Defining a Standard Set of Patient-Reported Outcomes for Patients With Advanced Ovarian Cancer.

Purpose: Advanced ovarian cancer (AOC) and its treatment cause several symptoms and impact on patients' health-related quality of life (HRQoL). We aim to reach a consensus on the most relevant patient-reported outcome (PROs), the corresponding measures (PROMs), and measurement frequency during AOC patients' follow-up from patients' and healthcare professionals' (HCP) perspective. Methods: The project comprised five steps: 1) a literature review, 2) a focus group with patients, 3) a nominal group with HCP, 4) two round-Delphi consultations with patients and HCP, and 5) a final meeting with HCP. Delphi questionnaire was elaborated based on literature review, focus group (n=5 patients), and nominal group (n=16 HCP). The relevance of each PRO and the appropriateness (A) and feasibility (F) of the proposed PROM were assessed (Likert scale 1=strongly agree; 9=strongly disagree). The consensus was reached when at least 75% of the panelists rated it as 'relevant', 'appropriate', or 'feasible' (score 7-9). Results: A total of 56 HCP [51.8% Hospital Pharmacy; 41.1% Oncology; 3.6% Nursing; and 3.6% Psycho-oncology; mean time in specialty 12.5 (8.0) years] and 10 AOC patients [mean time diagnosis 5.4 (3.0) years] participated in the 1st round. All PROs achieved consensus regarding their relevance, except dry skin (58.0%). Agreement was reached for PRO-CTCAE to be used to assess fatigue (A:84.9%; F:75.8%), neuropathy (A:92.4%; F:77.3%), diarrhea (A:87.9%; F:88.7%), constipation (A:86.4%; F:75.8%), nausea (A:89.4%; F:75.8%), insomnia (A:81.8%; F:88.7%), abdominal bloating (A:82.2%; F:82.2%) and sexuality (A:78.8%; F:88.6%); EQ-5D to determine patients' HRQoL (A:87.9%; F:80.3%), pain (A:87.9%; F:75.8%) and mood (A:77.7%; F:85.5%); to assess treatment adherence the Morisky-Green (A:90.9%; F:84.9%) and the dispensing register (A:80.3%; F:80.3%) were chosen. It was agreed to note in the medical record whether the patient's treatment preferences had been considered during decision-making (A:78.8%; F:78.8%) and to use a 5-point Likert scale to assess treatment satisfaction (A:86.4%; F:86.4%). Panelists agreed (A:92.4%; F: 77.3%) to collect these PROs (1) at the time of diagnosis/relapse; (2) one month after starting treatment/change therapeutic strategy; (3) every three months during the 1st-year of treatment; and later (4) every six months until treatment completion/change. Conclusions: The consensus reached represents the first step towards including the patient's perspective in AOC follow-up. The standardized collection of PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care.

An olaparib window-of-opportunity trial in patients with early-stage endometrial carcinoma: POLEN study.

OBJECTIVE: Olaparib is a potent inhibitor of poly(ADP-ribose) polymerase (PARP)-1, 2, and 3 with potential activity in endometrial cancer (EC). METHODS: In this window-of-opportunity trial, women with operable type 1 EC received olaparib oral tablets (300mg) twice daily for 28days before surgery. The primary objective was to evaluate the effects of olaparib on EC in tissue samples taken at baseline and at treatment completion. Signal of activity was defined as significant changes in the expression of the cell cycle-related proteins cyclin D1, Ki67, and cleaved caspase-3. RESULTS: A total of 31 patients were included in the biomarker analysis. The median time of olaparib exposure was 24 days (1-39). Significant inhibition was found for cyclin D1 (p < 0.01), but not for Ki67 and active caspase 3 immunostaining. PARP-1 levels positively correlated with cyclin D1 levels (rho = 0.661, p = 0.0001). Both PARP-1 and cyclin D1 levels were significantly lower (p = 0.022 and p = 0.004, respectively) in patients with ARID1A[-] tumors than ARID1A[+] tumors. A significant relationship between plasma olaparib concentrations and decreased GLUT1 activity was observed (r = -0.5885; p < 0.05). Drug-related toxicity consisted mostly of gastrointestinal and grade 1 or 2 adverse events. CONCLUSIONS: Olaparib reduced expression of cyclin D1, which positively correlated with PARP-1 levels. This effect was more evident in ARID1A-deficient tumors. Olaparib further induced inhibition of GLUT1 plasma activity. Our findings could have noteworthy implications in predicting which patients with EC would benefit from olaparib-based strategies.

