ABSTRACT
OBJECTIVE: This retrospective analysis aimed to evaluate the efficacy and adverse reactions of metronomic oral vinorelbine and its combination therapy as second- and later-line regimens for advanced non-small-cell lung cancer (NSCLC). METHODS: NSCLC patients undergoing metronomic oral vinorelbine as second- and later-line regimens in Fujian Cancer Hospital from October 2018 to October 2022 were enrolled, and patients' demographic and clinical characteristics were collected. The efficacy and safety of metronomic oral vinorelbine monotherapy and its combination therapy regimens were compared. RESULTS: Of 57 study subjects, 63.2% received third- and later-line therapy, with median progression-free survival (mPFS) of 4 months, overall response rate (ORR) of 10.5%, and disease control rate (DCR) of 80.7%. The incidence of therapy-related adverse events was 42.1%, and there was only one case presenting grades 3 and 4 adverse events (1.8%). Among driver gene-negative participants, vinorelbine combination therapy regimens achieved longer mPFS (4.6 vs. 1.2 months, hazards ratio = 0.11, P < 0.0001) and comparable toxicity in relative to metronomic oral vinorelbine, and metronomic oral vinorelbine combined with immune checkpoint inhibitors showed the highest response, with mPFS of 5.6 months (95% CI 4.8 to 6.4 months), ORR of 25%, and DCR of 81.3%. Among participants with gradual resistance to osimertinib, continuing osimertinib in combination with metronomic oral vinorelbine achieved mPFS of 6.3 months (95% CI 0.1 to 12.5 months) and DCR of 86.7%. CONCLUSION: Metronomic oral vinorelbine and its combination therapy regimens are favorable options as second- and later-line therapy for advanced NSCLC patients, with acceptable efficacy and tolerable toxicity. Vinorelbine combination therapy regimens show higher efficacy and comparable toxicity in relative to metronomic oral vinorelbine, and metronomic oral vinorelbine may have a synergistic effect with immunotherapy and EGFR-TKI targeted therapy.
ABSTRACT
OBJECTIVE: The optimal strategy for fluid management during gastrointestinal surgery remains unclear. Minimizing the variation in arterial pulse pressure, which is induced by mechanical ventilation, is a potential strategy to improve postoperative outcomes. We tested this hypothesis in a prospective, randomized study with lactated Ringer's solution and 6% hydroxyethyl starch solution. METHOD: A total of 60 patients who were undergoing gastrointestinal surgery were randomized into a restrictive lactated Ringer's group (n = 20), a goal-directed lactated Ringer's group (n = 20) and a goal-directed hydroxyethyl starch group (n = 20). The goal-directed fluid treatment was guided by pulse pressure variation, which was recorded during surgery using a simple manual method with a Datex Ohmeda S/5 Monitor and minimized to 11% or less by volume loading with either lactated Ringer's solution or 6% hydroxyethyl starch solution (130/0.4). The postoperative flatus time, the length of hospital stay and the incidence of complications were recorded as endpoints. RESULTS: The goal-directed lactated Ringer's group received the greatest amount of total operative fluid compared with the two other groups. The flatus time and the length of hospital stay in the goal-directed hydroxyethyl starch group were shorter than those in the goal-directed lactated Ringer's group and the restrictive lactated Ringer's group. No significant differences were found in the postoperative complications among the three groups. CONCLUSION: Monitoring and minimizing pulse pressure variation by 6% hydroxyethyl starch solution (130/0.4) loading during gastrointestinal surgery improves postoperative outcomes and decreases the discharge time of patients who are graded American Society of Anesthesiologists physical status I/II.
Subject(s)
Digestive System Surgical Procedures/methods , Fluid Therapy/methods , Adult , Aged , Analysis of Variance , Blood Pressure , Female , Humans , Hydroxyethyl Starch Derivatives/administration & dosage , Intraoperative Period , Isotonic Solutions/administration & dosage , Length of Stay , Male , Middle Aged , Postoperative Period , Ringer's Solution , Statistics, Nonparametric , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: The optimal strategy for fluid management during gastrointestinal surgery remains unclear. Minimizing the variation in arterial pulse pressure, which is induced by mechanical ventilation, is a potential strategy to improve postoperative outcomes. We tested this hypothesis in a prospective, randomized study with lactated Ringer's solution and 6% hydroxyethyl starch solution. METHOD: A total of 60 patients who were undergoing gastrointestinal surgery were randomized into a restrictive lactated Ringer's group (n = 20), a goal-directed lactated Ringer's group (n = 20) and a goal-directed hydroxyethyl starch group (n = 20). The goal-directed fluid treatment was guided by pulse pressure variation, which was recorded during surgery using a simple manual method with a Datex Ohmeda S/5 Monitor and minimized to 11% or less by volume loading with either lactated Ringer's solution or 6% hydroxyethyl starch solution (130/0.4). The postoperative flatus time, the length of hospital stay and the incidence of complications were recorded as endpoints. RESULTS: The goal-directed lactated Ringer's group received the greatest amount of total operative fluid compared with the two other groups. The flatus time and the length of hospital stay in the goal-directed hydroxyethyl starch group were shorter than those in the goal-directed lactated Ringer's group and the restrictive lactated Ringer's group. No significant differences were found in the postoperative complications among the three groups. CONCLUSION: Monitoring and minimizing pulse pressure variation by 6% hydroxyethyl starch solution (130/0.4) loading during gastrointestinal surgery improves postoperative outcomes and decreases the discharge time of patients who are graded American Society of Anesthesiologists physical status I/II.