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1.
J Appl Clin Med Phys ; 24(3): e13841, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36573256

RESUMO

PURPOSE: Single-visit radiotherapy (RT) is beneficial for patients requiring pain control and can limit interruptions to systemic treatments. However, the requirement for a dedicated planning CT (pCT)-scan can result in treatment delays. We developed a workflow involving preplanning on available diagnostic CT (dCT) imaging, followed by online plan adaption using a cone-beam CT (CBCT)-scan prior to RT-delivery, in order to account for any changes in anatomy and target position. METHODS: Patients previously treated with palliative RT for bone metastases were selected from our hospital database. Patient dCT-images were deformed to treatment CBCTs in the Ethos platform (Varian Medical Systems) and a synthetic CT (sCT) generated. Treatment quality was analyzed by comparing a coverage of the V95% of the planning/clinical target volume and different organ-at-risk (OAR) doses between adapted and initial clinical treatment plans. Doses were recalculated on the CBCT and sCT in a separate treatment planning system. Adapted plan doses were measured on-couch using an anthropomorphic phantom with a Gafchromic EBT3 dosimetric film and compared to dose calculations. RESULTS: All adapted treatment plans met the clinical goals for target and OARs and outperformed the original treatment plans calculated on the (daily) sCT. Differences in V95% of the target volume coverage between the initial and adapted treatments were <0.2%. Dose recalculations on CBCT and sCT were comparable, and the average gamma pass rate (3%/2 mm) of dosimetric measurements was 98.8%. CONCLUSIONS: Online daily adaptive RT using dCTs instead of a dedicated pCT is feasible using the Ethos platform. This workflow has now been implemented clinically.


Assuntos
Planejamento da Radioterapia Assistida por Computador , Radioterapia de Intensidade Modulada , Humanos , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador/métodos , Radioterapia de Intensidade Modulada/métodos , Fluxo de Trabalho , Tomografia Computadorizada de Feixe Cônico/métodos , Tomografia Computadorizada por Raios X
2.
J Appl Clin Med Phys ; 23(11): e13810, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36316761

RESUMO

PURPOSE: To quantify the clinical practice of respiratory motion management in radiation oncology. METHODS: A respiratory motion management survey was designed and conducted based on clinician survey guidelines. The survey was administered to American Association of Physicists in Medicine (AAPM) members on 17 August 2020 and closed on 13 September 2020. RESULTS: A total of 527 respondents completed the entire survey and 651 respondents completed part of the survey, with the partially completed surveys included in the analysis. Overall, 84% of survey respondents used deep inspiration breath hold for left-sided breast cancer. Overall, 83% of respondents perceived respiratory motion management for thoracic and abdominal cancer radiotherapy patients to be either very important or required. Overall, 95% of respondents used respiratory motion management for thoracic and abdominal sites, with 36% of respondents using respiratory motion management for at least 90% of thoracic and abdominal patients. The majority (60%) of respondents used the internal target volume method to treat thoracic and abdominal cancer patients, with 25% using breath hold or abdominal compression and 13% using gating or tracking. CONCLUSIONS: A respiratory motion management survey has been completed by AAPM members. Respiratory motion management is generally considered very important or required and is widely used for breast, thoracic, and abdominal cancer treatments.


Assuntos
Radioterapia (Especialidade) , Humanos , Estados Unidos , Dosagem Radioterapêutica , Tomografia Computadorizada por Raios X/métodos , Suspensão da Respiração , Movimento (Física) , Planejamento da Radioterapia Assistida por Computador/métodos , Inquéritos e Questionários
3.
Oncologist ; 26(2): e306-e315, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33145902

