bluuebunny/crossref_metadata_2025_split huggingface dataset:
Use of gemcitabine-platinum (Gem-P) in patients with advanced gall bladder (GB) cancer: A more aggressive disease compared to the West—Tata Memorial Centre (TMC) experience.
Authors: Sirohi Bhawna , Sheth Vipul , Singh Ashish , Gupta Alok , Goel Mahesh , Ramadvar Mukta , Shrikhande Shailesh V. 
Published: February 2017

349 Background: GB cancer is a common cancer in northern India. Gem-P is currently the standard of care for pts with advanced biliary tract cancers based on the ABC02 study which had 61 pts with GB cancer with a clinical benefit rate (CR+PR+SD) of 85%. Indian patients have a higher risk disease and present at a more advanced stage than in the West and data on treatment is lacking. Methods: This is retrospective analysis of the prospectively maintained database of 131 pts with advanced GB cancer treated at TMC between Jan 2012-May 2013. Aim of the study is to assess the clinical benefit rate in this group of pts with the Gem-P. Pts received cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 on D1 and D8 of a 21day cycle, for gem-oxaliplatin, pts received gemcitabine 1000mg/m2 on D1 and oxaliplatin 100mg/m2 on D2 every 14 days. Response was assessed after 3-4 cycles. Results: Of the 131 patients, 110 pts were treated with Gem-P (95 oxaliplatin, 15 cisplatin; 1 received cetuximab-Gem-P) and 21 (16%) pts received best supportive care alone in view of poor performance status and deranged organ function. Median age was 53 years (range, 27-76), 82F/49 M; median CA19.9 206 (<2-2251660); median CEA 6.9 (0.8-3541); site of metastases was liver in 66 (50%), nodal in 74(56%), peritoneal in 29(22%) and bilateral ovarian in 5(3.8%) patients. Of the 110 pts treated with GEM-P, PS was 0-1 in 91% of patients; median number of cycles received was 4 (1-12); grade 3 &4 toxicities were- thrombocytpenia-12 (11%), neutropenia -2 (2%), hepatitis -2 (2%) patients, neuropathy-4 (4%) and diarrhea-8 (7.2%). 86/110 (78%) were evaluable for response out of which 4 (5%) had CR, 31(36%) had PR, 13(15%) had SD, and 38 (44%) had progressive disease. 32/110 (29%) pts received 2nd-line chemotherapy (majority capecitabine -irinotecan based). Conclusions: This is the single largest study to show tolerance and efficacy of Gem-P in Indian pts with advanced GB cancer. Compared to the ABC 02 study, the clinical benefit rate is low at 56% suggesting that the biology of advanced GB cancers in Indian pts is likely to be aggressive and needs to be studied in prospectively designed studies.
90Y glass microspheres for the treatment of unresectable metastatic liver disease from chemotherapy-refractory gastrointestinal cancers: A pilot study.
Authors: Fidelman Nicholas , Kerlan Robert Keith , Hawkins Randall A. , Bergsland Emily K. , Kelley Robin Kate , Ko Andrew H. , Korn Wolfgang Michael , Venook Alan Paul 
Published: February 2017

359 Background: This prospective single-institution pilot study was undertaken to document the feasibility, safety, and efficacy of treatment of liver-dominant metastatic gastrointestinal cancer using 90Y glass microspheres. Methods: Between June 2010 and November 2012, 30 adult patients (22 men, 8 women; median age 61 years) with metastatic chemotherapy-refractory unresectable colorectal (n=15), neuroendocrine (n=9), biliary tract (n=3), pancreas (n=2), and esophageal (n=1) carcinomas underwent 45 lobar or segmental administrations of 90Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for 6 months after each treatment. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors, version 1.1. Time to maximum response, response duration, progression-free survival (hepatic and extrahepatic), and overall survival were measured. Results: Median target dose and activity were 111.6Gy and 2.5GBq per treatment session, respectively. All but 3 clinical AE were grade 1 or 2 in severity. The most frequent clinical AE were fatigue (83%), anorexia (50%), nausea (50%), abdominal pain (40%), vomiting (20%), fever (17%), and sweating (17%). Common metabolic and laboratory AE included hypoalbuminemia (50%), transaminitis (63%), and hyperbilirubinemia (27%). Serious AE included an unplanned hospital admission for carcinoid crisis, grade 3 vomiting, and grade 4 gastric ulcer. Patients with colorectal cancer had hepatic objective response rate (ORR) of 27% and a disease control rate (DCR) of 73%. Median progression-free and overall survival were 1.0 and 4.9 months, respectively. Patients with neuroendocrine tumors had hepatic ORR and DCR of 78% and 100%, respectively. Median progression-free survival was 18.5 months for this cohort. Conclusions: 90Y glass microspheres device has a favorable safety profile, and achieved prolonged disease control of hepatic tumor burden in a subset of patients, including all patients enrolled in the neuroendocrine cohort. Clinical trial information: NCT01290536.
Embolization versus embolization and systemic therapy in patients with hepatocellular carcinoma and metastatic disease: A retrospective analysis.
Authors: Kim Sunnie , Brown Karen T. , Fong Yuman , Solomon Stephen Barnett , Chou Joanne F. , Capanu Marinela , Harding James J. , O'Reilly Eileen Mary , Saltz Leonard , Abou-Alfa Ghassan K. 
Published: February 2017

