Paclitaxel and gemcitabine versus paclitaxel and vinorelbine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group (HeCOG).
BACKGROUND
Paclitaxel (Taxol) and vinorelbine have shown synergism of cytotoxic effects in vitro and clinical activity in phase I and II studies. This combination was compared prospectively with the paclitaxel/gemcitabine regimen in non-operable non-small-cell lung cancer.


METHODS
Chemotherapy-naive patients, stage IIIbwet and IV with performance status (0-1), were randomized to receive paclitaxel 200 mg/m(2) on day 1 plus gemcitabine 1 gm/m(2) (group A) on days 1 and 8 every 3 weeks or paclitaxel 80 mg/m(2) plus vinorelbine 22.5 mg/m(2) (group B) on days 1, 8 and 15 every 4 weeks.


RESULTS
A total of 398 out of 415 patients were eligible for analysis on intent-to-treat basis (group A: 196, group B: 202). Progression-free survival (PFS) was 5.0 months [95% confidence interval (CI) 4.3-5.6] and 4.4 months (95% CI 3.7-5.2) for groups A and B respectively (P=0.365). Median survival was 11.1 months (95% CI 9.2-13.0) and 8.6 months (95% CI 7.0-10.2) for groups A and B respectively (P = 0.147). Grade 3/4 neutropenia and leukopenia were worse in group B (P<0.001, in both cases). Febrile neutropenia and severe infections were more prominent (P<0.001, P=0.029 respectively) in group B.


CONCLUSIONS
Although response rate, PFS and survival were non-different in both groups, toxicity was significantly worse in group B and therefore further investigation of P-Vin is of no value.
Kosmidis
P A
PA
Department of Medical Oncology, Hygeia Hospital, Athens. Electronic address: parkosmi@otenet.gr.
Fountzilas
G
G
Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki.
Eleftheraki
A G
AG
Section of Biostatistics, Hellenic Cooperative Oncology Group Data Office, Athens.
Kalofonos
H P
HP
Division of Oncology, University Hospital of Patras, Patras.
Pentheroudakis
G
G
Department of Medical Oncology, University of Ioannina School of Medicine, Ioannina.
Skarlos
D
D
Department of Medical Oncology, Metropolitan Hospital, Piraeus.
Dimopoulos
M A
MA
Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens.
Bafaloukos
D
D
Department of Medical Oncology, Metropolitan Hospital, Piraeus.
Pectasides
D
D
2nd Department of Internal Medicine-Propaedeutic, Oncology Section, University General Hospital Attikon, Athens.
Samantas
E
E
3rd Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens.
Boukovinas
J
J
Department of Medical Oncology, Theagenio Hospital, Thessaloniki.
Lambaki
S
S
Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki.
Katirtzoglou
N
N
Oncology Unit, 3rd Department of Medicine, Athens Medical School, Sotiria General Hospital, Athens, Greece.
Bakogiannis
C
C
Department of Medical Oncology, Hygeia Hospital, Athens.
Syrigos
K N
KN
Oncology Unit, 3rd Department of Medicine, Athens Medical School, Sotiria General Hospital, Athens, Greece.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006115:Greece; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine; D000093542:Gemcitabine
D003841:Deoxycytidine; D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine; D000093542:Gemcitabine