XELOX Regimen Research Articles

Efficacy and safety of sintilimab in combination with XELOX in first-line gastric or gastroesophageal junction carcinoma (GC/GEJC).

4042 Background: Immune checkpoint inhibitors have shown clinical benefit in advanced GC/GEJC. This phase 1b study evaluates the efficacy and safety of sintilimab, an anti-programmed cell death-1 antibody (PD-1 Ab) in combination with XELOX for GC/GEJC in first-line setting. Methods: This phase 1b study enrolled treatment-naïve unresectable locally advanced or metastatic GC/GEJC patients without HER2 amplification in cohort F. Patients received sintilimab 200mg IV q3w until disease progression, unacceptable toxicity or death, in combination with XELOX regimen (oxaliplatin 130mg/m2 IV D1 and capecitabine 1000mg/m2 PO BID D1-14) for up to 6 cycles. The primary objective was to evaluate the efficacy of the combination per RECIST v1.1 and safety and tolerability. Results: Totally 20 patients were enrolled in cohort F. As data cutoff (15 Jan 2019), median follow up was 5.8 months (range, 2.4 to 12.5). The median dose of sintilimab was 6.5 (range, 4 to 12). The objective response rate (ORR) was 85.0% (95%CI, 62.1 to 96.8) and disease control rate (DCR) was 100.0% (95%CI, 83.2 to 100.0). Among 17 patient with BOR of PR, two patients achieved a complete response (CR) of the target lesion. The median duration of response (DOR) and median progression free survival (PFS) had not been met. Three patients underwent resection of primary tumor after achieving a BOR of partial response (N=2) and stable disease (N=1). The incidence of treatment emergent adverse events (TEAEs) was 85.0%. Treatment-related AEs (TRAEs) occurred in 14 (70.0%) patients. The incidence of TRAE ≥ Grade 3 was 15%. AEs of immune-related etiology, occurred in 6 patients (30.0%). There were no AEs that resulted in death. As data cutoff, 12 patients were still in treatment and 8 had discontinued treatment and were under survival follow up. The biomarker analysis including PD-L1 expression in tumor specimen was ongoing. Conclusions: Sintilimab in combination with XELOX in first-line GC/GEJC shows promising anti-tumor efficacy and a tolerable safety profile. The further randomized, phase 3 study of Sintilimab in combination with XELOX in this setting is ongoing (NCT03745170). Clinical trial information: NCT02937116.

EFFICIENCY OF ADJUVANT XELOX CHEMOTHERAPY FOR PATIENTS WITH RESECTABLE GASTRIC IN RUSSIA (SINGLE INSTITUTION RETROSPECTIVE STUDY)

Introduction. The effectiveness of the Asian regimen of adjuvant chemotherapy in patients with gastric cancer in the European population remains unclear. The aim of our study was a retrospective assessment of adjuvant chemotherapy (XELOX regimen) after radical surgery (R0) on overall survival. Methods. Database of pts with resectable gastric cancer with stage >pT3 and/or pN+ and M0, who were operated (R0) at single oncological institution during 2007-2017 was reviewed. In univariate and multivariate analyzes were included demographic characteristics, type of tumor according to Lauren, stage, type of treatment and others. Results. 396 pts were identified and 286 were available for analysis.106 (37%) pts received at least one cycle of adjuvant chemotherapy. In univariate analysis, 5OS rate was 64% [95% Cl, 52-80] и 56% [95% Cl, 48-64; p=0,21] in patients received adjuvant chemotherapy and only surgical treatment. After stratifying patients depending on the regional lymph nodes metastasis, 5OS rate in pts with pN1-3 was 69% [95% CI, 57-85] vs 47% [95% CI, 39-58; p = 0,01], respectively...

