Is it too early to recommend local treatment in oligometastatic non-small cell lung cancer: a plea for equipoise.

Oligometastatic non-small cell lung cancer (OMD NSCLC) has been proposed to bridge the spectrum between non-metastatic and widely metastatic states and is perceived as an opportunity for potential cure if removed. Twelve clinical trials on local treatment have been reported, yet none are conclusive. These trials informed the development of a joint clinical practice guideline by the American & European Societies for Radiation Oncology, which endorses local treatment for OMD NSCLC. However, the heterogeneity between prognostic factors within these trials likely influenced outcomes and can only support guidance at this time. Caution against an uncritical acceptance of the guideline is discussed, as strong recommendations are offered based on expert opinion and inconclusive evidence. The guideline is also examined by a patient's caregiver, who emphasizes that uncertain evidence impedes shared decision making.

Predicting 2-year survival in stage I-III non-small cell lung cancer: the development and validation of a scoring system from an Australian cohort.

BACKGROUND: There are limited data on survival prediction models in contemporary inoperable non-small cell lung cancer (NSCLC) patients. The objective of this study was to develop and validate a survival prediction model in a cohort of inoperable stage I-III NSCLC patients treated with radiotherapy. METHODS: Data from inoperable stage I-III NSCLC patients diagnosed from 1/1/2016 to 31/12/2017 were collected from three radiation oncology clinics. Patient, tumour and treatment-related variables were selected for model inclusion using univariate and multivariate analysis. Cox proportional hazards regression was used to develop a 2-year overall survival prediction model, the South West Sydney Model (SWSM) in one clinic (n = 117) and validated in the other clinics (n = 144). Model performance, assessed internally and on one independent dataset, was expressed as Harrell's concordance index (c-index). RESULTS: The SWSM contained five variables: Eastern Cooperative Oncology Group performance status, diffusing capacity of the lung for carbon monoxide, histological diagnosis, tumour lobe and equivalent dose in 2 Gy fractions. The SWSM yielded a c-index of 0.70 on internal validation and 0.72 on external validation. Survival probability could be stratified into three groups using a risk score derived from the model. CONCLUSIONS: A 2-year survival model with good discrimination was developed. The model included tumour lobe as a novel variable and has the potential to guide treatment decisions. Further validation is needed in a larger patient cohort.

Incident review in radiation oncology.

By its very nature, radiation oncology is a complex, multi-profession dynamic modality of cancer treatment. There are multiple steps with many handovers of work and many opportunities for patient safety to be compromised. Patient safety events can manifest as either actual incidents or near miss/close call events. Reporting and learning from these events is key to quality improvement and patient safety. In this paper, we aim to provide an overview of radiation oncology incident reporting and learning systems. We review the importance of the use of a standardized taxonomy and classification that is specific to radiation oncology workflow, the international systems in current use and the current reporting requirements in Australia and New Zealand. Equally important is the culture that exists alongside the incident learning system. A just culture, where support for reporting exists and there is an adaptive responsive environment to learn and improve patient safety. The incident learning and patient safety system requires constant effort to make it a success. We describe potential measures of safety culture and of relative patient safety and recommend their routine use. We offer this review to stimulate the effort towards a binational voluntary incident learning system, a key pillar for the improvement in patient safety in radiation oncology.

Does Motion Management Technique for Lung SBRT Influence Local Control? A Single Institutional Experience Comparing Abdominal Compression to Breath-Hold Technique.

