bluuebunny/crossref_metadata_2025_split huggingface dataset:
Nomogram including pretherapeutic parameters for prediction of early response after neoadjuvant treatment in rectal cancer: Results from a prospective randomized study.
Authors: Zhang Jianwei , Cai Yue , Hu Huabin , Lan Ping , Wang Lei , Huang Meijin , Kang Liang , Wu Xiaojian , Ling Jiayu , Xiao Jian , Wang Jianping , Deng Yanhong 
Published: February 2017

716 Background: To establish a clinical nomogram with pretherapeutic parameters for predicting pathologic complete response (pCR) and tumor downstaging after neoadjuvant treatment in patients with rectal cancer. Methods: From Jan 2011 to Feb 2015, complete data was available for 309 patients with rectal cancer who received concurrent chemoradiotherapy or chemotherapy alone enrolled in FOWARC study. All pre-treatment clinical parameters were collected to build a nomogram for pCR and tumor down-staging. The model was subjected to bootstrap internal validation. The predictive performance of the model was assessed with concordance index (c-index) and calibration. Results: Of the 309 patients, 55 (17.8%) had achieved pCR, 138 (44.7%) patients were classified as good down-staging with ypTNM stage 0-I. Basing on the multivariate logistic regression and clinical consideration, 5 factors were identified to be the independent predictors for pCR and good downstaging, respectively (Table 1). The predictive nomograms were developed (fig 1 and 2) to predict the probability of pCR and good down-staging with a C-index of 0.802 (95% CI: 0.736-0.867) and 0.73 (95% CI: 0.672-0.784). Calibration plots showed good performance on internal validation. Conclusions: The nomograms provide individual prediction of response to different preoperative treatment for patients with rectal cancer. This model may help physician in patient selection for optimized treatment. Further external validation is warranted. [Table: see text]
Short- and long-term outcomes of neoadjuvant-synchronus S-1+radiotherapy for locally advanced rectal cancer: Multicenter phase II study.
Authors: Hiratsuka Takahiro , Akagi Tomonori , Nakajima Kentaro , Empuku Shinichiro , Shibata Tomotaka , Ueda Yoshitake , Tojigamori Manabu , Shiroshita Hidefumi , Etoh Tsuyoshi , Ninomiya Shigeo , Hiroishi Kazuaki , Takeuchi Yu , Sasaki Atsushi , Tahara Koichiro , Fujii Kyuzo , Shiromizu Akio , Ishikawa Koichi , Matsumoto Toshifumi , Bando Toshio , Inomata Masafumi 
Published: February 2017

720 Background: Fluorouracil-based chemoradiotherapy (CRT) is regarded as a standard perioperative treatment in locally advanced rectal cancer. We investigated the efficacy and safety of substituting fluorouracil with the oral prodrug S-1. Methods: A multi-institutional (17 specialized centers), interventional phase II trial, was conducted from April 2009 to August 2011. For inclusion, patients must fulfill the following requirements before neoadjuvant CRT: (i) histologically proven rectal carcinoma; (ii) tumor located in the rectum (upper, lower); (iii) cancer classified as T3-4, N0–3 and M0; Two cycles of neoadjuvant CRT with S-1 (100 mg/m2 on days 1-5, 8-12, 22-26, and 29-33) was administered, and irradiation (total 45Gy/25fr, 1.8Gy/day, on days 1-5, 8-12, 15-19, 22-26, and 29-33) was performed. Total mesorectal excision was performed during the 4th and 8th week after the end of the neoadjuvant CRT. The primary endpoint is rate of complete treatment of neoadjuvant CRT. Secondary endpoints are response rate of neoadjuvant CRT, short-term clinical outcomes, rate of curative resection, and pathological response (grade2/3). Results: This trial included 37 patients (clinical StageIIA: 8, IIIB: 19, IIIC: 10; tumor located in the upper rectum; 4, the lower rectum; 33). A complete treatment of neoadjuvant CRT was found in 86.5% of patients (95%CI;75.5-97.5%), and an adverse event (grade 3/4) occurred in 4 patients(11.1%). Response rate (PR/CR;RECIST 1.0) was 56.8% (95%CI; 40.8-72.7%), and pathologic response rate (grade2/3) was 48.6% (95%CI; 32.5-64.8%). The median operating time was 448.5 min (IQR 340.5-505.5), and median blood loss was 422.5 mL (IQR 182.5-1125). Grade 3-4 postoperative complications occurred in 6 (16.7%) patients. The most common grade 3 or 4 postoperative complication was anastomotic leakage (2 [5.6%]). The 3-year overall survival rate was 88.5%. The 3-year disease free survival rate was 70.9%. Median length of follow-up was 42 months. Conclusions: A neoadjuvant-synchronus S-1+Radiotherapy for locally advanced rectal cancer is feasible in terms of pathological response, adverse events, accompany with favorable long-term outcome. Clinical trial information: 03396.
