Xuemei Liu1, Feng Xu2, Gang Wang3, Xiang Diao4, Youping Li1. 1. Chinese Cochrane/Evidence-Based Medicine Center, Chinese Journal of Evidence-Based Medicine, Periodical Press of West China Hospital of Sichuan University, Chengdu, China. 2. Department of Oncology, Periodical Press of West China Hospital of Sichuan University, Chengdu, China. 3. Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu, China. 4. Chinese Journal of Evidence-Based Medicine, West China Hospital of Sichuan University, Chengdu, China.
Abstract
BACKGROUND: Kanglaite (KLT) is a botanically sourced, molecularly targeted agent that is prepared as a microemulsion for IV use. The active substance is extracted from the herb Semen coicis. OBJECTIVE: The aim of this study was to evaluate the effectiveness and tolerability of KLT injection in patients with primary non-small cell lung cancer (NSCLC). METHODS: We electronically searched the literature of the China National Knowledge Infrastructure (Chinese language, 1979-March 2008), CBMdisc (Chinese, 1978-March 2008), The Cochrane Library (English, Issue 4, 2007), MEDLINE (English, 1966-March 2008), and EMBASE (English, 1984-March 2008), and manually searched 20 Chinese-language oncology journals to identify randomized controlled trials (RCTs) of KLT injection plus chemotherapy versus chemotherapy alone, regardless of their having been published or not, blinding, duration of treatment, or duration of follow-up. The quality of the included trials was assessed using the method recommended by The Cochrane Collaboration. The studies were assigned to 1 of the following 3 categories: A = all quality criteria met, low risk of bias; B = ≥1 of the quality criteria only partially met, moderate risk of bias; or C = ≥1 of the quality criteria not met, high risk of bias. If heterogeneity existed among subgroups, then overall results were calculated based on a random-effects model; otherwise, a fixed-effects model was used. RESULTS: Electronic database searches yielded 596 citations. A title review eliminated 377 manuscripts; 219 citations were marked for further evaluation. Finally, we identified 26 trials that met the inclusion and exclusion criteria. The 26 RCTs included in this meta-analysis included 2209 patients with NSCLC; no study was graded A, 9 were graded B, and 17 were graded C. The sample size of each trial varied from 40 to 305 patients; none of the trials had precalculated sample sizes. Pooled analyses performed using both fixed- and random-effects models revealed that compared with chemotherapy alone, KLT injection plus chemotherapy improved the response rate (relative risk [RR], 1.34; 95% CI, 1.19-1.51 and RR, 1.35; 95% CI, 1.20-1.51, respectively) and quality of life as measured by an increase ≥10 points in the Karnofsky Performance Status score (RR, 2.05; 95% CI, 1.60-2.64). KLT injection plus chemotherapy was associated with improvement in the symptoms of cough, dyspnea, chest pain, fatigue, and anorexia. KLT injection plus chemotherapy was also associated with significant reduction in the incidence of the following adverse events (AEs) based on the fixed and random effects models, respectively: grade II to IV leukopenia (RR, 0.29; 95% CI, 0.22-0.39 and RR, 0.33; 95% CI, 0.22-0.48), anemia (RR, 0.54; 95% CI, 0.42-0.70 and RR, 0.55; 95% CI, 0.40-0.76), thrombocytopenia (RR, 0.39; 95% CI, 0.21-0.71 and RR, 0.40; 95% CI, 0.21-0.78), nausea and vomiting (RR, 0.44; 95% CI, 0.34-0.57 and RR, 0.44; 95% CI, 0.35-0.57), phlebitis (RR, 3.44; 95% Cl, 1.30-9.15 and RR, 3.38; 95% CI, 1.28-8.89), and hepatic dysfunction (RR, 0.44; 95% CI, 0.15-1.35 and RR, 0.44; 95% CI, 0.24-0.81). CONCLUSION: This meta-analysis found that KLT injection in combination with chemotherapy was associated with improved response rate, quality of life, and symptoms, and a reduced incidence of AEs compared with chemotherapy alone in patients with NSCLC. These findings should be viewed with caution because of the low quality of the included trials.
BACKGROUND: Kanglaite (KLT) is a botanically sourced, molecularly targeted agent that is prepared as a microemulsion for IV use. The active substance is extracted from the herb Semen coicis. OBJECTIVE: The aim of this study was to evaluate the effectiveness and tolerability of KLT injection in patients with primary non-small cell lung cancer (NSCLC). METHODS: We electronically searched the literature of the China National Knowledge Infrastructure (Chinese language, 1979-March 2008), CBMdisc (Chinese, 1978-March 2008), The Cochrane Library (English, Issue 4, 2007), MEDLINE (English, 1966-March 2008), and EMBASE (English, 1984-March 2008), and manually searched 20 Chinese-language oncology journals to identify randomized controlled trials (RCTs) of KLT injection plus chemotherapy versus chemotherapy alone, regardless of their having been published or not, blinding, duration of treatment, or duration of follow-up. The quality of the included trials was assessed using the method recommended by The Cochrane Collaboration. The studies were assigned to 1 of the following 3 categories: A = all quality criteria met, low risk of bias; B = ≥1 of the quality criteria only partially met, moderate risk of bias; or C = ≥1 of the quality criteria not met, high risk of bias. If heterogeneity existed among subgroups, then overall results were calculated based on a random-effects model; otherwise, a fixed-effects model was used. RESULTS: Electronic database searches yielded 596 citations. A title review eliminated 377 manuscripts; 219 citations were marked for further evaluation. Finally, we identified 26 trials that met the inclusion and exclusion criteria. The 26 RCTs included in this meta-analysis included 2209 patients with NSCLC; no study was graded A, 9 were graded B, and 17 were graded C. The sample size of each trial varied from 40 to 305 patients; none of the trials had precalculated sample sizes. Pooled analyses performed using both fixed- and random-effects models revealed that compared with chemotherapy alone, KLT injection plus chemotherapy improved the response rate (relative risk [RR], 1.34; 95% CI, 1.19-1.51 and RR, 1.35; 95% CI, 1.20-1.51, respectively) and quality of life as measured by an increase ≥10 points in the Karnofsky Performance Status score (RR, 2.05; 95% CI, 1.60-2.64). KLT injection plus chemotherapy was associated with improvement in the symptoms of cough, dyspnea, chest pain, fatigue, and anorexia. KLT injection plus chemotherapy was also associated with significant reduction in the incidence of the following adverse events (AEs) based on the fixed and random effects models, respectively: grade II to IV leukopenia (RR, 0.29; 95% CI, 0.22-0.39 and RR, 0.33; 95% CI, 0.22-0.48), anemia (RR, 0.54; 95% CI, 0.42-0.70 and RR, 0.55; 95% CI, 0.40-0.76), thrombocytopenia (RR, 0.39; 95% CI, 0.21-0.71 and RR, 0.40; 95% CI, 0.21-0.78), nausea and vomiting (RR, 0.44; 95% CI, 0.34-0.57 and RR, 0.44; 95% CI, 0.35-0.57), phlebitis (RR, 3.44; 95% Cl, 1.30-9.15 and RR, 3.38; 95% CI, 1.28-8.89), and hepatic dysfunction (RR, 0.44; 95% CI, 0.15-1.35 and RR, 0.44; 95% CI, 0.24-0.81). CONCLUSION: This meta-analysis found that KLT injection in combination with chemotherapy was associated with improved response rate, quality of life, and symptoms, and a reduced incidence of AEs compared with chemotherapy alone in patients with NSCLC. These findings should be viewed with caution because of the low quality of the included trials.
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