Principles of Standardized Diagnosis and Treatment of Immune Checkpoint Inhibitors (ICIs) and Analysis of Legal Liability for Treatment-Related Tumor Hyperprogression (HPD) Under Chinese Law
Keywords:
immunotherapy, immune checkpoint inhibitors, tumor hyperprogression, standardized treatment, legal liability
Abstract
Immunotherapy, led by immune checkpoint inhibitors, has reshaped the landscape of tumor treatment, achieving long-acting drug responses in some patients with advanced malignancies, but not all patients can benefit from immunotherapy. In addition to primary drug-resistant patients, we cannot ignore hyperprogressive patients whose disease is accelerated instead after the use of immune checkpoint inhibitors, which are rare but often have a very poor prognosis and are prone to disputes. The mechanism of hyperprogression is still unknown, but not unknown, and some genetic mutations and biomarkers have been shown to be associated with a higher risk of hyperprogression. Clinicians should stratify patients with reference to markers and risk mutations to screen effective patients and inform them of the corresponding risks of immune checkpoint inhibitor therapy to ensure that patients make a fully informed choice of immunotherapy. Comply with evidence-based medical guidelines, standardize the use of medication, and timely monitor and intervene in related adverse events and hyperprogression. Under Chinese law, violation of the principles of diagnosis and treatment is subject to liability, except for those caused by the patient himself, such as backline treatment and sympathetic drug administration.
References
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[19] Oliveira, A., & Furtado, I. (2019). Review of PD-1/PD-L1 inhibitors in metastatic dMMR/MSI-H colorectal cancer. Frontiers in Oncology, 9, 396. https://doi.org/10.3389/fonc.2019.00396
[20] Li, S., & Huang, J. (2021). Research progress on predictive markers of tumor immunotherapy efficacy. International Journal of Oncology, 4(2021), 220-224.
[21] Losa, N., et al. (2015). The vigorous immune microenvironment of microsatellite instable colon cancer is balanced by multiple counter-inhibitory checkpoints. Journal for Immunotherapy of Cancer, 3, 410. https://doi.org/10.1186/2051-1426-3-S2-P410
[22] Daylan, & Cui, J. (2021). Predictive markers of immunotherapy efficacy from the perspective of tumor immune microenvironment. Chinese Journal of Cancer Prevention and Control, 6(6), 585-593.
[23] Wang, J., & Wei, S. J. (2021). Progress of research related to HLA-class I in immunotherapy for lung cancer. Chinese Journal of Immunology, 19(2021), 2428-2432.
[24] Sun, Y., et al. (2021). PTENα functions as an immune suppressor and promotes immune resistance in PTEN-mutant cancer. Nature Communications, 12, 5147. https://doi.org/10.1038/s41467-021-25417-6
[25] Rosenberg, J., et al. (2016). Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: A single-arm, multicentre, phase 2 trial. The Lancet (British Edition), 387, 1909-1920. https://doi.org/10.1016/S0140-6736(16)00561-4
[26] Larkin, J., et al. (2015). Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. The New England Journal of Medicine, 373, 23-34. https://doi.org/10.1056/NEJMoa1504030
[27] Escudier, B., et al. (2017). CheckMate 025 randomized phase 3 study: Outcomes by key baseline factors and prior therapy for nivolumab versus everolimus in advanced renal cell carcinoma. European Urology, 72, 962-971. https://doi.org/10.1016/j.eururo.2017.02.010
[28] Jain Arpit et al., (2022). Hyper-Progressive Disease (HPD) During Immune Checkpoint Inhibitor (ICI) Therapy. Indian J Med Paediatr Oncol, 43(02), 185-188. https://doi.org/10.1055/s-0042-1743505
[29] Huang, X., et al. (2019). Treatment of nivolumab results in hyperprogressive disease in a patient harboring EGFR exon 20 insertion and MYC amplification. Journal of Thoracic Oncology, 14, 189-191. https://doi.org/10.1016/j.jtho.2019.04.009
[30] Lo Russo, G., et al. (2019). Antibody-Fc/FcR interaction on macrophages as a mechanism for hyperprogressive disease in non-small cell lung cancer subsequent to PD-1/PD-L1 blockade. Clinical Cancer Research, 25, 989-999. https://doi.org/10.1158/1078-0432.CCR-18-1390
[31] Casey, S., et al. (2016). MYC regulates the antitumor immune response through CD47 and PD-L1. Science, 352, 227-231. https://doi.org/10.1126/science.aac9935
[32] Mazieres, J., et al. (2019). Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: Results from the IMMUNOTARGET registry. Annals of Oncology, 30, 1321-1328. https://doi.org/10.1093/annonc/mdz167
[33] Champiat, S., et al. (2017). Hyperprogressive disease is a new pattern of progression in cancer patients treated by anti-PD-1/PD-L1. Clinical Cancer Research, 23, 1920-1928. https://doi.org/10.1158/1078-0432.CCR-16-1741
[34] Kato, S., et al. (2017). Hyperprogressors after immunotherapy: Analysis of genomic alterations associated with accelerated growth rate. Clinical Cancer Research, 23, 4242-4250. https://doi.org/10.1158/1078-0432.CCR-17-1990
[35] Wong, D. J., et al. (2019). Hyperprogressive disease in hepatocellular carcinoma with immune checkpoint inhibitor use: A case series. Immunotherapy, 11, 167-175. https://doi.org/10.2217/imt-2018-0126
[36] Saâda-Bouzid, et al. (2017). Hyperprogression During Anti-PD-1/PD-L1 Therapy in Patients with Recurrent And or Metastatic Head and Neck Squamous Cell Carcinoma, 28 Annals of oncology, 1605, 1605-1611. https://doi.org/10.1093/annonc/mdx178
[37] Li Hongwen (2009). The Moral Basis of Informed Consent. Medicine and Philosophy (Humanities and Social Medicine Edition), 5, 27-29.
