bluuebunny/crossref_metadata_2025_split huggingface dataset:
Metastatic colorectal cancer (mCRC) treatment: A high-volume, single-center, real-life experience.
Authors: Bergamo Francesca , Lonardi Sara , Battaglin Francesca , Marsico Valentina Angela , Paladina Isabella , Crivellari Gino , Galiano Antonella , Rumano' Laura , Bellu Luisa , Carcea Elena , Bortoletto Gladis , Fiduccia Pasquale , Bertorelle Roberta , Mammano Enzo , Rugge Massimo , Cillo Umberto , Nitti Donato , Zagonel Vittorina 
Published: February 2017

733 Background: Few data are available on outcome of clinical practice unselected patients (pts) with mCRC. Methods: We retrospectively collected data of pts with mCRC followed at our Institution from January 2010 to December 2013 evaluating the clinical characteristics, treatments and survival outcomes. Results: A total of 584 pts were evaluated, 461 were followed at our Center while 123 were seen for a second opinion. Median age was 66 ys (25-94), 59% were male, 63% had an ECOG PS = 0 while 11% ≥2. 33% had right colon primary, 68% synchronous metastatic (mts) disease and 70% a single mts site. 81% underwent surgery on primary and 41% on metastases. 51% were RAS mutated (mut) and 5% BRAF mut. 57 pts didn't receive any systemic treatment, 33 due to frail clinical conditions and 24 due to radical surgical approach (R0). Among 404 treated pts, 239 received all 3 available cytotoxic agents (oxaliplatin, irinotecan, 5FU), 324 bevacizumab and 98 anti-EGFR; 153 (38%) were enrolled in clinical trials. Median overall survival (OS) was 27.6 months (mo) for the entire mCRC population, 3.7 mo for untreated frail pts, 28.7 mo for treated pts while it is still not reached for untreated R0 pts. OS was significantly longer for pts receiving first line combination therapy (29 vs 17 mo, p < 0.01) while a poor prognosis was confirmed for BRAF mut pts (p < 0.001). In a multivariate analysis age < 70, PS 0 and R0 surgery on mts disease showed a positive prognostic impact on OS while a right site of primary was a negative predictor of outcome. At logistic regression older age, low PS and peritoneal disease negatively affected the possibility to receive all 3 active drugs. Conclusions: Despite being an unselected population our outcomes are comparable with results of clinical trials in the corresponding period. We feel that such positive evidence derives from a personalization of treatment and a multidisciplinary approach to mts disease.
Phase II study of the early start of chemotherapy after excision of primary colorectal cancer with distant metastases (Pearl Star 02).
Authors: Tanimura Syu , Yoshida Yoichiro , Aisu Naoya , Komono Akira , Kojima Daibo , Mera Toshiyuki , Yamashita Yuichi 
Published: February 2017

746 Background: The start of chemotherapy usually requires a delay of about 4 weeks after surgical resection of colorectal cancer. However, there is no evidence for the required length of this delay interval. In addition, there is a chance that a patient may die because postoperative chemotherapy was not started soon enough and a metastatic tumor was able to develop rapidly. We have previously reported the first pilot study to determine the safety and feasibility of an early start of chemotherapy after resection of primary colorectal cancer with distant metastases. We therefore conducted a next study to determine the safety and efficacy of the early start of chemotherapy after the resection of colorectal cancer with distant metastases. Methods: The Pearl Star 02 study was a prospective and single-arm trial. They received XELOX therapy (130 mg/m2 of oxaliplatin on day 1 plus 1,000 mg/m2 of capecitabine twice daily on days 1–14) on the 7th postoperative day and XELOX+bevacizumab (7.5 mg/kg of bevacizumab on day 1) after the 2nd cycle of chemotherapy. Results: A total of 20 patients were enrolled from September 2011 to June 2015. Baseline characteristics included a median age of 64 years (range: 43-72) for 15 men and 5 women. The procedures included right hemicolectomy in 6 patients, sigmoidectomy in 3 patients, high anterior resection in 3 patients, low anterior resection in 2 patients, and Hartmann procedure in 6 patients. All patients started chemotherapy on postoperative day 7. Grade 3 or higher hemotoxicity and grade 3 or higher non-hematological toxicity was noted in 5.0 % and 25.0 % of patients, respectively. Postoperative complications were observed in 2 patients (superficial incisional surgical site infection and Ileus). Median progression-free survival was 14.9 months. Overall response rate was 75%. Conclusions: An early start of chemotherapy after surgery is safe and effective. These findings suggest possible changes in the start time of chemotherapy after surgery in the future. However, further studies are certainly needed to confirm these findings. Clinical trial information: UMIN000006310.
