ESMO 2021: A Prospective Phase II Trial of Cabazitaxel in Male Patients with Chemotherapy Pre-Treated Metastatic Germ-Cell Tumors: The CABA-GCT Study

( Male patients with advanced germ cell tumors (GCT) who progress after 2-3 lines of therapy have a poor prognosis, and no standard of care exists for treatment refractory GCT. Taxanes, especially paclitaxel, have established activity in GCT. The second generation taxane cabazitaxel may be a promising therapeutic agent given it can cross the blood brain barrier and is associated with limited peripheral neurotoxicity.

To test the activity of cabazitaxel in refractory GCT, the study authors designed the study shown below. Primary prophylaxis with G-CSF was not mandatory but was strongly encouraged. The primary endpoint of the study was the rate of favorable response, defined as either complete response or partial response with negative tumor markers.


A total of 34 patients were recruited to this study, with the majority having a primary testicular non-seminomatous GCT. More than half of patients had received more than two lines of chemotherapy, and 4 patients had brain metastases.


Only two patients achieved a favorable response with cabazitaxel monotherapy, and the overall disease control rate was 26.5%. The percentage of patients who were alive at six months was almost 60%, and almost 21% of patients had not progressed at the six-month time point. Only one patient experienced febrile neutropenia. 


Dr. Giulia Baciarello concluded her presentation by stating that cabazitaxel could be safely administered in patients with refractory GCT and had modest activity in this heavily pre-treated population. The limited number of patients with brain metastases limited the efficacy analysis in this subgroup of patients.

Presented by: Giulia Baciarello, MD, Department of Cancer Medicine at the Gustave Roussy, Villejuif, France and Department of Cancer Medicine at IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Written by: Alok Tewari, MD, PhD – Genitourinary Medical Oncologist, Instructor in Medicine, Dana-Farber Cancer Institute, Harvard Medical School, Twitter: @aloktewar during the 2021 European Society for Medical Oncology (ESMO) Annual Congress 2021, Thursday, Sep 16, 2021 – Tuesday, Sep 21, 2021.

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