Efficacy and Safety of Quxie Capsule () in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial / 中国结合医学杂志
Chin. j. integr. med
; Chin. j. integr. med;(12): 171-177, 2018.
Article
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| WPRIM
| ID: wpr-691366
Biblioteca responsable:
WPRO
ABSTRACT
<p><b>OBJECTIVE</b>To verify the efficacy and safety of Quxie Capsule () in patients with metastatic colorectal cancer (mCRC).</p><p><b>METHODS</b>The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio by sealed envelope. The treatment group received conventional therapy combined with Quxie Capsule for 3 months. The control group was treated with conventional therapy combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to age, right or left-sided disease, and second-line therapy to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until Dec 31st 2016.</p><p><b>RESULTS</b>The median OS was 23 months in the treatment group [95% confidence interval (CI): 15-not calculated] vs. 14 months in the control group (95% CI: 11-22, P=0.060). The OS of the treatment group tended to be longer than that of the control group (P>0.05). In the subgroups of patients <65 years old, left-sided colon, and 2nd-line therapy, the treatment group showed a significant survival benefit compared with the control group (P=0.006, 0.038, 0.013, respectively). There were no significant differences between the two groups in PFS (P>0.05). Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.</p><p><b>CONCLUSIONS</b>Quxie Capsule showed good safety and efficacy, and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733).</p>
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Base de datos:
WPRIM
Asunto principal:
Patología
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Placebos
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Cápsulas
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Medicamentos Herbarios Chinos
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Neoplasias Colorrectales
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Método Doble Ciego
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Supervivencia sin Enfermedad
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Usos Terapéuticos
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Quimioterapia
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Metástasis de la Neoplasia
Tipo de estudio:
Clinical_trials
Límite:
Aged
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Female
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Humans
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Male
Idioma:
En
Revista:
Chin. j. integr. med
Año:
2018
Tipo del documento:
Article