Paclitaxel and gemcitabine versus carboplatin and gemcitabine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group.
BACKGROUND
This phase III study was designed to compare the combination paclitaxel (Taxol)-gemcitabine (PG) versus carboplatin-gemcitabine (CG) in patients with advanced inoperable non-small-cell lung cancer.


METHODS
Chemotherapy-naive patients with performance status of zero or one were randomized to gemcitabine 1 gm/m(2) on days 1 and 8 plus either paclitaxel 200 mg/m(2) on day 1 (arm A) or carboplatin at an area under the concentration-time curve of 6 mg on day 1 (arm B) every 3 weeks. Primary end point was overall survival (OS). Secondary end points included objective response (OR), time to progression and toxicity.


RESULTS
A total of 512 patients were enrolled and 452 eligible (arm A, 225; arm B, 227) were analyzed. All characteristics were well balanced with the exception of vena cava obstruction symptoms and lymph node involvement. Median survival was 9.97 months [95% confidence interval (CI) 8.74-12.0] for group A and 10.49 (95% CI 9.04-11.94) for group B. There was no difference in the OS, 1-year survival, OR and TtP. However, statistically significant differences were seen in toxicity.


CONCLUSIONS
The two regimens are equally active. Myelotoxicity is worse in the CG group whereas alopecia, myalgia and neurotoxicity worse in the PG group.
Kosmidis
P A
PA
Department of Medical Oncology, Hygeia Hospital, Athens, Greece. parkosmi@otenet.gr
Kalofonos
H P
HP
Christodoulou
C
C
Syrigos
K
K
Makatsoris
T
T
Skarlos
D
D
Bakogiannis
C
C
Nicolaides
C
C
Bafaloukos
D
D
Bamias
A
A
Samantas
E
E
Xiros
N
N
Boukovinas
I
I
Fountzilas
G
G
Dimopoulos
M A
MA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D002927:Cimetidine / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003907:Dexamethasone / Q000008:administration & dosage; D004155:Diphenhydramine / Q000008:administration & dosage; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017294:Ondansetron / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D011292:Premedication; D016016:Proportional Hazards Models; D000093542:Gemcitabine
D003841:Deoxycytidine; D017294:Ondansetron; D003907:Dexamethasone; D002927:Cimetidine; D004155:Diphenhydramine; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine