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Incorporation of Astragalus polysaccharides injection during concurrent chemoradiotherapy in advanced pharyngeal or laryngeal squamous cell carcinoma: preliminary experience of a phase II double-blind, randomized trial

  • Chia-Hsun Hsieh
  • Chien-Yu Lin
  • Cheng-Lung Hsu
  • Kang-Hsing Fan
  • Shiang-Fu Huang
  • Chun-Ta Liao
  • Li-Yu Lee
  • Shu-Kung Ng
  • Tzu-Chen Yen
  • Joseph Tung-Chieh Chang
  • Jr-Rung Lin
  • Hung-Ming WangEmail author
Original Article – Cancer Research
  • 30 Downloads

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.

Keywords

Quality of life Astragalus polysaccharides Concurrent chemoradiotherapy Squamous cell carcinoma 

Abbreviations

AE

Adverse event

CCRT

Concurrent chemoradiotherapy

CRF

Cancer-related fatigue

DSS

Disease-specific survival

FU

Flurouracil

HNSCC

Head and neck squamous cell carcinoma

OS

Overall survival

PLSCC

Pharyngeal or laryngeal squamous cell carcinoma

PUL

Cisplatin, tegafur plus uracil, and leucovorin

QoL

Quality of life

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

Ethical approval was granted by the Institutional Review Board of Chang Gung Memorial Hospital at Linkou, and all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Supplementary material

432_2019_3033_MOESM1_ESM.docx (64 kb)
Supplementary material 1 (DOCX 68 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Chia-Hsun Hsieh
    • 1
  • Chien-Yu Lin
    • 2
  • Cheng-Lung Hsu
    • 1
  • Kang-Hsing Fan
    • 2
  • Shiang-Fu Huang
    • 3
  • Chun-Ta Liao
    • 3
  • Li-Yu Lee
    • 4
  • Shu-Kung Ng
    • 5
  • Tzu-Chen Yen
    • 6
  • Joseph Tung-Chieh Chang
    • 2
  • Jr-Rung Lin
    • 7
  • Hung-Ming Wang
    • 1
    Email author
  1. 1.Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou; College of MedicineChang Gung UniversityTaoyuanTaiwan, ROC
  2. 2.Department of Radiation OncologyChang Gung Memorial Hospital at Linkou and Chang Gung UniversityTaoyuanTaiwan, ROC
  3. 3.Department of Otorhinolaryngology, Head and Neck SurgeryChang Gung Memorial Hospital at Linkou and Chang Gung UniversityTaoyuanTaiwan, ROC
  4. 4.Department of PathologyChang Gung Memorial Hospital and Chang Gung University at LinkouTaoyuanTaiwan, ROC
  5. 5.Department of Diagnostic RadiologyChang Gung Memorial Hospital and Chang Gung University at LinkouTaoyuanTaiwan, ROC
  6. 6.Department of Nuclear Medicine and Molecular Imaging CenterChang Gung Memorial Hospital at Linkou and Chang Gung UniversityTaoyuanTaiwan, ROC
  7. 7.Clinical Informatics and Medical Statistics Research Center and Graduate Institute of Clinical Medical Sciences, College of MedicineChang Gung UniversityTaoyuanTaiwan, ROC

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