Osteoporosis therapy and outcomes for postmenopausal patients with hormone receptor–positive breast cancer: NCIC CTG MA.27

Allan Lipton, Judith Anne W. Chapman, Kim Leitzel, Ashwani Garg, Kathleen I. Pritchard, James N. Ingle, G. Thomas Budd, Matthew J. Ellis, George W. Sledge, Manuela Rabaglio, Lei Han, Catherine R. Elliott, Lois E. Shepherd, Paul E. Goss, Suhail M. Ali

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Abstract

BACKGROUND: Breast cancer patients in the MA.27 trial had similar outcomes with steroidal aromatase inhibitor (AI) exemestane and nonsteroidal anastrozole. AIs increase the risk of osteoporosis. This study examined the effects of self-reported osteoporosis and osteoporosis therapy (OPT) on outcomes. METHODS: The MA.27 phase 3 adjuvant trial enrolled 7576 postmenopausal women. The primary outcome was event-free survival (EFS), and the secondary outcome was distant disease–free survival (DDFS). Patients were permitted bisphosphonates to prevent or treat osteopenia/osteoporosis. In a multivariate, stratified Cox regression, factors were significant with a 2-sided Wald test P value ≤.05. RESULTS: Osteoporosis was reported at the baseline by 654 of the 7576 women (8.6%) and in total by 1294 patients. Oral OPT was received at the baseline by 815 of the 7576 women (10.8%) and in total by 2711 patients (36%). With a median follow-up of 4.1 years, 693 EFS events (9.15%) and 321 DDFS events (4.2%) occurred. Osteoporosis was not associated with EFS or DDFS. Few EFS events occurred before the initiation of OPT, with no substantive evidence of a time-differing effect on outcomes (nonproportional hazards). OPT (yes vs no) was significantly associated with improved EFS (hazard ratio [HR] for yes vs no, 0.67; 95% confidence interval [CI], 0.57-0.80; P <.001) and DDFS (HR, 0.57; 95% CI, 0.44-0.73; P <. 001). Time-differing (time-dependent) OPT was not (EFS; P =.45). OPT did not alter the incidence of visceral-only metastasis (P =.31). CONCLUSIONS: Oral OPT, administered to postmenopausal breast cancer patients receiving adjuvant AI therapy, was associated with improved EFS and DDFS; the time of OPT initiation (a time-dependent effect) did not affect the outcome. OPT did not alter the risk of visceral metastasis. Cancer 2017;123:2444–51.

Original languageEnglish (US)
Pages (from-to)2444-2451
Number of pages8
JournalCancer
Volume123
Issue number13
DOIs
StatePublished - Jul 1 2017

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Osteoporosis
Hormones
Breast Neoplasms
Disease-Free Survival
Therapeutics
Survival
Aromatase Inhibitors
exemestane
Confidence Intervals
Neoplasm Metastasis
Metabolic Bone Diseases
Diphosphonates

