RESUMEN
IMPORTANCE: The most appropriate dose fractionation for whole-breast irradiation (WBI) remains uncertain. OBJECTIVE: To assess acute and 6-month toxic effects and quality of life (QOL) with conventionally fractionated WBI (CF-WBI) vs hypofractionated WBI (HF-WBI). DESIGN, SETTING, AND PARTICIPANTS: Unblinded randomized trial of CF-WBI (n = 149; 50.00 Gy/25 fractions + boost [10.00-14.00 Gy/5-7 fractions]) vs HF-WBI (n = 138; 42.56 Gy/16 fractions + boost [10.00-12.50 Gy/4-5 fractions]) following breast-conserving surgery administered in community-based and academic cancer centers to 287 women 40 years or older with stage 0 to II breast cancer for whom WBI without addition of a third field was recommended; 76% of study participants (n = 217) were overweight or obese. Patients were enrolled from February 2011 through February 2014 and observed for a minimum of 6 months. INTERVENTIONS: Administration of CF-WBI or HF-WBI. MAIN OUTCOMES AND MEASURES: Physician-reported acute and 6-month toxic effects using National Cancer Institute Common Toxicity Criteria, and patient-reported QOL using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). All analyses were intention to treat, with outcomes compared using the χ2 test, Cochran-Armitage test, and ordinal logistic regression. RESULTS: Of 287 participants, 149 were randomized to CF-WBI and 138 to HF-WBI. Treatment arms were well matched for baseline characteristics, including FACT-B total score (HF-WBI, 120.1 vs CF-WBI, 118.8; P = .46) and individual QOL items such as somewhat or more lack of energy (HF-WBI, 38% vs CF-WBI, 39%; P = .86) and somewhat or more trouble meeting family needs (HF-WBI, 10% vs CF-WBI, 14%; P = .54). Maximum physician-reported acute dermatitis (36% vs 69%; P < .001), pruritus (54% vs 81%; P < .001), breast pain (55% vs 74%; P = .001), hyperpigmentation (9% vs 20%; P = .002), and fatigue (9% vs 17%; P = .02) during irradiation were lower in patients randomized to HF-WBI. The rate of overall grade 2 or higher acute toxic effects was less with HF-WBI than with CF-WBI (47% vs 78%; P < .001). Six months after irradiation, physicians reported less fatigue in patients randomized to HF-WBI (0% vs 6%; P = .01), and patients randomized to HF-WBI reported less lack of energy (23% vs 39%; P < .001) and less trouble meeting family needs (3% vs 9%; P = .01). Multivariable regression confirmed the superiority of HF-WBI in terms of patient-reported lack of energy (odds ratio [OR], 0.39; 95% CI, 0.24-0.63) and trouble meeting family needs (OR, 0.34; 95% CI, 0.16-0.75). CONCLUSIONS AND RELEVANCE: Treatment with HF-WBI appears to yield lower rates of acute toxic effects than CF-WBI as well as less fatigue and less trouble meeting family needs 6 months after completing radiation therapy. These findings should be communicated to patients as part of shared decision making. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01266642.
Asunto(s)
Neoplasias de la Mama/radioterapia , Carcinoma Ductal de Mama/radioterapia , Carcinoma Intraductal no Infiltrante/radioterapia , Fraccionamiento de la Dosis de Radiación , Hipofraccionamiento de la Dosis de Radiación , Traumatismos por Radiación/prevención & control , Centros Médicos Académicos , Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Carcinoma Ductal de Mama/patología , Carcinoma Ductal de Mama/cirugía , Carcinoma Intraductal no Infiltrante/patología , Carcinoma Intraductal no Infiltrante/cirugía , Distribución de Chi-Cuadrado , Femenino , Humanos , Modelos Logísticos , Mastectomía Segmentaria , Análisis Multivariante , Estadificación de Neoplasias , Oportunidad Relativa , Calidad de Vida , Traumatismos por Radiación/diagnóstico , Traumatismos por Radiación/etiología , Radioterapia Adyuvante/efectos adversos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
OBJECTIVES: To estimate the lifetime cost of bladder cancer and the contribution of complications to the total costs. METHODS: We reviewed the medical records of a retrospective cohort of 208 patients with bladder cancer who registered at our comprehensive cancer center from 1991 to 1999. We multiplied the number of resources used during management of bladder cancer by their unit charges. We converted charges into costs using the Medicare cost-to-charge ratio and inflated these to 2005 U.S. dollars. We estimated future costs by creating two extreme hypothetical scenarios. In the best-case scenario, we assumed patients with superficial disease developed recurrences at the cohort's mean rate and that patients with muscle-invasive disease were disease free after definitive therapy. Survival was based on the U.S. life expectancy in both cases. In the worst-case scenario, we assumed patients with superficial disease developed muscle-invasive disease and that all patients subsequently died of bladder cancer. RESULTS: The average cost of bladder cancer was 65,158 dollars among the cohort patients. Sixty percent of this cost (39,393 dollars) was associated with surveillance and treatment of recurrences, and 30% (19,811 dollars) was attributable to complications. The lifetime cost of bladder cancer was lower for the worst-case scenario (99,270 dollars) than for the best-case scenario (120,684 dollars). However, a greater proportion of the costs were attributable to complications with the worst-case scenario (43%, 42,290 dollars) compared with the best (28%, 34,169 dollars). CONCLUSIONS: The management of bladder cancer and its associated complications results in a major economic burden. More cost-effective surveillance strategies and approaches for preventing complications are crucial to minimizing the disease's clinical and economic consequences.
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Costo de Enfermedad , Neoplasias de la Vejiga Urinaria/complicaciones , Neoplasias de la Vejiga Urinaria/economía , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Modelos Económicos , Estudios RetrospectivosRESUMEN
BACKGROUND: Although deep venous thrombosis (DVT) often complicates the clinical course in patients with cancer, few studies of the outcomes of DVT in this population have been published. Furthermore, the cost of DVT is largely undescribed. We herein report the largest study of DVT in this population to date. METHODS: We reviewed the medical records of 529 consecutive cancer patients in whom DVT developed from January 1, 1994, through December 31, 1997, and followed up these patients through December 31, 2000, for outcomes. The cost of hospitalization was obtained from our hospital's cost-accounting system and inflated to 2002 US dollars using the Consumer Price Index for Medical Care. Logistic regression was used to identify factors that were associated with a high risk of poor outcomes. RESULTS: The most common complication of DVT was bleeding, which occurred in 13% of patients. Pulmonary embolus occurred in 4%. Five patients (1%) died of complications of DVT and 5 (1%) of complications of anticoagulation. Recurrence of DVT was common (17% overall), particularly among those who had inferior vena cava filters (32%; P<.001) or a previous episode of DVT (P =.03). All but 4 patients were hospitalized for initial anticoagulation therapy, for a mean of 11 days. The mean cost of hospitalization was 2002 US $20 065. CONCLUSIONS: Among patients with cancer, DVT frequently is associated with serious clinical outcomes. Its treatment is resource intensive and costly. More effective agents and less costly management strategies could have a significant impact on the outcomes and cost of DVT in this population.
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Costo de Enfermedad , Neoplasias/complicaciones , Trombosis de la Vena/economía , Trombosis de la Vena/etiología , Anciano , Anticoagulantes/efectos adversos , Femenino , Estudios de Seguimiento , Recursos en Salud/estadística & datos numéricos , Costos de Hospital , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Estados Unidos/epidemiología , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/epidemiologíaRESUMEN
BACKGROUND: The purpose of this study was to estimate the mean incremental cost of chemotherapy-induced thrombocytopenia and the drivers of cost. Another goal was to estimate the impact of depth and duration of thrombocytopenia on the cost of thrombocytopenia. METHODS: A retrospective cohort, consisting of a random sample of 75 solid tumor or lymphoma patients who developed chemotherapy-induced thrombocytopenia (= 50,000 platelets per microl), was chosen. The number of each type of resource used during 217 cycles with and 300 cycles without thrombocytopenia were multiplied by the cost of each resource and summed to yield the total cost of care (in 1999 dollars from the provider's perspective). RESULTS: Compared with cycles without thrombocytopenia, the mean incremental cost of thrombocytopenia was $1037 per cycle. However, 60% of cycles were usual cost, with a mean cost of thrombocytopenia of $43 per cycle less than control cycles. Twelve percent of cycles were high cost (mean incremental cost = $612 per cycle); 28% were very high cost (mean incremental cost = $3519). The excess cost during high-cost cycles was due to high consumption of prophylactic platelet transfusions and during very high-cost cycles to both higher platelet transfusion consumption and to a high incidence of major bleeding episodes. CONCLUSIONS: Although thrombocytopenia is a common complication of chemotherapy, only 40% of cycles with thrombocytopenia would be considered high or very high cost. Interventions targeted at this subset of cycles could significantly reduce the cost of thrombocytopenia provided they are initiated early enough in the chemotherapy experience to be effective.