Background: Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. Methods: We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Results: Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (−5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (−0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. Conclusion: GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

Background: This study investigated the prognostic impact of serum ferritin for survival in patients with relapsed or refractory metastatic colorectal cancer (mCRC).Methods: This retrospective cohort study reviewed clinicopathological characteristics and laboratory biomarkers in 120 mCRC patients being treated with Korean Medicine (KM). The overall survival (OS) of patients was calculated using the Kaplan-Meier method, and statistical significance was assessed using the log-rank test. Univariate and multivariate analyses of Cox proportional hazards regression were used to evaluate the prognostic impact for survival in relapsed or refractory mCRC patients.Results: Of the patients, 62.5% had liver metastases, 74.1% underwent greater than second-line chemotherapy, and 80.8% underwent surgery. Median OS was 7.6 months for all patients after the initiation of KM treatment, which was begun 13.7 months, on average, after mCRC diagnosis. Concerning prognostic factors such as the presence of liver metastasis (p = 0.024), high carcinoembryonic antigen level (CEA > 5 ng/mL, p = 0.044), elevated C-reactive protein (CRP ≥ 10.0 mg/L, p = 0.000), high absolute monocyte count (AMC > 413.3 cells/μL, p = 0.034), elevated serum ferritin (ferritin ≥ 150 ng/mL, p = 0.002), low hemoglobin level (Hb < 12 g/dL, p = 0.026) and low albumin (albumin < 3.5 g/dL, p = 0.003) were associated with increased hazard ratios and poor survival. According to the multivariate proportional hazards model with backward and forward manners, albumin (albumin < 3.5 g/dL; hazard ratio (HR) 2.218, 95% confidence interval (CI) 1.135 - 3.990, p = 0.019), CRP (CRP ≥ 10.0 mg/L; HR 2.506, 95% CI 1.644 - 3.822, p = 0.000), CEA (CEA > 5 ng/mL; HR 2.040, 95% CI 1.203 - 3.460, p = 0.008), and serum ferritin (ferritin ≥ 150 ng/mL; HR 1.763, 95% CI 1.169 - 2.660, p = 0.007) were independent prognostic biomarkers of survival in mCRC patients.Conclusions: These results indicate that serum ferritin acts as an independent prognostic biomarker for survival in relapsed or refractory mCRC patients.

These results indicate that the inflammatory markers, mGPS and LMR are independent prognostic factors for predicting overall survival in relapsed/refractory mCRC patients.

Objective: This study identified host-related prognostic biomarkers for survival in patients with advanced non-small cell lung cancer (NSCLC).Methods: This study was based on the retrospective review of the medical records of 135 patients with pathologically confirmed advanced NSCLC. The host-related biomarkers assessed in this study that reflected patient condition included hemoglobin (Hb) levels; platelet (PLT), neutrophil, lymphocyte, and monocyte counts; and ferritin concentrations. The overall survival (OS) was calculated by Kaplan-Meier analysis and compared using log-rank tests. Univariate and multivariate analyses of Cox proportional hazards regression were used to evaluate the prognostic impact for survival.Results: Of the enrolled patients, 91.1% had stage IV NSCLC, 42.2% had ECOG-PS scores of 2, and 57% had undergone multiple rounds of prior systemic therapy. The prognostic factors included low Hb concentration (men: Hb < 13 g/dL, women: Hb < 12 g/dL; p = 0.046), increased neutrophil count (> 7,700 cells/μL; p < 0.001), decreased lymphocyte count (≤ 1500 cells/μL; p = 0.011), increased monocyte count (> 800 cells/μL; p < 0.001), and high ferritin level (men: > 200 ng/mL, women: > 150 ng/mL; p < 0.001), which were associated with poor OS and increased hazard of mortality. The multivariate proportional hazards model revealed that lymphocyte count, monocyte count, and ferritin level were independent host-related prognostic biomarkers for survival. Increased monocyte count (HR, 3.15; 95% CI, 1.64-6.04; p < 0.001) and high ferritin level (HR, 1.81; 95% CI, 1.24-2.64; p = 0.002) were significantly associated with poor survival, whereas increased lymphocyte count (HR, 0.57; 95% CI, 0.40-0.83; p = 0.004) showed prolonged survival.Conclusion: Immune factors, such as lymphocyte and monocyte counts, as well as serum ferritin levels, are significant host-related prognostic biomarkers for survival with direct relevance to survival time in patients with advanced NSCLC.

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