Menstrual history and quality-of-life outcomes in women with node-positive breast cancer treated with adjuvant therapy on the NSABP B-30 trial

Patricia A. Ganz, Stephanie R. Land, Charles E. Geyer, Reena S. Cecchini, Joseph P. Costantino, Eduardo R. Pajon, Louis Fehrenbacher, James N. Atkins, Jonathan A. Polikoff, Victor G. Vogel, John K. Erban, Robert B. Livingston, Edith A. Perez, Eleftherios P. Mamounas, Norman Wolmark, Sandra M. Swain

Research output: Contribution to journalArticle

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Abstract

Purpose: Premenopausal women with breast cancer receiving adjuvant chemotherapy are at risk for amenorrhea. The National Surgical Adjuvant Breast and Bowel Project B-30 trial included menstrual history (MH) and quality-of-life (QOL) studies to compare treatments on these outcomes. Patients and Methods: Patients were randomly assigned to sequential doxorubicin (A) and cyclophosphamide (C) followed by docetaxel (T; AC→T), concurrent TAC, or AT, which varied in duration (24, 12, 12 weeks, respectively), and use of C. Endocrine therapy was prescribed for women with hormone receptor - positive tumors. MH and QOL were assessed with standardized questionnaires at baseline; cycle 4, day 1; and every 6 months through 24 months. Prespecified analyses examined rates of amenorrhea by treatment arm, the relationship between amenorrhea and QOL, and QOL by treatment arm. Results: Amenorrhea 12 months after random assignment was significantly different between treatment groups: 69.8% for AC→T, 57.7% for TAC, and 37.9% for AT (P < .001). The AT group without tamoxifen had the lowest rate of amenorrhea. QOL was poorer for patients receiving AC→T at 6 months but similar to others by 12 months. Post-treatment symptoms were increased above baseline for all treatments. Multivariable repeated measures modeling demonstrated that treatment arm, time point, age, and tamoxifen use were significantly associated with symptom severity (all P values < .002). Conclusion: Amenorrhea rates differed significantly by treatment arm, with the AT arm having the lowest rate. Patients treated with longer duration therapy (AC→T) had greater symptom severity and poorer QOL at 6 months, but did not differ from shorter duration treatments at 12 months.

Original languageEnglish (US)
Pages (from-to)1110-1116
Number of pages7
JournalJournal of Clinical Oncology
Volume29
Issue number9
DOIs
StatePublished - Mar 20 2011

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Quality of Life
Breast Neoplasms
Amenorrhea
Arm
Therapeutics
docetaxel
Tamoxifen
Adjuvant Chemotherapy
Doxorubicin
Cyclophosphamide
Breast
Hormones
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Menstrual history and quality-of-life outcomes in women with node-positive breast cancer treated with adjuvant therapy on the NSABP B-30 trial. / Ganz, Patricia A.; Land, Stephanie R.; Geyer, Charles E.; Cecchini, Reena S.; Costantino, Joseph P.; Pajon, Eduardo R.; Fehrenbacher, Louis; Atkins, James N.; Polikoff, Jonathan A.; Vogel, Victor G.; Erban, John K.; Livingston, Robert B.; Perez, Edith A.; Mamounas, Eleftherios P.; Wolmark, Norman; Swain, Sandra M.

In: Journal of Clinical Oncology, Vol. 29, No. 9, 20.03.2011, p. 1110-1116.

Research output: Contribution to journalArticle

Ganz, PA, Land, SR, Geyer, CE, Cecchini, RS, Costantino, JP, Pajon, ER, Fehrenbacher, L, Atkins, JN, Polikoff, JA, Vogel, VG, Erban, JK, Livingston, RB, Perez, EA, Mamounas, EP, Wolmark, N & Swain, SM 2011, 'Menstrual history and quality-of-life outcomes in women with node-positive breast cancer treated with adjuvant therapy on the NSABP B-30 trial', Journal of Clinical Oncology, vol. 29, no. 9, pp. 1110-1116. https://doi.org/10.1200/JCO.2010.29.7689
Ganz, Patricia A. ; Land, Stephanie R. ; Geyer, Charles E. ; Cecchini, Reena S. ; Costantino, Joseph P. ; Pajon, Eduardo R. ; Fehrenbacher, Louis ; Atkins, James N. ; Polikoff, Jonathan A. ; Vogel, Victor G. ; Erban, John K. ; Livingston, Robert B. ; Perez, Edith A. ; Mamounas, Eleftherios P. ; Wolmark, Norman ; Swain, Sandra M. / Menstrual history and quality-of-life outcomes in women with node-positive breast cancer treated with adjuvant therapy on the NSABP B-30 trial. In: Journal of Clinical Oncology. 2011 ; Vol. 29, No. 9. pp. 1110-1116.
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abstract = "Purpose: Premenopausal women with breast cancer receiving adjuvant chemotherapy are at risk for amenorrhea. The National Surgical Adjuvant Breast and Bowel Project B-30 trial included menstrual history (MH) and quality-of-life (QOL) studies to compare treatments on these outcomes. Patients and Methods: Patients were randomly assigned to sequential doxorubicin (A) and cyclophosphamide (C) followed by docetaxel (T; AC→T), concurrent TAC, or AT, which varied in duration (24, 12, 12 weeks, respectively), and use of C. Endocrine therapy was prescribed for women with hormone receptor - positive tumors. MH and QOL were assessed with standardized questionnaires at baseline; cycle 4, day 1; and every 6 months through 24 months. Prespecified analyses examined rates of amenorrhea by treatment arm, the relationship between amenorrhea and QOL, and QOL by treatment arm. Results: Amenorrhea 12 months after random assignment was significantly different between treatment groups: 69.8{\%} for AC→T, 57.7{\%} for TAC, and 37.9{\%} for AT (P < .001). The AT group without tamoxifen had the lowest rate of amenorrhea. QOL was poorer for patients receiving AC→T at 6 months but similar to others by 12 months. Post-treatment symptoms were increased above baseline for all treatments. Multivariable repeated measures modeling demonstrated that treatment arm, time point, age, and tamoxifen use were significantly associated with symptom severity (all P values < .002). Conclusion: Amenorrhea rates differed significantly by treatment arm, with the AT arm having the lowest rate. Patients treated with longer duration therapy (AC→T) had greater symptom severity and poorer QOL at 6 months, but did not differ from shorter duration treatments at 12 months.",
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T1 - Menstrual history and quality-of-life outcomes in women with node-positive breast cancer treated with adjuvant therapy on the NSABP B-30 trial

