Epirubicin Plus Cyclophosphamide Followed by Docetaxel Versus Epirubicin Plus Docetaxel Followed by Capecitabine As Adjuvant Therapy for Node-Positive Early Breast Cancer: Results From the GEICAM/2003-10 Study

Martín, Miguel; Simon, A.; Ruíz-Borrego, Manuel; Ribelles, Nuria; Rodríguez-Lescure, Álvaro; Muñoz-Mateu, Montserrat; González, Sónia; Vila, Mireia Margelí; Barnadas, Agustí; Ramos, Manuel; Berrón, Sonia del Barco; Jara, Carlos; Calvo, Lourdes; Martínez-Jáñez, Noelia; Fernández, César Mendiola; Rodrı́guez, César; Dueñas, Eduardo Martínez de; Andrés, Raquel; Plazaola, Arrate; Haba, Juan de la; López‐Vega, José Manuel; Adrover, Encarna; Ballesteros, Ana Isabel; Santaballa, Ana; Sánchez‐Rovira, Pedro; Baena-Cañada, José Manuel; Casas, Maribel; Cámara, María del Carmen; Carrasco, Eva; Lluch, Aña

doi:10.1200/jco.2015.61.9510

Cited by 57 publications

(49 citation statements)

References 19 publications

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“…15 It is likely that these women would benefit from adjuvant treatment to improve outcomes, and several trials have evaluated escalation of adjuvant therapy. [16][17][18] The recently published CREATE-X trial 19 evaluated 910 patients with HER2-negative breast cancer who had residual invasive disease or LN metastases after NAC. Women were randomized to either adjuvant capecitabine or observation.…”

Section: Discussionmentioning

confidence: 99%

Outcomes Following Neoadjuvant Chemotherapy for Breast Cancer in Women Aged 40 Years and Younger: Impact of Pathologic Nodal Response

Kozak¹,

Jacobson²,

Eyben³

et al. 2018

J Natl Compr Canc Netw

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We sought to evaluate whether pathologic nodal response was predictive of outcomes in women aged ≤40 years with breast cancer treated with neoadjuvant chemotherapy (NAC). A total of 220 patients treated with NAC between 1991 and 2015 were retrospectively reviewed. Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast and lymph nodes (LNs) (ypT0/Tis ypN0); partial response if there was no tumor in the LNs but residual tumor in the breast (ypT+ ypN0) or residual tumor in the LNs (ypT0/Tis ypN+); and limited response if there was residual tumor in both the breast and the LNs (ypT+ ypN+). Kaplan-Meier and Cox proportional hazards analyses were performed to identify factors predictive for overall survival (OS). A total of 155 patients were included. Following NAC, 39 patients (25.2%) achieved pCR, 57 (36.8%) achieved a partial response (either ypT+ ypN0 or ypT0/Tis ypN+), and 59 (38.1%) had a limited response. A total of 22 patients (14.2%) experienced local failure, 20 (12.9%) experienced regional failure, and 59 (38.1%) experienced distant failure. Median OS for patients who achieved pCR was not reached, and was significantly worse for patients who had residual disease in the breast and/or LNs (<.001). No difference in OS was seen among patients who had residual disease in the breast alone versus those who remained LN-positive (97 vs 83 months, respectively; =.25). Subset analysis did not reveal differences in OS based on year of treatment or cN1 disease at the time of initial diagnosis. Women aged ≤40 years who achieved pCR had excellent outcomes; however, those who achieved a pathologic response in the LNs but had residual disease in the breast continued to have outcomes similar to those who remained LN-positive.

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Section: Discussionmentioning

confidence: 99%

Outcomes Following Neoadjuvant Chemotherapy for Breast Cancer in Women Aged 40 Years and Younger: Impact of Pathologic Nodal Response

Kozak¹,

Jacobson²,

Eyben³

et al. 2018

J Natl Compr Canc Netw

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“…The adjuvant TACT 2 trial demonstrated that capecitabine has some advantages over standard CMF following anthracycline-based treatment [submitted, January 2017], because of lower toxicity and better quality of life with no apparent loss of efficacy. However, when capecitabine was added to docetaxel, doxorubicin and cyclophosphamide in the FINNXX trial 23 , there was no improvement in DFS and when capecitabine was substituted for cyclophosphamide in the GEICAM/2003-10 Study there was an increase in DFS events 24 . Nevertheless, there has been a recent renewal of interest, with the use of capecitabine after neoadjuvant chemotherapy in patients who had not achieved a pCR in the CREATE-X study 25 .…”

