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1.
Cancer ; 130(10): 1747-1757, 2024 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-38236702

RESUMEN

BACKGROUND: Patient-reported outcomes (PROs) are a better tool for evaluating the experiences of patients who have symptomatic, treatment-associated adverse events (AEs) compared with clinician-rated AEs. The authors present PROs assessing health-related quality of life (HRQoL) and treatment-related neurotoxicity for adjuvant capecitabine versus platinum on the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) EA1131 trial (ClinicalTrials.gov identifier NCT02445391). METHODS: Participants completed the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) and the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale (platinum arm only) at baseline, cycle 3 day 1 (C3D1), 6 months, and 15 months. Because of early termination, power was insufficient to test the hypothesis that HRQoL, as assessed by the NFBSI-16 treatment side-effect (TSE) subscale, would be better at 6 and 15 months in the capecitabine arm; all analyses were exploratory. Means were compared by using t-tests or the Wilcoxon rank-sum test, and proportions were compared by using the χ2 test. RESULTS: Two hundred ninety-six of 330 eligible patients provided PROs. The mean NFBSI-16 TSE subscale score was lower for the platinum arm at baseline (p = .02; absolute difference, 0.6 points) and for the capecitabine arm at C3D1 (p = .04; absolute difference, 0.5 points), but it did not differ at other times. The mean change in TSE subscale scores differed between the arms from baseline to C3D1 (platinum arm, 0.15; capecitabine arm, -0.72; p = .03), but not from baseline to later time points. The mean decline in Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale scores exceeded the minimal meaningful change (1.38 points) from baseline to each subsequent time point (all p < .05). CONCLUSIONS: Despite the similar frequency of clinician-rated AEs, PROs identified greater on-treatment symptom burden with capecitabine and complemented clinician-rated AEs by characterizing patients' experiences during chemotherapy.


Asunto(s)
Capecitabina , Medición de Resultados Informados por el Paciente , Calidad de Vida , Neoplasias de la Mama Triple Negativas , Adulto , Anciano , Femenino , Humanos , Persona de Mediana Edad , Capecitabina/uso terapéutico , Capecitabina/efectos adversos , Quimioterapia Adyuvante/métodos , Neoplasia Residual , Platino (Metal)/uso terapéutico , Neoplasias de la Mama Triple Negativas/tratamiento farmacológico
2.
Support Care Cancer ; 31(3): 172, 2023 Feb 16.
Artículo en Inglés | MEDLINE | ID: mdl-36795229

RESUMEN

PURPOSE: This manuscript aims to compare and contrast acceptability and perceived benefits of yoga-skills training (YST) and an empathic listening attention control (AC) in the Pro-You study, a randomized pilot trial of YST vs. AC for adults receiving chemotherapy infusions for gastrointestinal cancer. METHODS: Participants were invited for a one-on-one interview at week 14 follow-up, after completing all intervention procedures and quantitative assessments. Staff used a semi-structured guide to elicit participants' views on study processes, the intervention they received, and its effects. Qualitative data analysis followed an inductive/deductive approach, inductively identifying themes and deductively guided by social cognitive theory. RESULTS: Some barriers (e.g., competing demands, symptoms), facilitators (e.g., interventionist support, the convenience of clinic-based delivery), and benefits (e.g., decreased distress and rumination) were common across groups. YST participants uniquely described the importance of privacy, social support, and self-efficacy for increasing engagement in yoga. Benefits specific to YST included positive emotions and greater improvement in fatigue and other physical symptoms. Both groups described some self-regulatory processes, but through different mechanisms: self-monitoring in AC and the mind-body connection in YST. CONCLUSIONS: This qualitative analysis demonstrates that participant experiences in a yoga-based intervention or an AC condition reflect social cognitive and mind-body frameworks of self-regulation. Findings can be used to develop yoga interventions that maximize acceptability and effectiveness and to design future research that elucidates the mechanisms by which yoga is efficacious.


Asunto(s)
Meditación , Yoga , Adulto , Humanos , Yoga/psicología , Autoeficacia , Investigación Cualitativa
3.
JMIR Form Res ; 7: e41354, 2023 Jan 10.
Artículo en Inglés | MEDLINE | ID: mdl-36626203

RESUMEN

BACKGROUND: Most patients diagnosed with colorectal cancer will survive for at least 5 years; thus, engaging patients to optimize their health will likely improve outcomes. Clinical guidelines recommend patients receive a comprehensive care plan (CP) when transitioning from active treatment to survivorship, which includes support for ongoing symptoms and recommended healthy behaviors. Yet, cancer care providers find this guideline difficult to implement. Future directions for survivorship care planning include enhancing information technology support for developing personalized CPs, using CPs to facilitate self-management, and assessing CPs in clinical settings. OBJECTIVE: We aimed to develop an electronic tool for colorectal cancer follow-up care (CFC) planning. METHODS: Incorporating inputs from health care professionals and patient stakeholders is fundamental to the successful integration of any tool into the clinical workflow. Thus, we followed the Integrate, Design, Assess, and Share (IDEAS) framework to adapt an existing application for stroke care planning (COMPASS-CP) to meet the needs of colorectal cancer survivors (COMPASS-CP CFC). Constructs from the Consolidated Framework for Implementation Research (CFIR) guided our approach. We completed this work in 3 phases: (1) gathering qualitative feedback from stakeholders about the follow-up CP generation design and workflow; (2) adapting algorithms and resource data sources needed to generate a follow-up CP; and (3) optimizing the usability of the adapted prototype of COMPASS-CP CFC. We also quantitatively measured usability (target average score ≥70; range 0-100), acceptability, appropriateness, and feasibility. RESULTS: In the first phase, health care professionals (n=7), and patients and caregivers (n=7) provided qualitative feedback on COMPASS-CP CFC that informed design elements such as selection, interpretation, and clinical usefulness of patient-reported measures. In phase 2, we built a minimal viable product of COMPASS-CP CFC. This tool generated CPs based on the needs identified by patient-completed measures (including validated patient-reported outcomes) and electronic health record data, which were then matched with resources by zip code and preference to support patients' self-management. Elements of the CFIR assessed revealed that most health care professionals believed the tool would serve patients' needs and had advantages. In phase 3, the average System Usability Scale score was above our target score for health care professionals (n=5; mean 71.0, SD 15.2) and patients (n=5; mean 95.5, SD 2.1). Participants also reported high levels of acceptability, appropriateness, and feasibility. Additional CFIR-informed feedback, such as desired format for training, will inform future studies. CONCLUSIONS: The data collected in this study support the initial usability of COMPASS-CP CFC and will inform the next steps for implementation in clinical care. COMPASS-CP CFC has the potential to streamline the implementation of personalized CFC planning to enable systematic access to resources that will support self-management. Future research is needed to test the impact of COMPASS-CP CFC on patient health outcomes.

4.
J Clin Oncol ; 40(34): 3998-4024, 2022 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-36122322

RESUMEN

PURPOSE: The aim of this joint guideline is to provide evidence-based recommendations to practicing physicians and other health care providers on integrative approaches to managing pain in patients with cancer. METHODS: The Society for Integrative Oncology and ASCO convened an expert panel of integrative oncology, medical oncology, radiation oncology, surgical oncology, palliative oncology, social sciences, mind-body medicine, nursing, and patient advocacy representatives. The literature search included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2021. Outcomes of interest included pain intensity, symptom relief, and adverse events. Expert panel members used this evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS: The literature search identified 227 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS: Among adult patients, acupuncture should be recommended for aromatase inhibitor-related joint pain. Acupuncture or reflexology or acupressure may be recommended for general cancer pain or musculoskeletal pain. Hypnosis may be recommended to patients who experience procedural pain. Massage may be recommended to patients experiencing pain during palliative or hospice care. These recommendations are based on an intermediate level of evidence, benefit outweighing risk, and with moderate strength of recommendation. The quality of evidence for other mind-body interventions or natural products for pain is either low or inconclusive. There is insufficient or inconclusive evidence to make recommendations for pediatric patients. More research is needed to better characterize the role of integrative medicine interventions in the care of patients with cancer.Additional information is available at https://integrativeonc.org/practice-guidelines/guidelines and www.asco.org/survivorship-guidelines.