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Lipton, Allan ; Chapman, Judith Anne W. ; Leitzel, Kim ; Garg, Ashwani ; Pritchard, Kathleen I. ; Ingle, James N. ; Budd, G. Thomas ; Ellis, Matthew J. ; Sledge, George W. ; Rabaglio, Manuela ; Han, Lei ; Elliott, Catherine R. ; Shepherd, Lois E. ; Goss, Paul E. ; Ali, Suhail M. / Osteoporosis therapy and outcomes for postmenopausal patients with hormone receptor–positive breast cancer : NCIC CTG MA.27. In: Cancer. 2017 ; Vol. 123, No. 13. pp. 2444-2451.
@article{082d7b9686d246a4b40233894a165a27,
title = "Osteoporosis therapy and outcomes for postmenopausal patients with hormone receptor–positive breast cancer: NCIC CTG MA.27",
abstract = "BACKGROUND: Breast cancer patients in the MA.27 trial had similar outcomes with steroidal aromatase inhibitor (AI) exemestane and nonsteroidal anastrozole. AIs increase the risk of osteoporosis. This study examined the effects of self-reported osteoporosis and osteoporosis therapy (OPT) on outcomes. METHODS: The MA.27 phase 3 adjuvant trial enrolled 7576 postmenopausal women. The primary outcome was event-free survival (EFS), and the secondary outcome was distant disease–free survival (DDFS). Patients were permitted bisphosphonates to prevent or treat osteopenia/osteoporosis. In a multivariate, stratified Cox regression, factors were significant with a 2-sided Wald test P value ≤.05. RESULTS: Osteoporosis was reported at the baseline by 654 of the 7576 women (8.6{\%}) and in total by 1294 patients. Oral OPT was received at the baseline by 815 of the 7576 women (10.8{\%}) and in total by 2711 patients (36{\%}). With a median follow-up of 4.1 years, 693 EFS events (9.15{\%}) and 321 DDFS events (4.2{\%}) occurred. Osteoporosis was not associated with EFS or DDFS. Few EFS events occurred before the initiation of OPT, with no substantive evidence of a time-differing effect on outcomes (nonproportional hazards). OPT (yes vs no) was significantly associated with improved EFS (hazard ratio [HR] for yes vs no, 0.67; 95{\%} confidence interval [CI], 0.57-0.80; P <.001) and DDFS (HR, 0.57; 95{\%} CI, 0.44-0.73; P <. 001). Time-differing (time-dependent) OPT was not (EFS; P =.45). OPT did not alter the incidence of visceral-only metastasis (P =.31). CONCLUSIONS: Oral OPT, administered to postmenopausal breast cancer patients receiving adjuvant AI therapy, was associated with improved EFS and DDFS; the time of OPT initiation (a time-dependent effect) did not affect the outcome. OPT did not alter the risk of visceral metastasis. Cancer 2017;123:2444–51.",
author = "Allan Lipton and Chapman, {Judith Anne W.} and Kim Leitzel and Ashwani Garg and Pritchard, {Kathleen I.} and Ingle, {James N.} and Budd, {G. Thomas} and Ellis, {Matthew J.} and Sledge, {George W.} and Manuela Rabaglio and Lei Han and Elliott, {Catherine R.} and Shepherd, {Lois E.} and Goss, {Paul E.} and Ali, {Suhail M.}",
year = "2017",
month = "7",
day = "1",
doi = "10.1002/cncr.30682",
language = "English (US)",
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pages = "2444--2451",
journal = "Cancer",
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Lipton, A, Chapman, JAW, Leitzel, K, Garg, A, Pritchard, KI, Ingle, JN, Budd, GT, Ellis, MJ, Sledge, GW, Rabaglio, M, Han, L, Elliott, CR, Shepherd, LE, Goss, PE & Ali, SM 2017, 'Osteoporosis therapy and outcomes for postmenopausal patients with hormone receptor–positive breast cancer: NCIC CTG MA.27', Cancer, vol. 123, no. 13, pp. 2444-2451. https://doi.org/10.1002/cncr.30682

Osteoporosis therapy and outcomes for postmenopausal patients with hormone receptor–positive breast cancer : NCIC CTG MA.27. / Lipton, Allan; Chapman, Judith Anne W.; Leitzel, Kim; Garg, Ashwani; Pritchard, Kathleen I.; Ingle, James N.; Budd, G. Thomas; Ellis, Matthew J.; Sledge, George W.; Rabaglio, Manuela; Han, Lei; Elliott, Catherine R.; Shepherd, Lois E.; Goss, Paul E.; Ali, Suhail M.

In: Cancer, Vol. 123, No. 13, 01.07.2017, p. 2444-2451.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Osteoporosis therapy and outcomes for postmenopausal patients with hormone receptor–positive breast cancer

T2 - NCIC CTG MA.27

AU - Lipton, Allan

AU - Chapman, Judith Anne W.

AU - Leitzel, Kim

AU - Garg, Ashwani

AU - Pritchard, Kathleen I.

AU - Ingle, James N.

AU - Budd, G. Thomas

AU - Ellis, Matthew J.

AU - Sledge, George W.

AU - Rabaglio, Manuela

AU - Han, Lei

AU - Elliott, Catherine R.

AU - Shepherd, Lois E.

