bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy of belinostat in advanced hepatocellular carcinoma (HCC): Phase I and II multicentered study of the Mayo Phase 2 Consortium (P2C) and the Cancer Therapeutics Research Group (CTRG).
Authors: Chan Stephen Lam , Chung Hyun Cheol , Wang Ling-Zhi , Lim Robert S. C. , Picus Joel , Boyer Michael J. , Erlichman Charles , Chan Anthony T. C. , Goh Boon C. , Yeo Winnie 
Published: February 2017

259 Background: Belinostat is a novel histone deactylase inhibitor which demonstrates preclinical activity in HCC. We report the results of a phase I/II study on belinostat in patients (pts) with unresectable HCC. Methods: Major eligibility criteria included histologically confirmed HCC not amenable to curative treatment; PS ≤ 2; adequate organ function; prior systemic therapy was allowed. In the phase I portion, belinostat was given i.v. on D1-5 every 3 weeks with dose levels of 600, 900, 1200 and 1400 mg/m2/day. In the phase II portion, belinostat was tested at the MTD. Primary endpoint was PFS and secondary endpoints were RR according to RECIST and OS. CT assessment was done every 8 weeks. Results: Phase I portion: a total of 18 pts were accrued; no DLTs were observed at 1400mg/m2/day for 5 days, and this dose was selected for phase II development. Phase II portion: 42 pts were accrued; Median age = 57.5 years; 41 had Child’s A function, and 24 pt had ECOG 0. Sixteen (38%) had previous systemic therapy, and 21 (50%) had previous transarterial therapy. Median follow-up was 20.0 months. The PR and SD rate was 2.4% (1/42) and 45.2% (19/42). Median PFS was 2.64 months (95%C.I. 1.55-3.17) and OS was 6.60 months (95%C.I. 4.53-11.60). Grade 3 or higher toxicities (>5% rate) were abdominal pain (9.5%), (9.5%) hyperbilirubinemia (9.5%), raised ALT (9.5%); anemia (7.1%) and vomiting (7.1%). Conclusions: Belinostat demonstrates disease stabilization in a predominantly pretreated population of pts with unresectable HCC with an acceptable safety profile. Further randomized studies are warranted.Supported in part by N01-CM-62205.
Cholangiocarcinoma: A joint cancer database analysis.
Authors: Deutsch Yehuda Ethan , Sleeman Danny , Ribeiro Afonso , Franceschi Dido , Hosein Peter Joel , Akunyili Ikechukwu Immanuel , Macintyre Jessica , Soares Heloisa P. , Herna Stuart , Lally Brian E. , Levi Joe U , Rocha Lima Caio Max S. 
Published: February 2017

268 Background: Cholangiocarcinoma is an uncommon malignancy. In addition, only 10-30% of patients are eligible for curative surgical resection due to advanced disease at diagnosis. The role of adjuvant therapy is not yet established. The objective of this analysis is to assess the outcome of patients with cholangiocarcinoma managed with surgery, chemotherapy, radiation, and/or chemo-radiation. Methods: From 1997 to 2007, patients with biliary cancer from the joint tumor registry database at UMH, SCCC, and JHS had their demographics, stage, pathology, treatment (surgical management, adjuvant and palliative therapy) and survival collected. A total of 800 patients with the diagnoses of biliary cancer were reviewed. The site of cancer was the bile duct in 351 patients, gallbladder in 173, and ampulla of vater in 239 patients. Results: Cholangiocarcinoma - adenocarcinoma of the bile duct – in 334 patients of the 351 with bile duct tumors were analyzed. The mean age at diagnosis was 65 (range 26-92) and 55% of patients were male. Stage at presentation was as follows: 22% of patients presented with stage I, 18% with stage II, 21% with stage III, 26% with stage IV, and 13% were unknown. Potentially curative surgical resection was performed in 45% of the patients. 24% received chemotherapy, 20% received radiation, and 14% received chemo-radiation in combination. The overall median survival (MS) of all patients was 13 months - 22, 16, 14, and 10 months for stages I, II, III, and IV respectively. Surgery provided an overall survival benefit for all stages (24 vs. 9 months, p<.001), including stage III (n=31/71; 20 vs. 10 months, p=.026) and stage IV (n=28/88; 23 vs. 6 months, p<.001). Chemotherapy offered a trend to survival benefit for patients with stage IV (13 vs. 6 months, p=.06) and combined stages III and IV (13 vs. 10 months, p=.07). Combination chemo-radiation had a significant survival benefit in stage IV (19 vs. 6 months, p=.022) and in combined stages III and IV (14 vs. 10 months, p=.026). Conclusions: Chemotherapy and chemo-radiation had a positive impact on survival in patients with late stage cholangiocarcinoma. Surgery improved survival in both early and advanced stages. The lack of data on performance status and organ function did not allow factoring these variables in the analysis.
