Bandos Hanna, Kim Sungjin, Henry N Lynn, Hays Ron D, Calsavara Vinicius F, Luu Michael, Gresham Gillian, Lu Kit Y, Irvin William J, Suga J Marie, Siddique Shahzad, Cecchini Reena S, Rogatko André, Yothers Greg, Tighiouart Mourad, Ganz Patricia A
NRG Oncology SDMC, Pittsburgh, PA, United States.
Department of Biostatistics and Health Data Science, University of Pittsburgh, Pittsburgh, PA, United States.
JNCI Cancer Spectr. 2025 Apr 30;9(3). doi: 10.1093/jncics/pkaf032.
The PRO-CTCAE Measurement System was designed to enhance the quality of the standard toxicity evaluation in clinical trials. We developed a substudy within NRG-BR004, a phase III clinical trial in patients with newly documented HER2-positive metastatic breast cancer (MBC), to examine the added value and feasibility of frequent PRO-CTCAE data collection.
Patients were asked to complete 23 PRO-CTCAE items assessing 12 symptoms. Electronic PRO (ePRO) reporting was preferred; however, paper administration was allowed. The data on items assessed before treatment initiation, then weekly during Cycles 1-2 (12 weeks), are presented herein. Feasibility of frequent assessment with ePRO reporting was assessed using these data and was predefined as ≥25% of patients being compliant (submitted ≥75% of scheduled assessments). We also examined PRO-CTCAE and clinician-reported CTCAE data for key symptoms using maximum toxicity grade and the toxicity index (TI).
Overall, 80% of patients (82 of 103) were compliant with expected weekly assessments (90% CI = 0.72 to 0.86). For all symptoms, the median maximum grade (TI value) of clinician-reported CTCAE was lower than the median maximum score (TI value) of patient-reported PRO-CTCAE. The differences in the data trend for weekly vs less frequent assessment were more apparent when data were evaluated using the TI vs the maximum score.
Weekly assessments within the first two chemotherapy cycles were feasible in this trial of MBC patients. As expected, patients reported greater severity of symptoms than clinicians. Demonstrating the feasibility of frequent assessment could have implications for future research and clinical practice.
CLINICALTRIALS.GOV: NCT03199885 (https://clinicaltrials.gov/study/NCT03199885).
PRO-CTCAE测量系统旨在提高临床试验中标准毒性评估的质量。我们在NRG-BR004（一项针对新确诊的HER2阳性转移性乳腺癌（MBC）患者的III期临床试验）中开展了一项子研究，以检验频繁收集PRO-CTCAE数据的附加价值和可行性。
要求患者完成23项PRO-CTCAE条目，以评估12种症状。首选电子PRO（ePRO）报告；不过，也允许采用纸质报告。本文展示了治疗开始前以及第1-2周期（12周）每周评估的条目数据。利用这些数据评估了通过ePRO报告进行频繁评估的可行性，预先定义为≥25%的患者依从（提交≥75%的计划评估）。我们还使用最大毒性等级和毒性指数（TI）检查了关键症状的PRO-CTCAE数据和临床医生报告的CTCAE数据。
总体而言，80%的患者（103例中的82例）符合预期的每周评估要求（90%CI = 0.72至0.86）。对于所有症状，临床医生报告的CTCAE的中位最大等级（TI值）低于患者报告的PRO-CTCAE的中位最大评分（TI值）。当使用TI而非最大评分评估数据时，每周评估与不那么频繁评估的数据趋势差异更为明显。
在这项MBC患者试验中，在前两个化疗周期内进行每周评估是可行的。正如预期的那样，患者报告的症状严重程度高于临床医生。证明频繁评估的可行性可能会对未来的研究和临床实践产生影响。
NCT03199885（https://clinicaltrials.gov/study/NCT03199885）
