Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: The G-Step trial
- Autori: Gridelli C.; Gallo C.; Morabito A.; Iaffaioli R.V.; Favaretto A.; Isa L.; Barbera S.; Gamucci T.; Ceribelli A.; Filipazzi V.; Maione P.; Rossi A.; Barletta E.; Signoriello S.; De Maio E.; Piccirillo M.C.; Di Maio M.; Rocco G.; Vecchione A.; Perrone F.;Cesare Gridelli, Paolo Maione, Antonio Rossi, Ciro Gallo, Giuseppe Signoriello, Paolo Chiodini, Simona Signoriello, Francesco Perrone, Massimo Di Maio, Maria Carmela Piccirillo, Ermelinda De Maio, Jane Bryce, Alessandro Morabito, Raffaele Costanzo, Gaetano Rocco, Rosario Vincenzo Iaffaioli, Emiddio Barletta, Roberta Formato, Aldo Vecchione, Adolfo Favaretto, Giulia Pasello, Cristina Magro, Luciano Isa, Raffaele Venezia, Mario Comandè, Santi Barbera, Francesco Renda, Antonio Volpintesta, Teresa Gamucci, Maria Anna Giampaolo, Giovanni Mansueto, Anna Ceribelli, Ilaria Carbone, Domenica Pellegrini, Virginio Filipazzi, Elena Piazza, Sabrina Ferrario, Vittorina Zagonel, Giuditta di Isernia, Marco Ciaparrone, Francovito Piantedosi, Fabiana Vitiello, Nicolò Borsellino, Maria Elia Vitale, Luigi Brancaccio, Sergio Spina, Maria Rosaria Valerio, Raffaella Felletti, Salvatore Tafuto, Marianna Giampaglia, Rita Migliorino, Francesco Rosetti, Francesco Carrozza, Nestore Rossi, Mario Spatafora, Manlio Mencoboni, Ernest Marshall
- Anno di pubblicazione: 2012
- Tipologia: Articolo in rivista
- OA Link: http://hdl.handle.net/10447/368595
Abstract
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/m2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m2, 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. © 2011 by the International Association for the Study of Lung Cancer.