Efficacy of infusional 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) chemotherapy and analysis of prognostic factors in previously treated advanced hepatocellular carcinoma.
Authors: Lim Kyu-Hyoung , Han Sae-Won , Oh Do-Youn , Im Seock-Ah , Kim Tae-You , Bang Yung-Jue 
Published: February 2017

269 Background: In advanced HCC, the role of salvage chemotherapy after failure of prior chemotherapy including sorafenib has not been fully studied. The aims of this study were to evaluate the efficacy of infusional 5-fluorouracil (5-FU), doxorubicin, and mitomycin-C (iFAM) as salvage regimen in advanced HCC and to identify the prognostic factors in a salvage setting. Methods: Eligibility included the following: 1) age > 18 years; 2) Diagnosed as HCC; 3) previously treated with palliative chemotherapy; 4) ECOG PS 0-2; 5) Child-Pough Class A or B; and 6) adequate BM and renal function. iFAM consisted of 5-FU 800 mg/m2 over 10 hours on days 1-5, doxorubicin 30 mg/m2 on day 1 and mitomycin-C 8 mg/m2 on day 1, every 4 weeks. Response evaluation was done every 8 weeks with RECIST criteria. Results: A total of thirty-five patients were enrolled. The median age was 50.2 years (range: 23.3-74.7). ECOG PS was; PS 0-1 (80%) and PS 2 (20%). The etiology of HCC was; HBV (82.8%), HCV (2.9%) and others (14.3%). Liver function was; Child Pough A (91.4%) and B (8.6%). Nine patients had macrovascular invasion and all had extrahepatic metastatic lesion. Prior chemotherapies were sorafenib or 5-FU based regimens. A total of 94 cycles of iFAM were delivered (median 2: range 1-7). There were 2 PR and 6 SD, resulting in RR 5.7% (95% CI, 1.6-18.6%) and DCR 22.9% (95% CI, 12.1-39%). The PFS and OS were 2.4 months and 8.6 months, respectively. The 6- and 12-month survival rates were 67.7% and 35.3%, respectively. Grade 3/4 hematologic toxicity was neutropenia (14.3%). Frequent non-hematological toxicities were; anorexia (45.7%), alopecia (40%), stomatitis (20%), all of which were grade 1/2. In multivariate analysis, PS and serum α-FP were significantly associated with OS. Patients were classified into 3 risk groups based on the number of prognostic factors (0 vs. 1 vs. 2). This classification was well-correlated to OS (16.1 months vs. 10.5 months vs. 3.8 months, respectively; p < 0.0001). Conclusions: iFAM is an effective and tolerable treatment option in advanced HCC and could be considered as salvage regimen. PS and α-FP are significant prognostic factors in a salvage setting.
Evaluation of venous thromboembolism (VTE) risk among ambulatory patients with pancreatic cancer in a real-world setting.
Authors: Lin Jay , Dalal Mehul R. , Connolly Gregory Clayton , Khorana Alok A. 