RESUMO

Non-small cell lung cancer (NSCLC) accounts for approximately one in five cancer-related deaths, and management requires increasingly complex decision making by health care professionals. Many centers have therefore adopted a multidisciplinary approach to patient care, using the expertise of various specialists to provide the best evidence-based, personalized treatment. However, increasingly complex disease staging, as well as expanded biomarker testing and multimodality management algorithms with novel therapeutics, have driven the need for multifaceted, collaborative decision making to optimally guide the overall treatment process. To keep up with the rapidly evolving treatment landscape, national-level guidelines have been introduced to standardize patient pathways and ensure prompt diagnosis and treatment. Such strategies depend on efficient and effective communication between relevant multidisciplinary team members and have both improved adherence to treatment guidelines and extended patient survival. This article highlights the value of a multidisciplinary approach to diagnosis and staging, treatment decision making, and adverse event management in NSCLC. IMPLICATIONS FOR PRACTICE: This review highlights the value of a multidisciplinary approach to the diagnosis and staging of non-small cell lung cancer (NSCLC) and makes practical suggestions as to how multidisciplinary teams (MDTs) can be best deployed at individual stages of the disease to improve patient outcomes and effectively manage common adverse events. The authors discuss how a collaborative approach, appropriately leveraging the diverse expertise of NSCLC MDT members (including specialist radiation and medical oncologists, chest physicians, pathologists, pulmonologists, surgeons, and nursing staff) can continue to ensure optimal per-patient decision making as treatment options become ever more specialized in the era of biomarker-driven therapeutic strategies.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Oncologistas , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Carcinoma Pulmonar de Células não Pequenas/terapia , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/terapia , Equipe de Assistência ao Paciente
4.
Future Oncol ; 17(10): 1165-1184, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33583206

RESUMO

Aim: We retrospectively investigated the impact of tumor PD-L1 expression and prior chemoradiotherapy (CRT)-related variables on patient-reported outcomes (PROs) from PACIFIC. Patients & methods: PACIFIC was a Phase III study of durvalumab versus placebo after CRT in patients with unresectable, stage III non-small-cell lung cancer. If available, pre-CRT tumor tissue was tested for PD-L1 tumor-cell expression, scored at prespecified (25%) and post-hoc (1%) cut-offs. PROs were assessed using EORTC QLQ C30/-LC13. Results: Similar to the intent-to-treat (ITT) population, most PROs remained stable over time across PD-L1 and CRT subgroups, with few clinically relevant differences between treatment arms. Time to deterioration was generally similar to the ITT population. Conclusion: Neither PD-L1 expression nor prior CRT-related variables influenced PROs with durvalumab therapy. Clinical trial registration: NCT02125461 (ClinicalTrials.gov).


Assuntos
Anticorpos Monoclonais/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/patologia , Inibidores de Checkpoint Imunológico/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Antígeno B7-H1/antagonistas & inibidores , Antígeno B7-H1/genética , Carcinoma Pulmonar de Células não Pequenas/etiologia , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Feminino , Humanos , Inibidores de Checkpoint Imunológico/administração & dosagem , Inibidores de Checkpoint Imunológico/efeitos adversos , Neoplasias Pulmonares/etiologia , Neoplasias Pulmonares/mortalidade , Masculino , Terapia de Alvo Molecular , Estadiamento de Neoplasias , Medidas de Resultados Relatados pelo Paciente , Estudos Retrospectivos , Resultado do Tratamento
5.
Lancet ; 393(10185): 2051-2058, 2019 05 18.
Artigo em Inglês | MEDLINE | ID: mdl-30982687

RESUMO

BACKGROUND: The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative radiotherapy (SABR) on survival, oncological outcomes, toxicity, and quality of life in patients with a controlled primary tumour and one to five oligometastatic lesions. METHODS: This randomised, open-label phase 2 study was done at 10 hospitals in Canada, the Netherlands, Scotland, and Australia. Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0-1, and a life expectancy of at least 6 months were eligible. After stratifying by the number of metastases (1-3 vs 4-5), we randomly assigned patients (1:2) to receive either palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group), using a computer-generated randomisation list with permuted blocks of nine. Neither patients nor physicians were masked to treatment allocation. The primary endpoint was overall survival. We used a randomised phase 2 screening design with a two-sided α of 0·20 (wherein p<0·20 designates a positive trial). All analyses were intention to treat. This study is registered with ClinicalTrials.gov, number NCT01446744. FINDINGS: 99 patients were randomised between Feb 10, 2012, and Aug 30, 2016. Of 99 patients, 33 (33%) were assigned to the control group and 66 (67%) to the SABR group. Two (3%) patients in the SABR group did not receive allocated treatment and withdrew from the trial; two (6%) patients in the control group also withdrew from the trial. Median follow-up was 25 months (IQR 19-54) in the control group versus 26 months (23-37) in the SABR group. Median overall survival was 28 months (95% CI 19-33) in the control group versus 41 months (26-not reached) in the SABR group (hazard ratio 0·57, 95% CI 0·30-1·10; p=0·090). Adverse events of grade 2 or worse occurred in three (9%) of 33 controls and 19 (29%) of 66 patients in the SABR group (p=0·026), an absolute increase of 20% (95% CI 5-34). Treatment-related deaths occurred in three (4·5%) of 66 patients after SABR, compared with none in the control group. INTERPRETATION: SABR was associated with an improvement in overall survival, meeting the primary endpoint of this trial, but three (4·5%) of 66 patients in the SABR group had treatment-related death. Phase 3 trials are needed to conclusively show an overall survival benefit, and to determine the maximum number of metastatic lesions wherein SABR provides a benefit. FUNDING: Ontario Institute for Cancer Research and London Regional Cancer Program Catalyst Grant.


