Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 30
Filtrar
1.
Cancer Treat Res Commun ; 39: 100798, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38447475

RESUMEN

INTRODUCTION: We have shown in a Phase I trial that immediate adjuvant chemotherapy (IAC) during surgical resection and immediately postoperative is safe and feasible in patients with colon cancer (CC). IAC avoids delays in adjuvant treatment and has the potential to improve survival and quality of life. We aim to determine patients and providers attitudes toward this novel multidisciplinary treatment approach. METHODS: Two web-based surveys were administered to newly diagnosed CC patients, survivors, surgeons and oncologists. Surveys assessed treatment preferences and perceived barriers to IAC. Chi-square tests were conducted to compare differences between patients' and providers' responses. RESULTS: Responses were collected from 35 patients and 40 providers. Patients were more willing to: (1) proceed with IAC to finish treatment earlier thus possibly improving quality of life (p = 0.001); (2) proceed with IAC despite potential side effects (p < 0.001); and (3) proceed with a dose of intraoperative chemotherapy even if on final pathology, may not have been needed (p = 0.002). Patients were more likely to indicate no barriers to collaborative care (p = 0.001) while providers were more likely to cite that it is time consuming, thus a barrier to participation (p = 0.001), has scheduling challenges (p = 0.001), and physicians are not available to participate (p = 0.003). CONCLUSIONS: We observed a discordance between what providers and patients value in perioperative and adjuvant CC treatment. Patients are willing to accept IAC despite potential side effects and without survival benefit, highlighting the importance of understanding patient preference.


Asunto(s)
Neoplasias del Colon , Humanos , Neoplasias del Colon/tratamiento farmacológico , Neoplasias del Colon/cirugía , Neoplasias del Colon/psicología , Femenino , Masculino , Persona de Mediana Edad , Anciano , Quimioterapia Adyuvante/métodos , Actitud del Personal de Salud , Encuestas y Cuestionarios , Médicos/psicología , Calidad de Vida , Cuidados Intraoperatorios/métodos , Adulto
2.
Eur Ann Allergy Clin Immunol ; 55(4): 161-165, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-36515256

RESUMEN

Summary: Vespa velutina nigrithorax (VVN), commonly known as Asian wasp because endemic in Asia, represents an alien species in Europe. VVN can induce allergic reactions similar to those caused by other Hymenoptera and death after VVN stings, presumably due to fatal allergic reactions, has been reported. In the treatment of Hymenoptera venom hypersensitivity, specific immunotherapy (VIT) is highly effective. Currently, there is no specific available VIT for VVN, so it is relevant to assess if patients stung by VVN and showing allergic reactions could be treated with the Hymenoptera commercially available extracts Vespa crabro (VC) and Vespula spp (Vspp) or if they need the specific VIT with VVN venom extract. Methods. Four patients with a clinical history of systemic reactions after VVN sting were evaluated. Serum specific IgE were assayed quantitatively with an automated fluoro-enzyme immunoassay ImmunoCAP™ Specific IgE by Phadia™ 1000 System (Thermo Fisher Scientific, Uppsala, Sweden) for VC, Vspp and VVN. Cap inhibition assays were performed incubating serum samples with 200 µl of each venom at increasing concentrations and subsequently specific IgE against each of the venoms were determined in the samples by Phadia™ 250 System (Thermo Fisher Scientific, Uppsala, Sweden). Results. Our results suggested that both Vspp and VC venoms were able to inhibit the specific IgE for VVN, although the VC compared to the Vspp venom showed a higher inhibition. Conclusions. Our inhibition studies suggested that VIT with VC venom, nowadays when there is not specific available VIT for VVN, may be more effective than Vspp VIT in patients with VVN sting reactions.


Asunto(s)
Venenos de Artrópodos , Himenópteros , Hipersensibilidad , Mordeduras y Picaduras de Insectos , Hipersensibilidad al Veneno , Avispas , Animales , Humanos , Mordeduras y Picaduras de Insectos/terapia , Hipersensibilidad/diagnóstico , Hipersensibilidad/terapia , Hipersensibilidad/epidemiología , Venenos de Avispas/efectos adversos , Inmunoterapia , Inmunoglobulina E , Desensibilización Inmunológica/métodos
3.
J Clin Oncol ; 40(13): 1464-1473, 2022 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-35130043

RESUMEN

PURPOSE: GOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL). METHODS: Patients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study. Participants completed baseline (BL) surveys (symptom burden and controllability and QOL) before random assignment. WRITE interventions lasted 8 weeks to develop symptom management plans for three target symptoms. All women received EUC: monthly online symptom assessment with provider reports; online resources; and every 2-week e-mails. Outcomes were evaluated at 8 and 12 weeks after BL. Repeated-measures modeling with linear contrasts evaluated group by time effects on symptom burden, controllability, and QOL, controlling for key covariates. RESULTS: Participants (N = 497) reported mean age of 59.3 ± 9.2 years. At BL, 84% were receiving chemotherapy and reported a mean of 14.2 ± 4.9 concurrent symptoms, most commonly fatigue, constipation, and peripheral neuropathy. Symptom burden and QOL improved significantly over time (P < .001) for all three groups. A group by time interaction (P < .001) for symptom controllability was noted whereby both WRITE intervention groups had similar improvements from BL to 8 and 12 weeks, whereas EUC did not improve over time. CONCLUSION: Both WRITE Intervention groups showed significantly greater improvements in symptom controllability from BL to 8 and BL to 12 weeks compared with EUC. There were no significant differences between Nurse-WRITE and SD-WRITE. SD-WRITE has potential as a scalable intervention for a future implementation study.


