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Delayed Recovery and Increased Severity of Paclitaxel-Induced Peripheral Neuropathy in Patients With Diabetes

Pilar de la Morena Barrio, María Ángeles Vicente Conesa, Enrique González-Billalabeitia, Edgar Urrego, Elisa García-Garre, Elena García-Martínez, Marta Zafra Poves, Vicente Vicente, and Francisco Ayala de la Peña

Purpose: Although diabetes mellitus (DM) is recognized as a risk factor for chemotherapy-induced neurotoxicity, its true impact on intensity and time course of peripheral neuropathy is still unclear. The goal was to analyze the relevance of preexisting DM to weekly paclitaxel-induced peripheral neuropathy (PIPN). Methods: We performed a retrospective case-control study (1:2) including a total of 129 patients with breast cancer (43 with DM and 86 controls) treated with single-agent weekly paclitaxel (wP). Results: Compared with controls, patients with DM treated with wP experienced PIPN more frequently (74.4% vs 58.4%; P=.016) and with higher severity (grade 2–3: 51.2% vs 27.7%; P=.014). A significant delay in PIPN resolution was observed in women with DM (P=.001) and, in a multivariate analysis, DM was the only independent predictor for delayed recovery (hazard ratio [HR], 0.16; 95% CI, 0.05–0.55; P=.003). After 2 years, 68.7% of patients with DM (vs 29.2% of women without DM) still experienced PIPN, which was functionally significant (grade 2–3) in 18.2%. Conclusions: Significantly more dose delays and reductions because of PIPN occurred in patients with DM. Preexisting DM associates with long-lasting significant PIPN in patients treated with wP. Benefits and risks of long-term significant PIPN should be carefully balanced in patients with DM before starting wP chemotherapy.

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Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial

Sriram Yennurajalingam, Vicente Valero, Zhanni Lu, Diane D. Liu, Naifa L. Busaidy, James M. Reuben, Carolina Diaz Fleming, Janet L. Williams, Kenneth R. Hess, Karen Basen-Engquist, and Eduardo Bruera

Background: Despite the high frequency of cancer-related fatigue (CRF) and its debilitating effects on the quality of life of patients with advanced cancer, there are limited treatment options available. Treatments including physical activity (PA) or dexamethasone (Dex) improve CRF; however, they have lower adherence rates (PA) or long-term adverse effects (Dex). The aim of this study was to determine the feasibility of and preliminary results for the combination of PA and Dex in improving CRF. Methods: In this phase II randomized controlled trial, patients with advanced cancer and CRF scores of ≥4/10 on the Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks with either 4 mg of Dex (LoDex arm) or 8 mg of Dex (HiDex arm) twice a day for 7 days. Feasibility and change in the Functional Assessment of Cancer Illness Therapy-Fatigue subscale (FACIT-F) from baseline to day 8 and day 29 (primary outcome) were assessed. Secondary outcomes included changes in fatigue dimensions (FACIT-General, Patient-Reported Outcomes Measurement Information System [PROMIS]-Fatigue). Results: A total of 60 of 67 (90%) patients were evaluable. All patients were adherent to study medication. We found that 84% and 65% of patients in the LoDex arm and 96% and 68% of patients in the HiDex arm were adherent to aerobic and resistance exercise, respectively. The FACIT-F effect size in the LoDex arm was 0.90 (P<.001) and 0.92 (P<.001) and the effect size in the HiDex arm was 0.86 and 1.03 (P<.001 for both) at days 8 and 29, respectively. We found significant improvements in the Functional Assessment of Cancer Therapy-Physical (P≤.013) and the PROMIS-Fatigue (P≤.003) at days 8 and 29 in both arms. Mixed-model analysis showed a significant improvement in the FACIT-F scores at day 8 (P<.001), day 15 (P<.001), and day 29 (P=.002). Changes in the FACIT-F scores were not significantly different between patients in the 2 arms (P=.86). Conclusions: Our study found that the combination therapy of PA with Dex was feasible and resulted in the improvement of CRF. The improvement was seen for up to 3 weeks after the discontinuation of Dex. Further larger studies are justified.

ClinicalTrials.gov identifier: NCT02491632.

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QIM19-135: The Quality Oncology Practice Initiative Program: Experience in Spain

Rafael López, Antonio Antón, Enrique Aranda, Alfredo Carrato, Manuel Constenla, Juan Jesús Cruz, Eduardo Díaz-Rubio, Margarita Feyjóo, Jesús García-Foncillas, Pere Gascón, Vicente Guillem, Ilse Lugo, Álvaro Rogado, and Carlos Camps