“Real world” effectiveness of different postoperative adjuvant chemotherapy regimens in stage III colon cancer patients.
Authors: Chiang Jy Ming , Hung Hsin Yuan 
Published: February 2017

754 Background: In clinical practice, choosing oral chemotherapy or FOLFOX may depend to drug toxicity and patients’ age and comorbidities, in addition to heterogeneous stage III colon cancer. The benefit of oxaliplatin in the real world practice remained further clarified. Methods: 688 stage III colon cancer patients were collected. Treatment outcomes were retrospectively compared based on the type of chemotherapy in terms of OS and DFS. Multivariate Cox-regression modeling was used to adjust for the potential confounders. Results: This study included capecitabine (259 patients), fluorouracil-leucovorin plus oxaliplatin (FOLFOX) (283 patients) and Tegafur-uracil(146 patients). Comparing patients with capecitabine and tegafur regimens, patients receiving FOLFOX were significantly younger (mean age 56.5 yrs v.s. 65,1 yrs and 66,9 yrs ), more poor differentiation (15.9% v.s. 8.1% and 8.2%), deeper tumor invasion (T4 lesion 25.1% v.s. 15.8% and 17.1%), more advanced nodal involvement (N2/3 51.9% v.s. 18.1% and 20.5%) and had less comorbidity (50.2% v.s. 61.4% and 65.1%). Rate of completeness of chemotherapies (88.0% v.s. 87.6% and 81.5%) was no significant difference. Comparing treatment outcome, by univariate analysis, demonstrated significant (p = 0.0258) difference in OS for N2/3 patients but no difference in N1 patiens. However, by balancing confounding factors including co-morbidities, multivariate analysis showed that impact on overall survival in patients receiving capecitabine was statistically significant better than Tegafur (HR = 0.59, p = 0. 03) while no difference comparing with FOLFOX regimen (HR = 0.76, p = 0.3219). However, disease free survival (DFS) was no significantly different for FOLFOX comparing with capecitabine HR 0.97 and Tegafur HR 0.89 by multivariate Cox regression analyses. Conclusions: As post-operative adjuvant setting, oral chemotherapy either Capecitabine or Tegafur-uracil showed similar effectiveness as folfox in terms of DFS while in terms of OS, Capecitabine demonstrated similar effectiveness to folfox but better than Tegafur-urecil.
Role of adjuvant chemotherapy in locally advanced rectal cancer with ypT0-3N0 after neoadjuvant chemoradiation therapy.
