title: Biweekly docetaxel is better tolerated than conventional three-weekly dosing for advanced hormone-refractory prostate cancer.
abstract: BACKGROUND
  Docetaxel administered every three weeks is the standard treatment for advanced hormone-refractory prostate cancer (HRPC). However, biweekly administration might be better tolerated due to the reduced peak drug concentrations. Therefore, we compared biweekly to triweekly docetaxel as first- or second-line chemotherapy for advanced HRPC in this prospective randomized multicenter trial.
  
  
  METHODS
  In this study, 360 patients were randomly allocated to receive docetaxel 75 mg/m(2) i.v. d1 q3 weeks (tT) or 50 mg/m(2) i.v. d1 and d 14, q4 weeks (bT) from March 2004 to May 2009. Oral prednisolone (10 mg/day) was administered in both groups. The groups were well balanced according to the WHO performance status in terms of mean age (70 vs. 68, range 45-87 years) and median serum PSA level at the time of study entry (109 vs. 98 μg/l, range 11-1490 μg/l). The primary endpoint was time to treatment failure (TTF). ClinicalTrials.gov study identifier: NCT00255606.
  
  
  RESULTS
  Ultimately, 158 patients (tT=79; bT=79) were included in this preplanned interim safety analysis; 567 and 487 cycles (equivalent to 1701 and 1948 weeks of treatment) were administered in the tT and bT groups, respectively. The most common grade 3-4 adverse events (expressed as %/cycles) in tT /bT were neutropenia 20%/14%; infection with/without neutropenia 8%/3%; fatigue 3%/3%; febrile neutropenia 2%/1%; and bone pain 2%/1%. Serious adverse events occurred more frequently in the group tT (n=60, 10.6% of cycles) than in the group bT (n=29, 6.0%, p=0.012). One patient died due to coronary infarction, and another was diagnosed with acute lymphocytic leukemia (both in the bT group). Thirty patients (38%) in the bT group and 22 patients (28%) in the tT group were still receiving treatment at 6 months (p=0.176).
  
  
  CONCLUSIONS
  Biweekly docetaxel was tolerated better than conventional triweekly with fewer serious adverse events and more patients were still on the therapy at 6 months. Biweekly docetaxel therapy might be considered as an option for elderly patients exhibiting a compromised general condition.
authors.affiliation: Tampere University Hospital, Tampere, Finland. petteri.hervonen@uta.fi
authors.forename: Petteri
authors.initials: P
authors.lastname: Hervonen
authors.forename: Heikki
authors.initials: H
authors.lastname: Joensuu
authors.forename: Timo
authors.initials: T
authors.lastname: Joensuu
authors.forename: Claes
authors.initials: C
authors.lastname: Ginman
authors.forename: Ginman
authors.initials: G
authors.lastname: Claes
authors.forename: Ray
authors.initials: R
authors.lastname: McDermott
authors.forename: McDermott
authors.initials: M
authors.lastname: Ray
authors.forename: Ulrika
authors.initials: U
authors.lastname: Harmenberg
authors.forename: Harmenberg
authors.initials: H
authors.lastname: Ulrika
authors.forename: Paul
authors.initials: P
authors.lastname: Nyandoto
authors.forename: Nyandoto
authors.initials: N
authors.lastname: Paul
authors.forename: Tiina
authors.initials: T
authors.lastname: Luukkaala
authors.forename: Luukkaala
authors.initials: L
authors.lastname: Tiina
authors.forename: Akseli
authors.initials: A
authors.lastname: Hemminki
authors.forename: Hemminki
authors.initials: H
authors.lastname: Akseli
authors.forename: Igor
authors.initials: I
authors.lastname: Zaitsev
authors.forename: Zaitsev
authors.initials: Z
authors.lastname: Igor
authors.forename: Mirja
authors.initials: M
authors.lastname: Heikkinen
authors.forename: Heikkinen
authors.initials: H
authors.lastname: Mirja
authors.forename: Sten
authors.initials: S
authors.lastname: Nilsson
authors.forename: Nilsson
authors.initials: N
authors.lastname: Sten
authors.forename: Marjaana
authors.initials: M
authors.lastname: Luukkaa
authors.forename: Luukkaa
authors.initials: L
authors.lastname: Marjaanai
authors.forename: Ilari
authors.initials: I
authors.lastname: Lehtinen
authors.forename: Lehtinen
authors.initials: L
authors.lastname: Ilari
authors.forename: Pirkko-Liisa
authors.initials: PL
authors.lastname: Kellokumpu-Lehtinen
authors.forename: Kellokumpu-Lehtinen
authors.initials: KL
authors.lastname: Pirkko-Liisa
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077143:Docetaxel; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy*; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel