title: Sunitinib malate in previously untreated, nonsquamous, non-small cell lung cancer patients over the age of 70 years: results of a Phase II trial.
abstract: BACKGROUND
  Some elderly patients may have reduced tolerance the standard therapy (chemotherapy doublets) for stage III/IV non-small cell lung cancer (NSCLC). Sunitinib malate (S), an oral, multitargeted kinase inhibitor, shows promise as 2nd-line NSCLC treatment. This study explored the safety/efficacy of S in elderly patients with previously untreated NSCLC.
  
  
  METHODS
  
  
  
  OBJECTIVE
  disease control rate (DCR) at six-weeks.
  
  
  OBJECTIVE
  overall response (OR, CR+PR), progression-free survival (PFS), time to progression (TTP), one-yr survival, quality of life (QOL), and safety.
  
  
  METHODS
  S 37.5 mg daily/42-day cycle until PD or intolerable toxicity. Key inclusion: chemo-naïve stage IIIB/IV NSCLC (nonsquamous histology); ECOG PS=0-1; ≥ 70 years; normal organ function. Exclusion: hemoptysis, anticoagulation, or clotting diathesis. Other standard S-specific criteria applied.
  
  
  RESULTS
  63 patients enrolled/60 treated.
  
  
  METHODS
  51 % male, 95 % white, median age 78 years (range, 70-88), 73 % ECOG=1, 97 % Stage IV, 83 % adenocarcinoma, 44 % prior surgery, 19 % prior radiation. With a median of 2 cycles (range, 1-16), DCR=63 %, OR=7 % (0 CR, 4 PR). Median follow-up=5.8 months (all; 15.9 months survivors), median PFS =3.0 months (range, <1-25.1), median TTP=4.5 months (range, <1-25.1), and 1-year survival=26.4 % [95 % CI: 15.9, 38.2]. QOL declined initially, but improved over time. TREATMENT-related adverse events included: fatigue (48.3 %); diarrhea (38.3 %); thrombocytopenia (33.3 %), anorexia (26.7 %), mucositis (25.0 %); nausea (25.0 %), dysgeusia (20.0 %), and neutropenia (20.0 %). Conclusions The study met its primary endpoint. S produced acceptable DCR and QOL improved; however, OR was disappointing (7 %) and toxicity was greater than expected. A biomarker to identify patients more likely to benefit from S is needed.
authors.affiliation: Ocala Oncology, Ocala, FL, USA, Craig.Reynolds@USOncology.com.
authors.forename: Craig
authors.initials: C
authors.lastname: Reynolds
authors.forename: Alexander I
authors.initials: AI
authors.lastname: Spira
authors.forename: Larry
authors.initials: L
authors.lastname: Gluck
authors.forename: Suzanne J
authors.initials: SJ
authors.lastname: Bradie-Muller
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Mueller
authors.forename: Feng
authors.initials: F
authors.lastname: Zhan
authors.forename: Kristi A
authors.initials: KA
authors.lastname: Boehm
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011758:Pyrroles / Q000627:therapeutic use*; D011788:Quality of Life; D000077210:Sunitinib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D047428:Protein Kinase Inhibitors; D011758:Pyrroles; D000077210:Sunitinib