Gemcitabine and cisplatin as induction chemotherapy for patients with unresectable stage IIIA-bulky N2 and stage IIIB nonsmall cell lung carcinoma: An Italian lung cancer project observational study

Federico Cappuzzo, Giovanni Selvaggi, Vanesa Gregorc, Francesca Mazzoni, Maura Betti, Maria Rita Migliorino, Silvia Novello, Antonio Maestri, Filippo De Marinis, Samir Darwish, Verena De Angelis, Fabrizio Nelli, Stefania Bartolini, Giorgio V. Scagliotti, Maurizio Tonato, Lucio Crinò

Research output: Contribution to journalArticle

Abstract

BACKGROUND. The objective of this trial was to evaluate the activity and safety of one of the newer platinum-based doublets as a neoadjuvant regimen in patients with unresectable Stage IIIA-bulky N2 and Stage IIIB nonsmall cell lung carcinoma (NSCLC). METHODS. From June 1996 to April 2000, 129 consecutive patients with locally advanced NSCLC were treated with gemcitabine, 1000 mg/m2 on Days 1 and 8 and cisplatin, 70 mg/m2 on Day 2 (GC) of a 21-day treatment cycle, for 4 cycles, as part of a combined-modality approach. RESULTS. After induction chemotherapy, 80 patients (62%; 95% confidence interval, 53.6-70.4%) achieved a partial response, 43 patients (33%) had stable disease, and 6 patients (5%) had disease progression during chemotherapy. Forty patients (31%), were considered resectable and underwent thoracotomy. Complete resectability was obtained in 38 patients (29%), with 2% of patients achieving a pathologic complete response. After surgery, 9 patients with Mountain Classification Stage IIIA NSCLC and 9 patients with Stage IIIB NSCLC received definitive adjuvant radiotherapy. Forty-six of 52 patients with Stage IIIB disease and 24 of 37 patients with Stage IIIA disease who were not considered suitable for surgery received definitive radiotherapy. The median time to disease progression was 11.4 months, the median survival was 19.4 months (range, 1.2-55.2 + months), and the 1-year survival rate was 74%. The lungs (33%) and the brain (21%) were the main sites of recurrence. Major toxicity was comprised of Grade 3-4 thrombocytopenia, which occurred in 34 patients (27%). CONCLUSIONS. GC administered according to a 3-week schedule was a highly active and safe regimen in patients with primary, unresectable, locally advanced NSCLC.

Original languageEnglish
Pages (from-to)128-134
Number of pages7
JournalCancer
Volume98
Issue number1
DOIs
Publication statusPublished - Jul 1 2003

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gemcitabine
Induction Chemotherapy
Cisplatin
Observational Studies
Lung Neoplasms
Carcinoma
Lung
Disease Progression

Keywords

  • Chemotherapy
  • Cisplatin
  • Gemcitabine
  • Nonsmall cell lung carcinoma (NSCLC)

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Gemcitabine and cisplatin as induction chemotherapy for patients with unresectable stage IIIA-bulky N2 and stage IIIB nonsmall cell lung carcinoma : An Italian lung cancer project observational study. / Cappuzzo, Federico; Selvaggi, Giovanni; Gregorc, Vanesa; Mazzoni, Francesca; Betti, Maura; Migliorino, Maria Rita; Novello, Silvia; Maestri, Antonio; De Marinis, Filippo; Darwish, Samir; De Angelis, Verena; Nelli, Fabrizio; Bartolini, Stefania; Scagliotti, Giorgio V.; Tonato, Maurizio; Crinò, Lucio.

In: Cancer, Vol. 98, No. 1, 01.07.2003, p. 128-134.

Research output: Contribution to journalArticle

Cappuzzo, F, Selvaggi, G, Gregorc, V, Mazzoni, F, Betti, M, Migliorino, MR, Novello, S, Maestri, A, De Marinis, F, Darwish, S, De Angelis, V, Nelli, F, Bartolini, S, Scagliotti, GV, Tonato, M & Crinò, L 2003, 'Gemcitabine and cisplatin as induction chemotherapy for patients with unresectable stage IIIA-bulky N2 and stage IIIB nonsmall cell lung carcinoma: An Italian lung cancer project observational study', Cancer, vol. 98, no. 1, pp. 128-134. https://doi.org/10.1002/cncr.11460
Cappuzzo, Federico ; Selvaggi, Giovanni ; Gregorc, Vanesa ; Mazzoni, Francesca ; Betti, Maura ; Migliorino, Maria Rita ; Novello, Silvia ; Maestri, Antonio ; De Marinis, Filippo ; Darwish, Samir ; De Angelis, Verena ; Nelli, Fabrizio ; Bartolini, Stefania ; Scagliotti, Giorgio V. ; Tonato, Maurizio ; Crinò, Lucio. / Gemcitabine and cisplatin as induction chemotherapy for patients with unresectable stage IIIA-bulky N2 and stage IIIB nonsmall cell lung carcinoma : An Italian lung cancer project observational study. In: Cancer. 2003 ; Vol. 98, No. 1. pp. 128-134.
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abstract = "BACKGROUND. The objective of this trial was to evaluate the activity and safety of one of the newer platinum-based doublets as a neoadjuvant regimen in patients with unresectable Stage IIIA-bulky N2 and Stage IIIB nonsmall cell lung carcinoma (NSCLC). METHODS. From June 1996 to April 2000, 129 consecutive patients with locally advanced NSCLC were treated with gemcitabine, 1000 mg/m2 on Days 1 and 8 and cisplatin, 70 mg/m2 on Day 2 (GC) of a 21-day treatment cycle, for 4 cycles, as part of a combined-modality approach. RESULTS. After induction chemotherapy, 80 patients (62{\%}; 95{\%} confidence interval, 53.6-70.4{\%}) achieved a partial response, 43 patients (33{\%}) had stable disease, and 6 patients (5{\%}) had disease progression during chemotherapy. Forty patients (31{\%}), were considered resectable and underwent thoracotomy. Complete resectability was obtained in 38 patients (29{\%}), with 2{\%} of patients achieving a pathologic complete response. After surgery, 9 patients with Mountain Classification Stage IIIA NSCLC and 9 patients with Stage IIIB NSCLC received definitive adjuvant radiotherapy. Forty-six of 52 patients with Stage IIIB disease and 24 of 37 patients with Stage IIIA disease who were not considered suitable for surgery received definitive radiotherapy. The median time to disease progression was 11.4 months, the median survival was 19.4 months (range, 1.2-55.2 + months), and the 1-year survival rate was 74{\%}. The lungs (33{\%}) and the brain (21{\%}) were the main sites of recurrence. Major toxicity was comprised of Grade 3-4 thrombocytopenia, which occurred in 34 patients (27{\%}). CONCLUSIONS. GC administered according to a 3-week schedule was a highly active and safe regimen in patients with primary, unresectable, locally advanced NSCLC.",
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T1 - Gemcitabine and cisplatin as induction chemotherapy for patients with unresectable stage IIIA-bulky N2 and stage IIIB nonsmall cell lung carcinoma

