Abstract
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.
Highlights
Lung cancer is one of the most common malignancies with 1.8 million newly diagnosed cases and almost 1.6 million estimated deaths every year [1]
As an adjuvant therapy of chemotherapy, TFS showed an acceptable tolerability profile in the clinical practice of Chinese non-small cell lung cancer (NSCLC) patients with Qi and Yin deficiency syndrome, but it seems to have no effect on the objective response rate (ORR) and disease control rate (DCR)
The other key inclusion criteria include the following: patients have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; patients should have adequate hematological, hepatic, and renal function; traditional Chinese medicine syndrome differentiation is according to the standard of Qi and Yin deficiency syndrome; patients should have expected overall survival time of more than 3 months and be from 18 to 75 years old
Summary
Lung cancer is one of the most common malignancies with 1.8 million newly diagnosed cases (about 13% of the total cancer diagnoses) and almost 1.6 million estimated deaths every year [1]. Most NSCLC patients were diagnosed at an advanced stage where surgical intervention is not applicable and only chemotherapy and radiotherapy are the main therapeutic approaches for these patients [2]. Almost all chemotherapies are associated with severe side effects and usually result in a decreased life quality for NSCLC patients [3]. Novel therapeutic strategies are necessary to improve the clinical outcomes with fewer side effects for patients with NSCLC. Traditional Chinese medicine (TCM) is one of the most important types of CAM, with a unique system of diagnostics and therapies that rely on the accumulative clinical experience gained and translated through generations of doctors. Chinese herbal medicines, which contain multiple biologically active components with pleiotropic therapeutic efficacies, have minimal side effects and provide exclusive sources for the development of new drugs [3]
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