Asunto(s)
Neoplasias Ováricas , Calidad de Vida , Anciano , Carcinoma Epitelial de Ovario , Fatiga , Femenino , Humanos , Persona de Mediana Edad , Neoplasias Ováricas/tratamiento farmacológico , Cuidados Paliativos , Evaluación de Síntomas
4.
Gynecol Oncol ; 164(2): 428-436, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34903380

RESUMEN

INTRODUCTION: Chemotherapy plus radiation (Cis-RT + CP) did not demonstrate superiority in prolonging relapse-free survival compared to chemotherapy alone in patients with stage III or IVA endometrial carcinoma. The impact of treatment on quality of life (QOL), neurotoxicity (NTX) and psychometric properties of the gastrointestinal (GI) symptoms subscale during treatment and up to 1 year are described herein. METHODS: QOL assessments were scheduled at baseline, 6 weeks (post completion of RT (Cis-RT + CP) or prior to cycle 3 (CP)), then 18 weeks (end of treatment) and 70 weeks (1 year after the end of treatment) after starting treatment. QOL instruments included the FACT-En TOI, FACT/GOG-neurotoxicity (Ntx) subscale (short), and the gastrointestinal (GI) symptoms subscale. RESULTS: At the end of treatment, patients receiving Cis-RT + CP reported a statistically significant decreased QOL when compared to CP. The decline in QOL was reflected in physical well-being, functional well-being, and endometrial cancer specific concerns, but the minimally important differences (MID) were not considered clinically meaningful. Patients in both groups reported increased chemotherapy-induced Ntx symptoms with the CP group having worse scores and reaching peak symptoms at the time of chemotherapy completion. Patients on Cis-RT + CP reported statistically significantly worse GI symptoms after radiation therapy compared to patients on CP, this occurred across assessment intervals, though the MID was not meaningful. Psychometric evaluations indicated that the GI symptom scale is reliable, valid, and responsive to change. CONCLUSIONS: PROs indicate that the chemoradiotherapy group experienced worse HRQoL and GI toxicity compared to patients randomized to chemotherapy alone for locally advanced endometrial cancer though based on the MID, these were not clinically meaningful differences. The GI symptom subscale was a reliable and valid scale that has value for future trials. TRIAL REGISTRATION: NCT00942357.


Asunto(s)
Quimioradioterapia Adyuvante , Quimioterapia Adyuvante , Neoplasias Endometriales/terapia , Enfermedades Gastrointestinales/fisiopatología , Enfermedades del Sistema Nervioso Periférico/fisiopatología , Calidad de Vida , Carboplatino/administración & dosificación , Cisplatino/administración & dosificación , Supervivencia sin Enfermedad , Neoplasias Endometriales/patología , Femenino , Estado Funcional , Enfermedades Gastrointestinales/epidemiología , Humanos , Estadificación de Neoplasias , Paclitaxel/administración & dosificación , Medición de Resultados Informados por el Paciente , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/epidemiología
5.
Gynecol Oncol ; 160(1): 244-251, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33109392

RESUMEN

OBJECTIVE: To assess quality of life (QOL) in patients who developed lower-extremity lymphedema (LLE) after radical gynecologic cancer surgery on prospective clinical trial GOG 244. METHODS: The prospective, national, cooperative group trial GOG-0244 determined the incidence of LLE and risk factors for LLE development, as well as associated impacts on QOL, in newly diagnosed patients undergoing surgery for endometrial, cervical, or vulvar cancer from 6/4/2012-11/17/2014. Patient-reported outcome (PRO) measures of QOL (by the Functional Assessment of Cancer Therapy [FACT]), body image, sexual and vaginal function, limb function, and cancer distress were recorded at baseline (within 14 days before surgery), and at 6, 12, 18, and 24 months after surgery. Assessments of LLE symptoms and disability were completed at the time of lower limb volume measurement. A linear mixed model was applied to examine the association of PROs/QOL with a Gynecologic Cancer Lymphedema Questionnaire (GCLQ) total score incremental change ≥4 (indicative of increased LLE symptoms) from baseline, a formal diagnosis of LLE (per the GCLQ), and limb volume change (LVC) ≥10%. RESULTS: In 768 evaluable patients, those with a GCLQ score change ≥4 from baseline had significantly worse QOL (p < 0.001), body image (p < 0.001), sexual and vaginal function (p < 0.001), limb function (p < 0.001), and cancer distress (p < 0.001). There were no significant differences in sexual activity rates between those with and without LLE symptoms. CONCLUSIONS: LLE is significantly detrimental to QOL, daily function, and body image. Clinical intervention trials to prevent and manage this chronic condition after gynecologic cancer surgery are needed.


