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 language | English |
|---|---|
| Pages (from-to) | 67-70 |
| Number of pages | 4 |
| Journal | Clinical Lung Cancer |
| Volume | 16 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jan 1 2015 |
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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 journal › Article
}
TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=84927563085&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84927563085&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2014.09.001
DO - 10.1016/j.cllc.2014.09.001
M3 - Article
C2 - 25450879
AN - SCOPUS:84927563085
VL - 16
SP - 67
EP - 70
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
IS - 1
ER -