Background: Patient quality care is a discipline that has acquired enormous relevance in today’s healthcare. The Quality Oncology Practice Initiative (QOPI) is a referral worldwide in terms of quality for oncology practices. The ECO Foundation is a foundation of experts representing the major Spanish hospitals involved in the treatment of cancer patients. ECO reached an agreement with ASCO to involve Spanish hospitals in the QOPI program. Methods: 6 rounds of data collection have taken place (Fall 2015 to Round 1 2018). Practices had to register online and submit data into the QOPI platform, and the ECO Foundation offered all centers the necessary support. 17 Spanish hospitals have participated in the 6 rounds, and 7 of them have repeated participation. Core and lung cancer modules were completed. Results: During the 6 rounds, 1,877 charts were submitted by the Spanish practices. In most of the rounds, the highest scores were: pathology report confirming malignancy; number of chemotherapy cycles documented; patient consent for chemotherapy; and 5 measures of the lung cancer module. The lowest scores were: chemotherapy treatment summary provided to patient within 3 months of chemotherapy end; chemotherapy treatment summary provided or communicated to practitioner(s) within 3 months of chemotherapy end; smoking/tobacco use cessation counselling recommended to smokers/tobacco users in past year; and tobacco cessation counselling administered or patient referred in past year. The percentage of participating practices that presented results higher than 70% was successively 64%, 50%, 75%, and 100% in the last 3 rounds. For the 7 hospitals that repeated participation, 3 reported an improvement of their global scores. Regarding QOPI Certification, 3 Spanish hospitals received this accreditation in September 2017 and one in June 2018. Conclusions: These preliminary results are a good starting point for the continued implementation of the QOPI program in Spain, thus providing a well-structured approach to analyze cancer care. The ECO Foundation will continue pursuing excellence and quality with further activities like the QOPI Certification program and Quality Training Program, these being performed for the first time in Spain in 2017 and 2018, respectively.

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Quality Indicators to Assure and Improve Cancer Care in Spain Using the Delphi Technique

Carlos Camps, Joan Albanell, Antonio Antón, Enrique Aranda, Alfredo Carrato, Javier Cassinello, Daniel Castellano, Juan J. Cruz, Pilar Garrido, Vicente Guillem, Cristina Grávalos, Guillermo López, César Llorente, Antonio Lorenzo, Ana Lluch, Emilio Ignacio, and Eduardo Díaz-Rubio

Background: The quality of cancer care has become a priority for health care systems. The goal of this research was to develop a set of evidence-based quality indicators (QIs) for organization, palliative care, and colorectal, breast, and lung cancers for introducing a system of benchmarking in Spain. Methods: A comprehensive evidence-based literature search was performed to identify potential QIs. An expert panel (the health care quality promotion group) of 9 oncologists identified indicators and evaluated them. A Delphi process involving 58 physicians was used to rank QIs by clinical relevance (validity). The expert panel then evaluated the selected indicators in terms of the feasibility of measuring them in Spanish hospitals, their usefulness for comparisons, their degree of clinical relevance, and their sensitivity to the impact of health care improvements. Results: From the literature review, 99 potential QIs were identified. The Delphi process shortened the list to 72 QIs. A final set of 57 QIs was established by the health care quality promotion group: 12 related to organizational issues, 11 to colorectal cancer, 11 to breast cancer, 12 to lung cancer, and 11 to palliative care. This final set included structure (n=2), process (n=36), and outcome (n=19) indicators. Conclusions: A set of QIs has been developed using a validated Delphi method, meaning that we can be confident of their validity, feasibility, sensitivity, and acceptability. These QIs are to serve as the basis of a strategy for benchmarking across oncology services in Spanish hospitals and should enable us to assure and improve the quality of cancer care.

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QIM19-125: Nonclinical Needs of Cancer Patients in Spain Under Different Perspectives: A Comparative Study

Juan Jesús Cruz, Isabel Ruiz Martin, Ana Fernandez, Rosana Martín, Enrique Aranda, Alfredo Carrato, Eduardo Díaz-Rubio, Vicente Guillem, Rafael López, Margarita Feyoo, Nerea Gonzalez-Garcia, Ana Nieto-Librero, Ramón Ferrer, Alicia Gonzalo, and Carlos Camps

Background: Patients with cancer and their caregivers express unmet needs beyond the clinical approach to cancer. The ECO Foundation (Quality and Excellence in Oncology) and the Spanish Association Against Cancer (AECC) have promoted a qualitative research study with the objective to identify and compare the perceptions of newly diagnosed and 2–3 years after diagnosis cancer patients, caregivers, oncologists, nurses, and social workers in relation to a set of nonclinical needs expressed by cancer patients and caregivers, and to obtain concrete and feasible proposals for improvement aimed at satisfying these needs. Methods: A multidisciplinary group of experts developed a questionnaire about information processes for cancer patients and caregivers, shared decision-making, satisfaction with healthcare circuits, the architecture of consultations, psychological support, support of associations, and the received support of hospital social workers. 14 Medical Oncology Services of Spanish hospitals have participated in this study collecting opinions from the study groups. 310 forms were collected, and data were statistically analyzed using Fisher's exact test. Results: Information processes: The opportunity to have a second opinion is positively valuated for 72.6% of patients and 70.2% of caregivers. However, although 62.5% of oncologists referred to offer this option to their patients, only 10.9% of patients reported having received it. Shared decision-making: For 58% of oncologists, patients are sufficiently trained to share decision-making, but only 24.6% of newly diagnosed patients consider being prepared. In addition, although 95.8% of oncologists report offering the participation of their patients in decision-making, only 45.8% of newly diagnosed patients and 64.4% of 2–3 years after diagnosis patients consider having received this opportunity. Psychological support: Psychological assistance was considered positive for 94.2% of the patients, 97.4% of the caregivers, 85.4% of the oncologists, and 97.1% of the nurses. However, only 21.3% of oncologists and 31.4% of nurses recognize offering such care to patients. Conclusions: Knowing the nonclinical needs, not only of patients and caregivers, but also from the healthcare professionals, is essential when designing health strategies that should align the perceptions of patients and healthcare professionals.