Phase II trial of thalidomide with chemotherapy and as maintenance therapy for patients with poor prognosis small-cell lung cancer

Lung Cancer. 2008 Mar;59(3):364-8. doi: 10.1016/j.lungcan.2007.08.032. Epub 2007 Oct 24.


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.

Materials and 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.

Conclusion: 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.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / administration & dosage
  • Carcinoma, Small Cell / drug therapy*
  • Disease Progression
  • Etoposide / administration & dosage
  • Female
  • Humans
  • Lung Neoplasms / drug therapy*
  • Male
  • Prognosis
  • Survival Rate
  • Thalidomide / administration & dosage*
  • Treatment Outcome


  • Thalidomide
  • Etoposide
  • Carboplatin