PMID- 22546837
OWN - NLM
STAT- MEDLINE
DCOM- 20121218
LR  - 20181202
IS  - 1476-5608 (Electronic)
IS  - 1365-7852 (Linking)
VI  - 15
IP  - 3
DP  - 2012 Sep
TI  - 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.
PG  - 303-7
AB  - 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.
FAU - Kellokumpu-Lehtinen, P-L
AU  - Kellokumpu-Lehtinen PL
AD  - Department of Oncology and Radiotherapy, Tampere University Hospital, Tampere, 
      Finland. pirkko-liisa.kellokumpu-lehtinen@uta.fi
FAU - Hjalm-Eriksson, M
AU  - Hjalm-Eriksson M
FAU - Thellenberg-Karlsson, C
AU  - Thellenberg-Karlsson C
FAU - Astrom, L
AU  - Astrom L
FAU - Franzen, L
AU  - Franzen L
FAU - Marttila, T
AU  - Marttila T
FAU - Seke, M
AU  - Seke M
FAU - Taalikka, M
AU  - Taalikka M
FAU - Ginman, C
AU  - Ginman C
CN  - SPCG-13
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Prostate Cancer Prostatic Dis
JT  - Prostate cancer and prostatic diseases
JID - 9815755
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
RN  - 33515-09-2 (Gonadotropin-Releasing Hormone)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Chemotherapy, Adjuvant
MH  - Combined Modality Therapy
MH  - Docetaxel
MH  - Gonadotropin-Releasing Hormone/analogs & derivatives/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Prostatic Neoplasms/*drug therapy/pathology/radiotherapy
MH  - Taxoids/*adverse effects/therapeutic use
FIR - Fransson, Ann-Sofie
IR  - Fransson AS
FIR - Franzen, Lars
IR  - Franzen L
FIR - Astrom, Lennart
IR  - Astrom L
FIR - Seke, Mihail
IR  - Seke M
FIR - Hjalm-Eriksson, Marie
IR  - Hjalm-Eriksson M
FIR - Gorzov, Petr
IR  - Gorzov P
FIR - Leskinen, Markku
IR  - Leskinen M
FIR - Ala-Opas, Martti
IR  - Ala-Opas M
FIR - Marttila, Timo
IR  - Marttila T
FIR - Nyandoto, Paul
IR  - Nyandoto P
FIR - Turpeenniemi-Hujanen, Taina
IR  - Turpeenniemi-Hujanen T
FIR - Iversen, Jon R
IR  - Iversen JR
FIR - Keane, Maccon
IR  - Keane M
EDAT- 2012/05/02 06:00
MHDA- 2012/12/19 06:00
CRDT- 2012/05/02 06:00
PHST- 2012/05/02 06:00 [entrez]
PHST- 2012/05/02 06:00 [pubmed]
PHST- 2012/12/19 06:00 [medline]
AID - pcan201213 [pii]
AID - 10.1038/pcan.2012.13 [doi]
PST - ppublish
SO  - Prostate Cancer Prostatic Dis. 2012 Sep;15(3):303-7. doi: 10.1038/pcan.2012.13.