2-weekly versus 3-weekly docetaxel for prostate cancer
Mené sur 361 patients atteints d'un cancer de la prostate résistant à la castration, cet essai multicentrique de phase III compare, du point de vue du délai avant échec du traitement, deux modalités d'administration du docétaxel, une dose de 75 mg/m2 toutes les 3 semaines ou une dose de 50 mg/m2 toutes les deux semaines
In the early 1990s, a phase 1 trial of docetaxel administered in 2-weekly and 3-weekly schedules showed that a suitable dose for study in phase 2 trials was 100 mg/m2 every 3 weeks. The 2-weekly schedule was associated with unacceptable side-effects when doses were greater than 55 mg/m2. By 2000, 3-weekly docetaxel-based regimens had become the standard of care for patients with castration-resistant prostate cancer. Beer and colleagues reported that weekly docetaxel alone was potentially equally active and less toxic than 3-weekly combined regimens. TAX 3274 assessed 75 mg/m2 3-weekly docetaxel or 30 mg/m2 weekly docetaxel administered in 5 of every 6 weeks, combined with prednisone and compared these regimens with a standard chemotherapy regimen of prednisone and mitoxantrone. In TAX 327, 3-weekly docetaxel was associated with a significant improvement in survival compared with mitoxantrone, whereas weekly docetaxel was not. In the Southwest Oncology Group 9916 trial, 60 mg/m2 3-weekly docetaxel combined with estramustine was compared with mitoxantrone.5 The docetaxel dose was escalated to 70 mg/m2 in patients without grade 3 or higher toxic effects in the first cycle. Estramustine seemed to add no benefit. The US Food and Drug Administration, therefore, the approved dose of 75 mg/m2 docetaxel every 3 weeks in combination with oral prednisone based on these two phase 3 randomised trials...
The Lancet Oncology , commentaire en libre accès, 2012