scholarly journals Quality assurance of radiotherapy in the ongoing EORTC 1420 “Best of” trial for early stage oropharyngeal, supraglottic and hypopharyngeal carcinoma: results of the benchmark case procedure

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
J-J Stelmes ◽  
E. Vu ◽  
V. Grégoire ◽  
C. Simon ◽  
E. Clementel ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Early Stage ◽  
Prospective Trial ◽  
Similarity Index ◽  
Phase Iii ◽  
Current Phase ◽  
Hypopharyngeal Carcinoma ◽  
Transoral Surgery ◽  
Swallowing Function ◽  
The Impact

Abstract Introduction The current phase III EORTC 1420 Best-of trial (NCT02984410) compares the swallowing function after transoral surgery versus intensity modulated radiotherapy (RT) in patients with early-stage carcinoma of the oropharynx, supraglottis and hypopharynx. We report the analysis of the Benchmark Case (BC) procedures before patient recruitment with special attention to dysphagia/aspiration related structures (DARS). Materials and methods Submitted RT volumes and plans from participating centers were analyzed and compared against the gold-standard expert delineations and dose distributions. Descriptive analysis of protocol deviations was conducted. Mean Sorensen-Dice similarity index (mDSI) and Hausdorff distance (mHD) were applied to evaluate the inter-observer variability (IOV). Results 65% (23/35) of the institutions needed more than one submission to achieve Quality assurance (RTQA) clearance. OAR volume delineations were the cause for rejection in 53% (40/76) of cases. IOV could be improved in 5 out of 12 OARs by more than 10 mm after resubmission (mHD). Despite this, final IOV for critical OARs in delineation remained significant among DARS by choosing an aleatory threshold of 0.7 (mDSI) and 15 mm (mHD). Conclusions This is to our knowledge the largest BC analysis among Head and neck RTQA programs performed in the framework of a prospective trial. Benchmarking identified non-common OARs and target delineations errors as the main source of deviations and IOV could be reduced in a significant number of cases after this process. Due to the substantial resources involved with benchmarking, future benchmark analyses should assess fully the impact on patients’ clinical outcome.

Chemotherapy treatment patterns for early-stage breast cancer (ESBC): Decreasing use of anthracycline-based regimens.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 141-141
Author(s):  
Katherine M. Serrurier ◽  
Jimmy Hwang ◽  
Joseph P. McGuire ◽  
Ann C. Griffin ◽  
Michelle E. Melisko ◽  
...  
Keyword(s):  
Cancer Registry ◽  
Early Stage ◽  
Prospective Trial ◽  
Marked Change ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Stage Iii ◽  
Publication Date ◽  
Time Periods ◽  
The Impact

141 Background: Anthracyclines (A), given in sequence or combination with other agents, have been the mainstay of adjuvant chemotherapy (CTX) for ESBC for more than two decades. Recent molecular studies have questioned the value of A for lower risk disease. A single prospective trial presented in 2005 and published in 2006 (Jones et al) compared docetaxel and cyclophosphamide (TC) to doxorubicin and cyclophosphamide and reported improved disease free survival (2006) and overall survival (2009) with TC. We sought to understand the impact of this study on the type of CTX regimens used to treat ESBC. Methods: Using the UCSF Cancer Registry database and including patients who received at least one cycle of CTX at UCSF, we recorded use of A or non-anthracycline (NA) based CTX regimens in women with ESBC and correlated type of CTX with tumor stage, receptor status, and age. Based on the publication date of TC we looked at the use of A versus NA based CTX during two time periods, 2000-2005 and 2006-2010. Results: 1,116 patients met criteria for inclusion; 17 were excluded due to inadequate information. Patient characteristics were: median age 49 (range 21-78), stage I (24%), stage II (56%), and stage III (20%), 50% hormone receptor (HR) +, 25% HER2 +, 17% HR-/HER2-. From 2000-2010, 80% received A CTX. Overall use of A decreased from 95% to 65%, while use of NA based CTX increased from 5% to 35%. The table compares use of NA CTX during the two time periods by clinical variables. Conclusions: Use of NA CTX increased significantly over the 2nd half of the last decade in all cases except those patients with stage III disease. The timing of this marked change correlates with publication of TC, and emphasizes the impact of positive phase III trials on treatment practice. This study was supported by the UCSF Cancer Registry. [Table: see text]