363 Background: Transarterial chemoembolization (TACE) provides a survival benefit in a subset of patients with unresectable hepatocellular carcinoma (HCC). Even though data are lacking, patients with metastatic HCC (mHCC) are sometimes treated with transarterial therapies to address the hepatic disease. Sorafenib is a standard treatment for patients with mHCC. Methods: A retrospective analysis was conducted on patients diagnosed with HCC who had undergone hepatic arterial embolization (HAE) between 2006 and until 2013. Overall survival (OS) was calculated from date of HAE to date of death and estimated by Kaplan Meier Methods. Patients alive at their last follow up date were censored. Results: Of 243 patients who had undergone HAE at MSKCC during the study period, 36 patients had mHCC on initial diagnosis. Of these, 22 received HAE only, while 14 received HAE plus systemic therapy at some time during their whole treatment course. Conclusions: Patients with mHCC who underwent HAE alone had a poor OS. These data suggest that there maybe a survival benefit in patients with mHCC treated with transarterial therapies add to systemic therapy that is given at some time during their whole treatment course. These results contrast with recent data on the use of combined modality in locally advanced disease. Further studies of combined modality therapy in the setting of mHCC may be warranted. [Table: see text]
Sorafenib in hepatocellular carcinoma (HCC): Is there a role for starting patients on a total daily dose of 400mg daily?
Authors: Olowokure Olugbenga Olanrele , Singeltary Brian , Ghose, Abhimanyu , Mierzwa Michelle Lynn , Latif Tahir , Shah Shimul , Ristagno Ross , Dwivedi Alok kumar 
Published: February 2017

364 Background: S at a starting daily dose of 400mg twice daily (800mg) is considered the standard systemic therapy for HCC, in pts with well preserved liver function and advanced stage HCC, based largely on data reported by the SHARP and Asia-pacific trials. Due to complaints regarding SE and reluctance to start at full dose, we decide to retrospectively look at our HCC data base. This single institution retrospective review, evaluated the impact of starting S at a 400mg daily (200mg twice daily). Methods: From 06/01/09-09/01/13, using ICD code 155, newly registered advanced HCC pts, ECOG PS 2, Childs Pugh (CP) class A or B who were started on S 400mg daily were identified : CT scans and AFP levels were followed. PFS was estimated from the date of commencing therapy to date of progression or death if this occurred first and OS was estimated from date of commencing therapy until date of death or loss to follow up. Kaplan Meier survival estimates were obtained with 95% (CI). Log rank test was used to compare the PFS according to CP class. Results: 33 pts (M:F, 21:12), mean age of 59.8y (SD: 12.40) met inclusion criteria, the median duration (MD) of follow up was 8.7 m ( 1.07-27.43). 23(69.7%) pts were CP-A. 70% had abnormal AFP and this decreased > 50% from baseline in 8 (35%). 96% of the pts received prior locoregional therapy in CP-A and 50% in CP-B. Initial dose tolerance was observed in 23 (69.7%) pts. 16 pts (48.5%) needed dose reduction (CP-A: 56.5%, CP-B: 30%) while 19 (57.6%) pts were able to escalate their dose at some point (CP-A: 60.9%, CP-B: 50%). MD of (400mg/d) was 3m prior to any adjustment (CP-A: 3, CP-B: 2). Mean duration of S use was 8.88m (A-10.04, B-6.2). During follow up, 26 pts had POD and 24 pts died. There was no difference in PFS between CP-A and B and following POD 10/19 evaluable pts continued S. OS was 79 % (95%CI: 61-89%) at 3m, 67% (95%CI: 48-80%) at 6m, 50% (95%CI: 32-66%) at 9m, and 40% (95%CI: 23-57%) at 12m. The most common reported toxicities were fatigue 87.5%, diarrhea 53.1% and HFS/rash 43.8% Conclusions: In this cohort of pts S started at 400mg/d did not seem to result in worse outcomes compared to historic controls possibly due to the ability to tolerate therapy for a longer period of time.
Impact of body mass index on postoperative complications and long-term survival in patients with esophageal squamous cell carcinoma.
Authors: Kamachi Kenichi , Ozawa Soji , Hayashi Tsutomu , Kazuno Akihito , Ito Eisuke , Chino Osamu , Shimada Hideo , Makuuchi Hiroyasu 
Published: February 2017

