title: Toxicity in patients receiving adjuvant docetaxel + hormonal  treatment after radical radiotherapy for intermediate or  high-risk prostate cancer: a preplanned safety report of the  SPCG-13 trial.
abstract: BACKGROUND
  Radical radiotherapy (RT) combined with androgen deprivation therapy is currently the standard treatment for elderly patients with localized intermediate- or high-risk prostate cancer (PC). To increase the recurrence-free and overall survival, we conducted an adjuvant, randomized trial using docetaxel (T) in PC patients (Scandinavian Prostate Cancer Group trial 13).
  
  
  METHODS
  The inclusion criteria are the following: men >18 and ≤75 years of age, WHO/ECOG performance status 0--1, histologically proven PC within 12 months before randomization and one of the following: T2, Gleason 7 (4+3), PSA >10; T2, Gleason 8--10, any PSA; or any T3 tumors. Neoadjuvant/adjuvant hormone therapy is mandatory for all patients. The patients were randomized to receive six cycles of T (75 mgm(-2) d 1. cycle 21 d) or no docetaxel after radical RT (with a minimum tumor dose of 74 Gy). This study identifier number is NTC 006653848 (http://www.clinicaltrials.org).
  
  
  RESULTS
  In this preplanned safety analysis of 100 patients, T treatment induced grade (G) 3 adverse events (AEs) in 15 patients (30%) and G4 AEs in 30 patients (60%), mainly due to bone marrow toxicity. Neutropenia G3--4 was observed in 72% of the patients, febrile neutropenia was found in 24% of patients, neutropenic infection in 10% of patients and G3 infection without neutropenia in 4% of patients. Nonhematological G3 AEs were rare: anorexia, diarrhea, mucositis, nausea, pain (1 patient each) and fatigue (5). Other severe serious AEs related to T were pulmonary embolism and renal failure. However, only three patients discontinued T before completing the planned six cycles. No deaths had occurred. No patients in the control arm experienced G3--4 toxicities at 12 weeks after the randomization.
  
  
  CONCLUSIONS
  Adjuvant docetaxel chemotherapy after radiotherapy has a higher frequency of neutropenia than previous studies on patients with metastatic disease. Otherwise, the treatment was quite well tolerated.
authors.affiliation: Department of Oncology and Radiotherapy, Tampere University Hospital, Tampere, Finland. pirkko-liisa.kellokumpu-lehtinen@uta.fi
authors.forename: P-L
authors.initials: PL
authors.lastname: Kellokumpu-Lehtinen
authors.forename: M
authors.initials: M
authors.lastname: Hjälm-Eriksson
authors.forename: C
authors.initials: C
authors.lastname: Thellenberg-Karlsson
authors.forename: L
authors.initials: L
authors.lastname: Åström
authors.forename: L
authors.initials: L
authors.lastname: Franzen
authors.forename: T
authors.initials: T
authors.lastname: Marttila
authors.forename: M
authors.initials: M
authors.lastname: Seke
authors.forename: M
authors.initials: M
authors.lastname: Taalikka
authors.forename: C
authors.initials: C
authors.lastname: Ginman
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D000077143:Docetaxel; D007987:Gonadotropin-Releasing Hormone / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D043823:Taxoids / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D007987:Gonadotropin-Releasing Hormone