Adjuvant capecitabine for breast cancer after preoperative chemotherapy

N. Masuda, S. J. Lee, S. Ohtani, Y. H. Im, E. S. Lee, I. Yokota, K. Kuroi, S. A. Im, B. W. Park, S. B. Kim, Y. Yanagita, S. Ohno, S. Takao, K. Aogi, H. Iwata, J. Jeong, A. Kim, Kyong Hwa Park, H. Sasano, Y. OhashiM. Toi

Research output: Contribution to journalArticle

149 Citations (Scopus)

Abstract

BACKGROUND: Patients who have residual invasive carcinoma after the receipt of neoadjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative breast cancer have poor prognoses. The benefit of adjuvant chemotherapy in these patients remains unclear. METHODS We randomly assigned 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy (containing anthracycline, taxane, or both) to receive standard postsurgical treatment either with capecitabine or without (control). The primary end point was disease-free survival. Secondary end points included overall survival. RESULTS The result of the prespecified interim analysis met the primary end point, so this trial was terminated early. The final analysis showed that disease-free survival was longer in the capecitabine group than in the control group (74.1% vs. 67.6% of the patients were alive and free from recurrence or second cancer at 5 years; hazard ratio for recurrence, second cancer, or death, 0.70; 95% confidence interval [CI], 0.53 to 0.92; P = 0.01). Overall survival was longer in the capecitabine group than in the control group (89.2% vs. 83.6% of the patients were alive at 5 years; hazard ratio for death, 0.59; 95% CI, 0.39 to 0.90; P = 0.01). Among patients with triplenegative disease, the rate of disease-free survival was 69.8% in the capecitabine group versus 56.1% in the control group (hazard ratio for recurrence, second cancer, or death, 0.58; 95% CI, 0.39 to 0.87), and the overall survival rate was 78.8% versus 70.3% (hazard ratio for death, 0.52; 95% CI, 0.30 to 0.90). The hand-foot syndrome, the most common adverse reaction to capecitabine, occurred in 73.4% of the patients in the capecitabine group. CONCLUSIONS After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2- negative breast cancer who had residual invasive disease on pathological testing.

Original languageEnglish
Pages (from-to)2147-2159
Number of pages13
JournalNew England Journal of Medicine
Volume376
Issue number22
DOIs
Publication statusPublished - 2017 Jun 1
Externally publishedYes

Fingerprint

Breast Neoplasms
Drug Therapy
Disease-Free Survival
Second Primary Neoplasms
Confidence Intervals
Anthracyclines
Recurrence
Control Groups
Survival
Hand-Foot Syndrome
Capecitabine
Adjuvant Chemotherapy
Survival Rate
Carcinoma
Therapeutics
human ERBB2 protein
taxane

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Masuda, N., Lee, S. J., Ohtani, S., Im, Y. H., Lee, E. S., Yokota, I., ... Toi, M. (2017). Adjuvant capecitabine for breast cancer after preoperative chemotherapy. New England Journal of Medicine, 376(22), 2147-2159. https://doi.org/10.1056/NEJMoa1612645

Adjuvant capecitabine for breast cancer after preoperative chemotherapy. / Masuda, N.; Lee, S. J.; Ohtani, S.; Im, Y. H.; Lee, E. S.; Yokota, I.; Kuroi, K.; Im, S. A.; Park, B. W.; Kim, S. B.; Yanagita, Y.; Ohno, S.; Takao, S.; Aogi, K.; Iwata, H.; Jeong, J.; Kim, A.; Park, Kyong Hwa; Sasano, H.; Ohashi, Y.; Toi, M.

In: New England Journal of Medicine, Vol. 376, No. 22, 01.06.2017, p. 2147-2159.

