Yan Han1, Huan Wang1, Weiru Xu1, Bangwei Cao2, Lei Han3, Liqun Jia4, Yongmei Xu1, Qing Zhang1, Xiaoming Wang1, Ganlin Zhang1, Mingwei Yu1, Guowang Yang5. 1. Department of Oncology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No.23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China. 2. Department of Oncology, Beijing Friendship Hospital Affiliated to Capital Medical University, No.95 Yongan Road, Xicheng District, Beijing 100050, China. 3. Department of Oncology, Daxing Hospital Affiliated to Capital Medical University, No.26 Huangcun West Street, Daxing District, Beijing 12600, China. 4. Department of Integrative Medicine in Oncology, China-Japan Friendship Hospital, No.2 Yinghuayuan East Street, Chaoyang District, Beijing 100029, China. 5. Department of Oncology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No.23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China. Electronic address: guowang_yang@163.com.
Abstract
OBJECTIVE: The purpose of the study was to assess the efficacy and safety of using Chinese herbal medicine (CHM) as maintenance therapy considering the survival of advanced non-small-cell lung cancer (NSCLC) patients after first-line conventional platinum-based chemotherapy. DESIGN: An open-label, randomized, controlled trial. SETTING:Four hospitals in China. INTERVENTIONS AND MAIN OUTCOME MEASURES: A total of 106 patients were eligible and randomly divided into two groups from four hospitals in China. Both groups received the best supporting care (BSC). Additionally, patients in the trial group were given CHM every day until the disease became aggravated or the patients resigned. The study took both progression-free survival (PFS) and quality of life (QOL) as the primary outcomes to comprehensively evaluate the effect of the treatment. QOL was measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) 4.0 questionnaire. Side effects and safety were evaluated at the same time. RESULTS: Of the 106 patients, 99 completed the study. After treatment and follow-up for PFS, there were no significant differences in the median PFS time and the 6-month PFS probability between the two groups. However, the 3-month PFS probability in the trial group was significantly higher than that in the control group (FAS, PPS: P<0.01). For QOL, there were significant differences between the two groups in the following: physical well-being, emotional well-being, functional well-being, lung cancer symptom domain and total score of the FACT-L4.0 (FAS, PPS: P<0.05). There was no significant difference in the social well-being domain. No serious adverse side effects to the treatment were observed. CONCLUSIONS:CHM is well tolerated and may improve the QOL of advanced NSCLC patients. CHM is worth studying in future investigations.
RCT Entities:
OBJECTIVE: The purpose of the study was to assess the efficacy and safety of using Chinese herbal medicine (CHM) as maintenance therapy considering the survival of advanced non-small-cell lung cancer (NSCLC) patients after first-line conventional platinum-based chemotherapy. DESIGN: An open-label, randomized, controlled trial. SETTING: Four hospitals in China. INTERVENTIONS AND MAIN OUTCOME MEASURES: A total of 106 patients were eligible and randomly divided into two groups from four hospitals in China. Both groups received the best supporting care (BSC). Additionally, patients in the trial group were given CHM every day until the disease became aggravated or the patients resigned. The study took both progression-free survival (PFS) and quality of life (QOL) as the primary outcomes to comprehensively evaluate the effect of the treatment. QOL was measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) 4.0 questionnaire. Side effects and safety were evaluated at the same time. RESULTS: Of the 106 patients, 99 completed the study. After treatment and follow-up for PFS, there were no significant differences in the median PFS time and the 6-month PFS probability between the two groups. However, the 3-month PFS probability in the trial group was significantly higher than that in the control group (FAS, PPS: P<0.01). For QOL, there were significant differences between the two groups in the following: physical well-being, emotional well-being, functional well-being, lung cancer symptom domain and total score of the FACT-L4.0 (FAS, PPS: P<0.05). There was no significant difference in the social well-being domain. No serious adverse side effects to the treatment were observed. CONCLUSIONS:CHM is well tolerated and may improve the QOL of advanced NSCLCpatients. CHM is worth studying in future investigations.
Keywords:
Chinese herbal medicine; Maintenance therapy; Non-small cell lung cancer; Progression-free survival; Quality of life; Treatment according to syndrome differentiation