bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinicopathological and molecular biological characteristics of early-onset stage II/III colorectal adenocarcinoma: An analysis of 25 studies with 47,184 patients (pts) in the adjuvant colon cancer end points (ACCENT) database.
Authors: Jin Zhaohui , Dixon Jesse G. , Parekh Hiral D. , Alberts Steven R , Yothers Greg , Allegra Carmen Joseph , Kerr Rachel , Haller Daniel G. , De Gramont Aimery , Yoshino Takayuki , Van Cutsem Eric , Twelves Chris , Taieb Julien , Saltz Leonard B. , Seitz Jean-François , Andre Thierry , Mahipal Amit , Goldberg Richard M. , Shi Qian , George Thomas J. 
Published: May 2020

4099 Background: Colorectal cancer (CRC) incidence and mortality has decreased since the 1970s but the incidence is increasing in young adults (age 20-49). The incidence of early onset CRC (eoCRC) will keep increasing significantly based on the trends of the SEER CRC registry data. There is limited data suggesting eoCRC may have different behaviors compared to traditional CRC (tCRC, age ≥ 50). Methods: Individual pt data of 47184 stage II/III CRC pts from 25 randomized studies in the ACCENT database were pooled. The distributions of demographics, clinicopathological features, biomarker status, and treatment-related data were summarized by age group. Overall survival (OS), disease-free survival (DFS), recurrence-free rate (RFR), and survival after recurrence (SAR) were assessed by Kaplan-Meier curves and Cox models stratified by treatment arms within studies, adjusting for stage, performance status (PS), BMI and grade. Results: Using 5% difference between age groups as clinically meaningful cutoff, eoCRC had similar gender, race, ethnicity, PS, risk group, disease sidedness and T stage as tCRC. eoCRC were less likely overweight (30 vs 36%) and more pts had ≥ 12 lymph nodes resected (63 vs 51%). eoCRC had more frequent dMMR status (18 vs 12%), less BRAF mutations (5 vs 13%), and more dMMR/BRAF wild type (WT) status (17 vs 7%). Overall, eoCRC had better OS, DFS, and SAR, with the most significant differences between the < 30 and > = 70 age groups. Similar results were observed within pMMR pts. eoCRC experienced less hematological side effects, diarrhea, and stomatitis, but had more nausea and/or vomiting. Conclusions: eoCRC have unique characteristics; although statistically significant, the clinical differences in outcomes between eoCRC and tCRC are potentially due to the difference seen in extremely young and old pts. eoCRC have a different adverse events panel compared to tCRC. [Table: see text]
Randomized phase II trial of modified (m) FOLFOX6 induction chemotherapy with or without aflibercept before standard chemoradiotherapy (CRT) and total mesorectal excision (TME) in patients with high-risk rectal adenocarcinoma (HRRC): Final results of the GEMCAD 1402, and by molecular subtypes.
Authors: Fernandez-Martos Carlos , Machado Isidro , Pericay Carles , Salas Nuria , Feliu Batlle Jaime , ten Hoorn Sanne , Vermeulen Louis , Losa Ferran , Garcia Carbonero Rocio , Alonso Vicente , Vera Ruth , Gallego Javier , Capdevila Jaume , Salud Antonieta , Nogué Miguel , Maurel Joan , Layos Laura , Montagut Clara , Garcia-Albeniz Xabier 
Published: May 2020

4102 Background: Neoadjuvant chemotherapy (CT) followed by CRT and TME is a treatment option for clinically staged HRRC. The goal of the GEMCAD 1402 trial was to evaluate the benefit of adding an antiangiogenic drug to the neoadjuvant CT. The analysis of primary endpoint showed a better response rate in the experimental arm (Fernandez-Martos et al. Jama Oncol 2019). Here we present 3-year disease-free survival (DFS) and a retrospective analysis of consensus molecular subtypes by Immunohistochemistry (CMSs-IHQ). Methods: Patients (p) with middle or distal third, mrT3/T4/N2 rectal adenocarcinoma were randomly assigned (2:1), to mFOLFOX6 with (arm 1, n=115) or without Aflibercept (arm 2, n=65) prior to CRT (capecitabine with 50.4 Gy in 28 fractions) and TME. Tissue microarrays