Radiotherapy dose escalation on pelvic lymph node control in patients with cervical cancer.

OBJECTIVE: Data supporting dose escalation for node-positive cervical cancer are currently limited to small retrospective studies. The goal of this study was to assess whether radiation dose was associated with lymph node control or gastrointestinal toxicity in patients with node-positive cervical cancer. METHODS: A total of 390 patients with carcinoma of the uterine cervix were treated between October 1997 and October 2017. Patients included in our analysis were those with squamous cell carcinoma or adenocarcinoma who were node-positive, treated definitively, and with at least one follow-up visit and post-treatment imaging scan. We excluded those without follow-up and those treated with palliative intent. All patients were treated with external beam radiation to pelvic±para-aortic fields with concurrent weekly cisplatin. All lymph nodes present at the time of treatment were stratified by size as <2 cm or ≥2 cm. Acute and late gastrointestinal toxicity were recorded for all patients. RESULTS: A total of 77 patients with 206 lymph nodes were identified. Median stage at presentation was FIGO IIB. Thirteen patients underwent definitive surgical resection followed by adjuvant radiation, of which 12 were treated to doses ≤5040 (range 2700-5940) cGy. Sixty-four patients were treated with definitive chemoradiation, of which 42 (66%) received ≤5040 (range 4500-5040) cGy and 22 (34%) received >5040 (range 5300-6640) cGy. Patients with pre-chemoradiation lymph nodes ≥2 cm had inferior lymph node control compared with patients with pre-chemoradiation lymph node <2 cm at 12 months (77% vs 100%, p=0.002). Radiation dose >5040 cGy was not significantly associated with improved lymph node control compared with ≤5040 cGy when analyzing all patients (12 months, 100% vs 89%, p=0.112). In patients with pre-chemoradiation lymph nodes ≥2 cm, radiation dose >5040 cGy was associated with improved lymph node control (12 months, 100% vs 60%, p=0.020). Acute grade ≥2 gastrointestinal toxicity was not associated with radiation dose >5040 cGy (20% vs 13%, p=0.424). Two patients developed grade ≥2 late gastrointestinal toxicity, both of whom were treated to ≤5040 cGy. CONCLUSIONS: This series supports the role of dose escalation for patients with lymph nodes ≥2 cm. Dose escalation is associated with improved control in patients with larger lymph nodes, and is not associated with greater gastrointestinal toxicity.

Screening for depression in cancer patients receiving radiotherapy: Feasibility and identification of effective tools in the NRG Oncology RTOG 0841 trial.

BACKGROUND: Brief tools are needed to screen oncology outpatients for depressive symptoms. METHODS: Patients starting radiotherapy for the first diagnosis of any tumor completed distress screening tools, including the 9-item Patient Health Questionnaire (PHQ-9), the 2-item Patient Health Questionnaire (PHQ-2), the National Comprehensive Cancer Network Distress Thermometer (NCCN-DT), and the Hopkins Symptom Checklist (HSCL) (25-item version). Patients exceeding validated cutoff scores and a systematic sample of patients whose screening was negative completed the Structured Clinical Interview for DSM-IV (SCID) mood disorder modules via telephone. RESULTS: Four hundred sixty-three patients from 35 community-based radiation oncology sites and 2 academic radiation oncology sites were recruited. Sixty-six percent of the 455 eligible patients (n = 299) were women, and the eligible patients had breast (45%), gastrointestinal (11%), lung (10%), gynecologic (6%), or other cancers (27%). Seventy-five (16.5%) exceeded screening cutoffs for depressive symptoms. Forty-two of these patients completed the SCID. Another 37 patients whose screening was negative completed the SCID. Among the 79 patients completing the SCID, 8 (10.1%) met the criteria for major depression, 2 (2.5%) met the criteria for dysthymia, and 6 (7.6%) met the criteria for an adjustment disorder. The PHQ-2 demonstrated good psychometric properties for screening for mood disorders with a cutoff score of ≥3 (receiver operating characteristic area under the curve [AUC], 0.83) and was comparable to the PHQ-9 ( > 9; AUC = 0.85). The NCCN-DT did not detect depression (AUC = 0.59). CONCLUSIONS: The PHQ-2 demonstrated good psychometric properties for screening for mood disorders, which were equivalent to the PHQ-9 and superior to the NCCN-DT. These findings support using the PHQ-2 to identify patients in need of further assessment for depression, which has a low prevalence but is a clinically significant comorbidity. These findings could inform the implementation of distress screening accreditation standards. Cancer 2017;123:485-493. © 2016 American Cancer Society.