PURPOSE: Abdominal compression (COMP) and breath-hold with an active breathing coordinator (ABC) device are 2 different respiratory motion management techniques used in lung stereotactic body radiation therapy (SBRT) practice. We compared local failure (LF) results for COMP versus ABC. METHODS AND MATERIALS: We surveyed our institutional review board-approved prospective registry for patients who were treated with SBRT for either a primary lung cancer (PRIME) or an oligometastatic (OLIGO) diagnosis with a minimum of 6 months' follow-up to determine their rates of local failure by motion management modality. RESULTS: From October 2003 to July 2014, 873 patients with 931 lesions were treated. Patient characteristics included: 455 (52.1%) female; median age of 73 years (range, 37-97); median Karnofsky performance status (KPS) of 80 (range, 40-100); and median BMI of 26.2 (range, 12.1-56.3). Tumor characteristics included: median tumor size of 2.2 cm (range, 0.7-10.0); median maximum standardized uptake value from positron emission tomography PET SUVmax of 7.5 (range, 0.8-59); 234 (25.4%) were central lesions; 830 (89.2%) lesions were PRIME; and 101 (10.8%) were OLIGO. Median follow-up and SBRT dose were 16.4 months and 50 G in 5 fractions, respectively. Overall crude rate of LF was 9.9%. Use of ABC was not associated with increased LF compared with COMP: hazard ratio (HR) = 1.043 (95% CI 0.48-2.29; P = .92). Three-year actuarial rates of LF for ABC versus COMP were 13.8% and 16.5%, respectively. After stratifying by OLIGO/PRIME, neither ABC nor COMP was significantly associated with LF. Central location may be associated with LF with ABC (HR = 2.087, P = .066). On univariate analysis, BMI, tumor size, PET SUV max and central location were associated with failure, with size the most significant. CONCLUSIONS: LF rates after lung SBRT were not influenced by form of motion control overall or when stratified by tumor type. Further study on LF rates for central tumors where ABC is used is warranted.

Outpatient Anesthesia Facilitates Stereotactic Body Radiation Therapy for Early Stage Lung Cancer Patients With Advanced Cognitive Impairments.

PURPOSE: To report on the use of outpatient anesthesia (OPA) facilitating delivery of stereotactic body radiation therapy (SBRT) in patients with severe cognitive impairments (CI) diagnosed with inoperable early stage lung cancer. METHODS AND MATERIALS: We surveyed our institutional review board-approved prospective lung SBRT data registry to document the feasibility of using anesthesia in CI patients and to determine their SBRT outcomes. RESULTS: From 2004 to 2018, 8 from a total 2084 patients were identified for this analysis. The median age at treatment was 68 years (range, 44-78). Most patients were female (62.5%). CI diagnoses included Alzheimer-related dementia (3 patients), chronic schizophrenia (3 patients), severe anxiety disorder (1 patient), and severe developmental disability (1 patient). The median tumor size was 3.4 cm (range, 1.1-10.5), and 7 patients (87.5 %) had central lesions. The median follow-up time was 22.5 months. The most common (50%) SBRT schedule used was 50 Gy in 5 fractions. Intravenous propofol (10 mg/mL) was used for OPA in all cases at the time of simulation and with daily treatments. OPA was well tolerated and all patients completed SBRT as prescribed. There was one grade 5 but no other grade 3 or higher SBRT-related toxicities. One patient died with local failure and one of distant failure. CONCLUSIONS: OPA made lung SBRT feasible for patients with CIs. SBRT outcomes were in keeping with those reported in the literature. CI should not be considered a contraindication per se to SBRT delivery in patients otherwise appropriate for this modality.

Stereotactic Ablative Radiotherapy for ≥T1b Primary Renal Cell Carcinoma: A Report From the International Radiosurgery Oncology Consortium for Kidney (IROCK).

PURPOSE: Patients with larger (T1b, >4 cm) renal cell carcinoma (RCC) not suitable for surgery have few treatment options because thermal ablation is less effective in this setting. We hypothesize that SABR represents an effective, safe, and nephron-sparing alternative for large RCC. METHODS AND MATERIALS: Individual patient data from 9 institutions in Germany, Australia, USA, Canada, and Japan were pooled. Patients with T1a tumors, M1 disease, and/or upper tract urothelial carcinoma were excluded. Demographics, treatment, oncologic, and renal function outcomes were assessed using descriptive statistics. Kaplan-Meier estimates and univariable and multivariable Cox proportional hazards regression were generated for oncologic outcomes. RESULTS: Ninety-five patients were included. Median follow-up was 2.7 years. Median age was 76 years, median tumor diameter was 4.9 cm, and 81.1% had Eastern Cooperative Oncology Group performance status of 0 to 1 (or Karnofsky performance status ≥70%). In patients for whom operability details were reported, 77.6% were defined as inoperable as determined by the referring urologist. Mean baseline estimated glomerular filtration rate (eGFR) was 57.2 mL/min (mild-to-moderate dysfunction), with 30% of the cohort having moderate-to-severe dysfunction (eGFR <45mL/min). After SABR, eGFR decreased by 7.9 mL/min. Three patients (3.2%) required dialysis. Thirty-eight patients (40%) had a grade 1 to 2 toxicity. No grade 3 to 5 toxicities were reported. Cancer-specific survival, overall survival, and progression-free survival were 96.1%, 83.7%, and 81.0% at 2 years and 91.4%, 69.2%, 64.9% at 4 years, respectively. Local, distant, and any failure at 4 years were 2.9%, 11.1%, and 12.1% (cumulative incidence function with death as competing event). On multivariable analysis, increasing tumor size was associated with inferior cancer-specific survival (hazard ratio per 1 cm increase: 1.30; P < .001). CONCLUSIONS: SABR for larger RCC in this older, largely medically inoperable cohort, demonstrated efficacy and tolerability and had modest impact on renal function. SABR appears to be a viable treatment option in this patient population.