Published: February 2017

273 Background: Patients with cancer are at high risk for VTE, and risk varies by cancer type, patient demographics/history, chemotherapy regimen, and hospitalization status. This retrospective cohort analysis examined the incidence of and risk factors for VTE in a cohort of ambulatory cancer patients with primary pancreatic tumors who were starting chemotherapy. Methods: Data were extracted from the IMS Patient-Centric Database, a large administrative database of real-world US healthcare claims. Demographics/clinical characteristics of cancer patients with pancreatic and other solid tumors and a matched control cohort of patients without cancer were evaluated. The incidence of deep vein thrombosis (DVT), pulmonary embolism (PE), and DVT+PE was recorded during a follow-up period of 3-12 months after chemotherapy initiation in the group with pancreatic cancer. Results: Women composed 47% (632/1,336) of the pancreatic cancer and 51% (8,831/17,284) of the control cohort; mean age was 63 years in the pancreatic cancer cohort and 64 years in the control cohort. Mean Charlson Comorbidity Index scores were 6.8 and 0.6 respectively. VTE occurred in 19.2% of the pancreatic cancer cohort (odds ratio [OR], 5.39; 95% confidence interval [CI], 4.26, 6.80) compared with 1.4% in the control cohort (P<0.0001). The incidence of DVT, PE, and DVT+PE was 12.6%, 2.3%, and 4.4%, respectively, in the group with pancreatic cancer vs 1.0%, 0.2%, and 0.2% in the control cohort (P<0.0001 for all comparisons). The use of erythropoiesis-stimulating agents (ESAs) was associated with an increased incidence of VTE (OR, 1.71; 95% CI, 1.27, 2.31; P=0.0004 vs no ESA). Bleeding occurred in 23.4% of the pancreatic cancer cohort and 7.0% of the control cohort (P<0.0001). Conclusions: In a real-world setting, nearly 20% of this cohort of ambulatory cancer patients receiving chemotherapy experienced VTE. The presence of primary pancreatic cancer was associated with a 5-fold increase in VTE risk compared with controls. Use of ESA was associated with significant incremental risk of VTE.
Advanced hepatocellular carcinoma (HCC) treated with sunitinib (Su) and transarterial chemoembolization (TACE): Phase II trial final report.
Authors: Iyer Renuka V. , Tomaszewski Garin , Wu Yuhsin V , Kuvshinoff Boris W. , Groman Adrienne E. , Khushalani Nikhil I. , Grande Catherine , Zagst Patricia D. , Clark Kimberly , Fetterly Gerald J. 
Published: February 2017

275 Background: TACE and anti-angiogenic agents have individually been effective in inoperable HCC. In this prospective phase 2 study, the effects and PFS of Su+TACE was evaluated. Methods: Eligibility: ECOG PS 0, 1, inoperable HCC, Child Pugh (CP) A/B, platelets >100K, bilirubin < 2 and no contraindications to TACE. Treatment: Cycle (C) 1 -Su 37.5mg po days (d)1-7; - TACE with doxorubicin in lipodiol on d8;- Su 37.5mg po qd d15-36; - 2 wks off C2 onwards - Su 4 wks on (dose escalation to 50mg in pts without grade 3 toxicities);- 2 wks off DCE-MRI, sVEGFr, monocytes, and Su PK were assessed at d0, 8, 10, and 36. Results: Characteristics of the 16 pts were: median age 74 yr (range 40-86), all with CP A cirrhosis (etiology: hepB: 2, hepC: 6, ETOH: 1, unknown: 7), and PS 0: 12, PS 1: 4. 10 pts had liver only and 6 pts had extrahepatic disease. Median PFS was 8 mo (95% CI 4.3-9.3) and OS was 14.9 mo (95% CI 6.3-27.1) with a median follow up of 12.8 mo (5 pts still alive) receiving a median of 3 cycles (range 1-7). Responses by RECIST criteria were PR: 2, SD: 11 and PD: 3 for total clinical benefit of 81%. DCE-MRIs pts (8) showed median Ktrans change of -20% after d7 of Su and a further 7% after TACE+Su. There was concurrent decrease in viable tumor, 3% (d8) and 15% (d36) respectively. Steady-state Su concentration ranged from 20-150 ng/ml, which is above the IC50 values of 4-30 ng/ml for VEGF inhibition. PK/PD modeling estimated a Su IC50 values of 15 and 10 ng/ml to modulate Ktrans and AUC90. sVEGFR2 levels change with Ktrans and AUC90. Median monocyte counts of 0.4x109/L decreased by 50% on d36 after TACE. 11 pts (69%) had grade 3/4 toxicities attributable to Su. Of a total of 57 events, the most frequent (n>5) were thrombocytopenia (10), amylase/lipase increase (9), lymphopenia (7), and fatigue (6). Dose delays and dose reductions occurred in 13 and 3 pts respectively. Reasons for discontinuing therapy were toxicity (7), progression of disease (7), and withdrawal of consent (2). Conclusions: Improvement in PFS and OS was seen with acceptable toxicity in the first study of Su + TACE in HCC. In addition, it shows a relationship between Su concentration and Ktrans, AUC90, sVEGFR2 and monocytes; with additional decrease seen after TACE.
Efficacy of transcatheter arterial chemoembolization (TACE) in combination with sorafenib for the treatment of unresectable hepatocellular carcinoma in Chinese patients.
Authors: Qu Xudong , Wang Jianhua , Yan Zhiping 
Published: February 2017

279 Background: The purpose of this prospective trial is to evaluate the efficacy and safety of the concurrent use of TACE and sorafenib in a group of patients with unresectable HCC.The treatment outcomes of this group of patients were also compared in a retrospective fashion with a group of HCC patients with similar characteristics of patient and disease in a case controlled setting. Methods: A total of 45 patients (BCLC stage B/C: 16/29) with unresectable HCC were enrolled between June 2008 and Feb 2011 as experimental group and were treated with combination of sorafenib and TACE according to an institutional protocol. To evaluate the efficacy of the combination therapy, a group of 45 HCC patients (n=45, BCLC stage B/C: 17/28) with comparable baseline characteristics who had been treated with TACE alone in our institute were retrospectively selected as control group to compare the treatment outcomes. Median overall survival was compared between the two groups. Adverse events related to sorafenib were assessed according to CTCAE3.0 to observe safety endpoints. The study was approved by the Institutional Ethics Committee at Zhongshan Hospital, Fudan University, China. Results: The median follow-up time for the entire group of patients was 21 months (12.66 - 29.33). The median survival time for the TACE/sorafenib group was 27 months (21.89 - 32.10), and that for TACE alone group was 17 months (8.9 - 25.04) (P<0.05). The most common adverse events associated with sorafenib were hand-foot skin reaction (82.2%), rash (57.94%) and diarrhea (48.91%). Most of the drug-related adverse events were manageable with dose modification, and no CTCAE Grade 4 adverse event was observed. Conclusions: The combination treatment of TACE and sorafenib significantly prolonged median survival in Chinese patients with unresectable HCC, with well tolerated safety profile.
Second interim analysis of the Global Investigation of Therapeutic Decisions in Unresectable HCC (uHCC) and of Its Treatment with Sorafenib (GIDEON): Differences in AE reporting across physician specialties.
Authors: Venook Alan Paul , Lencioni Riccardo , Marrero Jorge A. , Kudo Masatoshi , Nakajima Keiko , Ye Sheng-Long , Cihon Frank 
Published: February 2017

286 Background: GIDEON is an ongoing, global, prospective, non-interventional study of patients (pts) with uHCC receiving sorafenib (Sor) in real-life practice. Differences in pt management across physician specialties can be explored. Methods: The 2nd interim analysis was pre-planned when ~1500 treated pts were followed for ≥4 months. The predefined descriptive subgroup analysis by specialty is presented. Results: Median days between visits varied across specialties: medical oncologists (Med Oncs) had the shortest. Sor dosing was broadly similar across specialties, with hepatologists/gastroenterologists (Hep/GIs) having the greatest incidence of dose reductions. Most commonly reported (>20% of pts) adverse events (AEs; e.g. diarrhea, hand-foot skin reaction [HFSR], fatigue) were similar across specialties, but the incidences varied. These AEs and grade 3/4 AEs were reported by more Hep/GIs and Med Oncs than by surgeons. The incidences of liver-related AEs varied across specialties. Interval-specific AE rates by specialty will be presented. Conclusions: Interim data from GIDEON highlight variations in the assessment and management of uHCC pts across specialties. The reporting of AEs and dose reductions may reflect the frequency of visits with physicians. Findings support the importance of a multidisciplinary team approach to optimize pt care. [Table: see text]
Biliary tract cancer: A large institutional experience.
Authors: McNamara Mairead , Horgan Anne M. , Walter Thomas , McKeever Elizabeth , Min Trisha , Hedley David W , Cleary Sean P , Gallinger Steven , Greig Paul David , Serra Stefano , Knox Jennifer J. 
Published: February 2017

288 Background: Biliary tract cancers (BTCs) encompass both cholangiocarcinoma (CC), arising in the intrahepatic, perihilar (klatskin), or distal biliary tree, ampulla of vater and gallbladder carcinoma (GBC). The prognosis is poor for the majority of these patients (pts). Given the rarity of BTC compared with other solid tumours, there have been few large studies looking at long-term outcomes. The aim of this study was to retrospectively review outcomes of pts who presented to a multidisciplinary team at Princess Margaret Hospital, Toronto, with a diagnosis of BTC. Methods: 950 pts with a diagnosis of BTC were followed from diagnosis to death between Jan 1987 and Sept 2011. Complete demographics, performance status, disease site, histological diagnosis, percentage receiving surgery with curative intent, other treatments and overall survival were analysed. Results: The cohort includes 497 (52%) males, performance status of 0-1 in 781 (82%) and 2-3 in 68 (7%) pts. A histological diagnosis of adenocarcinoma was confirmed in 806 (85%), 104 (11%) were non diagnostic, 40 (4%) other. Definitive surgery was performed in 42% and adjuvant chemotherapy (CT) or concurrent CT/radiotherapy given in only 7% and 4% respectively. The overall survival for the entire cohort of 950 pts was 18 months (mo) with survival for breakdown of tumour type detailed in table. At this time 319 (34%) pts are still alive, 561 (59%) are deceased and status is unknown in 70 (7%). CT or concurrent CT/radiotherapy was given for unresectable or metastatic disease in the first line palliative setting in 332 (35%) and 23 pts (2%) respectively. The response to first line CT in GB was 46% vs. 31% in CC and med survival was 12.2 and 11.2 mo respectively. Conclusions: This represents a large biliary cancer cohort with survival benchmarks obtained in the modern era of multidisciplinary care. The different sub-sites clearly have different prognosis. Responses and survival for advanced disease on CT are similar for GBC and CC. Updated data will be presented. [Table: see text]
Fear of cancer recurrence and quality of life among survivors of pancreatic and periampullary neoplasms.
Authors: Petzel Maria Q. B. , Parker Nathan H , Valentine Alan D. , Simard Sebastien , Nogueras Gonzalez Graciela M , Fleming Jason B. , Lee Jeffrey Edwin , Pisters Peter W. T. , Vauthey Jean-Nicolas , Katz Matthew H.G. 