AU - Ganz, Patricia A.

AU - Land, Stephanie R.

AU - Geyer, Charles E.

AU - Cecchini, Reena S.

AU - Costantino, Joseph P.

AU - Pajon, Eduardo R.

AU - Fehrenbacher, Louis

AU - Atkins, James N.

AU - Polikoff, Jonathan A.

AU - Vogel, Victor G.

AU - Erban, John K.

AU - Livingston, Robert B.

AU - Perez, Edith A.

AU - Mamounas, Eleftherios P.

AU - Wolmark, Norman

AU - Swain, Sandra M.

PY - 2011/3/20

Y1 - 2011/3/20

N2 - Purpose: Premenopausal women with breast cancer receiving adjuvant chemotherapy are at risk for amenorrhea. The National Surgical Adjuvant Breast and Bowel Project B-30 trial included menstrual history (MH) and quality-of-life (QOL) studies to compare treatments on these outcomes. Patients and Methods: Patients were randomly assigned to sequential doxorubicin (A) and cyclophosphamide (C) followed by docetaxel (T; AC→T), concurrent TAC, or AT, which varied in duration (24, 12, 12 weeks, respectively), and use of C. Endocrine therapy was prescribed for women with hormone receptor - positive tumors. MH and QOL were assessed with standardized questionnaires at baseline; cycle 4, day 1; and every 6 months through 24 months. Prespecified analyses examined rates of amenorrhea by treatment arm, the relationship between amenorrhea and QOL, and QOL by treatment arm. Results: Amenorrhea 12 months after random assignment was significantly different between treatment groups: 69.8% for AC→T, 57.7% for TAC, and 37.9% for AT (P < .001). The AT group without tamoxifen had the lowest rate of amenorrhea. QOL was poorer for patients receiving AC→T at 6 months but similar to others by 12 months. Post-treatment symptoms were increased above baseline for all treatments. Multivariable repeated measures modeling demonstrated that treatment arm, time point, age, and tamoxifen use were significantly associated with symptom severity (all P values < .002). Conclusion: Amenorrhea rates differed significantly by treatment arm, with the AT arm having the lowest rate. Patients treated with longer duration therapy (AC→T) had greater symptom severity and poorer QOL at 6 months, but did not differ from shorter duration treatments at 12 months.

AB - Purpose: Premenopausal women with breast cancer receiving adjuvant chemotherapy are at risk for amenorrhea. The National Surgical Adjuvant Breast and Bowel Project B-30 trial included menstrual history (MH) and quality-of-life (QOL) studies to compare treatments on these outcomes. Patients and Methods: Patients were randomly assigned to sequential doxorubicin (A) and cyclophosphamide (C) followed by docetaxel (T; AC→T), concurrent TAC, or AT, which varied in duration (24, 12, 12 weeks, respectively), and use of C. Endocrine therapy was prescribed for women with hormone receptor - positive tumors. MH and QOL were assessed with standardized questionnaires at baseline; cycle 4, day 1; and every 6 months through 24 months. Prespecified analyses examined rates of amenorrhea by treatment arm, the relationship between amenorrhea and QOL, and QOL by treatment arm. Results: Amenorrhea 12 months after random assignment was significantly different between treatment groups: 69.8% for AC→T, 57.7% for TAC, and 37.9% for AT (P < .001). The AT group without tamoxifen had the lowest rate of amenorrhea. QOL was poorer for patients receiving AC→T at 6 months but similar to others by 12 months. Post-treatment symptoms were increased above baseline for all treatments. Multivariable repeated measures modeling demonstrated that treatment arm, time point, age, and tamoxifen use were significantly associated with symptom severity (all P values < .002). Conclusion: Amenorrhea rates differed significantly by treatment arm, with the AT arm having the lowest rate. Patients treated with longer duration therapy (AC→T) had greater symptom severity and poorer QOL at 6 months, but did not differ from shorter duration treatments at 12 months.

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