Asunto(s)
Neoplasias de los Genitales Femeninos/cirugía , Linfedema/fisiopatología , Linfedema/psicología , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Pierna/patología , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/fisiopatología , Complicaciones Posoperatorias/psicología , Estudios Prospectivos , Calidad de Vida
6.
Mar Pollut Bull ; 160: 111605, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-33181918

RESUMEN

Polychlorinated biphenyls (PCBs) were quantified in sediments from the lower reaches of the Niger, Ase and Forcados Rivers in Nigeria with the aim of elucidating the sources, spatial characteristics and likely ecological and human health risks relating to exposure to PCBs in the sediments. A total of 28 PCB congeners, including 7 indicator PCBs and 12 dioxin-like PCBs, were identified and quantified after Soxhlet extraction with acetone/n-hexane/dichloromethane by gas chromatography-mass spectrometry. The Σ28 PCB concentrations in sediments from the Niger, Ase and Forcados Rivers ranged from 13.5 to 277 ng g-1, not detected to 1633 ng g-1 and 6.9 to 78.6 ng g-1 respectively. The PCB composition in sediments from these three rivers indicate the dominance of lower chlorinated (2-Cl to 5-Cl) congeners over higher chlorinated (6-Cl to 10-Cl) congeners. The ecological and human health risk assessment suggests potential risks for exposure of both organisms and humans to PCBs in sediments from these three river systems.


Asunto(s)
Bifenilos Policlorados , Contaminantes Químicos del Agua , Monitoreo del Ambiente , Sedimentos Geológicos , Humanos , Niger , Nigeria , Bifenilos Policlorados/análisis , Ríos , Contaminantes Químicos del Agua/análisis
7.
Int J Gynecol Cancer ; 30(5): 596-601, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-32114513

RESUMEN

INTRODUCTION: To describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab. METHODS: Summarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240. RESULTS: Of the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain. DISCUSSION: Patients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias del Cuello Uterino/tratamiento farmacológico , Privación de Tratamiento , Adulto , Anciano , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab/administración & dosificación , Bevacizumab/efectos adversos , Cisplatino/administración & dosificación , Cisplatino/efectos adversos , Femenino , Humanos , Persona de Mediana Edad , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Medición de Resultados Informados por el Paciente , Calidad de Vida , Topotecan/administración & dosificación , Topotecan/efectos adversos
8.
Gynecol Oncol ; 156(1): 131-139, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31759774

RESUMEN

BACKGROUND: Risk-reducing salpingo-oophorectomy (RRSO) and ovarian cancer screening (OCS) are management options for women at increased risk of ovarian cancer. Long-term effects of these interventions on quality of life (QOL) are not well understood. METHODS: GOG-0199 is a prospective cohort study of women at increased ovarian cancer risk who chose either RRSO or OCS as their risk management intervention. At study entry, 6, 12, 24 and 60 months of follow-up, participants completed the QOL questionnaire, which included the Medical Outcome Study Short Form-36, the Impact of Events Scales, the Center for Epidemiological Studies Depression Scale, the State-Trait Anxiety Inventory, the Functional Assessment of Cancer Therapy - Endocrine Subscale, and the Sexual Activity Questionnaire. QOL measures were compared between the RRSO and OCS cohort at baseline and over time. RESULTS: Five-hundred-sixty-two participants in the RRSO cohort and 1,010 in the OCS completed the baseline and at least one follow-up questionnaire. At baseline, participants selecting RRSO reported lower health-related QOL (HRQOL), greater ovarian cancer-related stress, greater anxiety, and more depressive symptomatology, which improved during follow-up, especially for ovarian cancer-related stress. Screening was not found to adversely impact HRQOL. Hormone-related menopausal symptoms worsened and sexual functioning declined during follow-up in both cohorts, but more so among participants who underwent RRSO. CONCLUSIONS: HRQOL improved after surgery among women who chose RRSO and remained stable among participants undergoing screening. The adverse effects of RRSO and screening on short-term and long-term sexual activity and sexual functioning warrant consideration in the decision-making process for high-risk women.