Asunto(s)
Medicina Integrativa , Oncología Integrativa , Neoplasias , Adulto , Niño , Humanos , Neoplasias/complicaciones , Neoplasias/terapia , Dolor , Manejo del Dolor
5.
J Pain Symptom Manage ; 63(1): 23-32, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34343620

RESUMEN

CONTEXT: It is important to address fatigue and co-occurring symptoms during chemotherapy to preserve quality of life in patients with gastrointestinal (GI) cancer. OBJECTIVE: To conduct a randomized controlled pilot study of a Yoga Skills Training (YST) intervention compared to an attention control (AC) among adults diagnosed with GI cancer. METHODS: YST consisted of four 30-minute sessions delivered individually during chemotherapy plus home practice. AC provided empathic attention plus home diaries. Patient-reported (PROMIS T-score) assessments of fatigue, depressive symptoms, sleep disturbances, and psychological stress (Perceived Stress Scale) were collected at chemotherapy visits: baseline, Week 8, Week 10 and Week 14, and analyzed using a mixed effects model. Inflammatory cytokines were assessed at baseline and Week 10. RESULTS: Forty-four of 77 adults approached agreed to participate (57%; YST n = 23; AC n = 21). Participants' mean age was 58 years and 48% were men. Participants randomized to YST reported a larger decline in fatigue (-2.4 difference, d = 0.30) and depressive symptoms (-2.5 difference, d = 0.30) than AC participants from baseline to Week 10 and sleep disturbances at Week 8 (-3.9 difference, d = 0.50). Differences in magnitude of change in symptoms were consistent with or exceeded a minimally important difference. Psychological stress decreased more in the AC at Week 10 (d = 0.30). Reductions in inflammatory cytokines (IL-6, sTNF R1) were larger in the YST group than AC. CONCLUSION: YST showed promise for improving fatigue, depressive symptoms, sleep disturbances, and inflammation. YST is also feasible and reaches patients underrepresented in yoga research (i.e., GI cancer, men), thus warranting further examination.


Asunto(s)
Meditación , Yoga , Adulto , Atención , Fatiga/terapia , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Calidad de Vida , Yoga/psicología
6.
Oncologist ; 25(5): e798-e807, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-31852811

RESUMEN

BACKGROUND: The addition of bevacizumab to chemotherapy improved outcomes for patients with metastatic colon cancer. E5204 was designed to test whether the addition of bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery, could improve overall survival (OS) in patients with stage II/III adenocarcinoma of the rectum. SUBJECTS, MATERIALS, AND METHODS: Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled. Patients were randomized to mFOLFOX6 (Arm A) or mFOLFOX6 with bevacizumab (Arm B) administered every 2 weeks for 12 cycles. RESULTS: E5204 registered only 355 patients (17% of planned accrual goal) as it was terminated prematurely owing to poor accrual. At a median follow-up of 72 months, there was no difference in 5-year overall survival (88.3% vs. 83.7%) or 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%, p = .029).The most common grade 3-4 treatment-related AEs were neutropenia, leukopenia, neuropathy, diarrhea (without prior colostomy), and fatigue. CONCLUSION: At 17% of its planned accrual, E5204 did not meet its primary endpoint. The addition of bevacizumab to FOLFOX6 in the adjuvant setting did not significantly improve OS in patients with stage II/III rectal cancer. IMPLICATIONS FOR PRACTICE: At 17% of its planned accrual, E5204 was terminated early owing to poor accrual. At a median follow-up of 72 months, there was no significant difference in 5-year overall survival (88.3% vs. 83.7%) or in 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. Despite significant advances in the treatment of rectal cancer, especially in improving local control rates, the risk of distant metastases and the need to further improve quality of life remain a challenge. Strategies combining novel agents with chemoradiation to improve both distant and local control are needed.


