Italian multicenter phase III randomized study of cisplatin-etoposide with or without bevacizumab as first-line treatment in extensive stage small cell lung cancer: Treatment rationale and protocol design of the GOIRC-AIFA FARM6PMFJM trial

Marcello Tiseo, Luca Boni, Francesca Ambrosio, Andrea Camerini, Maria Giuseppa Vitale, Editta Baldini, Saverio Cinieri, Francesca Zanelli, Efisio Defraia, Rodolfo Passalacqua, Lucio Crino, Claudio Dazzi, Carmelo Tibaldi, Gianni M. Turolla, Vito D'Alessandro, Nicoletta Zilembo, Ferdinando Riccardi, Andrea Ardizzoni

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Abstract

Background Neoangiogenesis is particularly abundant in small-cell lung cancer (SCLC) and is associated with poor prognosis. As a result of the promising nature of phase II studies, a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line chemotherapy with cisplatin-etoposide for treatment of extensive disease SCLC. We present the treatment rationale and study design of GOIRC trial (FARM6PMFJM study), a multicenter randomized phase III study, supported by AIFA (Agenzia Italiana del Farmaco). Patients and Methods Patients are randomized to receive either cisplatin 25 mg/m2 and etoposide 100 mg/m2 intravenously on days 1 to 3 (control arm) or the same chemotherapy combined with bevacizumab 7.5 mg/kg intravenously on day 1 (experimental arm). Treatment is repeated every 3 weeks and for a maximum of 6 courses. Patients randomized to the experimental arm in the absence of disease progression after 6 cycles continue bevacizumab alone until progression or for a maximum of 18 courses. Tumor assessment is done every 3 cycles. Major eligibility criteria are: age ≥ 18 years; histologically or cytologically documented extensive disease SCLC; Eastern Cooperative Oncology Group performance status ≤ 2; adequate hematological, hepatic and renal functions; no history of grade 2 or higher hemoptysis; and no evidence of tumor cavitation. The primary end point of this study is overall survival. Secondary end points include response rate, time to progression, and toxicity. Conclusion An interim futility analysis was performed by an Independent Data Monitoring Committee in September 2013 and the trial obtained approval to continue. As of July 31, 2014, 171 patients of 206 planned have been randomized.

Original languageEnglish
Pages (from-to)67-70
Number of pages4
JournalClinical Lung Cancer
Volume16
Issue number1
DOIs
Publication statusPublished - Jan 1 2015

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Antineoplastic Protocols
Small Cell Lung Carcinoma
Etoposide
Cisplatin
Clinical Trials Data Monitoring Committees
Medical Futility
Drug Therapy
Hemoptysis
Therapeutics
Multicenter Studies
Disease Progression
Neoplasms
Kidney
Survival
Bevacizumab
Liver

Keywords

  • Keywords Bevacizumab Extended disease SCLC Vascular endothelial growth factor

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Italian multicenter phase III randomized study of cisplatin-etoposide with or without bevacizumab as first-line treatment in extensive stage small cell lung cancer : Treatment rationale and protocol design of the GOIRC-AIFA FARM6PMFJM trial. / Tiseo, Marcello; Boni, Luca; Ambrosio, Francesca; Camerini, Andrea; Vitale, Maria Giuseppa; Baldini, Editta; Cinieri, Saverio; Zanelli, Francesca; Defraia, Efisio; Passalacqua, Rodolfo; Crino, Lucio; Dazzi, Claudio; Tibaldi, Carmelo; Turolla, Gianni M.; D'Alessandro, Vito; Zilembo, Nicoletta; Riccardi, Ferdinando; Ardizzoni, Andrea.

In: Clinical Lung Cancer, Vol. 16, No. 1, 01.01.2015, p. 67-70.

Research output: Contribution to journalArticle

Tiseo, M, Boni, L, Ambrosio, F, Camerini, A, Vitale, MG, Baldini, E, Cinieri, S, Zanelli, F, Defraia, E, Passalacqua, R, Crino, L, Dazzi, C, Tibaldi, C, Turolla, GM, D'Alessandro, V, Zilembo, N, Riccardi, F & Ardizzoni, A 2015, 'Italian multicenter phase III randomized study of cisplatin-etoposide with or without bevacizumab as first-line treatment in extensive stage small cell lung cancer: Treatment rationale and protocol design of the GOIRC-AIFA FARM6PMFJM trial', Clinical Lung Cancer, vol. 16, no. 1, pp. 67-70. https://doi.org/10.1016/j.cllc.2014.09.001
Tiseo, Marcello ; Boni, Luca ; Ambrosio, Francesca ; Camerini, Andrea ; Vitale, Maria Giuseppa ; Baldini, Editta ; Cinieri, Saverio ; Zanelli, Francesca ; Defraia, Efisio ; Passalacqua, Rodolfo ; Crino, Lucio ; Dazzi, Claudio ; Tibaldi, Carmelo ; Turolla, Gianni M. ; D'Alessandro, Vito ; Zilembo, Nicoletta ; Riccardi, Ferdinando ; Ardizzoni, Andrea. / Italian multicenter phase III randomized study of cisplatin-etoposide with or without bevacizumab as first-line treatment in extensive stage small cell lung cancer : Treatment rationale and protocol design of the GOIRC-AIFA FARM6PMFJM trial. In: Clinical Lung Cancer. 2015 ; Vol. 16, No. 1. pp. 67-70.
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abstract = "Background Neoangiogenesis is particularly abundant in small-cell lung cancer (SCLC) and is associated with poor prognosis. As a result of the promising nature of phase II studies, a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line chemotherapy with cisplatin-etoposide for treatment of extensive disease SCLC. We present the treatment rationale and study design of GOIRC trial (FARM6PMFJM study), a multicenter randomized phase III study, supported by AIFA (Agenzia Italiana del Farmaco). Patients and Methods Patients are randomized to receive either cisplatin 25 mg/m2 and etoposide 100 mg/m2 intravenously on days 1 to 3 (control arm) or the same chemotherapy combined with bevacizumab 7.5 mg/kg intravenously on day 1 (experimental arm). Treatment is repeated every 3 weeks and for a maximum of 6 courses. Patients randomized to the experimental arm in the absence of disease progression after 6 cycles continue bevacizumab alone until progression or for a maximum of 18 courses. Tumor assessment is done every 3 cycles. Major eligibility criteria are: age ≥ 18 years; histologically or cytologically documented extensive disease SCLC; Eastern Cooperative Oncology Group performance status ≤ 2; adequate hematological, hepatic and renal functions; no history of grade 2 or higher hemoptysis; and no evidence of tumor cavitation. The primary end point of this study is overall survival. Secondary end points include response rate, time to progression, and toxicity. Conclusion An interim futility analysis was performed by an Independent Data Monitoring Committee in September 2013 and the trial obtained approval to continue. As of July 31, 2014, 171 patients of 206 planned have been randomized.",
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T1 - Italian multicenter phase III randomized study of cisplatin-etoposide with or without bevacizumab as first-line treatment in extensive stage small cell lung cancer

T2 - Treatment rationale and protocol design of the GOIRC-AIFA FARM6PMFJM trial

AU - Tiseo, Marcello

AU - Boni, Luca

AU - Ambrosio, Francesca

AU - Camerini, Andrea

AU - Vitale, Maria Giuseppa

AU - Baldini, Editta

AU - Cinieri, Saverio

AU - Zanelli, Francesca

AU - Defraia, Efisio

AU - Passalacqua, Rodolfo

AU - Crino, Lucio

AU - Dazzi, Claudio

AU - Tibaldi, Carmelo

AU - Turolla, Gianni M.

AU - D'Alessandro, Vito

AU - Zilembo, Nicoletta

AU - Riccardi, Ferdinando

AU - Ardizzoni, Andrea

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Background Neoangiogenesis is particularly abundant in small-cell lung cancer (SCLC) and is associated with poor prognosis. As a result of the promising nature of phase II studies, a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line chemotherapy with cisplatin-etoposide for treatment of extensive disease SCLC. We present the treatment rationale and study design of GOIRC trial (FARM6PMFJM study), a multicenter randomized phase III study, supported by AIFA (Agenzia Italiana del Farmaco). Patients and Methods Patients are randomized to receive either cisplatin 25 mg/m2 and etoposide 100 mg/m2 intravenously on days 1 to 3 (control arm) or the same chemotherapy combined with bevacizumab 7.5 mg/kg intravenously on day 1 (experimental arm). Treatment is repeated every 3 weeks and for a maximum of 6 courses. Patients randomized to the experimental arm in the absence of disease progression after 6 cycles continue bevacizumab alone until progression or for a maximum of 18 courses. Tumor assessment is done every 3 cycles. Major eligibility criteria are: age ≥ 18 years; histologically or cytologically documented extensive disease SCLC; Eastern Cooperative Oncology Group performance status ≤ 2; adequate hematological, hepatic and renal functions; no history of grade 2 or higher hemoptysis; and no evidence of tumor cavitation. The primary end point of this study is overall survival. Secondary end points include response rate, time to progression, and toxicity. Conclusion An interim futility analysis was performed by an Independent Data Monitoring Committee in September 2013 and the trial obtained approval to continue. As of July 31, 2014, 171 patients of 206 planned have been randomized.

AB - Background Neoangiogenesis is particularly abundant in small-cell lung cancer (SCLC) and is associated with poor prognosis. As a result of the promising nature of phase II studies, a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line chemotherapy with cisplatin-etoposide for treatment of extensive disease SCLC. We present the treatment rationale and study design of GOIRC trial (FARM6PMFJM study), a multicenter randomized phase III study, supported by AIFA (Agenzia Italiana del Farmaco). Patients and Methods Patients are randomized to receive either cisplatin 25 mg/m2 and etoposide 100 mg/m2 intravenously on days 1 to 3 (control arm) or the same chemotherapy combined with bevacizumab 7.5 mg/kg intravenously on day 1 (experimental arm). Treatment is repeated every 3 weeks and for a maximum of 6 courses. Patients randomized to the experimental arm in the absence of disease progression after 6 cycles continue bevacizumab alone until progression or for a maximum of 18 courses. Tumor assessment is done every 3 cycles. Major eligibility criteria are: age ≥ 18 years; histologically or cytologically documented extensive disease SCLC; Eastern Cooperative Oncology Group performance status ≤ 2; adequate hematological, hepatic and renal functions; no history of grade 2 or higher hemoptysis; and no evidence of tumor cavitation. The primary end point of this study is overall survival. Secondary end points include response rate, time to progression, and toxicity. Conclusion An interim futility analysis was performed by an Independent Data Monitoring Committee in September 2013 and the trial obtained approval to continue. As of July 31, 2014, 171 patients of 206 planned have been randomized.

KW - Keywords Bevacizumab Extended disease SCLC Vascular endothelial growth factor

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