NRG Oncology HN006: Randomized phase II/III trial of sentinel lymph node biopsy versus elective neck dissection for early-stage oral cavity cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS6093-TPS6093
Author(s):  
Stephen Yenzen Lai ◽  
Pedro A. Torres-Saavedra ◽  
Neal E. Dunlap ◽  
Beth Michelle Beadle ◽  
Steven S. Chang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Quality Assurance ◽  
Neck Dissection ◽  
Phase Ii ◽  
Oral Cavity Cancer ◽  
Early Stage ◽  
Standard Of Care ◽  
Phase Iii ◽  
Elective Neck Dissection ◽  
Pet Ct

TPS6093 Background: Since patients with early-stage oral cavity cancer (OCC; T1-2N0M0; AJCC 8th ed) have a 20-30% rate of occult nodal metastases despite clinical and radiographic assessment, standard of care treatment includes elective neck dissection (END). Many patients have comprehensive surgical management of the regional cervical nodal basin even though the majority of those necks (70-80%) will not contain disease. Assessment of draining first echelon lymph nodes by sentinel lymph node (SLN) biopsy (Bx), a less invasive surgical procedure, may provide an alternative to END, while potentially reducing morbidity and cost. A decisive clinical trial comparing SLN Bx versus END can focus the HNC clinical and research community and resources on establishing the standard of care for management of the neck in early-stage OCC. Methods: In order to address the efficacy of SLN Bx in this population, we recently activated an international multi-institutional phase II/III prospective trial randomizing patients to two surgical arms: SLN Bx and END. PET/CT is an integral imaging biomarker in this trial. A node-negative PET/CT study with central read is required before randomization. Patients with a positive PET/CT central result will remain in a registry to compare imaging findings with final neck pathology. Given the current evidence available regarding morbidity for SLN Bx versus END, the phase II will determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the Neck Dissection Impairment Index (NDII) shows a signal of superiority of SLN Bx compared to END. A total of 228 randomized patients with negative PET/CT for potential evaluation of shoulder-related morbidity with difference in 6-month NDII scores (minimum important difference ³7.5; one-sided a = 0.10; 90% power) will serve as the “Go/No-Go” decision to move forward into phase III. The phase III portion is a non-inferiority (NI) trial with disease-free survival (DFS) as the primary endpoint (NI margin hazard ratio 1.34 based on a 5% absolute difference in 2-year DFS; one-sided alpha 0.05; 80% power, and an interim look for efficacy at 67% of the events based on an O’Brien-Fleming boundary). The NDII at 6 months after surgery is a hierarchical co-primary endpoint for the phase III. Target accrual of phase III is 618 PET/CT negative patients, including those randomized in phase II (297 DFS events required for the final analysis). In addition to radiotherapy and imaging credentialing, quality assurance will include central pathology review of all negative SLN Bx cases and surgeon credentialing through an education course and SLN Bx and END case review by the surgical co-chairs. A surgical quality assurance working group will review all trial SLN Bx and END outcomes. As of 02/15/21, 7 patients have been screened and 6 of the planned 228 randomized patients in phase II have been enrolled. Clinical trial information: NCT04333537.

COX2 and HLA immunohistochemical (IHC) staining in colorectal tumour samples from patients participating in the ASCOLT clinical trial of adjuvant aspirin therapy.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 695-695
Author(s):  
Eva Segelov ◽  
Oliver Sieber ◽  
John Whay Kuang Chia ◽  
David S Williams
Keyword(s):  
Clinical Trial ◽  
Internal Control ◽  
Prospective Trial ◽  
Antigen Expression ◽  
Phase Iii ◽  
Normal Epithelium ◽  
Colorectal Tumour ◽  
Class 1 ◽  
Hla Class 1 ◽  
The Impact

