Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer

Patricia A. Ganz; Hanna Bandos; Charles E. Geyer; André Robidoux; Alexander H.G. Paterson; Jonathan Polikoff; Luis Baez-Diaz; Adam M. Brufsky; Louis Fehrenbacher; Ann W. Parsons; Patrick J. Ward; Louise Provencher; John T. Hamm; Philip J. Stella; Robert L. Carolla; Richard G. Margolese; Henry R. Shibata; Edith A. Perez; Norman Wolmark

doi:10.1007/s10549-021-06475-2

Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer

Patricia A. Ganz, Hanna Bandos, Charles E. Geyer, André Robidoux, Alexander H.G. Paterson, Jonathan Polikoff, Luis Baez-Diaz, Adam M. Brufsky, Louis Fehrenbacher, Ann W. Parsons, Patrick J. Ward, Louise Provencher, John T. Hamm, Philip J. Stella, Robert L. Carolla, Richard G. Margolese, Henry R. Shibata, Edith A. Perez, Norman Wolmark

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

BACKGROUND: The NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted.

PATIENTS AND METHODS: Patients completed the QOL questionnaire at baseline, during treatment, and every 6 months through 36 months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12 months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18 months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12 months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF.

RESULTS: FEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6 months (P < 0.001); lower Vitality score at 6 months (P < 0.01), and lower PF score during the first year than AC patients. There were no statistically significant QOL score differences between the two groups beyond 12 months. No significant differences in symptom severity between the two groups were observed. Rates of amenorrhea were significantly different between FEC-100 and AC (67.4% vs. 59.1%, P < 0.001). There was no association between changes in LVEF and PF (P = 0.38).

CONCLUSIONS: Statistically significant QOL differences between the two groups favored AC; however, the magnitude was small and unlikely to be clinically meaningful. There was a clinical and statistically significant difference in risk for amenorrhea, favoring AC.

TRIAL REGISTRY: NCT00087178; Date of registration: 07/08/2004.

Original language	English (US)
Pages (from-to)	153-161
Number of pages	9
Journal	Breast Cancer Research and Treatment
Volume	192
Issue number	1
DOIs	https://doi.org/10.1007/s10549-021-06475-2
State	Published - Feb 2022

Keywords

Adjuvant chemotherapy
Amenorrhea
Cardiac function
Early-stage breast cancer
Quality of life
Doxorubicin/adverse effects
Epirubicin/adverse effects
Humans
Antineoplastic Combined Chemotherapy Protocols/adverse effects
Fluorouracil/adverse effects
Quality of Life
Female
Cyclophosphamide/adverse effects
Chemotherapy, Adjuvant
Outcome Assessment, Health Care
Breast Neoplasms/drug therapy

ASJC Scopus subject areas

Oncology
Cancer Research

Access to Document

10.1007/s10549-021-06475-2

Cite this

Ganz, P. A., Bandos, H., Geyer, C. E., Robidoux, A., Paterson, A. H. G., Polikoff, J., Baez-Diaz, L., Brufsky, A. M., Fehrenbacher, L., Parsons, A. W., Ward, P. J., Provencher, L., Hamm, J. T., Stella, P. J., Carolla, R. L., Margolese, R. G., Shibata, H. R., Perez, E. A., & Wolmark, N. (2022). Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer. Breast Cancer Research and Treatment, 192(1), 153-161. https://doi.org/10.1007/s10549-021-06475-2

Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer. / Ganz, Patricia A.; Bandos, Hanna; Geyer, Charles E. et al.
In: Breast Cancer Research and Treatment, Vol. 192, No. 1, 02.2022, p. 153-161.

Research output: Contribution to journal › Article › peer-review

Ganz, PA, Bandos, H, Geyer, CE, Robidoux, A, Paterson, AHG, Polikoff, J, Baez-Diaz, L, Brufsky, AM, Fehrenbacher, L, Parsons, AW, Ward, PJ, Provencher, L, Hamm, JT, Stella, PJ, Carolla, RL, Margolese, RG, Shibata, HR, Perez, EA & Wolmark, N 2022, 'Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer', Breast Cancer Research and Treatment, vol. 192, no. 1, pp. 153-161. https://doi.org/10.1007/s10549-021-06475-2

@article{09dd99dbede74cc9a69dd6d4e5176932,

title = "Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer",

abstract = "BACKGROUND: The NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted.PATIENTS AND METHODS: Patients completed the QOL questionnaire at baseline, during treatment, and every 6 months through 36 months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12 months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18 months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12 months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF.RESULTS: FEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6 months (P < 0.001); lower Vitality score at 6 months (P < 0.01), and lower PF score during the first year than AC patients. There were no statistically significant QOL score differences between the two groups beyond 12 months. No significant differences in symptom severity between the two groups were observed. Rates of amenorrhea were significantly different between FEC-100 and AC (67.4% vs. 59.1%, P < 0.001). There was no association between changes in LVEF and PF (P = 0.38).CONCLUSIONS: Statistically significant QOL differences between the two groups favored AC; however, the magnitude was small and unlikely to be clinically meaningful. There was a clinical and statistically significant difference in risk for amenorrhea, favoring AC.TRIAL REGISTRY: NCT00087178; Date of registration: 07/08/2004.",

keywords = "Adjuvant chemotherapy, Amenorrhea, Cardiac function, Early-stage breast cancer, Quality of life, Doxorubicin/adverse effects, Epirubicin/adverse effects, Humans, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Fluorouracil/adverse effects, Quality of Life, Female, Cyclophosphamide/adverse effects, Chemotherapy, Adjuvant, Outcome Assessment, Health Care, Breast Neoplasms/drug therapy",