Asunto(s)
Detección Precoz del Cáncer/métodos , Neoplasias Ováricas/prevención & control , Salpingooforectomía/métodos , Adulto , Anciano , Estudios de Cohortes , Detección Precoz del Cáncer/psicología , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/psicología , Neoplasias Ováricas/cirugía , Estudios Prospectivos , Calidad de Vida , Salpingooforectomía/psicología
9.
Support Care Cancer ; 27(2): 531-538, 2019 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-30003341

RESUMEN

PURPOSE: Social determinants may influence health-related quality of life (HRQOL) among women with ovarian cancer, potentially creating disparities in clinical outcomes. We investigated the relationship between HRQOL and social determinants of health, including travel distance to access cancer care and health insurance type, among women participating in a randomized trial of primary adjuvant treatment for advanced ovarian cancer. METHODS: The Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire captured HRQOL (physical well-being, functional well-being, ovarian-specific, and trial outcome index [TOI]) prior to chemotherapy (baseline), during the trial, and 84 weeks after initiation of chemotherapy for women with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. We constructed bivariate and multivariable linear mixed effects models examining the associations of social determinants of health (individual-level and contextual factors) with HRQOL scores at 84 weeks, clustering participants (n = 993) within treatment centers, and Census regions and controlling for baseline HRQOL. RESULTS: Most individual-level (race, age, cancer stage, adverse events) and contextual (travel distance to treatment center, community socioeconomic status) factors were not statistically significantly associated with HRQOL. Compared to participants with private health insurance, other participants had lower mean HRQOL (physical well-being: public insurance, - 1.00 (standard error[SE] = 0.49) points, uninsured, - 1.93 (SE = 0.63) points; functional well-being: public, - 1.29 (SE = 0.59), uninsured, - 1.98 (SE = 0.76); ovarian cancer-specific: public, - 1.60 (SE = 0.59), uninsured, - 1.66 (SE = 0.75); TOI: public, - 3.81 (SE = 1.46), uninsured, - 5.51 (SE = 1.86); all p < .05). CONCLUSIONS: Private health insurance was associated with improved HRQOL at the completion of treatment for advanced stage ovarian cancer. Implications of health insurance on HRQOL should be further investigated, particularly among women with ovarian cancer who receive standard of care treatment.


Asunto(s)
Disparidades en el Estado de Salud , Neoplasias Ováricas/epidemiología , Neoplasias Ováricas/terapia , Calidad de Vida , Determinantes Sociales de la Salud , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma Epitelial de Ovario/economía , Carcinoma Epitelial de Ovario/epidemiología , Carcinoma Epitelial de Ovario/patología , Carcinoma Epitelial de Ovario/terapia , Progresión de la Enfermedad , Femenino , Accesibilidad a los Servicios de Salud/economía , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Humanos , Individualidad , Seguro de Salud/estadística & datos numéricos , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Ováricas/economía , Neoplasias Ováricas/patología , Clase Social , Determinantes Sociales de la Salud/economía , Determinantes Sociales de la Salud/estadística & datos numéricos , Encuestas y Cuestionarios , Adulto Joven
10.
Lancet Oncol ; 19(8): 1126-1134, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-30026002

RESUMEN

BACKGROUND: In the phase 3 SOLO2 trial (ENGOT Ov-21), maintenance therapy with olaparib tablets significantly prolonged progression-free survival (primary endpoint) compared with placebo in patients with a germline BRCA1 or BRCA2 (BRCA1/2) mutation and platinum-sensitive, relapsed ovarian cancer who had received two or more lines of previous chemotherapy. The most common subjective adverse effects included fatigue, nausea, and vomiting, which were typically low grade and self-limiting. Our a-priori hypothesis was that maintenance olaparib would not negatively affect health-related quality of life (HRQOL) and additionally that the prolongation of progression-free survival with olaparib would be underpinned by additional patient-centred benefits. METHODS: In SOLO2, 196 patients were randomly assigned to olaparib tablets (300 mg twice daily) and 99 to placebo. Randomisation was stratified by response to previous chemotherapy (complete vs partial) and length of platinum-free interval (>6-12 vs >12 months). The prespecified primary HRQOL analysis evaluated the change from baseline in the Trial Outcome Index (TOI) score during the first 12 months of the study. To be assessable, patients had to have an evaluable score at baseline and at least one evaluable follow-up form. Secondary planned quality-of-life (QOL) analyses included the duration of good quality of life (defined as time without significant symptoms of toxicity [TWiST] and quality-adjusted progression-free survival [QAPFS]). Efficacy and QOL outcomes were analysed in all randomly assigned patients (the full analysis set), and safety outcomes were analysed in all randomly assigned patients who received at least one dose of study drug. This ongoing study is registered with ClinicalTrials.gov, number NCT01874353, and is closed to new participants. FINDINGS: The adjusted average mean change from baseline over the first 12 months in TOI was -2·90 (95% CI -4·13 to -1·67) with olaparib and -2·87 (-4·64 to -1·10) with placebo (estimated difference -0·03; 95% CI -2·19 to 2·13; p=0·98). Mean QAPFS (13·96 [SD 10·96] vs 7·28 [5·22] months; difference 6·68, 95% CI 4·98-8·54) and mean duration of TWiST (15·03 [SD 12·79] vs 7·70 [6·42] months; difference 7·33, 95% CI 4·70-8·96) were significantly longer with olaparib than with placebo. INTERPRETATION: Olaparib maintenance therapy did not have a significant detrimental effect on HRQOL compared with placebo. There were clinically meaningful patient-centred benefits in both TWiST and QAPFS despite the adverse effects associated with olaparib. These patient-centred endpoints support the improvement in progression-free survival, the primary endpoint in SOLO2, and should be included in future trials of maintenance therapies. FUNDING: AstraZeneca.