Asunto(s)
Fluorouracilo , Neoplasias del Recto , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab/uso terapéutico , Quimioterapia Adyuvante , Supervivencia sin Enfermedad , Fluorouracilo/uso terapéutico , Humanos , Leucovorina/uso terapéutico , Estadificación de Neoplasias , Compuestos Organoplatinos/uso terapéutico , Oxaliplatino/uso terapéutico , Calidad de Vida , Neoplasias del Recto/tratamiento farmacológico , Neoplasias del Recto/radioterapia
7.
JAMA Oncol ; 6(3): 367-374, 2020 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-31566680

RESUMEN

Importance: A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit. Objective: To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone. Design, Setting, and Participants: In this secondary analysis of data from a multicenter randomized clinical trial, 1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100 were prospectively assigned to receive adjuvant chemotherapy in addition to endocrine therapy. The analysis was conducted on May 12, 2019. Interventions: The adjuvant chemotherapy regimen was selected by the treating physician. Main Outcomes and Measures: Freedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS]). Results: Among the 9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100. The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-fluorouracil in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%). Conclusions and Relevance: The estimated rate of freedom from recurrence of breast cancer at a distant site in women with an RS of 26 to 100 treated largely with taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population. Trial Registration: ClinicalTrials.gov identifier: NCT00310180.


Asunto(s)
Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/genética , Quimioterapia Adyuvante , Recurrencia Local de Neoplasia/genética , Adulto , Anciano , Antraciclinas/uso terapéutico , Hidrocarburos Aromáticos con Puentes/uso terapéutico , Ciclofosfamida/uso terapéutico , Docetaxel/uso terapéutico , Femenino , Fluorouracilo/uso terapéutico , Humanos , Metotrexato/uso terapéutico , Persona de Mediana Edad , Taxoides/uso terapéutico , Resultado del Tratamiento , Adulto Joven
8.
Cancer ; 125(22): 4059-4068, 2019 11 15.
Artículo en Inglés | MEDLINE | ID: mdl-31373682

RESUMEN

BACKGROUND: Oncology practice can be enhanced by the integration of the assessment of patient-reported symptoms and concerns into the electronic health record (EHR) and clinical workflows. METHODS: Adult oncology outpatients (n = 6825) received 38,422 invitations to complete assessments through the EHR patient portal. Patient-Reported Outcomes Measurement Information System computer adaptive tests were administered to assess fatigue, pain interference, physical function, depression, and anxiety. Checklists identified psychosocial, nutritional, and informational needs. In real time, assessment results were populated in the EHR, and clinicians were notified of elevated symptoms and needs. RESULTS: In all, 3521 patients (51.6%) completed 8162 assessments; approximately 55% of the responding patients completed 2 or more within 32 months. Fatigue, pain, anxiety, and depression scores were comparable to those of the general population (approximately 5% of assessments triggered clinical alerts across those domains); mean scores indicated a lower level of physical function (with severe scores prompting alerts in nearly 5% of assessments). More than half of assessments triggered an alert based on patient endorsement of supportive care needs, with the majority of those being nutritional (41.82% of assessments). Patient endorsement of supportive care needs was associated with significantly higher anxiety, depression, fatigue, and pain interference scores and lower physical function scores. Patients who triggered clinical alerts tended to be younger and more recently diagnosed, to have greater comorbidities, and to be a racial/ethnic minority. Patients who triggered clinical alerts had more health care service encounters in the ensuing month. CONCLUSIONS: EHR integration facilitated the assessment and reporting of patient-reported symptoms and needs within routine oncology outpatient care.


Asunto(s)
Instituciones Oncológicas , Detección Precoz del Cáncer/métodos , Registros Electrónicos de Salud , Informática Médica/métodos , Oncología Médica/métodos , Cuidados Paliativos , Humanos , Oncología Médica/normas , Cuidados Paliativos/métodos , Autoinforme , Encuestas y Cuestionarios
10.
Theranostics ; 7(11): 2914-2923, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28824725

