ObjectivesStereotactic body radiotherapy (SBRT) is being increasingly used for the treatment of patients with lung cancer or lung metastasis who are medically unfit to undergo resection. In order to improve accuracy and confidence in targeting tumors, many centers rely on fiducial implantation. We evaluated the migration of a novel fiducial marker specifically designed for lung tissue implanted via electromagnetic navigation bronchoscopy (ENB).MethodsWe retrospectively quantified the individual and group migrations of SuperLock nitinol coil fiducials for 15 patients receiving lung stereotactic body radiotherapy (SBRT), in order to evaluate the reliability of using these fiducials as a target surrogate for cases where tumors cannot be clearly delineated on cone beam CTs (CBCTs). For each fraction, we compared the individual and group migrations of the fiducials between the planning CT and the acquired CBCT. The group migration was defined as the distance between the centroids of the fiducial group and GTV.ResultsA total of 16 lung targets were included in our study for these 15 patients (one patient with two targets). Of 55 fiducials placed, we observed a 100% retention rate. The mean individual migration was 1.87 mm (range, 0.63–5.25 mm) with a standard deviation of 1.26 mm. The mean group migration was 1.94 mm (range, 0.03–6.19 mm) with a standard deviation of 1.45 mm. Overall, there was minimal change in the relative locations of the markers with respect to each other, as well as to the target.ConclusionsWe found that the SuperLock nitinol coil fiducial marker positions are stable throughout the radiation treatment, and can be used as a reliable surrogate to target, and to avoid geometric misses during gated treatments.
Introduction: After local control and overall survival, acceptable cosmesis is the next most important goal of BCT. Digital photos (DP) are commonly used for assessing cosmesis on clinical trials. On NRG NSABP B39/RTOG 0413, DP at baseline, 1, and 3 years post-radiation were submitted for review by a panel of breast cancer specialists. Given no current standards for central DP review, this project seeks to develop a standard for subjective DP evaluation. The initial standardization of the photo database and reliability of the panel review is described. Methods: De-identified DP submitted and stored at NRG SDMC were downloaded to a secure FTP site. Cases with only 1 time point, no baseline, or photos from different patients were excluded. A minimum photo quality was set, including pre-specified criteria for contrast/light, breast/torso size, and cropping to exclude anatomy above the clavicle and below the umbilicus. DP were edited with MATLAB™ and saved in a Reformatted Digital Photo Database (RDPD). A training set was created defining 4 global cosmetic scores, and each individually assessed criteria of breast symmetry, shape, skin color, nipple, and scar appearance. A 14 case calibration set followed the training set. The process for panel review was adapted from the methods reported in the START and RAPID trials. The review panel consisted of 6 breast-specific radiation oncologists, who reviewed in groups of 3. For each session, the training set was reviewed and calibration set scored. A separate 30 case test set randomly selected from the RDPD was reviewed by 2 groups of 3. The calibration and test sets were evaluated for agreement of categorized scores (excellent/good vs. fair/poor). Results: There were 2064 DP from 892 patients on NRG NSABP B39/RTOG 0413 documenting the anterior view of both breasts. After exclusions, 1,717 reformatted DP were saved in the RDPD. Five 1-3 hour review sessions resulted in scoring of 777 DP (~ 155 per session). Only 2/777 (0.1%) DP were deemed poor quality and not able to be scored. There was full agreement in categorized scores for 12/14 cases (86%; kappa=0.82) across the 5 calibration sets; and 27/30 (90%; kappa=0.71) for the 2 test set reviews. Conclusions: Cosmesis DP prospectively collected on a large phase III clinical trial can be digitally formatted in a systematic fashion for consistent photo quality, allowing for cosmesis consensus panel review without photo quality bias. High agreement in categorized scores allowed reviews to be completed by multiple 3-person review groups. Future work will focus on creating an updated, semi-automatic analysis tool of these photos for objective evaluation of cosmesis using the same scoring guidelines that can then be compared to physician reported outcomes. Grant Support: FUJIFILM Medical Systems/RSNA Research Resident, NCI U10CA180868, U10CA180822 Note: This abstract was not presented at the meeting. Citation Format: Ashley Sekhon, Ruiqi Zhao, Yan Wang, Debora Grant, Kathryn A. Winter, Jennifer Moughan, Douglas W. Arthur, Stephen J. Chmura, Atif J. Khan, Simona F. Shaitelman, Aleix M. Martinez, Frank A. Vicini, Julia R. White. Creating a review process of a digital photo database collected on NRG NSABP B39/RTOG 0413 phase III clinical trial for evaluation of cosmetic results from breast conserving therapy (BCT) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 2764. doi:10.1158/1538-7445.AM2017-2764
