Locally advanced rectal cancer (LARC): A 12-year experience of multimodality approach.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 607-607
Author(s):  
F. Bertolini ◽  
L. Scarabelli ◽  
C. Del Giovane ◽  
S. Zironi ◽  
G. De Marco ◽  
...  
Keyword(s):  
Vascular Invasion ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Distant Metastases ◽  
Complete Response ◽  
Subsequent Treatment ◽  
University Hospital ◽  
Tumor Regression Grade ◽  
Histological Features

607 Background: Main objective of the report is to review retrospectively a 12 years experience of pre-operative chemo-radiotherapy (CRT) in patients (pts) with LARC at the University Hospital of Modena and to correlate clinical variables with outcome. Methods: Between 1998 and 2010, 275 consecutive pts with stage II, III and IV (oligometastatic in lung or liver) LARC who underwent neo-adjuvant CTR were identified from a single institution. All pts received fluoropyrimidine-based chemotherapy (alone or in combination) and RT (50-50.4 Gy). Results: On 275 pts, 166 were males (61%) and 109 females (39%); median age: 65.9 years (range: 26-84). Rectal primary site (on 260 pts): 112 low (43%), 91 medium (35%) and 57 high (22%). Stage at diagnosis (on 245): 2 cT2N0 (0.8%), 8 cT2N+ (3.3%), 68 cT3N0 (27.8%), 134 cT3N1 (54.7%), 11 cT4N0 (4.5%), 22 cT4N1 (8.9%). Pre-operative treatment (on 268 pts): 168 pts (62.6%) received 5fluorouracil (5FU) in continuous infusion, 37 (13.9%) capecitabine, 36 (13.5%) FU+oxaliplatin and 27 (10%) 5FU+cetuximab (clinical trial). On evaluable 177 pts, only 25 (14%) developed G3 toxicity and subsequent treatment interruption. No grade 4 toxicity was recorded. 252 pts underwent surgery (18 pts are still ongoing; 5 did not receive surgery for multiple distant metastases at pre-operative staging): 189 anterior resection (75%), 59 abdominal-perineal amputation (23.4%) and 4 endoscopic resection (1.6%). On 235 pts, 148 obtained a T and/or N downstaging (63%). Dworak tumor regression grade (TRG) was (on 209 pts): TRG4 (pathological complete response) 38 (18.3%), TRG3 37 (17.8%), TRG2 67 (32%), TRG1 63 (30%) and TRG0 4 (1.9%). 5 y-disease free survival (DFS) and overall survival (OS) are 75% and 73%, respectively. Down-staging, TRG 3-4 and histological features like the positivity for radial margins and vascular invasion correlate with both DFS and OS. Conclusions: Pre-operative CRT is well tolerated; downstaging, TRG and histological features such as radial margins and vascular invasion are the strongest predictors of survival. No significant financial relationships to disclose.

LincRNA-p21 as predictive response marker for preoperative chemoradiotherapy in rectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15534-e15534
Author(s):  
Jose Carlos Benitez ◽  
Tania Diaz ◽  
Carme Ferrer ◽  
Melissa Acosta ◽  
Mariano Monzo ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Preoperative Chemoradiotherapy ◽  
University Hospital ◽  
Stage Iii ◽  
Tumor Regression Grade ◽  
Binary Logistic Regression Analysis ◽  
Crt Response

