bluuebunny/crossref_metadata_2025_split huggingface dataset:
Skeletal muscle depletion to predict survival of patients with advanced biliary tract cancer undergoing palliative chemotherapy.
Authors: Cho Kyoung Min , Oh Do-Youn , Kim Tae Yong , Lee Kyung-Hun , Han Sae-Won , Im Seock-Ah , Kim Tae-You , Bang Yung-Jue 
Published: March 2017

460 Background: Reports regarding sarcopenia as a prognostic factor in advanced biliary tract cancer (BTC) are rare. Furthermore, no study has investigated the dynamics of body weight with body muscle mass as a prognostic factor in advanced BTC patients undergoing palliative chemotherapy. Hence, we investigated whether sarcopenia affects survival in patients with BTC, with a co-analysis of body weight loss and body mass index (BMI). Methods: We consecutively enrolled patients with advanced BTC who received palliative chemotherapy between 2003 and 2013. Total muscle cross-sectional area (cm2) at the L3 level assessed by computed tomography was analyzed. We defined sarcopenia as a skeletal muscle index (SMI) < 48.5 cm2/m2 (men) and < 39.5 cm2/m2(women) using ROC curves. Results: The proportion of patients with sarcopenia upon diagnosis was 52.4% and 42.2% for men and women, respectively. By multivariate analysis, sarcopenia at diagnosis and decreased SMI during chemotherapy ( P = 0.008 and P < 0.001, respectively) were poor prognostic factors for overall survival (OS). Subgroup analysis revealed that sarcopenic patients who were overweight or obese (BMI ≥ 25 kg/m2) showed worse OS ( P < 0.001). Additionally, patients with both decreased BMI and SMI during chemotherapy had worse OS ( P < 0.001). Furthermore, patients with decreased SMI had shorter survival regardless of change in BMI. However, for patients with SMI maintained during chemotherapy, decreased BMI had no effect on survival ( P = 0.576). Conclusions: Sarcopenia, sarcopenic obesity and muscle depletion during palliative chemotherapy are meaningful prognostic factors in advanced BTC. Considering muscle depletion with weight change could help to more accurately predict prognosis of patients with BTC.
The phase I study of concurrent chemoradiotherapy using a combination of gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer: Update.
Authors: Ioka Tatsuya , Katayama Kazuhiro , Takada Ryoji , Ohkawa Kazuyoshi , Takahashi Hidenori , Teshima Teruki 
Published: March 2017

462 Background: Gemcitabine (GEM) plus nab-paclitaxel (nP) are one of the standard of care for metastatic pancreatic cancer, but it is still controversial about the value in non-metastatic patients. Purpose: The primary objective of this study is to assess the toxicity of concurrent chemoradiotherapy (CRT) with a combination of GEM and nP for unresectable locally advanced pancreatic cancer (UR-LAPC). Methods: Chemotherapy-naive patients with histologically or cytologically proven UR-LAPC were enrolled to this trial. The patients received GEM and nP intravenously over 30 min. respectively on days 1, 8 and 15 every 28 days. Cycles were repeated every 28 days during radiotherapy. Patients were scheduled to receive GEM (mg/msq/week) and nP (mg/msq/day) at six dose levels: 600/50 (level 1), 600/75 (level 2), 600/100 (level 3), 800/100 (level 4), 1,000/100(level 5) and 1,000/125(level 6). Radiation therapy was delivered through four fields as a total dose of 50.4 Gy in 28 fractions over 5.5 weeks, and no prophylactic nodal irradiation was given. Dose-limiting toxicity (DLT) was defined as grade 4 hematological toxicity, grade 3 non-hematological toxicity and >14 days delay of treatment. Every patients were evaluated for response with RECIST criteria. Results: Twenty one patients were enrolled in this study between 12/2013 and 05/2015. Treatment was well tolerated; Every 21 patients completed radiotherapy of 50.4 Gy. Our recommended dose was level 3, Gem 600mg/ nP 100mg. Nine patients experienced DLT. The response rate was 67% (CR 0, PR 14, SD 6 and PD 1). Median OS was 23.8 months (95%CI: 17.0, -) and median PFS was 9.0 months (95%CI: 4.8, 11.9). Conclusions: The CRT with a combination of GEM and nP can be delivered almost safely for UR-LAPC. Clinical trial information: UMIN000012254.
Platelet-to-hemoglobin ratio to predict progression-free survival for patients with locally advanced hepatocellular carcinoma.
Authors: Li Xing , Xing Yan-Fang , Lin Zhi-Huan , Hong Ying-fen , Wu Dong-hao , Wang Tian-tian , Ma Xiao-kun , Huang Mingsheng , Dong Min , Lin Qu , Wu Xiang-yuan 
Published: March 2017