AU - Goss, Paul E.

AU - Ali, Suhail M.

PY - 2017/7/1

Y1 - 2017/7/1

N2 - BACKGROUND: Breast cancer patients in the MA.27 trial had similar outcomes with steroidal aromatase inhibitor (AI) exemestane and nonsteroidal anastrozole. AIs increase the risk of osteoporosis. This study examined the effects of self-reported osteoporosis and osteoporosis therapy (OPT) on outcomes. METHODS: The MA.27 phase 3 adjuvant trial enrolled 7576 postmenopausal women. The primary outcome was event-free survival (EFS), and the secondary outcome was distant disease–free survival (DDFS). Patients were permitted bisphosphonates to prevent or treat osteopenia/osteoporosis. In a multivariate, stratified Cox regression, factors were significant with a 2-sided Wald test P value ≤.05. RESULTS: Osteoporosis was reported at the baseline by 654 of the 7576 women (8.6%) and in total by 1294 patients. Oral OPT was received at the baseline by 815 of the 7576 women (10.8%) and in total by 2711 patients (36%). With a median follow-up of 4.1 years, 693 EFS events (9.15%) and 321 DDFS events (4.2%) occurred. Osteoporosis was not associated with EFS or DDFS. Few EFS events occurred before the initiation of OPT, with no substantive evidence of a time-differing effect on outcomes (nonproportional hazards). OPT (yes vs no) was significantly associated with improved EFS (hazard ratio [HR] for yes vs no, 0.67; 95% confidence interval [CI], 0.57-0.80; P <.001) and DDFS (HR, 0.57; 95% CI, 0.44-0.73; P <. 001). Time-differing (time-dependent) OPT was not (EFS; P =.45). OPT did not alter the incidence of visceral-only metastasis (P =.31). CONCLUSIONS: Oral OPT, administered to postmenopausal breast cancer patients receiving adjuvant AI therapy, was associated with improved EFS and DDFS; the time of OPT initiation (a time-dependent effect) did not affect the outcome. OPT did not alter the risk of visceral metastasis. Cancer 2017;123:2444–51.

AB - BACKGROUND: Breast cancer patients in the MA.27 trial had similar outcomes with steroidal aromatase inhibitor (AI) exemestane and nonsteroidal anastrozole. AIs increase the risk of osteoporosis. This study examined the effects of self-reported osteoporosis and osteoporosis therapy (OPT) on outcomes. METHODS: The MA.27 phase 3 adjuvant trial enrolled 7576 postmenopausal women. The primary outcome was event-free survival (EFS), and the secondary outcome was distant disease–free survival (DDFS). Patients were permitted bisphosphonates to prevent or treat osteopenia/osteoporosis. In a multivariate, stratified Cox regression, factors were significant with a 2-sided Wald test P value ≤.05. RESULTS: Osteoporosis was reported at the baseline by 654 of the 7576 women (8.6%) and in total by 1294 patients. Oral OPT was received at the baseline by 815 of the 7576 women (10.8%) and in total by 2711 patients (36%). With a median follow-up of 4.1 years, 693 EFS events (9.15%) and 321 DDFS events (4.2%) occurred. Osteoporosis was not associated with EFS or DDFS. Few EFS events occurred before the initiation of OPT, with no substantive evidence of a time-differing effect on outcomes (nonproportional hazards). OPT (yes vs no) was significantly associated with improved EFS (hazard ratio [HR] for yes vs no, 0.67; 95% confidence interval [CI], 0.57-0.80; P <.001) and DDFS (HR, 0.57; 95% CI, 0.44-0.73; P <. 001). Time-differing (time-dependent) OPT was not (EFS; P =.45). OPT did not alter the incidence of visceral-only metastasis (P =.31). CONCLUSIONS: Oral OPT, administered to postmenopausal breast cancer patients receiving adjuvant AI therapy, was associated with improved EFS and DDFS; the time of OPT initiation (a time-dependent effect) did not affect the outcome. OPT did not alter the risk of visceral metastasis. Cancer 2017;123:2444–51.

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DO - 10.1002/cncr.30682

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