RESUMEN

Background: Cancers related to tobacco use and African-American ancestry are under-characterized by genomics. This gap in precision oncology research represents a major challenge in the health disparities in the United States. Methods: The Precision Oncology trial at the Wake Forest Baptist Comprehensive Cancer Center enrolled 431 cancer patients from March 2015 to May 2016. The composition of these patients consists of a high representation of tobacco-related cancers (e.g., lung, colorectal, and bladder) and African-American ancestry (13.5%). Tumors were sequenced to identify mutations to gain insight into genetic alterations associated with smoking and/or African-American ancestry. Results: Tobacco-related cancers exhibit a high mutational load. These tumors are characterized by high-frequency mutations in TP53, DNA damage repair genes (BRCA2 and ATM), and chromatin remodeling genes (the lysine methyltransferases KMT2D or MLL2, and KMT2C or MLL3). These tobacco-related cancers also exhibit augmented tumor heterogeneities. Smoking related genetic mutations were validated by The Cancer Genome Atlas dataset that includes 2,821 cases with known smoking status. The Wake Forest and The Cancer Genome Atlas cohorts (431 and 7,991 cases, respectively) revealed a significantly increased mutation rate in the TP53 gene in the African-American subgroup studied. Both cohorts also revealed 5 genes (e.g. CDK8) significantly amplified in the African-American population. Conclusions: These results provide strong evidence that tobacco is a major cause of genomic instability and heterogeneity in cancer. TP53 mutations and key oncogene amplifications emerge as key factors contributing to cancer outcome disparities among different racial/ethnic groups.


Asunto(s)
Neoplasias Colorrectales/patología , Neoplasias Pulmonares/patología , Mutación , Fumar Tabaco/efectos adversos , Neoplasias de la Vejiga Urinaria/patología , Negro o Afroamericano , Humanos , Patología Molecular , Análisis de Secuencia de ADN , Proteína p53 Supresora de Tumor/genética , Población Blanca
11.
Cancer ; 123(3): 485-493, 2017 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-27861753

RESUMEN

BACKGROUND: Brief tools are needed to screen oncology outpatients for depressive symptoms. METHODS: Patients starting radiotherapy for the first diagnosis of any tumor completed distress screening tools, including the 9-item Patient Health Questionnaire (PHQ-9), the 2-item Patient Health Questionnaire (PHQ-2), the National Comprehensive Cancer Network Distress Thermometer (NCCN-DT), and the Hopkins Symptom Checklist (HSCL) (25-item version). Patients exceeding validated cutoff scores and a systematic sample of patients whose screening was negative completed the Structured Clinical Interview for DSM-IV (SCID) mood disorder modules via telephone. RESULTS: Four hundred sixty-three patients from 35 community-based radiation oncology sites and 2 academic radiation oncology sites were recruited. Sixty-six percent of the 455 eligible patients (n = 299) were women, and the eligible patients had breast (45%), gastrointestinal (11%), lung (10%), gynecologic (6%), or other cancers (27%). Seventy-five (16.5%) exceeded screening cutoffs for depressive symptoms. Forty-two of these patients completed the SCID. Another 37 patients whose screening was negative completed the SCID. Among the 79 patients completing the SCID, 8 (10.1%) met the criteria for major depression, 2 (2.5%) met the criteria for dysthymia, and 6 (7.6%) met the criteria for an adjustment disorder. The PHQ-2 demonstrated good psychometric properties for screening for mood disorders with a cutoff score of ≥3 (receiver operating characteristic area under the curve [AUC], 0.83) and was comparable to the PHQ-9 ( > 9; AUC = 0.85). The NCCN-DT did not detect depression (AUC = 0.59). CONCLUSIONS: The PHQ-2 demonstrated good psychometric properties for screening for mood disorders, which were equivalent to the PHQ-9 and superior to the NCCN-DT. These findings support using the PHQ-2 to identify patients in need of further assessment for depression, which has a low prevalence but is a clinically significant comorbidity. These findings could inform the implementation of distress screening accreditation standards. Cancer 2017;123:485-493. © 2016 American Cancer Society.


