Gemcitabine, paclitaxel, and cisplatin as induction chemotherapy for patients with biopsy-proven stage IIIA(N2) nonsmall cell lung carcinoma: A phase II multicenter study

Filippo De Marinis, Fabrizio Nelli, Maria Rita Migliorino, Olga Martelli, Enrico Cortesi, Stefano Treggiari, Luigi Portalone, Carlo Crispino, Luigi Brancaccio, Cesare Gridelli

Research output: Contribution to journalArticle

Abstract

BACKGROUND. The objective of the current study was to define the activity and tolerability, as well as the influence on resectability, of the combination of gemcitabine, paclitaxel, and cisplatin (GTP) as induction chemotherapy for patients with Stage IIIA(N2) nonsmall cell lung carcinoma (NSCLC). METHODS. Forty-nine chemotherapy-naïve patients (median age, 61 years; World Health Organization performance status, 0-1) with biopsy-proven Stage IIIA(N2) disease received 1000 mg/m2 gemcitabine, 125 mg/m2 paclitaxel, and 50 mg/m2 cisplatin on Days 1 and 8 of every 3 weeks until reevaluation for surgery or definitive radiotherapy. RESULTS. Grade 3-4 neutropenia was the most common hematologic toxicity, occurring in 32.7% of patients; however, only 1 case of febrile neutropenia was reported. Grade 3-4 thrombocytopenia occurred in 12.2% of patients but was not associated with bleeding. Severe nonhematologic toxicities were uncommon; the only Grade 4 nonhematologic toxicity was diarrhea, which occurred in 4% of patients. One patient died after the first course of therapy, but this event was found to be unrelated to treatment. Thirty-six patients (73.5%) achieved an objective response, and an additional 4 patients had stable disease with clearance of mediastinal lymph nodes. Overall, 29 patients underwent thoracotomy and 27 (55%) underwent complete resection. Mediastinal nodes were free of tumor in 35% of all cases, and 8 pathologic complete responses (16%) were reported. Median survival was 23 months, with a 1-year survival rate of 85%. CONCLUSIONS. GTP is highly active as an induction chemotherapy regimen for Stage IIIA(N2) NSCLC and yields good toxicity results. The use of GTP in combination with radiotherapy and new biologic drugs should be explored.

Original languageEnglish
Pages (from-to)1707-1715
Number of pages9
JournalCancer
Volume98
Issue number8
DOIs
Publication statusPublished - Oct 15 2003

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gemcitabine
Induction Chemotherapy
Multicenter Studies
Carcinoma
Biopsy
Lung
Radiotherapy
TP protocol
Febrile Neutropenia
Thoracotomy
Paclitaxel
Neutropenia

Keywords

  • Cisplatin
  • Gemcitabine
  • Induction chemotherapy
  • Nonsmall cell lung carcinoma
  • Paclitaxel
  • Stage IIIA(N2)

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Gemcitabine, paclitaxel, and cisplatin as induction chemotherapy for patients with biopsy-proven stage IIIA(N2) nonsmall cell lung carcinoma : A phase II multicenter study. / De Marinis, Filippo; Nelli, Fabrizio; Migliorino, Maria Rita; Martelli, Olga; Cortesi, Enrico; Treggiari, Stefano; Portalone, Luigi; Crispino, Carlo; Brancaccio, Luigi; Gridelli, Cesare.

In: Cancer, Vol. 98, No. 8, 15.10.2003, p. 1707-1715.

Research output: Contribution to journalArticle

De Marinis, F, Nelli, F, Migliorino, MR, Martelli, O, Cortesi, E, Treggiari, S, Portalone, L, Crispino, C, Brancaccio, L & Gridelli, C 2003, 'Gemcitabine, paclitaxel, and cisplatin as induction chemotherapy for patients with biopsy-proven stage IIIA(N2) nonsmall cell lung carcinoma: A phase II multicenter study', Cancer, vol. 98, no. 8, pp. 1707-1715. https://doi.org/10.1002/cncr.11662
De Marinis, Filippo ; Nelli, Fabrizio ; Migliorino, Maria Rita ; Martelli, Olga ; Cortesi, Enrico ; Treggiari, Stefano ; Portalone, Luigi ; Crispino, Carlo ; Brancaccio, Luigi ; Gridelli, Cesare. / Gemcitabine, paclitaxel, and cisplatin as induction chemotherapy for patients with biopsy-proven stage IIIA(N2) nonsmall cell lung carcinoma : A phase II multicenter study. In: Cancer. 2003 ; Vol. 98, No. 8. pp. 1707-1715.
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abstract = "BACKGROUND. The objective of the current study was to define the activity and tolerability, as well as the influence on resectability, of the combination of gemcitabine, paclitaxel, and cisplatin (GTP) as induction chemotherapy for patients with Stage IIIA(N2) nonsmall cell lung carcinoma (NSCLC). METHODS. Forty-nine chemotherapy-na{\"i}ve patients (median age, 61 years; World Health Organization performance status, 0-1) with biopsy-proven Stage IIIA(N2) disease received 1000 mg/m2 gemcitabine, 125 mg/m2 paclitaxel, and 50 mg/m2 cisplatin on Days 1 and 8 of every 3 weeks until reevaluation for surgery or definitive radiotherapy. RESULTS. Grade 3-4 neutropenia was the most common hematologic toxicity, occurring in 32.7{\%} of patients; however, only 1 case of febrile neutropenia was reported. Grade 3-4 thrombocytopenia occurred in 12.2{\%} of patients but was not associated with bleeding. Severe nonhematologic toxicities were uncommon; the only Grade 4 nonhematologic toxicity was diarrhea, which occurred in 4{\%} of patients. One patient died after the first course of therapy, but this event was found to be unrelated to treatment. Thirty-six patients (73.5{\%}) achieved an objective response, and an additional 4 patients had stable disease with clearance of mediastinal lymph nodes. Overall, 29 patients underwent thoracotomy and 27 (55{\%}) underwent complete resection. Mediastinal nodes were free of tumor in 35{\%} of all cases, and 8 pathologic complete responses (16{\%}) were reported. Median survival was 23 months, with a 1-year survival rate of 85{\%}. CONCLUSIONS. GTP is highly active as an induction chemotherapy regimen for Stage IIIA(N2) NSCLC and yields good toxicity results. The use of GTP in combination with radiotherapy and new biologic drugs should be explored.",
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T1 - Gemcitabine, paclitaxel, and cisplatin as induction chemotherapy for patients with biopsy-proven stage IIIA(N2) nonsmall cell lung carcinoma