e15534 Background: Preoperative chemoradiotherapy (CRT) is a standard treatment for locally advanced rectal cancer (RC) patients (pts). Despite the benefits of CRT, its use in non-responder pts can be associated with increased toxicities and resection delay. The identification of CRT response biomarkers, such as long non-coding RNAs (lncRNA), could improve the management of these pts. LincRNA-p21 is a lncRNA involved in the p53 pathway and angiogenesis regulation that acts as prognostic marker in several tumors. We aim to study lincRNA-p21 expression in pretreatment samples from RC pts treated with CRT to evaluate whether lincRNA-p21 can act as a predictive biomarker for CRT response. Methods: RNA from pretreatment endoscopy biopsies from 58 RC pts treated with preoperative CRT at Mutua Terrassa University Hospital were analyzed. Pathological response was classified according to the tumor regression grade (TRG) Dworak classification. LincRNA-p21 expression was determined by RTqPCR and was correlated with CRT response and, time to relapse (TTR), disease-free survival (DFS) and overall survival (OS). Results: Samples from 58 pts were analyzed. Most of them males (n = 40, 69%). Median age at diagnosis of 67 (44-82) years. Fifty (86.2%) pts reported stage III and, 42 (72.4%) pts assessed TRG 0-3 with a 70.7% of downstaging reported. LincRNA-p21 was upregulated in stage III tumors (p < 0.0001) and also in tumors with worst response to CRT regarding TRG, TGR0-3 (TRG0-3, n = 42 vs TRG4, n = 16, p = 0.019). In this line, the ROC curve analysis showed that lincRNA-p21 expression had capacity to distinguish pts with maximum response (TRG4) from others (AUC:0.7; p = 0.02). The binary logistic regression analysis validated its independence as response biomarker. LincRNA-p21 levels correlated with pts relapse after surgery. When the pts were classified in 3 groups, high, medium and low, according to lincRNA-p21 levels, RC pts with highest lincRNA-p21 expression had the shortest TTR. TTR for pts with high levels was 74.5 months (m) (95% CI:31-117), while it was 114 m (95% CI:95-133) for those with Medium levels and 123 m (95% CI:111-134) for those with low levels (p = 0.047). Conclusions: LincRNA-p21 is a marker of advanced disease and worse response to CRT. LincRNA-p21 may add valuable information for individualizing pre-operative CRT in locally advanced RC pts.

Serial ctDNA analysis as a real-time indicator of neoadjuvant chemoradiotherapy in rectal cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3569-3569 ◽  
Author(s):  
Jiaolin Zhou ◽  
Guole Lin ◽  
Yuhua Gong ◽  
Yanyan Zhang ◽  
Yan-Fang Guan ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Lymph Node ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Lymph Node Involvement ◽  
Tumor Regression Grade ◽  
Treatment Intensification

3569 Background: Neoadjuvant chemoradiotherapy (nCRT) is nowadays the standard of care for the locally advanced rectal cancer (LARC). However, there is no effective method to predict patients’ possible benefits from nCRT and monitor the response to it. Methods: Patients with locally advanced middle and low rectal cancer of stage cT3-4N0M0 or cTanyN+M0 were enrolled from August 2017 to July 2018. All patients received nCRT with long-term radiation plus fluorouracil based chemotherapy, followed by the radical surgery. Serial plasma samples were collected pre-nCRT, during nCRT, and preoperatively (8 weeks after the completion of nCRT). Somatic mutations were detected with next-generation sequencing using a 1021-gene panel with peripheral blood lymphocyte DNA as a germline control. Results: This prospective cohort study enrolled 61 patients with rectal cancer. The pathological complete response (pCR) rate and the downstage rate was 31% (19/61) and 80% (49/61), respectively. ctDNA was detectable in 77% (47/61), 18% (11/61) and 13% (8/61) of blood samples obtained pre-nCRT, during nCRT and preoperatively, respectively. No significant association was observed between pre-nCRT ctDNA status with any clinicopathological factors, including age, gender, differentiation or tumor circumferential extent. Among the 8 patients with detectable ctDNA preoperatively, pathological tumor regression grade (TRG) of CAP 2-3 were observed and hepatic metastasis was found in 4 patients within 2 months. For patients with undetectable pre-operative ctDNA, a higher proportion archived pathological downstaging (85% vs 50%). The correlation between preoperative ctDNA status and achievement of pathological downstage was independent of age, gender or differentiation (p = 0.02). In addition, preoperative ctDNA positivity was associated with the persistently involved lymph node (p = 0.02). However, neither pre-nCRT nor during-nCRT ctDNA status was associated with pathological downstaging or persistently lymph node involvement. Conclusions: Detectable ctDNA after the completion of nCRT is a predicator of unsatisfactory curative effect of patients with LARC, which might indicate novel treatment intensification studies. Clinical trial information: NCT03042000.

