A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy‐Induced Hematological Complications in Breast Cancer

Background. This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy‐induced hematological toxicity in breast cancer patients. Methods. Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2 weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and nonhematological toxicities, as well as the tolerability and safety of the study intervention. Results. Sixty‐five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to placebo treatment. Patients in the treatment group developed significantly less severe (grades 2–4) anemia (p < .01) and leukopenia (p < .03) when comparing grades 0–1 with grades 2–4, with significantly less neutropenia (p < .04) when comparing grades 0–2 with grades 3–4. This effect was more significant among patients undergoing a dose‐dense regimen. No statistically significant effect was found with respect to nonhematological toxicities, and side effect rates were not significantly different between the groups, with no severe or life‐threatening events observed in either group. Conclusion. The addition of LCS101 to anthracycline‐ and taxane‐based chemotherapy is safe and well tolerated, and may significantly prevent some chemotherapy‐induced hematological toxicities in early breast cancer patients. These results should encourage further larger and more extensive clinical trials. 摘要 背景. 本项前瞻性对照研究评估植物源化合物混合物LCS101预防乳腺癌患者化疗所致血液学毒性反应的安全性、耐受性和有效性。 方法. 确诊局部乳腺癌的女性患者随机接受传统化疗添加LCS101或安慰剂胶囊治疗。研究治疗方案为受试者口服LCS101胶囊（2g，每天3次），治疗始于化疗开始前2周，持续至化疗完成。评估受试者的血液学和非血液学毒性反应以及研究治疗方案的耐受性和安全性。 结果. 65例乳腺癌患者入组，分配至LCS101组和安慰剂组分别为34例和31例。0 ~ 1级与2 ~ 4级的血液学毒性反应比较显示，LCS101组严重（2 ~ 4级）贫血（P