A phase II study of carboplatin, etoposide, and exisulind in patients with extensive small cell lung cancer: CALGB 30104.
OBJECTIVE
To assess the efficacy and toxicity of carboplatin, etoposide, and exisulind as initial therapy for extensive stage small cell lung cancer.


METHODS
The Cancer and Leukemia Group B conducted a phase II study of carboplatin (area under the curve 6) day 1 and etoposide 80 mg/m(2) days 1-3 administered intravenously every 21 days with exisulind 250 mg orally twice daily in 44 evaluable patients with previously untreated extensive stage small cell lung cancer. The hypothesis was the addition of a novel cytostatic agent to standard therapy may increase survival time. The primary end point of the study was to evaluate overall survival. The secondary end points were to characterize response rates and toxicity.


RESULTS
The majority of the patients were male (64%), Caucasian (95%), and had performance status 0 or 1 (77%). The median age was 61 (range 44-82) years. The percentage of patients alive at 1 year was 36.4% (95% [confidence interval] CI: 24.6-53.8%). The median overall survival was 10.6 months (95% CI: 9.1-14.7). The best overall response rate was 77% (95% CI: 62-89%) with 16% of the patients achieving complete response. The most frequent grade 3 or grade 4 hematological toxicities were neutropenia (64%), thrombocytopenia (36%), and febrile neutropenia (16%). The most common grade 3 or grade 4 nonhematological toxicities were gastrointestinal (30%) and electrolyte changes (23%).


CONCLUSIONS
The addition of exisulind to a standard regimen of carboplatin and etoposide did not improve outcomes compared with historic controls treated with chemotherapy alone. Further evaluation of this regimen in small cell lung cancer is not warranted.
Govindan
Ramaswamy
R
Washington University School of Medicine and Alvin J Siteman Cancer Center, St Louis, MO 63110, USA. rgovinda@dom.wustl.edu
Wang
Xiaofei
X
Baggstrom
Maria Q
MQ
Burdette-Radoux
Susan
S
Hodgson
Lydia
L
Vokes
Everett E
EE
Green
Mark R
MR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D013467:Sulindac / Q000008:administration & dosage / Q000031:analogs & derivatives; D015996:Survival Rate; D016896:Treatment Outcome
D013467:Sulindac; D005047:Etoposide; D016190:Carboplatin; C025463:sulindac sulfone