CEREBEL (EGF111438): A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer
| Autor: | Stefania Gori, Magdolna Dank, Lajos Hornyak, Sergio Santillana, Michelle DeSilvio, Ramona F. Swaby, Vladimir Semiglazov, Roma Parikh, Sara Margolin, Alessandra Fabi, Xavier Pivot, Ewa Chmielowska, Bogdan Żurawski, Rozenn Allerton, P. Bidoli, Fareha Nagi, Boguslawa Karaszewska, Alexey Manikhas, Eva Ciruelos, Arnd Nusch, Stephen Chan |
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| Přispěvatelé: | Pivot, X, Manikhas, A, Żurawski, B, Chmielowska, E, Karaszewska, B, Allerton, R, Chan, S, Fabi, A, Bidoli, P, Gori, S, Ciruelos, E, Dank, M, Hornyak, L, Margolin, S, Nusch, A, Parikh, R, Nagi, F, Desilvio, M, Santillana, S, Swaby, R, Semiglazov, V |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Receptor ErbB-2 Breast Neoplasms Kaplan-Meier Estimate Antibodies Monoclonal Humanized Lapatinib Deoxycytidine Loading dose Disease-Free Survival Drug Administration Schedule law.invention Capecitabine Randomized controlled trial Trastuzumab law Internal medicine Antineoplastic Combined Chemotherapy Protocols Biomarkers Tumor Odds Ratio Humans Medicine Infusions Intravenous skin and connective tissue diseases Aged Neoplasm Staging Aged 80 and over business.industry Incidence (epidemiology) Middle Aged medicine.disease Metastatic breast cancer Clinical trial Treatment Outcome Quinazolines Female Fluorouracil Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 33:1564-1573 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | Purpose CEREBEL compared the incidence of CNS metastases as first site of relapse in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer receiving lapatinib-capecitabine or trastuzumab-capecitabine. Patients and Methods Patients without baseline CNS metastases were randomly assigned (1:1) to receive lapatinib-capecitabine (lapatinib 1,250 mg per day; capecitabine 2,000 mg/m2 per day on days 1 to 14 every 21 days) or trastuzumab-capecitabine (trastuzumab loading dose of 8 mg/kg followed by an infusion of 6 mg/kg every 3 weeks; capecitabine 2,500 mg/m2 per day on days 1 to 14 every 21 days). The primary end point was incidence of CNS metastases as first site of relapse. Secondary end points included progression-free survival (PFS) and overall survival (OS). Results The study was terminated early with 540 enrolled patients (271 received lapatinib-capecitabine, and 269 received trastuzumab-capecitabine). Incidence of CNS metastases as first site of relapse was 3% (eight of 251 patients) for lapatinib-capecitabine and 5% (12 of 250 patients) for trastuzumab-capecitabine (treatment differences, −1.6%; 95% CI, −2% to 5%; P = .360). PFS and OS were longer with trastuzumab-capecitabine versus lapatinib-capecitabine (hazard ratio [HR] for PFS, 1.30; 95% CI, 1.04 to 1.64; HR for OS, 1.34; 95% CI, 0.95 to 1.64). Serious adverse events were reported in 13% (34 of 269 patients) and 17% (45 of 267 patients) of patients in the lapatinib-capecitabine and trastuzumab-capecitabine arms, respectively. Conclusion CEREBEL is inconclusive for the primary end point, and no difference was detected between lapatinb-capecitabine and trastuzumab-capecitabine for the incidence of CNS metastases. A better outcome was observed with trastuzumab-capecitabine in the overall population. However, lapatinib-capecitabine efficacy may have been affected by previous exposure to a trastuzumab regimen and/or when treatment was given as first- or second-line therapy in the metastatic setting. |
| Databáze: | OpenAIRE |
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