Translating Clinical Evidence-Based Medicine into the Real World: Single-Center Experience with Cabazitaxel in Metastatic Prostate Cancer Patients.

We studied the efficacy and safety of cabazitaxel in unselected real-life patients.

We retrospectively investigated all patients with metastatic prostate cancer (mPC) treated with cabazitaxel 25 mg/m2 i.

v. every 3 weeks combined with oral prednisolone (10 mg once daily) after first-line docetaxel chemotherapy. Study issues were to report patient characteristics and cabazitaxel data in terms of tolerance and efficacy. Overall survival (OS) and progression-free survival (PFS) were evaluated using the Kaplan-Meier method. All data were compared with TROPIC results.

From 2011 to 2014, 41 patients received cabazitaxel; 15 patients (37%) had a performance status (PS) ≥2 versus 7% (p < 0. 0001) in TROPIC, and 38 patients (93%) presented a Gleason score ≥7 at baseline (vs. 60%; p < 0. 0001). All patients had metastatic disease at baseline. Previous therapies were radiotherapy in 17 patients (41 vs. 61%; p = 0. 01) and surgery in 24 patients (59 vs. 52%; p = 0. 4). The median number of cabazitaxel cycles was 5 (1-10) versus 6 (3-10) in TROPIC. Five patients completed 10 cycles of cabazitaxel (12%) versus 28% in TROPIC (p = 0. 03). Toxicities were anemia (12 patients, 29%), diarrhea (9 patients, 22%), nausea (7 patients, 17%), pain (6 patients, 15%), sepsis (4 patients, 10%), neutropenia (3 patients, 7%) and urinary tract infection (1 patient, 2%). The tumor response rate was 19. 5 versus 14. 4% in TROPIC (nonsignificant). PFS was 4. 5 months (95% CI 3. 3-6. 4) in our analysis and 2. 8 months (95% CI 2. 4-3. 0) in TROPIC. OS was 12. 1 months (95% CI 9. 2 to not reached) and 15. 1 months (95% CI 14. 1-16. 3), respectively.

In our unselected mPC patients with poorer baseline clinical conditions and aggressive disease, cabazitaxel seems efficient and not more toxic than in the TROPIC study.

Chemotherapy. 2016 Jan 12 [Epub ahead of print]

Guillaume Moriceau, Aline Guillot, Cécile Pacaut, Benoîte Méry, Alexander Tuan Falk, Jane-Chloé Trone, Olivier Collard, Guy De Laroche, Pierre Fournel, Yacine Merrouche, Nicolas Magné

PubMed