Abstract
Purpose: To compare a regimen of vinorelbine and cisplatin (VC) to the combination of mitomycin, vindesine, and cisplatin (MVP) in patients with stage IIIB or stage IV non-small cell lung cancer (NSCLC). The main endpoits were analysis of objective response rates, toxicity, time to progression, and overall survival. Patients and methods: 247 eligible patients were randomized to receive (a) vinorelbine 25 mg/m2 intravenous bolus on days 1and 8 plus cisplatin 100 mg/m2 on day 1 every 4 weeks, or (b) mitomycin c 8 mg/m2 i.v. on day 1, vindesine 3 mg/m2 i.v. on days 1, 8, 15 and 22, plus cisplatin 100 mg/m2 on day 1 every 4 weeks. In subsequent cycles vindesine was given every other week. For both treatments a maximum of six cycles was planned. Patients with performance status 0-2 according to the ECOG scale were enrolled. Response and toxicity were evaluated according to the WHO criteria. Analysis of clinical efficacy was performed according to an intent-to-treat analysis. Results: No statistically significant differences in clinical efficacy were observed between the two chemotherapy regimens. The overall objective response rates were 39% (95% CL, 31-49%) in the VC arm and 42% (95% CL, 33-51%) in the MVP arm (P=0.13). Median time to progression was 4.2 and 4.5 months for the MVP arm and the VC arm, respectively. Median overall survival was 7 months in the VC arm and 8 months in the MVP one (log-rank test, P=0.898). These differences were not statistically significant. However, leukopenia and thrombocytopenia were significantly higher in the MVP arm than in the VC (P=0.0001; P=0.0002). Grade 3 alopecia was more frequent in the MVP arm than in the VC one (P
| Original language | English |
|---|---|
| Pages (from-to) | 179-187 |
| Number of pages | 9 |
| Journal | Lung Cancer |
| Volume | 37 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2002 |
Fingerprint
Keywords
- Cisplatin
- Mitomycin
- Non-small cell lung cancer
- Vindesine
- Vinorelbine
ASJC Scopus subject areas
- Oncology
Cite this
Vinorelbine plus cisplatin versus cisplatin plus vindesine and mitomycin C in stage IIIB-IV non-small cell lung carcinoma : A prospective randomized study. / Gebbia, Vittorio; Galetta, Domenico; Riccardi, Fernando; Gridelli, Cesare; Durini, Ernesto; Borsellino, Nicolò; Gebbia, Nicolò; Valdesi, Matteo; Caruso, Michele; Valenza, Roberto; Pezzella, Giuseppe; Colucci, Giuseppe.
In: Lung Cancer, Vol. 37, No. 2, 2002, p. 179-187.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Vinorelbine plus cisplatin versus cisplatin plus vindesine and mitomycin C in stage IIIB-IV non-small cell lung carcinoma
T2 - A prospective randomized study
AU - Gebbia, Vittorio
AU - Galetta, Domenico
AU - Riccardi, Fernando
AU - Gridelli, Cesare
AU - Durini, Ernesto
AU - Borsellino, Nicolò
AU - Gebbia, Nicolò
AU - Valdesi, Matteo
AU - Caruso, Michele
AU - Valenza, Roberto
AU - Pezzella, Giuseppe
AU - Colucci, Giuseppe
PY - 2002
Y1 - 2002
N2 - Purpose: To compare a regimen of vinorelbine and cisplatin (VC) to the combination of mitomycin, vindesine, and cisplatin (MVP) in patients with stage IIIB or stage IV non-small cell lung cancer (NSCLC). The main endpoits were analysis of objective response rates, toxicity, time to progression, and overall survival. Patients and methods: 247 eligible patients were randomized to receive (a) vinorelbine 25 mg/m2 intravenous bolus on days 1and 8 plus cisplatin 100 mg/m2 on day 1 every 4 weeks, or (b) mitomycin c 8 mg/m2 i.v. on day 1, vindesine 3 mg/m2 i.v. on days 1, 8, 15 and 22, plus cisplatin 100 mg/m2 on day 1 every 4 weeks. In subsequent cycles vindesine was given every other week. For both treatments a maximum of six cycles was planned. Patients with performance status 0-2 according to the ECOG scale were enrolled. Response and toxicity were evaluated according to the WHO criteria. Analysis of clinical efficacy was performed according to an intent-to-treat analysis. Results: No statistically significant differences in clinical efficacy were observed between the two chemotherapy regimens. The overall objective response rates were 39% (95% CL, 31-49%) in the VC arm and 42% (95% CL, 33-51%) in the MVP arm (P=0.13). Median time to progression was 4.2 and 4.5 months for the MVP arm and the VC arm, respectively. Median overall survival was 7 months in the VC arm and 8 months in the MVP one (log-rank test, P=0.898). These differences were not statistically significant. However, leukopenia and thrombocytopenia were significantly higher in the MVP arm than in the VC (P=0.0001; P=0.0002). Grade 3 alopecia was more frequent in the MVP arm than in the VC one (P
AB - Purpose: To compare a regimen of vinorelbine and cisplatin (VC) to the combination of mitomycin, vindesine, and cisplatin (MVP) in patients with stage IIIB or stage IV non-small cell lung cancer (NSCLC). The main endpoits were analysis of objective response rates, toxicity, time to progression, and overall survival. Patients and methods: 247 eligible patients were randomized to receive (a) vinorelbine 25 mg/m2 intravenous bolus on days 1and 8 plus cisplatin 100 mg/m2 on day 1 every 4 weeks, or (b) mitomycin c 8 mg/m2 i.v. on day 1, vindesine 3 mg/m2 i.v. on days 1, 8, 15 and 22, plus cisplatin 100 mg/m2 on day 1 every 4 weeks. In subsequent cycles vindesine was given every other week. For both treatments a maximum of six cycles was planned. Patients with performance status 0-2 according to the ECOG scale were enrolled. Response and toxicity were evaluated according to the WHO criteria. Analysis of clinical efficacy was performed according to an intent-to-treat analysis. Results: No statistically significant differences in clinical efficacy were observed between the two chemotherapy regimens. The overall objective response rates were 39% (95% CL, 31-49%) in the VC arm and 42% (95% CL, 33-51%) in the MVP arm (P=0.13). Median time to progression was 4.2 and 4.5 months for the MVP arm and the VC arm, respectively. Median overall survival was 7 months in the VC arm and 8 months in the MVP one (log-rank test, P=0.898). These differences were not statistically significant. However, leukopenia and thrombocytopenia were significantly higher in the MVP arm than in the VC (P=0.0001; P=0.0002). Grade 3 alopecia was more frequent in the MVP arm than in the VC one (P
KW - Cisplatin
KW - Mitomycin
KW - Non-small cell lung cancer
KW - Vindesine
KW - Vinorelbine
UR - http://www.scopus.com/inward/record.url?scp=0036021714&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0036021714&partnerID=8YFLogxK
U2 - 10.1016/S0169-5002(02)00076-4
DO - 10.1016/S0169-5002(02)00076-4
M3 - Article
C2 - 12140141
AN - SCOPUS:0036021714
VL - 37
SP - 179
EP - 187
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 2
ER -