title: Quality-of-Life Analysis of the German Prospective Multicentre Trial of Single-cycle Adjuvant BEP Versus Retroperitoneal Lymph Node Dissection in Clinical Stage I Nonseminomatous Germ Cell Tumours.
abstract: BACKGROUND
  The superiority of one course of bleomycin, etoposide, and cisplatin (BEP) over retroperitoneal lymph node dissection (RPLND) as adjuvant treatment in patients with clinical stage I nonseminomatous germ cell tumours (CSI-NSGCT) in terms of recurrence has been shown. However, studies providing validated prospective quality-of-life (QoL) data in patients with CSI-NSGCT treated with only one cycle of BEP are lacking.
  
  
  OBJECTIVE
  To examine and compare QoL issues in patients with CSI-NSGCT after adjuvant treatment.
  
  
  METHODS
  Between 1996 and 2005, we randomly assigned a total of 382 patients with CSI-NSGCT to receive either one course of BEP or RPLND after orchiectomy. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) plus additional scales questionnaire (QLQ-C30+) was completed prospectively according to an a priori schedule, with a final assessment in 2011.
  
  
  METHODS
  We used the Mann-Whitney U test to detect a difference ≥17% on the global QoL item "overall strain."
  
  
  CONCLUSIONS
  Of 382 patients randomised to receive either one course of BEP (n=191, arm A) or RPLND (n=191, arm B), completed QLQ-C30+ and data on treatment response were available in 162 and 164 patients, respectively. All participants were included for intention-to-treat analysis. We evaluated treatment-related changes in QoL for the follow-up period up to 3 yr after treatment. We observed no significant differences between the treatment groups in any QoL domain except alopecia. Compared to QoL assessments in the general population, both arms had already recovered to normal values in all items by 6 mo.
  
  
  CONCLUSIONS
  The QoL assessment of this large randomised trial was not able to detect significant differences in QoL scores between patients undergoing RPLND and BEP in a community-based setting.
  
  
  RESULTS
  Retroperitoneal lymph node dissection and bleomycin, etoposide, and cisplatin are two adjuvant treatment options for patients with CSI-NSGCT after orchiectomy. Quality of life had already recovered to normal levels in both groups by 6 mo after treatment. No clinically relevant differences were detected.
authors.affiliation: Department of Child and Adolescent Psychiatry, Otto-von-Guericke University, Magdeburg, Germany.
authors.forename: Hans-Henning
authors.initials: HH
authors.lastname: Flechtner
authors.affiliation: Department of Urology, University of Bonn, Bonn, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Fischer
authors.affiliation: Department of Urology, Heinrich Heine University, Düsseldorf, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Albers
authors.affiliation: Department of Urology, Military Hospital Hamburg, Hamburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Hartmann
authors.affiliation: Department of Urology, University of Bonn, Bonn, Germany. Electronic address: Roswitha.Siener@ukb.uni-bonn.de.
authors.forename: Roswitha
authors.initials: R
authors.lastname: Siener
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000009:adverse effects / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D005047:Etoposide / Q000009:adverse effects / Q000627:therapeutic use; D005858:Germany; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009373:Neoplasms, Germ Cell and Embryonal / Q000523:psychology / Q000556:secondary / Q000628:therapy*; D009919:Orchiectomy / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013736:Testicular Neoplasms / Q000473:pathology / Q000523:psychology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001761:Bleomycin; D005047:Etoposide; D002945:Cisplatin
keywords: Chemotherapy; Clinical stage I NSGCT; Long-term follow-up; Quality of life; Randomised trial; Retroperitoneal lymph node dissection; Testicular cancer; Testis cancer