Asunto(s)
Antineoplásicos/uso terapéutico , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Ftalazinas/uso terapéutico , Piperazinas/uso terapéutico , Calidad de Vida , Adulto , Anciano , Proteína BRCA1/genética , Proteína BRCA2/genética , Carcinoma Epitelial de Ovario/genética , Carcinoma Epitelial de Ovario/mortalidad , Femenino , Humanos , Quimioterapia de Mantención/métodos , Persona de Mediana Edad , Mutación , Supervivencia sin Progresión , Encuestas y Cuestionarios
11.
Lancet Oncol ; 16(3): 301-11, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25638326

RESUMEN

BACKGROUND: GOG 240 was a practice-changing randomised phase 3 trial that concluded that chemotherapy plus bevacizumab for advanced cervical cancer significantly improves overall and progression-free survival, and the proportion of patients achieving an overall objective response, compared with chemotherapy alone. In this study, we aimed to analyse patient-reported outcomes in GOG 240. METHODS: Eligible adult participants (aged ≥18 years) had primary stage IVB or recurrent or persistent carcinoma of the cervix with measurable disease and GOG performance status of 0-1. Participants were randomly assigned by web-based permuted block randomisation (block size 4) in a 1:1:1:1 ratio to the four treatment groups: cisplatin (50 mg/m(2) intravenously on day 1 or 2 of the treatment cycle) and paclitaxel (135 mg/m(2) intravenously over 24 h or 175 mg/m(2) intravenously over 3 h on day 1), with or without bevacizumab (15 mg/kg intravenously on day 1 or 2), or paclitaxel (175 mg/m(2) over 3 h on day 1) and topotecan (0·75 mg/m(2) for 30 min on days 1-3) with or without bevacizumab (15 mg/kg intravenously on day 1). Treatment assignment was concealed at randomisation (everyone was masked to treatment assignment, achieved by the use of a computer encrypted numbering system at the National Cancer Institute) and became open-label when each patient was registered to the trial. Treatment cycles were repeated every 21 days until disease progression or unacceptable toxicity, whichever occurred first. The coprimary endpoints of the trial were overall survival and safety; the primary quality-of-life endpoint was the score on the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index (FACT-Cx TOI). For our analysis of patient-reported outcomes, participants were assessed before treatment cycles 1, 2, and 5, and at 6 and 9 months after the start of cycle 1, with the FACT-Cx TOI, items from the FACT-GOG-Neurotoxicity subscale, and a worst pain item from the Brief Pain Inventory. All patients who completed baseline quality-of-life assessments and at least one further follow-up assessment were evaluable for quality-of-life outcomes. This study is registered with ClinicalTrials.gov, number NCT00803062. FINDINGS: Between April 6, 2009, and Jan 3, 2012, a total of 452 patients were enrolled in the trial, of whom 390 completed baseline quality-of-life assessment and at least one further assessment and were therefore evaluable for quality-of-life outcomes. In these patients, patient-reported outcome completion declined from 426 (94%) of 452 (at baseline) to 193 (63%) of 307 (9 months post-cycle 1), but completion rates did not differ significantly between treatment regimens (p=0·78). The baseline FACT-Cx TOI scores did not differ significantly between patients who received bevacizumab versus those who did not (p=0·27). Compared with patients who received chemotherapy alone, patients who received chemotherapy plus bevacizumab reported FACT-Cx TOI scores that were an average of 1·2 points lower (98·75% CI -4·1 to 1·7; p=0·30). INTERPRETATION: Improvements in overall survival and progression-free survival attributed to the incorporation of bevacizumab into the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life. Patients responding to anti-angiogenesis therapy who maintain an acceptable quality of life could be suitable at progression for treatment with other novel therapies that might confer additional benefit. FUNDING: National Institutes of Health.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma/irrigación sanguínea , Carcinoma/tratamiento farmacológico , Neoplasias del Cuello Uterino/irrigación sanguínea , Neoplasias del Cuello Uterino/tratamiento farmacológico , Adulto , Anciano , Inhibidores de la Angiogénesis/administración & dosificación , Anticuerpos Monoclonales Humanizados/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab , Carcinoma/mortalidad , Carcinoma/patología , Cisplatino/administración & dosificación , Supervivencia sin Enfermedad , Esquema de Medicación , Europa (Continente) , Femenino , Humanos , Infusiones Intravenosas , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Estadificación de Neoplasias , Paclitaxel/administración & dosificación , Modelos de Riesgos Proporcionales , Calidad de Vida , Factores de Riesgo , Encuestas y Cuestionarios , Factores de Tiempo , Topotecan/administración & dosificación , Resultado del Tratamiento , Estados Unidos , Neoplasias del Cuello Uterino/mortalidad , Neoplasias del Cuello Uterino/patología
12.
Gynecol Oncol ; 136(2): 323-7, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25529832

