Skip to main content

Advertisement

SpringerLink
Log in

Efficacy and safety of Huachansu combined with adjuvant chemotherapy in resected colorectal cancer patients: a prospective, open-label, randomized phase II study

  • Original Paper
  • Published:
Medical Oncology Aims and scope Submit manuscript

Abstract

Although some studies in China have suggested Huachansu (HCS) combined with chemotherapy is effective in the treatment of various cancers, there are few studies on colorectal cancer (CRC), especially in postoperative adjuvant chemotherapy. The aim of this study was to test the hypothesis that HCS combined with adjuvant chemotherapy would improve survival probability in resected CRC patients. This was a prospective, open-label, randomized phase II study. Patients with stage III or high-risk stage II resected CRC were randomly assigned to the chemotherapy and HCS + chemotherapy groups. The Chemotherapy group was treated with the FOLFOX regimen for ≥ 6 cycles or the CAPEOX regimen for ≥ 4 cycles. The HCS + chemotherapy group was treated with HCS on the basis of the chemotherapy group. The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints were 3-year overall survival (OS) and toxicity. A total of 250 patients were included in this study (126 chemotherapy, 124 HCS + chemotherapy). There were significant differences in 3-year DFS between the two groups (median 28.7 vs. 31.6 months, respectively; P = 0.027), but no significant differences in 3-year OS between the two groups (median 32.7 vs. 34 months, respectively; P = 0.146). No patients experienced grade four adverse events, and the rates of leukopenia, neutropenia, and diarrhea in the HCS + chemotherapy group were lower than that those in the chemotherapy group. HCS combined with adjuvant chemotherapy after radical resection for patients with stage III or high-risk stage II CRC was demonstrated to be an effective and feasible treatment.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

Data availability

The corresponding author can provide the datasets used or analyzed in the current study upon reasonable request.

References

  1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2020;71(3):209–49.

    Article  Google Scholar 

  2. Cao W, Chen HD, Yu YW, et al. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics. Chin Med J (Engl). 2021;134(7):783–91.

    Article  PubMed  Google Scholar 

  3. Bonjer HJ, Deijen CL, Abis GA, et al. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015;372(14):1324–32.

    Article  PubMed  CAS  Google Scholar 

  4. Jayne DG, Guillou PJ, Thorpe H, et al. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC trial group. J Clin Oncol. 2007;25(21):3061–8.

    Article  PubMed  Google Scholar 

  5. Tiselius C, Gunnarsson U, Smedh K, et al. Patients with rectal cancer receiving adjuvant chemotherapy have an increased survival: a population-based longitudinal study. Ann Oncol. 2013;24(1):160–5.

    Article  PubMed  CAS  Google Scholar 

  6. Schmoll HJ, Twelves C, Sun W, et al. Effect of adjuvant capecitabine or fluorouracil, with or without oxaliplatin, on survival outcomes in stage III colon cancer and the effect of oxaliplatin on post-relapse survival: a pooled analysis of individual patient data from four randomised controlled trials. Lancet Oncol. 2014;15(13):1481–92.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  7. Liu G, Franssen E, Fitch MI, et al. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997;15(1):110–5.

    Article  PubMed  CAS  Google Scholar 

  8. Dhakal P, Wichman CS, Pozehl B, et al. Preferences of adults with cancer for systemic cancer treatment: do preferences differ based on age? Future Oncol. 2022;18(3):311–21.

    Article  PubMed  CAS  Google Scholar 

  9. Chionh F, Lau D, Yeung Y, et al. Oral versus intravenous fluoropyrimidines for colorectal cancer. Cochrane Database Syst Rev. 2017;7(7):D8398.

    Google Scholar 

  10. Zhan X, Wu H, Wu H, et al. Metabolites from Bufo gargarizans (Cantor, 1842): a review of traditional uses, pharmacological activity, toxicity and quality control. J Ethnopharmacol. 2020;246:112178.

    Article  PubMed  CAS  Google Scholar 

  11. Li R, Wu H, Wang M, et al. An integrated strategy to delineate the chemical and dynamic metabolic profile of Huachansu tablets in rat plasma based on UPLC-ESI-QTOF/MS(E). J Pharm Biomed Anal. 2022;218: 114866.

