bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of real-world treatment patterns, persistence, healthcare resource utilization (HRU) and costs between octreotide and lanreotide for the treatment of neuroendocrine tumors (NET).
Authors: Huynh Lynn , Cai Beilei , Sharperson Camara , Lejeune Dominique , Duh Mei Sheng , Kim Michelle Kang 
Published: January 2019

105 Background: There has been limited research assessing differences between somatostatin analogues (SSAs) as treatments for NET. This study aims to assess treatment pattern, persistence, HRUs and costs among patients (pts) with NET receiving long-acting octreotide versus lanreotide. Methods: Retrospective claims data from Symphony Health Solutions were analyzed for NET pts who initiated octreotide or lanreotide (index date) between 01/2015–11/2017 for ≥ 90 days. Pts with continuous clinical activity (≥ 180 pre and ≥ 90 days post index date) and without prior non-surgical NET treatment were included. A 1:1 propensity score matched sample was used to compare the two SSA groups with respect to treatment persistence (time to treatment discontinuation [TTD] using Kaplan-Meier) and to all cause and NET related HRUs and costs (provider charges for medical services and insurance payments for prescription drugs) using rate ratio (RR) and mean cost difference (CD) with 95% confidence interval (CI). Results: Among 2,043 NET pts identified, a balanced matched cohort of octreotide and lanreotide pts (N = 543 each) was achieved. In both cohorts, mean age was 65 years and baseline Charlson Comorbidity Index was 5.7. Approximately 80% of matched pts initiated monotherapy; others used SSAs in combination with chemo-, targeted or liver-directed therapy as first line therapy. Median TTD was directionally longer but did not reach statistical significance among octreotide vs lanreotide (19.2 vs 17.5 months, p = 0.6). Numerically lower hospitalization rates were observed among octreotide pts (RR [CI]: all cause = 0.87 [0.73, 1.05]; NET related = 0.85 [0.63, 1.15]). Statistically significantly fewer NET related outpatient visits (1.05 vs 1.10 per pts per month [PPPM]; RR [CI]: 0.95 [0.92, 0.99]) and lower total mean costs PPPM were observed for octreotide than lanreotide (CD [CI]: all cause = -$3,701 [-$5,205, -$2,355]; NET related = -$3,752 [-$4,948, -$2,455]). Conclusions: This study shows similar treatment patterns and persistence between SSA cohorts. Octreotide appeared to be associated with less HRU and total costs compared with lanreotide.
Efficacy of three-drug induction chemotherapy followed by preoperative chemoradiation in patients with localized gastric adenocarcinoma (GAC).
Authors: Mizrak Kaya Dilsa , Nogueras-Gonzalez Graciela M. , Das Prajnan , Blum Murphy Mariela A. , Ghazanfari Amlashi Fatemeh , Rogers Jane Elizabeth , Thomas Irene , Shanbhag Namita , Lee Jeffrey H , Bhutani Manoop S. , Weston Brian , Minsky Bruce D. , Matamoros Aurelio Aurelio , Sagebiel Tara L. , Devine Catherine E , Estrella Jeannelyn , Badgwell Brian D. , Ajani Jaffer A. 
Published: January 2019

106 Background: Preoperative induction chemotherapy followed by chemoradiation yields better R0 resection rates, pathologic complete response (pCR) rates and improved survival for localized GAC.Previous studies with two-drug induction chemotherapy showed 70-80% R0 resection rates and 20-30% pCR rates. We report the effect of three-drug induction chemotherapy on a large cohort of localized GAC patients. Methods: We identified 97 patients with localized GAC who received three-drug induction chemotherapy followed by preoperative chemoradiation therapy. We assessed various endpoints (overall survival [OS], recurrence-free survival [RFS], R0 resection and pCR rate). Results: The median follow-up time was 3.5 years (range; 0.4-16.7). Most of the patients were men (60.8%) and the median age was 60 years (range; 21-89). The induction chemotherapy regimen was a fluoropyrimidine and a platinum compound (cisplatin or oxaliplatin) with a taxane (docetaxel or paclitaxel) for 95% of patients. Seventy-three (75%) out of 97 patients underwent planned surgery. R0 resection and pCR rate were 93% and 21%, respectively. Pathologic partial response (< 50% residual carcinoma) rate was 50.7%. The median OS was 6.43 years (95% Cl 3.27-12.36) for the entire cohort and 11.1 years (95% Cl 7.1-not estimable) for patients that underwent surgery. The estimated 2- and 5-year OS rates were 72% (95% CI 62-80) and 54% (95% CI 43-64) for the entire cohort and 83% (95% CI 72-91) and 66% (95% CI 53-76) for patients that underwent surgery. Pathological lesser stage (stage I/II vs. stage III/IV) (p = 0.001) and R0 resection (p = 0.019) were independently associated with longer RFS in the multivariate analysis. Conclusions: Our data show that three-drug combination is feasible without providing substantial advantage in this setting of preoperative induction chemotherapy followed by chemoradiation and surgery.
The impact of muscle mass loss after esophagectomy for esophageal cancer on prognosis.
Authors: Shimoda Yota , Ogata Takashi , Nagasawa Shinsuke , Kumazu Yuta , Hayashi Tsutomu , Yamada Takanobu , Oshima Takashi 
Published: January 2019

