Neutrophil-lymphocyte ratio (NLR) as an important prognostic factor for paclitaxel as a second line chemotherapy in advanced gastric cancer (AGC): Results from phase III DREAM study

Abstract

Background: Paclitaxel is the most commonly used second‐line chemotherapy in AGC. Recently, the DREAM phase 3 study (NCT01839773) have demonstrated that the efficacy and safety of DHP107, an oral paclitaxel, is comparable to those of intravenous (i.v.) paclitaxel. This post‐hoc analysis was conducted to evaluate whether NLR is related with the treatment outcomes for both oral and i.v. paclitaxel. Methods: In the DREAM study, pts were randomized 1:1 to DHP107 (200 mg/m2 orally twice daily on days 1, 8, 15, every 4 weeks) or i.v. paclitaxel (175 mg/m2 on day 1, every 3 weeks). High vs low NLR was defined by the baseline median. With comparable efficacy between two arms in the original DREAM study, all the patients (n=236) enrolled in the DREAM study were included in this post‐hoc analysis for NLR. Results: Median age was 59 years (range, 27‐83) and 185 pts (78.4%) were male. The median for NLR was 2.08. Thirty‐four (28.8%) out of the 118 pts with low NLR (<2.08) achieved a complete or partial response, while 17 (14.4%) out of the 118 pts with high NLR (>2.08) showed responses (p=0.007). With a median follow up duration of 10.8 months (range, 0.4‐27.8) in surviving pts, median progression‐free survival (PFS) was 4.1 months (95% confidence interval [CI], 2.8‐4.3) with low NLR and 1.6 months (95% CI, 1.4‐2.5) with high NLR (p=0.0012); and median overall survival (OS) was 12.0 months (95% confidence interval [CI], 9.7‐14.5) with low NLR and 7.1 months (95% CI, 5.4‐9.1) with high NLR (p=0.0004). With a multivariate analysis including important clinical factors, low NLR remained an independent factor for better PFS (HR 0.66, 95% CI 0.49‐0.89, p=0.0065) and OS (HR 0.57, 95% CI 0.42‐0.78, p=0.0005). Conclusions: The current study demonstrates that low NLR is correlated with better treatment outcomes for both oral and intravenous paclitaxel as a second‐line chemotherapy in AGC.