Perrone Anna Myriam, Ferioli Martina, Argnani Lisa, De Terlizzi Francesca, Pirovano Cecilia, Covarelli Piero, Dondi Giulia, Tesei Marco, De Crescenzo Eugenia, Ravegnini Gloria, Galuppi Andrea, Morganti Alessio G, De Iaco Pierandrea
Division of Oncologic Gynecology Unit, IRCCS-Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
Centro di Studio e Ricerca delle Neoplasie Ginecologiche (CSR), University of Bologna, 40138 Bologna, Italy.
Cancers (Basel). 2021 Apr 1;13(7):1622. doi: 10.3390/cancers13071622.
The ELECHTRA (ELEctroChemoTherapy vulvaR cAncer) project was conceived to collect data on palliative electrochemotherapy (ECT) in vulvar cancer (VC) assessing patients' outcomes (response and survival) and impact on quality of life (QoL). After reporting outcome data in 2019, here, we present the results on QoL. A multicenter prospective observational study was conducted on patients with VC refractory or not amenable to standard therapies undergoing palliative ECT as per clinical practice. The following questionnaires were administered before and after ECT (two and four months later, early and late follow-up): visual analog pain scale (VAS), EuroQol 5-Dimension 5-Level (EQ-5D-L5) and Functional Assessment of Cancer Therapy-Vulva cancer (FACT-V). Analyses were conducted on both the whole study population and by subgroups (clinical response after ECT and site, number and size of lesions). Questionnaires from 55 patients were evaluated. Compared to the baseline (6.1 ± 2.1), the VAS was significantly reduced at early (4.3 ± 2.5) and late follow-up (4.6 ± 2.8) ( < 0.0001). The FACT-V score improved significantly at early (9.6 ± 4.0) ( < 0.0001) and late follow-up (8.9 ± 4.1) ( < 0.0054) as compared to the baseline (7.1 ± 3.6). No EQ-5D-5L statistically significant changes were observed. Subgroup analyses showed worse QoL in patients with stable or progressive disease, posterior site and multiple or larger than 3 cm nodules. This is the first study reporting improved QoL in VC patients after palliative ECT. Based on these results, ECT in VC should be considered an effective option based on the favorable outcomes both in terms of response and QoL.
ELECHTRA(外阴癌电化学疗法)项目旨在收集有关外阴癌(VC)姑息性电化学疗法(ECT)的数据,评估患者的治疗结果(反应和生存率)以及对生活质量(QoL)的影响。在2019年报告了治疗结果数据之后,在此我们展示生活质量方面的结果。根据临床实践,对难治性或不适合标准疗法的VC患者进行了姑息性ECT的多中心前瞻性观察研究。在ECT之前和之后(两个月和四个月后,早期和晚期随访)发放了以下问卷:视觉模拟疼痛量表(VAS)、欧洲五维健康量表5级(EQ-5D-L5)和癌症治疗功能评估-外阴癌(FACT-V)。对整个研究人群以及亚组(ECT后的临床反应和部位、病变的数量和大小)进行了分析。评估了55名患者的问卷。与基线(6.1±2.1)相比,VAS在早期随访(4.3±2.5)和晚期随访(4.6±2.8)时显著降低(<0.0001)。与基线(7.1±3.6)相比,FACT-V评分在早期随访(9.6±4.0)(<0.0001)和晚期随访(8.9±4.1)(<0.0054)时显著改善。未观察到EQ-5D-5L有统计学意义的变化。亚组分析显示,疾病稳定或进展、病变位于后部以及有多个结节或结节大于3 cm的患者生活质量较差。这是第一项报告姑息性ECT后VC患者生活质量改善的研究。基于这些结果,考虑到在反应和生活质量方面的良好结果,VC中的ECT应被视为一种有效的选择。