463 Background: The prognosis of locally advanced hepatocellular carcinoma (HCC) patients is far from being identified which makes the treatment decision controversial. The present study aimed to assess role of blood cell counts, routine liver function tests in predicting the progression-free survival (PFS) of these patients. Methods: A total of 243 HCC patients staged Barcelona Clinic Liver Cancer (BCLC) B or C were analyzed retrospectively. The current staging systems of HCC were investigated about their performance on predicting PFS. And then, the novel prognostic factors were evaluated by integrating in to the best staging systems which was used to determine their independent prognostic value. Results: Cancer of the liver Italian program (CLIP) score system and advanced liver cancer prognostic system (ALCPS) stages were indentified to be testing systems with best akaike information criterion (AIC) index and linear trend χ2 among all the current 12 staging systems for this patient subgroup. Then, the prognostic value of novel parameters was assessed by integration into CLIP and ALCPS score systems. Platelet-to-Hemoglobin Ratio (PHR) were confirmed to an independent predictor for PFS of locally advanced HCC patients when integrated into CLIP and ALCPS score systems ( p= 0.026 and 0.009, respectively) with the other parameters, including platelet and hemoglobin, failed to reach statistical significance. Moreover, PHR improved the performance of CLIP and ALCPS score systems by adjusted into it, which improved their discriminatory ability. Furthermore, PHR were designated ≤ 1.26 as low level and > 1.26 as high level, according to which HCC patients were dichotomized into two groups. Locally advanced HCC patients with low PHR presented better 1 year disease progress rate (24.0% vs 41%) and overall survival (62.5% vs 38.8%) compared with patients with high PHR level. Besides, PHR level was associated with prognostic factors such as international normalized ratio, presence of ascites, serum albumin, serum α-fetoprotein, total bilirubin and portal vein thrombosis. Conclusions: The present study firstly indentified PHR as an independent prognostic factor in locally advanced HCC patients.
Modified FOLFIRINOX for metastatic pancreatic adenocarcinoma after failure of nab-paclitaxel plus gemcitabine.
Authors: Ozaka Masato , Sasaki Takashi , Kataoka Seita , Kanata Ryo , Ishigaki Kazunaga , Yamada Ikuhiro , Matsuyama Masato , Takano Koichi , Sasahira Naoki 
Published: March 2017

