Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer: A poorly tolerated regimen. Results of a multicentre phase II study

Cesare Gridelli, Antonio Rossi, Emiddio Barletta, Nicola Panza, Luigi Brancaccio, Riccardo Cioffi, Tonino Pedicini, Giovanni Pietro Ianniello, Elena Piazza, Nestore Rossi, Rosario Vincenzo Iaffaioli, Paolo Maione, Massimo Di Maio, Ciro Gallo, Francesco Perrone

Research output: Contribution to journalArticle

Abstract

Purpose and methods: A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m2 days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial. Results: Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5-59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3-6.7). Median survival was 7.9 months (95% CI: 4.8-14.4). Conclusion: Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.

Original languageEnglish
Pages (from-to)327-332
Number of pages6
JournalLung Cancer
Volume36
Issue number3
DOIs
Publication statusPublished - 2002

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Carboplatin
Small Cell Lung Carcinoma
Granulocyte Colony-Stimulating Factor
Confidence Intervals
Toxicity Tests
Poisons
Area Under Curve
vinorelbine
Therapeutics
Drug Therapy
Survival

Keywords

  • Carboplatin
  • Chemotherapy
  • Elderly
  • Phase II study
  • Small-cell lung cancer
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology

Cite this

Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer : A poorly tolerated regimen. Results of a multicentre phase II study. / Gridelli, Cesare; Rossi, Antonio; Barletta, Emiddio; Panza, Nicola; Brancaccio, Luigi; Cioffi, Riccardo; Pedicini, Tonino; Ianniello, Giovanni Pietro; Piazza, Elena; Rossi, Nestore; Iaffaioli, Rosario Vincenzo; Maione, Paolo; Maio, Massimo Di; Gallo, Ciro; Perrone, Francesco.

In: Lung Cancer, Vol. 36, No. 3, 2002, p. 327-332.

Research output: Contribution to journalArticle

Gridelli, C, Rossi, A, Barletta, E, Panza, N, Brancaccio, L, Cioffi, R, Pedicini, T, Ianniello, GP, Piazza, E, Rossi, N, Iaffaioli, RV, Maione, P, Maio, MD, Gallo, C & Perrone, F 2002, 'Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer: A poorly tolerated regimen. Results of a multicentre phase II study', Lung Cancer, vol. 36, no. 3, pp. 327-332. https://doi.org/10.1016/S0169-5002(02)00003-X
Gridelli, Cesare ; Rossi, Antonio ; Barletta, Emiddio ; Panza, Nicola ; Brancaccio, Luigi ; Cioffi, Riccardo ; Pedicini, Tonino ; Ianniello, Giovanni Pietro ; Piazza, Elena ; Rossi, Nestore ; Iaffaioli, Rosario Vincenzo ; Maione, Paolo ; Maio, Massimo Di ; Gallo, Ciro ; Perrone, Francesco. / Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer : A poorly tolerated regimen. Results of a multicentre phase II study. In: Lung Cancer. 2002 ; Vol. 36, No. 3. pp. 327-332.
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abstract = "Purpose and methods: A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m2 days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial. Results: Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3{\%}, 95{\%} exact confidence interval (CI): 21.5-59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95{\%} CI: 3.3-6.7). Median survival was 7.9 months (95{\%} CI: 4.8-14.4). Conclusion: Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.",
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T1 - Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer

T2 - A poorly tolerated regimen. Results of a multicentre phase II study

AU - Gridelli, Cesare

AU - Rossi, Antonio

AU - Barletta, Emiddio

AU - Panza, Nicola

AU - Brancaccio, Luigi

AU - Cioffi, Riccardo

AU - Pedicini, Tonino

AU - Ianniello, Giovanni Pietro

AU - Piazza, Elena

AU - Rossi, Nestore

AU - Iaffaioli, Rosario Vincenzo

AU - Maione, Paolo

AU - Maio, Massimo Di

AU - Gallo, Ciro

AU - Perrone, Francesco

PY - 2002

Y1 - 2002

N2 - Purpose and methods: A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m2 days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial. Results: Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5-59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3-6.7). Median survival was 7.9 months (95% CI: 4.8-14.4). Conclusion: Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.

AB - Purpose and methods: A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m2 days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial. Results: Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5-59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3-6.7). Median survival was 7.9 months (95% CI: 4.8-14.4). Conclusion: Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.

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KW - Small-cell lung cancer

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