    Article  PubMed  CAS  Google Scholar 

  12. Peng C, Chen J, Cui W, et al. Comparative efficacy of various CHIs combined with western medicine for non-small cell lung cancer: a Bayesian network meta-analysis of randomized controlled trials. Front Pharmacol. 2022;13:1037620.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  13. Wu J, Zhang D, Ni M, et al. Effectiveness of Huachansu injection combined with chemotherapy for treatment of gastric cancer in China: a systematic review and meta-analysis. J Tradit Chin Med. 2020;40(5):749–57.

    PubMed  Google Scholar 

  14. Zhang D, Ni M, Wu J, et al. The optimal Chinese herbal injections for use with radiotherapy to treat esophageal cancer: a systematic review and bayesian network meta-analysis. Front Pharmacol. 2018;9:1470.

    Article  PubMed  CAS  Google Scholar 

  15. Tang M, He B, Zhai J, et al. Oral Chinese patent medicine combined with oxaliplatin-based chemotherapy regimen for the treatment of colorectal cancer: a network meta-analysis. Integr Cancer Ther. 2021;20:1543373305. https://doi.org/10.1177/15347354211058169.

    Article  CAS  Google Scholar 

  16. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer. 1981;47(1):207–14. https://doi.org/10.1002/1097-0142(19810101)47:1<207::aid-cncr2820470134>3.0.co;2-6

    Article  PubMed  CAS  Google Scholar 

  17. Lu XM, Zheng J, Zhu YJ. [Effect of Chinese materia medica combined chemotherapy on the survivals of stage II and III colorectal cancer]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012;32(9):1166–70.

    PubMed  Google Scholar 

  18. Sun J, Jiang T, Qiu Z, et al. Short-term and medium-term clinical outcomes of laparoscopic-assisted and open surgery for colorectal cancer: a single center retrospective case-control study. BMC Gastroenterol. 2011;11:85.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  19. Tao F. Effect of Huachasu on prevention and treatment of postoperative recurrence and metastasis of colorectal cancer. Guangdong Med J. 2013;34(24):3808–9.

    CAS  Google Scholar 

  20. Sun Q, He M, Zhang M, et al. Traditional Chinese medicine and colorectal cancer: implications for drug discovery. Front Pharmacol. 2021;12: 685002.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  21. Qi F, Li A, Inagaki Y, et al. Antitumor activity of extracts and compounds from the skin of the toad Bufo bufo gargarizans Cantor. Int Immunopharmacol. 2011;11(3):342–9.

    Article  PubMed  CAS  Google Scholar 

  22. Wei WL, Hou JJ, Wang X, et al. Venenum bufonis: an overview of its traditional use, natural product chemistry, pharmacology, pharmacokinetics and toxicology. J Ethnopharmacol. 2019;237:215–35.

    Article  PubMed  CAS  Google Scholar 

  23. Shi XK, Cheng C, Guo LS, et al. Clinical observation of Huachansu in preventing postoperative recurrence and metastasis of colorectal cancer. Shenzhen J Integr Tradit Chin West Med. 2016;26(11):72–3.

    Google Scholar 

  24. Meng Z, Garrett CR, Shen Y, et al. Prospective randomised evaluation of traditional Chinese medicine combined with chemotherapy: a randomised phase II study of wild toad extract plus gemcitabine in patients with advanced pancreatic adenocarcinomas. Br J Cancer. 2012;107(3):411–6.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  25. Meng Z, Yang P, Shen Y, et al. Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer. Cancer. 2009;115(22):5309–18.

    Article  PubMed  Google Scholar 

  26. Tan X, Liang X, Xi J, et al. Clinical efficacy and safety of Huachansu injection combination with platinum-based chemotherapy for advanced non-small cell lung cancer:a systematic review and meta-analysis of randomized controlled trials. Medicine. 2021;100(36): e27161.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  27. McQuade RM, Stojanovska V, Abalo R, et al. Chemotherapy-induced constipation and diarrhea: pathophysiology, current and emerging treatments. Front Pharmacol. 2016;7:414.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  28. Qu L, Tan W, Yang J, et al. Combination compositions composed of l-glutamine and Si-Jun-Zi-tang might be a preferable choice for 5-fluorouracil-induced intestinal mucositis: an exploration in a mouse model. Front Pharmacol. 2020;11:918.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  29. Tarricone R, Abu KD, Nyanzi-Wakholi B, et al. A systematic literature review of the economic implications of chemotherapy-induced diarrhea and its impact on quality of life. Crit Rev Oncol Hematol. 2016;99:37–48.