Assuntos
Metástase Neoplásica/radioterapia , Cuidados Paliativos , Radiocirurgia , Idoso , Intervalo Livre de Doença , Fracionamento da Dose de Radiação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica/terapia , Radiocirurgia/efeitos adversos , Radiocirurgia/métodos , Radiocirurgia/mortalidade , Análise de Sobrevida , Resultado do Tratamento
6.
BMC Cancer ; 20(1): 764, 2020 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-32795284

RESUMO

BACKGROUND: The likelihood of a tumor recurrence in patients with T3-4N0-1 non-small cell lung cancer following multimodality treatment remains substantial, mainly due distant metastases. As pathological complete responses (pCR) in resected specimens are seen in only a minority (28-38%) of patients following chemoradiotherapy, we designed the INCREASE trial (EudraCT-Number: 2019-003454-83; Netherlands Trial Register number: NL8435) to assess if pCR rates could be further improved by adding short course immunotherapy to induction chemoradiotherapy. Translational studies will correlate changes in loco-regional and systemic immune status with patterns of recurrence. METHODS/DESIGN: This single-arm, prospective phase II trial will enroll 29 patients with either resectable, or borderline resectable, T3-4N0-1 NSCLC. The protocol was approved by the institutional ethics committee. Study enrollment commenced in February 2020. On day 1 of guideline-recommended concurrent chemoradiotherapy (CRT), ipilimumab (IPI, 1 mg/kg IV) and nivolumab (NIVO, 360 mg flat dose IV) will be administered, followed by nivolumab (360 mg flat dose IV) after 3 weeks. Radiotherapy consists of once-daily doses of 2 Gy to a total of 50 Gy, and chemotherapy will consist of a platinum-doublet. An anatomical pulmonary resection is planned 6 weeks after the last day of radiotherapy. The primary study objective is to establish the safety of adding IPI/NIVO to pre-operative CRT, and its impact on pathological tumor response. Secondary objectives are to assess the impact of adding IPI/NIVO to CRT on disease free and overall survival. Exploratory objectives are to characterize tumor inflammation and the immune contexture in the tumor and tumor-draining lymph nodes (TDLN), and to explore the effects of IPI/NIVO and CRT and surgery on distribution and phenotype of peripheral blood immune subsets. DISCUSSION: The INCREASE trial will evaluate the safety and local efficacy of a combination of 4 modalities in patients with resectable, T3-4N0-1 NSCLC. Translational research will investigate the mechanisms of action and drug related adverse events. TRIAL REGISTRATION: Netherlands Trial Registration (NTR): NL8435 , Registered 03 March 2020.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma Pulmonar de Células não Pequenas/terapia , Inibidores de Checkpoint Imunológico/efeitos adversos , Ipilimumab/efeitos adversos , Neoplasias Pulmonares/terapia , Terapia Neoadjuvante/efeitos adversos , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Carcinoma Pulmonar de Células não Pequenas/imunologia , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Quimiorradioterapia Adjuvante/efeitos adversos , Quimiorradioterapia Adjuvante/métodos , Ensaios Clínicos Fase II como Assunto , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Inibidores de Checkpoint Imunológico/administração & dosagem , Ipilimumab/administração & dosagem , Pulmão/diagnóstico por imagem , Pulmão/patologia , Pulmão/cirurgia , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/imunologia , Neoplasias Pulmonares/mortalidade , Masculino , Terapia Neoadjuvante/métodos , Estadiamento de Neoplasias , Países Baixos , Nivolumabe/administração & dosagem , Nivolumabe/efeitos adversos , Pneumonectomia , Estudos Prospectivos , Tomografia Computadorizada por Raios X
7.
BMC Cancer ; 19(1): 816, 2019 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-31426760