Pathological evaluation of neoadjuvant chemotherapy in advanced gastric cancer

BackgroundAlthough pathological evaluation has been considered an effective evaluation method, some problems still exist in practice. Therefore, we explored whether there are more reasonable and practical pathological evaluation criteria for neoadjuvant chemotherapy in patients with advanced gastric cancer. Here, we aim to determine pathological judgment criteria for neoadjuvant chemotherapy in patients with advanced gastric cancer.MethodsEighty-seven patients with cT2–4 or cN+ were enrolled in this study. Pathological factors for overall survival (OS) were investigated using univariate and multivariate analyses, and the pathological criteria for neoadjuvant chemotherapy were then determined.ResultsA total of 87 patients underwent 3–4 cycles of neoadjuvant chemotherapy, with 67 (77.0%), 15 (17.2%), and 5 (5.8%) receiving Folfox6, Xelox, and SOX regimens, respectively. All patients showed different levels of graded histological regression (GHR) of the primary tumor, with a ≥ 50% regression rate of 50.6%. The univariate analysis showed that GHR ≥ 50% (p = 0.022), 66.7% (p = 0.013), and 90% (p = 0.028) were significantly correlated with OS. The multivariate analysis demonstrated that ypTNM (II/III) stage was significantly associated with OS compared with ypTNM (0+I) stage [HR = 3.553, 95% CI 1.886–6.617; HR = 3.576, 95% CI 1.908–6.703, respectively] and that the Lauren classification of diffuse type was also an independent risk factor for OS compared with the intestinal type (HR = 3.843, 95% CI 1.443–10.237).ConclusionsThe Lauren classification and ypTNM stage after neoadjuvant chemotherapy are independent prognostic factors in advanced gastric cancer. A GHR ≥ 50%/< 50% can be used as the primary criterion for advanced gastric cancer after neoadjuvant chemotherapy to determine postoperative adjuvant chemotherapy regimens.

Association of XPD Asp312Asn single nucleotide polymorphisms with oxaliplatin based chemotherapy

Objective This study was to determine the role of the Xeroderma pigmentosum group D (XPD) Asp312Asn polymorphism in predicting response to Oxaliplatin based chemotherapies and survival in patients with metastatic colorectal cancer. Methods This study enrolled a total of 106 patients treated with FOLFOX4 (n=72) or XELOX (n=34) regimen. The genotype of XPD Asp312Asn was analyzed by TaqMan probe based real-Time polymerase chain reaction (PCR). Logistic regression was used to predict the response to the treatments. Cox proportion hazards models and Kaplan-Meier method were applied to predict the survival. Results The effective rate of chemotherapy in 106 patients with colorectal cancer was 57.6%(61/106). There was no significant difference in the distribution of G/G, G/A and A/A genotypes between the two groups (P>0.05). Multivariate survival analysis showed that the survival time of patients with A/A genotype, carcinoembryonic antigen (CEA) (>5 ng/ml) and age (>65 years) was relatively short, with statistical significance (P<0.05). Conclusions XPD Asp312Asn single nucleic acid polymorphism can be used as a predictor of survival in patients with metastatic colorectal cancer, but it is not associated with oxaliplatin sensitivity and needs further study. Key words: Colorectal neoplasms/DT; Antineoplastic combined chemotherapy protocols; Organoplatinum compounds/AD; Xeroderma pigmentosum group D protein/GE; Polymorphism, single nucleotide

Gastric adenocarcinoma is concurrent with metastatic neuroendocrine cancer treated with nivolumab and chemotherapy: A case report.

Gastric adenocarcinoma concurrent with metastatic neuroendocrine cancer (NEC) is rare. In the present case report, a 39-year-old male was first pathologically diagnosed by gastric endoscopy as having a highly differentiated adenocarcinoma. Next, positron emission tomography-computed tomography examination and bone marrow biopsy confirmed extensive metastasis. Subsequently, the patient underwent 6 cycles of immunotherapy (nivolumab, 160 mg) and 5 cycles of chemotherapy based on the XELOX regimen (oxaliplatin + capecitabine). Following this, the patient received the final cycles of nivolumab and XELOX; however, the patient then succumbed. Further biopsy of the metastatic collarbone lymph nodes indicated NEC. Overall, the progression-free survival was ~3.5 months, and overall survival (OS) was ~6 months. The case presented the possibility of concurrent gastric adenocarcinoma and NEC in the clinic. In addition, the efficacy of a combined regimen such as immunotherapy and chemotherapy for such disorders still requires further validation in the future.

The high pCR rate of sandwich neoadjuvant treatment in locally advanced rectal cancer may translate into a better long-term survival benefit: 5-year outcome of a Phase II clinical trial.