RESUMEN

OBJECTIVES: To describe characteristics associated with neurotoxicity (NT) in advanced ovarian cancer patients treated on Gynecologic Oncology Group 218 and examine effect of substituting docetaxel for paclitaxel in these patients. METHODS: The development of NT was defined as Common Toxicity Criteria grade (G)≥1. The association between substitution with docetaxel and NT improvement was explored with generalized estimating equations adjusting for treatment cycle and NT grading at previous cycle. RESULTS: Of 1864 evaluable patients, 1329 (71%) developed G≥1 NT during the study. Nearly half appeared within the first two cycles of chemotherapy, with 31% experiencing G≥2. Older patients or those with worse quality of life (QoL) scores at baseline (p<0.05) were more likely to experience NT. One-hundred-six patients received docetaxel as substitute for paclitaxel. Of them, 47 patients started with docetaxel at cycle one due to reaction to paclitaxel (n=32), fear of NT (n=4), and other reasons (n=11), whereas 59 patients switched to docetaxel during cycle 2-6 due to NT (n=32), reaction to paclitaxel (n=19), and other reasons (n=8). Although the protocol instructed otherwise, the majority continued paclitaxel despite G≥2 NT symptoms. There was no evidence that substitution with docetaxel improved NT (Odds Ratio: 1.57; 95% CI 0.98-2.54; p>0.05). Of 59 patients who switched to docetaxel, only seven (12%) discontinued taxane prior to chemotherapy completion. A roughly equal chance of worsening NT was reported on paclitaxel (6%) as on docetaxel (5%). CONCLUSIONS: Age and worse QoL at baseline are associated with NT. Substitution of docetaxel did not improve NT symptoms.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias Ováricas/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Anciano , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Bevacizumab , Docetaxel , Femenino , Humanos , Persona de Mediana Edad , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Enfermedades del Sistema Nervioso Periférico/prevención & control , Calidad de Vida , Taxoides/administración & dosificación , Taxoides/efectos adversos
13.
Cancer Prev Res (Phila) ; 5(10): 1173-82, 2012 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-22827974

RESUMEN

Shortened telomere length is associated with increased cancer incidence and mortality. Populations experiencing chronic stress have accelerated telomere shortening. In this exploratory study, we examined associations between longitudinal changes in patient reported outcomes (PRO) of psychologic distress and peripheral blood mononuclear cell (PBMC) telomere length to test the hypothesis that modulation of the chronic stress response would also modulate telomere dynamics. Archived PBMC specimens (N = 22) were analyzed from a completed and reported randomized, longitudinal trial that showed a psychosocial telephone counseling intervention improved quality of life (QOL) and modulated stress-associated biomarkers in cervical cancer survivors. PROs and biospecimens were collected at baseline and 4 months postenrollment. Telomere length of archived PBMCs was evaluated using the flow-FISH assay. Longitudinal changes in psychologic distress, measured by the Brief Symptom Inventory-18, were significantly associated with increased telomere length within the CD14(+) (monocyte) population (r = -0.46, P = 0.043); a similar trend was observed for the CD14(-) population. Longitudinal changes in telomere length of the CD14(-) subset, primarily T lymphocytes, were associated with longitudinal increases in the naive T-cell population (r = 0.49, P = 0.052). Alterations in the chronic stress response were associated with modulation of telomere length in PBMCs, with evidence for mobilization of "younger" cells from progenitor populations. These data provide preliminary support for the (i) capacity to modulate the chronic stress response and the associated accelerated telomere shortening, (ii) inclusion of telomere length in the biobehavioral paradigm, and (iii) potential link between the chronic stress response and biologic mechanisms responsible for genomic integrity and carcinogenesis.


Asunto(s)
Calidad de Vida , Estrés Psicológico/genética , Homeostasis del Telómero/genética , Neoplasias del Cuello Uterino/prevención & control , Femenino , Citometría de Flujo , Humanos , Inmunofenotipificación , Hibridación Fluorescente in Situ , Leucocitos Mononucleares/metabolismo , Estudios Longitudinales , Persona de Mediana Edad , Monocitos/citología , Monocitos/metabolismo , Proyectos Piloto , Linfocitos T/inmunología , Linfocitos T/metabolismo , Neoplasias del Cuello Uterino/genética , Neoplasias del Cuello Uterino/psicología
14.
Expert Rev Pharmacoecon Outcomes Res ; 12(3): 279-81, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22812551

RESUMEN

Most women with ovarian cancer will suffer a recurrence. Unfortunately, although initial treatment can lead to undetectable disease, recurrent disease is often more challenging to control. As curative intent is less common after relapse, patients and doctors argue for improving quality-of-life (QoL) outcomes when therapies are selected. The article reviewed here discusses the QoL results of a trial in platinum-sensitive recurrent ovarian cancer where over 900 patients were randomized to the standard treatment (carboplatin and paclitaxel) versus carboplatin and pegylated liposomal doxorubicin. In the paper under evaluation, the standard of care is challenged based on a favorable clinical outcome in addition to QoL results in the experimental arm.