Asunto(s)
Trastorno Depresivo Mayor/diagnóstico , Neoplasias/epidemiología , Neoplasias/psicología , Radioterapia/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Trastorno Depresivo Mayor/epidemiología , Trastorno Depresivo Mayor/etiología , Trastorno Depresivo Mayor/patología , Femenino , Humanos , Masculino , Tamizaje Masivo , Persona de Mediana Edad , Neoplasias/complicaciones , Psicometría , Encuestas y Cuestionarios , Estados Unidos/epidemiología
12.
Lancet ; 387(10032): 2008-16, 2016 May 14.
Artículo en Inglés | MEDLINE | ID: mdl-26969090

RESUMEN

BACKGROUND: Renal-cell carcinoma is highly vascular, and proliferates primarily through dysregulation of the vascular endothelial growth factor (VEGF) pathway. We tested sunitinib and sorafenib, two oral anti-angiogenic agents that are effective in advanced renal-cell carcinoma, in patients with resected local disease at high risk for recurrence. METHODS: In this double-blind, placebo-controlled, randomised, phase 3 trial, we enrolled patients at 226 study centres in the USA and Canada. Eligible patients had pathological stage high-grade T1b or greater with completely resected non-metastatic renal-cell carcinoma and adequate cardiac, renal, and hepatic function. Patients were stratified by recurrence risk, histology, Eastern Cooperative Oncology Group (ECOG) performance status, and surgical approach, and computerised double-blind randomisation was done centrally with permuted blocks. Patients were randomly assigned (1:1:1) to receive 54 weeks of sunitinib 50 mg per day orally throughout the first 4 weeks of each 6 week cycle, sorafenib 400 mg twice per day orally throughout each cycle, or placebo. Placebo could be sunitinib placebo given continuously for 4 weeks of every 6 week cycle or sorafenib placebo given twice per day throughout the study. The primary objective was to compare disease-free survival between each experimental group and placebo in the intention-to-treat population. All treated patients with at least one follow-up assessment were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT00326898. FINDINGS: Between April 24, 2006, and Sept 1, 2010, 1943 patients from the National Clinical Trials Network were randomly assigned to sunitinib (n=647), sorafenib (n=649), or placebo (n=647). Following high rates of toxicity-related discontinuation after 1323 patients had enrolled (treatment discontinued by 193 [44%] of 438 patients on sunitinib, 199 [45%] of 441 patients on sorafenib), the starting dose of each drug was reduced and then individually titrated up to the original full doses. On Oct 16, 2014, because of low conditional power for the primary endpoint, the ECOG-ACRIN Data Safety Monitoring Committee recommended that blinded follow-up cease and the results be released. The primary analysis showed no significant differences in disease-free survival. Median disease-free survival was 5·8 years (IQR 1·6-8·2) for sunitinib (hazard ratio [HR] 1·02, 97·5% CI 0·85-1·23, p=0·8038), 6·1 years (IQR 1·7-not estimable [NE]) for sorafenib (HR 0·97, 97·5% CI 0·80-1·17, p=0·7184), and 6·6 years (IQR 1·5-NE) for placebo. The most common grade 3 or worse adverse events were hypertension (105 [17%] patients on sunitinib and 102 [16%] patients on sorafenib), hand-foot syndrome (94 [15%] patients on sunitinib and 208 [33%] patients on sorafenib), rash (15 [2%] patients on sunitinib and 95 [15%] patients on sorafenib), and fatigue 110 [18%] patients on sunitinib [corrected]. There were five deaths related to treatment or occurring within 30 days of the end of treatment; one patient receiving sorafenib died from infectious colitis while on treatment and four patients receiving sunitinib died, with one death due to each of neurological sequelae, sequelae of gastric perforation, pulmonary embolus, and disease progression. Revised dosing still resulted in high toxicity. INTERPRETATION: Adjuvant treatment with the VEGF receptor tyrosine kinase inhibitors sorafenib or sunitinib showed no survival benefit relative to placebo in a definitive phase 3 study. Furthermore, substantial treatment discontinuation occurred because of excessive toxicity, despite dose reductions. These results provide a strong rationale against the use of these drugs for high-risk kidney cancer in the adjuvant setting and suggest that the biology of cancer recurrence might be independent of angiogenesis. FUNDING: US National Cancer Institute and ECOG-ACRIN Cancer Research Group, Pfizer, and Bayer.


