Objective. Oxaliplatin-induced peripheral neurotoxicity continues to be a kind of frequent dose-limiting toxicity for many cancer patients. This study evaluated the preventive effects of Guilongtongluofang on peripheral neurotoxicity induced by oxaliplatin in patients with colorectal tumor.Patients and Methods. From May 2007 to May 2011, we conducted a randomized, double-blind, placebo-controlled trial. 120 patients of colorectal cancer treated with adjuvant oxaliplatin-based chemotherapy were randomly enrolled into the trial group and the control group. The trial group received Guilongtongluofang (at a dose of 200 mL once a day) from 3 days prior to chemotherapy. The control group received a placebo from 3 days prior to chemotherapy. Every 2-week cycle, neurotoxicity was evaluated using numeric rating scale for pain intensity and experienced relief. The primary endpoint was efficacy measurement which included oxaliplatin-induced neurotoxicity and tumor response. The differences of side effects between the two groups were also analyzed.Results. The percentage of grades 1-2 neurotoxicity was significantly lower in the trial group than that in the control group (13.3% versus 20.0%;P<0.05) after two cycles of treatment. The difference of the percentage of neurotoxicity between the two groups was significant after six cycles (51.7% versus 70.0%;P<0.05). Significant difference for the mean time to the development of grade 1+ neurotoxicity was found between the two groups (9.4 w in the trial group versus 6.5 w in the control group,P<0.05). The cumulative incidence of grade 1 or more sensory neurotoxicity was significantly lower in the trial group than that in the control group (P<0.05). No significant differences of tumor response rate were found between the two groups the trial group and the control group. No significant difference was found between the trial group and the control group (allP>0.05).Conclusion. This study provides evidence that Guilongtongluofang is a promising drug for the prevention of oxaliplatin-induced neurotoxicity in patients with colorectal cancer, and it does not reduce the efficacy of oxaliplatin.

Background: The vascular endothelial cells are important targets of radiotherapy, which may be involved in the pathogenesis of radiation pneumonitis (RP). This study investigated the variations of circulating endothelial progenitor cells (EPCs) and transforming growth factor-beta-1 (TGF-β1) during three-dimensional conformal radiation therapy (3D-CRT) in patients with non–small-cell lung cancer (NSCLC) and analyzed the correlation between these variations with the occurrence of RP. Patients and methods: From November 2008 to November 2009, eighty-four consecutive patients receiving 3D-CRT for stage III disease were evaluated prospectively. Circulating EPCs and TGF-β1 levels were measured at baseline, every 2 weeks during, and at the end of treatment. RP was evaluated prospectively at 6 weeks after 3D-CRT. Results: Thirty-eight patients (47.5%) experienced score 1 or more of RP. The baseline levels of EPCs and TGF-β1 were analyzed, no difference was found between patients with and without RP during and after 3D-CRT. By serial measurement of TGF-β1 and EPCs levels, we found that the mean levels of EPCs in the whole population remained stable during radiotherapy, but the mean levels of TGF-β1 increased slowly during radiotherapy. TGF-β1 and EPCs levels were all significantly higher at week 2, week 4 and week 6 in patients with RP than that in patients without RP, respectively. During the period of radiation treatment, TGF-β1 levels began to increase in the first 2 weeks and became significantly higher at week 6 (P < 0.01). EPCs levels also began to increase in the first 2 weeks and reached a peak at week 4. Using an ANOVA model for repeated-measures, we found significant associations between the levels of TGF-β1 and EPCs during the course of 3D-CRT and the risk of developing RP (P < 0.01). Most of the dosimetric factors showed a significant association with RP. Conclusion: Early variations of TGF-β1 and EPCs levels during 3D-CRT are significantly associated with the risk of RP. Variations of circulating TGF-β1 and EPCs levels during 3D-CRT may serve as independent predictive factors for RP. Trial registration: Trials registration number: 20070618

Purpose: As for local advanced non-small cell lung cancer (NSCLC), synchronous radiotherapy and chemotherapy is the standard treatment mode. But for patients with progress in half a year, which means the second-line chemotherapy effect is not ideal for them. We observed the efficacy and safety of anlotinib hydrochloride combined with PD-1 blockade as the second-line treatment for those patients in this trial. Patients and Methods: From January 2018 to December 2019, 57 patients with the progress of local advanced NSCLC treated with anlotinib plus PD-1 blockade until disease progression or intolerance as a result of adverse events. Patients have been assessed using computed tomography prior to treatment and during follow-up every 2 months until disease progression or death. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) and safety. Survival curves were created using the Kaplan–Meier method. Results: 57 patients were enrolled. The median age was 64 years, and 61.4% of the patients were men. The ORR was 50.9% with a median OS time of 14 months and the 1-year OS rates and PFS rates were 81.8% and 33.3%, respectively. The patients with squamous cell carcinoma, no brain or liver metastases had longer PFS than patients with liver metastasis. When the PFS was calculated from the time of second treatment, the median PFS was 9 months. Most adverse events (AEs) were grade 1– 3, one drug-related death was noted. Conclusion: The expected outcome of this study is that anlotinib combined with PD-1 blockade has tolerable toxicity and better ORR, OS than second-line chemotherapy. The results may indicate additional treatment options for patients with progress of local advance NSCLC in half a year after standard treatment.

Purpose: To identify cytokines in plasma that may predict objective response and progression-free survival (PFS) in patients with locally advanced non-small cell lung cancer (NSCLC) treated with chemoradiotherapy.Materials and Methods: From April 2016 to May 2017, thirty-one patients with locally advanced inoperable/unresectable NSCLC were included, and treated with concurrent chemoradiotherapy (CCRT). No immune checkpoint inhibitors were administered after CCRT. Plasma from each patient was collected before radiotherapy, and 25 cytokines in the plasma were measured by Luminex or U-PLEX assays. Logistic regression and COX regression were performed to identify the predictive factors for objective response and PFS, respectively. Kaplan-Meier survival analysis was used to compare the PFS between the groups.Results: High levels of IL-13 and TNF-α, and low levels of ICAM-1, IFN-γ, and soluble PD-L1 (sPD-L1) were significantly associated with objective response (P &lt;0.05). High levels of IL-8, CCL5, and CXCL3 also showed a trend toward association with objective response (P &lt;0.1). The combination of cytokines (IL-8 and ICAM-1, or TNF-α and sPD-L1) improved predictive accuracy. Univariate analysis identified IL-8 and ICAM-1 as potential markers to predict PFS. Multivariate analysis suggested that high level of IL-8 (P =0.010) and low level of ICAM-1 (P =0.011) correlated significantly with a longer PFS.Conclusion: IL-8 and ICAM-1 in plasma have the potential to predict objective response and PFS in patients with locally advanced NSCLC underwent chemoradiotherapy.