Prognostic significance of regional lymph nodes status in stage IV colorectal cancer.
Authors: Ahmed Shahid , Leis Anne , Kanthan Selliah , Fields Anthony L.A. , Reeder Bruce , Zaidi Adnan , Haider Kamal , Abbas Tahir , Iqbal Nayyer , Pahwa Punam 
Published: February 2017

721 Background: Lymph node involvement is one of the most important prognostic variables in early stage CRC and an indication for adjuvant therapy. However, the prognostic significance of regional nodal metastases and the ratio of metastatic to examined lymph nodes (LNR), in stage IV CRC remain unknown. The current study aims to determine prognostic importance of nodal status and LNR in patients with stage IV CRC who undergo primary tumor resection (PTR). Methods: Retrospective cohort study involving patients with synchronous metastatic CRC diagnosed in Saskatchewan, during 1992-2010 and underwent PTR. Cox Proportional multivariate analyses were performed to determine prognostic significance of nodal status and LNR. Results: 2,294 patients were diagnosed with synchronous metastatic CRC during the study period. Of those 1257 underwent PTR, 148 patients did not have information about nodal status and were excluded. Median age of 1109 eligible patients was 70 yrs (22-98) and M:F was 1.2:1. 26% patients had rectal cancer, 96% had T3/T4 tumor, and 82% had node positive disease. The median LNR was 0.36 (0-1.0). 54% received chemotherapy. Median overall survival of patients who had LNR of ≥ 0.36 and received chemotherapy was 29.7 months (95% CI: 26.6-32.9) compared with 15.6 months (13.6-17.6) with LNR of < 0.36 [p < 0.001]. On multivariate analyses, among prognostic variables use of any chemotherapy, HR: 2.36 (2.0-2.79); metastasectomy, HR: 1.95 (1.63-2.32); nodal status, HR 1.34 (1.14-1.59); LNR ≥0.36, HR: 1.59 (1.38-1.84); and T status, 1.23 (1.07-1.40) were correlated with survival. Test for interaction was positive for LNR and high grade cancer, HR: 1.17 (1.031-1.33). In a sub-cohort of patients who underwent metastasectomy both LNR using a cut-off of 0.36 and nodal status, independent of chemotherapy and other prognostic variables were correlated with survival, HR of 2.38 (95%: 1.64-3.47) for LNR ≥ 36 and 1.57 (95% CI: 1.05-2.34) for node positive disease. Conclusions: Our results suggest that regional nodal status and LNR are important prognostic factor independent of chemotherapy in stage IV CRC patients undergoing PTR. Future studies are required to elucidate the mechanism by which nodal status affect survival in stage IV CRC.
Capecitabine dosing using skeletal muscle index (SMI) compared to body surface area (BSA).
Authors: Sun Julia , Ilich Alastair , Kim Christina , Wong Grace , Ghosh Sunita , Danilak Melanie , Mulder Karen E. , Spratlin Jennifer L. , Chambers Carole , Sawyer Michael B. 
