Safety and Efficacy of Tianfoshen Oral Liquid in Non-Small Cell Lung Cancer Patients as an Adjuvant Therapy

ETHNOPHARMACOLOGICAL RELEVANCE: As an important Chinese herb injection, Tianfoshen (TFS) oral liquid is widely used in Chinese non-small cell lung cancer (NSCLC) patients. AIM OF THE STUDY: To evaluate the efficacy and safety of Tianfoshen (TFS) oral liquid plus chemotherapy in Chinese NSCLC patients with Qi and Yin deficiency syndrome, an observational study was conducted in Beijing Friendship Hospital between August 2012 and July 2016. Patients, enrolled in this study, were diagnosed with NSCLC and were treated with Cisplatin in combination with Paclitaxel/Navelbine/Gemcitabine/Docetaxel as a first-line treatment, or Pemetrexed for recurrent patients. The primary endpoint was the improvement of traditional Chinese medicine syndrome and objective response rate in patients. The secondary endpoint was the occurrence of drug-related adverse events. RESULTS: A total of 108 patients were included in this study and underwent the safety and efficacy assessments. Compared to the baseline, the total scores of traditional Chinese medicine (TCM) syndrome after 3 or 8/9 weeks of TFS treatment were statistically significant (P<0.0001), and the clinical efficiency rate was 36.11% and 50.93%, respectively. The objective response rate (ORR) and disease control rate (DCR) of TFS group were slightly higher than those of without-TFS group, although the comparison was not statistically significant. The incidence of common adverse events related to TFS was 7.41% whereas the incidence of serious adverse events was 0.93%. CONCLUSIONS: As an adjuvant therapy of chemotherapy, TFS showed an acceptable tolerability profile in the clinical practice of Chinese NSCLC patients with Qi and Yin deficiency syndrome, but it seems to have no effect on the ORR and DCR.