695 Background: ASCOLT is an international Phase III randomized control trial (NCT00565708) investigating the impact of adjuvant aspirin on recurrence and survival after curative resection of colorectal cancer (CRC). Retrospective data suggest that COX2 and HLA Class 1 antigen expression may predict for aspirin benefit (Reimers MS, JAMA internal medicine, 2014;174(5):732-739; and Chan AT, JAMA, 2009;302(6):649-658.) Translational studies aim to confirm putative biomarkers of aspirin sensitivity in this prospective trial. This study reports the IHC assessment of COX2 and HLA in representative samples. Methods: FFPE slides from consenting Australian patients were stained with COX2 and HLA Class 1 antibodies (Chan AT, JAMA, 2009;302(6):649-658.). Digital images were captured using Aperio software. IHC expression was scored by a pathologist (DW) blinded to sample identification. Intensity was assessed semi-quantitatively for each antibody in one area of dominant (primary) intensity and one of secondary intensity in each section. A scale was applied for staining intensity: 0=absent, 1=weak, 2=moderate and 3=strong; and for amount of tumor epithelium stained: 1= 5%-24%, 2= 25%-49%, 3=50%-74% 4= >75%. Normal epithelium, which typically has strong COX2 and HLA staining, was used as internal control. Only tumor epithelium was scored (not inflammatory cells). Results: 90 tumors were stained for both COX2 and HLA Class 1. All tumors showed diffuse staining for both markers, mostly strong, but with many tumors having regions with lesser degrees of expression (Table). Conclusions: COX2 expression was generally strong and HLA Class 1 was more likely to show regions of weak to moderate expression. No significant correlation was detected between COX2 and HLA expression levels. Further pathological analysis is underway and correlations will be made with outcome once trial data has matured in 2020. Clinical trial information: NCT00565708. [Table: see text]

Chemotherapy (CTX) treatment patterns for early-stage breast cancer (ESBC): Changing use of anthracyclines (A).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1083-1083
Author(s):  
Katherine M. Serrurier ◽  
Jimmy Hwang ◽  
Joseph P. McGuire ◽  
Daphne Lichtensztajn ◽  
Ann C. Griffin ◽  
...  
Keyword(s):  
Cancer Registry ◽  
Early Stage ◽  
Tumor Stage ◽  
Phase Iii ◽  
Two Phase ◽  
Receptor Status ◽  
Treatment Practice ◽  
Phase Iii Trials ◽  
The Impact

1083 Background: Anthracyclines (A), given in sequence or combination, have been the mainstay of adjuvant CTX for ESBC. Recent molecular studies have questioned the value of A for ESBC. Trials for ESBC, presented primarily in 2005, have demonstrated similar or improved efficacy with non-anthracycline (NA) CTX. We sought to understand changing use of A for ESBC from 2000-2010 as reported in the population-based 9-county Greater Bay Area Cancer Registry (GBACR). Methods: Using the GBACR database, we recorded use of A or NA based CTX regimens in women with ESBC and no prior CTX from 2000-2010, and correlated type of CTX with tumor stage, receptor status, and age. We evaluated the use of A vs. NA (80% taxane-based) CTX from 2000-2005 and 2006-2010. Results: 16,476 patients (pts) met criteria for inclusion; 2,032 (12%) were excluded (missing information, or CTX not given). Pt characteristics were: median age 52 (range 21-94), stage I (25%), II (56%), and III (19%), 69% HR+. From 2000-2010, 83% received A; overall use of A decreased (87% to 57%), and use of NA increased (13% to 43%). The Table compares use of NA CTX during the two time periods by clinical variables. With short follow-up there was no difference in survival based on use of A vs. NACTX. Conclusions: Use of NA CTX significantly increased during 2006-2010; this trend was independent of age or receptor status and was more pronounced in earlier stage disease. The timing of this change correlated with the presentation of two phase III trials, emphasizing the impact of early data from phase III trials on treatment practice, and confirming results from a large claims database (Giordano). Potential outcome differences will be evaluated in NSABP-B49 and with longer follow-up of this cohort. This study was supported by the UCSF Cancer Registry and CPIC. [Table: see text]

Evaluation of pharyngeal swallowing pressure using high-resolution manometry during transoral surgery for oropharyngeal cancer

2021 ◽  
Vol 135 (2) ◽  
pp. 153-158
Author(s):  
K Fujiwara ◽  
S Koyama ◽  
K Taira ◽  
K Kawamoto ◽  
T Fukuhara ◽  
...  
Keyword(s):  
High Resolution ◽  
Oropharyngeal Cancer ◽  
Objective Evaluation ◽  
Transoral Surgery ◽  
Swallowing Function ◽  
High Resolution Manometry ◽  
Pharyngeal Pressure ◽  
Significant Difference ◽  
Upper Oesophageal Sphincter ◽  
The Impact

AbstractBackgroundTransoral robotic surgery is frequently described, driven by the desire to offer a less morbid alternative to chemoradiation. However, the objective evaluation of post-operative function has rarely been reported. Therefore, high-resolution manometry was used in this study to evaluate the impact of changes in peri-operative swallowing function on pharyngeal pressure events.MethodsTen patients with various stages of oropharyngeal cancer underwent transoral surgery. High-resolution manometry and videofluoroscopic swallow studies were performed before surgery and two months afterwards. The following parameters were obtained: velopharyngeal and mesopharyngeal post-deglutitive upper oesophageal sphincter pressures, velo-meso-hypopharyngeal contractile integral, upper oesophageal sphincter relaxation pressure, and pharyngeal velocity.ResultsThere was no significant difference in pharyngeal pressure or contractile integral pre- versus post-operatively. However, pharyngeal velocity was significantly higher post-operatively than pre-operatively.ConclusionHigh-resolution manometry showed that transoral surgery in patients without pre-operative dysphagia preserved pharyngeal constriction. However, transoral surgery might produce scar formation in the pharynx, which could lead to narrowing of the pharynx.

scholarly journals Hypopharyngeal Cancer: Staging, Diagnosis, and Therapy

2021 ◽  
Author(s):  
Yi Huang ◽  
Yushan Liang ◽  
Weilin Zhao
Keyword(s):  
Early Stage ◽  
Tobacco Consumption ◽  
Hypopharyngeal Carcinoma ◽  
Voice Rehabilitation ◽  
Transoral Surgery ◽  
Second Primary ◽  
Advanced Stage ◽  
Endoscopic Screening ◽  
Primary Surgery ◽  
Similar Survival

Hypopharyngeal carcinoma is uncommon in all head and neck cancers. With a synergistic reaction of each, tobacco consumption and alcohol abuse contribute to the tumorigenesis. The aerodigestive tract epithelium exposure to similar risks causing multiple cancers. Thus, a pan-endoscopic screening offers a practical approach for evaluating second primary esophageal cancer. The common symptoms of hypopharyngeal carcinoma were globus pharyngeus, sore throat, dysphagia, otalgia, neck mass, hoarseness, and dyspnoea. However, approximately 75–80% of patients are initial diagnosed with advanced-stage. Although improvements in therapy, the prognosis is still lacking. In early-stage patients, primary surgical resection and radiotherapy achieved similar survival and locoregional control rates. T1–T2 malignancies with N0–N1 can usually be treated with radiation alone, open surgery, or transoral surgery. In some people, after primary surgery or transoral approaches is often required adjuvant radiotherapy. However, most cases have been in the advanced-stage when screened. Individual therapy programs should be chosen carefully to achieve a balance between swallowing-voice rehabilitation and organ preservation in advanced-stage ones. Meanwhile, reasonable reconstruction of intraoperative defect is essential for a surgeon who seeks satisfied postoperative outcomes. Considerable treatment (surgery or non-surgery) remains the key point of improving the survival rate.

The Impact of Central Quality Assurance Review Prior to Radiation Therapy on Protocol Compliance: POG 9426, a Trial in Pediatric Hodgkin’s Disease.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 753-753 ◽  
Author(s):  
Nancy P. Mendenhall ◽  
Josh Meyer ◽  
Jonathan Williams ◽  
Cameron Tebbi ◽  
Sandy Kessel ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Radiation Therapy ◽  
Hodgkin's Disease ◽  
Radiation Treatment ◽  
Early Stage ◽  
Hodgkin’S Disease ◽  
Quality Assurance Program ◽  
Radiation Quality ◽  
Protocol Compliance ◽  
The Impact