Research output: Contribution to journalArticle

Masuda, N, Lee, SJ, Ohtani, S, Im, YH, Lee, ES, Yokota, I, Kuroi, K, Im, SA, Park, BW, Kim, SB, Yanagita, Y, Ohno, S, Takao, S, Aogi, K, Iwata, H, Jeong, J, Kim, A, Park, KH, Sasano, H, Ohashi, Y & Toi, M 2017, 'Adjuvant capecitabine for breast cancer after preoperative chemotherapy', New England Journal of Medicine, vol. 376, no. 22, pp. 2147-2159. https://doi.org/10.1056/NEJMoa1612645
Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I et al. Adjuvant capecitabine for breast cancer after preoperative chemotherapy. New England Journal of Medicine. 2017 Jun 1;376(22):2147-2159. https://doi.org/10.1056/NEJMoa1612645
Masuda, N. ; Lee, S. J. ; Ohtani, S. ; Im, Y. H. ; Lee, E. S. ; Yokota, I. ; Kuroi, K. ; Im, S. A. ; Park, B. W. ; Kim, S. B. ; Yanagita, Y. ; Ohno, S. ; Takao, S. ; Aogi, K. ; Iwata, H. ; Jeong, J. ; Kim, A. ; Park, Kyong Hwa ; Sasano, H. ; Ohashi, Y. ; Toi, M. / Adjuvant capecitabine for breast cancer after preoperative chemotherapy. In: New England Journal of Medicine. 2017 ; Vol. 376, No. 22. pp. 2147-2159.
@article{2f24fa0dc219463f8eb353ad70e342d0,
title = "Adjuvant capecitabine for breast cancer after preoperative chemotherapy",
abstract = "BACKGROUND: Patients who have residual invasive carcinoma after the receipt of neoadjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative breast cancer have poor prognoses. The benefit of adjuvant chemotherapy in these patients remains unclear. METHODS We randomly assigned 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy (containing anthracycline, taxane, or both) to receive standard postsurgical treatment either with capecitabine or without (control). The primary end point was disease-free survival. Secondary end points included overall survival. RESULTS The result of the prespecified interim analysis met the primary end point, so this trial was terminated early. The final analysis showed that disease-free survival was longer in the capecitabine group than in the control group (74.1{\%} vs. 67.6{\%} of the patients were alive and free from recurrence or second cancer at 5 years; hazard ratio for recurrence, second cancer, or death, 0.70; 95{\%} confidence interval [CI], 0.53 to 0.92; P = 0.01). Overall survival was longer in the capecitabine group than in the control group (89.2{\%} vs. 83.6{\%} of the patients were alive at 5 years; hazard ratio for death, 0.59; 95{\%} CI, 0.39 to 0.90; P = 0.01). Among patients with triplenegative disease, the rate of disease-free survival was 69.8{\%} in the capecitabine group versus 56.1{\%} in the control group (hazard ratio for recurrence, second cancer, or death, 0.58; 95{\%} CI, 0.39 to 0.87), and the overall survival rate was 78.8{\%} versus 70.3{\%} (hazard ratio for death, 0.52; 95{\%} CI, 0.30 to 0.90). The hand-foot syndrome, the most common adverse reaction to capecitabine, occurred in 73.4{\%} of the patients in the capecitabine group. CONCLUSIONS After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2- negative breast cancer who had residual invasive disease on pathological testing.",
author = "N. Masuda and Lee, {S. J.} and S. Ohtani and Im, {Y. H.} and Lee, {E. S.} and I. Yokota and K. Kuroi and Im, {S. A.} and Park, {B. W.} and Kim, {S. B.} and Y. Yanagita and S. Ohno and S. Takao and K. Aogi and H. Iwata and J. Jeong and A. Kim and Park, {Kyong Hwa} and H. Sasano and Y. Ohashi and M. Toi",
year = "2017",
month = "6",
day = "1",
doi = "10.1056/NEJMoa1612645",
language = "English",
volume = "376",
pages = "2147--2159",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "22",

}

TY - JOUR

T1 - Adjuvant capecitabine for breast cancer after preoperative chemotherapy

AU - Masuda, N.

AU - Lee, S. J.

AU - Ohtani, S.

AU - Im, Y. H.

AU - Lee, E. S.

