title: Treatment of stage I seminoma, with one course of adjuvant carboplatin or surveillance, risk-adapted recommendations implementing patient autonomy: a report from the Swedish and Norwegian Testicular Cancer Group (SWENOTECA).
abstract: The purpose of the protocol was to reduce the treatment burden in clinical stage I (CSI) seminoma by offering risk-adapted treatment. The protocol aimed to prospectively validate the proposed risk factors for relapse, stromal invasion of the rete testis and tumor diameter >4 cm, and to evaluate the efficacy of one course of adjuvant carboplatin.
  
  
  
  From 2007 to 2010, 897 patients were included in a prospective, population-based, risk-adapted treatment protocol implementing one course of adjuvant carboplatin AUC7 (n = 469) or surveillance (n = 422). In addition, results from 221 patients receiving carboplatin between 2004 and 2007 are reported.
  
  
  
  At a median follow-up of 5.6 years, 69 relapses have occurred. Stromal invasion of the rete testis [hazard ratio (HR) 1.9, P = 0.011] and tumor diameter >4 cm (HR 2.7, P < 0.001) were identified as risk factors predicting relapse. In patients without risk factors, the relapse rate (RR) was 4.0% for patients managed by surveillance and 2.2% in patients receiving adjuvant carboplatin. In patients with one or two risk factors, the RR was 15.5% in patients managed by surveillance and 9.3% in patients receiving adjuvant carboplatin. We found no increased RR in patients receiving carboplatin <7 × AUC compared with that in patients receiving ≥7 × AUC.
  
  
  
  Stromal invasion in the rete testis and tumor diameter >4 cm are risk factors for relapse in CSI seminoma. Patients without risk factors have a low RR and adjuvant therapy is not justified in these patients. The efficacy of adjuvant carboplatin is relatively low and there is need to explore more effective adjuvant treatment options in patients with high-risk seminoma. The data do not support the concept of a steep dose response for adjuvant carboplatin.
authors.affiliation: The Cancer Clinic, St Olavs University Hospital, Trondheim, Norway torgrim.tandstad@stolav.no.
authors.forename: T
authors.initials: T
authors.lastname: Tandstad
authors.affiliation: Department of Oncology, Skane University Hospital, Lund, Sweden.
authors.forename: O
authors.initials: O
authors.lastname: Ståhl
authors.affiliation: Department of Clinical Science, Faculty of Medicine and Dentistry, University of Bergen, Bergen Department of Oncology, Haukeland University Hospital, Bergen.
authors.forename: O
authors.initials: O
authors.lastname: Dahl
authors.affiliation: Institute of Clinical Medicine, University of Tromsø, Tromsø Department of Oncology, University Hospital of North Norway, Tromsø, Norway.
authors.forename: H S
authors.initials: HS
authors.lastname: Haugnes
authors.affiliation: Department of Urology, Skåne University Hospital, Malmö
authors.forename: U
authors.initials: U
authors.lastname: Håkansson
authors.affiliation: Department of Oncology, Haukeland University Hospital, Bergen.
authors.forename: Å
authors.initials: Å
authors.lastname: Karlsdottir
authors.affiliation: Division of Urology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Kjellman
authors.affiliation: Department of Oncology, Oslo University Hospital, Oslo, Norway.
authors.forename: C W
authors.initials: CW
authors.lastname: Langberg
authors.affiliation: Uppsala University Hospital, Uppsala, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Laurell
authors.affiliation: Department of Oncology, Akershus University Hospital, Lørenskog Faculty of Medicine, University of Oslo, Oslo, Norway.
authors.forename: J
authors.initials: J
authors.lastname: Oldenburg
authors.affiliation: The Cancer Clinic, St Olavs University Hospital, Trondheim, Norway.
authors.forename: A
authors.initials: A
authors.lastname: Solberg
authors.affiliation: Norrland University Hospital, Umeå
authors.forename: K
authors.initials: K
authors.lastname: Söderström
authors.affiliation: Department of Oncology, Sahlgrenska University Hospital, Gothenburg Sahlgrenska Academy University of Gothenburg, Gothenburg, Sweden.
authors.forename: U
authors.initials: U
authors.lastname: Stierner
authors.affiliation: Department of Oncology, Skane University Hospital, Lund, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Cavallin-Ståhl
authors.affiliation: Department of Urology, Oslo University Hospital, Oslo, Norway.
authors.forename: R
authors.initials: R
authors.lastname: Wahlqvist
authors.affiliation: Institute of Clinical and Experimental Medicine, University of Linköping, Linköping Department of Oncology, Linköping University Hospital, Linköping.
authors.forename: N
authors.initials: N
authors.lastname: Wall
authors.affiliation: Department of Oncology-Pathology, Karolinska Institute, Stockholm Karolinska University Hospital, Stockholm, Sweden.
authors.forename: G
authors.initials: G
authors.lastname: Cohn-Cedermark
mesh_terms: D000328:Adult; D000368:Aged; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects*; D003131:Combined Modality Therapy / Q000009:adverse effects; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D009367:Neoplasm Staging; D009664:Norway / Q000453:epidemiology; D012307:Risk Factors; D018239:Seminoma / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D013548:Sweden / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin
keywords: adjuvant carboplatin; prognostic factors; risk-adapted; seminoma; surveillance; testicular cancer