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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)223-229
Number of pages7
JournalOncology
Volume68
Issue number2-3
DOIs
Publication statusPublished - Jul 2005

Fingerprint

Epirubicin
Small Cell Lung Carcinoma
Granulocyte Colony-Stimulating Factor
Mucositis
Poisons
Appetite
Paclitaxel
Neutropenia
Thrombocytopenia
Cisplatin
Disease-Free Survival
Vomiting
Fatigue
TP protocol
Sepsis
Survival Rate
Clinical Trials
Survival

Keywords

  • Cisplatin
  • Epirubicin
  • Paclitaxel
  • Small-cell lung cancer
  • Weekly chemotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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

In: Oncology, Vol. 68, No. 2-3, 07.2005, p. 223-229.

Research output: Contribution to journalArticle

Frasci, Giuseppe ; Comella, Pasquale ; Carreca, Ignazio ; DeCataldis, Giuseppe ; Muci, Domenico ; Brunetti, Cosimo ; Russo, Anna ; Palmeri, Sergio ; D'Aniello, Roberta ; Giordano, Renato ; D'Aiuto, Massimiliano ; Comella, Giuseppe. / 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, No. 2-3. pp. 223-229.
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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.",
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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

T2 - A SICOG phase II study

AU - Frasci, Giuseppe

AU - Comella, Pasquale

AU - Carreca, Ignazio

AU - DeCataldis, Giuseppe

AU - Muci, Domenico

AU - Brunetti, Cosimo

AU - Russo, Anna

AU - Palmeri, Sergio

AU - D'Aniello, Roberta

AU - Giordano, Renato

AU - D'Aiuto, Massimiliano

AU - Comella, Giuseppe

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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.

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