Published: February 2017

722 Background: Capecitabine dose used to treat colorectal (CRC) and breast cancer (BC) is calculated using BSA. Capecitabine dose is 1250 mg/m2 in CRC and 1000 mg/m2 in BC. Using BSA to calculate dose does not consider body composition. We hypothesize that differences in capecitabine dose between CRC and BC patients (pts) is due to body composition differences between men and women, not cancer type. We hypothesize females starting treatment at 1250 mg/m2 have a higher capecitabine dose/SMI than males, and dose reductions for dose-limiting toxicity (DLT) would lead to male and female CRC pts receiving the same capecitabine dose/SMI. Methods: This is a retrospective study of early stage CRC pts treated with adjuvant capecitabine from 2008-2012. Collected demographic data included age, stage, gender, height, weight, and performance status. Capecitabine doses at cycles 1 and 3 were documented. SMI was calculated using pre-treatment CT scans. Results: 183 pts (101 males, 82 females) were identified. Females received a higher starting capecitabine dose compared to males based on SMI. Mean capecitabine/SMI dose was 5107.4 mg/cm2/m2 (SD 1113.8) for females compared to 4711.9 mg/cm2/m2 (SD 870.6) for males (p = 0.009). At cycle 3, females still had a higher dose of 3875.1 mg/cm2/m2 (SD 1663.5), although it was not statistically significant from their male counterparts at 3691.6 mg/cm2/m2 (SD 1629.5) (p = 0.4580). Conclusions: Females received higher capecitabine doses/SMI than males at the CRC 1250 mg/m2 dose. This is in keeping with our previous study that showed female CRC pts on adjuvant capecitabine experience more DLTs compared to males. After adjusting capecitabine doses for DLTs, male and female CRC pts received the same cape dose/SMI. This suggests SMI may be more useful than BSA when adjusting capecitabine doses.
A retrospective comparison between regorafenib and TAS-102 for refractory metastatic colorectal cancer.
Authors: Masuishi Toshiki , Taniguchi Hiroya , Hamauchi Satoshi , Komori Azusa , Kito Yosuke , Mitani Seiichiro , Hasegawa Hiroko , Narita Yukiya , Kadowaki Shigenori , Ura Takashi , Ando Masashi , Mori Keita , Tajika Masahiro , Yasui Hirofumi , Muro Kei , Yamazaki Kentaro 
Published: February 2017

723 Background: Regorafenib (R) and TAS-102 (T) prolonged survival for patients (pts) with refractory metastatic colorectal cancer (mCRC) in phase 3 trials. However, little is known regarding optimal sequence of administration of R and T, because of lack of head-to-head trials. Methods: We retrospectively evaluated pts who had been treated with R or T in two institutions from May 2013 to March 2015. Inclusion criteria were ECOG PS 0–2, refractory or intolerant to fluoropyrimidines, oxaliplatin, irinotecan, angiogenesis inhibitors, and anti-EGFR antibodies (if KRAS wild type), and no previous treatment with R or T. Results: A total of 182 pts (R/T: 138/44) were eligible for the study. The baseline characteristics were similar for the two groups as follows (R/T): median age, 64/63.5; male, 61%/52%; and KRAS wild type, 52%/59%. However, the proportion of pts with ECOG PS 2 (8%/18%) and who had not received irinotecan (1%/14%) was lower in R than in T. Efficacies were as follows (R/T): response rate, 0.8%/0%; disease control rate, 34%/33%; median time to treatment failure, 1.8/1.9 months (m) (median duration of follow-up, 5.6/5.0 m); median progression-free survival (PFS), 2.1/2.0 m (HR 1.09, p= 0.62, adjusted HR 0.97, p= 0.89 [11 covariates such as age, PS, and KRAS status]); median survival time (MST), 5.9/5.8 m (HR 0.92, p= 0.70); and MST for 74 eligible pts (R/T: 30/44) after the approval of T in Japan, 6.4/5.8 m (HR 0.94, p= 0.84, median duration of follow-up 4.7/5.0 m). Subgroup analysis suggested that pts with higher age and poor PS had shorter PFS in R than in T. The frequency (R/T) of grade 3 or 4 hand–foot syndrome and increased ALT were higher in R than in T (21%/0% and 10%/0%). Conversely, the frequencies of grade 3 or 4 neutropenia, anemia, and febrile neutropenia were lower in R than in T (2%/34%, 8%/27%, and 0%/7%, respectively). The main reason for discontinuation was disease progression (R/T: 85%/82%). Subsequent chemotherapies were received in 53%/46% (R/T). Conclusions: Our retrospective analysis suggested that regorafenib and TAS-102 had similar efficacy in patients with refractory mCRC. Our study results indicate that different toxicity profiles should be considered when selecting a drug treatment.