15.
Gynecol Oncol ; 124(3): 379-82, 2012 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-22119995

RESUMEN

PURPOSE: To explore the association between baseline quality of life (QOL) scores and overall survival (OS) in ovarian cancer patients receiving adjuvant chemotherapy. METHODS: Patients with stage III ovarian cancer on Gynecologic Oncology Group protocol #172 completed the Functional Assessment of Cancer Therapy-General (FACT-G) and were then randomly assigned to either intravenous (IV) or intraperitoneal (IP) chemotherapy. The FACT scale includes physical, functional, social, and emotional well-being domains (PWB, FWB, SWB, EWB). The PWB item, lack of energy, was used to assess the presence of fatigue. RESULTS: After adjusting for patient age, treatment assignment, and the presence of gross disease, PWB was associated with OS. Patients who reported baseline PWB scores in the lowest 25% (PWB score<15 points) relative to those who scored in the highest 25% (PWB score>24 points) had decreased OS (HR: 1.81; 95% CI: 1.2-2.72; p=0.005). Patients experienced death rates 20% lower for every mean item point increase in PWB (Hazard Ratio [HR]: 0.80; 95% CI: 0.68-0.93; p=0.005). Patients complaining of fatigue did not have an increased risk of death compared with those not feeling fatigued (HR: 1.21; 95% CI: 0.91-1.61; p=0.19). CONCLUSIONS: Poor physical well-being reported at baseline is associated with risk of death in patients undergoing adjuvant chemotherapy for advanced ovarian cancer. Identifying modifiable characteristics that are associated with survival offers the potential for providing support that may improve outcomes.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/psicología , Calidad de Vida , Adulto , Anciano , Quimioterapia Adyuvante , Cisplatino/administración & dosificación , Fatiga/etiología , Fatiga/psicología , Femenino , Humanos , Infusiones Intravenosas , Infusiones Parenterales , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Ováricas/patología , Neoplasias Ováricas/cirugía , Paclitaxel/administración & dosificación , Tasa de Supervivencia
17.
Clin Cancer Res ; 14(7): 2111-8, 2008 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-18381952

RESUMEN

PURPOSE: Cancer diagnosis and treatment imparts chronic stressors affecting quality of life (QOL) and basic physiology. However, the capacity to increase survival by improving QOL is controversial. Patients with cervical cancer, in particular, have severely compromised QOL, providing a population well-suited for the evaluation of novel psychosocial interventions and the exploration of mechanisms by which modulation of the psychoneuroimmune axis might result in improved clinical outcomes. EXPERIMENTAL DESIGN: A randomized clinical trial was conducted in cervical cancer survivors that were enrolled at >or=13 and <22 months after diagnosis (n=50), comparing a unique psychosocial telephone counseling (PTC) intervention to usual care. QOL and biological specimens (saliva and blood) were collected at baseline and 4 months post-enrollment. RESULTS: The PTC intervention yielded significantly improved QOL (P=0.011). Changes in QOL were significantly associated with a shift of immune system T helper type 1 and 2 (Th1/Th2) bias, as measured by IFN-gamma/interleukin-5 ELISpot T lymphocyte precursor frequency; improved QOL being associated with increased Th1 bias (P=0.012). Serum interleukin-10 and the neuroendocrine variables of cortisol and dehydroepiandrosterone revealed trends supporting this shift in immunologic stance and suggested a PTC-mediated decrease of the subject's chronic stress response. CONCLUSIONS: This study documents the utility of a unique PTC intervention and an association between changes in QOL and adaptive immunity (T helper class). These data support the integration of the chronic stress response into biobehavioral models of cancer survivorship and suggests a novel mechanistic hypotheses by which interventions leading to enhanced QOL could result in improved clinical outcome including survival.


