Here is an OncologySTAT.com clinical study review of a new prostate cancer combination which highlights the fact researchers are fighting cancer month by month:
Prednisone Plus Cabazitaxel or Mitoxantrone for Metastatic Castration-Resistant Prostate Cancer Progressing After Docetaxel Treatment: A Randomised Open-Label Trial
Lancet. 2010 Oct 1;376(9747):1147-1154, JS de Bono, S Oudard, M Ozguroglu, S Hansen, J-P Machiels, I Kocak, G Gravis, I Bodrogi, MJ Mackenzie, L Shen, M Roessner, S Gupta, AO Sartor, for the TROPIC Investigators
Background: Cabazitaxel is a novel tubulin-binding taxane drug with antitumour activity in docetaxel-resistant cancers. We aimed to compare the efficacy and safety of cabazitaxel plus prednisone with those of mitoxantrone plus prednisone in men with metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment.
Methods: We undertook an open-label randomised phase 3 trial in men with metastatic castration-resistant prostate cancer who had received previous hormone therapy, but whose disease had progressed during or after treatment with a docetaxel-containing regimen. Participants were treated with 10 mg oral prednisone daily, and were randomly assigned to receive either 12 mg/m2 mitoxantrone intravenously over 15—30 min or 25 mg/m2 cabazitaxel intravenously over 1 h every 3 weeks. The random allocation schedule was computer-generated; patients and treating physicians were not masked to treatment allocation, but the study team was masked to the data analysis. The primary endpoint was overall survival. Secondary endpoints included progression-free survival and safety. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, NCT00417079.
Findings: 755 men were allocated to treatment groups (377 mitoxantrone, 378 cabazitaxel) and were included in the intention-to-treat analysis. At the cutoff for the final analysis (Sept 25, 2009), median survival was 15.1 months (95% CI 14.1—16.3) in the cabazitaxel group and 12.7 months (11.6—13.7) in the mitoxantrone group. The hazard ratio for death of men treated with cabazitaxel compared with those taking mitoxantrone was 0.70 (95% CI 0.59—0.83, p<0.0001). Median progression-free survival was 2.8 months (95% CI 2.4—3.0) in the cabazitaxel group and 1.4 months (1.4—1.7) in the mitoxantrone group (HR 0.74, 0.64—0.86, p<0.0001). The most common clinically significant grade 3 or higher adverse events were neutropenia (cabazitaxel, 303 [82%] patients vs mitoxantrone, 215 [58%]) and diarrhoea (23 [6%] vs one [<1%]). 28 (8%) patients in the cabazitaxel group and five (1%) in the mitoxantrone group had febrile neutropenia.
Interpretation: Treatment with cabazitaxel plus prednisone has important clinical antitumour activity, improving overall survival in patients with metastatic castration-resistant prostate cancer whose disease has progressed during or after docetaxel-based therapy.
Yes, this therapy seems to work a bit better–and for a prostate cancer patient who is running out of options, three months is better than nothing. But extending median life expectancy by 2.4 months isn’t exactly a cure. What this study doesn’t compare is the cost differential between the two therapies.
This feels like our war in Afghanistan. I appreciate the efforts of our troops/researchers–but we just aren’t winning the war.
Feel good and keep smiling! Pat