author = "Ganz, {Patricia A.} and Hanna Bandos and Geyer, {Charles E.} and Andr{\'e} Robidoux and Paterson, {Alexander H.G.} and Jonathan Polikoff and Luis Baez-Diaz and Brufsky, {Adam M.} and Louis Fehrenbacher and Parsons, {Ann W.} and Ward, {Patrick J.} and Louise Provencher and Hamm, {John T.} and Stella, {Philip J.} and Carolla, {Robert L.} and Margolese, {Richard G.} and Shibata, {Henry R.} and Perez, {Edith A.} and Norman Wolmark",

note = "Funding Information: This work was supported by the National Institutes of Health grants U10CA180868, UG1CA189867, -180822, and -44066-26 (Dr. Robidoux), and Pharmacia & Upjohn Company, a subsidiary of Pfizer, Inc. The funders had no role in the design of the study; the collection, analysis, and/or interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication. Publisher Copyright: {\textcopyright} 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.",

year = "2022",

month = feb,

doi = "10.1007/s10549-021-06475-2",

language = "English (US)",

volume = "192",

pages = "153--161",

journal = "Breast Cancer Research and Treatment",

issn = "0167-6806",

publisher = "Springer New York",

number = "1",

}

TY - JOUR

T1 - Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer

AU - Ganz, Patricia A.

AU - Bandos, Hanna

AU - Geyer, Charles E.

AU - Robidoux, André

AU - Paterson, Alexander H.G.

AU - Polikoff, Jonathan

AU - Baez-Diaz, Luis

AU - Brufsky, Adam M.

AU - Fehrenbacher, Louis

AU - Parsons, Ann W.

AU - Ward, Patrick J.

AU - Provencher, Louise

AU - Hamm, John T.

AU - Stella, Philip J.

AU - Carolla, Robert L.

AU - Margolese, Richard G.

AU - Shibata, Henry R.

AU - Perez, Edith A.

AU - Wolmark, Norman

N1 - Funding Information: This work was supported by the National Institutes of Health grants U10CA180868, UG1CA189867, -180822, and -44066-26 (Dr. Robidoux), and Pharmacia & Upjohn Company, a subsidiary of Pfizer, Inc. The funders had no role in the design of the study; the collection, analysis, and/or interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication. Publisher Copyright: © 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

PY - 2022/2

Y1 - 2022/2

N2 - BACKGROUND: The NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted.PATIENTS AND METHODS: Patients completed the QOL questionnaire at baseline, during treatment, and every 6 months through 36 months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12 months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18 months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12 months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF.RESULTS: FEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6 months (P < 0.001); lower Vitality score at 6 months (P < 0.01), and lower PF score during the first year than AC patients. There were no statistically significant QOL score differences between the two groups beyond 12 months. No significant differences in symptom severity between the two groups were observed. Rates of amenorrhea were significantly different between FEC-100 and AC (67.4% vs. 59.1%, P < 0.001). There was no association between changes in LVEF and PF (P = 0.38).CONCLUSIONS: Statistically significant QOL differences between the two groups favored AC; however, the magnitude was small and unlikely to be clinically meaningful. There was a clinical and statistically significant difference in risk for amenorrhea, favoring AC.TRIAL REGISTRY: NCT00087178; Date of registration: 07/08/2004.

AB - BACKGROUND: The NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted.PATIENTS AND METHODS: Patients completed the QOL questionnaire at baseline, during treatment, and every 6 months through 36 months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12 months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18 months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12 months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF.RESULTS: FEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6 months (P < 0.001); lower Vitality score at 6 months (P < 0.01), and lower PF score during the first year than AC patients. There were no statistically significant QOL score differences between the two groups beyond 12 months. No significant differences in symptom severity between the two groups were observed. Rates of amenorrhea were significantly different between FEC-100 and AC (67.4% vs. 59.1%, P < 0.001). There was no association between changes in LVEF and PF (P = 0.38).CONCLUSIONS: Statistically significant QOL differences between the two groups favored AC; however, the magnitude was small and unlikely to be clinically meaningful. There was a clinical and statistically significant difference in risk for amenorrhea, favoring AC.TRIAL REGISTRY: NCT00087178; Date of registration: 07/08/2004.

KW - Adjuvant chemotherapy

KW - Amenorrhea

KW - Cardiac function

KW - Early-stage breast cancer

KW - Quality of life

KW - Doxorubicin/adverse effects

KW - Epirubicin/adverse effects

KW - Humans

KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects

KW - Fluorouracil/adverse effects

KW - Quality of Life

KW - Female

KW - Cyclophosphamide/adverse effects

KW - Chemotherapy, Adjuvant

KW - Outcome Assessment, Health Care

KW - Breast Neoplasms/drug therapy

UR - http://www.scopus.com/inward/record.url?scp=85124081794&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85124081794&partnerID=8YFLogxK

U2 - 10.1007/s10549-021-06475-2

DO - 10.1007/s10549-021-06475-2

M3 - Article

C2 - 35112166

AN - SCOPUS:85124081794

SN - 0167-6806

VL - 192

SP - 153

EP - 161

JO - Breast Cancer Research and Treatment

JF - Breast Cancer Research and Treatment

IS - 1

ER -

Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this