Randomized Phase II Trial of First-Line Trastuzumab Plus Docetaxel and Capecitabine Compared With Trastuzumab Plus Docetaxel in <i>HER2</i>-Positive Metastatic Breast Cancer

Wardley, Andrew M; Pivot, Xavier; Morales-Vásquez, Flavia; Zetina, L.; Gauí, Maria de Fátima Dias; Reyes, Douglas Otero; Jassem, Jacek; Barton, Claire; Button, Peter; Hersberger, Veronica; Torres, A. Antón

doi:10.1200/jco.2008.21.6531

Cited by 109 publications

(59 citation statements)

References 27 publications

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“…Many drugs have not been assessed by RCT design in combination with trastuzumab for MBC patients with HER2+, but combined regimens are prescribed widely, such as gemcitabine (O'Shaughnessy et al, 2004). Another problem is finding the optimal combined regimen for these patients though clinical trials (Wardley et al, 2010;Valero et al, 2011).…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Trastuzumab Added to Standard Treatments for HER2-positive Metastatic Breast Cancer Patients

Zhu

Zhang²,

Chen³

et al. 2013

Asian Pacific Journal of Cancer Prevention

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Introduction: Trastuzumab, an HER2-targeting agents, has shown efficacy in metastatic HER2-positive breast cancer patients. Single-agent clinical trials have evaluated therapeutic regimens using trastuzumab for metastatic breast cancer patients. The aim of our study is to evaluate the efficacy and safety of trastuzumab in combination with chemotherapy or hormone therapy in HER2-positive metastatic breast cancer patients. Methods: A literature research was conducted in PubMed and to identify appropriate studies from relevant reviews. Randomized controlled trials comparing chemotherapy or hormone therapy regimens in combination with trastuzumab were eligible. Dadta on clinical outcomes, including safety, efficacy, and patient characteristics were collected. Results: Seven articles describing five trials were included in our systematic review and metaanalysis. Partners of trastuzumab included in trials were anthracycline, paclitaxel, docetaxel, anastrozole and letrozole. The addition of trastuzumab to chemotherapy improved the overall survival (HR=0.79, 95%CI 0.65-0.96), while to hormone therapy did not (HR=0.85 95%CI 0.56-1.30). All trastuzumab-containing regimens increased cardiac toxicity (RR=3.37, 95%CI 1.26-9.02) and grade Ⅲ-Ⅳ adverse events. Conclusions: Our study supports the addition of trastuzumab to chemotherapy which is effective and tolerated for metastatic breast cancer with HER2+ patients. Of note, more adverse events will occur followed the use of trastuzumab, especially cardiac toxicity, with two treatment regimens.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Trastuzumab Added to Standard Treatments for HER2-positive Metastatic Breast Cancer Patients

Zhu

Zhang²,

Chen³

et al. 2013

Asian Pacific Journal of Cancer Prevention

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“…Three phase III trials compared first-line XT with alternative docetaxel-containing doublets in HER2-negative MBC [4,5,6]. In addition, the randomized, phase II CHAT trial compared XT versus docetaxel, with trastuzumab given in both arms, as first-line therapy for HER2-positive MBC [7]. There was no difference in response rate between the 2 arms, but both time to progression and progression-free survival (PFS) were significantly improved in the XT plus trastuzumab arm.…”

Section: Introductionmentioning

confidence: 99%

Final Results of ERASME-4: A Randomized Trial of First-Line Docetaxel plus either Capecitabine or Epirubicin for Metastatic Breast Cancer

et al. 2011

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Objective: To assess the efficacy of capecitabine plus docetaxel (XT) versus epirubicin plus docetaxel (ET) as first-line therapy for metastatic breast cancer (MBC). Patients and Methods: Patients with no prior chemotherapy for MBC were randomized to 3-weekly cycles of either XT (capecitabine 1,000 mg/m² twice daily, days 1–14; docetaxel 75 mg/m², day 1) or ET (epirubicin 75 mg/m², day 1; docetaxel 75 mg/m², day 1). The primary endpoint was non-progression rate 6 months after randomization. The planned sample size was 106 patients based on a randomized, phase II selection design. Results: Between April 2004 and January 2007, 68 patients were randomized, giving 82% power to select the best regimen according to a 6-month non-progression rate. Slow accrual led to premature study termination. Baseline characteristics were generally well balanced between arms. The 6-month non-progression rates were 75.8% with XT versus 65.7% with ET (p = 0.36). After 42 months’ median follow-up, median progression-free survival was 12.4 versus 6.8 months, respectively (p = 0.040). The safety profiles were consistent with previous experience. Conclusion: Further larger studies are warranted to validate these results. Despite more grade 3 hand-foot syndrome, first-line XT may be a valid alternative to ET, potentially improving efficacy.

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“…15 Many Phase II and III studies have evaluated the combination of trastuzumab with chemotherapy for MBC in the first-line setting and beyond, yielding response rates ranging from 30% to 70%. [16][17][18][19][20][21][22][23][24][25] Trastuzumab has also been given in combination with hormonal manipulation. In the Phase III randomized TANDEM (Trastuzumab in Dual HER2 ERPositive Metastatic Breast Cancer) study, 207 patients with HER2+ and hormone receptor-positive MBC were randomly assigned to receive anastrozole alone or with trastuzumab.…”

Section: Trastuzumabmentioning

confidence: 99%

Role of lapatinib alone or in combination in the treatment of HER2-positive breast cancer

Hurvitz¹,

Kakkar²

2012

BCTT

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Purpose: This review aims to present the preclinical and clinical data regarding efficacy and safety of lapatinib alone and in combination with other agents in the treatment of human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer. Background: HER2-positive (HER2+) breast cancer remains a treatment challenge. It is more aggressive than other breast cancers and it is associated with a poor outcome. Targeted therapy for HER2+ breast cancer has significantly changed the clinical course of the disease. Despite advances in therapy, there remains an unmet need in the treatment of HER2+ breast cancer. Lapatinib is a novel, orally bioavailable epidermal growth factor receptor/HER2+ targeted agent. Many trials have investigated the efficacy and safety of lapatinib alone and in conjunction with other agents in the treatment of HER2+ breast cancer. Methods and results: Preclinical and clinical trials of lapatinib have shown that it is effective in the treatment on HER2+ breast cancer. More important, studies show that it is effective in the setting of trastuzumab resistance and in the treatment of central nervous system metastases, both of which are current treatment challenges. Furthermore, lapatinib is effective in conjunction with trastuzumab in the treatment of early breast cancer. Data regarding the safety of lapatinib show that it is generally well tolerated; however, multiple studies have shown significant (grade 3 and 4) diarrhea and rash associated with lapatinib, thereby limiting its use. Carditoxicity has not been a significant adverse event associated with the use of lapatinib. Conclusion: Lapatinib is effective alone and in conjunction with other agents in the treatment of HER2+ breast cancer. However, its use is limited by significant diarrhea and rash.

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Randomized Phase II Trial of First-Line Trastuzumab Plus Docetaxel and Capecitabine Compared With Trastuzumab Plus Docetaxel in HER2-Positive Metastatic Breast Cancer

Cited by 109 publications

References 27 publications

Efficacy and Safety of Trastuzumab Added to Standard Treatments for HER2-positive Metastatic Breast Cancer Patients

Efficacy and Safety of Trastuzumab Added to Standard Treatments for HER2-positive Metastatic Breast Cancer Patients

Final Results of ERASME-4: A Randomized Trial of First-Line Docetaxel plus either Capecitabine or Epirubicin for Metastatic Breast Cancer

Role of lapatinib alone or in combination in the treatment of HER2-positive breast cancer

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