467 Background: Both FOLFIRINOX and Nab-paclitaxel plus Gemcitabine standard treatment in first-line treatment of metastatic pancreatic adenocarcinoma (MPA). It could be of interest to use them consecutively, knowing that there is currently no standard for 2nd line treatments for MPA. The aim of this study was to evaluate the efficacy and tolerability of modified FOLFIRINOX after gemcitabine plus Nab-paclitaxel failure in MPA. Methods: From January 2015 to March 2016, medical records were retrospectively reviewed for consecutive patients receiving modified FOLFIRINOX for a histologically proven MPA after failure of Nab-paclitaxel plus Gemcitabine. Patients were treated with modified FOLFIRINOX every 2 weeks as follows: intravenous oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, 5-FU infusion 2,400 mg/m2 over 46 h, no bolus 5-FU, until disease progression, patient refusal or unacceptable toxicity. Results: Modified FOLFIRINOX was administered to 23 pts. Among these patients, median age was 64 years (range 42.4 - 74.2). 83% of the patients had a PS 0, the primary site of the tumor was the head of the pancreas in 39% of patients, and 26% of patients experienced recurrence after resection. Disease control rate was 66.7% (n = 17) with a 23.8 % (n = 17) objective response rate (RECIST). Within the whole cohort, median PFS was 4.3 months (95% CI: 3.1-5.3) and median overall survival (OS) was 9.3 months (95% CI: 3.8-14.8). Since the start date of first line chemotherapy with Nab-paclitaxel plus Gemcitabine, median OS was 18.8 months (95% CI: 9.6-27.9). No toxic death occured. Grade 3-4 toxicities were reported in 30% of patients and were neutropenia (17%), anemia (8%), cholangitis (8%) and acute kidney injury (4%). Conclusions: Modified FOLFIRINOX seems promising with a manageable toxicity profile after Nab-paclitaxel plus Gemcitabine failure, in selected patients able to receive second line treatment for a MPA. These promising results have now to be confirmed in a phase III randomized trial.
The short- and long-term outcomes of pancreatic resection for pancreatic adenocarcinoma in patients older than 75 years.
Authors: Kazama Keisuke , Aoyama Toru , Atsumi Yosuke , Murakawa Masaaki , Shiozawa Manabu , Kobayashi Satoshi , Ueno Makoto , Morimoto Manabu , Yukawa Norio , Oshima Takashi , Yoshikawa Takaki , Rino Yasushi , Masuda Munetaka , Morinaga Soichiro 
Published: March 2017

470 Background: The short- and long-term outcomes of pancreatic resection for pancreatic adenocarcinoma have not been evaluated in elderly patients. Methods: This retrospective study selected patients who underwent curative surgery for pancreatic cancer at our institution. Patients were categorized into two groups; non-elderly patients(age <75 years: group A) and non-elderly patients (age ≥75 years: group B). The surgical morbidity, motality, overall survival (OS), and recurrence-free survival (RFS) rates in the two groups were compared. Results: A total of 221 patients were evaluated in the study. The overall complication rates are 44.8% in Group A and 52.6% in Group B. Surgical mortality was observed in 2 patients due to an abdominal abcess and cardiovascular disease in Group A (1.1%) and in 1 patient due to postoperative bleeding in Group B (2.6%). There were no significant differences (p=0.379 and p=0.456, respectively). Furthermore, the 5-year OS and RFS rates were similar between the elderly patients and non-elderly patients (18.55% vs. 20.2%, p=0.946 and 13.1% vs. 16.0%, p=0.829 respectively). Conclusions: The short-term outcomes and long-term outcomes survival after pancreatic resection for pancreatic adenocarcinoma were almost equal in the elderly and the non-elderly patients in this study. Therefore, it is unnecessary to avoid pancreatic resection for pancreatic adenocarcinoma in elderly patients simply because of their age.
An open-label, single-group, multicenter phase II study of lanreotide autogel (LAN) in Japanese patients (pts) with neuroendocrine tumors (NET).
Authors: Ito Tetsuhide , Hisamatsu Seiichi , Nakajima Akihiro , Shimatsu Akira 
Published: March 2017