Asunto(s)
Consejo , Estrés Psicológico/inmunología , Estrés Psicológico/psicología , Neoplasias del Cuello Uterino/inmunología , Neoplasias del Cuello Uterino/psicología , Consejo/métodos , Deshidroepiandrosterona/sangre , Femenino , Humanos , Hidrocortisona/sangre , Inmunidad , Interferón gamma/sangre , Interleucina-10/sangre , Interleucina-5/sangre , Persona de Mediana Edad , Calidad de Vida/psicología , Teléfono , Células TH1/inmunología , Células Th2/inmunología
18.
Expert Rev Anticancer Ther ; 8(2): 227-41, 2008 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-18279064

RESUMEN

Supportive care is a multidimensional field, that involves caring for a patient's symptoms either during and/or after treatment. Ideally, once these supportive care needs are met, patients can enjoy an improved quality of life. Supportive care needs include all body systems, and are, therefore, difficult to manage, secondary to the fact that they require collaboration among multiple medical specialties. In this review, several components of supportive care are separated into two categories: tumor-related morbidities and treatment-related morbidities. Some of the themes discussed include nausea and vomiting, cancer pain, psychological distress, fatigue and anemia, small bowel obstruction and peripheral neuropathy. While all of these components are challenging to manage, it is perhaps the psychosocial realm that remains the most unmet need. Regardless, the oncologist must act as a facilitator who addresses these needs and, if unable to address the issue alone, knows how to steer the patient toward the appropriate provider. As these needs are met, the goal is for quality of life to improve; and with the improvement in quality of life we may expect to see improved survival outcomes.


Asunto(s)
Empatía , Neoplasias de los Genitales Femeninos/psicología , Neoplasias de los Genitales Femeninos/terapia , Cuidados Paliativos/métodos , Calidad de Vida , Apoyo Social , Salud de la Mujer , Terapia Combinada , Femenino , Neoplasias de los Genitales Femeninos/mortalidad , Humanos , Estadificación de Neoplasias , Pronóstico , Medición de Riesgo
19.
Genet Med ; 9(10): 705-12, 2007 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-18073584

RESUMEN

PURPOSE: The HEIRS Study screened 101,168 primary care participants for iron overload with serum transferrin saturation (TS), serum ferritin (SF), and C282Y and H63D mutations of the HFE gene. The objective of this study was to evaluate the impact of screening on participants' well-being. METHODS: All C282Y homozygotes, participants with an elevated TS and SF concentration, and a control group of phenotype-genotype negative persons, with neither C282Y nor H63D mutations in the HFE gene were recalled for a clinical evaluation. Health-related quality of life was assessed before screening and approximately 1 week after receipt of the results. Health worries were assessed only at follow-up. RESULTS: Participants (N = 1478) completed both initial and follow-up surveys. After adjusting for model covariates, phenotype and genotype combinations were statistically significant predictors of changes in psychological well-being (P = 0.0001) and general health (P = 0.0014). C282Y homozygotes with transient elevations in TS or SF were significantly more likely to worry about their health compared to study controls. Race, ethnicity, and preferred language subgroups differed on psychological well-being, general health, and health worry. CONCLUSION: Iron phenotype and HFE genotype are associated with health-related quality of life. Health worry was greatest among those considered genetically "at risk. " This may have important implications for multi-ethnic population-based screening studies in which genotype and phenotype are communicated.


Asunto(s)
Hemocromatosis/diagnóstico , Calidad de Vida , Grupos Raciales , Adulto , Femenino , Genotipo , Hemocromatosis/genética , Hemocromatosis/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Fenotipo
20.
Gynecol Oncol ; 107(2): 173-6, 2007 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-17950384

RESUMEN

OBJECTIVE: The unique characteristics of cancer, particularly issues involving the use of surrogate endpoints in clinical trials, present special challenges in the development of cancer drugs. In response, the U.S. Food and Drug Administration (FDA) has partnered with the American Society of Clinical Oncology, the American Association for Cancer Research, and the American Society of Hematology to conduct public workshops evaluating potential endpoints for drug approvals for the most common tumor types. METHODS: A workshop evaluating potential endpoints in ovarian cancer drug research was held in Bethesda, Maryland, in April 2006. Invited experts presented research findings and discussed endpoints in trials of drugs for treatment of Stage III and IV ovarian cancer. RESULTS: The panel responded to specific questions from FDA, discussing use of progression-free survival as a surrogate for overall survival and use of CA-125 levels as an indicator of response. Panel members also addressed endpoints in first-line therapy, second-line and subsequent therapy, and maintenance therapy. CONCLUSION: Expert commentary provided by panel members will inform FDA's draft guidance on clinical endpoints for cancer drug approvals and will be discussed at meetings of the FDA's Oncologic Drugs Advisory Committee. FDA intends to develop a set of principles that can be used to define efficacy standards for drugs used to treat ovarian and other cancers.


Asunto(s)
Biomarcadores de Tumor/sangre , Determinación de Punto Final , Neoplasias Ováricas/tratamiento farmacológico , Satisfacción del Paciente , Antineoplásicos , Investigación Biomédica , Antígeno Ca-125/sangre , Ensayos Clínicos como Asunto , Supervivencia sin Enfermedad , Aprobación de Drogas , Femenino , Ginecología , Estado de Salud , Humanos , Oncología Médica , Calidad de Vida , Sociedades Médicas , Resultado del Tratamiento , Estados Unidos , United States Food and Drug Administration
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA