Background: To investigate the effect of a pneumatic abdominal compression belt (PACB) on suppressing the movement of primary lesions in the oesophageal gastric junction (EGJ). Materials and Methods: Titanium clips A and B were placed on the upper and lower edges of the tumour grossly in 10 patients by using gastroscopy before preoperative chemoradiotherapy. Four sets of images of clips were obtained by 4DCT in each patient with and without PACB. Nine sets of CBCT images were obtained from each patient for analysis. Paired t tests and independent t tests were used to test for differences. Results: In the cranio-caudal (CC) directions, the internal motion of clip B was smaller with PACB than without PACB (P=0.000). The interfraction motion of clip B in the left-right (LR), anterior-posterior (AP) and CC directions was smaller with than without PACB (P=0.002, 0.002 and 0.005). We determined that 0.9, 0.9 and 0.9 cm ITV margins in the LR, AP and CC directions are suggested for EGJ lesions with PACB to better cover the tumour movements. Conclusion: A pneumatic abdominal compression belt can reduce the intra- and interfraction movements of EGJ tumours during preoperative radiotherapy.

Objective: To explore the safety and effectiveness of stereotactic body radiation therapy (SBRT) for oligometastases from colorectal cancer (CRC). Methods: This is a prospective, single-arm phase Ⅱ trial. Patients who had histologically proven CRC, 1 to 5 detectable liver or lung metastatic lesions with maximum diameter of any metastases ≤5 cm were eligible. SBRT was delivered to all lesions. The primary endpoint was 3-year local control (LC). The secondary endpoints were treatment-related acute toxicities of grade 3 and above, 1-year and 3-year overall survival (OS) and progression free survival (PFS). Survival analysis was performed using the Kaplan-Meier method and Log rank test. Results: Petients from 2016 to 2019 who were treated in Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Forty-eight patients with 60 lesions were enrolled, including 37 liver lesions and 23 lung lesions. Forty-six patients had 1 or 2 lesions, with median diameter of 1.3 cm, the median biologically effective dose (BED(10)) was 100.0 Gy. The median follow-up was 19.5 months for all lesions. Twenty-five lesions developed local failure, the median local progression free survival was 15 months. The 1-year LC, OS and PFS was 70.2% (95% CI, 63.7%~76.7%), 89.0% (95% CI, 84.3%~93.7%) and 40.4% (95%CI, 33.0%~47.8%). The univariate analysis revealed that planning target volume (PTV) and total dose were independent prognostic factors of LC (P<0.05). For liver and lung lesions, the 1-year LC, OS and PFS was 58.7% and 89.4% (P=0.015), 89.3% and 86.5% (P=0.732), 30.5% and 65.6% (P=0.024), respectively. No patients developed acute toxicity of grade 3 and above. Conclusion: SBRT is safe and effective treatment method for oligometastases from CRC under precise respiratory motion management and robust quality assurance.

Objective: To analyze the prognostic factors of breast cancer patients with isolated chest wall recurrence (ICWR) after mastectomy, and investigate the optimal treatment. Methods: A total of 201 breast cancer patients with ICWR after mastectomy who were treated in Cancer Hospital, Chinese Academy of Medical Sciences and the Fifth Medical Center Chinese PLA General Hospital from October 1998 to April 2018 were retrospectively analyzed. The median follow-up was 92.8 months and survival data were obtained. Results: Among 201 patients with ICWR, 103 patients developed subsequent locoregional recurrence (sLRR) and 5-year cumulative sLRR rate was 49.1%; 134 patients developed distant metastasis (DM) and 5-year DM rate was 64.4%; 103 patients died, the median progression-free survival (PFS) was 17.4 months and the 5-year PFS rate was 23.2%; the median overall survival (OS) was 62.5 months and the 5-year OS rate was 52.1%. Multivariate analysis showed that the recurrence interval (HR=2.17, 95% CI: 1.26-3.73) and the locoregional treatment (HR=1.59, 95% CI: 1.05-2.40) were the independent prognostic factors for sLRR. The initial HER2 status (HR=1.60, 95% CI: 1.03-2.48) was the independent prognostic factor for DM. The recurrence interval (HR=1.99, 95% CI: 1.30-3.04), the locoregional treatment (HR=1.99, 95% CI: 1.43-2.76) and the treatment modalities after recurrence (HR=1.70, 95% CI: 1.18-2.46) were the independent prognostic factors for PFS. The initial HER2 status (HR=1.69, 95% CI: 1.02-2.81), the recurrence interval (HR=1.85, 95% CI: 1.15-2.98) and the treatment modalities after recurrence (HR=2.48, 95% CI: 1.56-3.96) were the independent prognostic factors for OS. Conclusions: Breast cancer patients after ICWR have an optimistic OS until now, but the risk of sLRR and DM is high. Comprehensive treatment modalities including surgery, radiotherapy and systemic therapy improve the outcome of breast cancer patients with ICWR after mastectomy.