T2 - A phase II multicenter study

AU - De Marinis, Filippo

AU - Nelli, Fabrizio

AU - Migliorino, Maria Rita

AU - Martelli, Olga

AU - Cortesi, Enrico

AU - Treggiari, Stefano

AU - Portalone, Luigi

AU - Crispino, Carlo

AU - Brancaccio, Luigi

AU - Gridelli, Cesare

PY - 2003/10/15

Y1 - 2003/10/15

N2 - BACKGROUND. The objective of the current study was to define the activity and tolerability, as well as the influence on resectability, of the combination of gemcitabine, paclitaxel, and cisplatin (GTP) as induction chemotherapy for patients with Stage IIIA(N2) nonsmall cell lung carcinoma (NSCLC). METHODS. Forty-nine chemotherapy-naïve patients (median age, 61 years; World Health Organization performance status, 0-1) with biopsy-proven Stage IIIA(N2) disease received 1000 mg/m2 gemcitabine, 125 mg/m2 paclitaxel, and 50 mg/m2 cisplatin on Days 1 and 8 of every 3 weeks until reevaluation for surgery or definitive radiotherapy. RESULTS. Grade 3-4 neutropenia was the most common hematologic toxicity, occurring in 32.7% of patients; however, only 1 case of febrile neutropenia was reported. Grade 3-4 thrombocytopenia occurred in 12.2% of patients but was not associated with bleeding. Severe nonhematologic toxicities were uncommon; the only Grade 4 nonhematologic toxicity was diarrhea, which occurred in 4% of patients. One patient died after the first course of therapy, but this event was found to be unrelated to treatment. Thirty-six patients (73.5%) achieved an objective response, and an additional 4 patients had stable disease with clearance of mediastinal lymph nodes. Overall, 29 patients underwent thoracotomy and 27 (55%) underwent complete resection. Mediastinal nodes were free of tumor in 35% of all cases, and 8 pathologic complete responses (16%) were reported. Median survival was 23 months, with a 1-year survival rate of 85%. CONCLUSIONS. GTP is highly active as an induction chemotherapy regimen for Stage IIIA(N2) NSCLC and yields good toxicity results. The use of GTP in combination with radiotherapy and new biologic drugs should be explored.

AB - BACKGROUND. The objective of the current study was to define the activity and tolerability, as well as the influence on resectability, of the combination of gemcitabine, paclitaxel, and cisplatin (GTP) as induction chemotherapy for patients with Stage IIIA(N2) nonsmall cell lung carcinoma (NSCLC). METHODS. Forty-nine chemotherapy-naïve patients (median age, 61 years; World Health Organization performance status, 0-1) with biopsy-proven Stage IIIA(N2) disease received 1000 mg/m2 gemcitabine, 125 mg/m2 paclitaxel, and 50 mg/m2 cisplatin on Days 1 and 8 of every 3 weeks until reevaluation for surgery or definitive radiotherapy. RESULTS. Grade 3-4 neutropenia was the most common hematologic toxicity, occurring in 32.7% of patients; however, only 1 case of febrile neutropenia was reported. Grade 3-4 thrombocytopenia occurred in 12.2% of patients but was not associated with bleeding. Severe nonhematologic toxicities were uncommon; the only Grade 4 nonhematologic toxicity was diarrhea, which occurred in 4% of patients. One patient died after the first course of therapy, but this event was found to be unrelated to treatment. Thirty-six patients (73.5%) achieved an objective response, and an additional 4 patients had stable disease with clearance of mediastinal lymph nodes. Overall, 29 patients underwent thoracotomy and 27 (55%) underwent complete resection. Mediastinal nodes were free of tumor in 35% of all cases, and 8 pathologic complete responses (16%) were reported. Median survival was 23 months, with a 1-year survival rate of 85%. CONCLUSIONS. GTP is highly active as an induction chemotherapy regimen for Stage IIIA(N2) NSCLC and yields good toxicity results. The use of GTP in combination with radiotherapy and new biologic drugs should be explored.

KW - Cisplatin

KW - Gemcitabine

KW - Induction chemotherapy

KW - Nonsmall cell lung carcinoma

KW - Paclitaxel

KW - Stage IIIA(N2)

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