The prognosis valve of tumor regression grade in the same ypStage patients after neoadjuvant treatment in locally advanced rectal cancer: Post-hoc analysis of a prospective trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16129-e16129
Author(s):  
Jianwei Zhang ◽  
Yue Cai ◽  
Huabin Hu ◽  
Zehua Wu ◽  
Xiaoyu Xie ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Prospective Trial ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Tumor Regression Grade ◽  
Prognosis Factor

e16129 Background: The ypStage after neoadjuvant treatment was an important prognosis factor in locally advanced rectal cancer (LARC). pCR or ypStage 0 showed best prognosis, while ypStage II-III showed poor prognosis and further adjuvant chemotherapy with FOLFOX was recommended. Tumor regression grade (TRG) was another factor to evaluate the response to neoadjuvant treatment. Even in the same ypStage, the TRG could be different. Here, we tried to analyze the prognosis valve of TRG in the same ypStage after neoadjuvant treatment in LARC from a prospective trial (FOWARC study). Methods: Patients with stage II/III rectal cancer were randomly assigned (1:1:1) to five cycles of infusional fluorouracil plus radiotherapy followed by surgery and seven cycles of infusional fluorouracil as adjuvant treatment, the same treatment plus intravenous oxaliplatin 85 mg/m2 on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. The primary end point was 3-year disease-free survival (DFS). Survival analysis was performed on different ypStage and TRG (WHO classification) group. Results: In total, 495 patients were randomly assigned to different neoadjuvant treatment. 444 patients received surgery with a median follow-up of 45.2 months. The 3-year disease free survival (DFS) in ypStage 0, ypStage I, ypStage II and ypStage III was 95.8%, 89.2%, 71.7% and 55.1%, respectively (P < 0.0001). In TRG 0, 1, 2 and 3, the 3-year DFS was 93.3%, 83.2%, 68.4% and 63.6%, respectively (P < 0.0001). In ypStage I subgroup, TRG was not an independent prognosis factor, the 3-year DFS for TRG 1, 2 and 3 was 90.0%, 90.7% and 76.2%, respectively (P = 0.277). In ypStage II population, the 3-year DFS for TRG 1, 2 and 3 was 78.6%, 70.3% and 64.7%, respectively (P = 0.184). The ypStage III group showed great heterogeneity, the 3-year DFS for TRG 0-3 was 60.0%, 70.0%, 41.8% and 59.5%, respectively (P = 0.067). Conclusions: Both ypStage and TRG was strong prognosis factor for rectal cancer after neoadjuvant treatment. However, TRG was not an independent prognosis factor in the same ypStage after neoadjuvant treatment. Clinical trial information: NCT01211210 .

Phase II study of durvalumab plus total neoadjuvant therapy (TNT) in locally advanced rectal cancer: The GEMCAD-1703 DUREC trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS4122-TPS4122
Author(s):  
Jaume Capdevila ◽  
Ismael Macias Declara ◽  
Maria Carmen Riesco Martinez ◽  
Joan Maurel ◽  
Jorge Hernando ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Cell Death ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Rectal Adenocarcinoma ◽  
Disease Free Survival ◽  
Primary Objective ◽  
Tumor Regression Grade ◽  
Open Label ◽  
Post Surgery

TPS4122 Background: In clinical stages II and III (cT3-4 and/or N+), preoperative chemoradiotherapy (CRT) or short-course radiation followed by total mesorectal escision (TME) have been the standard of care for the last 15 years. Induction chemotherapy (CT) before CRT (strategy known as TNT) results in fewer toxic effects and improved compliance. TNT may release tumor-neoantigens with platinum-based induction CT, and radiotherapy has the potential ability to induce an immunogenic cell death and counteract an immune-suppressive tumor microenvironment that provides the rationale for combining with immunotherapies. In addition, the presence of tumor infiltrating lymphocytes has been demonstrated in patients with rectal cancer treated with neoadjuvant CRT, reinforcing the rational for immune check-point inhibitors in this setting. We hypothesize that combining TNT with durvalumab (an optimized monoclonal antibody directed against programmed cell death-1 ligand 1) would improve outcome. Methods: DUREC is a multicenter, single-arm, open-label, phase Ib/II study for patients with magnetic resonance (mr) image middle or distal third, mrT3c-d/T4/N2 rectal adenocarcinoma. Treatment: Patients will receive 6 cycles of modified FOLFOX6 prior to CRT (capecitabine with 50.4 Gy in 28 fractions) and TME, combined with durvalumab 1500 mg every 4 weeks during induction CT, CRT and waiting period until surgery. To assess the tolerability and toxicity profile we plan to perform a run-in treatment phase including the first 6 patients in the study, holding recruitment until all of them will be operated and 30-days post-surgery period completed. If ≤ 2 durvalumab-related dose-limiting toxicities (DLTs) are observed, recruitment will continue. The primary objective is pathological complete response (pCR) rate. Secondary endpoints include toxicity, tumor regression grade, R0 resections, clear circumferential margins, surgical complications, NAR score, disease-free survival and a biomarker program on tumor tissue, blood samples and stool microbiota. Statistical design: 58 evaluable patients (assuming a P0 of 16% and a P1 of 30%, with 0.1 alpha and 0.1 beta); Study started recruitment on December 2019. Clinical trial information: 2018-004835-56 .

scholarly journals Lincp21-RNA as Predictive Response Marker for Preoperative Chemoradiotherapy in Rectal Cancer

2021 ◽  
Vol 11 (5) ◽  
pp. 420
Author(s):  
Jose Carlos Benitez ◽  
Marc Campayo ◽  
Tania Díaz ◽  
Carme Ferrer ◽  
Melissa Acosta-Plasencia ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Predictive Biomarker ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Preoperative Chemoradiotherapy ◽  
Tumor Regression Grade ◽  
Roc Curve Analysis ◽  
Crt Response

Preoperative chemoradiotherapy (CRT) is a standard treatment for locally advanced rectal cancer (RC) patients, but its use in non-responders can be associated with increased toxicities and resection delay. LincRNA-p21 is a long non-coding RNA involved in the p53 pathway and angiogenesis regulation. We aimed to study whether lincRNA-p21 expression levels can act as a predictive biomarker for neoadjuvant CRT response. We analyzed RNAs from pretreatment biopsies from 70 RC patients treated with preoperative CRT. Pathological response was classified according to the tumor regression grade (TRG) Dworak classification. LincRNA-p21 expression was determined by RTqPCR. The results showed that lincRNA-p21 was upregulated in stage III tumors (p = 0.007) and in tumors with the worst response regarding TRG (p = 0.027) and downstaging (p = 0.016). ROC curve analysis showed that lincRNA-p21 expression had the capacity to distinguish a complete response from others (AUC:0.696; p = 0.014). LincRNA-p21 was shown as an independent marker of preoperative CRT response (p = 0.047) and for time to relapse (TTR) (p = 0.048). In conclusion, lincRNA-p21 is a marker of advanced disease, worse response to neoadjuvant CRT, and shorter TTR in locally advanced RC patients. The study of lincRNA-p21 may be of value in the individualization of pre-operative CRT in RC.

scholarly journals DPYD,TYMS,TYMP,TK1, andTK2Genetic Expressions as Response Markers in Locally Advanced Rectal Cancer Patients Treated with Fluoropyrimidine-Based Chemoradiotherapy

