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

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. Clinical trial identification: NCT01839773. Legal entity responsible for the study: Daehwa Pharmaceutical, Co., Ltd. Funding: Daehwa Pharmaceutical, Co., Ltd. Disclosure: Y-K. Kang: Consultant: Ono, BMS, Taiho, Roche, Lilly, Blueprint, Taiho, Daehwa, LSK Biopharma. All other authors have declared no conflicts of interest.