Stereotactic Radiotherapy as a Treatment Option for Renal Tumors in the Solitary Kidney: A Multicenter Analysis from the IROCK.

PURPOSE: Stereotactic ablative radiotherapy is an emerging treatment for renal cell carcinoma. Our study objective was to evaluate this therapy in patients with a solitary kidney, focusing on oncologic and renal function outcomes. MATERIALS AND METHODS: We pooled individual patient data from 9 IROCK (International Radiosurgery Oncology Consortium for Kidney) institutions in Germany, Australia, the United States of America, Canada and Japan. Median followup was 2.6 years. Baseline characteristics and outcomes were compared between the solitary and bilateral kidney cohorts. Predictors of renal function after stereotactic ablative radiotherapy were assessed by logistic regression modeling. RESULTS: A total of 81 patients with a solitary kidney underwent stereotactic ablative radiotherapy. Mean age was 67.3 years and 97.5% of patients had good performance status, including ECOG (Eastern Cooperative Oncology Group) 0-1 or KPS (Karnofsky Performance Status) 70% or greater. Median tumor diameter was 3.7 cm (IQR 2.5-4.3) and 37% of tumors were 4 cm or greater. The 138 patients in the bilateral cohort harbored larger tumors and were older (p <0.001) with a lower baseline estimated glomerular filtration rate (p = 0.024). After stereotactic ablative radiotherapy in the solitary kidney cohort the mean ± SD estimated glomerular filtration rate decrease was -5.8 ± 10.8 ml per minute (-9%). No patient with a solitary kidney required dialysis. After stereotactic ablative radiotherapy a tumor size of 4 cm or greater was associated with an estimated glomerular filtration rate decrease of 15 ml per minute or greater (OR 4.2, p = 0.029). At 2 years the rates of local control, and progression-free, cancer specific and overall survival in the solitary cohort were 98.0%, 77.5%, 98.2% and 81.5%, respectively. There was no significant difference in renal function or oncologic outcomes between the cohorts (p >0.05). CONCLUSIONS: In this analysis of the IROCK database stereotactic ablative radiotherapy in patients with a solitary kidney had an acceptable impact on renal function and achieved excellent oncologic outcomes, similar to those in patients with bilateral kidneys. Thus, stereotactic ablative radiotherapy represents a viable treatment option in patients with renal cell carcinoma in a solitary kidney.

Pooled analysis of stereotactic ablative radiotherapy for primary renal cell carcinoma: A report from the International Radiosurgery Oncology Consortium for Kidney (IROCK).

BACKGROUND: Stereotactic ablative radiotherapy (SABR) is an emerging therapy for primary renal cell carcinoma. The authors assessed safety, efficacy, and survival in a multi-institutional setting. Outcomes between single-fraction and multifraction SABR were compared. METHODS: Individual patient data sets from 9 International Radiosurgery Oncology Consortium for Kidney institutions across Germany, Australia, the United States, Canada, and Japan were pooled. Toxicities were recorded using Common Terminology Criteria for Adverse Events, version 4.0. Patient, tumor, and treatment characteristics were stratified according to the number of radiotherapy fractions (single vs multiple). Survival outcomes were examined using Kaplan-Meier estimates and Cox proportional-hazards regression. RESULTS: Of 223 patients, 118 received single-fraction SABR, and 105 received multifraction SABR. The mean patient age was 72 years, and 69.5% of patients were men. There were 83 patients with grade 1 and 2 toxicity (35.6%) and 3 with grade 3 and 4 toxicities (1.3%). The rates of local control, cancer-specific survival, and progression-free survival were 97.8%, 95.7%, and 77.4%, respectively, at 2 years; and they were 97.8%, 91.9%, and 65.4%, respectively, at 4 years. On multivariable analysis, tumors with a larger maximum dimension and the receipt of multifraction SABR were associated with poorer progression-free survival (hazard ratio, 1.16 [P < .01] and 1.13 [P = .02], respectively) and poorer cancer-specific survival (hazard ratio, 1.28 [P < .01] and 1.33 [P = .01], respectively). There were no differences in local failure between the single-fraction cohort (n = 1) and the multifraction cohort (n = 2; P = .60). The mean ( ± standard deviation) estimated glomerular filtration rate at baseline was 59.9 ± 21.9 mL per minute, and it decreased by 5.5 ± 13.3 mL per minute (P < .01). CONCLUSIONS: SABR is well tolerated and locally effective for treating patients who have primary renal cell carcinoma and has an acceptable impact on renal function. An interesting observation is that patients who receive single-fraction SABR appear to be less likely to progress distantly or to die of cancer. Cancer 2018;124:934-42. © 2017 American Cancer Society.