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Ming-Yii Huang ◽  
Chan-Han Wu ◽  
Chun-Ming Huang ◽  
Fu-Yen Chung ◽  
Ching-Wen Huang ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
High Sensitivity ◽  
Response Prediction ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Tumor Regression Grade ◽  
Genetic Biomarkers

This study is to investigate multiple chemotherapeutic agent- and radiation-related genetic biomarkers in locally advanced rectal cancer (LARC) patients following fluoropyrimidine-based concurrent chemoradiotherapy (CCRT) for response prediction. We initially selected 6 fluoropyrimidine metabolism-related genes (DPYD, ORPT, TYMS, TYMP, TK1, andTK2) and 3 radiotherapy response-related genes (GLUT1,HIF-1α, andHIF-2α) as targets for gene expression identification in 60 LARC cancer specimens. Subsequently, a high-sensitivity weighted enzymatic chip array was designed and constructed to predict responses following CCRT. After CCRT, 39 of 60 (65%) LARC patients were classified as responders (pathological tumor regression grade2~4). Using a panel of multiple genetic biomarkers (chip), includingDPYD,TYMS,TYMP,TK1, andTK2, at a cutoff value for 3 positive genes, a sensitivity of 89.7% and a specificity of 81% were obtained (AUC: 0.915; 95% CI: 0.840–0.991). Negative chip results were significantly correlated to poor CCRT responses (TRG 0-1) (P=0.014, hazard ratio: 22.704, 95% CI: 3.055–235.448 in multivariate analysis). Disease-free survival analysis showed significantly better survival rate in patients with positive chip results (P=0.0001). We suggest that a chip includingDPYD,TYMS,TYMP,TK1, andTK2genes is a potential tool to predict response in LARC following fluoropyrimidine-based CCRT.

scholarly journals Utility of ctDNA in predicting response to neoadjuvant chemoradiotherapy and prognosis assessment in locally advanced rectal cancer: A prospective cohort study

PLoS Medicine ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. e1003741
Author(s):  
Yaqi Wang ◽  
Lifeng Yang ◽  
Hua Bao ◽  
Xiaojun Fan ◽  
Fan Xia ◽  
...  
Keyword(s):  
Tumor Regression ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Recurrence Risk ◽  
Locally Advanced Rectal Cancer ◽  
Tumor Regression Grade ◽  
Plasma Samples ◽  
Regression Grade

Background For locally advanced rectal cancer (LARC) patients who receive neoadjuvant chemoradiotherapy (nCRT), there are no reliable indicators to accurately predict pathological complete response (pCR) before surgery. For patients with clinical complete response (cCR), a “Watch and Wait” (W&W) approach can be adopted to improve quality of life. However, W&W approach may increase the recurrence risk in patients who are judged to be cCR but have minimal residual disease (MRD). Magnetic resonance imaging (MRI) is a major tool to evaluate response to nCRT; however, its ability to predict pCR needs to be improved. In this prospective cohort study, we explored the value of circulating tumor DNA (ctDNA) in combination with MRI in the prediction of pCR before surgery and investigated the utility of ctDNA in risk stratification and prognostic prediction for patients undergoing nCRT and total mesorectal excision (TME). Methods and findings We recruited 119 Chinese LARC patients (cT3-4/N0-2/M0; median age of 57; 85 males) who were treated with nCRT plus TME at Fudan University Shanghai Cancer Center (China) from February 7, 2016 to October 31, 2017. Plasma samples at baseline, during nCRT, and after surgery were collected. A total of 531 plasma samples were collected and subjected to deep targeted panel sequencing of 422 cancer-related genes. The association among ctDNA status, treatment response, and prognosis was analyzed. The performance of ctDNA alone, MRI alone, and combining ctDNA with MRI was evaluated for their ability to predict pCR/non-pCR. Ranging from complete tumor regression (pathological tumor regression grade 0; pTRG0) to poor regression (pTRG3), the ctDNA clearance rate during nCRT showed a significant decreasing trend (95.7%, 77.8%, 71.1%, and 66.7% in pTRG 0, 1, 2, and 3 groups, respectively, P = 0.008), while the detection rate of acquired mutations in ctDNA showed an increasing trend (3.8%, 8.3%, 19.2%, and 23.1% in pTRG 0, 1, 2, and 3 groups, respectively, P = 0.02). Univariable logistic regression showed that ctDNA clearance was associated with a low probability of non-pCR (odds ratio = 0.11, 95% confidence interval [95% CI] = 0.01 to 0.6, P = 0.04). A risk score predictive model, which incorporated both ctDNA (i.e., features of baseline ctDNA, ctDNA clearance, and acquired mutation status) and MRI tumor regression grade (mrTRG), was developed and demonstrated improved performance in predicting pCR/non-pCR (area under the curve [AUC] = 0.886, 95% CI = 0.810 to 0.962) compared with models derived from only ctDNA (AUC = 0.818, 95% CI = 0.725 to 0.912) or only mrTRG (AUC = 0.729, 95% CI = 0.641 to 0.816). The detection of potential colorectal cancer (CRC) driver genes in ctDNA after nCRT indicated a significantly worse recurrence-free survival (RFS) (hazard ratio [HR] = 9.29, 95% CI = 3.74 to 23.10, P < 0.001). Patients with detectable driver mutations and positive high-risk feature (HR_feature) after surgery had the highest recurrence risk (HR = 90.29, 95% CI = 17.01 to 479.26, P < 0.001). Limitations include relatively small sample size, lack of independent external validation, no serial ctDNA testing after surgery, and a relatively short follow-up period. Conclusions The model combining ctDNA and MRI improved the predictive performance compared with the models derived from individual information, and combining ctDNA with HR_feature can stratify patients with a high risk of recurrence. Therefore, ctDNA can supplement MRI to better predict nCRT response, and it could potentially help patient selection for nonoperative management and guide the treatment strategy for those with different recurrence risks.

scholarly journals Towards an Organ-Sparing Approach for Locally Advanced Esophageal Cancer

2018 ◽  
Vol 36 (6) ◽  
pp. 462-469 ◽  
Author(s):  
Berend Jan van der Wilk ◽  
Ben M. Eyck ◽  
Manon C.W. Spaander ◽  
Roelf Valkema ◽  
Sjoerd M. Lagarde ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Active Surveillance ◽  
Residual Disease ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Distant Metastases ◽  
Phase Iii ◽  
Tumor Regression Grade ◽  
Surveillance Strategy

Background: Active surveillance after neoadjuvant therapies has emerged among several malignancies. During active surveillance, frequent assessments are performed to detect residual disease and surgery is only reserved for those patients in whom residual disease is proven or highly suspected without distant metastases. After neoadjuvant chemoradiotherapy (nCRT), nearly one-third of esophageal cancer patients achieve a pathologically complete response (pCR). Both patients that achieve a pCR and patients that harbor subclinical disseminated disease after nCRT could benefit from an active surveillance strategy. Summary: Esophagectomy is still the cornerstone of treatment in patients with esophageal cancer. Non-surgical treatment via definitive chemoradiotherapy (dCRT) is currently reserved only for patients not eligible for esophagectomy. Since salvage esophagectomy after dCRT (50–60 Gy) results in increased complications, morbidity and mortality compared to surgery after nCRT (41.4 Gy), the latter seems preferable in the setting of active surveillance. Clinical response evaluations can detect substantial (i.e., tumor regression grade [TRG] 3–4) tumors after nCRT with a sensitivity of 90%, minimizing the risk of development of non-resectable recurrences. Current scarce and retrospective literature suggests that active surveillance following nCRT might not jeopardize overall survival and postponed surgery could be performed safely. Key Message: Before an active surveillance approach could be considered standard treatment, results of phase III randomized trials should be awaited.

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