, Richard D. ; Coates, Alan S. / Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer : First results of International Breast Cancer Study Group trial 10-93. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 3. pp. 337-344.
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abstract = "Purpose: Axillary clearance in early breast cancer aims to improve locoregional control and provide staging information but is associated with undesirable morbidity. We therefore investigated whether avoiding axillary surgery in older women would result in improved quality of life (QL) with similar disease-free survival (DFS) and overall survival (OS). Patients and Methods: Between 1993 and 2002, women ≥ 60 years old with clinically node-negative operable breast cancer in whom adjuvant tamoxifen was considered indicated regardless of pathologic nodal status were randomly assigned to primary surgery plus axillary clearance (Sx + Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam for 5 consecutive years. The primary end point was QL reported by the patient and by physician assessment. Results: A total of 473 patients (234 to Sx + Ax, 239 to Sx) were randomly assigned. The median age was 74 years; 80{\%} had estrogen receptor-positive disease. In both the patients' subjective assessment of their QL and the physicians' perception of the patients' QL, the largest adverse QL effects of Ax were observed from baseline to the first postoperative assessment, but the differences tended to disappear in 6 to 12 months. At a median follow-up of 6.6 years, results for Sx + Ax and Sx yielded similar DFS (6-year DFS, 67{\%} v 66{\%}; hazard ratio [HR] Sx + Ax/Sx, 1.06; 95{\%} CI, 0.79 to 1.42; P = .69) and OS (6-year OS, 75{\%} v 73{\%}; HR Sx + Ax/Sx, 1.05; 95{\%} CI, 0.76 to 1.46; P = .77). Conclusion: Avoiding axillary clearance for women ≥ 60 years old who have clinically node-negative disease and receive Tam for endocrine-responsive disease yields similar efficacy with better early QL.",
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T1 - Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer

T2 - First results of International Breast Cancer Study Group trial 10-93

AU - Rudenstam, Carl Magnus

AU - Zahrieh, David

AU - Forbes, John F.

AU - Crivellari, Diana

AU - Holmberg, Stig B.

AU - Rey, Piercarlo

AU - Dent, David

AU - Campbell, Ian

AU - Bernhard, Jürg

AU - Price, Karen N.

AU - Castiglione-Gertsch, Monica

AU - Goldhirsch, Aron

AU - Gelber, Richard D.

AU - Coates, Alan S.

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N2 - Purpose: Axillary clearance in early breast cancer aims to improve locoregional control and provide staging information but is associated with undesirable morbidity. We therefore investigated whether avoiding axillary surgery in older women would result in improved quality of life (QL) with similar disease-free survival (DFS) and overall survival (OS). Patients and Methods: Between 1993 and 2002, women ≥ 60 years old with clinically node-negative operable breast cancer in whom adjuvant tamoxifen was considered indicated regardless of pathologic nodal status were randomly assigned to primary surgery plus axillary clearance (Sx + Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam for 5 consecutive years. The primary end point was QL reported by the patient and by physician assessment. Results: A total of 473 patients (234 to Sx + Ax, 239 to Sx) were randomly assigned. The median age was 74 years; 80% had estrogen receptor-positive disease. In both the patients' subjective assessment of their QL and the physicians' perception of the patients' QL, the largest adverse QL effects of Ax were observed from baseline to the first postoperative assessment, but the differences tended to disappear in 6 to 12 months. At a median follow-up of 6.6 years, results for Sx + Ax and Sx yielded similar DFS (6-year DFS, 67% v 66%; hazard ratio [HR] Sx + Ax/Sx, 1.06; 95% CI, 0.79 to 1.42; P = .69) and OS (6-year OS, 75% v 73%; HR Sx + Ax/Sx, 1.05; 95% CI, 0.76 to 1.46; P = .77). Conclusion: Avoiding axillary clearance for women ≥ 60 years old who have clinically node-negative disease and receive Tam for endocrine-responsive disease yields similar efficacy with better early QL.

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