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Pcr complete response8/15/2023 Postoperative length of stay (LOS), 30-day mortality and unplanned readmission were used as surrogate indicators for postoperative complications as this variable is not documented in the NCDB. Additional outcomes were the associations between postoperative complications with pCR. The notation ‘x’ in pathology reports indicates that tumor cannot be assessed in the specimen among patients with biopsy-proven tumor who then undergo neoadjuvant treatment, it signifies the absence of tumor in the final specimen (and thus a complete response). The main outcome was predictors of pCR, defined as the absence of tumor in the final pathologic specimen (ypT0/x, N0/x). Treatment variables included treating facility type, surgical procedure, surgical approach, radiation modality, radiation dose, and interval from end of radiation to surgery. Disease variables included year of diagnosis, grade, size, clinical TNM stage, pathologic TNM stage, number of nodes examined, preoperative carcinoembryonic antigen (CEA), presence of tumor deposits, lymphovascular invasion (LVI), perineural invasion (PNI), tumor regression grade, and margin status. Patient variables included age, sex, race, geographic setting, insurance coverage, and comorbidities. For adenocarcinoma, the following International Classification of Diseases (ICD)-O-3 codes were used: 8140–8148, 8200, 8260–8263, and 8480–8496.ĭata were collected regarding patient, disease, and treatment variables. Patients were queried from the rectal cancer Participant User Files (PUF) of the NCDB. ![]() circumferential resection margin) in the NCDB began at various time points between 20 thus, the study period was chosen to provide the largest sample of rectal cancer patients with the most complete information available in the database at the time the study was conducted. Documentation of several cancer-specific variables (e.g. The aim of this study was to identify clinicopathologic and treatment-related variables that predict pCR after nCRT for rectal cancer and to examine the impact of pCR on postoperative complications.Īfter approval from the Institutional Review Board, the American College of Surgeons’ (ACS) National Cancer Database (NCDB) was queried to identify patients from 2006 to 2011 with non-metastatic rectal adenocarcinoma who received nCRT followed by radical surgery. 16 Consequently, it is of clinical interest to identify factors that can predict pCR, both to optimize the likelihood of achieving pCR and to select patients who may potentially avoid surgery after completion of nCRT. 12, 13 Furthermore, even among patients with complete pathologic resolution of the primary tumor, residual nodal disease is present in up to 15 % of cases 14, 15 and is an independent predictor of poor outcomes. 7– 11 However, it is well established that cCR does not equate to pCR as residual tumor may be identified in up to 75 % of resected specimens where the gross tumor has clinically disappeared. ![]() 6 Emerging data suggest that certain low-risk tumors may be appropriate candidates for this strategy. 3– 5 In this approach, patients who demonstrate a complete clinical response (cCR) following neoadjuvant therapy do not undergo surgery but instead are monitored closely and offered salvage surgery in the event of relapse. Over the past decade, there has been increasing interest in ‘watchful waiting’ as an alternative to radical resection. 1, 2 Standard surgery for rectal cancer can result in significant morbidity with negative long-term impact on bowel, urinary and sexual function, and the need for a temporary or permanent ostomy. Some patients with rectal cancer who receive nCRT achieve a pathologic complete response (pCR) that is associated with an improved long-term prognosis compared with patients who have residual tumor in the final specimen. In the US, this therapy typically takes the form of concurrent long-course chemoradiation (nCRT). Neoadjuvant therapy is the current standard of care for locally advanced rectal cancer.
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