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Quality of Life with Vulvar Carcinoma Treated with Palliative Electrochemotherapy: The ELECHTRA (ELEctroCHemoTherapy vulvaR cAncer) Study.

ABSTRACT: 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) (p < 0.0001). The FACT-V score improved significantly at early (9.6 ± 4.0) (p < 0.0001) and late follow-up (8.9 ± 4.1) (p < 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.

SUBMITTER: Perrone AM

PROVIDER: S-EPMC8036723 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:There is limited high-quality research investigating the efficacy of palliative radiation (PPR) with regard to symptoms and quality of life (QOL) among cancer patients with pelvic soft tissue tumors. As a result, clinicians are left with mainly retrospective studies, without reliable data on which to base treatment decisions. As a first step of a subsequent analysis of PPR's efficacy, we aimed to determine whether it is feasible to prospectively measure symptoms and QOL among patients treated with PPR. A secondary aim was to explore patients' willingness to answer existential questions in the setting of palliative pelvic radiation.Patients referred for palliative radiation of soft-tissue pelvic tumors were invited to enter the study. Symptoms were scored by study physicians and QOL was assessed by the EORTC QLQ C-30 questionnaire and site specific modules (PR25, CR38 or BL24) prior to start of radiation and 6 and 12 weeks after its completion. In addition, patients answered existential questions at each of the study visits. A radiation therapist was available to participants in order to answer their questions and ensure that questionnaires were completed.Five female and 17 male patients with prostate cancer (14), colorectal cancer (5) and bladder cancer (3) were included in the study. The median age of the participants was 75 years (range 62-90). Twenty patients were still in the study at the 6-week follow-up and 18 patients at the 12-week follow-up. Twenty-one patients had valid responses within all the EORTC QLQ C-30 scales at baseline, 20/20 at the 6-week follow-up and at the 12-week follow-up 17/18 patients still in the study had valid responses within all scales. This level of response was similar in the site-specific modules and among the existential questions.Among patients with prostate, colorectal and bladder cancer, compliance to questionnaires assessing symptoms, QOL and existential questions 6 and 12 weeks after PPR is sufficient to enable evaluation in a larger and more homogeneous patient group in order to reach clinically valid conclusions as to the efficacy of PPR.

Project description:BackgroundPeople with advanced cancer experience multiple symptoms during their illness trajectory, which can fluctuate in intensity.AimTo describe the course of self-reported quality of life, emotional functioning, physical functioning and symptom intensity over time in cancer patients receiving palliative care.DesignLongitudinal study with monthly assessments, using the EORTC QLQ-C15-PAL. Data were analysed (1) prospectively, from baseline to ≥8-month follow-up; and (2) retrospectively, by taking death as index date and comparing results from three cross-sectional subsamples at different stages of illness (time to death ≥6, 5-3 and 2-0 months). Linear mixed models were calculated.Setting/participantsA total of 1739 patients (mean age 66, 50% male) from 30 palliative care centers in 12 countries were included.ResultsIn prospective analyses, quality of life, functioning and symptoms-except nausea/vomiting-remained generally stable over time. In retrospective analyses, patients 2-0 months before death reported significantly lower quality of life and physical functioning scores than those 5-3 months before death, who in turn scored lower than those ≥6 months before death, suggesting progressive decline. Emotional functioning remained initially unchanged, but decreased in the last months. Pain, fatigue and appetite loss showed a stable increase in intensity towards death. Dyspnea, insomnia and constipation increased from 5-3 to 2-0 months before death. Nausea/vomiting only increased when comparing those ≥6 months before death with those 2-0 months before death.ConclusionWhile the prospective approach showed predominantly stable patterns for quality of life, functioning and symptom severity throughout study duration, retrospective analyses indicated that deterioration was already apparent before the terminal phase and accelerated close to death. Our findings support the importance of early symptom identification and treatment in this population, and highlight the need for further studies to explore what characterizes those with either lower or higher symptom burden at different time points towards death.

Dataset Information

Quality of Life with Vulvar Carcinoma Treated with Palliative Electrochemotherapy: The ELECHTRA (ELEctroCHemoTherapy vulvaR cAncer) Study.

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