BACKGROUND: Accelerated partial breast irradiation (APBI) has emerged as an alternative to whole breast irradiation (WBI) following lumpectomy for select patients. However, the challenges to post-operative APBI include targeting inaccuracy and the inability to measure tumor response to radiation. We hypothesized that preoperative APBI (pAPBI) could reliably target the tumor using MRI-guidance that is acquired prone in combination with our established prone breast radiation delivery. We developed methodology for prone CT simulation to establish radiation position, MRI acquisition in treatment position, registration of MRI-CT data for treatment planning, and treatment delivery with daily cone-beam CT using the same immobilization platform. This study aimed to assess the reproducibility, toxicity and local control associated with MRI/CT-directed prone pAPBI. METHODS: This was a prospective, single arm study enrolling patients >50 yo with clinical (c) Stage IA ER+/PR+/HER2- breast cancer intending lumpectomy. Axillary US and MRI imaging to confirm clinical node negative disease was required. A planning CT in the prone position was followed by MRI using the same prone immobilization platform. Rigid registration of MRI-CT data was used for radiation planning. pAPBI of 3850 cGy was delivered in 10 fractions BID with the same prone immobilization technique. Another MRI was obtained 4 weeks post-APBI to assess tumor response. The intensity, kinetics and volume of the lesion on MRI was quantitatively assessed and an experienced reader evaluated MRI volume and kinetic changes in the tumor post-APBI. Lumpectomy was performed 4-6 weeks after APBI. Simon 2 stage design required assessment after accrual of 19 patients for assessment of feasibility. RESULTS: Nineteen cStage IA ER+/PR+/HER2- breast cancer patients with a median age of 65 (range 51-78) were enrolled on the study, completed APBI, lumpectomy, and adjuvant AI. Median follow up was 3.4 years. Mean clinical tumor size was 1.1 cm ± 0.4 and mean path tumor size was 0.94 cm ± 0.6. There was complete pathologic response in 10.5% (n=2) and an additional 36.8% (n=7) were downstaged from clinical stage (measured by mammogram/US) to pathologic stage, resulting in a total response of 47.4% (n=9). Six (31.6%) patients had stable disease after APBI. Four (21.0%) were upstaged from clinical stage to pathological stage. Tumor response detected by MRI significantly correlated with tumor response based on clinical to pathologic stage (p=0.03). Cosmesis was rated as excellent/good in 89.5% (n=17) patients post-APBI. Cosmesis worsened to fair in 2 patients post-APBI, one of which required adjuvant WBI after focal triple negative breast cancer was detected on pathology. Three patients had positive macrometastatic lymph nodes on final pathology despite clinically negative nodes on imaging. One in-breast recurrence outside the RT field was detected by MRI at 14 months, resulting in a locoregional recurrence rate of 5.4% at 3.4 years. Another patient developed metastases at 20 months. CONCLUSIONS: Using the same prone platform, all patients successfully underwent CT simulation, MRI acquisition, and completed pAPBI. Nearly half of enrolled patients had a measurable tumor response to pAPBI based on MRI and pathologic response, confirming the accuracy and reproducibility of defining tumor targets with our MRI/CT-directed pAPBI approach. While this methodology for prone pAPBI resulted in good cosmesis and local control and remains a promising approach for select patients, the challenge of excluding patients with subclinical lymph node positive disease remains. Correlative studies will determine whether Ki-67 and OncotypeDx pre- and post-APBI can help predict response to pAPBI. Citation Format: Sasha Beyer, Tamara Smith, Ashley Sekhon, Jose Bazan, Sachin Jhawar, Erin Healy, Lai Wei, Vedat Yildiz, Mohamed Mohamed, Michael Knopp, Julia White. Preliminary results of a feasibility study assessing radiation response with MRI/CT directed preoperative accelerated partial breast irradiation in the prone position for hormone responsive early stage breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-19-03.
Background: Tumor mutational burden (TMB) is a potential biomarker to predict tumor response to immuno-oncology agents in patients with metastatic non-small cell lung cancer (NSCLC). Materials and Methods: A multi-site cohort study evaluated patients diagnosed with stage IV NSCLC between 2012 and 2019 who had received comprehensive genomic profiling (CGP) and any NSCLC-related treatment at 9 U.S. cancer centers. Baseline characteristics and clinical outcomes were compared between patients with TMB <10 and TMB ≥10. Results: Among the 667 patients with CGP results, most patients received CGP from Foundation Medicine (64%) or Caris (20%). Patients with TMB ≥10 (vs. TMB <10) were associated with a positive smoking history. TMB was associated with ALK ( p = 0.01), EGFR ( p < 0.01), and TP53 ( p < 0.05) alterations. TMB >10 showed a significant association towards longer overall survival (OS) (HR: 0.43, 95% CI: 0.21–0.88, p = 0.02) and progression-free survival (PFS) (HR: 0.43, 95% CI: 0.21–0.85, p = 0.02) in patients treated with first-line immunotherapy and tested by Foundation Medicine or Caris at treatment initiation. Conclusions: TMB levels greater than or equal to 10 mut/Mb, when tested by Foundation Medicine or Caris at treatment initiation, were significantly associated with improved OS and PFS among patients treated with first-line immunotherapy-containing regimens. Additional prospective research is warranted to validate this biomarker along with PD-L1 expression.
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