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1.
Radiother Oncol ; 185: 109687, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37169300

RESUMEN

BACKGROUND: Although short-course radiotherapy is an effective treatment for patients with painful bone metastases, pain is not always sufficiently controlled. We therefore investigated the additional effect of a nurse-led pain education program on pain control and quality of life (QoL). PATIENTS AND METHODS: In this multicenter study, patients with solid tumor bone metastases and a worst pain intensity of ≥5 on a 0-10 numeric rating scale (NRS) were randomized between care as usual (control-group) and care as usual plus the Pain Education Program (PEP-group). PEP consisted of a structured interview and personalized education with follow-up phone calls. Patients completed the Brief Pain Inventory, EORTC QLQ-C15-PAL and BM22 at week 0, 1, 4, 8 and 12. The primary outcome was pain control, defined as the number of patients whose worst pain intensity was <5 on a 0-10 NRS after 12 weeks. Secondary outcomes were time to reach control of pain (NRS < 5), mean worst pain and average pain, and QoL at weeks 1, 4, 8 and 12. RESULTS: Of 308 included patients, 182 (92 PEP-group) completed 12 weeks follow-up. At 12 weeks, more patients in the PEP-group (71%) compared to the control-group (52%) reported pain control (P =.008). In the PEP-group, pain control was reached earlier than in the control-group (median 29 days versus 56 days; P =.003). Mean worst and average pain decreased in both groups but decreased more in the PEP-group. QoL did not differ between the groups. CONCLUSION: The addition of PEP to care as usual for patients treated with radiotherapy for painful bone metastases resulted in less pain and faster pain control.


Asunto(s)
Neoplasias Óseas , Calidad de Vida , Humanos , Cuidados Paliativos/métodos , Dolor/etiología , Dolor/radioterapia , Resultado del Tratamiento , Proyectos de Investigación , Neoplasias Óseas/radioterapia , Neoplasias Óseas/secundario
2.
BMC Cancer ; 23(1): 419, 2023 May 09.
Artículo en Inglés | MEDLINE | ID: mdl-37161377

RESUMEN

BACKGROUND: Partial breast irradiation (PBI) is standard of care in low-risk breast cancer patients after breast-conserving surgery (BCS). Pre-operative PBI can result in tumor downstaging and more precise target definition possibly resulting in less treatment-related toxicity. This study aims to assess the pathologic complete response (pCR) rate one year after MR-guided single-dose pre-operative PBI in low-risk breast cancer patients. METHODS: The ABLATIVE-2 trial is a multicenter prospective single-arm trial using single-dose ablative PBI in low-risk breast cancer patients. Patients ≥ 50 years with non-lobular invasive breast cancer ≤ 2 cm, grade 1 or 2, estrogen receptor-positive, HER2-negative, and tumor-negative sentinel node procedure are eligible. A total of 100 patients will be enrolled. PBI treatment planning will be performed using a radiotherapy planning CT and -MRI in treatment position. The treatment delivery will take place on a conventional or MR-guided linear accelerator. The prescribed radiotherapy dose is a single dose of 20 Gy to the tumor, and 15 Gy to the 2 cm of breast tissue surrounding the tumor. Follow-up MRIs, scheduled at baseline, 2 weeks, 3, 6, 9, and 12 months after PBI, are combined with liquid biopsies to identify biomarkers for pCR prediction. BCS will be performed 12 months after radiotherapy or after 6 months, if MRI does not show a radiologic complete response. The primary endpoint is the pCR rate after PBI. Secondary endpoints are radiologic response, toxicity, quality of life, cosmetic outcome, patient distress, oncological outcomes, and the evaluation of biomarkers in liquid biopsies and tumor tissue. Patients will be followed up to 10 years after radiation therapy. DISCUSSION: This trial will investigate the pathological tumor response after pre-operative single-dose PBI after 12 months in patients with low-risk breast cancer. In comparison with previous trial outcomes, a longer interval between PBI and BCS of 12 months is expected to increase the pCR rate of 42% after 6-8 months. In addition, response monitoring using MRI and biomarkers will help to predict pCR. Accurate pCR prediction will allow omission of surgery in future patients. TRIAL REGISTRATION: The trial was registered prospectively on April 28th 2022 at clinicaltrials.gov (NCT05350722).


Asunto(s)
Neoplasias de la Mama , Humanos , Femenino , Neoplasias de la Mama/radioterapia , Estudios Prospectivos , Calidad de Vida , Biopsia Líquida , Imagen por Resonancia Magnética , Estudios Multicéntricos como Asunto
3.
Lancet Oncol ; 24(3): e121-e132, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36858728

RESUMEN

Stereotactic body radiotherapy (SBRT) for patients with metastatic cancer, especially when characterised by a low tumour burden (ie, oligometastatic disease), receiving targeted therapy or immunotherapy has become a frequently practised and guideline-supported treatment strategy. Despite the increasing use in routine clinical practice, there is little information on the safety of combining SBRT with modern targeted therapy or immunotherapy and a paucity of high-level evidence to guide clinical management. A systematic literature review was performed to identify the toxicity profiles of combined metastases-directed SBRT and targeted therapy or immunotherapy. These results served as the basis for an international Delphi consensus process among 28 interdisciplinary experts who are members of the European Society for Radiotherapy and Oncology (ESTRO) and European Organisation for Research and Treatment of Cancer (EORTC) OligoCare consortium. Consensus was sought about risk mitigation strategies of metastases-directed SBRT combined with targeted therapy or immunotherapy; a potential need for and length of interruption to targeted therapy or immunotherapy around SBRT delivery; and potential adaptations of radiation dose and fractionation. Results of this systematic review and consensus process compile the best available evidence for safe combination of metastases-directed SBRT and targeted therapy or immunotherapy for patients with metastatic or oligometastatic cancer and aim to guide today's clinical practice and the design of future clinical trials.


Asunto(s)
Neoplasias , Oncología por Radiación , Radiocirugia , Humanos , Consenso , Inmunoterapia , Oncología Médica
4.
Cancers (Basel) ; 14(23)2022 Nov 29.
Artículo en Inglés | MEDLINE | ID: mdl-36497388

RESUMEN

Patients with femoral metastases are at risk of fracturing bones. It is important to prevent fractures in order to maintain mobility and quality of life. The BOne Strength (BOS) score is based on a computed tomography (CT)-based patient-specific finite element (FE) computer model that objectively calculates bone strength. In this pilot study, the added clinical value of the BOS score towards treatment-related decision making was assessed. In December 2019, the BOS score was implemented in four radiotherapy centers. The BOS scores and fracture risks of individual patients were calculated and returned to the physician to assist in treatment decisions. The physicians filled out a questionnaire, which was qualitatively analyzed. A follow-up to identify fractures and/or death was performed after six months. Until June 2021, 42 BOS scores were delivered (20 high, 9 moderate, and 13 low fracture risk). In 48%, the BOS score led to an adaptation of treatment plans. Physicians indicated that the BOS score provided objective insight into fracture risk, was reassuring for physicians and patients, and improved multidisciplinary discussions and shared decision making. In conclusion, the BOS score is an objective tool to assess fracture risk in femoral bone metastases and aids physicians and patients in making a more informed decision regarding the most appropriate treatment.

6.
Int J Radiat Oncol Biol Phys ; 108(3): 546-553, 2020 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-32446951

RESUMEN

PURPOSE: After radiation therapy for painful bone metastases, up to 44% of patients report a pain flare (PF). Our study compared 2 dose schedules of dexamethasone versus placebo to prevent PF. METHODS AND MATERIALS: This double-blind, randomized, placebo-controlled trial allocated patients with painful bone metastases from solid tumors randomly to receive 8 mg dexamethasone before radiation therapy followed by 3 daily doses (group A), 8 mg dexamethasone followed by 3 doses of placebo (group B), or 4 doses of placebo (group C). Patients reported worst pain scores, study medication side effects, and opioid intake before treatment and thereafter daily for 14 days and on day 28. PF was defined as at least a 2-point increase on a 0 to 10 pain scale with no decrease in opioid intake or a 25% or greater increase in opioid intake with no decrease in pain score, followed by a return to baseline or lower. The primary analysis was by intention to treat with patients who had missing data classified as having a PF. RESULTS: From January 2012 to April 2016, 295 patients were randomized. PF incidence was 38% for group A, 27% for group B, and 39% for group C (P = .07). Although patients in group B had the lowest PF incidence, a relatively high percentage did not return to baseline pain levels, indicating pain progression. The mean duration of PF was 2.1 days for group A, 4.5 days for group B, and 3.3 days for group C (P = .0567). Dexamethasone postponed PF occurrence; in group A 52% occurred on days 2 to 5 versus 73% in group B and 99% in group C (P = .02). Patients in group A reported lower mean pain scores on days 2 to 5 than those in group B or C (P < .001). Side effects were similar. CONCLUSIONS: There was insufficient evidence that dexamethasone reduced the incidence of radiation-induced PF. However, dexamethasone postponed the occurrence of PF and led to lower mean pain scores on days 2 to 5.


Asunto(s)
Neoplasias Óseas/radioterapia , Dolor en Cáncer/prevención & control , Dexametasona/administración & dosificación , Glucocorticoides/administración & dosificación , Brote de los Síntomas , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/administración & dosificación , Antiinflamatorios no Esteroideos/administración & dosificación , Neoplasias Óseas/secundario , Dolor en Cáncer/tratamiento farmacológico , Dolor en Cáncer/epidemiología , Progresión de la Enfermedad , Método Doble Ciego , Femenino , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Países Bajos , Evaluación de Resultado en la Atención de Salud , Dimensión del Dolor , Cuidados Paliativos/métodos , Placebos/administración & dosificación , Factores de Tiempo
7.
Bone ; 130: 115101, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31655223

RESUMEN

PURPOSE: To determine whether patient-specific finite element (FE) computer models are better at assessing fracture risk for femoral bone metastases compared to clinical assessments based on axial cortical involvement on conventional radiographs, as described in current clinical guidelines. METHODS: Forty-five patients with 50 femoral bone metastases, who were treated with palliative radiotherapy for pain, were included (64% single fraction (8Gy), 36% multiple fractions (5 or 6x4Gy)) and were followed for six months to determine whether they developed a pathological femoral fracture. All plain radiographs available within a two month period prior to radiotherapy were obtained. Patient-specific FE models were constructed based on the geometry and bone density obtained from the baseline quantitative CT scans used for radiotherapy planning. Femoral failure loads normalized for body weight (BW) were calculated. Patients with a failure load of 7.5 x BW or lower were identified as having high fracture risk, whereas patients with a failure load higher than 7.5 x BW were classified as low fracture risk. Experienced assessors measured axial cortical involvement on conventional radiographs. Following clinical guidelines, patients with lesions larger than 30mm were identified as having a high fracture risk. FE predictions were compared to clinical assessments by means of diagnostic accuracy values (sensitivity, specificity and positive (PPV) and negative predictive values (NPV)). RESULTS: Seven femurs (14%) fractured during follow-up. Median time to fracture was 8 weeks. FE models were better at assessing fracture risk in comparison to axial cortical involvement (sensitivity 100% vs. 86%, specificity 74% vs. 42%, PPV 39% vs. 19%, and NPV 100% vs. 95%, for the FE computer model vs. axial cortical involvement, respectively). CONCLUSIONS: Patient-specific FE computer models improve fracture risk assessments of femoral bone metastases in advanced cancer patients compared to clinical assessments based on axial cortical involvement, which is currently used in clinical guidelines.


Asunto(s)
Neoplasias Óseas , Fémur , Densidad Ósea , Neoplasias Óseas/diagnóstico por imagen , Simulación por Computador , Fémur/diagnóstico por imagen , Análisis de Elementos Finitos , Humanos , Medición de Riesgo
8.
Int J Radiat Oncol Biol Phys ; 105(3): 559-566, 2019 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-31344434

RESUMEN

PURPOSE: Pain response rates are equivalent after single 8 Gy and fractionated palliative radiation therapy for bone metastases. Reirradiation remains more frequent after a single fraction, although this does not simply reflect pain recurrence. Given the possible role of stereotactic radiation therapy in providing durable pain control, measures of durability are required. Net pain relief (NPR), the proportion of remaining life spent with pain response, may provide this. This study assesses the use of NPR as an outcome measure after palliative radiation therapy for bone metastases. METHODS AND MATERIALS: This is a secondary analysis of data collected in the Dutch Bone Metastasis Study, a randomized trial comparing palliative radiation therapy delivered as 8 Gy in a single fraction and 24 Gy in 6 fractions. NPR was assessed by survival cohorts, treatment regimen, and primary diagnoses. The consequences of missing data upon the use of NPR in future studies were considered within sensitivity analyses. RESULTS: Patients whose pain improved after palliative radiation therapy experienced improvement for 56.6% of their remaining lives. Missing responses in questionnaires mean the range of uncertainty in NPR is 36.1% to 62.1%. When response beyond reirradiation was excluded, NPR after treatments of single-fraction 8 Gy and 24 Gy in 6 fractions was 49.0% and 56.5%, respectively (P = .004). Differential willingness to reirradiate may be influencing this outcome. When response beyond reirradiation was included, this difference was not seen (NPR of 55.4% vs 57.7%, respectively [P = .191]). CONCLUSIONS: Patients who responded to conventional radiation therapy experienced improved pain control for approximately half of their remaining life. NPR may provide valuable information in assessing pain response durability. Missing data are, however, inevitable in this population. This must be minimized and the consequences recognized and reported. Additionally, reirradiation protocols and the frequency and duration of trial follow-up may have a significant impact upon this outcome, requiring careful consideration during trial design if NPR is to be used in future studies.


Asunto(s)
Neoplasias Óseas/radioterapia , Neoplasias Óseas/secundario , Dolor en Cáncer/radioterapia , Manejo del Dolor/métodos , Cuidados Paliativos/métodos , Radiocirugia/métodos , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/uso terapéutico , Neoplasias Óseas/mortalidad , Dolor en Cáncer/tratamiento farmacológico , Dolor en Cáncer/etiología , Fraccionamiento de la Dosis de Radiación , Femenino , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Países Bajos , Evaluación de Resultado en la Atención de Salud , Dosificación Radioterapéutica , Reirradiación , Factores de Tiempo , Incertidumbre
9.
J Radiat Oncol ; 7(1): 17-26, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29576859

RESUMEN

BACKGROUND: Conventional radiotherapy for painful spinal metastases can be delivered with a single posterior-anterior (PA) or two opposed anterior-posterior (APPA) fields. We studied the effectiveness and toxicity of both techniques and studied whether treatment technique was predictive for abdominal and skin toxicity. PATIENTS AND METHODS: Within the Dutch Bone Metastasis Study, 343 patients received 8 Gray in a single fraction or 24 Gray in six fractions for painful spinal metastases. Treatment technique was not randomized. At baseline and weekly during follow-up, patients reported pain and other physical complaints. Any complaint increasing within 4 weeks after treatment was noted as a side effect. Pain response was calculated according to international standards, taking into account changes in pain score and medication. Repeated measurement analyses and multivariate logistic analyses were performed. RESULTS: Patients were mainly treated on the thoracic (34%) and lumbar (53%) spine and 73% received a PA field. Pain response was similar between both techniques (74%). In patients treated at the thoraco-lumbar and lumbar spine, with multiple fractions, significantly more abdominal complaints were noticed. In multivariate analysis, radiotherapy technique did not predict for side effects. CONCLUSION: Conventional radiotherapy of painful spinal metastases provides limited toxicity. Radiotherapy technique is not an independent predictor of abdominal and skin toxicity of irradiation.

10.
Acta Oncol ; 56(12): 1720-1727, 2017 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-28893119

RESUMEN

BACKGROUND: Psychological distress (PD) has a major impact on quality of life. We studied the incidence of PD before and after radiotherapy for painful bone metastases. Furthermore, we aimed to identify factors predictive for PD. METHODS: Between 1996 and 1998, the Dutch Bone Metastasis Study included 1157 patients with painful bone metastases. Patients were randomized between two fractionation schedules. The study showed a pain response of 74% in both groups. Patients filled out weekly questionnaires for 13 weeks, then monthly for two years. The questionnaires included a subscale for PD on the Rotterdam Symptom Checklist. We used generalized estimating equations and multivariable logistic regression analyses. RESULTS: At baseline, 290 patients (27%) had a high level of PD. For the entire group, the level of PD remained constant over time. The majority of patients with a low level of PD at baseline remained at a low level during follow-up. In patients with a high level of PD at baseline, the mean level of PD decreased after treatment and stabilized around the cutoff level. Female patients, higher age, worse performance, lower pain score and worse self-reported QoL were associated with an increased chance of PD, although the model showed moderate discriminative power. CONCLUSIONS: A substantial proportion of patients had a high level of PD before and after radiotherapy for painful bone metastases. Most patients who reported high levels of PD when referred for palliative radiotherapy remained at high levels thereafter. Therefore, screening of PD prior to treatment seems appropriate, in order to select patients requiring intervention.


Asunto(s)
Neoplasias Óseas/psicología , Neoplasias de la Mama/psicología , Dolor en Cáncer/psicología , Neoplasias Pulmonares/psicología , Neoplasias de la Próstata/psicología , Estrés Psicológico/psicología , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias Óseas/complicaciones , Neoplasias Óseas/radioterapia , Neoplasias Óseas/secundario , Neoplasias de la Mama/patología , Dolor en Cáncer/etiología , Fraccionamiento de la Dosis de Radiación , Femenino , Humanos , Incidencia , Modelos Logísticos , Neoplasias Pulmonares/patología , Masculino , Tamizaje Masivo , Persona de Mediana Edad , Análisis Multivariante , Países Bajos/epidemiología , Dimensión del Dolor , Neoplasias de la Próstata/patología , Calidad de Vida , Radioterapia/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estrés Psicológico/diagnóstico , Estrés Psicológico/epidemiología , Encuestas y Cuestionarios
11.
Int J Radiat Oncol Biol Phys ; 95(5): 1391-1398, 2016 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-27315664

RESUMEN

PURPOSE: To study the course of quality of life (QoL) after radiation therapy for painful bone metastases. PATIENTS AND METHODS: The Dutch Bone Metastasis Study randomized 1157 patients with painful bone metastases between a single fraction of 8 Gy and 6 fractions of 4 Gy between 1996 and 1998. The study showed a comparable pain response of 74%. Patients filled out weekly questionnaires for 13 weeks, then monthly for 2 years. In these analyses, physical, psychosocial, and functional QoL domain scores and a score of general health were studied. Mixed modeling was used to model the course of QoL and to study the influence of several characteristics. RESULTS: In general, QoL stabilized after 1 month. Psychosocial QoL improved after treatment. The level of QoL remained stable, steeply deteriorating at the end of life. For most QoL domains, a high pain score and intake of opioids were associated with worse QoL, with small effect sizes (-0.11 to -0.27). A poor performance score was associated with worse functional QoL, with a medium effect size (0.41). There is no difference in QoL between patients receiving a single fraction of 8 Gy and 6 fractions of 4 Gy, except for a temporary worsening of physical QoL after 6 fractions. CONCLUSION: Although radiation therapy for painful bone metastases leads to a meaningful pain response, most domains of QoL do not improve after treatment. Only psychosocial QoL improves slightly after treatment. The level of QoL is related to the actual survival, with a rather stable course of QoL for most of the remaining survival time and afterward a sharp decrease, starting only a few weeks before the end of life. Six fractions of 4 Gy lead to a temporary worse physical QoL compared with a single fraction of 8 Gy.


Asunto(s)
Neoplasias Óseas/radioterapia , Neoplasias Óseas/secundario , Dolor/prevención & control , Dolor/psicología , Calidad de Vida/psicología , Radioterapia Conformacional/psicología , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/uso terapéutico , Neoplasias Óseas/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Dolor/diagnóstico , Cuidados Paliativos/métodos , Resultado del Tratamiento
12.
Int J Radiat Oncol Biol Phys ; 93(3): 694-701, 2015 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-26281825

RESUMEN

PURPOSE: To study quality of life (QoL) in responders and nonresponders after radiation therapy for painful bone metastases; and to identify factors predictive for a pain response. PATIENTS AND METHODS: The prospectively collected data of 956 patients with breast, prostate, and lung cancer within the Dutch Bone Metastasis Study were used. These patients, irradiated for painful bone metastases, rated pain, QoL, and overall health at baseline and weekly afterward for 12 weeks. Using generalized estimating equations analysis, the course of QoL was studied, adjusted for primary tumor. To identify predictive variables, proportional hazard analyses were performed, taking into account death as a competing risk, and C-statistics were calculated for discriminative value. RESULTS: In total, 722 patients (76%) responded to radiation therapy. During follow-up, responders had a better QoL in all domains compared with nonresponders. Patients with breast or prostate cancer had a better QoL than patients with lung cancer. In multivariate analysis, baseline predictors for a pain response were breast or prostate cancer as primary tumor, younger age, good performance status, absence of visceral metastases, and using opioids. The discriminative ability of the model was low (C-statistic: 0.56). CONCLUSIONS: Responding patients show a better QoL after radiation therapy for painful bone metastases than nonresponders. Our model did not have enough discriminative power to predict which patients are likely to respond to radiation therapy. Therefore, radiation therapy should be offered to all patients with painful bone metastases, aiming to decrease pain and improve QoL.


Asunto(s)
Neoplasias Óseas/radioterapia , Neoplasias Óseas/secundario , Neoplasias de la Mama , Neoplasias Pulmonares , Dolor/radioterapia , Neoplasias de la Próstata , Calidad de Vida , Anciano , Femenino , Humanos , Estado de Ejecución de Karnofsky , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Cuidados Paliativos , Modelos de Riesgos Proporcionales , Factores de Tiempo , Resultado del Tratamiento
13.
Anticancer Res ; 34(12): 7315-7, 2014 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-25503166

RESUMEN

BACKGROUND: After thoracic radiotherapy a pneumonitis may occur, mostly confined to the irradiated volume of the lung. In general, it resolves spontaneously without long-term effects. CASE REPORT: A 68-year-old man was diagnosed with a stage IIIA adenocarcinoma of the lung and was treated with sequential chemoradiation. He had a heart and kidney transplant for which an immunosuppressant was taken. During the fourth week of radiotherapy, he developed a bilateral interstitial pneumonia. Despite antibiotics and steroids, the patient died twelve days after the onset of complaints due to respiratory failure. Autopsy showed in all pulmonary lobes extensive diffuse alveolar damage, probably leading to respiratory insufficiency and death. Literature and Conclusion: Bilateral pneumonitis after radiotherapy is thought to be an immunologically-mediated response, which usually resolves without long-term effects. Since in radiation pneumonitis an increase in T-cells is described, the suppression of these cells by an immunosuppressant might have exaggerated the pulmonary toxicity.


Asunto(s)
Adenocarcinoma/radioterapia , Quimioradioterapia/efectos adversos , Terapia de Inmunosupresión/efectos adversos , Neoplasias Pulmonares/radioterapia , Neumonitis por Radiación/etiología , Adenocarcinoma del Pulmón , Anciano , Antibacterianos/uso terapéutico , Resultado Fatal , Trasplante de Corazón , Humanos , Trasplante de Riñón , Masculino , Neumonitis por Radiación/tratamiento farmacológico , Neumonitis por Radiación/patología
14.
Int J Radiat Oncol Biol Phys ; 90(4): 739-47, 2014 Nov 15.
Artículo en Inglés | MEDLINE | ID: mdl-25260489

RESUMEN

PURPOSE: Patients with bone metastases have a widely varying survival. A reliable estimation of survival is needed for appropriate treatment strategies. Our goal was to assess the value of simple prognostic factors, namely, patient and tumor characteristics, Karnofsky performance status (KPS), and patient-reported scores of pain and quality of life, to predict survival in patients with painful bone metastases. METHODS AND MATERIALS: In the Dutch Bone Metastasis Study, 1157 patients were treated with radiation therapy for painful bone metastases. At randomization, physicians determined the KPS; patients rated general health on a visual analogue scale (VAS-gh), valuation of life on a verbal rating scale (VRS-vl) and pain intensity. To assess the predictive value of the variables, we used multivariate Cox proportional hazard analyses and C-statistics for discriminative value. Of the final model, calibration was assessed. External validation was performed on a dataset of 934 patients who were treated with radiation therapy for vertebral metastases. RESULTS: Patients had mainly breast (39%), prostate (23%), or lung cancer (25%). After a maximum of 142 weeks' follow-up, 74% of patients had died. The best predictive model included sex, primary tumor, visceral metastases, KPS, VAS-gh, and VRS-vl (C-statistic = 0.72, 95% CI = 0.70-0.74). A reduced model, with only KPS and primary tumor, showed comparable discriminative capacity (C-statistic = 0.71, 95% CI = 0.69-0.72). External validation showed a C-statistic of 0.72 (95% CI = 0.70-0.73). Calibration of the derivation and the validation dataset showed underestimation of survival. CONCLUSION: In predicting survival in patients with painful bone metastases, KPS combined with primary tumor was comparable to a more complex model. Considering the amount of variables in complex models and the additional burden on patients, the simple model is preferred for daily use. In addition, a risk table for survival is provided.


Asunto(s)
Neoplasias Óseas/mortalidad , Neoplasias Óseas/secundario , Estado de Ejecución de Karnofsky , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Neoplasias Óseas/radioterapia , Neoplasias de la Mama , Femenino , Estudios de Seguimiento , Humanos , Neoplasias Pulmonares , Masculino , Persona de Mediana Edad , Dolor/radioterapia , Dimensión del Dolor , Modelos de Riesgos Proporcionales , Neoplasias de la Próstata , Calidad de Vida , Factores Sexuales , Análisis de Supervivencia
15.
BMC Cancer ; 14: 347, 2014 May 20.
Artículo en Inglés | MEDLINE | ID: mdl-24885354

RESUMEN

BACKGROUND: Radiotherapy has a good effect in palliation of painful bone metastases, with a pain response rate of more than 60%. However, shortly after treatment, in approximately 40% of patients a temporary pain flare occurs, which is defined as a two-point increase of the worst pain score on an 11-point rating scale compared to baseline, without a decrease in analgesic intake, or a 25% increase in analgesic intake without a decrease in worst pain score, compared to baseline. A pain flare has a negative impact on daily functioning and mood of patients. It is thought to be caused by periostial edema after radiotherapy. Dexamethasone might diminish this edema and thereby reduce the incidence of pain flare. Two non-randomized studies suggest that dexamethasone reduces the incidence of a pain flare by 50%. The aim of this trial is to study the effectiveness of dexamethasone to prevent a pain flare after palliative radiotherapy for painful bone metastases and to determine the optimal dose schedule. METHODS AND DESIGN: This study is a three-armed, double-blind, placebo-controlled multicenter trial. We aim to include 411 patients with uncomplicated painful bone metastases from any type of primary solid tumor who receive short schedule radiotherapy (all conventional treatment schedules from one to six fractions). Arm 1 consists of daily placebo for four days, arm 2 starts with 8 mg dexamethasone before the (first) radiotherapy and three days placebo thereafter. Arm 3 consists of four days 8 mg dexamethasone. The primary endpoint is the occurrence of a pain flare. Secondary endpoints are pain, quality of life and side-effects of dexamethasone versus placebo. Patients complete a questionnaire (Brief Pain Inventory with two added questions about side-effects of medication, the EORTC QLQ-C15-PAL and QLQ-BM22 for quality of life) at baseline, daily for two weeks and lastly at four weeks. DISCUSSION: This study will show whether dexamethasone is effective in preventing a pain flare after palliative radiotherapy for painful bone metastases and, if so, to determine the optimal dose. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov: NCT01669499.


Asunto(s)
Analgésicos/administración & dosificación , Neoplasias Óseas/radioterapia , Neoplasias Óseas/secundario , Dexametasona/administración & dosificación , Dolor/prevención & control , Cuidados Paliativos , Analgésicos/efectos adversos , Neoplasias Óseas/complicaciones , Dexametasona/efectos adversos , Fraccionamiento de la Dosis de Radiación , Método Doble Ciego , Esquema de Medicación , Humanos , Países Bajos , Dolor/diagnóstico , Dolor/etiología , Dimensión del Dolor , Estudios Prospectivos , Calidad de Vida , Radioterapia/efectos adversos , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento
16.
Radiother Oncol ; 111(2): 264-9, 2014 May.
Artículo en Inglés | MEDLINE | ID: mdl-24746581

RESUMEN

BACKGROUND: Multimorbidity and declining performance in elderly cancer patients may result in less treatment benefit. We investigated whether age is a predictor for pain response and quality of life (QoL) after radiotherapy in patients with painful bone metastases. METHODS: The database of the Dutch Bone Metastasis Study was used (1996-1999). 1157 patients, irradiated for painful bone metastases, rated their pain, QoL-domains and overall health at baseline and during follow-up. Response was calculated taking into account changes in pain score and medication. Patients were grouped into three age cohorts: A: <65 (n=520), B: 65-74 (n=410) and C: ⩾75years (n=227). RESULTS: No significant difference existed in pain response between cohorts: 78% in cohort A, 74% in B and 67% in C. When assessing baseline QoL, a significant difference in activity level was noticed, with more impairment in elderly compared to younger patients (C versus B (p=0.01), C versus A (p<0.001)). Other QoL-domains were similar at baseline and during follow-up among cohorts. A pain response was significantly associated with improvement of health-related QoL (OR 3.74, 95% CI 2.66-5.25). CONCLUSION: The majority of elderly patients with painful bone metastases responded to radiotherapy and showed comparable overall QoL compared to their younger counterparts. Age is not a predictor for pain response or QoL.


Asunto(s)
Factores de Edad , Neoplasias Óseas/radioterapia , Neoplasias Óseas/secundario , Dolor/radioterapia , Cuidados Paliativos/métodos , Calidad de Vida , Anciano , Anciano de 80 o más Años , Análisis de Varianza , Neoplasias Óseas/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Encuestas y Cuestionarios
17.
Spine J ; 12(4): 324-8, 2012 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-22436488

RESUMEN

BACKGROUND CONTEXT: Most patients with painful spinal metastases are sufficiently palliated by hypofractionated radiotherapy. However, a small group of patients will need surgical intervention to treat symptomatic spinal cord compression and/or gross mechanical instability. Irradiation of a (prospective) surgical area may lead to postsurgery complications, including wound dehiscence, infection, and chronic wound ulcers. Decreasing the radiation dose to the surgical area could reduce radiation-induced toxicity and associated surgical complications. PURPOSE: To investigate an alternative radiation technique designed to lower the surgical area dose while delivering an adequate target dose and minimal off-target dose. STUDY DESIGN: Comparison of radiation doses received by various anatomic structures after simulating irradiation with a routine posteroanterior single field (SF) technique and experimental multiple field (MF) technique in a setting of thoracic metastatic spinal disease. METHODS: The computed tomography (CT) data from six previously treated patients with a total of 10 thoracic spinal metastases were used to plan four radiation schemes (SF8 Gy; SF20 Gy; MF8 Gy; and MF20 Gy). Discrete anatomic structures were defined on CT data, including a posterior surgical area, and after simulation the doses received were calculated and compared for the 8 Gy and 20 Gy techniques. RESULTS: With the experimental MF technique, a clinically relevant dose could be delivered to the affected vertebra, whereas the dose received at the (prospective) surgical area could be significantly reduced compared with the SF technique. The dose received at the nontarget tissues fell below the threshold level for clinical relevance. CONCLUSIONS: This radiation planning study showed the feasibility of sparing the surgical area while delivering an adequate dose to affected vertebrae in thoracic metastatic spinal disease.


Asunto(s)
Planificación de la Radioterapia Asistida por Computador , Radioterapia Conformacional/métodos , Neoplasias de la Columna Vertebral/radioterapia , Vértebras Torácicas/efectos de la radiación , Neoplasias Óseas/radioterapia , Neoplasias Óseas/secundario , Relación Dosis-Respuesta en la Radiación , Humanos , Complicaciones Posoperatorias/prevención & control , Dosis de Radiación , Neoplasias de la Columna Vertebral/secundario , Vértebras Torácicas/patología , Tomografía Computarizada por Rayos X
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