Asunto(s)
Antineoplásicos/administración & dosificación , Carcinoma de Células Renales/tratamiento farmacológico , Indoles/administración & dosificación , Neoplasias Renales/tratamiento farmacológico , Niacinamida/análogos & derivados , Compuestos de Fenilurea/administración & dosificación , Pirroles/administración & dosificación , Administración Oral , Antineoplásicos/efectos adversos , Carcinoma de Células Renales/mortalidad , Quimioterapia Adyuvante/mortalidad , Supervivencia sin Enfermedad , Método Doble Ciego , Esquema de Medicación , Femenino , Humanos , Indoles/efectos adversos , Neoplasias Renales/mortalidad , Masculino , Persona de Mediana Edad , Niacinamida/administración & dosificación , Niacinamida/efectos adversos , Compuestos de Fenilurea/efectos adversos , Pirroles/efectos adversos , Sorafenib , Sunitinib , Resultado del Tratamiento
13.
J Community Support Oncol ; 13(12): 423-8, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26863872

RESUMEN

The recommendations of numerous groups, such as the Institute of Medicine and the National Comprehensive Cancer Network, have resulted in the first regulatory standard on distress screening in oncology implemented in 2015 by the American College of Surgeons Commission on Cancer. This practice-changing standard promises to result in better quality cancer care, but presents unique challenges to many centers struggling to provide high-quality practical assessment and management of distress. The current paper reviews the history behind the CoC standard, identifies the most prevalent symptoms underlying distress, and discusses the importance of distress screening. We also review some commonly used instruments for assessing distress, and address barriers to implementation of screening and management.

14.
J Clin Oncol ; 30(11): 1154-9, 2012 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-22412134

RESUMEN

There is a growing consensus that psychosocial care should be integrated into the routine care of patients with cancer. This consensus is consistent with the considerable body of evidence about the deleterious effects of allowing psychosocial needs to remain unmet and the growing body of evidence about the beneficial effects of providing psychosocial services to address unmet needs. Despite this evidence, available data suggest that a considerable portion of the population of patients with cancer does not receive needed psychosocial care. Three lines of professional activity initiated in recent years have the potential to address this issue in fundamental ways: the formulation of standards of cancer care that address the psychosocial component of care, the issuance of clinical practice guidelines for psychosocial care of patients with cancer, and the development and implementation of measurable indicators of the quality of psychosocial care in oncology settings. This article provides an overview of accomplishments in each of these areas; it is designed to ensure that oncologists and other cancer treatment providers are knowledgeable about current standards for psychosocial care, existing consensus- and evidenced-based recommendations for clinical practice in this area, and resources and tools for evaluating and, if indicated, improving the quality of the psychosocial care their patients are receiving. The article concludes with a critical appraisal of these activities and a consideration of how current efforts might be enhanced.


Asunto(s)
Prestación Integrada de Atención de Salud , Neoplasias/psicología , Neoplasias/terapia , Calidad de la Atención de Salud , Humanos , Guías de Práctica Clínica como Asunto
15.
Oncology (Williston Park) ; 21(11 Suppl 5): 34-6, 2007 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-18154217

RESUMEN

Dermatologic toxicities associated with EGFR inhibitors can have a profound impact on patients' health-related quality of life (HRQL) and may interfere with treatment adherence. We interviewed 20 patients and 12 expert clinicians to identify the most bothersome aspects of dermatologic toxicities to better understand the impact on patients' HRQL Patients and expert clinicians reported that dermatologic toxicities have an impact on patients' physical, functional, emotional, and social well-being. Patients identified the physical discomfort as having the most impact on their HRQL, specifically the sensations of pain, burning, and skin sensitivity. Patients experienced worry, frustration, and depression because of their dermatologic symptoms and reported withdrawing from social activities. Cognitive behavioral strategies such as guided imagery and symptom reframing (eg, rash means treatment is working) may provide patients with valuable skills for the management of this physical discomfort. Cognitive behavioral strategies may also be useful in helping patients manage anxiety and depression associated with any changes in their social function caused by skin rash, as well as distress associated with having a cancer diagnosis.


Asunto(s)
Antineoplásicos/efectos adversos , Erupciones por Medicamentos/psicología , Receptores ErbB/antagonistas & inhibidores , Calidad de Vida , Adulto , Anciano , Antineoplásicos/uso terapéutico , Ansiedad , Depresión , Erupciones por Medicamentos/terapia , Emociones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor , Encuestas y Cuestionarios
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