Sunitinib malate in previously untreated, nonsquamous, non-small cell lung cancer patients over the age of 70 years: Results of a Phase II trial

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 Primary objective: disease control rate (DCR) at six-weeks. Secondary objectives: overall response (OR, CR+PR), progression-free survival (PFS), time to progression (TTP), one-yr survival, quality of life (QOL), and safety. Treatment: S 37.5 mg daily/42-day cycle until PD or intolerable toxicity. Key inclusion: chemo-naive 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. Demographics: 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.