Survival Benefits of Ganoderma Lucidum in Early-stage Triple-negative Breast Cancer: A Real World Study.

Baohong Jiang, Na Li, Wei Du, Lijun Zeng, Yuanbin Tang, Lunqi Luo, Hongbo Zhu, Feng Ye
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Abstract

Background: Ganoderma lucidum extracts are widely used as adjuvants in the treatment of triple-negative breast cancers (TNBC) in China. However, its clinical value in TNBC remains unclear. Therefore, we investigated the clinical effect of Ganoderma lucidum spore powder (GLSP) on prognosis in patients with early-stage TNBC in this study.

Methods: A total of 388 patients who were diagnosed with TNBC at the Sun Yat-sen University Cancer Center from February 2012 to December 2017 were retrospectively reviewed. The propensity score matching (PSM) method was applied to balance baseline data. Kaplan-Meier method and Cox proportional hazards model were used to evaluate the relationship between GLSP and prognosis.

Results: Of the 388 patients, 72 (18.6%) patients took GLSP. After PSM, 208 patients were selected for analysis, including 71 (34.1%) patients who took the powder. The median followup period was 51 months. The patients who took GLSP (the treatment group) and those who did not take GLSP (the control group) were similar in most clinico-pathological features before being matched. However, the proportion of patients who received breast-conserving surgery in the treatment group was higher (27.8% vs. 16.1%; p =0.021) than in the control group. No significant difference was found in the baseline data between the two groups for the matched cohort (all p >0.05). Univariate analysis and multivariate analysis showed that patients taking GLSP benefited from improved overall survival (OS) (HR=0.159, p = 0.002) and disease-free survival (DFS) (HR=0.232, p = 0.005) before being matched. The main result of the survival analysis after matching was similar to that described above. Patients in the treatment group achieved both greater OS and DFS benefits than patients in the control group (all p < 0.05). In stratified analysis according to TNM stages, after adjusting for the significant prognostic factors, multivariate analysis revealed that the treatment group had better OS than the control group for patients in stages II and III (HR=0.172, p =0.004).

Conclusions: The results of this real-world propensity-score-matched study suggest that GLSP can improve OS and DFS in early-stage TNBC patients. A higher OS was observed for patients taking GLSP, particularly in stage II and stage III.

灵芝对早期三阴性乳腺癌患者生存的益处:一项真实世界研究
背景:灵芝提取物在中国被广泛用作治疗三阴性乳腺癌(TNBC)的辅助药物。然而,其在 TNBC 中的临床价值仍不明确。因此,本研究探讨了灵芝孢子粉(GLSP)对早期TNBC患者预后的临床影响:回顾性分析2012年2月至2017年12月在中山大学肿瘤防治中心确诊的388例TNBC患者。采用倾向评分匹配法(PSM)平衡基线数据。采用Kaplan-Meier法和Cox比例危险模型评估GLSP与预后的关系:388例患者中,72例(18.6%)服用了GLSP。经过PSM后,208名患者被选中进行分析,其中71名(34.1%)患者服用了GLSP粉。中位随访期为 51 个月。在配对前,服用格列卫粉的患者(治疗组)和未服用格列卫粉的患者(对照组)在大多数临床病理特征上相似。不过,治疗组中接受保乳手术的患者比例(27.8% 对 16.1%;P =0.021)高于对照组。在配对队列中,两组患者的基线数据无明显差异(P 均大于 0.05)。单变量分析和多变量分析显示,在配对前,服用GLSP的患者总生存期(OS)(HR=0.159,P=0.002)和无病生存期(DFS)(HR=0.232,P=0.005)均有改善。配对后生存分析的主要结果与上述结果相似。治疗组患者的 OS 和 DFS 均优于对照组患者(所有 P <0.05)。在根据TNM分期进行的分层分析中,在调整了重要的预后因素后,多变量分析显示,对于II期和III期患者,治疗组的OS优于对照组(HR=0.172,P=0.004):这项真实世界倾向分数匹配研究的结果表明,GLSP可改善早期TNBC患者的OS和DFS。服用GLSP的患者,尤其是II期和III期患者的OS更高。
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