Lung cancer symptoms with cetuximab/taxane/carboplatin in first-line advanced NSCLC: Analysis of the BMS099 trial

e19011 Background: The phase III BMS099 trial investigated cetuximab (C) added to taxane/carboplatin (TC) for 1st line treatment of advanced NSCLC. Progression-free survival (PFS) was not significantly different with C; response rate (RR) was significantly higher. Median overall survival (OS) was longer, with a difference not statistically significant, but similar in magnitude to the significant OS improvement from the FLEX trial (cisplat/vinorelb±C). A secondary objective of the BMS099 study was to assess the effect of C on Lung Cancer Symptoms (LCS). Methods: Chemonaïve patients (pts) with stage IIIB/IV NSCLC (any histology or EGFR expression status) were randomized to TC±C. LCS were measured using the functional assessment of cancer treatment-lung cancer subscale questionnaire (FACT-LCS), given at baseline and before each therapy cycle until disease progression (scoring 7 symptoms: breath loss, weight loss, clear thinking, coughing, appetite, chest tightness, breath ease, on a 0–4 scale). The main endpoints were rates of symptom response/progression (≥ 2 point improvement/decrease from baseline in 2 consecutive assessments), compared between arms with a stratified Cochran-Mantel-Haenszel (CMH) test; a stratified log-rank test was used to compare time to symptomatic progression. A Wei-Lachin test was used to compare between arms the changes from baseline in LCS score, and a longitudinal model was constructed to measure treatment effect on those score changes. Results: With 676 patients randomized, the baseline compliance rates for the FACT-LCS questionnaire were 99.4% and 99.1% for CTC and TC respectively, decreasing by week 18 to 74.0% and 66.4%. Baseline FACT-LCS scores were similar across treatment arms (median, 19.0). Symptom response rates were similar with CTC vs TC (32.6% vs 28.5%, CMH P=0.26), and time to symptomatic progression was not significantly different (log-rank P=0.58). Changes from baseline in FACT-LCS scores did not differ significantly between arms (Wei Lachin P=0.912; longitudinal model P=0.81). Conclusions: The addition of C to TC for the 1st treatment of advanced NSCLC resulted in similar symptom response/progression rates and did not affect trends in LCS score changes throughout treatment. [Table: see text]