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Abstract：
BACKGROUND: Trastuzumab has had a major impact on the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). Anti-HER2 biosimilars such as Ogivri have demonstrated safety and clinical equivalence to trastuzumab (using Herceptin as the reference product) in clinical trials. To our knowledge, there has been no real-world report of the side effects and quality of life (QoL) in patients treated with biosimilars using electronic patient-reported outcomes (ePROs).
OBJECTIVE: The primary objective of this prospective observational study (OGIPRO study) was to compare the ePRO data related to treatment side effects collected with the medidux app in patients with HER2-positive BC treated with the trastuzumab biosimilar Ogivri (prospective cohort) to those obtained from historical cohorts treated with Herceptin alone or combined with pertuzumab and/or chemotherapy (ClinicalTrials.gov NCT02004496 and NCT03578731).
METHODS: Patients were treated with Ogivri alone or combined with pertuzumab and/or chemotherapy and hormone therapy in (neo)adjuvant and palliative settings. Patients used the medidux app to dynamically record symptoms (according to the Common Terminology Criteria for Adverse Events [CTCAE]), well-being (according to the Eastern Cooperative Oncology Group Performance Status scale), QoL (using the EQ-5D-5L questionnaire), cognitive capabilities, and vital parameters over 6 weeks. The primary endpoint was the mean CTCAE score. Key secondary endpoints included the mean well-being score. Data of this prospective cohort were compared with those of the historical cohorts (n=38 patients; median age 51, range 31-78 years).
RESULTS: Overall, 53 female patients with a median age of 54 years (range 31-87 years) were enrolled in the OGIPRO study. The mean CTCAE score was analyzed in 50 patients with available data on symptoms, while the mean well-being score was evaluated in 52 patients with available data. The most common symptoms reported in both cohorts included fatigue, taste disorder, nausea, diarrhea, dry mucosa, joint discomfort, tingling, sleep disorder, headache, and appetite loss. Most patients experienced minimal (grade 0) or mild (grade 1) toxicities in both cohorts. The mean CTCAE score was comparable between the prospective and historical cohorts (29.0 and 30.3, respectively; mean difference -1.27, 95% CI -7.24 to 4.70; P=.68). Similarly, no significant difference was found for the mean well-being score between the groups treated with the trastuzumab biosimilar Ogivri and Herceptin (74.3 and 69.8, respectively; mean difference 4.45, 95% CI -3.53 to 12.44; P=.28).
CONCLUSIONS: Treatment of patients with HER2-positive BC with the trastuzumab biosimilar Ogivri resulted in equivalent symptoms, adverse events, and well-being as found for patients treated with Herceptin as determined by ePRO data. Hence, integration of an ePRO system into research and clinical practice can provide reliable information when investigating the real-world tolerability and outcomes of similar therapeutic compounds.
BACKGROUND: ClinicalTrials.gov NCT05234021; https://clinicaltrials.gov/study/NCT05234021.
OBJECTIVE: The primary objective of this prospective observational study (OGIPRO study) was to compare the ePRO data related to treatment side effects collected with the medidux app in patients with HER2-positive BC treated with the trastuzumab biosimilar Ogivri (prospective cohort) to those obtained from historical cohorts treated with Herceptin alone or combined with pertuzumab and/or chemotherapy (ClinicalTrials.gov NCT02004496 and NCT03578731).
METHODS: Patients were treated with Ogivri alone or combined with pertuzumab and/or chemotherapy and hormone therapy in (neo)adjuvant and palliative settings. Patients used the medidux app to dynamically record symptoms (according to the Common Terminology Criteria for Adverse Events [CTCAE]), well-being (according to the Eastern Cooperative Oncology Group Performance Status scale), QoL (using the EQ-5D-5L questionnaire), cognitive capabilities, and vital parameters over 6 weeks. The primary endpoint was the mean CTCAE score. Key secondary endpoints included the mean well-being score. Data of this prospective cohort were compared with those of the historical cohorts (n=38 patients; median age 51, range 31-78 years).
RESULTS: Overall, 53 female patients with a median age of 54 years (range 31-87 years) were enrolled in the OGIPRO study. The mean CTCAE score was analyzed in 50 patients with available data on symptoms, while the mean well-being score was evaluated in 52 patients with available data. The most common symptoms reported in both cohorts included fatigue, taste disorder, nausea, diarrhea, dry mucosa, joint discomfort, tingling, sleep disorder, headache, and appetite loss. Most patients experienced minimal (grade 0) or mild (grade 1) toxicities in both cohorts. The mean CTCAE score was comparable between the prospective and historical cohorts (29.0 and 30.3, respectively; mean difference -1.27, 95% CI -7.24 to 4.70; P=.68). Similarly, no significant difference was found for the mean well-being score between the groups treated with the trastuzumab biosimilar Ogivri and Herceptin (74.3 and 69.8, respectively; mean difference 4.45, 95% CI -3.53 to 12.44; P=.28).
CONCLUSIONS: Treatment of patients with HER2-positive BC with the trastuzumab biosimilar Ogivri resulted in equivalent symptoms, adverse events, and well-being as found for patients treated with Herceptin as determined by ePRO data. Hence, integration of an ePRO system into research and clinical practice can provide reliable information when investigating the real-world tolerability and outcomes of similar therapeutic compounds.
