Efficacy of chemotherapy for ER-negative and ER-positive isolated locoregional recurrence of breast cancer

Final analysis of the CALOR trial

Irene L. Wapnir, Karen N. Price, Stewart J. Anderson, André Robidoux, Miguel Martín, Johan W.R. Nortier, Alexander H.G. Paterson, Mothaffar F. Rimawi, I. Láng, José Manuel Baena-Cañada, Beat Thürlimann, Eleftherios P. Mamounas, Charles E. Geyer, Shari Gelber, Alan S. Coates, Richard D. Gelber, Priya Rastogi, Meredith M. Regan, Norman Wolmark, Stefan Aebi

Research output: Contribution to journalArticle

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Abstract

Purpose Isolated locoregional recurrence (ILRR) predicts a high risk of developing breast cancer distant metastases and death. The Chemotherapy as Adjuvant for LOcally Recurrent breast cancer (CALOR) trial investigated the effectiveness of chemotherapy (CT) after local therapy for ILRR. A report at 5 years of median follow-up showed significant benefit of CT for estrogen receptor (ER)–negative ILRR, but additional follow-up was required in ER-positive ILRR. Patients and Methods CALOR was an open-label, randomized trial for patients with completely excised ILRR after unilateral breast cancer. Eligible patients were randomly assigned to receive CT or no CT and stratified by prior CT, hormone receptor status, and location of ILRR. Patients with hormone receptor–positive ILRR received adjuvant endocrine therapy. Radiation therapy was mandated for patients with microscopically involved margins, and anti–human epidermal growth factor receptor 2 therapy was optional. End points were disease-free survival (DFS), overall survival, and breast cancer-free interval. Results From August 2003 to January 2010, 162 patients were enrolled: 58 with ER-negative and 104 with ER-positive ILRR. At 9 years of median follow-up, 27 DFS events were observed in the ER-negative group and 40 in the ER-positive group. The hazard ratios (HR) of a DFS event were 0.29 (95% CI, 0.13 to 0.67; 10-year DFS, 70% v 34%, CT v no CT, respectively) in patients with ER-negative ILRR and 1.07 (95% CI, 0.57 to 2.00; 10-year DFS, 50% v 59%, respectively) in patients with ER-positive ILRR (Pinteraction = .013). HRs were 0.29 (95% CI, 0.13 to 0.67) and 0.94 (95% CI, 0.47 to 1.85), respectively, for breast cancer-free interval (Pinteraction = .034) and 0.48 (95% CI, 0.19 to 1.20) and 0.70 (95% CI, 0.32 to 1.55), respectively, for overall survival (Pinteraction = .53). Results for the three end points were consistent in multivariable analyses adjusting for location of ILRR, prior CT, and interval from primary surgery. Conclusion The final analysis of CALOR confirms that CT benefits patients with resected ER-negative ILRR and does not support the use of CT for ER-positive ILRR.

Original languageEnglish
Pages (from-to)1073-1079
Number of pages7
JournalJournal of Clinical Oncology
Volume36
Issue number11
DOIs
Publication statusPublished - Apr 10 2018

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Estrogen Receptors
Breast Neoplasms
Recurrence
Drug Therapy
Disease-Free Survival
Hormones
Survival
Adjuvant Chemotherapy
Epidermal Growth Factor Receptor
Radiotherapy
Therapeutics
Neoplasm Metastasis

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Efficacy of chemotherapy for ER-negative and ER-positive isolated locoregional recurrence of breast cancer : Final analysis of the CALOR trial. / Wapnir, Irene L.; Price, Karen N.; Anderson, Stewart J.; Robidoux, André; Martín, Miguel; Nortier, Johan W.R.; Paterson, Alexander H.G.; Rimawi, Mothaffar F.; Láng, I.; Baena-Cañada, José Manuel; Thürlimann, Beat; Mamounas, Eleftherios P.; Geyer, Charles E.; Gelber, Shari; Coates, Alan S.; Gelber, Richard D.; Rastogi, Priya; Regan, Meredith M.; Wolmark, Norman; Aebi, Stefan.

In: Journal of Clinical Oncology, Vol. 36, No. 11, 10.04.2018, p. 1073-1079.