Published: February 2017

289 Background: Fear of Cancer Recurrence (FCR) is well documented among survivors of breast, colon and prostate cancer. Incurable recurrence is common following resection of pancreatic and periampullary neoplasms. The incidence and significance of FCR in this population is unknown. We hypothesized that FCR represents an important source of psychosocial distress following resection of pancreatic neoplasms. Methods: We conducted a cross-sectional study of patients with non-recurrent pancreatic ductal (PDAC), periampullary adenocarcinoma or pancreatic neuroendocrine tumor (PNET) treated with potentially curative surgery 1991–2011. We assessed 7 discrete dimensions of FCR using the Fear of Recurrence Inventory (FCRI) and evaluated quality of life (QOL) and psychosocial distress using the Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire and Hospital Anxiety and Depression Scale. Participants completed these validated instruments by mail. Results: 188 (53%) of 355 eligible patients completed at least one instrument, a median of 49 months (range, 6–222 months) following potentially curative resection. Participants included 73 (39%) patients with PDAC, 55 (29%) with periampullary adenocarcinoma, and 60 (32%) with PNET. The median FCR severity score was higher than a previously established cutoff for clinical significance in 55%, 51% and 63% of patients with PDAC, periampullary adenocarcinoma and PNET, respectively. Older age, male gender, periampullary adenocarcinoma, negative lymph nodes, and longer interval since operation were clinical factors associated with lower total FCR score (all p<0.05). In multivariate analysis, only age (p=0.01) and gender (p=0.03) were independently associated with severity of FCR. A higher total FCR score was significantly associated with higher anxiety (r=0.64), depression (r=0.41) and lower QOL (r =−0.53), all p<0.001. Conclusions: Fear of cancer recurrence is pervasive following resection of pancreatic neoplasms, regardless of survivors’ histopathologic diagnosis, disease severity, or time since resection. Given its association with anxiety, depression and lower QOL, FCR represents a critical therapeutic target.
Outcomes and efficiency of national gastric cancer screening program in Korea: Single-center, large-scale study.
Authors: Kim Beom Jin , Heo Chae , Cha Bong Ki , Kim Jae G. , Kim Sang-Jung 
Published: February 2017

29 Background: Gastric cancer is a major cause of death and a substantial socioeconomic burden in Korea. The National Cancer Screening Program for Medicaid recipients was initiated in 1999 and has contributed to reduction of cancer-related mortality in Korea. Endoscopy may be cost-effective screening tool in Korea, where the cost of endoscopy and UGIS are similar and the incidence of gastric cancer is high. Most of Japanese studies on the efficiency of mass screening for gastric cancer have dealt with photoflurography as a screening tool. Although biennial gastric cancer screening by endoscopy has been increasing in Korea as part of the National Cancer Screening Program, few studies have evaluated its efficiency. Therefore, we analyzed the outcomes and efficiency of the National Gastric Cancer Screening Program using endoscopy in Korea. Methods: We reviewed medical records from the National Gastric Cancer Screening Program at Chung-Ang University hospital in Korea from January 2007 to December 2010. The study population was comprised of Medicaid recipients ≥ 40 years of age who were taken from the National Health Insurance Corporation. Results: A total of 41,150 asymptomatic subjects underwent endoscopy for gastric cancer screening. The mean age of the screened subjects was 56.3 years for men and 48.9 years for women. The male to female ratio of the screened subjects was 1.57:1. Gastric cancer was diagnosed in 102 (0.24%) of 41,150 subjects (60 men and 42 women). Their mean age was 54.4 years. Of these, 76 subjects (0.18%) were diagnosed as early gastric cancer and 26 subjects (0.06%) as advanced gastric cancer. The proportion of early gastric cancer among total gastric cancers was 74.5%. During the period, only 6,586 (16.0%) subjects participated in the biennial gastric cancer screening (59% for men and 49% for women). Conclusions: Despite accomplishments of the National Gastric Cancer Screening Program in Korea, low compliance to the screening program remains an issue. Furthermore, its cost-effectiveness analysis will be needed for successful progression.