Abstract Introduction. To reduce protocol non-compliance as a confounding variable impacting trial outcome, Pediatric Oncology Group (POG) mandated pre-radiation quality assurance review in POG 9426, a trial in pediatric early stage Hodgkin’s disease (HD). This report documents the impact of this quality assurance program. Patients and Methods. POG 9426 investigated response-based therapy in Stages IA, IIA, and IIIA1 HD without large mediastinal masses. Early complete responders to 2 cycles of ABVE received 25 Gy of radiation therapy (XRT) to involved field(s). Partial responders to 2 cycles of ABVE received 2 more cycles of ABVE before XRT. A minimum 2 cm XRT field margin was required on all imaged diseases, as a first step in the transition from historical standard XRT field design to image-based field design. Before XRT, initial and response imaging and XRT planning films were submitted for Pre-radiation Review (PR) at QARC. Treating radiation oncologists were notified within 24 hours as to whether plans were compliant or required revision. In some cases, multiple revisions were required. The 9426 Protocol Coordinators conducted a Final Review (FR) of protocol compliance at a later date. POG 9426 enrolled 294 patients, including 246 from 85 POG institutions and 48 from 33 CCG institutions. After the first 28 cases, the directorship of QARC changed. Forty-seven cases were invaluable (incomplete submission of data) and 31 patients were removed from study before XRT leaving a total of 216 patients with both PR and FR for analysis. Results. Thirty-nine of 53 (74%) cases from institutions exempt from the requirement for pre-radiation data submission and 137 of 163 (84%) cases from non-exempt institutions submitted data for PR, indicating widespread and voluntary compliance with centralized PR at Quality Assurance Review Center (QARC). Sixteen of 40 (40%) of cases not submitted for PR were judged major protocol violations at FR, compared with 23 of 176 cases (13%) subjected to PR. At PR, modifications to achieve protocol compliance were suggested in all but 40 cases. In only 19 were modifications not made, suggesting widespread willingness to change radiation field design to achieve protocol compliance. There were discrepancies between the PR and FR in 13 of the 176 cases. The causes for disparity were interpretation of “equivocal” disease (4), gross disease (5), and adequacy of margin (3), or difference in studies available for the two reviews (1). Five (39%) of the 13 disparate reviews occurred in the initial 13 of 176 (11%) reviews, suggesting a learning curve in interpreting protocol intent. Conclusions. There was widespread acceptance of the concept of centralized pre-radiation quality assurance review and willingness both to submit diagnostic, response, and radiation treatment planning images and to implement recommended changes. We believe this to be the first centralized pre-therapy review and intervention in a U.S. based cooperative trial group. Interventions were frequently required and offered an excellent opportunity for investigator education. There were fewer major protocol violations at FR in cases subjected to PR than in cases not submitted for PR, indicating a major impact on eliminating protocol non-compliance as a variable influencing outcomes in cooperative group trials.

scholarly journals Characterization of dysphagia and laryngeal findings in COVID-19 patients treated in the ICU—An observational clinical study

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252347
Author(s):  
Hanna Osbeck Sandblom ◽  
Hans Dotevall ◽  
Kristina Svennerholm ◽  
Lisa Tuomi ◽  
Caterina Finizia
Keyword(s):  
Rating Scales ◽  
Early Stage ◽  
Standard Procedure ◽  
Oral Intake ◽  
Vocal Folds ◽  
Silent Aspiration ◽  
Swallowing Function ◽  
Video Recordings ◽  
And Function ◽  
The Impact

Background Dysphagia appears to be common in patients with severe COVID-19. Information about the characteristics of dysphagia and laryngeal findings in COVID-19 patients treated in the intensive care unit (ICU) is still limited. Objectives The aim of this study was to evaluate oropharyngeal swallowing function and laryngeal appearance and function in patients with severe COVID-19. Method A series of 25 ICU patients with COVID-19 and signs of dysphagia were examined with fiberendoscopic evaluation of swallowing (FEES) during the latter stage of ICU care or after discharge from the ICU. Swallowing function and laryngeal findings were assessed with standard rating scales from video recordings. Results Pooling of secretions was found in 92% of patients. Eleven patients (44%) showed signs of silent aspiration to the trachea on at least one occasion. All patients showed residue after swallowing to some degree both in the vallecula and hypopharynx. Seventy-six percent of patients had impaired vocal cord movement. Erythema of the vocal folds was found in 60% of patients and edema in the arytenoid region in 60%. Conclusion Impairment of oropharyngeal swallowing function and abnormal laryngeal findings were common in this series of patients with severe COVID-19 treated in the ICU. To avoid complications related to dysphagia in this patient group, it seems to be of great importance to evaluate the swallowing function as a standard procedure, preferably at an early stage, before initiation of oral intake. Fiberendoscopic evaluation of swallowing is preferred due to the high incidence of pooling of secretion in the hypopharynx, silent aspiration, and residuals. Further studies of the impact on swallowing function in short- and long-term in patients with COVID-19 are warranted.

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