title: Phase II trial of thalidomide with chemotherapy and as maintenance therapy for patients with poor prognosis small-cell lung cancer.
abstract: BACKGROUND
  Despite the high response rates achieved following standard chemotherapy for small-cell lung cancer (SCLC), the majority of patients will subsequently die from disease progression.
  
  
  METHODS
  We examined the efficacy and toxicity of thalidomide, an anti-angiogenic agent, in combination with carboplatin and etoposide and as maintenance therapy in patients with untreated SCLC. Twenty-five chemotherapy-naive patients with extensive disease (ED) or limited disease (LD) SCLC were enrolled in a single-arm phase II study. Carboplatin and etoposide were given every 3 weeks for 6 cycles with concurrent thalidomide 100mg orally daily. The treatment with thalidomide was continued as maintenance for up to 2 years.
  
  
  RESULTS
  Median progression free and overall survival were 8.3 months and 10.1 months, respectively. One-year survival was 40% and the 1-year progression-free survival was 36%. The overall response rate was 68% (95% CI 46-85%) with four complete remissions (20%) and 13 partial remissions (48%). We observed no increase in chemotherapy related toxicity. Thalidomide was well-tolerated and median time on thalidomide treatment was 7.6 months.
  
  
  CONCLUSIONS
  Concurrent thalidomide with chemotherapy followed by maintenance thalidomide appears to be well tolerated. The results on tumour response rate and survival led us to initiate a randomised phase III trial in the United Kingdom.
authors.affiliation: Department of Oncology, University College Hospital, 250 Euston Road, London NW1 2PG, UK. sm.lee@uclh.nhs.uk
authors.forename: Siow Ming
authors.initials: SM
authors.lastname: Lee
authors.forename: Lindsay
authors.initials: L
authors.lastname: James
authors.forename: Tomas
authors.initials: T
authors.lastname: Buchler
authors.forename: Mike
authors.initials: M
authors.lastname: Snee
authors.forename: Paul
authors.initials: P
authors.lastname: Ellis
authors.forename: Allan
authors.initials: A
authors.lastname: Hackshaw
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D018450:Disease Progression; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D011379:Prognosis; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D005047:Etoposide; D016190:Carboplatin