37 Background: Chachexia and undernutrition have been suggested to be risk factors for postoperative complications and survival in cancer patients. The aim of this study was to investigate whether body mass index (BMI) is related to the short-term and long-term outcomes in patients who undergo an esophagectomy for the resection of esophageal squamous cell cancer. Methods: Three hundred forty patients who underwent an esophagectomy for the resection of esophageal squamous cell cancer between 2003 and 2008 were retrospectively reviewed. The patients were divided into two groups: an L-BMI group characterized by a BMI < 18.5 kg/m2, and an N-BMI group characterized by a BMI ≥ 18.5 kg/m2. The overall and disease-free survival curves of the two BMI groups were determined using the Kaplan-Meier method and were compared using a log-rank test. A Cox proportional hazards regression analysis was used for the univariate and multivariate analyses. Results: The study included 40 patients in the L-BMI group and 300 patients in the N-BMI group. Pulmonary complications seemed to occur more frequently in the L-BMI group (P = 0.006). A histopathological assessment showed that nodal involvement was seen more frequently in the L-BMI group (P = 0.016). The 5-year overall survival rate was higher in the N-BMI group (63.6%) than in the L-BMI group (32.3%) (P < 0.001). The 5-year disease-free survival rate was also higher in the N-BMI group (64.2%) than in the L-BMI group (32.3%) (P = 0.014). In a multivariate analysis, a lower BMI, an upper tumor location, an advanced pathological T stage, and a larger number of metastatic lymph nodes were independent prognostic factors for overall survival (P < 0.05). Conclusions: Our data suggested that a lower BMI not only increased pulmonary complications but also impaired overall and disease-free survival after an esophagectomy for the resection of esophageal squamous cell cancer.
Second-line systemic treatment for advanced cholangiocarcinoma.
Authors: Rogers Jane Elizabeth , Law Lindsey , Nguyen D. Van , Qiao Wei , Javle Milind M. , Kaseb Ahmed Omar , Shroff Rachna T. 
Published: February 2017

371 Background: Five-year survival for advanced cholangiocarcinoma (aCC) is reported at 5-10%. For advanced, unresectable patients, gemcitabine plus platinum (GEM-P) combination chemotherapy is common practice as first-line treatment with progression free survival (PFS) of 8 months and overall survival (OS) of 11.7 months. Data regarding chemotherapy treatment after first-line progression is limited. Methods: We performed a retrospective chart review of patients with aCC from 1/1/2009 to 12/31/2012 who received second-line chemotherapy at M.D. Anderson Cancer Center (MDACC). Median PFS was the primary endpoint. Secondary objectives included disease control rate (complete response + partial response + stable disease) and OS. Inclusion criteria: aCC diagnosis, progression on first-line therapy, and reimaging studies at MDACC. Exclusion criteria: patients who received localized treatment for aCC prior to second-line therapy or consolidative chemoradiation, mixed histology tumors, and those with a history of another malignancy. Results: 56 patients were identified, with the majority having intrahepatic aCC (95%). 80% of patients received gemcitabine based first-line treatment (GEM-P +/- erlotinib, GEM monotherapy). Second-line systemic treatment included GEM-P (19.6%), GEM + fluoropyrmidine (GEM-FU) (28.6%), fluoropyrmidine combination (FU-combo) (37.5%), and other consisting of chemotherapy or biotherapy monotherapy or combination (14.3%). Total median PFS was 2.7 months (95% CI = 2.3 to 3.8). Disease control rate was 50% with a median OS of 13.8 months (95% CI = 12 to19.3). No significant difference in PFS or OS was identified between the four second line treatment groups. A higher CA 19-9 at the start of second line treatment correlated with a worse survival (p= <0.01). Conclusions: This retrospective study revealed a 50% disease control rate, median PFS of 2.7 months, and a potential for improvement in OS in patients who received second line systemic treatment. Agents that may be considered include GEM + FU, FU-combination therapy, or GEM-P if not given first line.
Prognosis of advanced hepatocellular carcinoma (HCC) in patients undergoing surgery combined with peri- or postoperative treatment with sorafenib.
Authors: Wu Liqun , Pang Xufeng , Cao Jingyu , Wang Zusen 
Published: February 2017

