Comparison of gemcitabine and carboplatin versus cisplatin and etoposide for patients with poor-prognosis small cell lung cancer.
BACKGROUND
The combination of cisplatin and etoposide (PE) has been a standard treatment for patients with poor-prognosis small cell lung cancer (SCLC). This non-inferiority design trial aimed to determine whether the combination of gemcitabine and carboplatin (GC) results in similar survival but is less toxic with better quality of life.


METHODS
Previously untreated patients with SCLC with extensive disease or limited stage with poor prognostic factors were randomly assigned to six 3-weekly cycles of GC or PE.


RESULTS
241 patients (121 GC, 120 PE) were recruited, of which 216 (90%) had died. There was no difference in overall survival (HR 1.01, 95% CI 0.77 to 1.32). Median survival with GC and PE was 8.0 and 8.1 months, respectively. Median progression-free survival was 5.9 months with GC and 6.3 months with PE. Grade 3 or 4 myelosuppressions were more frequent with GC (anaemia: 14% GC vs 2% PE; leucopenia: 32% GC vs 13% PE; thrombocytopenia: 22% GC vs 4% PE), but these were not associated with increased hospital admissions, infections or fatalities. Grade 2-3 alopecia (68% PE vs 17% GC) and nausea (43% PE vs 26% GC) were more frequent with PE. Patients given GC received more chemotherapy as outpatients (89% GC vs 66% PE of treatment cycles). In QoL questionnaires, more patients receiving PE reported being upset by hair loss (p = 0.004) and impaired cognitive functioning (p = 0.04).


CONCLUSIONS
GC is as effective as PE in terms of overall survival and progression-free survival and has a toxicity profile more acceptable to patients.


BACKGROUND
ISRCTN 39679215.
Lee
S M
SM
Department of Oncology, University College Hospital, London, UK. sm.lee@uclh.nhs.uk
James
L E
LE
Qian
W
W
Spiro
S
S
Eisen
T
T
Gower
N H
NH
Ferry
D R
DR
Gilligan
D
D
Harper
P G
PG
Prendiville
J
J
Hocking
M
M
Rudd
R M
RM
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002423:Cause of Death; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D005047:Etoposide; D016190:Carboplatin; D002945:Cisplatin; D000093542:Gemcitabine