Abstract
Objectives: The study aims to evaluate the therapeutic efficacy and safety of Chinese herbal medicine (Xiaoaiping) injections for chemotherapy-induced thrombocytopenia (CIT) in nonsmall cell lung cancer (NSCLC) and gastric cancer.Design: A randomized, controlled, multicenter study from December 2013 to August 2015.Settings/Location: All patients are from China.Subjects: One hundred forty patients with either NSCLC or gastric cancer were enrolled in this trial.Interventions: The intervention group (n = 70) was given Xiaoaiping injections (1 dose/day for 10 days) with chemotherapy, whereas the control group (n = 70) was given chemotherapy only. The follow up period was 11 days after the final injection.Outcome measures: Platelet (PLT) count was tested at day 0, 7, 14, and 21 as the primary outcome for evaluation. Safety measurements, including red blood cells (RBC), hemoglobin (HBG), white blood cells (WBC), neutrophil (NE)#, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), creatine kinase (CK), creatinine (Cr), and blood urea nitrogen (BUN) were tested at day 0 and 21 as the secondary outcomes.Results: (1) Two patients in the intervention group and four patients in the control group were lost upon follow-up. (2) PLT count: there was no significant difference in PLT count between the two groups from baseline (day 0), day 7, and day 14. At day 21, the intervention group indicated an upward trend of PLT count with a statistically significant difference than that of the control group (p < 0.05). (3) NSCLC: there was significant difference in PLT count between the two groups on day 21 (p < 0.01). (4) Gastric cancer: there was no significant difference in PLT count between the two groups during this trial (p > 0.05). (5) There was no statistically significant difference between the intervention group and the control group with the safety figures (secondary outcomes) RBC, HGB, WBC, NE#, AST, ALT, LDH, CK, Cr, and BUN measured (p > 0.05). (6) Adverse events: one gastric cancer patient in the control group was diagnosed with gastrointestinal bleeding on day 3.Conclusions: In conclusion, Xiaoaiping injections may provide a safe and effective option for CIT in patients with NSCLC.
Highlights
IntroductionChemotherapy is the predominant treatment method for cancer with substantial progress being made in the last 50 years
Cancer is the leading cause of death in China and a major public health concern, increasing in rate of both incidence and mortality.[1,2,3] Lung cancer and gastric cancer are the first and second most prominent cancers in China, respectively, in terms of incidence and mortality rates.[4]Chemotherapy is the predominant treatment method for cancer with substantial progress being made in the last 50 years
chemotherapy-induced thrombocytopenia (CIT) is treated with platelet (PLT) transfusion, recombinant human thrombopoietin, and recombinant human interleukin-11,9 all of which are approved by the China Food and Drug Agency (CFDA)
Summary
Chemotherapy is the predominant treatment method for cancer with substantial progress being made in the last 50 years. Platinum-based chemotherapy is used significantly, with benefits, including increasing overall survival rates, enhancing quality of life (QoL), and increasing survival in advanced-stage disease.[5] thrombocytopenia is a common side effect in cancer patients resulting from cytotoxicity.[6] Development of chemotherapy-induced thrombocytopenia (CIT) may cause a delay or reduction to the course of chemotherapy, subsequently affecting its effectiveness.[7] CIT is the main dose-limiting toxicity factor of platinum-based chemotherapy.[8] CIT is treated with platelet (PLT) transfusion, recombinant human thrombopoietin (rhTPO), and recombinant human interleukin-11 (rhIL-11),[9] all of which are approved by the China Food and Drug Agency (CFDA). Several side effects of rhTPO and rhIL-11 have been documented, including fever, chills, fatigue, rash, edema, dyspnea, pleural effusion, atrial arrhythmia, and headache.[11,12]
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