377 Background: Liver resection/transplantation are effective therapies for primary hepatocellular carcinoma (HCC), but high relapse rates can significantly impact long term survival, especially for patients with advanced disease. The objective of this study was to investigate the effects of surgery plus sorafenib on the prognosis of patients with advanced HCC. Methods: 36 male and 2 female patients of mean age 52.6 (range 36-65) years and an ECOG performance status score 0-1 (n=26) or 2 (n=12), received surgical therapy (28 liver resection and 10 liver transplantation) plus sorafenib for treatment of HCC with a high risk of relapse (n=3) or had relapsed. Sorafenib was administered orally 400 mg once or twice daily, and the dose was reduced or the treatment temporarily discontinued if a grade 3 or worse adverse event occurred. Treatment duration was >3 months and patients were evaluated every 4 weeks. The main endpoints were overall survival (OS) and time to progression (TTP). Results: Median follow-up time was 12.9 (range 4-59) months. Kaplan-Meier analysis demonstrated that median OS was 17 months (95%CI: 11.6-22.4), median TTP was 15 months (95%CI: 11.6-18.4). During follow-up, 20 patients died (18 from disease progression, 1 from a lung infection, and 1 accidently). Univariate analysis demonstrated that serum ALT >60 U/L at the beginning of treatment, Child-Pugh grade B, ECOG performance status score 2, tumor cell embolism in blood vessels, tumor volume ≥3 liver segments, and a tumor involving 2 vital organs were important factors affecting OS. The median OS of patients with a tumor volume ≥3 liver segments vs. patients with tumor volume <3 liver segments was 8 vs. 28 months (log-rank test, p<0.001), and median TTP was 5 vs. 24 months (p<0.001). Conclusions: Surgical resection in combination with sorafenib helped prolong OS and TTP in patients with advanced or relapsed HCC. OS for patients treated with sorafenib peri-operatively was longer than that for patients who received therapy after a relapse had occurred. Decreasing tumor burden and administering sorafenib as early as possible are helpful strategies to improve prognosis in patients with HCC.
Neoadjuvant rectal cancer (RC) score to predict survival: Potential surrogate endpoint for early-phase trials.
Authors: Yothers Greg , George Thomas J. , Petrelli Nicholas J. , O'Connell Michael J. , Beart Robert W. , Allegra Carmen Joseph , Roh Mark S. , Lopa Samia H. , Sharif Saima , Wolmark Norman 
Published: February 2017

384 Background: Valentini, et al. (J Clin Oncol 29: 2011, 3163-72) developed nomograms for predicting overall survival (OS) based on clinical factors available after neoadjuvant therapy (tx). Pathologic T-stage (pT), N-stage (pN), and clinical T (cT) were the most important independent predictors of OS. We developed a neoadjuvant RC score (NAR score) using pN and downstaging of T (cT – pT) based on relative weights suggested by the nomograms. NSABP’s R-04 trial presents an opportunity for independent validation of the NAR score. Methods: Pts with clinical stage II/III RC undergoing preoperative RT (4,500cGy in 25 fractions over 5 wks + boost of 540-1,080cGy in 3-6 daily fractions) were randomized to one of four regimens in a 2x2 design: CVI 5-FU (225mg/m2 5 days/wk), with or without oxaliplatin (Ox) (50mg/m2 /wk x 5) or oral capecitabine (825 mg/m2 BID 5 days/wk), with or without Ox. The NAR score is computed as [5 pN – 3 (cT – pT) + 12]2/ 9.61 where: cT in {1, 2, 3, 4}, pT in {0, 1, 2, 3, 4}, and pN in {0, 1, 2}. The NAR score takes values from 0 to 100; higher scores indicate poorer prognosis. Analyses based on the score should be stratified by cT. NAR score is compared to pathologic complete response (ypCR) by Akaike’s information criterion (AIC) to determine the better predictor of OS. Results: 1,479 pts had data for the NAR score and follow-up for OS. Continuous NAR score was significantly associated with OS (HR/unit 1.04 95% CI 1.03-1.05, p<0.0001). Pts were grouped into low, intermediate, and high risk of death categories based on tertiles of the NAR score. Categories were significantly associated with OS (p<0.0001) with 5yr OS values of 92, 89, and 68%, respectively. ypCR was also significantly associated with OS (HR 0.37 95% CI 0.24-0.58, p<0.0001). Continuous NAR score had a much lower AIC (2,902.49) than ypCR (2,987.08) suggesting stronger association with OS. Conclusions: The NAR score has been validated as a predictor of OS after neoadjuvant tx for RC. AIC of the continuous NAR score suggests it is a better predictor of OS than dichotomous ypCR. NAR score could be used in place of ypCR as a surrogate endpoint for OS in early phase neoadjuvant rectal trials. Support: U10-CA-12027, U10-CA-37377, U10-CA-69651, U-10-CA-69974; Sanofi; Roche. Clinical trial information: NCT00058474.
Analysis of medical expenses according to the stage of gastric cancer during the first year after diagnosis.
Authors: Kim Sung Soo , Kim Jie-Hyun , Cheung Dae Young , Park Soo-Heon 
Published: February 2017