Objective: To investigate the prognostic values of three different staging schemes including the number of lymph node metastasis (N stage), lymph node ratio (LNR) and log odd of positive lymph nodes (LODDS) in pancreatic cancer patients after R0 resection. Methods: The clinical and pathological data of 307 pancreatic cancer patients who underwent R0 resection at Cancer Hospital of Chinese Academy of Medical Sciences from January 2010 to December 2018 were retrospectively analyzed. Kaplan-Meier and Cox proportional hazard regression models were used to analyze the independent prognostic factors. The area under the receiver operator characteristic curve (AUC) was used to compare the prognostic efficacy of different lymph node staging systems. Results: The median survival was 24.0 months, 1-year, 3-year, and 5-year survival rates were 72.0%, 35.5% and 24.0%, respectively. Multivariate analysis showed that CA199, differentiation, T stage, adjuvant therapy, N stage, LNR stage, and LODDS stage were independent prognostic factors for pancreatic cancer patients after R0 resection (P<0.05). The AUC values of the 1-year survival rate for N stage, LNR stage, and LODDS stage were 0.591, 0.592 and 0.609, respectively. The AUC values of the 3-year survival rate for N stage, LNR stage, and LODDS stage were 0.585, 0.588 and 0.593, respectively. The AUC values of the 5-year survival rate for N stage, LNR stage, and LODDS stage were 0.554, 0.557 and 0.589, respectively. The AUC values of the LODDS stage were the highest while the N stage were the lowest, but there was no significant difference among these three systems (P>0.05). For all patients, the LODDS staging system was slightly better than the N and LNR staging systems, but the difference was not statistically significant (P>0.05). For patients with N0 stage, the LODDS staging system showed better prediction performance than the N stage and LNR staging systems (P<0.05). Conclusions: The N stage, LNR stage, and LODDS stage are independent prognostic factors for pancreatic cancer patients after R0 resection. For patients without lymph node metastasis, LODDS staging system is superior to N and LNR staging systems in predicting prognosis.

Prior studies demonstrated HF whole breast irradiation (HF-WBI) provides equivalent long-term efficacy and toxicity as CF radiotherapy (CFRT), with inconsistent data on how to integrate tumor bed boost to a HF regimen. This study aimed to determine if a 3.5-week schedule of HFRT is non-inferior (NI) to a standard 6-week schedule of CFRT. Patients from 4 major cancer institutions in China, who had undergone breast conserving surgery and had T1-2N0-3 invasive breast cancers, participated this study. Patients were randomized (1:1) using a computer-generated central randomization schedule, without stratification, to receive WBI ± nodal irradiation followed by tumor bed boost, either at a dose of 50 Gy in 25 fractions over 5 weeks followed by a boost of 10Gy in 5 fractions over 1 week (CFRT) or 43.5 Gy in 15 fractions over 3 weeks followed by a boost of 8.7 Gy in 3 daily fractions (HFRT). Treatment was delivered using intensity-modulated radiotherapy (IMRT) or three-dimensional conformal radiotherapy (3D-CRT) techniques. The intention-to-treat population was used in primary and safety analyses. The primary endpoint was 5-year local recurrence (LR). At 1-sided alpha = 0.025, 720 patients and at least 61 LR events were needed to provide 80% power to establish NI with a margin of HR = 2.05. The trial was registered at ClinicalTrials.gov, number NCT01413269. Between August 9, 2010 and November 14, 2015, 734 patients were assigned to HFRT (n = 368) or CFRT (n = 366). Intention-to-treat analyses included 365 participants with HFRT and 364 with CFRT. 30 (4.1%) patients (11 in HFRT group and 19 in CFRT group) received additional nodal irradiation. At a median follow-up of 73.5 months (IQR 60.5-91.4), a total of 13 LR events were observed and 5-year cumulative incidence of LR was 1·2% in the HFRT group and 2·0% in the CFRT group (HR = 0.62, 95% CI:0.20-1.88, p = 0.017 for NI). The 5-year OS and DFS were 97.5% and 93.0% in the HFRT group, compared with 98.0% (HR 1·20, 95% CI, 0·50–2·91, p = 0.680) and 94.1% (HR 1.24, 95% CI, 0·74–2·08, p = 0.422) in the CFRT group, respectively. There were no significant differences in acute and late toxicities, except that the HFRT group had less G2-3 acute skin toxicity than the CFRT group (p = 0.019). The incidence of excellent/good breast cosmesis was 87.4% and 88.9% for the HFRT and CFRT group (P = 0·775). Due to lower than expected LR rates, in order to provide a timely and clinically relevant report, the final analysis was performed without observing the needed LR events. HF-WBI followed by hypofractionated boost may have similar tumor control and did not increase toxicities compared with the conventional schedule.

We described the clinical and neuroimaging characteristics of seven Chinese patients with anti-GAD65 antibody-associated neurological disorders of whom epileptic seizures were the initial and main symptoms. All patients were given immunotherapy and followed up monthly. The outcome demonstrates that immunotherapy is helpful for non-seizure manifestations of anti-GAD65-associated neurological autoimmunity and is less effective in the treatment of seizures, yet partial responses can still occur in the early stage. Taken together we suggest a trial with immunotherapy in all patients in the early stage of the disease, and in patients with non-epilepsy symptoms in the later stage.