RESUMO

BACKGROUND: Stereotactic ablative radiotherapy (SABR) has emerged as a new treatment option for patients with oligometastatic disease. SABR delivers precise, high-dose, hypofractionated radiotherapy, and achieves excellent rates of local control for primary tumors or metastases. A recent randomized phase II trial evaluated SABR in a group of patients with a small burden of oligometastatic disease (mostly with 1-3 metastatic lesions), and found that SABR was associated with benefits in progression-free survival and overall survival. The goal of this phase III trial is to assess the impact of SABR in patients with 4-10 metastatic cancer lesions. METHODS: One hundred and fifty-nine patients will be randomized in a 1:2 ratio between the control arm (consisting of standard of care palliative-intent treatments), and the SABR arm (consisting of standard of care treatment + SABR to all sites of known disease). Randomization will be stratified by two factors: histology (Group 1: prostate, breast, or renal; Group 2: all others), and type of pre-specified systemic therapy (Group 1: immunotherapy/targeted; Group 2: cytotoxic; Group 3: observation). SABR is to be completed within 2 weeks, allowing for rapid initiation of systemic therapy. Recommended SABR doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions, or 35 Gy in 5 fractions, chosen to minimize risks of toxicity. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, time to development of new metastatic lesions, quality of life, and toxicity. Translational endpoints include assessment of circulating tumor cells, cell-free DNA, and tumor tissue as prognostic and predictive markers, including assessment of immunological predictors of response and long-term survival. DISCUSSION: This study will provide an assessment of the impact of SABR on clinical outcomes and quality of life, to determine if long-term survival can be achieved for selected patients with 4-10 oligometastatic lesions. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03721341 . Date of registration: October 26, 2018.


Assuntos
Neoplasias/diagnóstico por imagem , Neoplasias/radioterapia , Células Neoplásicas Circulantes/efeitos da radiação , Radiocirurgia , Biomarcadores Tumorais/sangue , Fracionamento da Dose de Radiação , Feminino , Seguimentos , Humanos , Imageamento por Ressonância Magnética , Masculino , Neoplasias/sangue , Seleção de Pacientes , Prognóstico , Intervalo Livre de Progressão , Qualidade de Vida , Inquéritos e Questionários , Tomografia Computadorizada por Raios X , Carga Tumoral
9.
Acta Oncol ; 56(4): 548-554, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28358667

RESUMO

BACKGROUND: Volumetric-modulated arc therapy (VMAT) delivery for stereotactic ablative radiotherapy (SABR) of multiple lung tumors allows for faster treatments. We report on clinical outcomes and describe a general approach for treatment planning. MATERIAL AND METHODS: Patients undergoing multi iso-center VMAT-based SABR for ≥2 lung lesions between 2009 and 2014 were identified from the VU University Medical Center and London Health Sciences Centre. Patients were eligible if the start date of the SABR treatment for the different lesions was within a time range of 30 days. SABR was delivered using separate iso-centers for lesions at a substantial distance from each other. Tumors were either treated with a single fraction of 34 Gy, or using three risk-adapted dose-fractionation schemes, namely three fractions of 18 Gy, five fractions of 11 Gy, or eight fractions of 7.5 Gy, depending on the tumor size and the location. Multivariable analysis was performed to assess factors predictive of clinical outcomes. RESULTS: Of 84 patients (188 lesions) identified, 46% were treated for multiple metastases and 54% for multiple primary NSCLC. About 97% were treated for two or three lesions, and 56% had bilateral disease. After a median follow-up of 28 months, median overall survival (OS) for primary tumors was 27.6 months, and not reached for metastatic lesions (p = .028). Grade ≥3 toxicity was observed in 2% of patients. Multivariable analysis showed that grade 2 or higher radiation pneumonitis (n = 9) was best predicted by a total lung V35Gy of ≥6.5% (in 2Gy/fraction equivalent) (p = .007). CONCLUSION: Severe toxicity was uncommon following SABR using VMAT for up to three lung tumors. Further investigations of planning parameters are needed in patients presenting with more lesions.


Assuntos
Neoplasias Pulmonares/radioterapia , Radiocirurgia/métodos , Planejamento da Radioterapia Assistida por Computador/métodos , Radioterapia de Intensidade Modulada/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade
11.
Lancet ; 395(10222): e20, 2020 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-32035556

Assuntos
Radiocirurgia
12.
Lancet ; 385(9962): 36-42, 2015 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-25230595

RESUMO

BACKGROUND: Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. We assessed thoracic radiotherapy for treatment of this patient group. METHODS: We did this phase 3 randomised controlled trial at 42 hospitals: 16 in Netherlands, 22 in the UK, three in Norway, and one in Belgium. We enrolled patients with WHO performance score 0-2 and confirmed ES-SCLC who responded to chemotherapy. They were randomly assigned (1:1) to receive either thoracic radiotherapy (30 Gy in ten fractions) or no thoracic radiotherapy. All underwent prophylactic cranial irradiation. The primary endpoint was overall survival at 1 year in the intention-to-treat population. Secondary endpoints included progression-free survival. This study is registered with the Nederlands Trial Register, number NTR1527. FINDINGS: We randomly assigned 498 patients between Feb 18, 2009, and Dec 21, 2012. Three withdrew informed consent, leaving 247 patients in the thoracic radiotherapy group and 248 in the control group. Mean interval between diagnosis and randomisation was 17 weeks. Median follow-up was 24 months. Overall survival at 1 year was not significantly different between groups: 33% (95% CI 27-39) for the thoracic radiotherapy group versus 28% (95% CI 22-34) for the control group (hazard ratio [HR] 0.84, 95% CI 0.69-1.01; p=0.066). However, in a secondary analysis, 2-year overall survival was 13% (95% CI 9-19) versus 3% (95% CI 2-8; p=0.004). Progression was less likely in the thoracic radiotherapy group than in the control group (HR 0.73, 95% CI 0.61-0.87; p=0.001). At 6 months, progression-free survival was 24% (95% CI 19-30) versus 7% (95% CI 4-11; p=0.001). We recorded no severe toxic effects. The most common grade 3 or higher toxic effects were fatigue (11 vs 9) and dyspnoea (three vs four). INTERPRETATION: Thoracic radiotherapy in addition to prophylactic cranial irradiation should be considered for all patients with ES-SCLC who respond to chemotherapy. FUNDING: Dutch Cancer Society (CKTO), Dutch Lung Cancer Research Group, Cancer Research UK, Manchester Academic Health Science Centre Trials Coordination Unit, and the UK National Cancer Research Network.


Assuntos
Neoplasias Pulmonares/radioterapia , Carcinoma de Pequenas Células do Pulmão/radioterapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Bélgica , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Noruega , Resultado do Tratamento , Reino Unido
13.
Eur Respir J ; 48(3): 852-60, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27390281

RESUMO

In lung cancer, outcome measurement has been mostly limited to survival. Proper assessment of the value of lung cancer treatments, and the performance of institutions delivering care, requires more comprehensive measurement of standardised outcomes.The International Consortium for Health Outcomes Measurement convened an international, multidisciplinary working group of patient representatives, medical oncologists, surgeons, radiation oncologists, pulmonologists, palliative care specialists, registry experts and specialist nurses to review existing data and practices. Using a modified Delphi method, the group developed a consensus recommendation ("the set") on the outcomes most essential to track for patients with lung cancer, along with baseline demographic, clinical and tumour characteristics (case-mix variables) for risk adjustment.The set applies to patients diagnosed with nonsmall cell lung cancer and small cell lung cancer. Our working group recommends the collection of the following outcomes: survival, complications during or within 6 months of treatment and patient-reported domains of health-related quality of life including pain, fatigue, cough and dyspnoea. Case-mix variables were defined to improve interpretation of comparisons.We defined an international consensus recommendation of the most important outcomes for lung cancer patients, along with relevant case-mix variables, and are working to support adoption and reporting of these measures globally.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/terapia , Neoplasias Pulmonares/terapia , Oncologia/normas , Pneumologia/normas , Carcinoma Pulmonar de Células não Pequenas/psicologia , Consenso , Tosse/diagnóstico , Dispneia/diagnóstico , Fadiga/diagnóstico , Humanos , Comunicação Interdisciplinar , Cooperação Internacional , Neoplasias Pulmonares/psicologia , Oncologia/organização & administração , Avaliação de Resultados em Cuidados de Saúde , Medição da Dor , Assistência Centrada no Paciente , Pneumologia/organização & administração , Qualidade de Vida , Sistema de Registros , Resultado do Tratamento
14.
Lancet Oncol ; 16(6): 630-7, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25981812

RESUMO

BACKGROUND: The standard of care for operable, stage I, non-small-cell lung cancer (NSCLC) is lobectomy with mediastinal lymph node dissection or sampling. Stereotactic ablative radiotherapy (SABR) for inoperable stage I NSCLC has shown promising results, but two independent, randomised, phase 3 trials of SABR in patients with operable stage I NSCLC (STARS and ROSEL) closed early due to slow accrual. We aimed to assess overall survival for SABR versus surgery by pooling data from these trials. METHODS: Eligible patients in the STARS and ROSEL studies were those with clinical T1-2a (<4 cm), N0M0, operable NSCLC. Patients were randomly assigned in a 1:1 ratio to SABR or lobectomy with mediastinal lymph node dissection or sampling. We did a pooled analysis in the intention-to-treat population using overall survival as the primary endpoint. Both trials are registered with ClinicalTrials.gov (STARS: NCT00840749; ROSEL: NCT00687986). FINDINGS: 58 patients were enrolled and randomly assigned (31 to SABR and 27 to surgery). Median follow-up was 40·2 months (IQR 23·0-47·3) for the SABR group and 35·4 months (18·9-40·7) for the surgery group. Six patients in the surgery group died compared with one patient in the SABR group. Estimated overall survival at 3 years was 95% (95% CI 85-100) in the SABR group compared with 79% (64-97) in the surgery group (hazard ratio [HR] 0·14 [95% CI 0·017-1·190], log-rank p=0·037). Recurrence-free survival at 3 years was 86% (95% CI 74-100) in the SABR group and 80% (65-97) in the surgery group (HR 0·69 [95% CI 0·21-2·29], log-rank p=0·54). In the surgery group, one patient had regional nodal recurrence and two had distant metastases; in the SABR group, one patient had local recurrence, four had regional nodal recurrence, and one had distant metastases. Three (10%) patients in the SABR group had grade 3 treatment-related adverse events (three [10%] chest wall pain, two [6%] dyspnoea or cough, and one [3%] fatigue and rib fracture). No patients given SABR had grade 4 events or treatment-related death. In the surgery group, one (4%) patient died of surgical complications and 12 (44%) patients had grade 3-4 treatment-related adverse events. Grade 3 events occurring in more than one patient in the surgery group were dyspnoea (four [15%] patients), chest pain (four [15%] patients), and lung infections (two [7%]). INTERPRETATION: SABR could be an option for treating operable stage I NSCLC. Because of the small patient sample size and short follow-up, additional randomised studies comparing SABR with surgery in operable patients are warranted. FUNDING: Accuray Inc, Netherlands Organisation for Health Research and Development, NCI Cancer Center Support, NCI Clinical and Translational Science Award.


Assuntos
Lobectomia Temporal Anterior , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Recidiva Local de Neoplasia/radioterapia , Recidiva Local de Neoplasia/cirurgia , Radiocirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/patologia , Feminino , Seguimentos , Humanos , Linfonodos/patologia , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Países Baixos , Resultado do Tratamento
15.
BMC Cancer ; 15: 959, 2015 Dec 16.
Artigo em Inglês | MEDLINE | ID: mdl-26673216

RESUMO

BACKGROUND: Surgery and stereotactic ablative radiotherapy (SABR) are both curative treatment options for patients with a stage I non-small cell lung cancer (NSCLC). Consequently, there is growing interest in studying the role of patients in treatment decision making. We studied how patients with stage I NSCLC perceived shared decision making (SDM) in general, and how they viewed different aspects of SDM. METHODS: A sequential mixed methods design was used, consisting of qualitative interviews (N=11), as well as a survey study (N=76) focusing on different SDM-related aspects. Participants were interviewed to understand their own experience with treatment decision making. In the survey study, patients rated the importance of 20 aspects of shared decision making that were identified during interviews. Descriptive analysis and explorative factor analysis were performed. RESULTS: We assessed six qualitative themes covering SDM aspects that were determined by patients to be important. The survey identified four SDM-related factors with sufficient internal consistency, namely (1) 'guidance by clinician' (α=.741), (2) 'conduct of clinician' (α=.774); (3) 'preparation for treatment decision making' (α=.864); and (4) 'active role of patient in treatment decision making' (α=.782). Of these, clinician guidance was rated as most important by patients (M=3.61; SD=.44). Only 28.9% of patients in the survey study reported that both treatment options were discussed with them. CONCLUSIONS: Patients with a stage I NSCLC found clinician guidance to be important when making treatment decisions. Nevertheless, the majority of patients reported not being offered both treatment options, which might have influenced this finding.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/cirurgia , Tomada de Decisões , Neoplasias Pulmonares/cirurgia , Participação do Paciente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Relações Médico-Paciente , Pneumonectomia , Estudos Prospectivos , Pesquisa Qualitativa , Radiocirurgia
16.
Acta Oncol ; 59(5): 569-573, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32079446
17.
Oncologist ; 19(8): 880-5, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24951606

RESUMO

BACKGROUND: The Cancer Risk Management Model (CRMM) was used to estimate the health and economic impact of introducing stereotactic ablative radiotherapy (SABR) for stage I non-small cell lung cancer (NSCLC) in Canada. METHODS: The CRMM uses Monte Carlo microsimulation representative of all Canadians. Lung cancer outputs were previously validated internally (Statistics Canada) and externally (Canadian Cancer Registry). We updated costs using the Ontario schedule of fees and benefits or the consumer price index to calculate 2013 Canadian dollars, discounted at a 3% rate. The reference model assumed that for stage I NSCLC, 75% of patients undergo surgery (lobectomy, sublobar resection, or pneumonectomy), 12.5% undergo radiotherapy (RT), and 12.5% undergo best supportive care (BSC). SABR was introduced in 2008 as an alternative to sublobar resection, RT, and BSC at rates reflective of the literature. Incremental cost effectiveness ratios (ICERs) were calculated; a willingness-to-pay threshold of $100,000 (all amounts are in Canadian dollars) per quality-adjusted life-year (QALY) was used from the health care payer perspective. RESULTS: The total cost for 25,085 new cases of lung cancer in 2013 was calculated to be $608,002,599. Mean upfront costs for the 4,318 stage I cases were $7,646.98 for RT, $8,815.55 for SABR, $12,161.17 for sublobar resection, $16,266.12 for lobectomy, $22,940.59 for pneumonectomy, and $14,582.87 for BSC. SABR dominated (higher QALY, lower cost) RT, sublobar resection, and BSC. RT had lower initial costs than SABR that were offset by subsequent costs associated with recurrence. Lobectomy was cost effective when compared with SABR, with an ICER of $55,909.06. CONCLUSION: The use of SABR for NSCLC in Canada is projected to result in significant cost savings and survival gains.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Recidiva Local de Neoplasia/epidemiologia , Radiocirurgia , Canadá/epidemiologia , Carcinoma Pulmonar de Células não Pequenas/economia , Carcinoma Pulmonar de Células não Pequenas/patologia , Análise Custo-Benefício , Política de Saúde/economia , Humanos , Recidiva Local de Neoplasia/economia , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Pneumonectomia , Anos de Vida Ajustados por Qualidade de Vida
18.
Acta Oncol ; 53(3): 330-5, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24050574

RESUMO

BACKGROUND: [corrected] Stereotactic radiotherapy for central lung tumors has a narrower therapeutic index than that for peripheral tumors. Tumor tracking strategies have been proposed to reduce treatment volumes and toxicity, however they need to consider uncertainties in tumor size and shape change throughout respiration to ensure optimal local control. We quantified these uncertainties and explored strategies to account for them. MATERIAL AND METHODS: Ten patients with central tumors, PTV > 100 cm(3), motion > 5 mm and a 10-phase 4DCT without significant artifact in the tumor region were evaluated. Uncertainties were quantified using GTV size in different phases, and the Hausdorff distance (HD) between the phase 50% GTV and other phases after soft-tissue rigid registration. An individualized internal target volume for tracking (ITV(T)) was generated from the union of the GTVs in all phases after rigid registration. This was compared to ITVs generated for tracking based on the phase 50% GTV alone or with isotropic margins of 3 or 5 mm for size and volume overlap. RESULTS: Median free-breathing PTV size and motion were 162.1 cm(3) (110-210) and 8.9 mm (6.1-14.1). Overall, median GTV size variation and HD were 4.7% (0.2-22.3) and 6.3 mm (3.9-17.6). Tracking using GTV 50% alone resulted in median volume overlap with ITV(T) of 71.7% (range 56.8-85.1). Isotropic margins of 3 or 5mm always resulted in a volume overlap less than 95% or a volume larger than the ITV(T). CONCLUSIONS: Changes in size and shape of central lung tumors are substantial during respiration. These limit the ability to reduce treatment volumes with tracking, especially if isotropic margins are used. An individualized ITV for tracking, such as the ITV(T) is preferred.


