TY - JOUR
T1 - Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2
T2 - The G-Step trial
AU - Gridelli, Cesare
AU - Gallo, Ciro
AU - Morabito, Alessandro
AU - Iaffaioli, Rosario Vincenzo
AU - Favaretto, Adolfo
AU - Isa, Luciano
AU - Barbera, Santi
AU - Gamucci, Teresa
AU - Ceribelli, Anna
AU - Filipazzi, Virginio
AU - Maione, Paolo
AU - Rossi, Antonio
AU - Barletta, Emiddio
AU - Signoriello, Simona
AU - De Maio, Ermelinda
AU - Piccirillo, Maria Carmela
AU - Di Maio, Massimo
AU - Rocco, Gaetano
AU - Vecchione, Aldo
AU - Perrone, Francesco
PY - 2012/1
Y1 - 2012/1
N2 - Introduction: Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence. Methods: Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m 2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m 2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥60% and unacceptable toxicity ≤25% were required to define a combination worthy of further studies. Results: Median age of 78 eligible patients was 74 years. GemVin produced a 36.7% objective response rate. GemEto and GemCis arms were found not sufficiently active. GemCar produced 16 responses (14 with area under the curve [AUC] 3.5 and 2 with AUC 4.0) in 26 patients (61.5%) and 6 cases of unacceptable toxicity (3 at each Car dose). Conclusions: In elderly patients with extensive SCLC, GemVin, GemEto, and GemCis are not enough active and do not merit further studies. Gem plus Car might deserve further attention.
AB - Introduction: Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence. Methods: Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m 2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m 2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥60% and unacceptable toxicity ≤25% were required to define a combination worthy of further studies. Results: Median age of 78 eligible patients was 74 years. GemVin produced a 36.7% objective response rate. GemEto and GemCis arms were found not sufficiently active. GemCar produced 16 responses (14 with area under the curve [AUC] 3.5 and 2 with AUC 4.0) in 26 patients (61.5%) and 6 cases of unacceptable toxicity (3 at each Car dose). Conclusions: In elderly patients with extensive SCLC, GemVin, GemEto, and GemCis are not enough active and do not merit further studies. Gem plus Car might deserve further attention.
KW - Elderly
KW - Etoposide
KW - Gemcitabine
KW - Platinum compounds
KW - SCLC
KW - Vinorelbine
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U2 - 10.1097/JTO.0b013e318233d6c2
DO - 10.1097/JTO.0b013e318233d6c2
M3 - Article
C2 - 22031232
AN - SCOPUS:84655170229
VL - 7
SP - 233
EP - 242
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
SN - 1556-0864
IS - 1
ER -