Treatment Terminations During Radiation Therapy: A Ten-Year Experience.

PURPOSE: Patients undergoing radiation therapy may terminate treatment for any number of reasons. The incidence of treatment termination (TT) during radiation therapy has not been studied. Herein we present a cohort of TT at a large multi-center radiation oncology department over 10 years. METHODS AND MATERIALS: TTs between 1/2013 and 1/2023 were prospectively analyzed as part of an ongoing departmental quality and safety program. TT was defined as any premature discontinuation of therapy after initiating radiation planning. The rate of TT was calculated as a percentage of all patients starting radiation planning. All cases were presented at monthly morbidity and mortality (MM) conferences with a root cause reviewed (RCA). RESULTS: A total of 1,448 TTs were identified out of 31,199 planned courses of care (4.6%). Six hundred eighty-six (47.4%) involved patients treated with curative intent, while 753 (52.0%) with palliative intent, and 9 (0.6%) for benign disease. The rate of TT decreased from 8.49% in 2013 to 3.02% in 2022 with rates decreasing yearly. The most common disease sites for TT were CNS (21.7%), H&N (19.3%), Thorax (17.5%), and Bone (14.2%). The most common causes of TT were hospice and/or patient expiration (35.9%), patient choice unrelated to toxicity (35.2%), and clinician choice unrelated to toxicity (11.5%). CONCLUSION: This 10-year prospective review of TTs identified a year-over-year decrease in TTs as a percentage of planned patients. This decrease may be associated with the addition of RCA for TTs and discussion monthly at MM rounds, coupled with departmental upstream quality initiatives implemented over time. Understanding the reasons behind TTs may help to decrease preventable TTs. While some TTs may be unavoidable, open discourse and quality improvement changes effectively reduce TT incidents over time.

Patient Experience Performance at a Primary Cancer Center Versus Affiliated Community Facilities.

Purpose: Patient experience tools are used throughout health care to evaluate physician and departmental performance. In radiation medicine, these tools are important in evaluating patient-specific metrics throughout their care journey. This study compared patient experience outcomes from a central tertiary cancer program with network clinics in a health care network. Methods and Materials: Radiation medicine patient experience surveys (Press Ganey, LLC) were collected from a central facility and 5 network locations from January 2017 through June 2021. Surveys were distributed to patients after treatment completion. The study cohort was divided into the central facility and satellites. Questions were converted to a 0 to 100 scale from the Likert scale (1-5). To compare scores between site types, 2-way analysis of variance tests for the significance of sites adjusted for years of operations and adjustments for multiple comparisons (Dunnett's test) were completed on each question. Results: The number of consecutively returned surveys analyzed was 3777; a response rate of 33.3% was observed. The central site conducted 117,583 linear accelerator, 1425 Gamma Knife, 273 stereotactic radiosurgery, and 830 stereotactic body radiation therapy procedures. All satellites combined conducted 76,788 linear accelerator, 131 Gamma Knife, 95 stereotactic radiosurgery, and 355 stereotactic body radiation therapy procedures. The central facility fared better than the satellites on "Convenience of parking" (95.9 vs 87.9; P = .0001) but worse in other domains of care. Conclusions: All sites yielded exemplary patient experience rates. Community clinics scored higher than the main campus. The higher scores at the network sites require a deeper analysis of factors influencing the central facility, as the survey did not account for varying patient volumes and disparities in care complexity across sites. Attributes to satellites include lower patient volumes and easily navigable layouts. These results counter the impression that increased resources at the main campus create a better patient experience relative to network clinics and suggest that high-volume tertiary facilities will require unique initiatives to improve the patient experience.