Time to first-line chemotherapy and travel distance to the cancer center and their relationship to subsequent-line therapies in stage IV CRC.
Authors: Iqbal Mahjabeen Fatima , Suo Aleksi Emil , Papneja Neha , Iqbal Nayyer , Abbas Tahir , Haider Kamal , Zaidi Adnan , Ahmed Shahid 
Published: February 2017

724 Background: Second and third line therapies in stage IV colorectal (CRC) have been associated with significant improvement in survival. However, not all patients receive all available therapies. Delay in starting treatment and travel burden can affect patient access and use of future therapy. Little is known about time to first line chemotherapy (TC) and travel distance to cancer center (TD) and their relationship to future therapies in stage IV CRC. The study aims to determine relationship between TC and TD with second and subsequent line of therapies. Methods: A patients cohort diagnosed with synchronous stage IV CRC during 2006-2010 in the province of Saskatchewan, Canada was studied. Patients with ECOG performance status of > 1 or who did not receive chemotherapy were excluded. The logistic regression analyses were performed to assess relationship between TC and TD and subsequent line therapies. Results: 569 patients were diagnosed with synchronous stage IV CRC. 326 patients received first line chemotherapy (mostly FOLFIRI ± bevacizumab). Of 326 patients 62 with ECOG performance status (PS) > 1 were excluded. The median age of 264 eligible patients was 62 yrs (IQR:53-72). 61% were male and 38% had ECOG PS of 0. Mean Charlson score was 9±1.3. 24% underwent metastasectomy. Median TC was 77 days (IQR: 53-107) and median TD was 64.4 km (IQR:4.8-166). 42.8% patients had to travel > 100 km for their treatment. Of 326 patients 144 (55%) received future therapies. On multivariate analysis absence of comorbid illness (as per Charlson comorbid index), odd ratio (OR) 1.45 (95% CI: 1.19-1.77), no metastasectomy, OR 1.89 (1.03-3.46) and TD < 100 km, OR 1.69 (1.003-2.84) were correlated with the utility of 2ndand subsequent line therapies. Conclusions: Our result revealed that although time to first line chemotherapy did not correlate with future systemic therapies, travel distance to Cancer Center > 100 km was associated with low rate of second or subsequent line therapies in statge IV CRC patients with good performance status.
Systemic therapy for advanced anorectal squamous cell carcinomas: A single institutional experience.