Authors: Kim Chang-gon , Jung Minkyu , Jung Inkyung , Shin Sang Joon , Beom Seung Hoon , Kim Joo Hoon , Heo Su Jin , Kim Ji Hyung , Koom Woong Sub , Hur Hyuk , Min Byung Soh , Kim Nam Kyu , Kim Ho Geun , Ahn Joong Bae 
Published: February 2017

760 Background: Clinical benefit of adjuvant chemotherapy (AC) is still controversial in locally advanced rectal cancer (LARC) after neoadjuvant chemoradiation therapy (CRT) followed by total mesorectal excision (TME). We aim to explore the role of adjuvant chemotherapy with fluoropyrimidine for ypT0-3N0 patients. Methods: Patients with ypT0-3N0 rectal cancer after neoadjuvant CRT and TME were included using retrospective cohort of Yonsei Cancer Center. Patients were categorized according to receipt of adjuvant chemotherapy (AC vs. no AC). Disease free survival (DFS) and overall survival (OS) between treatment groups were compared using all patients’ cohort (APC) and propensity score-matched patients’ cohort (PSMPC). Results: total of 339 patients were evaluated. Of all, 87 patients (25.7%) did not receive AC. There was no difference in DFS between two groups [hazard ratio (HR) = 1.079, p-value = 0.782 in APC; HR = 1.22, p-value in PSMPC]. Also there was no difference in OS between two groups (HR = 1.140, p-value 0.717 in APC; HR = 1.366, p-value 0.472 in PSMPC). Advanced T stage and positive resection margin were associated with inferior DFS and OS by multivariate analysis. In subgroup analysis by baseline characteristics, we could not find any group with benefit of adjuvant chemotherapy. Conclusions: AC did not improve DFS and OS of patients with ypT0-3N0 rectal cancer after neoadjuvant CRT followed by TME. The role of AC in LARC with ypT0-3N0 after preoperative CRT should be evaluated in prospective randomized trials with larger sample size.
Review of efficacy and safety of the new oral anticoagulants (NOACS) in the treatment of venous thromboembolism in gastrointestinal (GI) oncology patients.
Authors: Patel Hitendra , Diri Reem , Aljabri Ahmed , Campen Christopher Jon , Elquza Emad , Malangone Steve , Abraham Ivo , McBride Ali 
Published: February 2017

761 Background: The occurrence of venous thrombosis (VTE) has been reported to increase the likelihood of death for cancer patients by 2- to 6-fold. Additionally, cancer patients have both a higher rate of VTE recurrence during oral anticoagulant therapy with warfarin and a higher anticoagulation-associated hemorrhagic risk as compared with non-cancer patients. New oral anticoagulants (NOACs) have administration and monitoring advantages treatment options for patients, however, there is limited data on the use of NOACs for cancer patients. Methods: We performed a single-institution retrospective review of electronic medical records of patients with GI cancer who received rivaroxaban with an active VTE diagnosis. Data collected included patient demographics, diagnosis, previous and active chemotherapy, previous history of VTE, and clinical outcomes. Results: Thirty-two patients were identified, with 28 patients concurrently treated with chemotherapy. Rivaroxaban was given to treat DVT = 23 patient and PE = 9 patients with average length of therapy 181 days. Forty-one percent of patients started on rivaroxaban, while 25% received enoxaparin, and 22% received warfarin prior to rivaroxaban. Overall, 13/32 (41%) patients experienced a bleeding episode; 7 patients had their dose held and 6 patients were noted to have minor bleeding. Conclusions: In our retrospective study, rivaroxaban did show efficacy in secondary prophylaxis for VTE in patients with active cancer. However our results revealed a rather high rate of bleeds in patients being treated with chemotherapy and rivaroxaban as compared to previous studies. [Table: see text]
The effect of body mass index (BMI) and nutrition on morbidity and mortality in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC).
