J Cancer 2014; 5(5):320-327. doi:10.7150/jca.8748
Eribulin Mesylate in Pretreated Breast Cancer Patients: A Multicenter Retrospective Observational Study
1. Medical Oncology Unit ASL Frosinone, Frosinone, Italy;
2. Oncology Unit I, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy;
3. Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome, Italy;
4. Biostatistics Unit, Regina Elena National Cancer Institute, Rome, Italy;
5. Division of Medical Oncology A, Regina Elena National Cancer Institute, Rome, Italy;
6. Department of Medical Oncology, University Campus Bio-Medico, Rome, Italy;
7. Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy;
8. Medical Oncology, S.M. Goretti Hospital, Latina, Italy;
9. Medical Oncology, San Pietro Hospital, Rome, Italy;
10. Division of Medical Oncology, Department of Oncology, Belcolle Hospital, ASL Viterbo, Viterbo, Italy.
* These two authors contributed equally to this work and serve as first co-authors.
Background: Eribulin was recently approved in patients progressing after being treated with anthracyclines and taxanes and after two or more chemotherapy lines for advanced disease.
Objectives: This multicenter observational retrospective study was performed in order to evaluate activity and tolerability of eribulin in real-world patient population.
Methods: 133 advanced breast cancer patients pretreated with ≥ 2 chemotherapy lines for metastatic disease were retrospectively enrolled in the observational trial in 11 italian cancer centres.
Results: A median of 5 cycles of eribulin (range, 1-15) were administered. Twenty-eight partial responses were observed, for an overall response rate of 21.1% (95%CI,14.1-28.0). A stable disease was recorded in 57 patients (42.8%), and a clinical benefit (response or stable disease lasting ≥ six months) was observed in 51 patients (38.3%, 95%CI, 30.1-46.6). The subgroup analysis showed that a significant improvement in term of partial response and clinical benefit was achieved when eribulin was administered in HER-2 negative tumors (p=0.01 and p=0.004, respectively) and when it is given as third-line (p=0.09 and p=0.02, respectively). Toxicity was manageable; fatigue is the most common side effect observed, usually of low-grade, and clearly cumulative-dose related.
Conclusions: In this retrospective, observational analysis eribulin confirmed its efficacy and manageable tolerability even in real-world population and in heavily pretreated patients.
Keywords: advanced breast cancer, eribulin mesylate, real-world population, heavily pretreated patients, chemotherapy.
Gamucci T, Michelotti A, Pizzuti L, Mentuccia L, Landucci E, Sperduti I, Di Lauro L, Fabi A, Tonini G, Sini V, Salesi N, Ferrarini I, Vaccaro A, Pavese I, Veltri E, Moscetti L, Marchetti P, Vici P. Eribulin Mesylate in Pretreated Breast Cancer Patients: A Multicenter Retrospective Observational Study. J Cancer 2014; 5(5):320-327. doi:10.7150/jca.8748. Available from http://www.jcancer.org/v05p0320.htm