Low-risk meningioma: Initial outcomes from NRG Oncology/RTOG 0539.

BACKGROUND: Three- and five-year progression-free survival (PFS) for low-risk meningioma managed with surgery and observation reportedly exceeds 90%. Herewith we summarize outcomes for low-risk meningioma patients enrolled on NRG/RTOG 0539. METHODS: This phase II trial allocated patients to one of three groups per World Health Organization grade, recurrence status, and resection extent. Low-risk patients had either gross total (GTR) or subtotal resection (STR) for a newly diagnosed grade 1 meningioma and were observed after surgery. The primary endpoint was 3-year PFS. Adverse events (AEs) were scored using Common Terminology Criteria for Adverse Events (CTCAE) version 3. RESULTS: Among 60 evaluable patients, the median follow-up was 9.1 years. The 3-, 5-, and 10-year rates were 91.4% (95% CI, 84.2 to 98.6), 89.4% (95% CI, 81.3 to 97.5), 85.0% (95% CI, 75.3 to 94.7) for PFS and 98.3% (95% CI, 94.9 to 100), 98.3%, (95% CI, 94.9 to 100), 93.8% (95% CI, 87.0 to 100) for overall survival (OS), respectively. With centrally confirmed GTR, 3/5/10y PFS and OS rates were 94.3/94.3/87.6% and 97.1/97.1/90.4%. With STR, 3/5/10y PFS rates were 83.1/72.7/72.7% and 10y OS 100%. Five patients reported one grade 3, four grade 2, and five grade 1 AEs. There were no grade 4 or 5 AEs. CONCLUSIONS: These results prospectively validate high PFS and OS for low-risk meningioma managed surgically but raise questions regarding optimal management following STR, a subcohort that could potentially benefit from adjuvant therapy.

Implementation of Telehealth in Radiation Oncology: Rapid Integration During COVID-19 and Its Future Role in Our Practice.

PURPOSE: The widespread coronavirus disease 2019 (COVID-19) pandemic has resulted in significant changes in care delivery among radiation oncology practices and has demanded the rapid incorporation of telehealth. However, the impact of a large-scale transition to telehealth in radiation oncology on patient access to care and the viability of care delivery are largely unknown. In this manuscript, we review our implementation and report data on patient access to care and billing implications. Because telehealth is likely to continue after COVID-19, we propose a radiation oncology-specific algorithm for telehealth. METHODS AND MATERIALS: In March 2020, our department began to use telehealth for all new consults, posttreatment encounters, and follow-up appointments. Billable encounters from January to April 2020 were reviewed and categorized into 1 of the following visit types: in-person, telephonic, or 2-way audio-video. Logistic regression models tested whether visit type differed by patient age, income, or provider. RESULTS: There was a 35% decrease in billable activity from January to April. In-person visits decreased from 100% to 21%. Sixty percent of telehealth appointments in April were performed with 2-way audio-video and 40% by telephone only. In-person consultation visits were associated with higher billing codes compared with 2-way audio-video telehealth visits (P < .01). No difference was seen for follow-up visits. Univariate and multivariable analysis identified that older patient age was associated with reduced likelihood of 2-way audio-video encounters (P < .01). The physician conducting the telehealth appointment was also associated with the type of visit (P < .01). Patient income was not associated with the type of telehealth visit. CONCLUSIONS: Since the onset of the COVID-19 pandemic, we have been able to move the majority of patient visits to telehealth but have observed inconsistent utilization of the audio-video telehealth platform. We present guidelines and quality metrics for incorporating telehealth into radiation oncology practice, based on type of encounter and disease subsite.

Computed tomography-based flap brachytherapy for non-melanoma skin cancers of the face.

