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.

An investigation of a novel reusable radiochromic sheet for 2D dose measurement.

PURPOSE: Radiochromic film remains a useful and versatile clinical dosimetry tool. Current film options are single use. Here, we introduce a novel prototype two-dimensional (2D) radiochromic sheet, which optically clears naturally at room temperature after irradiation and can be reused. We evaluate the sheets for potential as a 2D dosimeter and as a radiochromic bolus with capability for dose measurement. METHODS: A novel derivative of reusable Presage® was manufactured into thin sheets of 5 mm thickness. The sheets contained 2% cumin-leucomalachitegreen-diethylamine (LMG-DEA) and plasticizer (up to 25% by weight). Irradiation experiments were performed to characterize the response to megavoltage radiation, including dose sensitivity, temporal decay rate, consistency of repeat irradiations, intra and inter-sheet reproducibility, multi-modality response (electrons and photons), and temperature sensitivity (22°C to 36°C). The local change in optical-density (ΔOD), before and after radiation, was obtained with a flat-bed film scanner and extracting the red channel. Repeat scanning enabled investigation of the temporal decay of ΔOD. Additional studies investigated clinical utility of the sheets through application to IMRT treatment plans (prostate and a TG119 commissioning plan), and a chest wall electron boost treatment. In the latter test, the sheet performed as a radiochromic bolus. RESULTS: The radiation induced OD change in the sheets was found to be proportional to dose and to exponentially decay to baseline in ~24 h (R2 = 0.9986). The sheet could be reused and had similar sensitivity (within 1% after the first irradiation) for at least eight irradiations. Importantly, no memory of previous irradiations was observed within measurement uncertainty. The consistency of dose response from photons (6 and 15 MV) and electrons (6-20 MeV) was found to be within calibration uncertainty (~1%). The dose sensitivity of the sheets had a temperature dependence of 0.0012 ΔOD/°C. For the short (1 min) single field IMRT QA verification, good agreement was observed between the Presage sheet and EBT film (gamma pass rate 97% at 3% 3 mm dose-difference and distance-to-agreement tolerance, with a 10% threshold). For the longer (~13 min) TG-119 9-field IMRT verification the gamma agreement was lower at 93% pass rate at 5% 3 mm, 10% threshold, when compared with Eclipse. The lower rate is attributed to uncertainty arising from signal decay during irradiation and indicates a current limitation. For the electron cutout treatment, both Presage and EBT agreed well (within 2% RMS difference) but differed from the Eclipse treatment plan (~7% RMS difference) indicating some limitations to the Eclipse modeling in this case. The worst case estimates of uncertainty introduced by the signal decay for deliveries of 2, 5, and 10 min are 0.6%, 1.4%, and 2.8% respectively. CONCLUSIONS: Reusable Presage sheets show promise for 2D dose measurement and as a radiochromic bolus for in vivo dose measurement. The current prototype is suitable for deliveries of length up to 5 min, where the uncertainty introduced by signal decay is anticipated to be ~1% (worst case 1.4%), or for longer deliveries where there is no temporal modulation (e.g. physical compensators, or open beams). Additionally, spatial resolution is limited by sheet thickness and scanner resolution, resulting in a practical resolution of 0.8 mm.

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.

Active Breathing Coordinator reduces radiation dose to the heart and preserves local control in patients with left breast cancer: report of a prospective trial.

PURPOSE: Incidental radiation dose to the heart and lung during breast radiation therapy (RT) has been associated with an increased risk of cardiopulmonary morbidity. We conducted a prospective trial to determine if RT with the Active Breathing Coordinator (ABC) can reduce the mean heart dose (MHD) by ≥20% and dose to the lung. METHODS AND MATERIALS: Patients with stages 0-III left breast cancer (LBC) were enrolled and underwent simulation with both free breathing (FB) and ABC for comparison of dosimetry. ABC was used during the patient's RT course if the MHD was reduced by ≥5%. The median prescription dose was 50.4 Gy plus a boost in 77 patients (90%). The primary endpoint was the magnitude of MHD reduction when comparing ABC to FB. Secondary endpoints included dose reduction to the heart and lung, procedural success rate, and adverse events. RESULTS: A total of 112 patients with LBC were enrolled from 2002 to 2011 and 86 eligible patients underwent both FB and ABC simulation. Ultimately, 81 patients received RT using ABC, corresponding to 72% procedural success. The primary endpoint was achieved as use of ABC reduced MHD by 20% or greater in 88% of patients (P < .0001). The median values for absolute and relative reduction in MHD were 1.7 Gy and 62%, respectively. RT with ABC provided a statistically significant dose reduction to the left lung. After a median follow up of 81 months, 8-year estimates of locoregional relapse, disease-free, and overall survival were 7%, 90%, and 96%, respectively. CONCLUSIONS: ABC was well tolerated and significantly reduced MHD while preserving local control. Use of the ABC device during RT should be considered to reduce the risk of ischemic heart disease in populations at risk.

Complication rates in patients with negative axillary nodes 10 years after local breast radiotherapy after either sentinel lymph node dissection or axillary clearance.