107 Background: Several reports revealed that preoperative presence of sarcopenia was related with poor prognosis for esophageal cancer. However, the influence of muscle mass loss during perioperative period on prognosis is unknown. The alternation of muscle mass during perioperative period is attractive topic as surgeon have chance to intervene for maintaining muscle mass in perioperative care. The aim of this study was to assess the influence of loss of muscle after esophagectomy to discharge on prognosis. Methods: This study retrospectively analyzed 150 consecutive patients with esophageal and gastroesophageal junction cancer, who underwent the open right thoraco−abdominal approach esophagectomy, pathologically diagnosed as squamous cell carcinoma or adenocarcinoma, between September 2011 and June 2015. Patients who had pathologically diagnosed as T4 or stageⅣ according to the UICC 7th edition TNM classification were excluded. This study investigated the influence of muscle mass loss after esophagectomy to discharge on prognosis. Body composition was analyzed using the Tanita MC−190EM bioelectrical impedance analyzer, evaluated within 1 week before surgery and at discharge. The primary end−point is over−all survival after esophagectomy. Results: The median % muscle mass loss was 4.38% (range −3.3 to +18.8). Patients were divided into two groups based on the % muscle mass loss by cut−off 4.38 (group A: less % muscle mass loss, group B: more % muscle mass loss). N stage (0/1/2/3) was 39/28/6/2 in group A, and 26/23/19/7 in group B. The rate of 2/3 was significantly higher in group B. Postoperative complication rate was 31% (23/75) in group A, and 48% (36/75) in group B. The complication rate was significantly higher in group B. The 3−years survival rate was 89.2% in group A, and 70.9% in group B. Group B was significantly worse for over−all survival than group A (p = 0.033). Multivariate Cox regression analysis showed that the patients who had % muscle mass loss over 4.38 (p = 0.045; HR 2.008; HR 95% CI 1.014−3.977), T2/3 (p = 0.001; HR 3.649; HR 95% CI 1.660−8.019) associated with worse over−all survival. Conclusions: Our study found correlation between loss of muscle after esophagectomy to discharge and worse outcomes.
Role of volume reduction gastrectomy according to tumor location in patients with gastric cancer with a single noncurable factor: REGATTA trial (JCOG0705/KGCA01) supplementary analysis.
Authors: Terashima Masanori , Fujitani Kazumasa , Yang Han-Kwang , Mizusawa Junki , Tsujinaka Toshimasa , Nakamura Kenichi , Katayama Hiroshi , Lee Hyuk-Joon , Lee Jun Ho , Iwasaki Yoshiaki , An Ji Yeong , Takagane Akinori , Park Young-Kyu , Choi Seung Ho , Song Kyo Young , Sasako Mitsuru 
Published: January 2019

