Albumin-bound paclitaxel in first-line chemotherapy for patients with HER2-negative advanced gastric cancer

Objective To evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel)-combined chemotherapy (CT) as first-line for patients with her-2 negative advanced gastric cancer (GC) in Chinese single-center practice and explore the correlation between clinical characteristics and survival. Methods From December 17,2011 to January 10,2018,44 patients who underwent nab-paclitaxel (nab-PTX) combined therapy as first line with HER2-negative advanced GC were included in this study,including 34 males and 10 females with median age of 57 years (28-85 years).Of the 44 cases,19 (38.6%) cases underwent percutaneous endoscopic gastrostomy.Moderate differentiation was found in 17 cases and poor differentiation in 27 cases.Liver metastasis was found in 15 cases,lung metastasis in 4 cases,lymph node metastasis in 19 cases,bone metastasis in 3 cases and peritoneal metastasis in 6 cases.All cases had undergone nanoparticle albumin-bound paclitaxel (nab-paclitaxel)-combined chemotherapy (CT) as first-line.The progression free survival (PFS),overall survival (OS),clinical characteristics,objective response rate (ORR),disease control rate (DCR) and treatment-related adverse efects (AEs) were reviewed and evaluated. Results The median number of cycles was 4 (range:2-8).Their overall response rate (ORR) was 40.9% and the disease control rate (DCR) was 90.9%.Median progression-free survival (PFS) and overall survival (OS) were 5.1 months (95% CI:3.9-6.3 months) and 14.1 months (95% CI:10.7-14.5 months),respectively.The toxicities associated with nab-PTX combined therapy were generally tolerable with a total grade 3/4 AEs rate of 15.9%.The most common grade 3 adverse events were leukopenia (n=7,15.9%).Grade 1-2 non-hematologic toxicities included nausea and vomiting (n=16,36.3%),hand–foot syndrome (n=10,22.7%),anorexia (n=10,22.7%),fatigue (n=9,20.4%),alopecia (n=9,20.4%),and peripheral sensory neuropathy (n=6,13.6%).According to multivariate analysis,median CEA<5μg/L was a significant predictor for longer OS (HR,3.5;95% CI,1.48-8.23,P=0.004).Patients with G0-2 chemotherapy-induced leukopenia (CIL) showed an improved trend in PFS (HR,2.734,95% CI,1.00-7.46,P=0.05) and OS (HR,17.79;95% CI,4.7-66.4,P=0.000) when compared with those with G3-4 CIL.The OS of patients treated with nab-PTX combined S1 versus Cisplatin were significant different (12.5 months vs 17.0 months;HR:0.513;95% CI,0.31-0.84;P=0.005).The OS of patients with early onset of CIL were 18.2 months compared with 11.5 months in those of later onset of CIL (HR,2.48;95% CI,1.13-5.42,P=0.02). Conclusion Nab-paclitaxel (nab-PTX) combined S1 or Cisplatin may be options as first line for patients with HER-2 negative advanced gastric cancer.Patients who experienced G0-2 chemotherapy-induced leukopenia (CIL) and early-onset CIL have more favorable prognosis.Patients with CEA<5μg/L will be more likely to achieve improvement from nab-PTX therapy.