BackgroundIn a Phase II clinical trial, we reported the effectiveness and safety of a sandwich neoadjuvant treatment based on a modified oxaliplatin plus capecitabine (XELOX) regimen for locally advanced rectal cancer (LARC). The pathologic complete response (pCR) rate was 42.2%, and no patient presented Grade 4 acute toxicities. This study was performed to evaluate whether the high pCR rate could translate into an improved long-term survival benefit by analyzing the 5-year follow-up results of the trial.MethodsFifty-one patients with LARC were initially enrolled in the trial. Of these, 2 cases were eliminated due to distant metastasis before treatment. In addition, 4 cases were eliminated for refusing surgery after neoadjuvant chemoradiotherapy (NACRT). Finally, a total of 45 patients were treated with the sandwich NACRT plus total mesorectal excision. We followed up these patients and calculated their overall survival (OS) and disease-free survival (DFS) through a Kaplan–Meier approach. A log-rank test and multivariate survival analysis based on a Cox proportional hazard model were performed to explore the risk factors influencing distant metastasis.ResultsThe median follow-up time was 60.8 months, and among the 45 patients analyzed, 1 (2.2%) patient suffered local recurrence, and 9 (20.0%) suffered distant metastasis. The 3-year OS and DFS were 95.6% and 84.4%, respectively. In addition, the 5-year OS and DFS were 91.1% and 80.0%, respectively. In the multivariate analysis, postsurgical pathological N stage and carbohydrate antigen 19–9 before treatment maintained statistical significance on distant metastasis.ConclusionsThe sandwich NACRT with XELOX regimen might reduce distant metastasis and improve the survival of LARC patients. However, long-term benefits should be verified through further Phase III clinical trials.

Adjuvant chemotherapy with S-1 plus oxaliplatin improves survival of patients with gastric cancer after D2 gastrectomy: A multicenter propensity score-matched study.

AIMTo investigate the safety and efficacy of S-1 plus oxaliplatin (SOX) as an adjuvant chemotherapy regimen in gastric cancer (GC) after D2 dissection.METHODSGC Patients who underwent D2 gastrectomy from September 2009 to December 2011 in four Chinese institutions were enrolled. Patients with stage IB-IIIC GC, who received adjuvant SOX treatment were matched by propensity scores with those who underwent surgery alone and those who conducted capecitabine plus oxaliplatin (XELOX) regimen. Disease-free survival (DFS) and overall survival (OS) were compared among the groups. In addition, adverse events in SOX patients were analyzed.RESULTSOf 1944 GC patients who underwent D2 dissection, 867 were included for analysis. One hundred and seventeen patients treated with SOX were matched to 234 patients who conducted surgery alone. Fifty-seven patients treated with SOX were matched to 57 patients who received XELOX. The estimated five-year DFS was 57.5% in the adjuvant SOX group which was higher than that (44.6%) in the surgery alone group (P = 0.001); and the estimated five-year OS was 68.3% which was higher than that (45.8%) of surgery alone group (P < 0.001). Survival benefit was also revealed in stage III and > 60 years old subgroups (P < 0.001 and P = 0.015, respectively). Compared with XELOX regimen, SOX showed no significant difference in DFS (P = 0.340) and OS (P = 0.361). The most common ≥ 3 grade adverse events of SOX regimen were neutropenia (22.6%), leukopenia (8.9%) and thrombocytopenia (5.6%).CONCLUSIONCompared with surgery alone, SOX regimen significantly improves the long-term survival and has acceptable toxicity in patients with stage IB-IIIC GC after D2 dissection. It may be a novel adjuvant chemotherapy regimen in GC patients.

Efficacy after preoperative capecitabine and oxaliplatin (XELOX) versus docetaxel, oxaliplatin and S1 (DOS) in patients with locally advanced gastric adenocarcinoma: a propensity score matching analysis

BackgroundThe aim of this study was to compare the efficacies of the XELOX and DOS regimens as preoperative chemotherapy in patients with locally advanced gastric cancer.MethodsAll cases of locally advanced gastric cancer treated with the XELOX or DOS regimen were reviewed retrospectively. Propensity score matching (PSM) was carried out to reduce selection bias based on age, gender, location, Lauren type, carcinoembryonic antigen level, clinical tumor stage, and clinical node stage.ResultsFrom January 2010 to December 2016, 248 patients were matched; 159 of them received the XELOX regimen and 89 the DOS regimen. The response rates in the XELOX and DOS groups were 34.5 and 38.1%, respectively (P = 0.823). After four cycles of chemotherapy, 111 patients (69.8%) in the XELOX group and 65 patients (73.0%) in the DOS group underwent radical surgery (P = 0.485). The median progression-free survival (33.0 months vs. 18.7 months, P = 0.0356) and the median overall survival (43.8 months vs. 29.1 months, P = 0.0003) were longer for patients who received the DOS regimen than for those who received the XELOX regimen. The occurrence of grade 3 to 4 toxicity was similar in the two groups.ConclusionsFor locally advanced gastric cancer patients, the DOS regimen showed more benefit than the XELOX regimen as preoperative chemotherapy, without any added toxicity effects.