109 Background: Chemotherapy (CTX) is the standard of care for incurable advanced gastric cancer (AGC). REGATTA trial, which investigated survival benefit of reduction gastrectomy (Gx) in patients (pts) with AGC with a single non-curable factor, failed to demonstrate the superiority of Gx followed by CTX over CTX alone. However, there was a significant interaction between the treatment effect and tumor location in the subset analysis. In addition, treatment effect appeared to be different between Japan and Korea. So, the aim of this supplementary analysis was to explore the subgroups for which volume reduction Gx was beneficial with special reference to the tumor location and country. Methods: REGATTA trial was a randomized phase III trial at 44 institutions in Japan, Korea, and Singapore. Patients with AGC with a single non-curable factor were randomly assigned in each country to CTX alone or Gx plus CTX. The primary endpoint was overall survival (OS). In this analysis, OS was compared according to tumor location, country, and operative procedure. Results: A total of 175 pts (95 in Japan, 80 in Korea) was randomized to CTX alone (86 pts) or Gx followed by CTX (89 pts). MST was 16.6 months in CTX alone and 14.3 months in GX plus CTX (HR 1.09, 95% CI: 0.78–1.52, p = 0.70) (primary analysis). In subgroup analysis according to the country, OS curves were separated between the arms, worse in Gx plus CTX arm in Japan (HR 1.32, 95% CI: 0.85-2.05), whereas, that was not in Korea (HR 0.85. 95% CI: 0.52-1.40). HRs according to tumor location were 2.23 in upper third, 0.95 in middle third, and 0.63 in lower third. OS tended to be better in pts who received distal GX compared with CTX alone (HR = 0.69), and worse in pts who received total GX compared with CTX alone (HR = 1.34). This trend was more remarkable in Korea than in Japan. Multivariate analysis demonstrated that histological type was selected as an independent prognostic factor. Conclusions: Primary CTX is a standard of care for AGC; however, it would be still an open question whether volume reduction Gx have a survival benefit when the tumors located at the distal stomach for which the pts receive distal Gx. Clinical trial information: UMIN000001012.
A retrospective analysis of neoadjuvant chemotherapy followed by surgery or definitive chemoradiotherapy in patients with advanced esophageal squamous cell carcinoma.
Authors: Nakatsumi Hiroshi , Komatsu Yoshito , Nakano Shintaro , Sawada Kentaro , Muranaka Tetsuhito , Kawamoto Yasuyuki , Yuki Satoshi , Uchinami Yusuke , Taguchi Hiroshi , Shirato Hiroki , Ebihara Yuma , Shichinohe Toshiaki , Hirano Satoshi , Sakamoto Naoya 
Published: January 2019

115 Background: The standard treatment of resectable esophageal cancer in Japan is neoadjuvant chemotherapy (NAC) followed by surgery, while definitive chemoradiotherapy (CRT) is considered as an alternative treatment. There are no randomized clinical trials comparing NAC and CRT in Japan. The aim of this study was to evaluate the efficacy of NAC or CRT in clinical practice. Methods: We retrospectively analyzed the clinical data of 43 patients (pts) with clinical stage IB/II/III thoracic esophageal squamous cell carcinoma (ESCC) who received NAC (n = 26) or CRT (n = 17) in Hokkaido University Hospital from January 2009 to December 2014. To compare NAC with CRT, Fisher’s exact test or Mann-Whitney U test was used in terms of pts’ characteristics, and Log-rank test was used in progression-free survival (PFS) and overall survival (OS). Results: Pts’ characteristics were as follows; Gender (male/female): 24/2 in NAC and 16/1 in CRT, median age (range): 65y (55-78) in NAC and 72y (57-80) in CRT, primary lesion (Ut/Mt/Lt): 4/12/10 in NAC and 2/9/6 in CRT, clinical stage IB-II/III: 11/15 in NAC and 9/8 in CRT. Four pts (15.4%) in NAC and seven pts (41.2%) in CRT had multiple primary cancer. All pts in NAC and 15 pts in CRT received 5-FU+cisplatin (CDDP), and two pts in CRT received 5-FU+nedaplatin. RT dose in CRT was 50.4Gy in 11 pts, 59.4Gy in five pts and 60Gy in one patient. Four out of 10 pts in NAC with local recurrence received salvage CRT, and three out of 10 pts in CRT with local recurrence received salvage surgery. Median PFS was 21.6 months in NAC and 8.7 months in CRT (HR 1.282, 95% confidence interval (CI) 0.871-1.887, p = 0.203), and median OS was 50.4 months in NAC and 48.6 months in CRT (HR 1.151, 95% CI 0.752-1.761, p = 0.516). 5-year OS rate was 49.7% in NAC and 48.3% in CRT. Conclusions: Definitive CRT showed comparable outcome to NAC followed by surgery in pts with resectable thoracic ESCC. Efficacy of NAC or CRT were not sufficient compared to clinical trials. Improvement in efficacy by development of optimal multimodality therapy was warranted.
A phase I/Ib study of crenolanib with ramucirumab (RAM)/paclitaxel (PTX) as second-line therapy (2L tx) for advanced esophagogastric adenocarcinoma (EGA).
Authors: Greally Megan , Jha Sujata , Yoon Sam S. , Li Jia , Desai Avni Mukund , Won Elizabeth , Kelsen David Paul , Ilson David H. , Janjigian Yelena Yuriy , Aljallad Kathrena , Ku Geoffrey Yuyat 
Published: January 2019