BACKGROUND: ClinicalTrials.gov NCT05234021; https://clinicaltrials.gov/study/NCT05234021.
摘要：
背景：曲妥珠单抗对人类表皮生长因子受体2（HER2）阳性乳腺癌（BC）的治疗产生了重大影响。抗HER2生物类似物如Ogivri在临床试验中已证明与曲妥珠单抗(使用赫赛汀作为参考产品)的安全性和临床等效性。据我们所知,对于使用电子患者报告结局(ePROs)的生物仿制药治疗患者的副作用和生活质量(QoL),目前尚无真实报道.
目的：这项前瞻性观察性研究（OGIPRO研究）的主要目的是比较在接受曲妥珠单抗生物相似物Ogivri（前瞻性队列）治疗的HER2阳性BC患者中，与治疗副作用相关的ePRO数据。从单独使用Herceptin或联合使用Pertuzinmab和/或N2007CT031N35ctoalv治疗的历史
方法：患者在（新）辅助和姑息治疗中单独使用Ogivri或与帕妥珠单抗和/或化疗和激素疗法联合使用。患者使用medidux应用程序动态记录症状（根据不良事件通用术语标准[CTCAE]），幸福感(根据东部肿瘤协作组绩效状态量表)，QoL(使用EQ-5D-5L问卷)，认知能力，和重要参数超过6周。主要终点是平均CTCAE评分。关键次要终点包括平均幸福感评分。将该前瞻性队列的数据与历史队列的数据进行比较（n=38例患者；中位年龄51，范围31-78岁）。
结果：总体而言，53名中位年龄为54岁（范围31-87岁）的女性患者被纳入OGIPRO研究。分析了50例患者的平均CTCAE评分，这些患者有关于症状的可用数据，而在有可用数据的52例患者中评估了平均幸福感评分。两个队列中最常见的症状包括疲劳，味觉障碍,恶心,腹泻,粘膜干燥，关节不适,刺痛,睡眠障碍,头痛,和食欲减退。大多数患者在两个队列中都经历了轻微（0级）或轻度（1级）毒性。前瞻性和历史队列的平均CTCAE评分具有可比性（分别为29.0和30.3；平均差-1.27，95％CI-7.24至4.70；P=.68）。同样，曲妥珠单抗生物相似物Ogivri和赫赛汀治疗组的平均健康评分无显著差异(分别为74.3和69.8;平均差异4.45,95%CI-3.53~12.44;P=.28).
结论：用曲妥珠单抗生物仿制药Ogivri治疗HER2阳性BC患者可产生等效症状，不良事件,以及通过ePRO数据确定的接受赫赛汀治疗的患者的健康状况。因此，当调查真实世界的耐受性和类似治疗化合物的结果时,将ePRO系统集成到研究和临床实践中可以提供可靠的信息.
背景：ClinicalTrials.govNCT05234021;https://clinicaltrials.gov/study/NCT05234021。
目的：这项前瞻性观察性研究（OGIPRO研究）的主要目的是比较在接受曲妥珠单抗生物相似物Ogivri（前瞻性队列）治疗的HER2阳性BC患者中，与治疗副作用相关的ePRO数据。从单独使用Herceptin或联合使用Pertuzinmab和/或N2007CT031N35ctoalv治疗的历史
方法：患者在（新）辅助和姑息治疗中单独使用Ogivri或与帕妥珠单抗和/或化疗和激素疗法联合使用。患者使用medidux应用程序动态记录症状（根据不良事件通用术语标准[CTCAE]），幸福感(根据东部肿瘤协作组绩效状态量表)，QoL(使用EQ-5D-5L问卷)，认知能力，和重要参数超过6周。主要终点是平均CTCAE评分。关键次要终点包括平均幸福感评分。将该前瞻性队列的数据与历史队列的数据进行比较（n=38例患者；中位年龄51，范围31-78岁）。
结果：总体而言，53名中位年龄为54岁（范围31-87岁）的女性患者被纳入OGIPRO研究。分析了50例患者的平均CTCAE评分，这些患者有关于症状的可用数据，而在有可用数据的52例患者中评估了平均幸福感评分。两个队列中最常见的症状包括疲劳，味觉障碍,恶心,腹泻,粘膜干燥，关节不适,刺痛,睡眠障碍,头痛,和食欲减退。大多数患者在两个队列中都经历了轻微（0级）或轻度（1级）毒性。前瞻性和历史队列的平均CTCAE评分具有可比性（分别为29.0和30.3；平均差-1.27，95％CI-7.24至4.70；P=.68）。同样，曲妥珠单抗生物相似物Ogivri和赫赛汀治疗组的平均健康评分无显著差异(分别为74.3和69.8;平均差异4.45,95%CI-3.53~12.44;P=.28).
结论：用曲妥珠单抗生物仿制药Ogivri治疗HER2阳性BC患者可产生等效症状，不良事件,以及通过ePRO数据确定的接受赫赛汀治疗的患者的健康状况。因此，当调查真实世界的耐受性和类似治疗化合物的结果时,将ePRO系统集成到研究和临床实践中可以提供可靠的信息.
背景：ClinicalTrials.govNCT05234021;https://clinicaltrials.gov/study/NCT05234021。