Application value of the modified Overlap esophagojejunostomy in totally laparoscopic total gastrectomy

Objective To investigate the application value of the modified Overlap esophagojejunostomy in totally laparoscopic total gastrectomy (TLTG). Methods The retrospective cross-sectional study was conducted. The clinicopathological data of 32 patients who underwent TLTG with modified Overlap esophagojejunostomy in the Ruijin Hospital of Shanghai Jiaotong University School of Medicine between January 2015 and December 2017 were collected. The main points of the modified Overlap method: surgeons stood on the right of patients when digestive tract reconstruction, suspension of left half liver and clockwise rotation before esophageal transection were performed, regulating esophageal opening position and building jejunal loop, and then closing openings using 45.0 mm Endo-GIA and barbed wire. Patients who were diagnosed as ⅠA stage by postoperative pathological examination were followed up; patients with lymph node metastases underwent chemotherapy of XELOX regimen and patients in ⅠB and Ⅱ stages without lymph node metastases underwent oral S-1 single agent. Observation indicators: (1) surgical and postoperative recovery situations; (2) follow-up and survival situations. Follow-up using outpatient examination and telephone interview was performed to detect postoperative adjuvant therapy, long-term complications and survival up to March 2018. Measurement data with normal distribution were represented as ±s, and measurement data with skewed distribution were described as M (range). Results (1) Surgical and postoperative recovery situations: all the 32 patients underwent successful TLTG and modified Overlap esophagojejunostomy. The operation time, esophagojejunostomy time, volume of intraoperative blood loss, time to initial anal exsufflation, time for initial fluid diet intake, time for initial semi-fluid diet intake and time of postoperative drainage-tube removal were respectively (227±19)minutes, (22±7)minutes, (69±11)mL, (2.1±0.5)days, (3.4±0.4)days, (4.9±0.6)days and (7.5±1.7)days. There was no anastomotic stoma-related complication in 32 patients. One patient was complicated with duodenal stump leakage at 5 days postoperatively and was cured by continuous three-cavity irrigation and conservative treatment. Results of postoperative pathological examination: number of lymph node dissected in 32 patients was 32±4. TNM staging: 1, 5, 7, 11, 6, 1 and 1 patients were detected respectively in ⅠA, ⅠB, ⅡA, ⅡB, ⅢA, ⅢB and ⅢC. Duration of postoperative hospital stay of 32 patients was (8.1±2.1)days. (2) Follow-up and survival situations: 32 patients were followed up for 3-38 months, with a median time of 18 months. During the follow-up, in addition to 1 patient in IA stage, 31 patients underwent postoperative adjuvant therapy; patients can take the common soft food, without symptoms of choking and burning feelings, and gastroscopy reexamination was performed at 6 months postoperatively and showed anastomosis patency. One patient died of malignant tumor of maxillary sinus at 9 months postoperatively, 1 was detected liver metastasis at 20 months postopeartively and survived with tumor, the other patients had no tumor recurrence or metastasis. Conclusion The modified Overlap esophagojejunostomy is safe and feasible in TLTG, with good short-term outcomes. Key words: Gastric neoplasms; Gastric carcinoma, upper; Carcinoma of esophagogastric junction; Radical resection; Total gastrectomy; Digestive tract reconstruction; Esophagojejunostomy; Laparoscopy

Effects of proton pump inhibitors (PPIs) on FOLFOX and XELOX regimens in colorectal cancer (CRC).

Effects of proton pump inhibitors (PPIs) on FOLFOX and XELOX regimens in colorectal cancer (CRC).

Oxaliplatin-containing adjuvant chemotherapy improves the survival of locally advanced rectal cancer patients with pathological complete response after pre-operative chemoradiotherapy

BackgroundThe necessity for adjuvant chemotherapy (ACT) in locally advanced rectal cancer (LARC) patients who achieve pathological complete response (pCR) after pre-operative chemoradiotherapy (CRT) is still not identified. We aimed to investigate the therapeutic value of ACT in these patients.MethodsClinical data were retrospectively collected from 105 consecutive LARC patients who achieved pCR after pre-operative CRT and underwent radical tumor resection between December 2008 and April 2014 in a comprehensive cancer center. Perioperative chemotherapy (CT) was administered by combining oxaliplatin with capecitabine (XELOX regimen). Disease-free survival (DFS) and overall survival (OS) rates of patients with or without ACT were compared.ResultsEighty-three (79.0%) patients received ACT and 22 (21.0%) did not. With a median follow-up of 49 months, the ACT group had a significantly higher 3-year DFS rate (92.8 vs 86.4%, p = 0.029) and 3-year OS rate (95.1 vs 86.1%, p = 0.026) than the non-ACT group. In multivariable analyses, the presence of ACT was an independent prognostic factor for DFS (hazard ratio [HR]: 0.271; 95% confidence interval (CI): 0.080–0.916; p = 0.036) but not for OS. This benefit was more obvious in patients younger than 60 years via subgroup analysis (adjusted HR: 0.106; 95% CI: 0.019–0.606; p = 0.012).ConclusionsOxaliplatin-containing ACT may confer survival benefits to patients with pCR, particularly younger patients. However, the routine use of ACT in patients with pCR needs further validation.

