Effect of Feitai Capsule () on quality of life and progression-free survival of patients with unresectable non-small cell lung cancer.
OBJECTIVE
To examine the effect of a Chinese medicinal herbal formula (Feitai Capsule, ) on the quality of life (QOL) and progression-free survival (PFS) of patients with unresectable non-small cell lung cancer (NSCLC).


METHODS
Sixty-two patients were randomly divided into the treatment group (31 cases) and the control group (31 cases). For the treatment group, 4 capsules (1.2 g/capsule) of Feitai Capsule were administered 3 times a day after meals for 3 weeks; then no drug was administered for 1 week. This schedule was continued for at least 3 more cycles (12 weeks totally). If there were no obvious toxic reactions, the treatment was extended. The patients were evaluated at least once every 8 weeks until progressive disease (PD). For the control group, the regular follow-up and evaluation were performed at least once every 8 weeks until PD. Clinical symptoms, objective response, physical constitution and energy, QOL, and PFS were evaluated regularly. Analysis of variance (ANOVA), a non-parametric test, and analysis of covariance were used to compare clinical features, amelioration of clinical symptoms, physical constitution and energy, and QOL. Kaplan-Meier analysis was used to compare the two-group PFS.


RESULTS
Sixty patients finished the final evaluation, with 30 patients in each group. Baseline characters between groups were not significantly different (P>0.05). The control group had a 36.7% improvement in clinical symptoms, while the treatment group had a 73.3% improvement. This difference was statistically significant (Z= -2.632, P=0.008). The control group had a 26.7% improvement in the Karnofsky performance status (KPS), while the treatment group had a 53.4% improvement. This was also significantly different (Z=-2.182, P=0.029). A comparative analysis indicated a positive correlation (r=0.917, P<0.001). Compared with the control group, QOL in the treatment group was significantly improved, except in the social/family condition and doctor-patient relationship indicators. The PFS of the treatment group and control group were 6.23 months and 4.67 months, respectively (P=0.048).


CONCLUSIONS
Feitai Capsule, a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients.
Department of Oncology, Fuzhou General Hospital, Nanjing Military Command, Fuzhou, China. yuzy527@yahoo.com.cn
Zong-Yang
ZY
Yu
Zhi-Zhen
ZZ
Liu
Xue-Nong
XN
Ouyang
Jian
J
Du
Xi-Hu
XH
Dai
Xi
X
Chen
Zhong-Quan
ZQ
Zhao
Wen-Wu
WW
Wang
Jie
J
Li
D000328:Adult; D000368:Aged; D002214:Capsules; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000601:surgery*; D016022:Case-Control Studies; D018572:Disease-Free Survival; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life
D002214:Capsules; D004365:Drugs, Chinese Herbal; C500582:Feitai