Holland-Hart Daniella, Carucci Margherita, Slusarczyk Magdalena, Longo Mirella, Campbell Susan, Irving Alys, Noble Simon, Jayson Gordon, Hopewell-Kelly Noreen
Cardiff University, Cardiff, UK
Cardiff University, Cardiff, UK.
BMJ Open. 2025 Jul 13;15(7):e088474. doi: 10.1136/bmjopen-2024-088474.
VALTIVE1 is a multi-centre, single-arm, non-interventional biomarker study for patients with advanced ovarian cancer. Plasma samples (Tie2 concentration) are collected to detect vascular control in tumours during standard treatment with chemotherapy and bevacizumab. This qualitative study embedded in VALTIVE1 aimed to assess the acceptability and feasibility of a potential VALTIVE2 trial. It explored the participants' perceptions of the study and treatments and how they might feel if bevacizumab were discontinued based on the results from the biomarker test.
This qualitative study used semi-structured telephone interviews, which were analysed using deductive and inductive thematic analysis.
Cancer treatment sites in the UK.
Participants recruited to VALTIVE1 were invited to take part in qualitative interviews. 11 female participants took part from four clinical sites.
Participants reported that they experienced side effects attributed to bevacizumab, including stiffness, pain, fatigue, nose bleeds and muscle aches. Participants felt that combining chemotherapy and bevacizumab may have increased the severity of the side effects they experienced. Most participants felt that it was acceptable, if not preferable, to be allocated to a group in a future VALTIVE2 study where bevacizumab may be discontinued according to the results from the biomarker test. A clear preference of participants was to be informed of the biomarker test results, health status and treatment side effects.
A future trial should consider ensuring all participants have access to test results, as participants indicated a preference to know whether bevacizumab was working and to discontinue bevacizumab if it had not prevented tumour growth based on the biomarker results. Comprehensive and ongoing information and support regarding treatment side effects should be provided to all participants throughout their cancer pathways and trials.
NCT04523116.
VALTIVE1是一项针对晚期卵巢癌患者的多中心、单臂、非干预性生物标志物研究。收集血浆样本（Tie2浓度）以检测在化疗和贝伐单抗标准治疗期间肿瘤的血管控制情况。这项纳入VALTIVE1的定性研究旨在评估潜在的VALTIVE2试验的可接受性和可行性。它探讨了参与者对研究和治疗的看法，以及基于生物标志物测试结果停用贝伐单抗时他们可能的感受。
这项定性研究采用半结构化电话访谈，并使用演绎和归纳主题分析进行分析。
英国的癌症治疗场所。
招募到VALTIVE1的参与者被邀请参加定性访谈。来自四个临床场所的11名女性参与者参加了访谈。
参与者报告称他们经历了归因于贝伐单抗的副作用，包括僵硬、疼痛、疲劳、鼻出血和肌肉疼痛。参与者认为化疗和贝伐单抗联合使用可能增加了他们所经历副作用的严重程度。大多数参与者认为，在未来的VALTIVE2研究中，根据生物标志物测试结果可能停用贝伐单抗的分组方式是可以接受的，甚至是更可取的。参与者明确的偏好是被告知生物标志物测试结果、健康状况和治疗副作用。
未来的试验应考虑确保所有参与者都能获得测试结果，因为参与者表示倾向于了解贝伐单抗是否有效，以及如果根据生物标志物结果它未能阻止肿瘤生长就停用贝伐单抗。在所有参与者的癌症治疗过程和试验中，应提供关于治疗副作用的全面且持续的信息和支持。
NCT04523116。
