2-weekly versus 3-weekly docetaxel for prostate cancer

Abstract

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. 1 Extra JM Rousseau F Bruno R Clavel M Le BN Marty M Phase I and pharmacokinetic study of Taxotere (RP 56976; NSC 628503) given as a short intravenous infusion. Cancer Res. 1993; 53: 1037-1042 PubMed Google Scholar 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. 2 Petrylak DP Docetaxel (Taxotere) in hormone-refractory prostate cancer. Semin Oncol. 2000; 27: 24-29 PubMed Google Scholar Beer and colleagues 3 Beer TM Pierce WC Lowe BA Henner WD Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer. Ann Oncol. 2001; 12: 1273-1279 Crossref PubMed Scopus (180) Google Scholar reported that weekly docetaxel alone was potentially equally active and less toxic than 3-weekly combined regimens. TAX 327 4 Tannock IF de Wit R Berry WR et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004; 351: 1502-1512 Crossref PubMed Scopus (4876) Google Scholar 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 Petrylak DP Tangen CM Hussain MH et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004; 351: 1513-1520 Crossref PubMed Scopus (3254) Google Scholar 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. 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trialAdministration of docetaxel every 2 weeks seems to be well tolerated in patients with castration-resistant advanced prostate cancer and could be a useful option when 3-weekly single-dose administration is unlikely to be tolerated. Full-Text PDF