PURPOSE: Non-melanoma skin cancers of the face are at high-risk for local recurrence and metastatic spread. While surgical interventions such as Mohs microsurgery are considered the standard of care, this modality has the potential for high rates of toxicity in sensitive areas of the face. Catheter flap high-dose-rate (HDR) brachytherapy has shown promising results, with high rates of local control and acceptable cosmetic outcomes. MATERIAL AND METHODS: Patients with non-melanoma skin cancers (NMSC) located on the face were treated with 40 Gy in 8 fractions, given twice weekly via catheter flap HDR brachytherapy. Clinical target volume (CTV) included the visible tumor plus a margin of 5 mm in all directions, with no additional planning target volume (PTV) margin. RESULTS: Fifty patients with 53 lesions on the face were included, with a median follow-up of 15 months. All were considered high-risk based on NCCN guidelines. Median tumor size and thickness were 18 mm and 5 mm, respectively. Median PTV volume and D90 were 1.7 cc and 92%, respectively. Estimated rate of local control at twelve months was 92%. Three patients (5%) experienced acute grade 2 toxicity. Two patients (4%) continued to suffer from chronic grade 1 skin toxicity at 12 months post-radiotherapy (RT), with an additional two patients (4%) experiencing chronic grade 2 skin toxicity. Forty-nine lesions (92%) were found to have a good or excellent cosmetic outcome with complete tumor remission. CONCLUSIONS: CT-based flap applicator brachytherapy is a valid treatment option for patients with NMSC of the face. This modality offers high rates of local control with acceptable cosmetic outcomes and low rates of toxicity.

Psychological Treatment for Patients Receiving Radiation: Results of NRG Oncology/RTOG 0841.

PURPOSE: NRG/RTOG 0841 assessed the feasibility of a depression screening procedure in patients receiving radiation therapy (RT). As a secondary endpoint, availability and barriers to psychosocial care data were collected in hopes of providing recommendations for improved psychosocial care among patients receiving RT. METHODS AND MATERIALS: Patients starting RT were prospectively recruited and assessed with self-reported distress screening tools. Patients exceeding a validated cutoff and a sample of patients who screened negative received the Structured Clinical Interview for DSM-IV (SCID) mood disorder modules via telephone. During that SCID evaluation, patients completed a validated scale ranking interview on barriers to psychosocial care and interest in various psychosocial intervention modalities. RESULTS: A total of 463 patients from 35 community-based and 2 academic RT oncology sites were recruited. Of the 455 eligible, 75 (16%) exceeded screening cutoffs for depressive symptoms. From this group, 78 patients completed the SCID; most were female (76%), white (88%), and had breast cancer (55%). Overall, the most common barriers to treatment, regardless of insurance, were costs (58%), daily responsibilities (44%), and physical health symptoms (38%). Patients from RT facilities without mental health services were significantly more likely to report difficulty with physical health problems, specifically serious illness and walking, compared with those treated at RT facilities with services (P = .013 and P = .039, respectively). Overall, there was interest in obtaining psychosocial services with face-to-face counseling at the cancer center and printed educational materials as the most commonly preferred interventions. Patients with difficult barriers to psychosocial interventions were significantly less interested in support away from the cancer center (P = .016), telephone and Internet counseling (P = .0062 &P = .011), and Internet support (P = .0048). CONCLUSION: Radiation oncology patients are interested in obtaining psychosocial services but face barriers to access to mental health services including cost, debilitating symptoms, and time constraints that prevent adequate care.

Improving efficiency and safety in external beam radiation therapy treatment delivery using a Kaizen approach.

INTRODUCTION: Modern external beam radiation therapy treatment delivery processes potentially increase the number of tasks to be performed by therapists and thus opportunities for errors, yet the need to treat a large number of patients daily requires a balanced allocation of time per treatment slot. The goal of this work was to streamline the underlying workflow in such time-interval constrained processes to enhance both execution efficiency and active safety surveillance using a Kaizen approach. METHODS AND MATERIALS: A Kaizen project was initiated by mapping the workflow within each treatment slot for 3 Varian TrueBeam linear accelerators. More than 90 steps were identified, and average execution times for each were measured. The time-consuming steps were stratified into a 2 × 2 matrix arranged by potential workflow improvement versus the level of corrective effort required. A work plan was created to launch initiatives with high potential for workflow improvement but modest effort to implement. Time spent on safety surveillance and average durations of treatment slots were used to assess corresponding workflow improvements. RESULTS: Three initiatives were implemented to mitigate unnecessary therapist motion, overprocessing of data, and wait time for data transfer defects, respectively. A fourth initiative was implemented to make the division of labor by treating therapists as well as peer review more explicit. The average duration of treatment slots reduced by 6.7% in the 9 months following implementation of the initiatives (P = .001). A reduction of 21% in duration of treatment slots was observed on 1 of the machines (P < .001). Time spent on safety reviews remained the same (20% of the allocated interval), but the peer review component increased. CONCLUSIONS: The Kaizen approach has the potential to improve operational efficiency and safety with quick turnaround in radiation therapy practice by addressing non-value-adding steps characteristic of individual department workflows. Higher effort opportunities are identified to guide continual downstream quality improvements.