Which are the best Chinese herbal injections combined with XELOX regimen for gastric cancer?: A PRISMA-compliant network meta-analysis.

Background:The optimal Chinese herbal injections (CHIs) combined with XELOX regimen for patients with gastric cancer remains elusive. The aim of our network meta-analysis (NMA) is to explore the best options among different CHIs for gastric cancer.Methods:PubMed, Embase, the Cochrane Library, the China National Knowledge Infrastructure Database (CNKI), Wan-fang Database, Cqvip Database (VIP), China Biology Medicine disc (CBMdisc) were searched to identify RCTs which focused on CHIs against gastric cancer. The quality assessment of included randomized controlled trials (RCTs) was conducted by the Cochrane risk of bias tool. Standard pair-wise and Bayesian NMAs were performed to compare the efficacy and safety of different CHIs combined with the XELOX regimen via Stata 13.0 and WinBUGS1.4 software.Results:A total of 2316 records were searched, the network of evidence included 26 eligible RCTs involving 13 types of CHIs and 2154 patients. The results suggested that Shenqifuzheng+ XELOX, Huachansu+ XELOX, Kangai+ XELOX, Javanica oil emulsion+ XELOX, Aidi injection+ XELOX might be the optimal treatment for gastric cancer in improving the performance status than using XELOX regimen single, with odds ratios (OR) and 95% confidence intervals (CIs) of 2.74 (1.24, 6.17), 8.27 (1.74, 42.43), 4.28 (1.80, 10.48), 5.14 (1.87, 16.28), 0.20 (0.090, 0.44). At the aspects of ADRs (adverse reactions), Compound Kushen+ XELOX, Lentinan+ XELOX, Xiaoaiping injection+ XELOX could obviously relieve leukopenia than only receiving XELOX regimen, and their ORs and 95% CIs were 5.62 (1.41, 36.24), 8.16 (2.25, 29.43), 5.69 (1.85, 15.77). Furthermore, Disodium cantharidinate and vitamin B6+ XELOX, Shenqifuzheng+ XELOX, Kangai+ XELOX, Lentinan+ XELOX could obviously relieve the nausea and vomiting than receiving the XELOX regimen alone, with ORs and 95% CIs of 5.29 (1.30, 23.96), 2.50 (1.16, 5.26), 2.42 (1.06, 5.63), 9.04 (3.24, 26.73). Nevertheless, CHIs combined with XELOX regimen did not confer higher better clinical effectiveness rate over receiving XELOX regimen alone, with nonstatistically significant between-group differences.Conclusions:As the available evidence suggested that CHIs combined with XELOX regimen could provide treatment benefits for patients with gastric cancer. Among 13 types of CHIs, Javanica oil emulsion and Compound Kushen injection is the optimal treatment in improving the clinical effectiveness rate and performance status, and Lentinan injection was superior in relieving ADRs.

Effects of proton pump inhibitors (PPIs) on FOLFOX and XELOX regimens in colorectal cancer (CRC).

621 Title: Effects of Proton Pump Inhibitors (PPIs) on FOLFOX and XELOX Regimens in Colorectal Cancer (CRC) Background: First-line adjuvant chemotherapy options for stage II-III CRC include XELOX (capecitabine (cape), oxaliplatin) and FOLFOX (oxaliplatin, leucovorin, 5FU). Cape is an oral 5FU prodrug, and recent studies suggested that PPIs may detrimentally affect cape efficacy. Conversely, some literature posits that PPIs may negatively impact CRC itself. Our primary objective was to compare 3-year recurrence-free survival (RFS) rates between XELOX-treated PPI-users and non-PPI users, and FOLFOX-treated PPI users and non-PPI users. Our main secondary objective was to compare overall survival (OS). Methods: We conducted a retrospective chart review of 389 stage II-III CRC patients (pts) who received adjuvant XELOX or FOLFOX from a tertiary cancer center in Alberta, Canada between 2004-2013. Information regarding PPI use, cancer treatment, and pt outcomes were gathered and analyzed from pharmacy databases. Results: 23.4% of XELOX-treated pts and 28.0% of FOLFOX -treated pts used PPIs concurrently with treatment. 3-year RFS was significantly lower in XELOX-treated PPI pts than non-PPI pts (69.5 vs. 82.6%, P=0.029). Unadjusted analysis showed that XELOX-treated PPI pts were twice as likely to experience cancer recurrence or death as XELOX-treated non-PPI pts (HR 2.03, P=0.033). FOLFOX-treated PPI pts had a non-significant increase in three-year RFS versus non-PPI pts (82.9 vs. 61.7%, P=0.066), and no significant difference in recurrence or death (HR 0.51, P=0.071). No significant differences were seen in OS. Conclusions: Our results suggest that PPIs negatively impacted RFS in early-stage XELOX-treated CRC pts, and yielded no significant effect amongst FOLFOX-treated patients. Further studies are required to corroborate our findings. [Table: see text]