471 Background: LAN is a long-acting somatostatin analog indicated in EU for the treatment of carcinoid syndrome and in the US and EU as antiproliferative treatment in pts with gastroenteropancreatic (GEP) -NET. The antitumor efficacy of LAN in pts with GEP-NET was evaluated in the phase III CLARINET study. No study to date has reported the antitumor effects of somatostatin analog in Japanese pts with NET. Methods: In this open-label, single-arm study, Japanese pts with Grade 1 or 2 unresectable metastatic or locally advanced NET received 120 mg once every 4 weeks for 48 weeks. Pts who completed the study were subsequently enrolled in the long-term extension study. The primary endpoint was the clinical benefit rate (CBR: the ratio of pts with a complete response, a partial response (PR), or stable disease over 24 weeks). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR) (RECIST 1.1, central review), serum chromogranin A (CgA) level and quality of life using the EORTC QLQ-C30. The results of the CLARINET study cohort were compared with those from a matched population. Results: 32 pts were recruited in 10 sites. Mean age was 61.7 years. 67.9% were male. The primary tumor sites were pancreas (n = 14), foregut (2), midgut (2), hindgut (8), and unknown (6). Four pts had gastrinoma, and 3 of them had multiple endocrine neoplasia type 1. In the Full Analysis Set (n = 28), 39.3% of pts had progressive disease at baseline according to RECIST criteria. The CBR at 24 weeks was 64.3% (18 of 28 pts) and the median PFS was 36.3 weeks. A PR was confirmed in 1 patient during the 60 weeks of the extension study (ORR: 3.6%). For PFS, the subgroup analysis showed that the results of pts with no progressive disease at baseline or prior treatments for NET were similar to the results of pts in the CLARINET study. LAN decreased serum CgA by at least 50% in 15 of 17 pts (88.2%) who had elevated CgA levels at baseline. Frequent adverse reactions included injection site induration (28.1%), pale stools (18.8%), flatulence (12.5%), and diabetes (12.5%). Conclusions: The efficacy and safety of LAN in this study clearly show that LAN will be a useful treatment option for Japanese pts with NET. Clinical trial information: 132375,142698.
The efficacy of first-line chemotherapy in recurrent pancreatic cancer after S-1 adjuvant chemotherapy.
Authors: Kanata Ryo , Ozaka Masato , Kataoka Seita , Ishigaki Kazunaga , Yamada Ikuhiro , Sasaki Takashi , Matsuyama Masato , Takano Kouichi , Sasahira Naoki 
Published: March 2017

475 Background: In Japan, adjuvant chemotherapy with S-1 for 6 months is standard care for resected pancreatic cancer. However, the efficacy of chemotherapy for recurrent pancreatic cancer(RPC) after adjuvant S-1 chemotherapy is not well evaluated. Methods: Medical records were retrospectively reviewed for consecutive patients who had RPC after adjuvant S-1 treatment and received chemotherapy between April 2013 and July 2016. Recurrence free interval (RFI) was defined as the interval from adjuvant S-1 initiation to cancer recurrence. Overall survival (OS) and progression free survival (PFS) after 1st line chemotherapy for RPC were compared between patients with RFIs of shorter than 6 month (Group S) and longer than 6 months (Group L). Results: In the 53 patients evaluated, the median duration of adjuvant S-1 chemotherapy was 5.1 months, and the median RFI was 8.3 months. After recurrence, they received Gemcitabine alone (20 patients), Gemcitabine+nab-paclitaxel (28 patients), modified FOLFIRINOX (one patient), and other regimen (4 patients). In all patients, the median PFS was 7.3 months and the median OS was 14.8 months. When compered in two groups (group S and group L), median OS in group S and group L was 6.7 months (95% confidence interval(CI): 4.2-12.9) and NA (95% CI: 13 months-NA) , respectively (p < 0.001), and median PFS was 3.8 months (95%CI: 2.5-9.1) and 7.3 months (95%CI: 3.9-15.3), respectively (p = 0.11). Multivariate Cox regression analysis revealed CEA < 4.0 mg/dl before chemotherapy and an RFI of ≥ 6 months were significantly associated with longer survival. Conclusions: These data suggest that RFI < 6 months is a surrogate marker for a poor prognosis in patients with RPC.
A phase II study of gemcitabine, erlotinib, and S-1 in patients with advanced pancreatic cancer.
Authors: Han Boram , Kim Hyeong Su , Choi Dae Ro , Shim Byoungyong , Lee Kyung Hee , Kim Jin Won , Kim Jung Han , Kim Jung Hoon , Song Hunho , Park Choong Kee , Moon Sung Hoon , Kim Jong Hyeok , Jeon Jang Yong , Lee Jung Woo , Zang Dae Young 
Published: March 2017