To evaluate the prognostic significance of neoadjuvant rectal (NAR) score and downstaging depth score (DDS) after neoadjuvant chemoradiotherapy (nCRT) for locally advanced rectal cancer (LARC). Retrospective analysis was performed for 200 patients with LARC (T3-4 and/or N1-2, M0), who were initially treated in the department of radiation oncology from Mar. 2015 to Mar. 2018. All patients had baseline MRI assessments and received nCRT and radical resection. All patients received preoperative radiotherapy with doses of 45.0-50.0Gy and concurrent capecitabine. The median interval between surgery and nCRT was 9.2 weeks (5.5-20.7 weeks). The relationship of NAR score and DDS (DDS = pretreatment score-posttreatment score; The T0-4N0 stages were 0 to 4 points, respectively, and the T0.4N (+) stages were 5 to 9 points, respectively.) and prognosis was analyzed, and the area under the receiver-operating characteristic (ROC) curves was calculated. The accuracy of NAR score and DDS in predicting the 3-year disease-free survival (DFS) was evaluated. The 3-year DFS calculated using the Kaplan-Meier method, and compared by the Log rank test. The median distance from tumor edge to anal verge was 4 cm. 188 (94%) patients finished radiation of 45-50Gy in 25 fractions, as well as concurrent chemotherapy. After chemoradiotherapy, T-downstage rate and N-downstage rate of the whole group were 40.7% and 62.7%, respectively. The R0 resection rate was 82.0%. With median follow-up of 31 months (14-39 months),14 patients (7.0%) died and 45 patients (22.5%) experienced relapse (4 local and distant, 41 distant only). The 3-year DFS rate was 75.9% (95% CI: 69.2,82.5). The univariate survival analysis showed that DDS and NAR score were correlated with 3-year DFS (P<0.05). The median DDS and NAR score were 5 and 14.98. In terms of DDS, the 3-year DFS rate were 56.4%, 81.3% and 86.2% in ≤0 group, 0-5 group and >5 group, respectively (p = 0.018). In terms of NAR, the 3-year DFS rate were 90.1%, 73.8% and 53.6% in ≤8 group, 8-16 group and >16 group, respectively(p = 0.000).The cutoff value of DDS on 3-year DFS was 0; The sensitivity and specificity of predicting the DFS were 48.9% and 73.6%, respectively with the area under curve (AUC) 0.63. The cutoff value of NAR score on 3-year DFS was 8.43; The sensitivity and specificity of predicting the DFS were 88.2% and 49.0%, respectively with the area under curve (AUC) 0.68. Youden index of DDS and NAR score were 0.22 and 0.31 respectively (p = 0.0302). High DDS and low NAR scores after nCRT indicate good prognosis for patients with LARC, but which scores is more valuable needs further investigation.

To evaluate the risk of locoregional recurrence (LRR) in T1-2N1 breast cancer patients and the efficacy of postmastectomy radiotherapy (PMRT) in different risk groups. T1-2N1 breast cancer patients who underwent mastectomy and axillary lymph node dissection without neoadjuvant chemotherapy between 1999 and 2014 were included in the study. All patients were restaged according to the AJCC staging system, 8th edition. Recurrence score was determined by risk factors identified for locoregional recurrence (LRR) in patients without PMRT, and prognostic groups were constructed according to recurrence score. LRR, distant metastasis (DM), disease-free survival (DFS), and overall survival (OS) rates were calculated using the Kaplan-Meier method and compared with the log-rank test. Cox proportional hazards model was used for multivariate analysis. 2793 patients (2213 PMRT, 580 no PMRT) were included. The 5-year LRR rate was 5.3% and 7.1% for patients with and with no PMRT (p=0.064). In no PMRT group, recurrence score determined by age, tumor location, AJCC 8th edition stage, number of positive lymph nodes and lymphovascular invasion, divided patients into low, low-intermediate, high-intermediate and high risk groups. The 5 year LRR rates were 1.9%, 2.8%, 6.4% and 15.4%, the 5 year DM rates were 4.2%, 6.0%, 11.0% and 18.5% (p<0.001) for the four groups. PMRT significantly reduced LRR (p<0.001) and improved DFS (p=0.039) in high risk group. The recurrence score divides patients with T1-2N1 breast cancer into four groups with significant different prognosis. PMRT is recommended for high-risk patients. The findings of this study need further validation.

To compare the survival outcomes between breast-conserving surgery (BCS) and mastectomy, and investigate the role of radiotherapy (RT) in patients with T1-2N1M0 breast cancer in a real-world setting. There were 4209 women with T1-2N1M0 breast cancer treated in two institutions between 1999 and 2014 were retrospectively reviewed. All had received lumpectomy or mastectomy and axillary lymph node dissection without neoadjuvant chemotherapy. 3858 patients underwent modified radical mastectomy (MRM), 832 (21.6%) of them received postoperative RT (MRM + RT). 351 patients received BCS, all of them received postoperative RT (BCS + RT). Overall survival (OS) and disease-free survival (DFS) rates were calculated by using the Kaplan-Meier method and compared by log-rank test. The association of survival outcome with choice of different surgical modalities (BCS vs. MRM) and the role of RT were evaluated using multivariable proportional hazards regression and further confirmed with propensity score-matching (PSM) methods. At a median follow-up of 70 months (range, 6-226 months), the 5-year OS rates of the BCS and MRM group were 96.0% and 92.7% (p=0.005), and the corresponding 5-year DFS rates were 92.8% vs 84.0% (p<0.001). Multivariate analysis revealed that T stage, the number of positive axillary lymph node, histological grade, molecular subtype, Her2 status & target therapy, and RT were all independent prognostic factors for OS (p<0.05) and DFS (p<0.05). However, the type of breast surgery was not independently associated with either OS (p=0.788) or DFS (p=0.088). Between 326 pairs of patients (BCS + RT vs. MRM without RT) matched by PSM, BCS + RT group enjoyed significantly higher 5-year OS (96.0% vs. 94.0%, p=0.045) and DFS (92.8% vs. 87.0%, p=0.018). In further analysis of 1116 pairs of patients (BCS or MRM + RT vs. MRM without RT) matched by PSM, BCS or MRM + RT group had significantly higher 5-year OS (94.3% vs. 87.3%, p<0.001) and DFS (86.4% vs. 78.0%, p<0.001) than MRM without RT group. Based on this real-world-case analysis, we find that breast conserving surgery had superior survival outcomes to mastectomy in patients with T1-2N1M0 breast cancer, in which postoperative radiotherapy plays an important role. These findings need further validation.

To investigate the prognostic relevance of baseline and post-treatment MRI parameters in locally advanced rectal cancer patients undergoing primary chemoradiotherapy. A retrospective analysis of 96 patients with locally advanced rectal cancer (T3-T4 and/or N+) was performed in the department of radiation oncology from October 2015 to October 2017. All patients underwent long-term concurrent chemoradiotherapy (fluorouracil-based regimen) and received surgery 6-10 weeks after treatment. MRI was performed twice around concurrent radiotherapy which was 1-2 weeks before the treatment and 4-8 weeks after it. The baseline and post-treatment MRI parameters were recorded and reviewed by two independent diagnostic doctors including mrT, mrN stage, status of mesorectal fasciae (MRF) and Extra-mural venous invasion (EMVI). Three-year disease-free survival (DFS) was estimated by using the Kaplan–Meier product-limit method, and Cox proportional hazards models were used to determine associations between MRI parameters and DFS. The median distance from tumor edge to anal verge was 4 cm. All patients finished full dose of radiation of DT 50Gy in 25 fractions, as well as concurrent chemotherapy. Afterwards, 56 patients (56.5%) underwent Mile's surgery and 31 patients (33.7%) under Dixon surgery with R1 resection rate 12.5%. After chemoradiotherapy, the number of mrT3/T4 reduced from 96 of 96 to 71 of 96, and the number of mrN1/2 reduced from 82 of 96 to 43 of 96, respectively, The number of MRF positive reduced from 63 of 96 to 37 of 96. The number of mrEMVI positive reduced from 41 of 96 to 23 of 96. With median follow-up 30.7 (14.0-39.0) months, 6 patients(6.25%)died and 20 patients(20.8%)experienced relapse (1 local and distant, 19 distant). The 3-year DFS rate was 79.9% (95% CI: 71.1-86.1). Cox-proportional hazard model was analyzed on DFS by baseline MRI staging variables (mrT, mrN, mrMRF, and mrEMVI) and post-chemoradiotherapy MRI re-staging variables (ymrT, ymrN, ymrEMVI, ymrMRF, mrMRF status change, and mrEMVI status change). The univariate survival analysis showed that mrEMVI status change and ymrN were correlated with 3-year DFS (P<0.05). Multivariate analysis showed that mrEMVI status change and ymrN carried independent prognostic factor for 3-year DFS (P<0.05) with hazard ratio of 2.53 (95% CI: 1.33-4.97) and 2.61 (95% CI: 1.00-6.87), respectively. The 3-year DFS rate was 67.4% (95% CI: 52.5-79.5) in the ymrN positive group and 88.7% (95% CI: 77.4-94.7) in the negative group. The 3-year DFS rate was 59.3% (95% CI: 40.7-75.5) in mrEMVI positive throughout treatment group; In mrEMVI negative throughout treatment group, the 3-year DFS rate was 94.6% (95% CI: 82.3-98.5); In EMVI status change group, the 3-year DFS rate was 78.1%. (95% CI: 61.3-89.0). The mrEMVI was positive throughout treatment and ymrN positive are independent prognostic parameters for poor outcome in rectal cancer treated with neoadjuvant chemoradiotherapy.

To present the preliminary results of SBRT for oligometastases primary from colorectal cancer. This is a prospective, observational, single-arm phase II study. 49 patients with oligometastases from CRC were prospectively selected for SBRT between January 2016 and February 2019. Inclusion criteria are: histologically proven CRC, age ≥18 years old, controlled primary tumor, controlled extra-hepatic or extra-pulmonary lesions, ECOG performance status 0-1, at least one measurable lesion but less than 5, not a candidate for surgical resection. Patients who have liver metastasis undergo a percutaneous, Ultrasound-guided, fiducial marker implantations, then simulate with abdominal compression using 4-dimentional CT (4D-CT) and MRI. The gross tumor volume (GTV) is delineated in each 4D-CT phase, the internal target volume (ITV) was the envelope of GTVs from each phase of 4D-CT. The planning treatment volume (PTV) was ITV plus an isotropic margin of 3-5 mm. For patients of lung metastasis, 4D-CT simulation or simulation in DIBH are all allowed. The dose and fractionation are chosen according to the location and size of lesion. Cone-beam CT (CBCT) will be used to verify patient positioning at every treatment. The primary endpoint is 3-year local control rate (LC), secondary endpoint is ≥ G3 treatment-related toxicities and 3-year overall survival. We plan to enroll 50 patients until December 2020. All patients signed the informed consent, the study is approved by Ethics Committee. Forty-five patients (59 lesions) are amenable to analysis, including 32 males and 13 females. The median age is 62 years old (39-79). There are 35 hepatic lesions, 21 pulmonary lesions, and 3 lesions located in lymph nodes. The most common primary site is rectum (30 patients), while 12 patients have colon cancer, and 3 patients have bi-primary carcinoma. The median ITV is 12.612 cm3 (1.07-160.54 cm3). The median PTV is 31.726 cm3 (5.296- 323.117cm3). The median BED for lung metastasis is 100Gy (72Gy - 119Gy) and 96Gy (48-151.2 Gy) for hepatic metastasis. The median follow-up is 21 months for pulmonary lesions and 16 months for hepatic lesions. At the time of analysis, 13 lesions have local recurrence, 3 lesions are pulmonary, 1 lesion is of spleen, another 9 lesions are hepatic. One-year LC is 78.8%. 1-y pulmonary LC is 92.9%, and 68.7 % for hepatic lesion. Four patients died. The median OS is 10.5 months. One-year OS is 94.5%. Treatments were well-tolerated. For patients who have liver metastasis, no patient developed grade 3 radiation-induced liver disease. Some patients had transiently increased levels of hepatic transaminase, which normalized within 3 months after SBRT. Other side effects are nausea, anorexia, fatigue, gastritis. No patients had severe (grade 3-5) pulmonary toxicity. Some patients may have radiological change, but no clinical symptoms presented. SBRT is safe and effective for oligometastases from colorectal cancer under respiratory motion management and robust quality assurance.

To analyze the failure patterns of locoregional recurrence (LRR) and identify the prognostic factors for local recurrence (LR) and regional recurrence (RR) in breast cancer patients after mastectomy. Between 1999 and 2014, 7207 women with breast cancer after mastectomy and axillary dissection were analyzed. All didn't receive postmastectomy radiotherapy (PMRT). 4671 (64.8%) had pT1-2N0 disease (low-risk), 2078 (28.8%) had pT1-2N1 disease (intermediate-risk) and 458 (6.4%) were defined as high-risk, which included 360 with pT3-4 or pN2-3 disease and 98 pT1-2N1 after neoadjuvant chemotherapy. Among the 5427 patients who had sufficient information to construct molecular subtype, there were 2451 (45.2%) luminal A, 579 (10.7%) luminal B-Her2 negative, 814 (15.0%) luminal B-Her2 positive, 593 (10.9%) Her2 enriched, and 990 (18.2%) triple negative (TN). The distribution of accumulated LRR was analyzed. The LR and RR rates were estimated by the Kaplan-Meier method, and the differences were compared with Log-rank test. Multivariate analysis was performed using Cox logistic regression analysis. With a median follow-up of 62.9 months (6.0-194.6), 481 patients had LRR, including chest wall in 225 (46.8%), supraclavicular/infraclavicular nodes (SCN) in 242 (50.3%), axilla in 96 (20.0%) and internal mammary nodes (IMN) in 52 (10.8%) patients. For LRR patients with low, intermediate and high risk group, 93 (54.1%), 83 (44.9%), 69 (55.6%) had chest wall recurrence, 68 (39.5%), 110 (59.5%), 64 (51.6%) had SCN recurrence, 27 (15.7%), 37 (20.0%), 32 (25.8%) had axilla recurrence, and 28 (16.3%), 20 (10.8%), 4 (3.2%) had IMN recurrence. For LRR patients with luminal A, luminal B-Her2 negative, luminal B-Her2 positive, Her2-enriched, and TN tumors, 48 (45.3%), 23 (56.1%), 25 (43.1%), 25 (57.2%), 61 (58.1%) had chest wall recurrence, 51 (48.1%), 23 (56.1%), 32 (55.2%), 33 (62.3%), 51 (48.6%) had SCN recurrence, 21 (19.8%), 10 (24.4%), 13 (22.4%), 9 (17.0%), 22 (21.0%) had axilla recurrence, and 9 (8.5%), 7 (17.1%), 6 (10.3%), 7 (13.2%), 14 (13.3%) had IMN recurrence. The median interval to LR and RR was 51.6 and 29.2 months. In multivariate analysis, age (≤45 years vs. >45 years), tumor location (inner quadrant vs. other quadrants), T stage (T3-4 vs. T1-2), N stage (pN3 vs. pN2 vs. pN1 vs. pN0), hormone receptor status (negative vs. positive) were significant prognostic factors for both LR and RR (p < 0.05). In breast cancer after mastectomy without PMRT, both chest wall and supraclavicular/infraclavicular nodal region are common sites of LRR, irrespective of TN stage or molecular subtypes. The prognostic factors for LR and RR are similar, which indicates that chest wall and supraclavicular/infraclavicular nodal irradiation should be considered in all patients who planned to receive PMRT.

