Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.
Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.
Int J Radiat Oncol Biol Phys. 2023 Aug 1;116(5):1110-1125. doi: 10.1016/j.ijrobp.2023.02.041. Epub 2023 Mar 1.
This secondary analysis of clinical trial TROG 12.01, involving patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma, aimed to identify patient-reported outcome (PRO) trajectories before, during, and after chemoradiotherapy.
Head and neck cancer symptom severity (HNSS) and interference (HNSI), generic health-related quality of life (HRQL), and emotional distress were assessed with the MD Anderson Symptom Inventory-Head and Neck, Functional Assessment of Cancer Therapy-General, and Hospital Anxiety and Depression Scale questionnaires, respectively. Latent class growth mixture modeling (LCGMM) was used to identify distinct underlying trajectories. Baseline and treatment variables were compared between trajectory groups.
The LCGMM identified latent trajectories for all PROs: HNSS, HNSI, HRQL, anxiety, and depression. Four HNSS trajectories (HNSS1-4) were identified, distinguished by differences in HNSS at baseline, during the peak of treatment symptoms, and during early and intermediate recovery. All trajectories were stable beyond 12 months. The reference trajectory (HNSS4, n = 74) score was 0.1 (95% confidence interval [CI], 0.1-0.2) at baseline, peaking at 4.6 (95% CI, 4.2-5.0), with rapid early recovery (1.1; 95% CI, 0.8-2.2) and gradual improvement to 12 months (0.6; 95% CI, 0.5-0.8). Patients in HNSS2 (high baseline, n = 30) reported higher baseline scores (1.4; 95% CI, 0.8-2.0) but were otherwise similar to HNSS4. Patients in HNSS3 (low acute, n = 53) reported reduced acute symptoms (2.5; 95% CI, 2.2-2.9) with stable scores beyond 9 weeks after chemoradiotherapy (1.1; 95% CI, 0.9-1.4). Patients in HNSS1 (slow recovery, n = 25) had slower recovery from an acute peak of 4.9 (95% CI, 4.3-5.6) to 0.9 (95% CI, 0.6-1.3) at 12 months. Age, performance status, education, receipt of cetuximab, and baseline anxiety varied between trajectories. The other PRO models demonstrated clinically relevant trajectories, with distinct associations with baseline factors.
LCGMM identified distinct PRO trajectories during and after chemoradiotherapy. These and their associations with variations in the characteristics and treatment factors of patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma provide clinically relevant insights into identifying patients who may require increased support before, during, or after chemoradiotherapy.
本研究为临床试验 TROG 12.01 的二次分析,涉及人乳头瘤病毒相关口咽鳞状细胞癌患者,旨在确定放化疗前后患者报告的结局(PRO)轨迹。
使用 MD 安德森症状量表-头颈部、癌症治疗功能评估-一般和医院焦虑和抑郁量表分别评估头颈部癌症症状严重程度(HNSS)和干扰(HNSI)、一般健康相关生活质量(HRQL)和情绪困扰。采用潜在类别增长混合模型(LCGMM)识别不同的潜在轨迹。比较轨迹组之间的基线和治疗变量。
LCGMM 确定了所有 PRO 的潜在轨迹:HNSS、HNSI、HRQL、焦虑和抑郁。确定了四个 HNSS 轨迹(HNSS1-4),其区别在于基线、治疗症状高峰期以及早期和中期恢复期间的 HNSS 差异。所有轨迹在 12 个月后均保持稳定。参考轨迹(HNSS4,n=74)基线得分 0.1(95%置信区间 [CI],0.1-0.2),峰值为 4.6(95% CI,4.2-5.0),早期快速恢复(1.1;95% CI,0.8-2.2),12 个月时逐渐改善(0.6;95% CI,0.5-0.8)。HNSS2(基线高,n=30)患者报告基线时评分较高(1.4;95% CI,0.8-2.0),但其余方面与 HNSS4 相似。HNSS3(急性低,n=53)患者报告急性症状减轻(2.5;95% CI,2.2-2.9),放化疗后 9 周以上评分稳定(1.1;95% CI,0.9-1.4)。HNSS1(恢复缓慢,n=25)从急性峰值 4.9(95% CI,4.3-5.6)到 12 个月时的 0.9(95% CI,0.6-1.3)恢复较慢。年龄、表现状态、教育程度、接受西妥昔单抗治疗以及基线焦虑程度在不同轨迹之间存在差异。其他 PRO 模型显示出具有临床意义的轨迹,与患者人乳头瘤病毒相关口咽鳞状细胞癌特征和治疗因素的变化有明显关联。
LCGMM 在放化疗期间和之后确定了不同的 PRO 轨迹。这些轨迹及其与 HPV 相关口咽鳞状细胞癌患者特征和治疗因素变化的关联,为确定在放化疗前、期间或之后可能需要更多支持的患者提供了具有临床意义的见解。