Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham, United Kingdom.
Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
J Clin Oncol. 2020 Aug 1;38(22):2552-2557. doi: 10.1200/JCO.20.00056. Epub 2020 Jun 4.
Human papillomavirus (HPV)-positive oropharyngeal cancer (OPC) is increasing rapidly. The younger age, significantly improved prognosis, and relative morbidity of the standard-of-care cisplatin and radiotherapy in this population have led to the popularization of the concept of treatment de-escalation. The recent results of the first 3 randomized de-escalation trials, however, have shown a clear detriment in survival when cisplatin is omitted or substituted. In view of these results, the Head and Neck Cancer International Group identified the need to issue guidance regarding future de-escalation studies for patients with HPV-positive head and neck cancer to avoid the possibility of patients being harmed. We review the current state of the literature regarding HPV de-escalation trials and present a framework and guidance on future and existing clinical trials for treatment de-escalation of HPV-positive OPC. De-escalation paradigms of HPV-positive OPC should be evaluated in phase II studies, and results should be awaited before proceeding to phase III studies. Implementation into clinical practice before high-level evidence is available should be undertaken in this context. Finally, harm-minimization techniques should also be evaluated as an alternative to de-escalation of treatment in these patient groups.
人乳头瘤病毒（HPV）阳性口咽癌（OPC）的发病率正在迅速上升。在这一人群中，标准护理顺铂和放疗具有更低的年龄、显著改善的预后和相对较低的发病率，这导致了治疗降级概念的普及。然而，最近 3 项随机降级试验的结果表明，当省略或替代顺铂时，生存明显受到损害。鉴于这些结果，头颈部癌症国际组织确定有必要就 HPV 阳性头颈部癌症患者的未来降级研究发布指导意见，以避免患者受到伤害的可能性。我们回顾了关于 HPV 降级试验的现有文献，并提出了一个关于 HPV 阳性 OPC 治疗降级的未来和现有临床试验的框架和指导。HPV 阳性 OPC 的降级方案应在 II 期研究中进行评估，在进行 III 期研究之前，应等待结果。在有高级别证据之前，应在这一背景下将其纳入临床实践。最后，还应评估伤害最小化技术作为这些患者群体治疗降级的替代方法。