Authors: Patel Komal , Oliver Joseph B , Chokshi Ravi , Patel Jimmy S , Spiegler Kevin 
Published: February 2017

765 Background: In patients with peritoneal malignancies undergoing CRS-HIPEC, their weight and nutritional factors may be affected by the presence of cachexia or obesity. With the potential morbidity of these radical operations, the selection of patients is paramount. BMI and albumin have long been utilized to predict outcomes in surgical patients. Our study evaluated whether BMI and albumin had an impact on CRS-HIPEC morbidity and mortality. Methods: Demographics, comorbidities, intraoperative variables and post-operative outcomes were analyzed using a retrospective database comprising of 28 patients undergoing CRS-HIPEC at our institution from 2012 to 2015. Median BMI of 25 and median albumin of 3.8 were used to compare the 2 groups. Primary outcome was overall survival, while secondary outcomes included complications, length of stay and intraoperative variables. Results: Patients were organized into 2 groups: < 25 BMI (n = 13) and > 25 BMI (n = 15). Albumin levels were assigned to each group and demonstrated similar values (4.0 vs 3.8, p = 0.44). Demographic data described similarly aged (54 vs 56 years, p = 0.42), gender (92% vs 93% females, p = 0.92), and peritoneal carcinomatosis index (21 vs 18, p = 0.60). The > 25 BMI group had slightly higher number of comorbidities (Charlson Comorbidity Index > 0 in 23% vs 60%, p = 0.04). Both had similar operative times (566 vs 549 minutes, p = 0.73), blood loss (700 vs 550 ml, p = 0.96) and median numbers of organs removed during cytoreduction (4 vs 3, p = 0.28). Length of stay was no different between the 2 groups (11.5 vs 10.5 days, p = 0.86). Six of the thirteen < 25 BMI individuals died during follow up (mean 5.6 months) compared to only two of the fifteen > 25 BMI individuals (mean 10.2 months) (p = 0.01). Conclusions: In our single center series, patients > 25 BMI had a better survival when compared to < 25 BMI patients. However, the analysis of the albumin levels did not demonstrate a statistically significant difference. There were no other significant differences in preoperative, intraoperative or other post-operative outcomes. Higher powered studies with longer follow-up are needed to confirm our results.
Mir-935 to suppress gastric signet ring cell carcinoma tumorigenesis by targeting Notch1 expression.
Authors: Yan Chao , Yu Jianchun , Kang Weiming 
Published: February 2017

77 Background: Although the comprehensive treatment has improved outcomes in most advanced gastric cancers, these protocols have had little effect on advanced gastric signet-ring cell carcinoma (GSRCC). New biomarkers and therapeutic targets are needed to improve its outcomes. MicroRNAs have been closely linked to the carcinogenesis of gastric cancer and have been considered as powerful prognostic markers. The function of miR-935 has never been reported in cancer before. Methods: We used microarrays in six cell lines to explore which miRNAs had dysregulated expression in GSRCC, includingGES-1, SGC-7901, MGC8-03, AGS,MKN-45 and KATO-III. We selected MKN-45 and KATO-III (with down-regulated miR-935) to transfect the miR-935 mimic, and MGC8-03 and HGC-27 (with up-regulated miR-935) to transfect the miR-935 inhibitor. TargetScan 7.0 predicted that Notch1 would have a single conserved binding sequence for miR-935 in the 3′UTR. We also assessed miR-935 expression in clinical gastric carcinoma tissue samples with adjacent normal tissue samples from the same patient. Data were analyzed with SPSS v.17.0 software. Results: Over-expression of miR-935 markedly decreased proliferation, migration and invasion of MKN-45 and KATO-III cells compared with the negative control. In contrast, the inhibitor that was transfected into MGC8-03 and HGC-27 cells significantly increased proliferation, migration and invasion compared the negative control. These results indicate that ectopic miR-935 expression decreases GSRCC proliferation, migration and invasion in vitro, and acted as a tumor suppressor for GSRCC. Expression of Notch1 is negatively regulated by miR-935. Notch1 knock-down significantly inhibited GSRCC proliferation, migration and invasion. MiR-935 was downregulated in GSRCC tissues. Conclusions: The expression of miR-935 in GSRCC cell lines is lower than in non-GSRCC cell lines, and enhanced expression of miR-935 in GSRCC cell-lines inhibit cell proliferation, migration and invasion. Notch1 is a direct target of miR-935 to reduce the proliferation, migration/invasion of GSRCC cells. MiR-935 is a potential marker for GSRCC diagnosis and therapy.
