Vinorelbine plus cisplatin versus cisplatin plus vindesine and mitomycin C in stage IIIB-IV non-small cell lung carcinoma: A prospective randomized study

Vittorio Gebbia, Domenico Galetta, Fernando Riccardi, Cesare Gridelli, Ernesto Durini, Nicolò Borsellino, Nicolò Gebbia, Matteo Valdesi, Michele Caruso, Roberto Valenza, Giuseppe Pezzella, Giuseppe Colucci

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)179-187
Number of pages9
JournalLung Cancer
Volume37
Issue number2
DOIs
Publication statusPublished - 2002

Fingerprint

Vindesine
Mitomycin
Non-Small Cell Lung Carcinoma
Cisplatin
Prospective Studies
vinorelbine
Survival
Alopecia
Leukopenia
Thrombocytopenia
Drug Therapy

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 journalArticle

Gebbia, V, Galetta, D, Riccardi, F, Gridelli, C, Durini, E, Borsellino, N, Gebbia, N, Valdesi, M, Caruso, M, Valenza, R, Pezzella, G & Colucci, G 2002, 'Vinorelbine plus cisplatin versus cisplatin plus vindesine and mitomycin C in stage IIIB-IV non-small cell lung carcinoma: A prospective randomized study', Lung Cancer, vol. 37, no. 2, pp. 179-187. https://doi.org/10.1016/S0169-5002(02)00076-4
Gebbia, Vittorio ; Galetta, Domenico ; Riccardi, Fernando ; Gridelli, Cesare ; Durini, Ernesto ; Borsellino, Nicolò ; Gebbia, Nicolò ; Valdesi, Matteo ; Caruso, Michele ; Valenza, Roberto ; Pezzella, Giuseppe ; Colucci, Giuseppe. / Vinorelbine plus cisplatin versus cisplatin plus vindesine and mitomycin C in stage IIIB-IV non-small cell lung carcinoma : A prospective randomized study. In: Lung Cancer. 2002 ; Vol. 37, No. 2. pp. 179-187.
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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",
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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

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