Weekly Dose-Dense Cisplatin-Epirubicin-Paclitaxel Administration with Granulocyte Colony-Stimulating Factor Support Does Not Substantially Improve Prognosis in Extensive Disease Small-Cell Lung Cancer A SICOG Phase II Study

Ignazio Carreca, Roberta D'Aniello, Massimiliano D'Aiuto, Ignazio Carreca, Giuseppe Comella, Giuseppe Frasci, Sergio Palmeri, Cosimo Brunetti, Renato Giordano, Pasquale Comella, Giuseppe Decataldis, Domenico Muci, Anna Russo

Risultato della ricerca: Article

5 Citazioni (Scopus)

Abstract

Purpose: The present study was aimed at defining the antitumor activity of the cisplatin-epirubicin-paclitaxel (PET) weekly administration with granulocyte colony-stimulating factor (G-CSF) support in chemonaive small-cell lung cancer patients with extensive disease (ED-SCLC). Methods: Chemonaive ED-SCLC patients received cisplatin 30 mg/sqm, epirubicin 50 mg/sqm and paclitaxel 120 mg/sqm, weekly, with G-CSF (5 μg/kg from day 3 to 5) support, for a maximum of 12 weeks. Results: Thirty-nine patients were treated, for a total of 354 cycles delivered. Eight complete (21%), and 22 partial responses (56%) were recorded, giving a 77% (95% Cl = 61-89%) objective response rate (ORR). After 14 (range, 7-28)-month median follow-up, 24 deaths have occurred. Median progression-free and overall survival were 7 months and 11 months, with 1- and 2-year projected survivals of 45 and 24%, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocytopenia occurred in 4 (10%) and 1 (3%) patients, respectively. Only one case of neutropenic sepsis was recorded, while hemorrhagic thrombocytopenia was never observed. Emesis, loss of appetite, mucositis and fatigue were the main nonhematological toxicities, being severe in 9, 8, 4 and 7 patients, respectively. Conclusions: The weekly PET combination with G-CSF support represents an active therapeutic approach in chemonaive ED-SCLC patients. However, both ORR and median survival does not seem substantially better than those achievable with a standard regimen. In view of that, and in consideration of the relevant nonhematological toxicity, this approach should not be pursued outside clinical trials.
Lingua originaleEnglish
pagine (da-a)223-229
Numero di pagine7
RivistaOncology
Volume68
Stato di pubblicazionePublished - 2005

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Weekly Dose-Dense Cisplatin-Epirubicin-Paclitaxel Administration with Granulocyte Colony-Stimulating Factor Support Does Not Substantially Improve Prognosis in Extensive Disease Small-Cell Lung Cancer A SICOG Phase II Study. / Carreca, Ignazio; D'Aniello, Roberta; D'Aiuto, Massimiliano; Carreca, Ignazio; Comella, Giuseppe; Frasci, Giuseppe; Palmeri, Sergio; Brunetti, Cosimo; Giordano, Renato; Comella, Pasquale; Decataldis, Giuseppe; Muci, Domenico; Russo, Anna.

In: Oncology, Vol. 68, 2005, pag. 223-229.

Risultato della ricerca: Article

Carreca, I, D'Aniello, R, D'Aiuto, M, Carreca, I, Comella, G, Frasci, G, Palmeri, S, Brunetti, C, Giordano, R, Comella, P, Decataldis, G, Muci, D & Russo, A 2005, 'Weekly Dose-Dense Cisplatin-Epirubicin-Paclitaxel Administration with Granulocyte Colony-Stimulating Factor Support Does Not Substantially Improve Prognosis in Extensive Disease Small-Cell Lung Cancer A SICOG Phase II Study', Oncology, vol. 68, pagg. 223-229.
Carreca, Ignazio ; D'Aniello, Roberta ; D'Aiuto, Massimiliano ; Carreca, Ignazio ; Comella, Giuseppe ; Frasci, Giuseppe ; Palmeri, Sergio ; Brunetti, Cosimo ; Giordano, Renato ; Comella, Pasquale ; Decataldis, Giuseppe ; Muci, Domenico ; Russo, Anna. / Weekly Dose-Dense Cisplatin-Epirubicin-Paclitaxel Administration with Granulocyte Colony-Stimulating Factor Support Does Not Substantially Improve Prognosis in Extensive Disease Small-Cell Lung Cancer A SICOG Phase II Study. In: Oncology. 2005 ; Vol. 68. pagg. 223-229.
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title = "Weekly Dose-Dense Cisplatin-Epirubicin-Paclitaxel Administration with Granulocyte Colony-Stimulating Factor Support Does Not Substantially Improve Prognosis in Extensive Disease Small-Cell Lung Cancer A SICOG Phase II Study",
abstract = "Purpose: The present study was aimed at defining the antitumor activity of the cisplatin-epirubicin-paclitaxel (PET) weekly administration with granulocyte colony-stimulating factor (G-CSF) support in chemonaive small-cell lung cancer patients with extensive disease (ED-SCLC). Methods: Chemonaive ED-SCLC patients received cisplatin 30 mg/sqm, epirubicin 50 mg/sqm and paclitaxel 120 mg/sqm, weekly, with G-CSF (5 μg/kg from day 3 to 5) support, for a maximum of 12 weeks. Results: Thirty-nine patients were treated, for a total of 354 cycles delivered. Eight complete (21{\%}), and 22 partial responses (56{\%}) were recorded, giving a 77{\%} (95{\%} Cl = 61-89{\%}) objective response rate (ORR). After 14 (range, 7-28)-month median follow-up, 24 deaths have occurred. Median progression-free and overall survival were 7 months and 11 months, with 1- and 2-year projected survivals of 45 and 24{\%}, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocytopenia occurred in 4 (10{\%}) and 1 (3{\%}) patients, respectively. Only one case of neutropenic sepsis was recorded, while hemorrhagic thrombocytopenia was never observed. Emesis, loss of appetite, mucositis and fatigue were the main nonhematological toxicities, being severe in 9, 8, 4 and 7 patients, respectively. Conclusions: The weekly PET combination with G-CSF support represents an active therapeutic approach in chemonaive ED-SCLC patients. However, both ORR and median survival does not seem substantially better than those achievable with a standard regimen. In view of that, and in consideration of the relevant nonhematological toxicity, this approach should not be pursued outside clinical trials.",
keywords = "Small-cell lung cancer, Weekly chemotherapy, Paclitaxel, Epirubicin, Cisplatin",
author = "Ignazio Carreca and Roberta D'Aniello and Massimiliano D'Aiuto and Ignazio Carreca and Giuseppe Comella and Giuseppe Frasci and Sergio Palmeri and Cosimo Brunetti and Renato Giordano and Pasquale Comella and Giuseppe Decataldis and Domenico Muci and Anna Russo",
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pages = "223--229",
journal = "Oncology",
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TY - JOUR

