title: Short-course adjuvant chemotherapy in high-risk stage I nonseminomatous germ cell tumors of the testis: a Medical Research Council report.
abstract: OBJECTIVE
  This United Kingdom Medical Research Council (UK-MRC) study prospectively evaluated efficacy and long-term toxicity of adjuvant chemotherapy in high-risk stage I nonseminomatous germ cell tumors of the testis (NSGCTT).
  
  
  METHODS
  Eligible patients were those identified by the local histopathologist as having features confirmed in MRC surveillance studies to indicate an approximate 50% risk of relapse. Central histopathology review was undertaken. Chemotherapy consisted of two courses of cisplatin 100 mg/m2, bleomycin 30 mg weekly x 3, and etoposide 120 mg/m2 x 3, every 21 days (BEP).
  
  
  RESULTS
  One hundred fourteen eligible cases were enrolled. Median time of follow-up was 4 years, with 93 patients followed-up for at least 2 years. There have been two relapses, including one patient who did not have a germ cell tumor (GCT), according to the reference histopathologist. This patient is alive with active disease, the other has died. There was one death after a cerebrovascular accident during treatment. Assessment of fertility, lung function, and audiometry pretreatment and more than 9 months posttreatment indicated no clinically significant changes. A mean decrease in transfer factor coefficient (KCO) of 15% of the predicted value was noted, but no patient had symptomatic respiratory dysfunction.
  
  
  CONCLUSIONS
  There have been only two relapses among 114 cases of high-risk stage I NSGCTT treated with two courses of adjuvant BEP chemotherapy. The 95% confidence interval (CI) excludes a true relapse rate of more than 5%. Of 104 patients confirmed on histopathology review to have GCT, there has been only one relapse. Adjuvant chemotherapy is free from significant long-term toxicity, offering an effective alternative to surveillance or retroperitoneal lymph node dissection (RPLND) followed by surveillance, and may be preferred by some patients.
authors.affiliation: Birmingham Oncology Centre, Queen Elizabeth Hospital, Birmingham, United Kingdom.
authors.forename: M H
authors.initials: MH
authors.lastname: Cullen
authors.forename: S P
authors.initials: SP
authors.lastname: Stenning
authors.forename: M C
authors.initials: MC
authors.lastname: Parkinson
authors.forename: S D
authors.initials: SD
authors.lastname: Fossa
authors.forename: S B
authors.initials: SB
authors.lastname: Kaye
authors.forename: A H
authors.initials: AH
authors.lastname: Horwich
authors.forename: S J
authors.initials: SJ
authors.lastname: Harland
authors.forename: M V
authors.initials: MV
authors.lastname: Williams
authors.forename: R
authors.initials: R
authors.lastname: Jakes
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004407:Dysgerminoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D005047:Etoposide / Q000008:administration & dosage; D006801:Humans; D008297:Male; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D009919:Orchiectomy; D011379:Prognosis; D012307:Risk Factors; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001761:Bleomycin; D005047:Etoposide; D002945:Cisplatin