    Article  PubMed  Google Scholar 

  30. Maroun JA, Anthony LB, Blais N, et al. Prevention and management of chemotherapy-induced diarrhea in patients with colorectal cancer: a consensus statement by the Canadian working group on chemotherapy-induced diarrhea. Curr Oncol. 2007;14(1):13–20.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  31. Bai Y, Wang S, Xu W, et al. Cinobufacini ameliorates experimental colitis via modulating the composition of gut microbiota. PLoS ONE. 2019;14(9): e223231.

    Article  Google Scholar 

  32. Burzykowski T, Buyse M, Yothers G, et al. Exploring and validating surrogate endpoints in colorectal cancer. Lifetime Data Anal. 2008;14(1):54–64.

    Article  PubMed  Google Scholar 

  33. Iveson TJ, Kerr RS, Saunders MP, et al. 3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2018;19(4):562–78.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Funding

This study was supported by the National Natural Science Foundation of China (81973625), the key medical specialty plan of Shanghai (ZK2019B18), the construction project of clinical special diseases of health system in Putuo District, Shanghai (2019tszk01), and the independent innovation research project of health system in Putuo District, Shanghai (2013ptkw002).

Author information

Author notes

  1. Shichao Li and Dongxiao Shen have contributed equally to this work.

Authors and Affiliations

  1. Anorectal Department, The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, China

    Shichao Li & Wusheng Li

  2. General Surgery Department, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China

    Shichao Li, Dongxiao Shen, Qingsong Zuo, Shengzi Wang, Lingjia Meng, Jiaojiao Yu, Yang Liu, Chao Chen, Peihao Yin, Teng Chen & Jie Wang

  3. Shanghai Putuo Central School of Clinical Medicine, Anhui Medical University, Shanghai, China

    Chao Chen, Peihao Yin, Teng Chen & Jie Wang

Authors
  1. Shichao Li
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Dongxiao Shen
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Qingsong Zuo
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Shengzi Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Lingjia Meng
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Jiaojiao Yu
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Yang Liu
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Wusheng Li
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Chao Chen
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Peihao Yin
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Teng Chen
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Jie Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

SL: Conceptualization (equal); investigation (equal); methodology (equal); writing—original draft (equal); writing—review and editing (equal). DS: Investigation (equal); methodology (equal); writing—review and editing (equal). QZ: Investigation (equal); writing—review and editing (equal). SW: Investigation (equal); writing—review and editing (equal). LM: Investigation (equal); writing—review and editing (equal). JY: Investigation (equal); writing—review and editing (equal). YL: Investigation (equal); writing—review and editing (equal). WL: Methodology (equal); writing—review and editing (equal). CC: Investigation (equal); writing—review and editing (equal). PY: Investigation (equal); writing—review and editing (equal). TC: Conceptualization (equal); data curation (equal); funding acquisition (equal); investigation (equal); supervision (equal); writing—review and editing (equal). JW: Conceptualization (equal); data curation (equal); funding acquisition (equal); investigation (equal); supervision (equal); writing—review and editing (equal).

Corresponding authors

Correspondence to Teng Chen or Jie Wang.

Ethics declarations

Conflict of interest

The authors declare that they have no competing interests.

Ethical approval

The study was approved by the Institutional Review Board of Putuo Hospital affiliated with Shanghai University of Traditional Chinese Medicine (PTEC-A-2016-3-1).

Informed consent

All the participants signed an informed consent before participating in the study.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Li, S., Shen, D., Zuo, Q. et al. Efficacy and safety of Huachansu combined with adjuvant chemotherapy in resected colorectal cancer patients: a prospective, open-label, randomized phase II study. Med Oncol 40, 358 (2023). https://doi.org/10.1007/s12032-023-02217-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s12032-023-02217-0

Keywords

Search

Navigation