Section: Discussionmentioning

confidence: 99%

Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo): final 10-year follow-up of an open-label, randomised, phase 3 trial

Earl

Hiller

Howard

et al. 2017

The Lancet Oncology

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(2017) Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo) : final 10-year follow-up of an open-label, randomised, phase 3 trial. The Lancet Oncology, 18 (6). pp. 755-769. Permanent WRAP URL:http://wrap.warwick.ac.uk/98810 Copyright and reuse:The Warwick Research Archive Portal (WRAP) makes this work by researchers of the University of Warwick available open access under the following conditions. Copyright © and all moral rights to the version of the paper presented here belong to the individual author(s) and/or other copyright owners. To the extent reasonable and practicable the material made available in WRAP has been checked for eligibility before being made available.Copies of full items can be used for personal research or study, educational, or not-for-profit purposes without prior permission or charge. Provided that the authors, title and full bibliographic details are credited, a hyperlink and/or URL is given for the original metadata page and the content is not changed in any way.

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“…This adjuvant trial for patients with operable node-positive BC (T1-3/N1-3) compared 2 different 3-drug regimens, epirubicin plus cyclophosphamide followed by docetaxel vs. epirubicin plus docetaxel followed by capecitabine. 12 Patients who received ET-X did not receive cyclophosphamide in order to keep docetaxel and administer sequential capecitabine, although both arms received a regimen containing three drugs. Results of this study were surprising- the DFS results favored the control arm with a hazard ratio 1.30; 95% CI 1.03 to 1.64; log-rank p = 0.03).…”

Section: Review and Analysis Of The Datamentioning

confidence: 99%

CREATE-X a role for capecitabine in early-stage breast cancer: an analysis of available data

Zujewski

Rubinstein

2017

npj Breast Cancer

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Breast cancer patients with residual disease after neoadjuvant chemotherapy and surgery may benefit from additional anti-cancer therapies. Capecitabine, an oral antimetabolite and prodrug of 5-Flurouracil, has been approved for treating metastatic breast cancer. One randomized clinical trial (CREATE-X) of capecitabine versus no additional therapy has been conducted in women with early stage breast cancer who received standard chemotherapy pre-operative therapy and had residual invasive breast cancer at the time of surgery. Results from CREATE-X, showed that capecitabine had a statistically significant survival advantage compared with no additional therapy. This perspective provides a review and analysis of the available data from CREATEx in the context of results from other adjuvant trials of capecitabine in early stage breast cancer that had disease–free survival as a primary endpoint. We conclude that although the previously published studies of capecitabine in the adjuvant setting did not meet their primary endpoint, the data from these studies are consistent with the hypothesis that capecitabine may offer additional survival benefit in patients with chemo-refractory breast cancer at the time of surgery after receiving standard chemotherapy. In these patients, offering a course of adjuvant capecitabine or enrolling the patient in a clinical trial are appropriate therapeutic options. The patient should be informed about both the increased survival observed in the CREATEx trial and the expected toxicities from capecitabine chemotherapy.

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Epirubicin Plus Cyclophosphamide Followed by Docetaxel Versus Epirubicin Plus Docetaxel Followed by Capecitabine As Adjuvant Therapy for Node-Positive Early Breast Cancer: Results From the GEICAM/2003-10 Study

Abstract: Invasive disease-free survival, but not OS, was significantly superior for patients with node-positive early BC who received the adjuvant standard schedule EC-T than for those who received the experimental ET-X regimen. Toxicity profiles differed substantially across arms.

Cited by 57 publications

References 19 publications

Outcomes Following Neoadjuvant Chemotherapy for Breast Cancer in Women Aged 40 Years and Younger: Impact of Pathologic Nodal Response

Outcomes Following Neoadjuvant Chemotherapy for Breast Cancer in Women Aged 40 Years and Younger: Impact of Pathologic Nodal Response

Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo): final 10-year follow-up of an open-label, randomised, phase 3 trial

CREATE-X a role for capecitabine in early-stage breast cancer: an analysis of available data

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