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Patients in long response during Halaven® treatment

Marie-Ange MOURET-REYNIER, MD

There is currently no strict recommendations for the management of patients who have received at least one or two lines of anthracyclines-based chemotherapy and taxane therapy for advanced breast cancer. However, Halaven® can represent a therapeutic alternative at this stage of the disease.

Indeed, since march 2011, Halaven® has been granted Marketing Authorization (MA) for patients with metastatic or locally advanced breast cancer, whose disease has progressed after at least two lines of chemotherapy for advanced disease (3rd line). In these patients, the indication for marketing authorization specifies that the previous treatment must have included an anthracycline and a taxane except in patients who can not receive these treatments.

An extension of indication was obtained on 27/06/2014 with a marketing authorization obtained in the treatment of locally advanced or second-line metastatic breast cancer.

According to the Transparency Commission of the High Authority of Health (HAS dated September 23, 2015), Halaven® (Eribulin), administered as monotherapy, in the third line of treatment and beyond, represents a therapeutic option, because it brings an improvement of medical service rendered compared to Capecitabine (XELODA®) and Vinorelbine (NAVELBINE®).

In addition, Halaven® (Eribuline) administrated as monotherapy in second-line of treatment is an alternative to other monotherapies recommended for the treatment of locally advanced or metastatic relapsed breast cancer, such as Capecitabine (XELODA®). and Vinorelbine (NAVELBINE®). But, no improvement of medical service rendered has been reported in second line of treatment.

According to these results, it would be interesting to have additional data concerning the use of Halaven® (Eribulin), in the second and third lines, but also in the fourth line.

For this purpose, the investigators propose to perform a study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.

In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 and December 2016, to have a sufficient follow-up for the survival data of the patients.

The investigators will perform a cross-sectional study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.

In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 (the year of obtaining the MA in the 3rd line of treatment) and December 2016, to have a sufficient follow-up for the survival data of the patients.

The investigators will also focus on patients with liver metastases because there is limited data in this population.

Only female patients will be included in order to have an homogeneous group

Loreline Study: Characterization of Long Responders Under Eribuline

National Retrospective Study to Characterize LOng REsponder Under EribuLINE (HALAVEN®) Metastatic Breast Cancer Patients

-patient's age at the beginning of Halaven® treatment

number of patients who have received neoadjuvant treatments number of patients who have received adjuvant treatments

-number of lines of treatment received for metastatic disease, including treatment received before Halaven®

number of patients with metastatic localizations

number of patients with liver metastasis, surgery of liver metastasis

-number of Halaven® injections until the " best " response is obtained

-duration of the " best " response under Halaven® (in months)

hormonal receptors of primitive tumor (percentage of stained cells)

-pathology of primitive cancer : Scarff Bloom Richardson grade The Scarff Bloom Richardson garde will be measured with a scale from I to III. A grade III represent a worse outcome.

Percentage of patients in objective response or in stability during 6 months and more since the beginning of Halaven® treatment among all patients treated by Halaven® (in second, third and fourth line of treatment). This percentage will be collected in each participating center at the end of the study.

-Percentage of liver metastatic patients in complete or partial response or in stability under Halaven®

Number and percentage of patients who have a grade 3 and a grade 4 toxicity (for each toxicity reported)

-Collection of toxicities under Halaven® Toxicities considered are toxicities grade 3, 4 and 5 (CTCAE V4.03 dated on june 14, 2010) : nausea, vomiting,diarrhea, neutropenia, anemia, leucopenia, fatigue, peripheral neuropathy, alopecia, loss of apetite. If others toxicities appear, they will be notified in the e-CRF.

-Percentage of patients in complete or partial reponse or in stability under Halaven®. This percentage will be calculated in patients treated by Halaven® in second, third or fourth line of treatment

-Measure of time to progression (in months or in years) The PFS will be calculated from date of Halaven start to first progression date whatever the type of progression (local progression, progression of a previous metastasis and/or appearance of new metastasis, and/or new cancer).

Measure of overall survival (in months or in years) Overall survival calculated from start of Halaven to death, whatever the cause, or date of last consultation if patients are alive at the 12/31/2017.

Spots Global Cancer Trial Database for patients in long response during halaven® treatment