Pathology concordance levels for meningioma classification and grading in NRG Oncology RTOG Trial 0539.

BACKGROUND: With advances in the understanding of histopathology on outcome, accurate meningioma grading becomes critical and drives treatment selection. The 2000 and 2007 WHO schema greatly increased the proportion of grade II meningiomas. Although associations with progression-free survival (PFS) and overall survival (OS) have been independently validated, interobserver concordance has not been formally assessed. METHODS: Once mature, NRG Oncology RTOG-0539 will report PFS and OS in variably treated low-, intermediate-, and high-risk cohorts. We address concordance of histopathologic assessment between enrolling institutions and central review, performed by a single pathologist (AP), who is also involved in developing current WHO criteria. RESULTS: The trial included 170 evaluable patients, 2 of whom had 2 eligible pathology reviews from different surgeries, resulting in 172 cases for analysis. Upon central review, 76 cases were categorized as WHO grade I, 71 as grade II, and 25 as grade III. Concordance for tumor grade was 87.2%. Among patients with WHO grades I, II, and III meningioma, respective concordance rates were 93.0%, 87.8%, and 93.6% (P values < .0001). Moderate to substantial agreement was encountered for individual grading criteria and were highest for brain invasion, ≥20 mitoses/10 high-powered field [HPF], and spontaneous necrosis, and lowest for small cells, sheeting, and ≥4 mitoses/10 HPF. In comparison, published concordance for gliomas in clinical trials have ranged from 8%-74%. CONCLUSION: Our data suggest that current meningioma classification and grading are at least as objective and reproducible as for gliomas. Nevertheless, reproducibility remains suboptimal. Further improvements may be anticipated with education and clarification of subjective criteria, although development of biomarkers may be the most promising strategy.

Prospective contouring rounds: A novel, high-impact tool for optimizing quality assurance.

PURPOSE: This study was designed to present the results of a novel prospective contouring rounds (CR), in which peer review occurs once the contours and written directive are completed but before initiation of treatment planning. METHODS AND MATERIALS: Beginning in 2012, all patients undergoing conventionally fractionated radiation therapy at a high-volume academic center were reviewed in a newly initiated daily, prospective, multidisciplinary CR. Cases were scheduled for presentation 2 days after simulation with the expectation that contours would be complete. The clinical suitability of the clinical plan, prescription, contours, and written directive were evaluated and recorded in a prospective database. Treatment planning did not commence until CR approval. Patient information and the prospective database from the first 6 months since program inception, which represented 581 consecutive treatment plans, were pooled and analyzed retrospectively to determine the impact of the prospective peer review at this stage of care delivery. RESULTS: Sixty-four percent of cases were completed on time without correction. The remaining 36% of cases required modification before treatment planning was initiated. Incomplete contours, target-volume modifications, and alterations to the written directive were the most common corrections or reasons for delay. Decreasing rates of incomplete contours, contour modifications, and miscellaneous delays were seen over time as the program became established. The percentage of cases that had no delays or modifications increased continuously as the program matured in the first 6 months, from 59% to 70%. CONCLUSIONS: Prospective CR is a meaningful and impactful tool in the quality assurance process. More than one-third of cases required contour, directive, or scheduling modification. The establishment of CR improved quality of care, with the percentage of timely, errorless cases increasing steadily over time. The impact of clinical peer review may be optimized by implementation at this early stage of delivery of care rather than at the time of traditional chart rounds.

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine.

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice.