Cetuximab and gemcitabine in elderly or adult PS2 patients with advancednon-small-cell lung cancer: The cetuximab in advanced lung cancer (CALC1-E andCALC1-PS2) randomized phase II trials.

Maria Rosaria Valerio, Vittorio Gebbia, Tina Cascone, Maria Carmela Piccirillo, Roberto Bollina, Francesco Carrozza, Massimo Di Maio, Giuseppe Valmadre, Fortunato Ciardiello, Antonio Rossi, Maria Grazia Viganò, Floriana Morgillo, Claudio Verusio, Paolo Maione, Manlio Mencoboni, Rodolfo Mattioli, Alessandro Morabito, Francesco Perrone, Cesare Gridelli, Ciro Gallo

Risultato della ricerca: Article

26 Citazioni (Scopus)

Abstract

Two parallel randomized phase 2 trials were performed to choose theoptimal way of combining cetuximab with gemcitabine in the first-line treatmentof elderly (CALC1-E) and adult PS2 (CALC1-PS2) patients with advanced NSCLC.METHODS: Stage IV or IIIB NSCLC patients, aged > or =70 years with PS 0-2 forCALC1-E or aged <70 with PS2 for CALC1-PS2, not selected for EGFR expression,were eligible. Patients were randomized to concomitant (gemcitabine, for amaximum of 6 cycles, plus cetuximab until progression) or sequential(gemcitabine, for a maximum of 6 cycles, followed by cetuximab) strategy. Aselection design, with 1-year survival rate as the primary endpoint, was applied,requiring 58 elderly and 42 PS2 patients. RESULTS: All planned patients wererandomized. In sequential arms, 34.5% and 60.0% patients were not able to receivecetuximab after gemcitabine in CALC1-E and CALC1-PS2, respectively. Survivalrates (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 10months 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 toxicitywithin the first two cycles of treatment. CONCLUSION: In both groups of patients,sequential strategy cannot be proposed for future trials because of lowcompliance. Inconsistency of survival outcomes makes also concomitant treatmentnot a candidate for further testing in unselected elderly and PS2 NSCLC patients.
Lingua originaleEnglish
pagine (da-a)86-92
Numero di pagine7
RivistaLung Cancer
Volume67
Stato di pubblicazionePublished - 2010

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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