AU - Yokota, I.

AU - Kuroi, K.

AU - Im, S. A.

AU - Park, B. W.

AU - Kim, S. B.

AU - Yanagita, Y.

AU - Ohno, S.

AU - Takao, S.

AU - Aogi, K.

AU - Iwata, H.

AU - Jeong, J.

AU - Kim, A.

AU - Park, Kyong Hwa

AU - Sasano, H.

AU - Ohashi, Y.

AU - Toi, M.

PY - 2017/6/1

Y1 - 2017/6/1

N2 - BACKGROUND: Patients who have residual invasive carcinoma after the receipt of neoadjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative breast cancer have poor prognoses. The benefit of adjuvant chemotherapy in these patients remains unclear. METHODS We randomly assigned 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy (containing anthracycline, taxane, or both) to receive standard postsurgical treatment either with capecitabine or without (control). The primary end point was disease-free survival. Secondary end points included overall survival. RESULTS The result of the prespecified interim analysis met the primary end point, so this trial was terminated early. The final analysis showed that disease-free survival was longer in the capecitabine group than in the control group (74.1% vs. 67.6% of the patients were alive and free from recurrence or second cancer at 5 years; hazard ratio for recurrence, second cancer, or death, 0.70; 95% confidence interval [CI], 0.53 to 0.92; P = 0.01). Overall survival was longer in the capecitabine group than in the control group (89.2% vs. 83.6% of the patients were alive at 5 years; hazard ratio for death, 0.59; 95% CI, 0.39 to 0.90; P = 0.01). Among patients with triplenegative disease, the rate of disease-free survival was 69.8% in the capecitabine group versus 56.1% in the control group (hazard ratio for recurrence, second cancer, or death, 0.58; 95% CI, 0.39 to 0.87), and the overall survival rate was 78.8% versus 70.3% (hazard ratio for death, 0.52; 95% CI, 0.30 to 0.90). The hand-foot syndrome, the most common adverse reaction to capecitabine, occurred in 73.4% of the patients in the capecitabine group. CONCLUSIONS After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2- negative breast cancer who had residual invasive disease on pathological testing.

AB - BACKGROUND: Patients who have residual invasive carcinoma after the receipt of neoadjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative breast cancer have poor prognoses. The benefit of adjuvant chemotherapy in these patients remains unclear. METHODS We randomly assigned 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy (containing anthracycline, taxane, or both) to receive standard postsurgical treatment either with capecitabine or without (control). The primary end point was disease-free survival. Secondary end points included overall survival. RESULTS The result of the prespecified interim analysis met the primary end point, so this trial was terminated early. The final analysis showed that disease-free survival was longer in the capecitabine group than in the control group (74.1% vs. 67.6% of the patients were alive and free from recurrence or second cancer at 5 years; hazard ratio for recurrence, second cancer, or death, 0.70; 95% confidence interval [CI], 0.53 to 0.92; P = 0.01). Overall survival was longer in the capecitabine group than in the control group (89.2% vs. 83.6% of the patients were alive at 5 years; hazard ratio for death, 0.59; 95% CI, 0.39 to 0.90; P = 0.01). Among patients with triplenegative disease, the rate of disease-free survival was 69.8% in the capecitabine group versus 56.1% in the control group (hazard ratio for recurrence, second cancer, or death, 0.58; 95% CI, 0.39 to 0.87), and the overall survival rate was 78.8% versus 70.3% (hazard ratio for death, 0.52; 95% CI, 0.30 to 0.90). The hand-foot syndrome, the most common adverse reaction to capecitabine, occurred in 73.4% of the patients in the capecitabine group. CONCLUSIONS After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2- negative breast cancer who had residual invasive disease on pathological testing.

UR - http://www.scopus.com/inward/record.url?scp=85020023159&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85020023159&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1612645

DO - 10.1056/NEJMoa1612645

M3 - Article

C2 - 28564564

AN - SCOPUS:85020023159

VL - 376

SP - 2147

EP - 2159

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 22

ER -