Chia-Hsun Hsieh1, Chien-Yu Lin2, Cheng-Lung Hsu1, Kang-Hsing Fan2, Shiang-Fu Huang3, Chun-Ta Liao3, Li-Yu Lee4, Shu-Kung Ng5, Tzu-Chen Yen6, Joseph Tung-Chieh Chang2, Jr-Rung Lin7, Hung-Ming Wang8. 1. Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou; College of Medicine, Chang Gung University, No. 5, Fushin St., Gueishan District, Taoyuan, 333, Taiwan, ROC. 2. Department of Radiation Oncology, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan, Taiwan, ROC. 3. Department of Otorhinolaryngology, Head and Neck Surgery, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan, Taiwan, ROC. 4. Department of Pathology, Chang Gung Memorial Hospital and Chang Gung University at Linkou, Taoyuan, Taiwan, ROC. 5. Department of Diagnostic Radiology, Chang Gung Memorial Hospital and Chang Gung University at Linkou, Taoyuan, Taiwan, ROC. 6. Department of Nuclear Medicine and Molecular Imaging Center, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan, Taiwan, ROC. 7. Clinical Informatics and Medical Statistics Research Center and Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan, ROC. 8. Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou; College of Medicine, Chang Gung University, No. 5, Fushin St., Gueishan District, Taoyuan, 333, Taiwan, ROC. whm526@cgmh.org.tw.
Abstract
PURPOSE:Concurrent chemoradiotherapy (CCRT) is one of the standard treatments for patients with advanced head and neck squamous cell carcinoma (HNSCC). However, CCRT may lead to decreased quality of life (QoL) and treatment compliance. This study aimed to determine the effects of PG2 (Astragalus polysaccharides) injection on CCRT-associated adverse events (AEs) and patients' compliance with the CCRT course. METHODS: In this phase II double-blind randomized placebo-controlled trial, PG2 injection (sterile powder form) or placebo was administrated three times per week in parallel with CCRT to patients with HNSCC. The chemotherapy regimen included 50 mg/m2 cisplatin every 2 weeks with daily tegafur-uracil (300 mg/m2) and leucovorin (60 mg/day). RESULTS: The study was terminated prematurely due to the successful launch of a newly formulated PG2 injection (lyophilized form). A total of 17 patients were enrolled. The baseline demographics and therapeutic compliance were comparable between the CCRT/PG2 and CCRT/placebo groups. During CCRT, severe treatment-associated AEs were less frequent in the CCRT/PG2 group than in the CCRT/placebo group. Furthermore, less QoL fluctuations from the baseline during CCRT were noted in the CCRT/PG2 group than in the CCRT/placebo group, with a significant difference in the pain, appetite loss, and social eating behavior. The tumor response, disease-specific survival and overall survival did not differ between the two groups. CONCLUSION: This preliminary study demonstrated PG2 injection exhibited an excellent safety profile, and has potential in ameliorating the deterioration in QoL and the AEs associated with active anticancer treatment among patients with advanced pharyngeal or laryngeal HNSCC under CCRT. Further research in patients with other cancer types or treatment modalities may widen PG2's application in clinical settings.
RCT Entities:
PURPOSE: Concurrent chemoradiotherapy (CCRT) is one of the standard treatments for patients with advanced head and neck squamous cell carcinoma (HNSCC). However, CCRT may lead to decreased quality of life (QoL) and treatment compliance. This study aimed to determine the effects of PG2 (Astragalus polysaccharides) injection on CCRT-associated adverse events (AEs) and patients' compliance with the CCRT course. METHODS: In this phase II double-blind randomized placebo-controlled trial, PG2 injection (sterile powder form) or placebo was administrated three times per week in parallel with CCRT to patients with HNSCC. The chemotherapy regimen included 50 mg/m2 cisplatin every 2 weeks with daily tegafur-uracil (300 mg/m2) and leucovorin (60 mg/day). RESULTS: The study was terminated prematurely due to the successful launch of a newly formulated PG2 injection (lyophilized form). A total of 17 patients were enrolled. The baseline demographics and therapeutic compliance were comparable between the CCRT/PG2 and CCRT/placebo groups. During CCRT, severe treatment-associated AEs were less frequent in the CCRT/PG2 group than in the CCRT/placebo group. Furthermore, less QoL fluctuations from the baseline during CCRT were noted in the CCRT/PG2 group than in the CCRT/placebo group, with a significant difference in the pain, appetite loss, and social eating behavior. The tumor response, disease-specific survival and overall survival did not differ between the two groups. CONCLUSION: This preliminary study demonstrated PG2 injection exhibited an excellent safety profile, and has potential in ameliorating the deterioration in QoL and the AEs associated with active anticancer treatment among patients with advanced pharyngeal or laryngeal HNSCC under CCRT. Further research in patients with other cancer types or treatment modalities may widen PG2's application in clinical settings.
Authors: Augusta P Silveira; Joaquim Gonçalves; Teresa Sequeira; Cláudia Ribeiro; Carlos Lopes; Eurico Monteiro; Francisco L Pimentel Journal: Head Neck Oncol Date: 2010-10-31
Authors: Jan B Vermorken; Eva Remenar; Carla van Herpen; Thierry Gorlia; Ricard Mesia; Marian Degardin; John S Stewart; Svetislav Jelic; Jan Betka; Joachim H Preiss; Danielle van den Weyngaert; Ahmad Awada; Didier Cupissol; Heinz R Kienzer; Augustin Rey; Isabelle Desaunois; Jacques Bernier; Jean-Louis Lefebvre Journal: N Engl J Med Date: 2007-10-25 Impact factor: 91.245