Phase II trial of thalidomide as maintenance therapy for extensive stage small cell lung cancer after response to chemotherapy.
BACKGROUND
Extensive-stage small cell lung cancer (SCLC) is a highly aggressive malignancy for which little therapeutic progress has been made over the past 20 years. SCLC is a highly angiogenic tumor and targeting angiogenesis is being investigated. The putative mechanism of action of thalidomide is through inhibition of new blood vessel formation. This trial was designed to evaluate thalidomide in ES-SCLC.


METHODS
Patients who had received first-line chemotherapy without disease progression were eligible. Patients received thalidomide 200 mg daily as maintenance therapy starting 3-6 weeks after completion of chemotherapy.


RESULTS
Thirty patients were enrolled. Toxicity was minimal with grade 1 neuropathy in 27% of patients and only one case of grade 3 neuropathy. Median survival from time of initiation of induction chemotherapy was 12.8 months (95% CI: 10.1-15.8 months) and 1-year survival of 51.7% (95% CI: 32.5-67.9%). Median duration on thalidomide was 79 days.


CONCLUSIONS
Thalidomide 200mg daily is well tolerated when given as maintenance therapy for ES-SCLC after induction chemotherapy. Further evaluation of anti-angiogenic agents in SCLC is warranted.
Dowlati
Afshin
A
Division of Hematology/Oncology, Case Western Reserve University and University Hospitals of Cleveland, CASE Comprehensive Cancer Center, Cleveland, Ohio 44106, USA. afshin.dowlati@case.edu
Subbiah
Shanmuga
S
Cooney
Matthew
M
Rutherford
Kimberly
K
Mekhail
Tarek
T
Fu
Pingfu
P
Chapman
Robert
R
Ness
Anne
A
Cortas
Tania
T
Saltzman
Joel
J
Levitan
Nathan
N
Warren
Gregory
G
D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008824:Michigan / Q000453:epidemiology; D008875:Middle Aged; D009367:Neoplasm Staging; D009820:Ohio / Q000453:epidemiology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
D020533:Angiogenesis Inhibitors; D013792:Thalidomide