Institute of Head and Neck Studies and Education (InHANSE), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, Edgbaston, Birmingham. B15 2TT, UK.
BMC Cancer. 2024 Jul 10;24(1):823. doi: 10.1186/s12885-024-12470-9.
Approximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies.
PETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.
We hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.
ISRCTN: 13,709,798; 15-Oct-2021.
大约 40%的头颈部癌症（HNC）治疗患者会出现复发。复发的风险随着治疗后的时间而降低。目前的指南建议在治疗后前两年每两个月进行一次临床随访，然后在接下来的三年内减少随访强度。然而，缺乏这些方案在检测复发方面有效性的证据，因此需要更灵活、以患者为中心的随访策略。
PETNECK2 是一项英国多中心研究项目，旨在研究一种新的随访模式，即使用正电子发射断层扫描-计算机断层扫描（PET-CT）引导、基于症状、由患者发起的监测。该模式正在一项非盲、非劣效性、三期、随机对照试验（RCT）中进行测试。在完成治愈性治疗一年后，无局部区域或远处转移的临床症状或体征的 HNC 患者将通过 1:1 分配比例随机分配至常规定期随访或 PET-CT 引导的、由患者发起的随访。复发风险较低（PET-CT 阴性）的患者将接受面对面的教育课程以及信息和支持（I&S）资源包，以监测症状并在需要时控制紧急预约的发起。RCT 的主要结局是总生存率。该 RCT 还具有内置的先导研究、嵌套的 QuinteT 招募干预（QRI）以及关于患者体验和对癌症复发恐惧（FCR）的嵌套混合方法研究。已完成初步的单臂可行性研究，该研究确定了患者发起的监测干预的可接受性、基线问卷的完成率，并在 RCT 实施之前优化了 I&S 资源。
我们假设，在治疗后额外增加 12 个月的 PET-CT 扫描和 I&S 资源，既可以识别无症状复发的患者，也可以识别那些未来复发风险较低的患者，从而使他们能够监测自己的症状，并在怀疑复发时尽早寻求临床随访。这种以患者为中心的护理模式的改变可能会对生活质量和对癌症复发的恐惧产生影响。
ISRCTN: 13709798；2021 年 10 月 15 日。
