Efficacy and Safety of Traditional Chinese Medicine Combined With First Lines Chemotherapy for Small-cell Lung Cancer: a Prospective Cohort Study

Abstract

\n Background: Small cell lung cancer (SCLC) tends to respond well to the standard treatment of chemotherapy, but disease progression, chemotherapy resistance, and adverse reactions still remain major problems that have long limited its effectiveness. Although Traditional Chinese Medicine (TCM) is wildly applied for patients with SCLC in China, using TCM in the treatment for SCLC is still in the absence of sufficient evidence.Purpose: To evaluate the efficacy and safety of TCM combined with the first lines chemotherapy for SCLC.Method: In this perspective, two-center cohort studies, overall survival (OS), progression free survival (PFS), overall response rate (ORR), and disease control rate (DCR) were compared between patients who received chemotherapy with or without TCM, with adverse events (AEs) also on the list of comparison.Results: When the follow-up ended, 168 patients were included in this study. Compared with patients treated with chemotherapy alone (non-TCM group), those with TCM and chemotherapy (TCM group) had better PFS (adjusted HR 0.552, 95% CI 0.389–0.783, P=0.01), median PFS (11.83 months vs. 8.60 months, P = 0.004), rates of ORR (85.88% vs 75.90% after second cycle treatment, 61.2% vs. 43.4% after fourth cycle treatment), rates of DCR(100% vs 98.80% after second cycle treatment, 95.3% vs. 89.2% after fourth cycle treatment). The number of cases with leukopenia, anorexia, constipation, fatigue, nausea in patients receiving TCM treatment is lower than those in patients not receiving TCM (P < 0.05). There was no difference between the two groups in median OS (23.4 months vs. 20.1 months, P = 0.301). Subgroup analysis showed there was no difference between the two groups in median OS with 34.5 months vs. 22.6 months for LS-SCLC (P=0. 586) and 18.5 months vs. 17.37 months for ES-SCLC (P=0.162). Patients in the TCM group have better median PFS than patients in the non-TCM group for both LS-SCLC and ES-SCLC with 14.73 months vs. 9.2 months (P=0.040) and 9.53 months vs. 7.47 months (P=0.007) respectively.Conclusion: This study indicated that TCM combined with chemotherapy for SCLC may prolong PFS, improve therapeutic effect, reduce the side effects of chemotherapy, but may not be effective in the prolongation of OS. More large-scale and higher quality clinical studies are warranted to support our findings.Clinical registration number: ChiCTR2000040151. (http://www.chictr.org.cn)