4 Background: Gastric cancer is one of the most common malignant cancer in Korea as 33,000 new patients are being diagnosed annually. Department of Health and Human Services has performed cancer screening project that recommends adults over 40 years old get mandatorily gastrointestinal endoscopy or gastrography for the detection of early gastric cancer every two years for free. This contributes to the discovery of early gastric cancer. However, the effectiveness of gastric cancer screening project is often questioned due to the lack of accurate data of the difference in the medical expenses between early gastric cancer and advanced gastric cancer. This study was aimed to investigate that the detection of early gastric cancer can lead to a reduction in health care costs. Methods: For the patients with newly diagnosed with gastric cancer in nine medical institutions during December 1, 2011 to June 30, 2012, the cost of the initial treatment, a total of one-year costs related to gastric cancer, inpatient and outpatient visits, test costs according to the tumor stage were investigated using a retrospective analysis of the medical records. Results: The cost of the initial treatment ($1,877 USD, $7,749 USD, $8,020 USD, and $6,809 USD, respectively by stage; P=0.000) and a one-year care costs ($1,441 USD, $5,142 USD, $8,444 USD, and $24,950 USD, respectively by stage; P=0.008) were significantly lower in stage I as compared with stage II, stage III, and stage IV. The numbers of hospitalizations, outpatient visits and abdominal CT and PET-CT scans were also significantly fewer in stage I as compared with more advanced stages. There was no difference in the cost of the initial treatment and one year care costs associated with gastric cancer between stage II, III, and IV. Chemotherapy had no effect on the difference in medical expenses. In the treatment of gastric cancer, medical expenses was affected significantly by early stage, whether or not endoscopic resection and complications. Conclusions: Detection of early gastric cancer is valuable not only for the possibility of a complete cure, but also for the reduction of the medical costs that are responsible for the patients and national health insurance.
Are patients with colonoscopy also more likely to undergo other cancer screening? A population-based analysis.
Authors: Cooper Gregory , Kou Tzuyung Doug 
Published: February 2017

401 Background: Colonoscopy use in the United States has been increasing but remains short of target rates, especially among minorities and lower SES; these same groups are also less likely to receive breast and prostate cancer screening. However, at a population level, it is not known whether disparities are accounted for by the same individuals. Methods: Using a 5% national random sample of fee-for-service Medicare beneficiaries, we identified patients ≥ 70 years in 2009. Medicare claims from 2004-2008 were used to identify receipt of prior colonoscopy and exclude previous cancer, and claims from 2009-10 were used to identify receipt of colonoscopy, mammography in women and PSA testing in men. Differences in mammography and PSA were compared between four groups: no prior colonoscopy (2004-8)/no colonoscopy in follow up (2009-10) (group 1), no prior colonoscopy/colonoscopy in follow up (group 2), prior colonoscopy/no colonoscopy in follow up (group 3), and prior colonoscopy/colonoscopy in follow-up (group 4). Differences were also evaluated in a multivariate logistic regression model that adjusted for SES and physician supply at the level of the hospital referral region (HRR). Results: 717,334 beneficiaries (453,945 women and 263,389 men) were included in the study. During 2009-2010, the frequency of mammography was 38.0%, PSA was 41.7% and colonoscopy was 16.1%. All three procedures were less frequently performed in patients who were older, nonwhite, and with higher comorbidity scores. The presence of additional cancer risk factors was also associated with screening. Screening receipt according to colonoscopy status is shown in the Table. Conclusions: In this population-based analysis, we found that individuals with repeat colonoscopy were also more likely to undergo other screening procedures, including mammography and PSA. The findings may be accounted for by patient factors as well as physician practice patterns. [Table: see text]