Updated analysis of phase II trial of irinotecan/s-1/cetuximab (IRIS/Cet) as second-line treatment in patients with KRAS exon2 wild type metastatic colorectal cancer (mCRC): HGCSG0902—Comparison of administration interval in cetuximab treatment.
Authors: Kondo Tomohiro , Yuki Satoshi , Kawamoto Yasuyuki , Tsuji Yasushi , Hosokawa Ayumu , Nakamura Michio , Muto Osamu , Kato Takashi , Iwanaga Ichiro , Sato Atsushi , Eto Kazunori , Furukawa Kouichi , Hayashi Hideyuki , Tateyama Miki , Takahashi Yasuo , Sogabe Susumu , Honda Takuya , Sakata Yuh , Komatsu Yoshito 
Published: February 2017

771 Background: HGCSG0902 is the multicenter phase II study to investigate the safety and efficacy of irinotecan, S-1 (IRIS) plus cetuximab as second line treatment in patients with KRAS exon2 wild type mCRC. Response rate (RR) was 33.3% (95%CI 20.8-45.9%), therefore primary endpoint was met (Muto O, et al. ESMO 2014). Here we report an exploratory analysis of outcomes based on administration interval of cetuximab (every week [EW] vs bi-weekly [BW]). Methods: Eligibility includes histologically confirmed mCRC, previously received oxaliplatin-contained chemotherapy, PS: 0-1, EGFR positive and KRAS exon2 wild type. Patients received S-1 80-120 mg/day p.o. on days 1-14 and irinotecan 100mg/m2 on day 1 and 15 repeated every 28 days. Cetuximab was administrated 400mg/m2 as loading dose and continued 250mg/m2 every week or 500mg/m2 bi-weekly. The primary endpoint was RR and the secondary endpoints were disease control rate, PFS, OS and safety. To compare with EW and BW, Fisher’s exact test was used in terms of patient characteristics, AE, RR, and Log-rank test was used in terms of PFS and OS. Results: Between Mar 2010 and Sep 2013, 58 pts were enrolled. One patient was not administered (57 pts were safety analysis set), and 3 pts were ineligible (54 pts were efficacy analysis set). Based on each physician’s choice, 34 patients of EW and 23 of BW were included in the full safety analysis set. RR was 34.4% in the EW and 31.8% in the BW (p = 1.000). Median PFS was 4.2 months in the EW and 6.1 months in the BW (HR 0.752, p = 0.350). Median OS was 8.9 months in the EW and 10.7 months in the BW (HR 0.902, p = 0.737). The most common non-hematological adverse events of grade 3 or higher were diarrhea (23.5% in the EW vs 52.2% in the BW: p = 0.005) and stomatitis (2.9% in the EW vs 30.4% in the BW group: p = 0.046), these were significantly more common in the BW. Conclusions: IRIS/Cet appeared to be highly effective with RR, PFS and OS in the both treatment schedule. Diarrhea and stomatitis were significantly more common in the BW. Therefore, in case of treatment with IRIS/Cet should be administered in the EW. Clinical trial information: UMIN000004882.
Risk factors for loss of lean body mass after gastrectomy for gastric cancer.
