Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: Adherence companion study 60104

Ann H. Partridge, Laura Archer, Alice B. Kornblith, Julie Gralow, Debjani Grenier, Edith Perez, Antonio C. Wolff, Xiaofei Wang, Helen Kastrissios, Donald Berry, Clifford Hudis, Eric Winer, Hyman Muss

Research output: Contribution to journalArticle

83 Citations (Scopus)

Abstract

Purpose: Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial. Patients and Methods: Cancer and Leukemia Group B study CALGB 49907 was a randomly assigned trial comparing standard chemotherapy versus oral chemotherapy with capecitabine in patients age 65 years or older with early-stage breast cancer. We used microelectronic monitoring system (MEMS) caps on participants' capecitabine bottles to record pill bottle openings. Capecitabine was given in two divided daily doses for 14 consecutive days of a 21-day cycle for six cycles. Adherence was calculated as the number of doses taken divided by doses expected, taking into account toxicity-related dosing changes. A participant was defined as adherent if 80% or more of expected doses were recorded by MEMS. Results: Overall, 161 patients were enrolled. Median age was 71 years (range, 65 to 89 years); 124 patients (83%) persisted with capecitabine to completion of planned protocol therapy. Adherence was 78% across all cycles, and adherence did not vary by cycle (P = .32). Twenty-five percent of participants took fewer than 80% of expected doses and were nonadherent. In a logistic regression model, participants with node-negative disease (P = .01) and mastectomy (P = .01) were more likely to be nonadherent. Adherence was not related to age, tumor stage, or hormone receptor status. Adherence was not significantly associated with relapse-free survival or grade 3 or 4 toxicity. Conclusion: Most older women with early-stage breast cancer were adherent to short-term oral chemotherapy in a randomized clinical trial. Age was not associated with adherence.

Original languageEnglish (US)
Pages (from-to)2418-2422
Number of pages5
JournalJournal of Clinical Oncology
Volume28
Issue number14
DOIs
StatePublished - May 10 2010
Externally publishedYes

Fingerprint

Adjuvant Chemotherapy
Breast Neoplasms
Drug Therapy
Logistic Models
Mastectomy
Patient Compliance
Multicenter Studies
Neoplasms
Leukemia
Randomized Controlled Trials
Capecitabine
Clinical Trials
Hormones
Recurrence
Survival
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907 : Adherence companion study 60104. / Partridge, Ann H.; Archer, Laura; Kornblith, Alice B.; Gralow, Julie; Grenier, Debjani; Perez, Edith; Wolff, Antonio C.; Wang, Xiaofei; Kastrissios, Helen; Berry, Donald; Hudis, Clifford; Winer, Eric; Muss, Hyman.

In: Journal of Clinical Oncology, Vol. 28, No. 14, 10.05.2010, p. 2418-2422.

Research output: Contribution to journalArticle

Partridge, AH, Archer, L, Kornblith, AB, Gralow, J, Grenier, D, Perez, E, Wolff, AC, Wang, X, Kastrissios, H, Berry, D, Hudis, C, Winer, E & Muss, H 2010, 'Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: Adherence companion study 60104', Journal of Clinical Oncology, vol. 28, no. 14, pp. 2418-2422. https://doi.org/10.1200/JCO.2009.26.4671
Partridge, Ann H. ; Archer, Laura ; Kornblith, Alice B. ; Gralow, Julie ; Grenier, Debjani ; Perez, Edith ; Wolff, Antonio C. ; Wang, Xiaofei ; Kastrissios, Helen ; Berry, Donald ; Hudis, Clifford ; Winer, Eric ; Muss, Hyman. / Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907 : Adherence companion study 60104. In: Journal of Clinical Oncology. 2010 ; Vol. 28, No. 14. pp. 2418-2422.
@article{266172e0d2d94620b7da2d56355ac31a,
title = "Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: Adherence companion study 60104",
abstract = "Purpose: Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial. Patients and Methods: Cancer and Leukemia Group B study CALGB 49907 was a randomly assigned trial comparing standard chemotherapy versus oral chemotherapy with capecitabine in patients age 65 years or older with early-stage breast cancer. We used microelectronic monitoring system (MEMS) caps on participants' capecitabine bottles to record pill bottle openings. Capecitabine was given in two divided daily doses for 14 consecutive days of a 21-day cycle for six cycles. Adherence was calculated as the number of doses taken divided by doses expected, taking into account toxicity-related dosing changes. A participant was defined as adherent if 80{\%} or more of expected doses were recorded by MEMS. Results: Overall, 161 patients were enrolled. Median age was 71 years (range, 65 to 89 years); 124 patients (83{\%}) persisted with capecitabine to completion of planned protocol therapy. Adherence was 78{\%} across all cycles, and adherence did not vary by cycle (P = .32). Twenty-five percent of participants took fewer than 80{\%} of expected doses and were nonadherent. In a logistic regression model, participants with node-negative disease (P = .01) and mastectomy (P = .01) were more likely to be nonadherent. Adherence was not related to age, tumor stage, or hormone receptor status. Adherence was not significantly associated with relapse-free survival or grade 3 or 4 toxicity. Conclusion: Most older women with early-stage breast cancer were adherent to short-term oral chemotherapy in a randomized clinical trial. Age was not associated with adherence.",
author = "Partridge, {Ann H.} and Laura Archer and Kornblith, {Alice B.} and Julie Gralow and Debjani Grenier and Edith Perez and Wolff, {Antonio C.} and Xiaofei Wang and Helen Kastrissios and Donald Berry and Clifford Hudis and Eric Winer and Hyman Muss",
year = "2010",
month = "5",
day = "10",
doi = "10.1200/JCO.2009.26.4671",
language = "English (US)",
volume = "28",
pages = "2418--2422",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "14",