476 Background: Gemcitabine-based chemotherapy is considered as a standard front-line treatment for patients with advanced pancreatic cancer. Although addition of erlotinib or S-1 to gemcitabine has yielded better outcomes, it has showed just modest improvement in survival. To overcome this limitation, we evaluated the efficacy and safety of the combination of gemcitabine, erlotinib, and S-1 for the treatment of advanced pancreatic cancer. Methods: Chemotherapy-naïve patients with pathologically proven locally advanced, recurrent or metastatic pancreatic adenocarcinoma were assessed for eligibility. Gemcitabine at 1,000 mg/m2 was administered intravenously on day 1, and 8, erlotinib at 100 mg/day was administered on day 1-21, and S-1 at 60 mg/m2 was administered on days 1-14 every 21 days and continued to maximum of 8 cycles of treatment. Dose escalation of S-1 to 80 mg/m2 was permitted from second cycle for pre-defined tolerable patients. Results: Thirty-seven patients (median age 61.5 years) were enrolled. A total of 140 cycles of chemotherapy were administered (median of 3.8; range 1–8 cycles). Toxicities were evaluated in 36 patients, and the responses were evaluated in 31 patients. Major grade 3/4 toxicities included neutropenia (25%), febrile neutropenia (2.8%), fatigue (22.2%), infection (8.3%), vomiting (5.6%), and mucositis (5.6%). The overall response rate was 12.9% [95% confidence interval (CI), 5.1-28.9%] and disease control rate was 74.2% (95% CI, 56.8-86.3%). The median progression-free survival and overall survival were 3.4 months (95 % CI, 2.3-4.5 months) and 5.7 months (95 % CI, 3.9-7.6 months), respectively. Conclusions: The combination of gemcitabine, erlotinib, and S-1 provided an acceptable toxicity profile and modest clinical benefits in patients with advanced pancreatic cancer. Clinical trial information: NCT01693419.
Clinical outcomes of FOLFIRINOX in locally advanced pancreatic cancer: A single center experience.
Authors: Lee Jongchan , Lee Jong-Chan , Kim Hyoung Woo , Kim Jaihwan , Hwang Jin-Hyeok 
Published: March 2017

480 Background: Approximately, one third of pancreatic cancer patients have locally advanced status at diagnosis. Systemic chemotherapy or chemoradiotherapy is the main option for patients with locally advanced pancreatic cancer (LAPC). Recently, many studies have been investigating the efficacy of FOLFIRINOX (5-fluorouracil [5-FU], oxaliplatin, irinotecan and leucovorin) in LAPC patients. The aim of this study is to assess the clinical outcomes of FOLFIRINOX in patients with LAPC. Methods: Patients with LAPC who received FOLFIRINOX as an initial chemotherapy were identified via the Seoul National University Bundang Hospital database warehouse retrospectively. Demographic characteristics, disease status, chemotherapy duration and cumulative relative dose intensity (cRDI), conversion to resection and clinical outcomes were reviewed. Resectabilitywas determined based on National Cancer Comprehensive Network (NCCN) guidelines version 1.2016. Results: Fifty-one LAPC patients between Apr. 2012 and Dec. 2015 were enrolled. The median age of the patients was 60 years (30-77 years). The median overall survival (OS) of total patients was 13.3 months. The number of treatment cycles administered was 10 (2-20) and cRDI was 69.2% (35.6-91.2%). Fourteen of 51 patients (27.5%) underwent surgery and R0 resection was achieved in 11 patients (78.6%). Three patients received preoperative radiotherapy. The median OS of resected patients did not reach the 50% mark during the follow-up period compared with 13.3 months of OS in the patients without resection. Eleven of 14 resected patients did not experience recurrence during the follow-up of 10.7 months (1.8-23.5 months). The cRDI was higher in resected patients versus others (71.5 vs. 66.7%). The median time to resection was 6.7 months (3.2-14.3 months). Conclusions: FOLFIRINOX is considerable active regimen in patients with LAPC promising R0 resection rate. Future research should assess adequate duration and dose intensity of FOLFIRINOX and proper point of radiotherapy in the patients with LAPC to achieve higher rate of R0 resection.
Patterns of treatment outcomes in older patients with metastatic pancreatic cancer.
Authors: Jung Hyun Ae , Lim Sung Hee , Han Boram , Kim Ho Young , Kim Hyo Jung , Zang Dae Young , Jung Joo Young 
Published: March 2017