from 90 (58 arm1, 32 arm 2) p were stained for nine markers (CDX2, FRMD6, HTR2B, ZEB1, KER, MSH2, MSH6, PMS2 and MLH1) by IHQ using both semiquantitative and quantitative approaches. Cases were classified as CMS1-IHQ1, CMS-IHQ2/3 or CMS-IHQ 4 (immune, epithelial or mesenchymal subtypes). Results: In the intention-to-treat population after a median follow-up time of 38 months, 29 p (25%) in arm 1 had a DFS-related event, as compared with 14 p (21%) in arm 2 (HR 1.2063, 95% confidence interval 0.6374 to 2.2829, P=0.5644. The rate of DFS at three years was 75.2% (95% confidence interval, 66.1% to 82.2%) in arm 1 and 81.5% (95% confidence interval, 69.8% to 89.1%) in arm 2 (P=0.5638 by the exact stratified log-rank test). Overall 0/80/10 p were classified as CMS-IHQ1, CMS-IHQ2/3 or CMS-IHQ4 respectively. The pathological complete response (pCR) rate (ypT0N0) was achieved in 27.5% and 0% in epithelial and mesenchymal subtypes respectively. A trend towards worse survival for the mesenchymal subtype was observed. Conclusions: Adding aflibercept to induction mFOLFOX6 is not associated with an improvement in DFS. Our findings suggest that CMSs-IHQ subtypes could be predictive for pCR with this treatment strategy. Clinical trial information: NCT02340949 .
Impact of antibiotics (ATB) on the recurrence of resected colorectal cancer (CRC): Results of EVADER-1 a nation-wide pharmacoepidemiologic study.
Authors: Rousseau Benoit , Hilmi Marc , Khati Ines , Turpin Anthony , Andremont Antoine , Burdet Charles , Grall Nathalie , Vidal Joana , Bousquet Philippe Jean , Le Bihan Christine 
Published: May 2020

4106 Background: Recent studies suggest that ATB increase the overall risk of CRC incidence through disruption of gut microbiota. Impact of ATB on the risk of CRC recurrence after curative resection remains unknown. Methods: Using the French nation-wide Institut National du Cancer (INCa – Système National des Données de Santé) database of cancer patients, all newly diagnozed localized CRC patients resected between 01/2012 and 12/2014 were involved. The perioperative ATB intake (6 month before until 1 year after surgery) was classified according to the spectrum, doses and period of use. The primary endpoint was 3-year Disease-Free Survival (3-DFS), stratified on chemotherapy (chemo) administration (yes/no), and assessed using multivariate Cox models. Results: Out of 219,884 CRC patients, the present study included 36,640 patients: male 53%, age≥75 years 39%, left colon/rectal 59%, exposure to chemo 44%, at least one ATB intake 74%. At 3-years, 29% of patients had recurred and 18% had died. In multivariate analysis, in patients not receiving chemo, ATB intake as an out-patient was significantly associated with better 3-DFS [HR (one ATB only) = 0.88 (0.82-0.94)]. This effect remained in the same range whatever the number of ATB or cumulative exposure to ATB. In patients receiving chemo, ATB intake as an out-patient had a significant detrimental effect on 3-DFS [HR (one ATB only) = 1.15 (1.08-1.23)], increasing with the number of ATB [HR (≥5 ATB) = 1.54 (1.39-1.71)] and longer exposure [HR ( > 30 days) = 1.39 (1.31-1.48)]. Penicillin A, quinolones and ATB combinations were associated with worse 3-DFS. The timing of ATB intake related to chemo revealed that the strongest deleterious effect was observed when ATB were taken during chemo [HR = 1.64 (1.53-1.75)]. No difference in the mean number of chemo cycle was observed comparing patients receiving ATB or not. Conclusions: This nation-wide study is the first to suggest that ATB modulate 3-DFS in resected CRC with a differential impact according to chemo exposure. Importantly, ATB intake with chemo is detrimental in a dose- and time-dependent manner suggesting that dysbiosis of gut microbiota during adjuvant chemo might increase risk of recurrence.
Total mesorectal excision compared to local excision in locally advanced rectal cancer achieving complete pathological response with neoadjuvant therapy: A National Cancer Database Analysis.
Authors: Abdalla Ahmed , Malapati Sindhu Janarthanam , Singh Sunny R K , Szpunar Susan , Hadid Tarik H. , Kafri Zyad , Aref Amr 
Published: May 2020

4107 Background: Total mesorectal excision (TME) is the standard surgical intervention for patients with locally advanced rectal cancer (LARC) regardless of response to neoadjuvant therapy. In this study, we perform a comprehensive review of the National Cancer Database (NCDP) to compare the clinical and surgical outcomes of TME to local excision (LE) in patients with LARC. Methods: NCDP was systematically researched to abstract all patients with stage II and III rectal adenocarcinoma between the years 2004 and 2015. We subsequently excluded all the patients who did not achieve complete pathological response (pT0) after neoadjuvant therapy. The patients were then divided into two groups; those who underwent TME and those who underwent LE. Data were analyzed using SPSS v. 26.0, SAS v. 9.4. Results: A total of 4,705 were included in the study; 4,589 in the TME group and 116 in the LE group. Baseline characteristics were similar between the groups except for age. A total of 81(1.8%) of patients in the TME group and 8(6.9%) of patients in the LE group did not receive radiation (p=0.006) and 19(0.4%) of patients the TME group and 4(3.4%) of patients in the LE group did not receive chemotherapy. There was no difference in median overall survival between TME and LE groups. The median length of hospital stay was remarkably shorter in the LE group compared to the TME group (1 day vs 6 days, p<0.0001). The rate of 30-day and 90-day postoperative mortality were similar between the two groups (p-value=0.334 and 0.06, respectively). In the LE group, 4 (3.4%) of patients were readmitted within 30 days of the resection compared to 374 (8.5%) in the TME group but was not a statistically significant difference (p=0.059). Conclusions: In this study, TME and LE had similar overall survival and time to 25% mortality in patients with LARC who achieved complete pathological response after neoadjuvant therapy. Also, LE had a shorter hospital stay compared to the TME group. This study is limited by its retrospective nature, however these interesting observations warrant further investigation in randomized clinical trials. [Table: see text]
Does neoadjuvant FOLFOX chemotherapy improve the oncological prognosis of high-risk stage II and III colon cancers ? Three years’ follow-up results of the Prodige 22 phase II randomized multicenter trial.
Authors: Karoui Medhi , Gallois Claire , Piessen Guillaume , Legoux Jean-Louis , Barbier Emilie , De Chaisemartin Cecile , Lecaille Cedric , Bouché Olivier , Ammarguellat Hanifa , Brunetti Francesco , Prudhomme Michel , Regimbeau Jean-Marc , Glehen Olivier , Lièvre Astrid , Portier Guillaume , Hartwig Johannes , Goujon Gael , Romain Benoît , Lepage Come , Taieb Julien 
Published: May 2020

4110 Background: Neoadjuvant chemotherapy in a perioperative setting has proven valuable in locally advanced resectable colon cancer (CC) in terms of toxicity, postoperative morbidity and downstaging, but its effect on oncological outcomes remains uncertain. Methods: Prodige 22 was a randomized multicenter phase II trial in patients with resectable high-risk T3, T4 and/or N2 CC on baseline CT-scan. Patients were randomized to receive either 6 months of adjuvant FOLFOX after colectomy (control) or perioperative FOLFOX for 4 cycles before surgery and 8 cycles after (FOLFOX peri-op). In RAS wild-type (wt) patients a third arm testing perioperative FOLFOX-cetuximab was added. Primary endpoint was the Tumor Regression Grade. Secondary endpoints were 3-years overall (OS), disease-free survival (DFS) and time to recurrence (TTR). Results: 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped for futility. The remaining 104 patients (control, n = 52; FOLFOX peri-op n = 52) represented our intention-to-treat population. In the FOLFOX peri-op group, 96% received the schedule 4 cycles prior to surgery and all but one underwent adjuvant FOLFOX for a total of 12 cycles. In the control arm, 38 patients received adjuvant FOLFOX (1 postoperative death and 13 low-risk stage II patients). Median follow-up was 54.3 months [48.5-57.2]. Nineteen deaths and 26 disease recurrences were observed leading to a 3 years-OS of 90.3% in both arms (p = 0.7) and to a 3-years DFS of 76.8% and 69.2% in the peri-op and control arm respectively (p = 0.6). A trend to a better TTR in the peri-op arm was observed with a 3-years TTR of 82% as compared to 72% in the control arm (p = 0.3). No benefit from adding Cetuximab was observed in the 16 RAS-wt treated patients. Conclusions: In this pilot randomized study, perioperative FOLFOX chemotherapy has no detrimental effect on long term oncological outcomes and may be an option for some patients with locally advanced CC. A pooled analysis of randomized trials testing peri-operative strategies in this setting is warranted. Clinical trial information: NCT01675999 .
Pembrolizumab (pembro) versus standard of care chemotherapy (chemo) in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Asian subgroup analysis of KEYNOTE-062.
Authors: Satake Hironaga , Lee Keun Wook , Chung Hyun Cheol , Lee Jeeyun , Yamaguchi Kensei , Chen Jen-Shi , Yoshikawa Takaki , Amagai Kenji , Yeh Kun-Huei , Goto Masahiro , Chao Yee , Lam Ka-On , Han Shi Rong , Shiratori Shinichi , Shah Sukrut , Shitara Kohei 
Published: May 2020

4523 Background: First-line treatment with pembro or pembro + chemo vs chemo alone was evaluated in patients with PD-L1 combined positive score (CPS) ≥1, HER2-negative advanced gastric cancer in the randomized, active-controlled, phase 3 KEYNOTE-062 study (NCT02494583). We present results from the Asian subpopulation receiving pembro monotherapy or chemo. Methods: Eligible patients were randomly assigned 1:1:1 to pembro 200 mg, pembro + chemo (cisplatin + 5-FU or capecitabine), or placebo + chemo every 3 weeks for ≤35 cycles (~2 years). Randomization was stratified by region, disease status, and fluoropyrimidine treatment. Primary end points for this analysis were overall survival (OS) in patients with CPS ≥1 and patients with CPS ≥10; progression-free survival (PFS) and objective response rate (ORR) were exploratory end points. Data cutoff was March 26, 2019. Results: Globally, 256 patients received pembro monotherapy and 250 received chemo. Pembro was noninferior to chemo for OS in CPS ≥1 per prespecified margins (median OS, 10.6 vs 11.1 months, respectively; HR [99.2% CI], 0.91 [0.69-1.18]). In the Asian population 62 patients received pembro and 61 received chemo; 26 and 22 had CPS ≥10 (Table). Compared with the global population, Asian patients had a higher proportion of ECOG performance status 0, more diagnoses of stomach cancer, and a greater proportion with 0-2 metastatic sites. Median OS was longer with pembro than chemo using both CPS cutoffs (HR [95% CI]: CPS ≥1, 0.54 [0.35-0.82]; CPS ≥10, 0.43 [0.21-0.89]); 12- and 24-month OS rates were higher for pembro using both CPS cutoffs (12-month OS: CPS ≥1, 69% vs 54%; CPS ≥10, 81% vs 68%; 24-month OS: CPS ≥1, 45% vs 23%; CPS ≥10, 54% vs 27%). The HR (95% CI) for PFS was 1.11 (0.76-1.64) for CPS ≥1 and 0.71 (0.36-1.39) for CPS ≥10. Conclusions: In Asian patients with advanced gastric cancer, OS favored pembro in patients with CPS ≥1 and CPS ≥10. Clinical trial information: NCT02494583 . [Table: see text]
A phase Ib study of nivolumab plus trastuzumab with S-1/capecitabine plus oxaliplatin for HER2-positive advanced gastric cancer (Ni-HIGH study): Safety evaluation.