T2 - An Italian lung cancer project observational study

AU - Cappuzzo, Federico

AU - Selvaggi, Giovanni

AU - Gregorc, Vanesa

AU - Mazzoni, Francesca

AU - Betti, Maura

AU - Migliorino, Maria Rita

AU - Novello, Silvia

AU - Maestri, Antonio

AU - De Marinis, Filippo

AU - Darwish, Samir

AU - De Angelis, Verena

AU - Nelli, Fabrizio

AU - Bartolini, Stefania

AU - Scagliotti, Giorgio V.

AU - Tonato, Maurizio

AU - Crinò, Lucio

PY - 2003/7/1

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N2 - BACKGROUND. The objective of this trial was to evaluate the activity and safety of one of the newer platinum-based doublets as a neoadjuvant regimen in patients with unresectable Stage IIIA-bulky N2 and Stage IIIB nonsmall cell lung carcinoma (NSCLC). METHODS. From June 1996 to April 2000, 129 consecutive patients with locally advanced NSCLC were treated with gemcitabine, 1000 mg/m2 on Days 1 and 8 and cisplatin, 70 mg/m2 on Day 2 (GC) of a 21-day treatment cycle, for 4 cycles, as part of a combined-modality approach. RESULTS. After induction chemotherapy, 80 patients (62%; 95% confidence interval, 53.6-70.4%) achieved a partial response, 43 patients (33%) had stable disease, and 6 patients (5%) had disease progression during chemotherapy. Forty patients (31%), were considered resectable and underwent thoracotomy. Complete resectability was obtained in 38 patients (29%), with 2% of patients achieving a pathologic complete response. After surgery, 9 patients with Mountain Classification Stage IIIA NSCLC and 9 patients with Stage IIIB NSCLC received definitive adjuvant radiotherapy. Forty-six of 52 patients with Stage IIIB disease and 24 of 37 patients with Stage IIIA disease who were not considered suitable for surgery received definitive radiotherapy. The median time to disease progression was 11.4 months, the median survival was 19.4 months (range, 1.2-55.2 + months), and the 1-year survival rate was 74%. The lungs (33%) and the brain (21%) were the main sites of recurrence. Major toxicity was comprised of Grade 3-4 thrombocytopenia, which occurred in 34 patients (27%). CONCLUSIONS. GC administered according to a 3-week schedule was a highly active and safe regimen in patients with primary, unresectable, locally advanced NSCLC.

AB - BACKGROUND. The objective of this trial was to evaluate the activity and safety of one of the newer platinum-based doublets as a neoadjuvant regimen in patients with unresectable Stage IIIA-bulky N2 and Stage IIIB nonsmall cell lung carcinoma (NSCLC). METHODS. From June 1996 to April 2000, 129 consecutive patients with locally advanced NSCLC were treated with gemcitabine, 1000 mg/m2 on Days 1 and 8 and cisplatin, 70 mg/m2 on Day 2 (GC) of a 21-day treatment cycle, for 4 cycles, as part of a combined-modality approach. RESULTS. After induction chemotherapy, 80 patients (62%; 95% confidence interval, 53.6-70.4%) achieved a partial response, 43 patients (33%) had stable disease, and 6 patients (5%) had disease progression during chemotherapy. Forty patients (31%), were considered resectable and underwent thoracotomy. Complete resectability was obtained in 38 patients (29%), with 2% of patients achieving a pathologic complete response. After surgery, 9 patients with Mountain Classification Stage IIIA NSCLC and 9 patients with Stage IIIB NSCLC received definitive adjuvant radiotherapy. Forty-six of 52 patients with Stage IIIB disease and 24 of 37 patients with Stage IIIA disease who were not considered suitable for surgery received definitive radiotherapy. The median time to disease progression was 11.4 months, the median survival was 19.4 months (range, 1.2-55.2 + months), and the 1-year survival rate was 74%. The lungs (33%) and the brain (21%) were the main sites of recurrence. Major toxicity was comprised of Grade 3-4 thrombocytopenia, which occurred in 34 patients (27%). CONCLUSIONS. GC administered according to a 3-week schedule was a highly active and safe regimen in patients with primary, unresectable, locally advanced NSCLC.

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KW - Nonsmall cell lung carcinoma (NSCLC)

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