Authors: Boland Patrick McKay , Wang Katy , Kohen Aniqa 
Published: February 2017

728 Background: Anorectal squamous cell carcinomas (SCCs) are rare in the United States with < 10,000 cases annually. Uncommonly, patients present with stage IV disease or recurrence after definitive therapy. Limited options exist for these patients. We queried Roswell Park Cancer Institute (RPCI) patient records to determine systemic treatments utilized and outcomes for these patients. Methods: Patients with anal or rectal SCC between 1/1/99 and 7/1/2014 were identified via the cancer registry. 65 patients were flagged for review. From manual review, 31 patients received treatment at RPCI and were deemed evaluable. Demographic data, histology, staging, treatment history, time receiving any specific therapy and response assessment were abstracted from the records. Results: Of the 31 patients, 45% were male, 55% female. Primary tumors were anorectal (84%) or rectal (16%) in origin. 5(16%) presented with rectal SCC. Sites of metastatic disease were most commonly identified as lymph nodes (48%), liver (35) or lung (16%). At the time of analysis 5 (16%) were alive, with 3 (10%) disease free. Median overall survival (OS) was 44.1 months (95% CI, 28.9 - 62.6). The most commonly utilized chemotherapy regimens were 5-fu/cisplatin (n = 22 patients) and taxol (n = 10). Mean time on therapy was 4 months for 5-fu/platinum doublets (n = 24), 4 months for taxanes/platinum combinations (n = 6), 3.4 months for anti-EGFR containing regimens (n = 7) and 2.43 months for taxane monotherapy (n = 10). The most common reasons for discontinuation of therapy were progressive disease (47%) or patient choice (15%). Conclusions: New therapies are desperately needed for advanced anorectal SCCs. At present, 5-FU/cisplatin is the best endorsed and most frequently utilized regimen. Consistent with other reports, platinum doublets and anti-EGFR targeted therapies appear to confer significant benefits, within the realm of 5-fu/cisplatin, with single agent taxanes appearing to have lesser activity. Small absolute patient numbers and lack of reliable response measurements preclude firm conclusions. Future clinical trials to evaluate systemic therapies in advanced anorectal SCCs, including anti-EGFR regimens, are warranted.
Perioperative outcomes for robotic total mesorectal excision after preoperative chemoradiation for rectal cancer.
Authors: Nassour Ibrahim , Borja Nicholas , El-Mokdad Ali , Hirsch Hannah , Meyer Jeffrey John , Polanco Patricio , Balch Glen C. 
Published: February 2017

732 Background: Laparoscopic total mesorectal excision (TME) after preoperative chemoradiation therapy (P-CRT) for mid to low rectal cancer was shown to be safe and feasible by a recent randomized trial (COREAN trial). However, the safety and short-term efficacy for robotic assisted laparoscopic TME has not been demonstrated. This study is a review of the perioperative outcomes of robotic TME after P-CRT for mid to low rectal cancer at our institution. Methods: All patients that underwent robotic TME after P-CRT for rectal cancer were retrospectively reviewed in our prospectively maintained, IRB-approved surgical oncology database. All relevant demographic, clinical, operative, pathology and perioperative data were analyzed. These were compared to the COREAN trial results. Results: From 2010 to 2014, 42 patients underwent robotic TME for rectal cancer after P-CRT. Mean patient age was 60+/-13. Robotic low anterior resections (R-LAR) were performed in 69% and 31% had a robotic abdominoperineal resection (R-APR). A majority were obese patients as 74% had a BMI ≥ 25, and 50% had an ASA ≥ 3. Conversion to open rate was 9.5% (n = 4) but 3 of these were within the first 8 cases. Median estimated blood loss was 105 ml (50-400 ml). The 30-day major complication rate (Clavien III-IV) was 11.9% (n = 5) and 90-day rate was 14.2% (n = 6). One patient (2.4%) had an anastomotic leak. There were no mortalities within 90-days from operation. Median length of stay was 7 days (6-12 days). Pathological complete response was 19% while 24% had no response. The average number of lymph nodes harvested was 14.2+/-9.5. The circumferential resection margin was negative in 95.2% (n = 40) of patients. Conclusions: As compared to laparoscopic TME patients in the COREAN trial, the robotic patients in our series were more obese and had a higher ASA classification. Our conversion rate was slightly higher, but this was related to the learning curve. All other short-term outcomes were similar. It appears that robotic TME is safe and feasible after P-CRT even among a more obese and higher risk population than previously reported in large series.
Rectal adenocarcinoma: Surveillance and timing of surgical resection after neoadjuvant chemoradiotherapy in a retrospective cohort.
