Abstract
Background: Adjuvant chemotherapy is beneficial in non-small-cell lung cancer (NSCLC), but balancing toxicity and efficacy requires improvement. Recently, we demonstrated safety & feasibility for CPx with less toxicity & superior dose delivery compared to CVb. Here we report 3-years efficacy data.
Methods: R0 resected NSCLC pts, stages pIB-T3N1, were randomized to 4 cycles of C(50 mg/m2 d1+8)/Vb(25 mg/m2 d1,8,15,22) q4 weeks or of C(75 mg/m2)/Px(500 mg/m2)d1 q3 weeks. Follow-up occurred every 3-6 months (mo) and overall (OS), relapse free (RFS), distant metastases free (DMFS), local relapse free (LRFS), lung cancer related survival (LCRS) and multivariate Cox regression analyses were evaluated.
Results: 132 pts were randomized (stages 38%IB [14%<4cm/24%>4cm]), 10%IIA, 47%IIB, 5%pT3pN1; histology 43% squamous, 57% non-squamous). After a median of 39 mo OS did not differ between treatment arms (median not reached for CPx, 59 mo for CVb, p=0.86). Tumor relapse occurred in 36% CPx versus 26% CVb pts, but RFS did not differ significantly (medians not reached, 25%-survival time (mo) 13 for CPx, 21 for CVb, p=0.81). Also DMFS (p=0.86), LRFS (p=0.88) and LCRS (p=0.61) were not different. Multivariate cox regression analysis revealed that occurrence of dose limiting toxicity (HR 67.5, p= 0.002) and non-feasibility (HR 37.3 p=0.002) significantly impacted OS. In the CPx treated pts, histology and tumor size in stage IB did not influence survival.
Conclusions: While adjuvant chemotherapy with CPx is safe with less toxicity compared to CVb, survival is not influenced by treatment arm, but by DLT and feasibility.
- © 2014 ERS