}

TY - JOUR

T1 - Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907

T2 - Adherence companion study 60104

AU - Partridge, Ann H.

AU - Archer, Laura

AU - Kornblith, Alice B.

AU - Gralow, Julie

AU - Grenier, Debjani

AU - Perez, Edith

AU - Wolff, Antonio C.

AU - Wang, Xiaofei

AU - Kastrissios, Helen

AU - Berry, Donald

AU - Hudis, Clifford

AU - Winer, Eric

AU - Muss, Hyman

PY - 2010/5/10

Y1 - 2010/5/10

N2 - Purpose: Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial. Patients and Methods: Cancer and Leukemia Group B study CALGB 49907 was a randomly assigned trial comparing standard chemotherapy versus oral chemotherapy with capecitabine in patients age 65 years or older with early-stage breast cancer. We used microelectronic monitoring system (MEMS) caps on participants' capecitabine bottles to record pill bottle openings. Capecitabine was given in two divided daily doses for 14 consecutive days of a 21-day cycle for six cycles. Adherence was calculated as the number of doses taken divided by doses expected, taking into account toxicity-related dosing changes. A participant was defined as adherent if 80% or more of expected doses were recorded by MEMS. Results: Overall, 161 patients were enrolled. Median age was 71 years (range, 65 to 89 years); 124 patients (83%) persisted with capecitabine to completion of planned protocol therapy. Adherence was 78% across all cycles, and adherence did not vary by cycle (P = .32). Twenty-five percent of participants took fewer than 80% of expected doses and were nonadherent. In a logistic regression model, participants with node-negative disease (P = .01) and mastectomy (P = .01) were more likely to be nonadherent. Adherence was not related to age, tumor stage, or hormone receptor status. Adherence was not significantly associated with relapse-free survival or grade 3 or 4 toxicity. Conclusion: Most older women with early-stage breast cancer were adherent to short-term oral chemotherapy in a randomized clinical trial. Age was not associated with adherence.

AB - Purpose: Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial. Patients and Methods: Cancer and Leukemia Group B study CALGB 49907 was a randomly assigned trial comparing standard chemotherapy versus oral chemotherapy with capecitabine in patients age 65 years or older with early-stage breast cancer. We used microelectronic monitoring system (MEMS) caps on participants' capecitabine bottles to record pill bottle openings. Capecitabine was given in two divided daily doses for 14 consecutive days of a 21-day cycle for six cycles. Adherence was calculated as the number of doses taken divided by doses expected, taking into account toxicity-related dosing changes. A participant was defined as adherent if 80% or more of expected doses were recorded by MEMS. Results: Overall, 161 patients were enrolled. Median age was 71 years (range, 65 to 89 years); 124 patients (83%) persisted with capecitabine to completion of planned protocol therapy. Adherence was 78% across all cycles, and adherence did not vary by cycle (P = .32). Twenty-five percent of participants took fewer than 80% of expected doses and were nonadherent. In a logistic regression model, participants with node-negative disease (P = .01) and mastectomy (P = .01) were more likely to be nonadherent. Adherence was not related to age, tumor stage, or hormone receptor status. Adherence was not significantly associated with relapse-free survival or grade 3 or 4 toxicity. Conclusion: Most older women with early-stage breast cancer were adherent to short-term oral chemotherapy in a randomized clinical trial. Age was not associated with adherence.

UR - http://www.scopus.com/inward/record.url?scp=77952476227&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77952476227&partnerID=8YFLogxK

U2 - 10.1200/JCO.2009.26.4671

DO - 10.1200/JCO.2009.26.4671

M3 - Article

C2 - 20368559

AN - SCOPUS:77952476227

VL - 28

SP - 2418

EP - 2422

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 14

ER -