Research output: Contribution to journalArticle

Wapnir, IL, Price, KN, Anderson, SJ, Robidoux, A, Martín, M, Nortier, JWR, Paterson, AHG, Rimawi, MF, Láng, I, Baena-Cañada, JM, Thürlimann, B, Mamounas, EP, Geyer, CE, Gelber, S, Coates, AS, Gelber, RD, Rastogi, P, Regan, MM, Wolmark, N & Aebi, S 2018, 'Efficacy of chemotherapy for ER-negative and ER-positive isolated locoregional recurrence of breast cancer: Final analysis of the CALOR trial', Journal of Clinical Oncology, vol. 36, no. 11, pp. 1073-1079. https://doi.org/10.1200/JCO.2017.76.5719
Wapnir, Irene L. ; Price, Karen N. ; Anderson, Stewart J. ; Robidoux, André ; Martín, Miguel ; Nortier, Johan W.R. ; Paterson, Alexander H.G. ; Rimawi, Mothaffar F. ; Láng, I. ; Baena-Cañada, José Manuel ; Thürlimann, Beat ; Mamounas, Eleftherios P. ; Geyer, Charles E. ; Gelber, Shari ; Coates, Alan S. ; Gelber, Richard D. ; Rastogi, Priya ; Regan, Meredith M. ; Wolmark, Norman ; Aebi, Stefan. / Efficacy of chemotherapy for ER-negative and ER-positive isolated locoregional recurrence of breast cancer : Final analysis of the CALOR trial. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 11. pp. 1073-1079.
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title = "Efficacy of chemotherapy for ER-negative and ER-positive isolated locoregional recurrence of breast cancer: Final analysis of the CALOR trial",
abstract = "Purpose Isolated locoregional recurrence (ILRR) predicts a high risk of developing breast cancer distant metastases and death. The Chemotherapy as Adjuvant for LOcally Recurrent breast cancer (CALOR) trial investigated the effectiveness of chemotherapy (CT) after local therapy for ILRR. A report at 5 years of median follow-up showed significant benefit of CT for estrogen receptor (ER)–negative ILRR, but additional follow-up was required in ER-positive ILRR. Patients and Methods CALOR was an open-label, randomized trial for patients with completely excised ILRR after unilateral breast cancer. Eligible patients were randomly assigned to receive CT or no CT and stratified by prior CT, hormone receptor status, and location of ILRR. Patients with hormone receptor–positive ILRR received adjuvant endocrine therapy. Radiation therapy was mandated for patients with microscopically involved margins, and anti–human epidermal growth factor receptor 2 therapy was optional. End points were disease-free survival (DFS), overall survival, and breast cancer-free interval. Results From August 2003 to January 2010, 162 patients were enrolled: 58 with ER-negative and 104 with ER-positive ILRR. At 9 years of median follow-up, 27 DFS events were observed in the ER-negative group and 40 in the ER-positive group. The hazard ratios (HR) of a DFS event were 0.29 (95{\%} CI, 0.13 to 0.67; 10-year DFS, 70{\%} v 34{\%}, CT v no CT, respectively) in patients with ER-negative ILRR and 1.07 (95{\%} CI, 0.57 to 2.00; 10-year DFS, 50{\%} v 59{\%}, respectively) in patients with ER-positive ILRR (Pinteraction = .013). HRs were 0.29 (95{\%} CI, 0.13 to 0.67) and 0.94 (95{\%} CI, 0.47 to 1.85), respectively, for breast cancer-free interval (Pinteraction = .034) and 0.48 (95{\%} CI, 0.19 to 1.20) and 0.70 (95{\%} CI, 0.32 to 1.55), respectively, for overall survival (Pinteraction = .53). Results for the three end points were consistent in multivariable analyses adjusting for location of ILRR, prior CT, and interval from primary surgery. Conclusion The final analysis of CALOR confirms that CT benefits patients with resected ER-negative ILRR and does not support the use of CT for ER-positive ILRR.",
author = "Wapnir, {Irene L.} and Price, {Karen N.} and Anderson, {Stewart J.} and Andr{\'e} Robidoux and Miguel Mart{\'i}n and Nortier, {Johan W.R.} and Paterson, {Alexander H.G.} and Rimawi, {Mothaffar F.} and I. L{\'a}ng and Baena-Ca{\~n}ada, {Jos{\'e} Manuel} and Beat Th{\"u}rlimann and Mamounas, {Eleftherios P.} and Geyer, {Charles E.} and Shari Gelber and Coates, {Alan S.} and Gelber, {Richard D.} and Priya Rastogi and Regan, {Meredith M.} and Norman Wolmark and Stefan Aebi",
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TY - JOUR

T1 - Efficacy of chemotherapy for ER-negative and ER-positive isolated locoregional recurrence of breast cancer

T2 - Final analysis of the CALOR trial

AU - Wapnir, Irene L.

AU - Price, Karen N.

AU - Anderson, Stewart J.

AU - Robidoux, André

AU - Martín, Miguel

AU - Nortier, Johan W.R.

AU - Paterson, Alexander H.G.

AU - Rimawi, Mothaffar F.

AU - Láng, I.

AU - Baena-Cañada, José Manuel

AU - Thürlimann, Beat

AU - Mamounas, Eleftherios P.