[38] Qiang Mei-ying (2010). Legal and Ethical Reflections on Medical Informed Consent. Medicine and Philosophy (Humanities and Social Medicine Edition), 5, 14-16.
[39] Duan Kuang & He Xiangyu (1999). The Doctor's Obligation to Inform and the Patient's Commitment. Liang Huixing, ed. Civil and Commercial Law Series, 12. Law Publishing House, 1999 edition, p. 185.
[40] Corrigan, O. (2003). Empty ethics: The problem with informed consent. Sociology of Health & Illness, 25, 768-792. https://doi.org/10.1046/j.1467-9566.2003.00369.x
[41] Frohock, F. M. (1988). A history and theory of informed consent. American Political Science Review, 82, 271-273. https://doi.org/10.2307/1958076
[42] Elken (2008). On the Theory of Medical Informed Consent. Hebei Law Journal, 8, 81-88.
[43] Liu, Y. (2012). The origin and development of the principle of informed consent. Medicine and Philosophy, 5, 17-19.
[44] Liu, A. (2015). The historical transformation and legal revelation of the right to medical informed consent in the United States. Huxiang Forum, 2, 94-97.
[45] Grossman, S. A., et al. (1994). Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? Journal of Clinical Oncology, 12, 2211-2215. https://doi.org/10.1200/JCO.1994.12.10.2211
[46] Ding, L., Guan, S., & Qian, G. (2023). Progress in the study of factors influencing immune-related adverse reactions to tumor immune checkpoint inhibitors and their relationship with clinical efficacy. Electronic Journal of Comprehensive Oncology Treatment, 4(4), 78-86.
[47] Wang, Q., Huang, T., & Liu, W. (2023). A study on the rule of law in the formulation of diagnosis and treatment norms in China. Medicine and Society, 8, 110-115.
[48] ISO/IEC 17000: 2004.
[49] Liu, J., & Nie, A. (2021). The modern transformation of China's standardized legal system: Taking
[50] Yue, Y., & Xu, H. (2023). Research on the legal reality dilemma and countermeasures of the clinical application of overspecified medication. China Modern Applied Pharmacy, 14, 2003-2009.
[51] Wang, P., Xu, J., & Zhang, J. (2023). The regulatory progress of the U.S. system of ultra-drug instructions for drug use and lessons learned. Medicine and Law, 15, 63-68.
[52] Ding Lijuan, Guan Shasha & Qianguisong (2023). Research progress on the influencing factors of immune-related adverse reactions to tumor immune checkpoint inhibitors and their relationship with clinical efficacy. Electronic Journal of Comprehensive Oncology Treatment, 4(4), 78-86.
[53] Ogawara, D., et al. (2018). Remarkable response of nivolumab-refractory lung cancer to salvage chemotherapy. Thoracic Cancer, 9, 175-180. https://doi.org/10.1111/1759-7714.12543
[54] Schvartsman, G., et al. (2017). Response rates to single-agent chemotherapy after exposure to immune checkpoint inhibitors in advanced non-small cell lung cancer. Lung Cancer, 112, 90-95. https://doi.org/10.1016/j.lungcan.2017.07.034
[55] Champiat, S., et al. (2017). Hyperprogressors after immunotherapy: Analysis of genomic alterations associated with accelerated growth rate. Clinical Cancer Research, 23, 4242-4250. https://doi.org/10.1158/1078-0432.CCR-16-3133
[56] Gandara, D. R. et al. (2018). Fast progression in patients treated with a checkpoint inhibitor (cpi) vs chemotherapy in OAK, a phase III trial of atezolizumab (atezo) vs docetaxel (doc) in 2L+ NSCLC. Annals of Oncology, 29(x39). https://doi.org/10.1093/annonc/mdy511
[57] Kong, L., Li, M., Zhang, Y., Teng, F., Han, A., Kong, L., & Zhu, H. (2016). PD-1/PD-L1 blockades in non-small-cell lung cancer therapy. Onco Targets Ther., 9, 489-502. https://doi.org/10.2147/OTT.S94993
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