Authors: Takahari Daisuke , Shoji Hirokazu , Minashi Keiko , Hara Hiroki , Chin Keisho , Ooki Akira , Ogura Mariko , Nakayama Izuma , Kato Ken , Iwasa Satoru , Hirano Hidekazu , Amanuma Yusuke , Ishizuka Naoki , Boku Narikazu , Yamaguchi Kensei 
Published: May 2020

4525 Background: Addition of an anti-PD-1 antibody to trastuzumab (Tmab) reportedly enhances ADCC activity of Tmab, leading to an additive antitumor effect. We investigated the safety and tolerability of nivolumab (Nivo) plus Tmab combined with S-1 or capecitabine (Cape) and oxaliplatin (Ox) for pts with HER2-positive (+) advanced gastric cancer (AGC). Here, we report the safety evaluation results. Methods: This open-label, phase 1b study was conducted at four centers in Japan. The study consisted of safety (n = 12) and expansion (n = 24–30) parts. Chemotherapy-naïve pts aged ≥ 20 years with histopathologically confirmed HER2+ AGC and measurable lesions were eligible. In the safety evaluation, pts were assigned to cohort 1 or 2 in sequence. Pts received Nivo (360 mg, day 1), Tmab (course 1: 8 mg/kg; course 2–: 6 mg/kg, day 1), Ox (130 mg/m2, day 1) and either S-1 (40 mg/m2 bid, days 1–14; cohort 1) or Cape (1000 mg/m2 bid, days 1–14; cohort 2) every 3 weeks until disease progression or unacceptable toxicity. The primary purpose of the safety evaluation was to determine the toxicity and tolerability of this combination therapy. An independent data and safety monitoring committee assessed the tolerability of the study treatments before starting the second treatment course. A preliminary evaluation of tumor response on the cut-off date (December 16, 2019) was also performed. Results: From November 2018 to August 2019, 12 pts with HER2+ AGC were enrolled in the safety part (six pts each in cohorts 1 and 2). During the 1st course, all 12 pts experienced at least one adverse event (AE). The most common AEs were peripheral sensory neuropathy (PSN) (n = 4) and leukocytopenia (n = 3) in cohort 1 and PSN (n = 5) and anorexia (n = 4) in cohort 2. AEs of grade ≥ 3 were observed in only one pt in cohort 1 (grade 3 neutropenia). No pt suspended or discontinued study treatments due to AEs. One pt in cohort 1 reduced dose of S-1 due to grade 2 erythema and continued the subsequent courses with the dose. After a median follow-up of 6.1 (range, 3.1–13.3) months, one pt from cohort 1 achieved a complete response, eight pts (four in each cohort) achieved a partial response, and three pts (one in cohort 1 and two in cohort 2) showed stable disease. No progressive disease was observed. Conclusions: Both Nivo plus Tmab and either S-1 or Cape plus Ox are tolerable in pts with HER2+ AGC. Both cohorts 1 and 2 have progressed to the expansion part of the study. Clinical trial information: 000034222 .
Assessment of FcgRIIIA single nucleotide polymorphisms (SNPs) on the efficacy of IgG1 monoclonal antibodies (mAbs) in PANGEA study patients (pts) with advanced gastroesophageal adenocarcinoma (aGEA).
Authors: Serritella Anthony , Peterson Bryan , Zhou Katherine I. , Arndt Nicole , Del Gaudio Daniela , Arndt Kelly , Das Soma , Klempner Samuel J , Liu Ping , Catenacci Daniel V.T. 
Published: May 2020

4526 Background: Targeted therapies (Ttx) have had limited efficacy in aGEA. The phase IIa PANGEA trial assessed the outcomes of pts treated with IgG1 mAbs targeting receptor tyrosine kinases (RTKs) or PD-1 based on predefined molecular groups. The fragment C (Fc) portion of mAbs binds to IgG receptors (FcgR) of immunologic effector cells such as natural killer (NK) cells, leading to antibody-dependent cell-mediated cytotoxicity (ADCC). The FcgR subclass, FcgRIIIA, has genetic variants with different Fc binding affinities. A single nucleotide polymorphism (SNP) in FcgRIIIA substitutes phenylalanine (F) with valine (V) at amino acid position 158, enhancing FcgR’s affinity for the IgG1 Fc domain. Pts with V/V or V/F FcgRIIIA allotypes have enhanced NK cell binding affinity compared to the homozygous F/F allotype. We evaluated the association of FcgRIIIA SNPs on Ttx outcomes amongst PANGEA pts and another cohort of aGEA pts treated with IgG1 mAbs. Methods: Whole-blood samples were identified from aGEA pts (N = 104), including 70/80 available PANGEA pts, who were treated with an IgG1 mAb (trastuzumab 24, anti-EGFR 21, anti-PD1 30, ramucirumab 48) in at least 1 Ttx line. After lymphocyte DNA extraction, FcgRIIIA genotyping was performed. The Cox proportional hazard model and log-rank tests, adjusted for pt age, were used to assess for an association of genotype with overall survival (OS). Results: Of 104 genotyped pts, the F/F, F/V & V/V genotypes were observed at a frequency of 32%, 51% and 17% respectively. There was no significant difference in median OS (mOS) between the F/F, F/V or V/V or comparing F/F vs V/F+V/V overall, nor in the PANGEA-only cohort. A trend of increased mOS was seen in 20 non-PANGEA pts harboring F/V or V/V compared to 14 F/F pts (mOS 43.4 vs 23.1 months, HR 0.41 [0.15-1.14] p = 0.09). However, 3-year OS rates trended higher in V/F+V/V pts (22%, 16/71) compared to F/F pts (7%, 2/33) (p = 0.09). At 3 years, 50% of V/V+V/F non-PANGEA pts were alive versus 13% of F/F pts (p = 0.04), while 13% of V/V+V/F PANGEA pts were alive versus 0% of F/F pts (p = 0.32). Conclusions: Amongst pts receiving IgG1 mAbs, the high affinity V FcgRIIIA SNP enriched for a subgroup of ‘extreme responders’ alive 3 years from diagnosis. Multivariate analyses accounting for baseline characteristics in a larger number of pts are ongoing to further elucidate the role of FcgRIIIA SNPs as predictive biomarkers. These findings may have implications on IgG1 mAb ADCC optimization.
X versus XELOX versus PF in definitive concurrent chemoradiotherapy (DCRT) for local advanced squamous esophageal cancer (ESCC): Update from a multicenter, open-label, randomized III trial, CRTCOESC trial.
Authors: Jia Ruinuo , Shan Tanyou , Wan Lixin , Zheng Anping , Hui Shuang , Xu Zhiqiao , Wang Feng , Zheng Guobao , Lu Ping , Zhang Guifang , Zheng Yingjuan , Cui Yanhui , Luo Xiaoyong , Zhang Weiguo , Li Wanying , Li Ruonan , Zhou Fuyou , Gao Shegan 
Published: May 2020

4531 Background: PF (5-fluorouracil plus cisplatin) is the standard regimen for local advanced ESCC with DCRT. CRTCOESC aims to evaluate the effect and safety of X (capecitabine) regimen versus XELOX (capecitabine plus oxaliplatin) and PF in Chinese local advanced ESCC with DCRT by randomized, open-label, multicenter designed. Methods: Patients with ESCC (T2-4N0-2M0) were randomized to 3 groups as X (capecitabine 625mg/m2, bid d1-5, 6 weeks), XELOX (oxaliplatin: 65mg/m2, d1, 8, 22, 29; capecitabine: 625mg/m2, bid d1-5; 6 weeks), or PF (cisplatin: 75mg/m2 d1, 29, 5-Fu: 750mg/m2 CIV24h d1-4, d29-32), Intensity Modulated Radiation Therapy (IMRT) was delivered by 50Gy/2Gy currently. In addition, quadratic randomize were done within all groups to decide whether 2 cycles chemotherapy adding or not after DCRT. 2-year OS and Grade 3-5 AEs were the primary endpoints, 2-year PFS and short-term efficacy (STE) as rates of CR and ORR (CR+PR+SD) (confirmed by gastroscopy biopsy at 16 weeks) were the secondary endpoints. Results: 244 pts successfully were accrued from 13 centers during 2014.10-2020.1. 209 pts were finished DCRT and 193 were evaluated STE at 16 weeks. 192 and 147 pts were followed up for 1- and 2- years respectively. There were no differences between 3 groups on patients’ baseline characters including age, gender, ECGO score, clinical stage, pathology grade and smoking. In X, XELOX and PF groups, the 2-year OS were 63.8% (30/46), 61.5% (32/52) and 62.5% (30/49) ( P = 0.973), the median OS were 39.7 (6.567), 40 (5.195) and 34 (5.736) (months, P = 0.703); the incidences of AEs (grade 3-5) were 26.5% (18/68), 33.8% (25/74) and 49.3% (33/67) ( P = 0.0193); the 2-year PFS were 54.3% (25/46), 53.8% (28/52) and 51% (25/49) ( P = 0.939), the median PFS were 29.06 (6.124), 17.4 (8.745) and 24.833 (6.777) (months, P = 0.811); the CR rate were 43.8% (28/64), 41.4% (29/70), and 42.4% (25/59) ( P = 0.964), and the ORR were 85.6%, 88.6%, and 96.6% ( P = 0.119), respectively. There were no differences on OS, PFS and rates of CR and ORR between 3 groups but the incidence of AEs in X group was the lowest significantly. Subgroup analysis results shown adding 2 cycles chemotherapy after CRT had both OS and PFS advantages but lacked statistically significance. Conclusions: Compared with PF, DCRT with X or XELOX shown lower incidence of AEs and similar OS, PFS and STE. X regimen carried out the lowest AEs incidence. Adding 2 cycles chemotherapy after DCRT seemly had advantages on OS and PFS. Clinical trial information: NCT02025036 .