Phase II trial of oxaliplatin plus oral capecitabine as first-line chemotherapy for patients with advanced gastric cancer.

The efficacy of chemotherapy for advanced gastric cancer is now widely accepted. However, the survival advantage is small, and no internationally accepted standard regimen has emerged. The present study investigated the efficacy and safety of oxaliplatin plus oral capecitabine (XELOX regimen) as first-line chemotherapy in previously untreated patients with advanced gastric cancer. Patients received intravenous oxaliplatin (130 mg/m2 over 2 h on day 1) plus oral capecitabine (1,000 mg/m2 twice daily on days 1-14). Treatments were repeated every 3 weeks. Seventy-four patients were enrolled in the study, median age was 61 years (range, 32-74); median follow-up was 13.2 months (range, 2-24.5). In total, 364 cycles of chemotherapy were delivered. Overall response rate was 62.2% (95% CI, 51.2-73.2), with 3 complete and 43 partial responses; median time to progression and overall survival were 5.9 (95% CI, 4.8-7.0) and 10.8 months (95% CI, 7.9-13.7), respectively. The most common hematological adverse event was anemia (67.6% of patients). Grade 3-4 neutropenia was observed in 5 patients. The most common nonhematological toxicities were neuropathy (64.9%), nausea/vomiting (48.6%), diarrhea (28.4%), and hand-foot syndrome (39.2%). Grade 3-4 toxicities were rare. There were no treatment-related deaths. The XELOX regimen was active and well-tolerated as first-line chemotherapy in patients with advanced gastric cancer.

Long-Term Outcome of Oxaliplatin and Capecitabine (XELOX) Concomitant with Neoadjuvant Radiotherapy and Extended to the Resting Period in High Risk Locally Advanced Rectal Cancer

Purpose: This study aimed at investigating the long-term outcomes of oxaliplatin and capecitabine (XELOX) administered concurrently with preoperative radiation and extended to the resting period in patients with high-risk locally advanced rectal cancer (LARC).Methods: From January 2010 to December 2013, 45 patients were recruited. Study treatment consisted two cycles of XELOX regimen concomitant with preoperative radiation and then followed by an additional cycle of XELOX regimen between completion of neoadjuvant radiotherapy and surgery. Disease-free survival (DFS) time and overall survival (OS) time were analyzed.Results: The median follow-up was 51 months. Twelve (26.7%) patients developed local recurrence or distant metastasis, including 10 (22.2%) patients developing distant metastasis only, 1 (2.2%) patient local recurrence only, and 1 (2.2%) patient both local recurrence and distant metastasis. The estimated 3-year DFS and OS was 75.5% (95% CI, 63.0%-88.0%) and 88.6% (95% CI, 98.0%-79.2%), respectively. Receiving adjuvant chemotherapy was a significant predictor for DFS, with hazard ratio 0.24 (95% CI: 0.08-0.74).Conclusion: This intensified strategy with oxaliplatin and capecitabine (XELOX) administered concomitantly with neoadjuvant radiotherapy and then extended to the resting period in high-risk LARC patients is efficient. The long-term outcome is promising. Further study of this strategy is warranted.

Effect analysis of laparoscopy-assisted and open D2 radical gastrectomy for gastric cancer

Objective To compare the effect of laparoscopy-assisted gastrectomy (LAG) and open D2 radical gastrectomy (OG) for gastric cancer. Methods The retrospective cohort study was conducted. The clinicopathological data of 117 patients who underwent D2 radical gastrectomy at the Guangdong General Hospital from January 2014 to December 2014 were collected. Of 117 patients, 60 undergoing LAG and 57 undergoing OG were respectively allocated into the LAG group and OG group. Total gastrectomy, distal subtotal gastrectomy and proximal subtotal gastrectomy were performed according to the location of the tumor. The perigastric lymph nodes dissection was performed according to the Japanese Gastric cancer treatment protocol (the 14th edition). Eligible patients received the adjuvant chemotherapy of XELOX regimen according to the Guideline published by National Comprehensive Cancer Network (NCCN). Observation indicators: (1) comparison of intra- and post-operative recovery between groups; (2) stratified analysis of number of lymph node dissected; (3) relationship among surgical method, number of lymph node dissected and postoperative complication; (4) follow-up and survival. Follow-up using outpatient examination and telephone interview was performed to detect the postoperative adjuvant chemotherapy, tumor-free survival and tumor recurrence or metastasis up to December 2016. Measurement data with normal distribution were represented as ±s and comparison between groups was analyzed using the independent-sample t test. Count data were analyzed using the chi-square test or Fisher exact probability. The relationship between number of lymph node dissected and postoperative complication was done using the Logistic regression model. Results (1) Comparison of intra- and post-operative recovery between groups: all the patients completed the operation successfully. Volume of intraoperative blood loss, time to postoperative anal exsufflation and duration of postoperative hospital stay were (113±36)mL, (4.3±2.1)days, (9.7±2.9)days in the LAG group and (209±77)mL, (5.3±2.2)days, (11.2±3.9)days in the OG group, respectively, with statistically significant differences between groups (t=6.850, -2.604, -2.405, P 0.05). All the patients with complications received symptomatic treatment, 1 patient with abdominal bleeding in the OG group died and other patients recovered smoothly. (2) Stratified analysis of number of lymph node dissected: number of lymph node dissected in patients with total gastrectomy, distal subtotal gastrectomy and proximal subtotal gastrectomy were 35±8, 29±5, 27±4 in the LAG group and 34±5, 34±6, 29±6 in the OG group, respectively, with no statistically significant difference between groups (t=0.846, 1.052, 0.934, P>0.05). Number of lymph node dissected in patients with stageⅠ, Ⅱ and Ⅲ of TNM staging were respectively 31±5, 32±9, 31±6 in the LAG group and 34±7, 32±4, 35±6 in the OG group, with no statistically significant difference between groups (t=0.494, 1.657, 0.136, P>0.05). (3) Relationship among surgical method, number of lymph node dissected and postoperative complication: surgical method (LAG and OG) and number of lymph node dissected were used as the independent variable and postoperative complication between groups was used as the dependent variable, the Logistic regression model showed that surgical method and number of lymph node dissected were not related factors affecting the postoperative complication (OR=1.062, 2.049, 95% confidence interval: 0.998-1.140, 0.695-6.042, P>0.05). (4) Follow-up and survival: 108 of 117 patients (54 in each group) were followed up for 2-35 months, with a median time of 28 months. During the follow-up, numbers of patients undergoing postoperative adjuvant chemotherapy, with tumor-free survival and with tumor recurrence were 45, 43, 10 in the LAG group and 42, 42, 10 in the OG group, respectively, with no statistically significant difference in the tumor-free survival and tumor recurrence between groups (χ2=0.055, 0.002, P>0.05). Conclusion Laparoscopy-assisted D2 radical gastrectomy is safe and feasible, which equivalent to clinical effect of open radical gastrectomy, meanwhile, it also can reduce volume of intraoperative blood loss and duration of postoperative hospital stay, and accelerate recovery of postoperative gastrointestinal function. Key words: Gastric neoplasms; Radical resection; Lymph node dissection; Laparoscopy

Penile metastasis from rectal adenocarcinoma: a case report

BackgroundDespite its rich vasculature, the penis is rarely involved by metastasis. Since the first description of penile metastasis in 1870, fewer than 500 cases have been reported in the literature. The pelvic organs are the main source of primary tumors that metastasize to the penis.Case presentationWe report a case of a 46-year-old Arabic man who presented with erectile dysfunction and painful induration of the penile root. Eight months ago, he had undergone abdomino-perineal resection for rectal adenocarcinoma after neo-adjuvant chemotherapy. The histological evaluation of the resected specimen disclosed a ypT3N0 tumor with a poor therapeutic response (around 5%). An adjuvant chemotherapy by XELOX (oxaliplatin plus capecitabine) regimen has been prescribed for the patient. The magnetic resonance imaging (MRI) showed tumoral infiltration of penile structures and a biopsy of the corpora cavernosa was performed. The histological examination disclosed a penile metastasis from the patient’s previous rectal adenocarcinoma. The patient is still alive and continues his adjuvant therapy.ConclusionPenile secondary tumors are very rare and usually occur in patients with advanced tumor stages. A diagnosis of penile metastasis should be considered in patients with a history of malignancies who present with genitourinary symptoms. These patients have a dismal prognosis as they often die in the year after the diagnosis.

Cost-effectiveness analysis of XELOX versus XELOX plus bevacizumab for metastatic colorectal cancer in a public hospital school

BackgroundMetastatic colorectal cancer imposes a substantial burden on patients and society. Over the last years, progresses in the treatment have been made especially due to the introduction of monoclonal antibodies, such as bevacizumab which, on the other hand, has considerably increased the costs of treatment. We performed a cost-effectiveness analysis of bevacizumab plus XELOX in comparison with XELOX alone in metastatic colorectal cancer in first-line therapy, from the perspective of a public hospital school in Brazil.MethodsThis was a cost-effectiveness analysis performed by a decision tree and Markov models. Costs were expressed in local currency and outcomes were expressed in months of life gained. The model was constructed using the TreeAge Pro 2013® software.ResultsThe incremental difference in years of life gained was 2.25 months, with an extra cost of 47,833.57 BRL, resulting in an incremental cost-effectiveness of 21,231.43 BRL per month of life gained.ConclusionsAlthough the XELOX plus bevacizumab regimen is a more expensive and more effective treatment than XELOX, it does not fit the reimbursement values fixed by the public healthcare system in Brazil.

Addition of oxaliplatin to capecitabine-based preoperative chemoradiotherapy for locally advanced rectal cancer: Long-term outcome of a phase II study.

Our previous study reported the favorable short-term outcome and good tolerance of integrating oxaliplatin into capecitabine-based (XELOX regimen) preoperative chemoradiotherapy (CRT) for locally advanced rectal cancer (LARC). The present study reported the long-term oncological outcome of this phase II study. A total of 47 patients with rectal adenocarcinoma (stage II or III) were enrolled and received radiotherapy (46 Gy in 23 fractions) in combination with capecitabine (1,000 mg/m2, twice daily, on days 1–14 and 22–35) and oxaliplatin (130 mg/m2 on days 1 and 22). Overall survival (OS) rate, disease-free survival (DFS) rate and cumulative incidence of recurrences and long-term complications were calculated or observed. As a result, 41 patients underwent surgery after preoperative CRT, and the cumulative OS rates at 1, 3 and 5 years for these patients were 100.0, 84.5 and 81.8%, respectively. For the 38 patients who received R0 resection, the cumulative OS rates at 1, 3 and 5 years were 100.0, 89.0 and 86.2%, respectively, while the cumulative DFS rates at 1, 3 and 5 years were 94.6, 75.3 and 69.7%, respectively. After follow-up at 84 months, the cumulative incidence rates of local and distant recurrences at 5 years were 6.6 and 28.2%, respectively. Oxaliplatin-associated long-term complications were seldom observed. Overall, the addition of oxaliplatin to capecitabine-based preoperative radiotherapy achieved favorable OS and DFS without increased long-term complications in patients with LARC. Therefore, this preoperative CRT strategy is a feasible option for such patients.

Mid-term outcomes of a prospective phase II trial of preoperative sandwich-like neoadjuvant chemoradiotherapy for locally advanced rectal cancer

Objective To evaluate the mid-to long-term survival benefits of preoperative sandwich-like neoadjuvant chemoradiotherapy (CRT) in patients with locally advanced rectal cancer (LARC). Methods A total of 45 LARC patients who underwent neoadjuvant sandwich CRT in the form of XELOX regimen prior to, concurrently with, and following volumetric modulated arc radiotherapy (VMAT) in 2012 were enrolled in this study. VMAT was given at a gross tumor volume dose of 50 Gy in 25 fractions, and a clinical target volume dose of 45-46 Gy in 25 fractions. Total mesorectal excision was performed 6 to 8 weeks after completion of VMAT.The overall survival (OS) and disease-free survival (DFS) were determined by the Kaplan-Meier method, and survival comparison and univariate prognostic analysis were performed using the log-rank test. Results The median follow-up time was 46.7 months. There was no local recurrence detected among the patients. The 3-year distant metastasis (DM) rate was 18%, and the 3-year OS and DFS were 96% and 84%, respectively. Univariate analysis indicated that perineural invasion, N1-N2 pathology (pathological stage Ⅲ), and Ca-199>35 U/ml before treatment were risk factors for DM (P=0.000, 0.000, and 0.013, respectively). Conclusions The significant short-term efficacy of preoperative sandwich-like neoadjuvant CRT can be extended to a positive mid-term survival in LARC patients. However, further phase Ⅲ clinical studies will be needed to confirm this finding. Key words: Rectal neoplasms/chemoradiotherapy; Chemoradiotherapy, neoadjuvant; Prognosis