Authors: Pachón Olmos Vanessa , Reguera Puertas Pablo , Saavedra Serrano Cristina , Ferreiro Monteagudo Reyes , Longo Federico , Guillén Ponce Carmen , Gómez Rueda Ana , Rodríguez Garrote Mercedes , Vaz Salgado María Ángeles , Gion Cortés Maria , Salgado Alfonso Cortes , Muñoz del Toro Jacobo , Cortez Castedo Silvia Patricia , Hervás Morón Asunción , Sempere Ortega Cayetano , Die Trill Javier , García Pérez Juan Carlos , Moreno Montes Irene , Tobaruela de Blas Estela , Carrato Alfredo 
Published: February 2017

737 Background: There is some evidence relating delay of surgery (DS) by more than 8 weeks after the end of chemoradiotherapy and achievement of complete pathological response (ypCR). However, the relationship with overall survival (OS) seems to be negative. Methods: Records of 171 patients diagnosed from January 2003 to December 2011 with rectal adenocarcinoma T3/T4 and/or positive node staged by ultrasound or MRI were collected retrospectively from the Pathology Department database. Results: Of the 171 patients, 62% were male, median age at diagnosis 69.3 years (31.3 years -85.3 years). All of them received 50.4 Gy with different concomitant regimens (capecitabine, continuous infusion of fluoracil or bolus of fluoracil-leucovorin). 72.5% of the cohort received adjuvant chemotherapy. 13% of patients achieved ypCR, independently of DS (13.7% in DS vs 11.8%, p 0.722). OS was significantly worse among DS patients (67.9 months vs 54.8 months, p 0.016). In addition, more sphincter preservations (SP) were not achieved (60.8% in DS vs 57.1%, p 0.881). Conclusions: In contrast with published literature, in our cohort DS failed to show higher rates of ypCR. Neither an improvement in OS or SP was observed with DS. It is recommended that clinical trials be designed in order to establish ideal surgical timing.
Blood serum albumin as prognostic factor in patients with colorectal carcinoma.
Authors: Onate-Ocana Luis F. , Gonzalez-Trejo Sagrario , Nunez Gloria , Herrera-Goepfert Roberto , Carrillo Jose F. , Ochoa-Carrillo Francisco J. , Aiello-Crocifoglio Vincenzo 
Published: February 2017

740 Background: During the las decades, Colorectal carcinoma (CRC) has become the commonest gastrointestinal neoplasm in Mexico, being stages III and IV the most frequent, reaching thus,, diagnosed by colonoscopy and biopsyand a dismal prognosis. Basal blood serum albumin has been reported as significant prognostic factor in several diseases and in several cancers. Therefore, our aim is to define the role of the basal measurement of blood serum albumin at diagnosis as prognostic factor. Methods: Consecutive cases with CRC diagnosed by colonoscopy and biopsy and treated at a single cancer center in Mexico City from January 2010 to December 2014, were included in this cohort. Clinical history and laboratory data were registered, and patients were treated according to standard guidelines. Follow-up continued until September 2015; the Kaplan-Meier method and the Cox model were used to analyze the association of prognostic factors and overall survival (OS). Results: There were 567 patients with CRC: 258 women (45.5%) and 309 males (55.5%); mean age was 60.04 years (SD 15.6). Fifty-seven, 155, 113 and 242 were stages I, II, III and IV, respectively; 132 were located in right colon, 33 in transverse, 35 in left, 114 in sigmoid, 239 in rectum and 14 in anal canal. Neither gender, age, blood hemoglobin, lymphocyte count, albumin-lymphocyte interaction, nor Nutritional prognostic index were significantly associated with OS. Serum albumin was associated to OS, by bivariate and by multivariate analysis. This association remainded significant after adjustment for TNM stages, locations, and other clinically relevant factors. Conclusions: Serum albumin at diagnosis is an independent, significant, simple, cheap and widely available prognostic factor in patients with CRC in Mexico, adding significant prognostic information to TNM classification. Feasibly, it can be used to develop multivariate prognostic models with clinical impact.