title: Risk-adapted management for patients with clinical stage I seminoma: the Second Spanish Germ Cell Cancer Cooperative Group study.
abstract: OBJECTIVE
  To assess the efficacy of a risk-adapted treatment policy for patients with stage I seminoma by using universally accepted risk criteria.
  
  
  METHODS
  Between 1999 and 2003, 314 patients with clinical stage I seminoma after orchiectomy were prospectively included. One hundred patients (31.8%) presented no risk factors and were managed with surveillance. In contrast, 131 patients (41.7%) had tumors larger than 4 cm, 33 patients (10.5%) had rete testis involvement, and 50 patients (15.9%) had both risk factors. All the latter received two courses of adjuvant carboplatin.
  
  
  RESULTS
  Chemotherapy was well tolerated, as only 17 patients (7.9%) presented grade 3 to 4 toxicity. Relapses were observed in six patients (6.0%) on surveillance and in seven patients (3.3%) treated with carboplatin (0.8% of tumors larger than 4 cm, 9.1% of those involving the rete testis, and 6.0% of patients with both risk criteria). All were located at the retroperitoneum, except for one at the spermatic cord. Median tumor size was 25 mm (range, 11 to 70 mm), and median time to relapse was 9 months (range, 4 to 28 months). All patients were rendered disease-free with chemotherapy (etoposide plus cisplatin). Median follow-up was 34 months (range, 12 to 72 months). The actuarial 5-year disease-free survival rate was 93.4% for patients on surveillance and 96.2% for patients treated with adjuvant chemotherapy. Overall 5-year survival was 100%.
  
  
  CONCLUSIONS
  Adjuvant carboplatin is effective in reducing the relapse rate in patients with stage I seminoma and risk factors. A risk-adapted strategy is safe and feasible and should be considered an alternative to systematic approaches, such as irradiation, chemotherapy, or surveillance.
authors.affiliation: Department of Medical Oncology, Hospital Universitario La Fe, Avda Campanar 21, E-46009 Valencia, Spain. japariciou@seom.org
authors.forename: Jorge
authors.initials: J
authors.lastname: Aparicio
authors.forename: José R
authors.initials: JR
authors.lastname: Germà
authors.forename: Xavier
authors.initials: X
authors.lastname: García del Muro
authors.forename: Pablo
authors.initials: P
authors.lastname: Maroto
authors.forename: José A
authors.initials: JA
authors.lastname: Arranz
authors.forename: Alberto
authors.initials: A
authors.lastname: Sáenz
authors.forename: Agustín
authors.initials: A
authors.lastname: Barnadas
authors.forename: Joan
authors.initials: J
authors.lastname: Dorca
authors.forename: Josep
authors.initials: J
authors.lastname: Gumà
authors.forename: David
authors.initials: D
authors.lastname: Olmos
authors.forename: Romá
authors.initials: R
authors.lastname: Bastús
authors.forename: Joan
authors.initials: J
authors.lastname: Carles
authors.forename: Daniel
authors.initials: D
authors.lastname: Almenar
authors.forename: Miguel
authors.initials: M
authors.lastname: Sánchez
authors.forename: Luis
authors.initials: L
authors.lastname: Paz-Ares
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Satrústegui
authors.forename: Begoña
authors.initials: B
authors.lastname: Mellado
authors.forename: Ana
authors.initials: A
authors.lastname: Balil
authors.forename: Marta
authors.initials: M
authors.lastname: López-Brea
authors.forename: Alfredo
authors.initials: A
authors.lastname: Sánchez
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D018997:Chorionic Gonadotropin, beta Subunit, Human / Q000097:blood; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D009919:Orchiectomy; D011446:Prospective Studies; D012307:Risk Factors; D018239:Seminoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000970:Antineoplastic Agents; D018997:Chorionic Gonadotropin, beta Subunit, Human; D016190:Carboplatin