A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer.
BACKGROUND
Paclitaxel-carboplatin is used as the standard regimen for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was designed to compare gemcitabine + carboplatin or gemcitabine + paclitaxel to the standard regimen.


METHODS
A total of 1135 chemonaive patients with stage IIIB or IV NSCLC were randomly allocated to receive gemcitabine 1000 mg/m(2) on days 1 and 8 plus carboplatin area under the concentration-time curve (AUC) 5.5 on day 1 (GC), gemcitabine 1000 mg/m(2) on days 1 and 8 plus paclitaxel 200 mg/m(2) on day 1 (GP), or paclitaxel 225 mg/m(2) plus carboplatin AUC 6.0 on day 1 (PC). Stratification was based on disease stage, baseline weight loss, and presence or absence of brain metastases. Cycles were repeated every 21 days for up to six cycles or disease progression.


RESULTS
Median survival (months) with GC was 7.9 compared with 8.5 for GP and 8.7 for PC. Response rates (RRs) were as follows: GC, 25.3%; GP, 32.1%; and PC, 29.8%. The GC arm was associated with a greater incidence of grade 3 or 4 hematologic events but a lower rate of neurotoxicity and alopecia when compared with GP and PC.


CONCLUSIONS
Non-platinum and non-paclitaxel gemcitabine-containing doublets demonstrate similar overall survival and RR compared with the standard PC regimen. However, the treatment arms had distinct toxicity profiles.
Treat
J A
JA
US Medical Division, Lilly USA, Indianapolis, IN. Electronic address: treatjo@lilly.com.
Gonin
R
R
Westat, Rockville, MD.
Socinski
M A
MA
Division of Hematology/Oncology, Multidisciplinary Thoracic Oncology Group, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Edelman
M J
MJ
Division of Hematology/Oncology, University of Maryland Greenbaum Cancer Center, Baltimore, MD.
Catalano
R B
RB
Drexel University College of Medicine, Philadelphia, PA.
Marinucci
D M
DM
Drexel University College of Medicine, Philadelphia, PA.
Ansari
R
R
Northern Indiana Cancer Research Consortium, South Bend, IN.
Gillenwater
H H
HH
Department of Hematology/Oncology, University of Virginia Cancer Center, Charlottesville, VA.
Rowland
K M
KM
Department of Medicine, Carle Clinic Cancer Center, Urbana, IL.
Comis
R L
RL
Drexel University College of Medicine, Philadelphia, PA.
Obasaju
C K
CK
US Medical Division, Lilly USA, Indianapolis, IN.
Belani
C P
CP
Division of Hematology/Oncology, Penn State Hershey Cancer Institute, Hershey, PA, USA.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000556:secondary; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine