Objective A phase Ⅰ study was conducted to determine the maximal tolerated dose (MTD) and the dose-limiting toxicity(DLT) of chemotherapy of oral doxifluridine(5-dFUR) and leucovorin with concurrent standard radiotherapy(RT) as adjuvant treatment in patients with rectal cancer. Methods Patients aged 18-75 years old, Karnofsky scored ≥70%, stage Ⅱ/Ⅲ rectal cancer after curative surgery were eligible. Total RT dose was delivered as DT 50 Gy in the fraction of 2.0 Gy per day for 5 weeks to the pelvic area. 5-dFUR was administered concurrently with radiotherapy in escalating doses, and oral leucovorin was The DLTs included grade 3 or grade 4 hematologic and nonhematologic toxicity. Results From Aug. 2005 the most common side effects although all neutropenia was less grade 3. The DLT was observed in 1 patient of RT. In the following 3 enrolled patients, one suffered grade 3 abdominal cramp pain, diarrhea, fatigue, nausea/vomit and grade 2 neutropinea and fever. Grade 3 diarrhea was also observed in all the additional 3 papatients didn't complete the scheduled concurrent chemoradiotherapy due to severe side effects,including 1 at grade 3 abdominal cramp pain,fatigue and nausea/vomit. Conclusions Diarrhea is the most common and severe side effect in this phase Ⅰ study. The MTD of doxifluridine, concurrently with RT and fixed dose of oral cramp pain is often accompanied with diarrhea and nauser/vomit when the dose of doxifluridine exceeds 550 mg/( m2 · d) or 900 mg/d,patients need to be observed carefully.

Objective To investigate the efficacy and toxicity of postmastectomy hypofractionation radiotherapy in patients with high-risk breast cancer. Methods Postmastectomy radiation of 43.5 Gy in 15 fractions of 2.9 Gy over 3 weeks was delivered to 38 patients with breast cancer. The incidence of acute radi-ation toxicity and lecoregional recurrence was evaluated. Results With a median follow up of 13 months, all patients were alive. No patient had locoregional recurrence within radiation field. Five (13%) had dis-tant metastases. Five (13%) developed grade 3 radiation dermatitis at 2 to 3 weeks after the course of radia-tion. Three (8%) had grade 2 radiation pneumonitis. Conclusions Hypofractionation radiation of 43.5 Gy in 15 fractions of 2.9 Gy over 3 weeks is effective in the near time for patients with high-risk breast cancer after mastectomy, and the acute toxicities are tolerable.

Objective To reduce the radiation dose to the hematopoietic bone marrow (hBM) and acute hematologic toxicity (HT) in patients with rectal cancer undergoing intensity-modulated radiotherapy (IMRT).Methods The previously untreated patients with rectal cancer were enrolled in a prospective study.Pelvic magnetic resonance imaging ( MRI) was used to determine and delineate the distribution of hBM,and dose limitations were set (V5<95%,V10<90%,V20<80%,V30<65%).The neoadjuvant therapeutic regimen included concurrent IMRT (95% PTV 50 Gy/25 fractions,2 Gy/fractions),oxaliplatin 50 mg/m2 , qw,and capecitabine 1650 mg/m2 ,1 fractions/d (twice a day during radiotherapy).Results A total of 35 patients were enrolled and completed the therapeutic regimen.The incidence of grade 2-4 HT was 31.4%;among these patients, 9 ( 26%) experienced leucopenia, 6 ( 17%) experienced neutropenia, 1 ( 3%) experienced erythropenia,and 1(3%) experienced thrombocytopenia.No patients experienced grade ≥3 anemia.The multivariate logistic linear regression analysis showed that hBM-V5 was significantly correlated with the lowest counts of leukocytes ( P=0.005),neutrophils ( P=0.002),and platelets ( P=0.017).Conclusions The radiation dose to the hBM in the pelvis on MRI is significantly correlated with the incidence and severity of acute HT in patients with rectal cancer undergoing neoadjuvant concurrent chemoradiotherapy.Clinical Trial Registry ClinicalTrials.gov,registration number:NCT01863420.

Objective The aim of this study was to investigate whether the addition of neoadjuvant chemoradiotherapy ( NACRT ) to surgery can improve outcomes better than neoadjuvant chemotherapy in terms of rate of R0 resection, pathological complete response ( pCR ) and side effects. Methods This exploratory study included primary gastric adenocarcinoma patients staged as clinical T4N0 or anyTN1-3. Intensity modulated radiotherapy was delivered of 40 to 50 Gy in 22 to 25 fractions,5 days/week.Concurrent chemotherapy regimens included S-1 or Capecitabine or a combination of Paclitaxel plus Carboplatin.Results Eleven eligible patients were enrolled. R0 and R2 resections were performed in 9 ( 9/11) and 1 patients, respectively.Peritoneal metastasis was found in 1 case during exploratory laparotomy.The pCR was observed in 1 patient with R0 resection ( 1/10 ) . Ten cases completed radiotherapy and 8 cases completed chemotherapy. Nausea ( 3/11 ) , vomit ( 2/11 ) and anorexia ( 2/11 ) were the most common Grade 3 toxicities. Conclusions NACRT showed an acceptable toxicity and promising activity in locally advanced gastric adenocarcinoma.

Objective To analyze the outcome and prognostic factors in breast cancer at high-risk of recurrence and evaluate the role of radiotherapy. Methods 381 breast cancer patients treated with mastec-tomy and axillary dissection were retrospectively analyzed. The including criterias were pathologic diagnosis of invasive breast cancer, T_3-T_4 and/or four or more positive axillary nodes. The survival rates was calculat-ed by Kaplan-Meier method, and compared by Logrank test. Cox regression model was used to select poten-tial prognostic variables. Results The median follow up was 48 months. The 5-year overall survival (OS) and locoregional recurrence-free survival (LRFS) rates were 76.8% and 89.7%, respectively. Radiothera-py significantly improved the OS (80.9% vs. 62.3%, χ~2=15.47, P=0.001) and LRFS (93.4% vs. 77.1% χ~2=19.95,P=0.000). The use of ipsilateral chest wall and supraclavicular nodal radiation was associated with increased 5-year chest wall recurrence free survival (96.8% : 86.2%, χ~2= 12.66, P=0.001) and 5-year supraclavicular node recurrence free survival (97.7% : 90.7 %, χ~2= 9.98, P=0.002).However, axillary irradiation had no impact on 5-year axillary recurrence free survival (98.4% : 96.1% ,χ~2=0.74, P=0.389). In multivariate analysis, absence of radiotherapy (χ~2=14.42, P=0.000), 10 or more positive axillary nodes (χ~2=21.60, P=0.000), and T_4 stage (χ~2=10.79, P=0.001) were inde-pendent unfavorable prognostic factors for overall survival. Conclusions Radiotherapy improves the overall survival of breast cancer patients with T_3, T_4 and/or four or more positive axillary nodes. The chest wall and supraclavicular nodal radiation should be given to this group of patients.

erall survival.

Objective To analyze the outcomes and the role of radiotherapy in breast cancer pa-tients with T1-T2 and one to three positive axillary nodes treated with modified radical mastectomy, and to investigate the prognostic factors for loco - regional recurrence in patients without radiotherapy . Methods Three hundred and seventy breast cancer patients with T1-T2 and one to three positive axillary lymph nodes treated with mastectomy and axillary dissection were retrospectively analyzed. Kaplan-Meier method was used to calculate the overall survival (OS) and loco-regional recurrence-free survival (LRFS) rates. The Logrank test was used for the comparison of the survival curves of patients with or without radiotherapy. Univariate analyses of potential prognostic variables for LRFS were performed. Results The 5-year OS and LRFS rates were 85.4% and 91%. Radiotherapy significantly improved the 5-year LRFS rate ( 100% vs. 89.5% ;x2 = 5.17, P=0.023). However, there was no significant difference in overall survival rate between patients with and without radiotherapy. In univariate analyses, T stage, the number of positive axillary nodes, C-erbB-2 and PR status were the significant predictive factors for LRFS. Conclusions For breast cancer pa-tients with T1-T2. and one to three positive axillary nodes, radiotherapy improves the LRFS, but not OS. T stage, the number of positive axillary nodes, C-erbB-2 and PR status are predictive factors for loco-regional recurrence in patients without radiotherapy.

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.

Objective:To investigate the efficacy and prognosis of hypofractionated intensity-modulated radiation therapy combined with hormonal therapy in the treatment of pelvic lymph node metastatic prostate cancer.Methods:Clinical data of 42 IV A prostate cancer patients who received hypofractionated intensity-modulated radiation therapy combined with hormonal therapy in Cancer Hospital of Chinese Academy of Medical Sciences between 2006 and 2018 were retrospectively analyzed. The total irradiation doses to the prostate and seminal vesicles were 67.5 Gy/25f, 2.7 Gy/f. The prophylactic irradiation doses to the pelvic lymph nodes were 45-50 Gy with a daily fraction dose of 1.8-2.0 Gy. Thirty-three patients with residual lymph nodes were boosted to 60.0-67.5 Gy for the residual area, 2.4-2.7 Gy/f. Androgen deprivation therapy included surgical castration or luteinizing hormone-releasing hormone agonists combined with antiandrogens. Survival rate was calculated using Kaplan- Meier method. The differences between two groups were analyzed by log-rank test. Prognostic factors were identified by univariate and multivariate analyses. Results:The median follow-up was 65.5 months (range, 5 to 150 months). The 5-year and 10-year failure-free survival (FFS) rates in the whole group were 67% and 45%, respectively. No clinical recurrence was observed in the irradiation field. The 5-year and 10-year prostate cancer-specific survival/overall survival (PCSS/OS) rates were 85% and 60%, respectively. Gleason score (≥8 and<8) and duration of hormonal therapy impacted the FFS (both P<0.05). The duration of hormonal therapy was an independent prognostic factor for PCSS/OS ( P=0.003). Conclusions:Hypofractionated intensity-modulated radiotherapy combined with hormonal therapy yields optimistic clinical efficacy in the treatment of pelvic lymph node metastatic prostate cancer. Gleason score (≥8 and <8) and duration of hormonal therapy are critical prognostic factors.

Objective To observe the incidence of adverse reactions and short-term efficacy of S-1 and concurrent intensity-modulated radiotherapy ( IMRT) for locally advanced gastric cancer in a phase Ⅱclinical trial based on the phase I clinical trial.Methods Patients pathologically diagnosed with stage TN (+) gastric adenocarcinoma with local or distal metastasis after R0 resection were enrolled as subjects.IMRT was delivered 5 times per week with a total dose of 45 Gy in 25 fractions.S-1 was orally administered on the day of radiotherapy at a dose of 80 mg/m2 .Results A total of 40 patients, consisting of 6 patients from the phase I trial and 34 patients from the phaseⅡtrial, were enrolled in this study.In those patients, the age ranged between 27 and 73 years ( median age 50 years) and the male-to-female ratio was 3:1.Thirty-nine ( 98%) out of the forty patients completed radiotherapy and thirty-five ( 88%) completed concurrent chemotherapy.The most common grade 3-4 adverse reactions were nausea/anorexia ( 13%) , leukopenia ( 10%) , vomiting ( 8%) , radiation esophagitis ( 5%) , and neutropenia ( 5%) .There was no perioperative death.The 2-year overall survival and disease-free survival rates were 74% and 77%, respectively. Conclusions Postoperative S-1 and concurrent IMRT achieve satisfactory outcomes and tolerable toxicity in patients with locally advanced gastric cancer.