The Pattern of Use of Hypofractionated Radiation Therapy for Early-Stage Breast Cancer in New South Wales, Australia, 2008 to 2012.

PURPOSE: Increasing phase 3 evidence has been published about the safety and efficacy of hypofractionated radiation therapy, in comparison with standard fractionation, in early-stage, node-negative breast cancer. However, uptake of hypofractionation has not been universal. The aim of this study was to investigate the hypofractionation regimen variations in practice across public radiation oncology facilities in New South Wales (NSW). METHODS AND MATERIALS: Patients with early breast cancer registered in the NSW Clinical Cancer Registry who received radiation therapy for early-stage breast cancer in a publicly funded radiation therapy department between 2008 and 2012 were identified. Data extracted and analyzed included dose and fractionation type, patient age at first fraction, address (for geocoding), year of diagnosis, year of treatment, laterality, and department of treatment. A logistic regression model was used to identify factors associated with fractionation type. RESULTS: Of the 5880 patients fulfilling the study criteria, 3209 patients (55%) received standard fractionation and 2671 patients (45%) received hypofractionation. Overall, the use of hypofractionation increased from 37% in 2008 to 48% in 2012 (range, 7%-94% across departments). Treatment facility and the radiation oncologist prescribing the treatment were the strongest independent predictors of hypofractionation. Weaker associations were also found for age, tumor site laterality, year of treatment, and distance to facility. CONCLUSIONS: Hypofractionated regimens of whole breast radiation therapy have been variably administered in the adjuvant setting in NSW despite the publication of long-term trial results and consensus guidelines. Some factors that predict the use of hypofractionation are not based on guideline recommendations, including lower rates of left-sided treatment and increasing distance from a treatment facility.

Different usage of the same oncology information system in two hospitals in Sydney--lessons go beyond the initial introduction.

BACKGROUND AND PURPOSE: The experience of clinicians at two public hospitals in Sydney, Australia, with the introduction and use of an oncology information system (OIS) was examined to extract lessons to guide the introduction of clinical information systems in public hospitals. METHODS AND MATERIALS: Semi-structured interviews were conducted with 12 of 15 radiation oncologists employed at the two hospitals. The personnel involved in the decision making process for the introduction of the system were contacted and their decision making process revisited. The transcribed data were analyzed using NVIVO software. Themes emerged included implementation strategies and practices, the radiation oncologists' current use and satisfaction with the OIS, project management and the impact of the OIS on clinical practice. RESULTS: The hospitals had contrasting experiences in their introduction and use of the OIS. Hospital A used the OIS in all aspects of clinical documentation. Its implementation was associated with strong advocacy by the Head of Department, input by a designated project manager, and use and development of the system by all staff, with timely training and support. With no vision of developing a paperless information system, Hospital B used the OIS only for booking and patient tracking. A departmental policy that data entry for the OIS was centrally undertaken by administrative staff distanced clinicians from the system. All the clinicians considered that the OIS should continuously evolve to meet changing clinical needs and departmental quality improvement initiatives. CONCLUSIONS: This case study indicates that critical factors for the successful introduction of clinical information systems into hospital environment were an initial clear vision to be paperless, strong clinical leadership and management at the departmental level, committed project management, and involvement of all staff, with appropriate training. Clinician engagement is essential for post-adoption evolution of clinical information systems.