TY - JOUR
T1 - Cetuximab and gemcitabine in elderly or adult PS2 patients with advanced non-small-cell lung cancer
T2 - The cetuximab in advanced lung cancer (CALC1-E and CALC1-PS2) randomized phase II trials
AU - Gridelli, Cesare
AU - Morabito, Alessandro
AU - Gebbia, Vittorio
AU - Mencoboni, Manlio
AU - Carrozza, Francesco
AU - Viganò, Maria Grazia
AU - Verusio, Claudio
AU - Bollina, Roberto
AU - Mattioli, Rodolfo
AU - Valerio, Maria Rosaria
AU - Valmadre, Giuseppe
AU - Maione, Paolo
AU - Rossi, Antonio
AU - Cascone, Tina
AU - Morgillo, Floriana
AU - Di Maio, Massimo
AU - Piccirillo, Maria Carmela
AU - Gallo, Ciro
AU - Perrone, Francesco
AU - Ciardiello, Fortunato
N1 - Funding Information:
The study was supported by: Merck-Serono, Italy, that supplied cetuximab and contributed a grant for trial coordination, without being involved in plan, conduction and analysis of the study; Health Minister finalized project FSN 2004. The Clinical Trials Unit of National Cancer Institute of Napoli and Medical Statistic Unit of Second University of Napoli are partially supported by the no-profit “Associazione Italiana per la Ricerca sul Cancro” (AIRC).
Funding Information:
The trial was sponsored by the National Cancer Institute of Naples, a public Institution devoted to research and treatment of cancer. Merck-Serono, Italy, supplied cetuximab and contributed a grant for trial coordination, without any rights of property of data nor any involvement in study plan, conduction and analysis and in writing of manuscript.
PY - 2010/1
Y1 - 2010/1
N2 - Background: Two parallel randomized phase 2 trials were performed to choose the optimal way of combining cetuximab with gemcitabine in the first-line treatment of elderly (CALC1-E) and adult PS2 (CALC1-PS2) patients with advanced NSCLC. Methods: Stage IV or IIIB NSCLC patients, aged ≥70 years with PS 0-2 for CALC1-E or aged <70 with PS2 for CALC1-PS2, not selected for EGFR expression, were eligible. Patients were randomized to concomitant (gemcitabine, for a maximum of 6 cycles, plus cetuximab until progression) or sequential (gemcitabine, for a maximum of 6 cycles, followed by cetuximab) strategy. A selection design, with 1-year survival rate as the primary endpoint, was applied, requiring 58 elderly and 42 PS2 patients. Results: All planned patients were randomized. In sequential arms, 34.5% and 60.0% patients were not able to receive cetuximab after gemcitabine in CALC1-E and CALC1-PS2, respectively. Survival rates (95% CI) at 1-year for concomitant and sequential arms were 41.4% (23.5-61.1) and 31.0% (15.3-50.8) in CALC1-E and 27.3% (10.7-50.2) and 35.0% (15.4-59.2) in CALC1-PS2. In both studies, survival curves crossed at about 10 months and the worse arm until that time became the better one at 1-year. Toxicity was similar across treatment groups. In concomitant arm of CALC1-E (but not of CALC1-PS2), survival was longer for patients who developed skin toxicity within the first two cycles of treatment. Conclusion: In both groups of patients, sequential strategy cannot be proposed for future trials because of low compliance. Inconsistency of survival outcomes makes also concomitant treatment not a candidate for further testing in unselected elderly and PS2 NSCLC patients.
AB - Background: Two parallel randomized phase 2 trials were performed to choose the optimal way of combining cetuximab with gemcitabine in the first-line treatment of elderly (CALC1-E) and adult PS2 (CALC1-PS2) patients with advanced NSCLC. Methods: Stage IV or IIIB NSCLC patients, aged ≥70 years with PS 0-2 for CALC1-E or aged <70 with PS2 for CALC1-PS2, not selected for EGFR expression, were eligible. Patients were randomized to concomitant (gemcitabine, for a maximum of 6 cycles, plus cetuximab until progression) or sequential (gemcitabine, for a maximum of 6 cycles, followed by cetuximab) strategy. A selection design, with 1-year survival rate as the primary endpoint, was applied, requiring 58 elderly and 42 PS2 patients. Results: All planned patients were randomized. In sequential arms, 34.5% and 60.0% patients were not able to receive cetuximab after gemcitabine in CALC1-E and CALC1-PS2, respectively. Survival rates (95% CI) at 1-year for concomitant and sequential arms were 41.4% (23.5-61.1) and 31.0% (15.3-50.8) in CALC1-E and 27.3% (10.7-50.2) and 35.0% (15.4-59.2) in CALC1-PS2. In both studies, survival curves crossed at about 10 months and the worse arm until that time became the better one at 1-year. Toxicity was similar across treatment groups. In concomitant arm of CALC1-E (but not of CALC1-PS2), survival was longer for patients who developed skin toxicity within the first two cycles of treatment. Conclusion: In both groups of patients, sequential strategy cannot be proposed for future trials because of low compliance. Inconsistency of survival outcomes makes also concomitant treatment not a candidate for further testing in unselected elderly and PS2 NSCLC patients.
KW - Cetuximab
KW - Elderly patients
KW - Gemcitabine
KW - NSCLC
KW - PS2 patients
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U2 - 10.1016/j.lungcan.2009.03.021
DO - 10.1016/j.lungcan.2009.03.021
M3 - Article
C2 - 19380175
AN - SCOPUS:71849107743
SN - 0169-5002
VL - 67
SP - 86
EP - 92
JO - Lung Cancer
JF - Lung Cancer
IS - 1
ER -