Purpose: The overall survival (OS) of resected locally advanced rectal cancer patients who underwent neoadjuvant chemoradiotherapy (nCRT) was significantly different, even among patients with the same tumor stage. The nomogram was designed to predict OS of rectal cancer with nCRT and divide the patients into different risk groups. Materials and Methods: Based on materials from 911 rectal cancer patients with nCRT, the multivariable Cox regression model was carried out to select the significant prognostic factors for overall survival. And then, the nomogram was formulated using these independent prognostic factors. The discrimination of the nomogram was assessed by concordance index (C-index), calibration curves and time-dependent area under curve (AUC). The patients respective risk scores were calculated through the nomogram. The best cutoff risk score was calculated to stratify the patients. The survival curves of the two different risk cohorts were performed, which assessed the predictive ability of the nomogram. Results: Age, cT stage, pretreatment CEA, pretreatment CA19-9, surgery, posttreatment CEA, posttreatment CA19-9, pT stage, pN stage and adjuvant chemotherapy were selected for the construction of the nomogram. And then the nomogram was constructed with independent prognostic factors. The C-index of the nomogram was 0.724, which showed the nomogram provided good discernment. The acceptable agreement between the predictions of nomogram and actual observations was illustrated by calibration plots for 3-, 5-and 10-year OS in the cohort. Time-dependent AUC with 6-fold cross-validation also showed consistent results of the nomogram. Risk group stratification confirmed that the nomogram had great capacity for distinguishing the prognosis. Conclusion: The nomogram was developed and validated to predict overall survival of resected locally advanced rectal cancer patients with nCRT. The proposed nomogram might help clinicians to develop individualized treatment strategies. However, further studies are warranted to optimize the nomogram by finding out other unknown prognostic factors, and more external validation is still required.

<b><i>Background:</i></b> Elevated pretreatment carcinoembryonic antigen (CEA) levels are related to poor prognosis in patients with locally advanced rectal cancer (LARC) treated with neo-CRT followed by TME. In patients with normal pretreatment CEA levels, the prognostic significance of carbohydrate antigen 199 (CA199) is controversial. <b><i>Objectives:</i></b> The aim of this study was to explore the prognostic value of pretreatment serum CA199 in patients with LARC who had normal pretreatment CEA levels treated with neo-CRT followed by curative surgery. <b><i>Methods:</i></b> A retrospective study of 456 patients with LARC treated with neo-CRT followed by TME between January 2006 and May 2017 was performed. We employed the maximal χ² method to determine the CA199 threshold of 9.1 U/mL based on the difference in survival and divided patients into 2 groups. Group 1: patients with pretreatment s-CEA &#x3c; 5 ng/mL and CA199 ≥ 9.1 U/mL. Group 2: patients with pretreatment s-CEA &#x3c; 5 ng/mL and CA199 &#x3c; 9.1 U/mL. Overall survival (OS) across CA199 was assessed using Cox proportional hazard regression models (PS:CEA ≥ 5 ng/mL was seen as elevated). <b><i>Results:</i></b> Multivariate analyses demonstrated that the following factors were significantly related to OS in patients with LARC with normal pretreatment CEA levels: ypT (odds ratio [OR] 1.863, <i>p</i> = 0.030), ypN (OR 1.622, <i>p</i> = 0.026), and pretreatment CA199 levels (OR 1.886, <i>p</i> = 0.048). <b><i>Conclusion:</i></b> Pretreatment CA199 is an independent factor for OS in patients with LARC with normal pretreatment CEA levels, which may reach the clinic to guide individualized decision-making.

IntroductionThe question of how to administer adequate chemotherapy to synchronise stereotactic body radiation therapy (SBRT) treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with borderline resectable (BRPC) and locally advanced (LAPC) pancreatic cancer is a challenging and debatable issue. No studies have yet evaluated the efficacy of split-course SBRT as the neoadjuvant chemoradiotherapy regimen. We aimed to study whether neoadjuvant chemotherapy plus split-course SBRT results in better outcomes in BRPC and LAPC patients.Methods and analysisTreatment-naïve patients with radiographically confirmed BRPC or LAPC, supporting biopsy results and no severe comorbidities will be enrolled. They will be treated with nab-paclitaxel plus gemcitabine (nab-P+Gem) chemotherapy plus split-course SBRT, followed by an investigator’s choice of continuation of treatment with nab-P+Gem or surgery. nab-P+Gem chemotherapy will commence on day 1 for each of six cycles: nab-paclitaxel 125 mg/m2 intravenous infusion over approximately 30–45 min, followed by gemcitabine 1000 mg/m2 intravenous infusion over about 30 min on days 1 and 15 of each 28-day cycle. During the first and second cycles of chemotherapy, SBRT will be given as a single irradiation of 10 Gy four times (days 2 and 16 of each 28-day cycle). The primary endpoint is progression-free survival; while the secondary outcomes are the time to treatment failure, disease control rate, overall response rate, overall survival, R0 resection rate and incidence of adverse effects.Ethics and disseminationThe study protocol was approved by the Ethics Committee of Xiehe Affiliated Hospital of Fujian Medical University (No. 2019YF015-01). Results from our study will be disseminated in international peer-reviewed journals. All study procedures were developed in order to assure data protection and confidentiality.Trial registration numberNCT04289792.

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Purpose The prognostic significance of pretreatment elevated and normalized CEA after neoadjuvant chemoradiotherapy (nCRT) was evaluated. Materials and Methods The characteristics of 951 locally advanced rectal cancer patients with nCRT were retrieved and were analyzed retrospectively. Pretreatment CEA levels were defined as CEA evaluated one week prior to the nCRT. CEA after nCRT was deemed as CEA measured one week before surgery. The normal CEA levels were set at <5 ng/mL. The normal CEA group was defined as patients with normal pretreatment CEA levels. The normalized CEA group was defined as patients with elevated pretreatment CEA levels and normal CEA levels after nCRT. The elevated CEA group was defined as patients with elevated pretreatment CEA levels and elevated CEA levels after nCRT. Results Compared with the elevated CEA group, the normalized CEA group was associated with better overall survival (OS) (HR: 0.625, 95%CI: 0.416–0.938, P =0.022). There was no difference between the normalized CEA group and the normal CEA group (HR: 1.143, 95%CI: 0.84–1.557, P =0.395). Conclusion In conclusion, the study indicated that OS of the normalized CEA group and the normal CEA group was better than the elevated CEA group.