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. 2019 Jan 22;11(2):128.
doi: 10.3390/cancers11020128.

Karnofsky Performance Status as A Predictive Factor for Cancer-Related Fatigue Treatment with Astragalus Polysaccharides (PG2) Injection-A Double Blind, Multi-Center, Randomized Phase IV Study

Cheng-Hsu Wang  1 , Cheng-Yao Lin  2 , Jen-Shi Chen  3   4 , Ching-Liang Ho  5 , Kun-Ming Rau  6   7   8 , Jo-Ting Tsai  9   10 , Cheng-Shyong Chang  11 , Su-Peng Yeh  12 , Chieh-Fang Cheng  13 , Yuen-Liang Lai  14   15
Affiliations

Karnofsky Performance Status as A Predictive Factor for Cancer-Related Fatigue Treatment with Astragalus Polysaccharides (PG2) Injection-A Double Blind, Multi-Center, Randomized Phase IV Study

Cheng-Hsu Wang et al. Cancers (Basel). .

Abstract

Fatigue is a common and debilitating symptom in patients with advanced cancer, resulting in poor quality of life and reduced treatment efficacy. Phytotherapeutic agents have shown potential effects to relieve cancer-related fatigue in these patients. The aim of this study was to evaluate the efficacy and safety of Astragalus Polysaccharides injection and identify predictive factors associated with this treatment. Patients with advanced cancer receiving palliative care with moderate to severe cancer-related fatigue were enrolled in this study for two treatment cycles. Fatigue improvement response rates were analyzed as the primary endpoint at the end of the first cycle to determine treatment efficacy. The drug safety profile was evaluated by the reporting of adverse events. Three hundred and ten patients were enrolled in this study and 214 patients were included ITT population. Improvement in fatigue scores by at least 10% was observed in greater than 65% of subjects after one treatment cycle compared to scores at baseline. Patients with higher Karnofsky Performance Status (KPS) responded better to the Astragalus Polysaccharides injection. Drug-related adverse event rates were less than 9%. This study identified KPS as a promising predictive factor for the therapeutic efficacy of Astragalus Polysaccharides injection.

Keywords: KPS; cancer; eywords: astragalus polysaccharides; fatigue; palliative care.

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Conflict of interest statement

C.-F.C. is a research and development manager of PhytoHealth Corporation, Taipei 10547, Taiwan. Other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Study flow chart and patient flow diagram. (A) Patients were randomly divided into high dose (500 mg) and low dose (250 mg) groups. Each patient was expected to receive two cycles of treatment. Each cycle lasted 4 weeks, and patients received three doses of PG2 injection per week. (B) Three hundred and twenty-three patients were screened and 310 were randomly divided into two groups. Three hundred and seven patients were enrolled in the safety population, and 214 were included in the intention-to-treat population.
Figure 2
Figure 2
Summary of Fatigue Improvement Response Rate at the end of treatment cycle 1. Patients who received high or low dose PG2 treatments were evaluated using the Brief Fatigue Inventory-Taiwanese version at the first visit (baseline) and once each following week. Fatigue improvement response rates using different cut off scores were calculated at the end of treatment cycle 1.
Figure 3
Figure 3
Fatigue Improvement Response Rate and KPS for patients with different cancer types. (A) Breast, colon, lung, and gastric cancer patients were selected for analysis. Fatigue improvement response rates for these patients were analyzed and compared. (B) KPS for breast, colon, lung, and gastric cancer patients were analyzed and compared. (C) KPS for responders and non-responders in the overall patient population. (* p < 0.01 versus breast cancer patients).
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