Assuntos
Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/cirurgia , Radiocirurgia/efeitos adversos , Radiocirurgia/métodos , Humanos , Planejamento da Radioterapia Assistida por Computador/métodos
19.
Acta Oncol ; 53(3): 316-23, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23957648

RESUMO

BACKGROUND: Concurrent chemo-radiotherapy (CON-CRT) is recommended for selected patients with stage III non-small cell lung cancer (NSCLC), but utilization varies. We assessed the response to national guidelines introduced in 2004 and the impact on outcomes. MATERIAL AND METHODS: Retrospective study of stage III NSCLC patients treated with radical intent non-surgical treatment during 2003-2010 in a university medical center characterized by multidisciplinary assessment, routine use of four-dimensional computed tomography for radiotherapy planning, and rapid implementation of radiotherapy advances. RESULTS: Between 2003 and 2010, 319/435 (73%) patients with stage III NSCLC received (chemo) radiotherapy. The number receiving CON-CRT in successive two-year periods increased from 13/48 (27%) - 40/80 (50%) - 63/90 (70%), to 74/101 (73%). Median overall survival (OS) from start of radiotherapy was 18.6 months for CON-CRT (190/319) and 17.4 months for sequential (SEQ), typically hypofractionated, CRT (90/319) (p = 0.78). Eleven months OS with radiotherapy alone (39/319) was significantly shorter (p = 0.006). OS did not differ between the four periods (p = 0.87). CON-CRT was not over-represented in the 16% of patients dying within five months of starting radiotherapy. CONCLUSIONS: Between 2003 and 2010, CON-CRT for stage III NSCLC was rapidly and safely increased. However, OS did not increase and, as practiced, did not differ between CON- or SEQ-CRT.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/radioterapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/patologia , Quimiorradioterapia , Feminino , Tomografia Computadorizada Quadridimensional , Humanos , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
20.
BMC Med Inform Decis Mak ; 14: 116, 2014 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-25481306

RESUMO

BACKGROUND: Online cancer information can support patients in making treatment decisions. However, such information may not be adequately tailored to the patient's perspective, particularly if healthcare professionals do not sufficiently engage patient groups when developing online information. We applied qualitative user testing during the development of a patient information website on stereotactic ablative radiotherapy (SABR), a new guideline-recommended curative treatment for early-stage lung cancer. METHODS: We recruited 27 participants who included patients referred for SABR and their relatives. A qualitative user test of the website was performed in 18 subjects, followed by an additional evaluation by users after website redesign (N = 9). We primarily used the 'thinking aloud' approach and semi-structured interviewing. Qualitative data analysis was performed to assess the main findings reported by the participants. RESULTS: Study participants preferred receiving different information that had been provided initially. Problems identified with the online information related to comprehending medical terminology, understanding the scientific evidence regarding SABR, and appreciating the side-effects associated with SABR. Following redesign of the website, participants reported fewer problems with understanding content, and some additional recommendations for better online information were identified. CONCLUSIONS: Our findings indicate that input from patients and their relatives allows for a more comprehensive and usable website for providing treatment information. Such a website can facilitate improved patient participation in treatment decision-making for cancer.


Assuntos
Informação de Saúde ao Consumidor/organização & administração , Letramento em Saúde , Neoplasias Pulmonares/radioterapia , Educação de Pacientes como Assunto/normas , Participação do Paciente , Radiocirurgia/métodos , Idoso , Idoso de 80 Anos ou mais , Compreensão , Informação de Saúde ao Consumidor/normas , Tomada de Decisões , Feminino , Humanos , Internet , Neoplasias Pulmonares/psicologia , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto/métodos , Desenvolvimento de Programas/métodos , Pesquisa Qualitativa , Terminologia como Assunto
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