title: Cetuximab and gemcitabine in elderly or adult PS2 patients with advanced non-small-cell lung cancer: The cetuximab in advanced lung cancer (CALC1-E and CALC1-PS2) randomized phase II trials.
abstract: 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 > or =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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Oncologia Medica, Az. Sanitaria S. Giuseppe Moscati, Avellino, Contrada Amoretta-83100, Italy. cgridelli@libero.it
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Morabito
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Manlio
authors.initials: M
authors.lastname: Mencoboni
authors.forename: Francesco
authors.initials: F
authors.lastname: Carrozza
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Viganò
authors.forename: Claudio
authors.initials: C
authors.lastname: Verusio
authors.forename: Roberto
authors.initials: R
authors.lastname: Bollina
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Mattioli
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Valerio
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Valmadre
authors.forename: Paolo
authors.initials: P
authors.lastname: Maione
authors.forename: Antonio
authors.initials: A
authors.lastname: Rossi
authors.forename: Tina
authors.initials: T
authors.lastname: Cascone
authors.forename: Floriana
authors.initials: F
authors.lastname: Morgillo
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Maio
authors.forename: Maria Carmela
authors.initials: MC
authors.lastname: Piccirillo
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Fortunato
authors.initials: F
authors.lastname: Ciardiello
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D000068818:Cetuximab; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068818:Cetuximab; D000093542:Gemcitabine