AU - Geyer, Charles E.

AU - Gelber, Shari

AU - Coates, Alan S.

AU - Gelber, Richard D.

AU - Rastogi, Priya

AU - Regan, Meredith M.

AU - Wolmark, Norman

AU - Aebi, Stefan

PY - 2018/4/10

Y1 - 2018/4/10

N2 - Purpose Isolated locoregional recurrence (ILRR) predicts a high risk of developing breast cancer distant metastases and death. The Chemotherapy as Adjuvant for LOcally Recurrent breast cancer (CALOR) trial investigated the effectiveness of chemotherapy (CT) after local therapy for ILRR. A report at 5 years of median follow-up showed significant benefit of CT for estrogen receptor (ER)–negative ILRR, but additional follow-up was required in ER-positive ILRR. Patients and Methods CALOR was an open-label, randomized trial for patients with completely excised ILRR after unilateral breast cancer. Eligible patients were randomly assigned to receive CT or no CT and stratified by prior CT, hormone receptor status, and location of ILRR. Patients with hormone receptor–positive ILRR received adjuvant endocrine therapy. Radiation therapy was mandated for patients with microscopically involved margins, and anti–human epidermal growth factor receptor 2 therapy was optional. End points were disease-free survival (DFS), overall survival, and breast cancer-free interval. Results From August 2003 to January 2010, 162 patients were enrolled: 58 with ER-negative and 104 with ER-positive ILRR. At 9 years of median follow-up, 27 DFS events were observed in the ER-negative group and 40 in the ER-positive group. The hazard ratios (HR) of a DFS event were 0.29 (95% CI, 0.13 to 0.67; 10-year DFS, 70% v 34%, CT v no CT, respectively) in patients with ER-negative ILRR and 1.07 (95% CI, 0.57 to 2.00; 10-year DFS, 50% v 59%, respectively) in patients with ER-positive ILRR (Pinteraction = .013). HRs were 0.29 (95% CI, 0.13 to 0.67) and 0.94 (95% CI, 0.47 to 1.85), respectively, for breast cancer-free interval (Pinteraction = .034) and 0.48 (95% CI, 0.19 to 1.20) and 0.70 (95% CI, 0.32 to 1.55), respectively, for overall survival (Pinteraction = .53). Results for the three end points were consistent in multivariable analyses adjusting for location of ILRR, prior CT, and interval from primary surgery. Conclusion The final analysis of CALOR confirms that CT benefits patients with resected ER-negative ILRR and does not support the use of CT for ER-positive ILRR.

AB - Purpose Isolated locoregional recurrence (ILRR) predicts a high risk of developing breast cancer distant metastases and death. The Chemotherapy as Adjuvant for LOcally Recurrent breast cancer (CALOR) trial investigated the effectiveness of chemotherapy (CT) after local therapy for ILRR. A report at 5 years of median follow-up showed significant benefit of CT for estrogen receptor (ER)–negative ILRR, but additional follow-up was required in ER-positive ILRR. Patients and Methods CALOR was an open-label, randomized trial for patients with completely excised ILRR after unilateral breast cancer. Eligible patients were randomly assigned to receive CT or no CT and stratified by prior CT, hormone receptor status, and location of ILRR. Patients with hormone receptor–positive ILRR received adjuvant endocrine therapy. Radiation therapy was mandated for patients with microscopically involved margins, and anti–human epidermal growth factor receptor 2 therapy was optional. End points were disease-free survival (DFS), overall survival, and breast cancer-free interval. Results From August 2003 to January 2010, 162 patients were enrolled: 58 with ER-negative and 104 with ER-positive ILRR. At 9 years of median follow-up, 27 DFS events were observed in the ER-negative group and 40 in the ER-positive group. The hazard ratios (HR) of a DFS event were 0.29 (95% CI, 0.13 to 0.67; 10-year DFS, 70% v 34%, CT v no CT, respectively) in patients with ER-negative ILRR and 1.07 (95% CI, 0.57 to 2.00; 10-year DFS, 50% v 59%, respectively) in patients with ER-positive ILRR (Pinteraction = .013). HRs were 0.29 (95% CI, 0.13 to 0.67) and 0.94 (95% CI, 0.47 to 1.85), respectively, for breast cancer-free interval (Pinteraction = .034) and 0.48 (95% CI, 0.19 to 1.20) and 0.70 (95% CI, 0.32 to 1.55), respectively, for overall survival (Pinteraction = .53). Results for the three end points were consistent in multivariable analyses adjusting for location of ILRR, prior CT, and interval from primary surgery. Conclusion The final analysis of CALOR confirms that CT benefits patients with resected ER-negative ILRR and does not support the use of CT for ER-positive ILRR.

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