BACKGROUND: We assess complication rates in node negative breast cancer patients treated with breast radiotherapy (RT) only after sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND). MATERIALS AND METHODS: Between 1995 and 2001, 226 women with AJCC stage I-II breast cancer were treated with lumpectomy, either SLND or SLND+ALND, and had available toxicities in follow-up: 111/136 (82%) and 115/129 (89%) in SLND and ALND groups, respectively. RT targeted the breast to median dose of 48.2 Gy (range, 46.0 to 50.4 Gy) without axillary RT. Chi-square tests compared complication rates of 2 groups for axillary web syndrome (AWS), seroma, wound infection, decreased range of motion of the ipsilateral shoulder, paresthesia, and lymphedema. RESULTS: Median follow-up was 9.9 years (range, 8.3-15.3 y). Median number of nodes assessed was 2 (range, 1-5) in SLND and 18 (range, 7-36) in ALND (P < 0.0001). Acute complications occurred during the first 2 years and were AWS, seroma, and wound infection. Incidences of seroma 5/111 (4.5%) in SLND and 16/115 (13.9%) in ALND (P < 0.02, respectively) and wound infection 3/111 (2.7%) in SLND and 10/115 (8.7%) in ALND (P < 0.05, respectively) differed significantly. AWS was not statistically different between the groups. At 10 years, the only chronic complications decreased were range of motion of the shoulder 46/111 (41.4%) in SLND and 92/115 (80.0%) in ALND (P < 0.0001), paresthesia 12/111 (10.8%) in SLND and 39/115 (33.9%) in ALND (P < 0.0001), and lymphedema assessed by patients 10/111 (10.0%) in SLND and 39/115 (33.9%) in ALND (P < 0.0001). Chronic lymphedema, assessed by clinicians, occurred in 6/111 (5.4%) in SLND and 21/115 (18.3%) in ALND cohorts, respectively (P < 0.0001). CONCLUSIONS: Our mature findings support that in patients with negative axillary nodal status SLND and breast RT provide excellent long-term cure rates while avoiding morbidities associated with ALND or addition of axillary RT field.

Early postoperative paclitaxel followed by concurrent paclitaxel and cisplatin with radiation therapy for patients with resected high-risk head and neck squamous cell carcinoma: report of the phase II trial RTOG 0024.

PURPOSE: We sought to improve outcomes for patients with high-risk head and neck squamous cell cancer (HNSCC) after surgical resection by testing the feasibility and safety of early postoperative chemotherapy followed by concurrent chemoradiotherapy. PATIENTS AND METHODS: Eligible patients had resected, stages III to IV HNSCC with positive margins, extracapsular nodal extension, or multiple positive nodes. Paclitaxel (80 mg/m(2)) was given once weekly during postoperative weeks 2, 3, and 4 and was given before radiation therapy (RT). Paclitaxel (30 mg/m(2)) and cisplatin (20 mg/m(2)) were given once weekly during the last 3 weeks of RT (60 Gy over 6 weeks, beginning 4 to 5 weeks after surgery). The primary end points were treatment safety and tolerability compared with concurrent cisplatin (100 mg/m(2) every 3 weeks) and RT, as tested in Radiation Therapy Oncology Group trial RTOG 9501. RESULTS: The median follow-up time for the 70 patients enrolled was 3.3 years (range, 0.6 to 4.4 years) for surviving patients. Tolerability of all treatment components was comparable to that of RTOG 9501 treatment, which is the current standard of care (compliance rate, 75%; 95% CI, 63% to 85%). One patient died, and seven patients experienced grade 4 nonhematologic toxicities. Rates of locoregional control, disease-free survival, and overall survival exceeded those of RTOG 9501 after adjustment for important prognostic variables (ie, positive margins, extracapsular extension, primary site, and performance status). CONCLUSION: Chemotherapy soon after surgery followed by concurrent chemoradiotherapy therapy was feasible; tolerance was in line with standard postoperative chemoradiotherapy; and this regimen led to excellent rates of locoregional control and disease-free survival.

Neck dissection followed by chemoradiotherapy for stage IV (N+) oropharynx cancer.

PURPOSE: This study evaluated the strategy of performing neck dissection (ND) without primary tumor resection prior to definitive chemoradiotherapy (CRT) for N2+ oropharynx cancer. METHODS: We analyzed records of 25 patients who underwent ND before concurrent CRT with weekly low-dose concurrent paclitaxel and a platinum compound. The extent of ND was highly customized (1 to 39 nodes) and median radiotherapy dose was 70 Gy. RESULTS: Median follow-up was 36 months. Two-year and 3-year actuarial locoregional control rates were 95% and 88%. No patient had regional neck nodal failure. Two-year rate of freedom from distant metastases was 91%. The 2- and 3-year event-free survival rates were 88% and 75%. Fifteen percent had Grade 3+ late toxicity; none had permanent gastrostomy tube dependence. CONCLUSIONS: Neck dissection without primary tumor resection before definitive chemoradiotherapy for oropharynx cancer is a safe and effective management program and warrants further exploration.