Authors: Aoyama Toru , Sato Tsutomu , Segami Kenki , Maezawa Yukio , Kano Kazuki , Kawabe Taiichi , Fujikawa Hirohito , Hayashi Tsutomu , Yamada Takanobu , Yukawa Norio , Oshima Takashi , Rino Yasushi , Masuda Munetaka , Ogata Takashi , Cho Haruhiko , Yoshikawa Takaki 
Published: February 2017

79 Background: Lean body mass loss after surgery, which decreases compliance of adjuvant chemotherapy, is frequently observed in gastric cancer patients who underwent gastrectomy for gastric cancer. However, the risk factors of lean body mass loss remain unclear. Methods: The present study retrospectively examined the patients who underwent curative gastrectomy for gastric cancer between June 2010 and March 2014 at Kanagawa Cancer Center. All patients received perioperative care of the enhanced recovery after surgery protocol. % Lean body mass loss was calculated by percentile of lean body mass at one month after surgery to preoperative lean body mass. Severe lean body mass loss was defined as % lean body mass loss over 5%. Risk factors for severe lean body mass loss were determined by both univariate and multivariate logistic regression analyses. Results: Four-hundred eighty five patients were examined. Median age was 67 years. Operative procedure was total gastrectomy in 190 patients and distal gastrectomy in 295 patients. Surgical complications of grade 2 or more defined by Clavien-Dindo classification was observed in 78 patients including pancreatic fistula in 19, anastomotic leakage in 11 and abdominal abscess in 7. Mortality was observed in one patient. Both univariate and multivariate logistic analyses demonstrated that surgical complications (odds rate 3.576, p = 0.001), total gastrectomy (odds rate 2.522, p = 0.0001), and gender (odds rate 1.928, p = 0.001) were significant independent risk factors for severe lean body mass loss. Conclusions: Male, surgical complications, and total gastrectomy were significant risk factors for 5% of lean body mass loss at first month after gastrectomy. To maintain lean body mass after gastrectomy, the physician need careful attention for the patients who had these risk factors.
The recurrence patterns and post-recurrence survivals in patients with locally advanced esophageal squamous cell carcinoma (ESCC) treated with preoperative paclitaxel/cisplatin-based chemoradiotherapy.
Authors: Kuo Hung-Yang , Guo Jhe-Cyuan , Huang Ta-Chen , Lin Chia-Chi , Hsieh Min-Shu , Lee Jang-Ming , Cheng Jason C. , Wang Hsiu-Po , Yeh Kun-Huei , Hsu Chih-Hung 
Published: February 2017

80 Background: More than half of patients (pts) with locally advanced ESCC would have disease recurrence after curative preoperative chemoradiation (CRT) followed by surgery. Whether recurrence pattern correlates with the post-recurrence survival remains uncertain. Methods: We included 131 pts with locally advanced ESCC (clinical T3N0-1M0 or T1-3N1M0 or M1a according to AJCC 6thedition) who were enrolled in 3 phase II clinical trials of preoperative CRT followed by surgery and had successfully completed CRT and surgery. These pts received preoperative twice weekly paclitaxel/cisplatin-based CRT with radiotherapy 40Gy given in 20 fractions followed by esophagectomy. When pts had first disease recurrence, we divided them into three groups according to their recurrence patterns: loco-regional recurrence (LRR), distant metastasis only (DM), and both LRR and DM (LRR+DM). Survival outcomes were compared using the Kaplan-Meier curves. Results: With a median follow-up of 34.8 months, 75 pts (57.3%) had disease recurrence (Table 1) and the median post-recurrence survival of these pts is 6.7 months (m). Among them, 24 pts (32.0%) had LRR, 19 (25.3%) pts had DM, and 32 pts (42.7%) had LRR+DM. There is no statistical difference of the post-recurrence survivals (Fig. 1) among 3 groups (5.4, 7.5, 4.9m, p = 0.43 in LRR, DM, and LRR+DM group respectively). It is noteworthy that 4 pts in the DM group with limited distant metastasis (1 had brain metastasis, 3 had lung metastasis) had long post-recurrence survival (56.2+, 51.6+, 13.8+, 13.1+m) after receiving metastasectomy with or without chemotherapy. Conclusions: The post-recurrencesurvival of locally advanced ESCC pts who received preoperative CRT followed by surgerywere similar regardless of recurrence pattern (loco-regional recurrence or both loco-regional and distant failure). However, in pts with limited metastasis, curative metastasectomy might provide the opportunity of achieving long-term survival. (The work was supported by the Grant of MOST 103-2314-B-002-092, MOST 104-2314-B-002-111- and HCH104-024)