Objective: To validate whether the prognostic stage groups by the 8th edition of the American Joint Committee on Cancer (AJCC) staging system provides improved prognostic accuracy in T1-2N1M0 postmastectomy breast cancer patients compared to 7th edition. Methods: a total of 1 823 female patients with T1-2N1M0 breast cancer who underwent mastectomy and axillary lymph node dissection without neoadjuvant chemotherapy were analyzed and restaged according to 8th edition. Univariate analysis of prognostic factors was evaluated by using log-rank test. Multivariate analysis was estimated by using the Cox proportional hazards model. The prognostic accuracy of the two staging systems was compared using receiver operating characteristic (ROC) analyses and the concordance index (C-index). Results: 5-year locoregional recurrence rate (LRR) for the whole group was 6.0%, 5-year distant metastasis (DM) rate was 11.5%, 5-year disease-free survival (DFS) was 85.0%, and 5-year overall survival (OS) was 93.1%. Cox analysis showed that 7th edition of the AJCC staging system and progesterone receptor status were independent risk factors for LRR, DM, DFS and OS (P<0.05). Compared with stage by 7th edition, 1 278(70.1%) were assigned to a different prognostic stage group: 1 088 (85.1%) to a lower stage and 190 (14.9%) to a higher stage. LRR, DM, DFS and OS were significantly different between prognostic stage ⅠA, ⅠB, ⅡA, ⅡB and ⅢA according to 8th edition of the AJCC staging system(P<0.001). Prognostic stage had significantly higher C-indexes and provided better estimation of prognosis compared to stage by 7th edition of the AJCC staging system (P<0.001). Conclusion: The prognostic stage groups of 8th edition AJCC staging system has superior prognostic accuracy compared to 7th edition in T1-2N1M0 breast cancer, and has better clinical therapeutic guidance value.

This phase II study was designed to evaluate whether NACRT was superior to NACT with both followed by surgery and postoperative chemotherapy for locally advanced gastroesophageal and gastric adenocarcinoma. Patients with resectable or unresectable gastric cancer (cT3-4NxM0 or cTxN1-3M0) were randomized to either NACT arm or NACRT arm in a 1:1 ratio with stratification by clinical T stage (cT1-3 vs cT4). NACT arm consisted of three cycles of SOX followed by radical surgery and another postoperative three cycles of SOX. NACRT arm received intensity-modulated radiation therapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor (45.1Gy and 40.04Gy in 22 fractions) concurrently with S-1 followed by surgery and four to six cycles of SOX at the same dosage with NACT arm. The primary end point was surgical resection rate (NCT02301481). From January 2014 to October 2017, 75 patients were randomly assigned to two arms: 38 in NACRT and 37 in NACT arm. Since two of each arm refused surgery after neoadjuvant treatment (NA), 71 were finally eligible for evaluation. R0 resection rate and D2 lymphadenectomy were performed in 77.8% (28/36) and 92.9% (26/28) in NACRT and 77.1% (27/35) and 96.3% (26/27) in NACT arm. The severe and moderate pathologic responses were significantly achieved with a higher rate of 96.6% (27/28) in NACRT than in NACT arm (66.7%, 18/27, P=0.013), in which 14.3% (4/28) and 11.1% (3/27) had pCR (P=0.724). NACRT arm were observed with much less detected median total number of lymph nodes than NACT (25 vs 37, P<0.001). More grade 1 to 3 myelosuppression including thrombocytopenia (61.3% vs 5.3%, P<0.001), neutropenia (77.4% vs 28.9%, P=0.067) and liver dysfunction (16.1% vs 0, P=0.037) occurred in NACT and NACRT arm had more gastritis (39.5% vs 5.9%, P=0.008) and radiation esophagitis (26.7% vs 0, P=0.001). There were no toxic death or postoperative death in both arms. Postoperative complications were similar in the two treatment groups (NACRT vs NACT, 6.9% vs 7.1%). The compliance with NACRT was 97.4% for radiation and 89.5% for S-1. In NACT arm, 97.3% of patients completed three planned cycles preoperatively. However, only 62.1% and 66.7% completed planned cycles of adjuvant chemotherapy in NACRT and NACT arm. With a median follow-up of 27 months, the 2-year overall survival was not significant difference in all 71 patients (NACRT vs NACT, 75.4% vs 70.1%, P=0.455) and in patients with R0 resection (NACRT vs NACT, 91.3% vs 80.3%, P=0.113). However, patients with R0 resection treated with NACRT were associated with significantly higher disease-free survival (DFS, 87.1% vs 63.9%, p=0.050) and locoregional recurrence free survival (LRFS, 100% vs 79.3%, p=0.014) as compared with NACT. The design of preoperative concurrent SIB-IMRT with oral S-1 showed better DFS and LRFS with an acceptable toxicity profile, which encouraged future randomized phase III trials comparing NACRT with NACT for resectable or unresectable gastric adenocarcinoma.

Background: Postoperative radiotherapy is still recommended for stage II/III rectal cancer after defnitive surgery who did not receive preoperative chemoradiotherapy. This phase III study aims to explore the role of oxaliplatin combined with postoperative concurrent capecitabine and radiotherapy for stage II/III rectal cancer. Methods: Patients with pathologically confirmed stage II/III rectal cancer were randomized (1:1) to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). Radiotherapy consisted of 45-50.4 Gy in 25-28 fractions. In the Cap-RT group, concurrent chemotherapy consisted of two cycles of oral capecitabine (1,600 mg/m2) on days 1–14 and 22–35. The Capox-RT group received radiotherapy concurrent with oral capecitabine (1,300 mg/m2) on days 1–14 and 22–35, and a 2-h infusion of oxaliplatin (60 mg/m2) on weeks 1, 2, 4, and 5. Following 4 weeks of completing chemoradiation, 4-12 cycles of fluorouracil based adjuvant chemotherapy was delivered. The primary endpoint was 3-year disease-free survival rate (DFS). Results: Between April 1, 2008 and September 30, 2015, we enrolled 589 participants from nine centers in China. Of these participants recruited, 294 were in the Cap-RT group and 295 in the Capox-RT group. Baseline characteristics were well balanced between two groups. The 3-year and 5-year DFS rate was 73.7% and 69.7% in the Capox-RT group and 76.1% and 71.2% in the Cap-RT group (p = 0.546), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence or distant metastasis between two groups (p > 0.05). More grade 3-4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group, but not significantly (47.1% vs. 39.5%, p = 0.065). In N2 subgroup analysis, DFS rate in Capox-RT group was significantly higher than Cap-RT group (p = 0.045). Conclusions: In stage II/III rectal cancer, either radiotherapy with concurrent capecitabine or capecitabine and oxaliplatin are equally beneficial in long-term survival. N2 subsets of patients may benefit from intensive concurrent chemotherapy regimen. Clinical trial identification: NCT00714077. Legal entity responsible for the study: Jing Jin. Funding: Chinese National Nature Science Funding. Disclosure: All authors have declared no conflicts of interest.

To compare the treatment outcomes of breast conserving surgery plus radiotherapy (BCS+RT) vs. mastectomy plus radiotherapy (mastectomy+RT) vs. mastectomy without radiotherapy (mastectomy alone) for patients with pT1-2N1 triple negative breast cancer (TNBC). A total of 412 patients with pT1-2N1 TNBC treated between 1999 and 2013 were analyzed. Patients underwent BCS+RT (n=48) or mastectomy+RT (n=103) or mastectomy alone (n=261). No neoadjuvant chemotherapy was used and axillary dissection was performed for all patients. All received adjuvant chemotherapy, mainly anthrathycline- and/or taxane-based regimens. The Locoregional recurrence (LRR), disease-free survival (DFS) and overall survival (OS) rates were calculated by the Kaplan-Meier method and compared with log-rank test. Multivariate analysis was performed by Cox model. The median follow-up time was 61 months.The median age was 49 years (range, 21-82). The median nubmer of positive axillary nodes was 1 (range, 1-3) and the median number of nodes dissected was 19. BCT+RT group and mastectomy+RT group had more patients with age < 50 years than mastectomy alone group (68.8% vs. 63.1% vs. 46.0%, p < 0.001). mastectomy+RT group had more patients with 2-3 positive nodes than BCT+RT group and mastectomy alone group (63.1% vs. 41.7% vs. 41.4%, p = 0.001). BCT+RT group had more T1 tumors than mastectomy+RT group and mastectomy alone group (64.5% vs. 31.1% vs. 44.4%, p < 0.001). mastectomy+RT group had more T2 tumors than mastectomy alone group (68.9% vs. 55.6%, p = 0.019). Among BCT+RT group, mastectomy+RT group and mastectomy alone group, the 5-year LRR rates were 2.4% vs. 6.2% vs. 12.8% (p=0.180), the 5-year DFS rates were 90.4% vs. 85.7% vs. 72.7% (p=0.038), the 5-year OS rates were 91.6% vs. 89.4% vs. 85.6% (p=0.098). There were no significant differences in DFS and OS between BCT+RT group and mastectomy+RT group (p=0.267, p=0.814), however mastectomy only group had lower DFS and OS than matectomy+RT group (p=0.034, p=0.082). Multivariate analysis showed similar results after adjusting for covariates: there were no significant differences in LRR, DFS and OS between BCT+RT group and mastectomy+RT group; mastectomy alone was independently associated with higher LRR (p=0.008, HR:2.86) and lower DFS and OS (p=0.002, HR:2.08; and p=0.009, HR:2.35) as compared with BCT or mastectomy plus RT. T2 tumors was independent unfavorable prognostic factor for LRR, DFS and OS (p=0.026, p=0.002, p=0.010, respectively). In addition, age < 50 years (p=0.017) and 2-3 positive nodes (p=0.019) were independent unfavorable prognostic factor for LRR. In pT1-2N1 TNBC, breast conserving surgery plus RT achieved comparable outcomes with mastectomy plus RT, but mastectomy without RT had poorer outcomes. This indicates that breast conserving therapy is safe and postmastecomy RT is recommended for all patients.

To compare the treatment outcomes of breast conserving surgery plus radiotherapy (BCS+RT) vs. mastectomy for patients with pT1-2N0 triple negative breast cancer (TNBC). There was a total of 822 patients with pT1-2N0 TNBC treated between 1999 and 2013 that were analyzed. All patients underwent BCS+RT (n=158) or mastectomy without radiotherapy (n=664) with negative margins. All patients received adjuvant chemotherapy, mainly with anthrathycline- and/or taxane-based regimens. Survival and recurrence rates were calculated by using the Kaplan-Meier method and compared by log-rank test. Multivariate analysis was performed by Cox model. The median follow-up time was 69 months for all patients, 66 months for BCT+RT group and 70 months for mastectomy group. The median age was 48 years (range, 22 to 75 years). Compared with mastectomy group, BCT+RT group had more patients with age less than 50 years (74.1% vs. 51.8%, p < 0.001), and T1 tumors (79.1% vs. 48.5%, p<0.001). Other characteristics, including tumor grade, lymphovascular invasion and multiple tumors, were not significantly different between the two groups. The 5-year locoregional recurrence, disease-free, and overall survival rates of BCS+RT group vs. mastectomy group were 7.2% vs. 7.7%, 90.8% vs. 87.0%, and 98.8% vs. 94.5% respectively (p=0.481, p=0.119, and p=0.115). Multivariate analysis confirmed that the differences were not significant (p=0.682, p=0.208, and p=0.121, respectively). T2 tumors, age less than 50 years were independent unfavorable prognostic factors for LRR and DFS. In pT1-2N0 TNBC, breast conserving surgery plus RT achieved comparable locoregional control, disease-free, and overall survival rates with mastectomy without RT, indicating breast conserving therapy is safe and mastectomy without RT is adequate.

Objective: To investigate the overall efficacy of early breast cancer after breast-conserving treatment. To analyze risk factors affecting local regional recurrence (LRR), distant metastasis (DM) and survival. Methods: 1 791 breast cancer patients treated with breast-conserving surgery were retrospectively analyzed. The inclusion criteria were pathologic diagnosis of invasive breast cancer without supraclavicular and internal mammary node metastasis, T1-2N0-3M0, and no neoadjuvant therapy. Univariate analysis of survival was performed by Kaplan-Meier method and log rank test. Cox regression model was used for multivariate analysis. Results: The median follow-up time was 4.2 years. For all patients, the 5-year LRR, DM, disease-free survival(DFS) and overall survival(OS) rates were 3.6%, 4.6%, 93.0% and 97.4%, respectively. The LRR rates of patients with Luminal A, Luminal B1, Luminal B2, HER-2 over-expressed and triple-negative breast cancer were 2.0%, 6.1%, 5.9%, 0 and 10.0%, while the DM rates were 3.2%, 6.7%, 8.3%, 4.8% and 7.3%, respectively. Among the N0 patients, axillary dissection was performed in 689 cases and sentinel lymph node biopsy in 652 cases. The 5-year LRR rates were 3.3% and 3.2% (P=0.859), and the OS rates were 98.2% and 98.3% (P=0.311) respectively, which showed no statistically significant. There were 1 576 patients that underwent postoperative radiotherapy. Postoperative radiotherapy significantly reduced the 5-year LRR compared with surgery alone (2.5% vs 12.9%). The 5-year LRR rates of patients who received conventional fractionated radiotherapy and hypo-fractionated radiotherapy were 2.7% and 3.1%, respectively. But the difference was not statistically significant (P=0.870). Multivariate analysis showed that age, lymphovascular invasion, pathological T staging, postoperative radiotherapy, ER/PR status and endocrine therapy were independent factors of LRR in breast cancer patients (all P<0.05). Histological grade and pathological N staging were independent factors of DM (all P<0.05). The age, lymphovascular invasion, pathological T and N staging, postoperative radiotherapy, ER/PR status and endocrine therapy were independent factors for DFS (all P<0.05). Histological grade, pathological N staging, ER/PR status and endocrine therapy were factors for OS (all P<0.05). Conclusions: With contemporary standard treatment, the recurrence rate of early breast cancer after breast conserving treatment is less than 10%. Node-negative patients after sentinel lymph node biopsy did not need axillary dissection. The overall utilization of radiotherapy after breast conserving surgery is satisfactory. Hypofractionated radiotherapy is as effective as conventional fractionated radiotherapy. Local regional recurrence and distant metastasis have different risk factors.

To evaluate the efficacy of radiotherapy in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy and mastectomy, and investigate the possibility of individualizing radiotherapy according to response of neoadjuvant chemotherapy. A total of 523 patients with clinical stage IIIA and IIIB breast cancer treated between 1999 and 2013 were retrospectively reviewed. All received neoadjuvant chemotherapy and mastectomy. Of them, 404 (77.2%) patients received postmastectomy radiotherapy (PMRT) and 119 (22.8%) not. 420(80.3%)had adjuvant chemotherapy. 289 out of 348 (83.0%) patients with ER and/or PR positive disease had hormone therapy. 67 out of 204 (32.8%) patients with Her2 positive disease had trastuzumab targeted therapy. The locoregional recurrence (LRR), disease-free Survival (DFS) and overall survival (OS) rates were calculated using the Kaplan-Meier method, and differences were compared using the log-rank test. Multivariate prognostic analysis was performed using the Cox regression model. With a median follow up time of 66 months (range, 4-201 months), the 5-year LRR, DFS and OS were 16.3%, 61.4% and 82.1% respectively. For patients with and without PMRT, the 5-year LRR rates were 13.9% and 24.8%(P = 0.013),DFS were 64.1% and 53.9%(P = 0.048),and OS were 83.2% and 78.2%(P = 0.389) respectively. In the subgroups of patients with ypT3-4, ypN2-3 and Stage III disease, PMRT significantly reduced LRR (P ≤ 0.01 for all comparisons),and improved OS (P ≤ 0.003 for all comparisons). Of the 158 patients who achieved ypN0, the 5-year LRR rates were 1.0% and 12.4%(P = 0.004),DFS were 89.9% and 70.1%(p=0.009),and OS were 96.9% and 95.8%(P = 0.802)for patients with and without PMRT. Of 41 patients who achieved pCR, 2 patients without PMRT developed LRR, whereas none of patients with PMRT had LRR (P = 0.020). Multivariate analysis indicated that lack of PMRT was an independent prognostic factor associated with increased LRR and decreased DFS for all patients and ypN0 patients respectively. For patients with clinical stage IIIA and IIIB breast cancer treated with neoadjuvant chemotherapy and mastectomy, PMRT reduces LRR significantly for all patients, and reduces both recurrence and mortality risk for patients presenting with ypT3-4, ypN2-3 and pathologic stage III. PMRT might not be omitted safely for patients who achieved ypN0 or pCR, and further research is warranted.