T1 - Weekly Dose-Dense Cisplatin-Epirubicin-Paclitaxel Administration with Granulocyte Colony-Stimulating Factor Support Does Not Substantially Improve Prognosis in Extensive Disease Small-Cell Lung Cancer A SICOG Phase II Study

AU - Carreca, Ignazio

AU - D'Aniello, Roberta

AU - D'Aiuto, Massimiliano

AU - Carreca, Ignazio

AU - Comella, Giuseppe

AU - Frasci, Giuseppe

AU - Palmeri, Sergio

AU - Brunetti, Cosimo

AU - Giordano, Renato

AU - Comella, Pasquale

AU - Decataldis, Giuseppe

AU - Muci, Domenico

AU - Russo, Anna

PY - 2005

Y1 - 2005

N2 - Purpose: The present study was aimed at defining the antitumor activity of the cisplatin-epirubicin-paclitaxel (PET) weekly administration with granulocyte colony-stimulating factor (G-CSF) support in chemonaive small-cell lung cancer patients with extensive disease (ED-SCLC). Methods: Chemonaive ED-SCLC patients received cisplatin 30 mg/sqm, epirubicin 50 mg/sqm and paclitaxel 120 mg/sqm, weekly, with G-CSF (5 μg/kg from day 3 to 5) support, for a maximum of 12 weeks. Results: Thirty-nine patients were treated, for a total of 354 cycles delivered. Eight complete (21%), and 22 partial responses (56%) were recorded, giving a 77% (95% Cl = 61-89%) objective response rate (ORR). After 14 (range, 7-28)-month median follow-up, 24 deaths have occurred. Median progression-free and overall survival were 7 months and 11 months, with 1- and 2-year projected survivals of 45 and 24%, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocytopenia occurred in 4 (10%) and 1 (3%) patients, respectively. Only one case of neutropenic sepsis was recorded, while hemorrhagic thrombocytopenia was never observed. Emesis, loss of appetite, mucositis and fatigue were the main nonhematological toxicities, being severe in 9, 8, 4 and 7 patients, respectively. Conclusions: The weekly PET combination with G-CSF support represents an active therapeutic approach in chemonaive ED-SCLC patients. However, both ORR and median survival does not seem substantially better than those achievable with a standard regimen. In view of that, and in consideration of the relevant nonhematological toxicity, this approach should not be pursued outside clinical trials.

AB - Purpose: The present study was aimed at defining the antitumor activity of the cisplatin-epirubicin-paclitaxel (PET) weekly administration with granulocyte colony-stimulating factor (G-CSF) support in chemonaive small-cell lung cancer patients with extensive disease (ED-SCLC). Methods: Chemonaive ED-SCLC patients received cisplatin 30 mg/sqm, epirubicin 50 mg/sqm and paclitaxel 120 mg/sqm, weekly, with G-CSF (5 μg/kg from day 3 to 5) support, for a maximum of 12 weeks. Results: Thirty-nine patients were treated, for a total of 354 cycles delivered. Eight complete (21%), and 22 partial responses (56%) were recorded, giving a 77% (95% Cl = 61-89%) objective response rate (ORR). After 14 (range, 7-28)-month median follow-up, 24 deaths have occurred. Median progression-free and overall survival were 7 months and 11 months, with 1- and 2-year projected survivals of 45 and 24%, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocytopenia occurred in 4 (10%) and 1 (3%) patients, respectively. Only one case of neutropenic sepsis was recorded, while hemorrhagic thrombocytopenia was never observed. Emesis, loss of appetite, mucositis and fatigue were the main nonhematological toxicities, being severe in 9, 8, 4 and 7 patients, respectively. Conclusions: The weekly PET combination with G-CSF support represents an active therapeutic approach in chemonaive ED-SCLC patients. However, both ORR and median survival does not seem substantially better than those achievable with a standard regimen. In view of that, and in consideration of the relevant nonhematological toxicity, this approach should not be pursued outside clinical trials.

KW - Small-cell lung cancer, Weekly chemotherapy, Paclitaxel, Epirubicin, Cisplatin

UR - http://hdl.handle.net/10447/12447

M3 - Article

VL - 68

SP - 223

EP - 229

JO - Oncology

JF - Oncology

SN - 0030-2414

ER -