Role of parenteral nutrition in oncologic patients with intestinal occlusion and peritoneal carcinomatosis / Papel de la nutrición parenteral en pacientes oncológicos con oclusión intestinal y carcinomatosis peritoneal

Introduction and aims: the precise role of parenteral nutrition in the management of oncologic patients with intestinal occlusion is not well defined yet. We aimed to identify the effects of parenteral nutrition in these patients regarding prognosis. Material and methods: 55 patients with intestinal occlusion and peritoneal carcinomatosis were included. Parenteral nutrition aimed at 20-35 kcal/Kg/day, and 1.0 g/kg/day of amino-acids. Weight, body mass index, type of tumor, type of chemotherapy, and ECOG among others were recorded and analyzed. Results: 69.1% of the patients had gastrointestinal tumors, 18.2% gynecologic and 12.7% others. Age was 60 ± 13y, baseline ECOG 1.5 ± 0.5 and body mass index 21.6 ± 4.3. Malnutrition was present in 85%. Survival from the start of parenteral nutrition was not significant when considering baseline ECOG (log rank = 0.593, p = 0.743), previous lines of chemotherapy (log rank = 2.117, p = 0.548), baseline BMI (log rank = 2.686, p = 0.261), or type of tumor (log rank = 2.066, p = 0.356). Survival in patients who received home parenteral nutrition after hospital discharge was higher than those who stayed in-hospital (log rank = 7.090, p = 0.008). Survival in patients who started chemotherapy during or after parenteral nutrition was higher than those who did not so (log rank = 17.316, p < 0.001). A total of 3.6% of patients presented catheter related infection without affecting survival (log rank = 0.061, p = 0.804). Conclusions: Parenteral nutrition in patients with advanced cancer and intestinal occlusion is safe, and in those who respond to chemotherapy, further administration of home parenteral nutrition together with chemotherapy may enhance prolonged survival (AU)

Introducción y objetivos: el papel preciso de la nutrición parenteral en el manejo de los pacientes oncológicos con obstrucción intestinal no está bien definido todavía. El objetivo del presente trabajo es evaluar los efectos de la nutrición parenteral en este tipo de pacientes en cuanto al pronóstico. Material y métodos: fueron incluidos 55 pacientes con obstrucción intestinal y carcinomatosis peritoneal. La nutrición parenteral proporcionó 20-35 kcal/Kg/día y 1.0 g/kg/día de aminoácidos. El peso, el IMC, el tipo de tumor, el tipo de quimioterapia recibida y el ECOG, entre otras variables, fueron recogidas y analizadas. Resultados: un 69,1% de los pacientes presentaban tumors gastrointestinales, un 18,2% ginecológicos y otros tumores el 12,7% restante. La edad media fue de 60 ± 13 años, con un ECOG basal de 1,5 ± 0,5 y un IMC de 21,6 ± 4,3. La presencia de malnutrición fue de un 85%. La supervivencia desde el inicio de la nutrición parenteral no fue significativamente distinta entre los pacientes al considerar su ECOG basal (log rank = 0,593, p = 0,743), las líneas previas de quimioterapia recibida (log rank = 2,117, p = 0,548), el IMC basal (log rank = 2,686, p = 0,261), o el tipo de tumor (log rank = 2,066, p = 0,356). La supervivencia en los pacientes en que fue posible el alta hospitalaria con nutrición parenteral fue superior (log rank = 7,090, p = 0,008). La supervivencia en los pacientes en que se inició la quimioterapia durante o tras iniciar la nutrición parenteral fue también superior (log rank = 17,316, p < 0,001). Un total de 3,6% de los pacientes presentaron infección relacionada con el catéter sin afectar la supervivencia (log rank = 0,061, p = 0,804). Conclusión: la nutrición parenteral en los pacientes oncológicos con obstrucción intestinal y carcinomatosis peritoneal es segura y, en aquellos que responden a quimioterapia, el uso de la nutrición parenteral domiciliaria, junto con en tratamiento antitumoral activo, aumentan la supervivencia (AU)