481 Background: Although pancreatic cancers are common in older age-groups, treatment approaches and outcomes are understudied in this population. We undertook this study to compare treatment outcomes for older patients with metastatic pancreatic cancer. Methods: Data from 167 patients aged 70 years or over with metastatic pancreatic cancer from January 2010 to July 2015, were analyzed. The clinic-pathologic variables and treatment outcome retrospectively reviewed. Results: One hundred and sixty three patients were identified. Among them, only 22.1% (n=36) patients receive palliative chemotherapy. The median age was 74.0 years old (range: 70-84) in the groups of chemotherapy as compared with 78.6 years old (range: 70-94.6) in the groups of supportive care. The median survival was 9.2 months (range: 1.0-24.9) in the chemotherapy group as compared with 2.3 month (range: 0.1-31.8) in the supportive care group. Among chemotherapy group, 50% (n=18) patients receive gemcitabine-based double therapy. Nine patients (30%) receive 2nd line chemotherapy. In group of supportive care, 55.8% (n=74) were survival less than 3 months. However, the median survival except for early deaths (less than 3 months) was 6.5 months. Conclusions: The current results showed that older patient with metastatic pancreatic cancer received chemotherapy less likely. However, the survival benefit from the chemotherapy was comparable outcome with historical data. Further study of identifying older patients who would benefit from cytotoxic chemotherapy was needed.
The efficacy and safety of gemcitabine + nab-PTX for recurrence and refractory pancreatic cancer.
Authors: Saito Kei , Nakai Yousuke , Isayama Hiroyuki , Takahara Naminatsu , Mizuno Suguru , Kogure Hirofumi , Matsubara Saburo , Tada Minoru , Koike Kazuhiko 
Published: March 2017

485 Background: Gemcitabine + nab-Paclitaxel (GnP) is considered as one of the standard first-line chemotherapy for advanced pancreatic cancer (PC), but its efficacy and safety of GnP in patients with refractory or recurrent (Ref/Rec) PC has not been fully reported. Therefore, we conducted this retrospective analysis of GnP in patients with Ref/Rec PC. Methods: Consecutive patients with PC who received GnP at the University of Tokyo Hospital were retrospectively studied. Clinical outcomes in patients with Ref/Rec PC were compared with those in patients with PC receiving GnP as 1st line therapy. Dose intensity was calculated as the total amout of drug given in eight weeks. Tumor response was evaluated using RECIST 1.1 and adverse event using CTCAE ver 4.0. Progression free survival (PFS) were evaluated using the Kaplan-Meier method and compared by long-rank test. Cox regression models were used to calculate hazard ratios (HRs) to evaluate the prognostic factors in patients with Ref/Rec PC and in patients receiving GnP as 1stline therapy. Results: A total of 80 patients (37 as 1st line, 18 refractory and 25 recurrent) received GnP between January 2015 and July 2016. There were no significant differences in patient characteristics between 1st line therapy group and Ref/Rec group other than sex (Male in 41 vs. 67%). In relative dose intensity (RDI), there were no significant difference (75 vs. 72%). AE rates, both hematologic and non-hematologic, did not differ significantly between two groups. RDI was 75 vs. 72% for gemcitabine and 80 vs. 79% for nab-Paclitaxel. Response rate and disease control rate were 23 and 93% vs. 11 and 86%. The median PFS were 9.0 (95%CI: 4.9-13.9) vs. 5.5 (95%CI: 3.5-8.0) months (p = 0.06) and 1-year survival rate were 42.9 vs. 14.3% (p = 0.16). In the multivariate analyses, HRs of RDI < 70 were 2.44 (95%CI: 1.07-5.49, p = 0.04) in Ref/Rec group, while the association was not significant in the 1st line group (HR 1.70 [95%CI: 0.63-4.25], p = 0.28). Conclusions: GnP was safely administered in patients with Ref/Rec PC with DI comparable to 1st line therapy. However, PFS in refractory and recurrent group tended to be short compared to those receiving GnP as 1st line therapy. DI was associated with the prognosis only in Ref/Rec PC.