116 Background: PTX/RAM as 2L tx for patients (pts) with EGA is a standard-of-care based on the RAINBOW trial (Lancet Oncol 2014;15:1224). However, benefit is modest. Upregulation of the platelet-derived growth factor (PDGF)/PDGF receptor-β (PDGFR-β) pathway causes resistance to VEGF inhibition. Crenolanib is a selective inhibitor of PDGFR-β. We report initial results of the dose escalation phase of a study of crenolanib plus RAM/PTX in pts with previously treated advanced EGA. Methods: This phase I/Ib study is enrolling ECOG PS 0-1 EGA pts with progression on first-line chemo. PTX 80 mg/m2/ day on day 1, 8, 15 and RAM 8mg/kg q 14 days were administered with escalating doses of crenolanib (60, 80, 100 mg BID) after a 7 day “run-in” of crenolanib to assess crenolanib-related toxicities. The primary objective was to determine the maximum tolerated dose (MTD) of crenolanib plus RAM/PTX. Safety and preliminary efficacy were examined. Results: 15 pts were treated; 12 male, median age 58 (32-73), 66% were ECOG PS 1. Primary site was gastric in nine pts, GEJ in 4 pts and esophageal in two pts. Three pts each received crenolanib 60mg BID and 80mg BID, six pts received 100mg BID and three pts received higher doses. At data cutoff, eight pts continued on treatment. 12 pts have completed the DLT evaluation period across 3 dose levels (60 to 100 mg BID). Median treatment duration was 76 days (35-191). The combination was well tolerated, with no DLTs or serious adverse events (SAEs) attributed to study drug. Treatment related adverse events occurred in two pts (17%), all grade 1. These were fatigue, nausea, vomiting and hypertension. Disease progression was the most common reason for treatment discontinuation; no pt discontinued due to study drug related AEs. Nine pts were evaluable for response. One pt had objective response; the disease control rate was 78%. Median PFS and OS were 4.1 and 11.9 months respectively. Conclusions: Crenolanib plus RAM/PTX appears well tolerated at a dose level of 100mg BID. Further evaluation is needed to determine efficacy. Accrual is ongoing at higher doses. Once the MTD is defined, the dose expansion phase will enroll 25 pts. Updated data with pharmacokinetics and biomarkers will be presented. Clinical trial information: NCT03193918.
Systemic chemo (CTX) plus surgery and intraperitoneal (IP) CTX for patients (pts) with gastric cancer (GC) and peritoneal carcinomatosis (PC).
Authors: Greally Megan , Strong Vivian E. , Yoon Sam S. , Chou Joanne F. , Capanu Marinela , Kelsen David Paul , Janjigian Yelena Yuriy , Ilson David H. , Ku Geoffrey Yuyat 
Published: January 2019

117 Background: The role of IP CTX in pts with GC and PC is unclear. The PHOENIX-GC phase III study (J Clin Oncol 2018;35:1922) did not show overall survival (OS) benefit for IP CTX plus systemic CTX while a retrospective French study suggested benefit for IP CTX and cytoreductive surgery (J Clin Oncol 36:8 [abstr]). Prolonged survival may be possible in pts with chemosensitive disease (dz). Methods: We reviewed GC pts diagnosed with PC (+ve cytology and/or gross dz) at diagnostic laparoscopy (DL). We identified pts treated with gastrectomy and IP floxuridine 1,000mg/ m2/leucovorin 240 mg/m2 ×3d q14d and pts who had CTX alone. Pts with visible dz on imaging were excluded. Progression-free survival (PFS) and OS were calculated from surgery date and estimated using Kaplan-Methods in surgery + IP CTX pts. Pt characteristics were compared using Fisher’s exact test and Wilcoxon Rank-Sum tests. Results: From 2000-2017, 18 pts had surgery + IP CTX (IP); 45 pts received CTX alone. Median age was 50 in IP pts and 65 in CTX only pts (p = 0.002); 94% of IP pts were ECOG PS 0/1 vs. 78% in CTX only pts (p = 0.16). 56% and 67% of pts had gross dz at DL in IP and CTX only pts respectively; remaining pts had +ve cytology only. IP pts received CTX (72% 5-FU/platinum based) for a median 3.3 months before repeat DL. 14/18 pts cleared dz; four pts with residual dz (1 +ve cytology only) had gross dz at baseline. Fourteen pts had R0 resection; 83% of tumors were ypT3-4N+. 4 pts had R1 resection; three had residual gross PC at DL. Pts received IP CTX for a median of 1 month post surgery. Median PFS and OS were 12.4 and 23 months respectively in surgery + IP CTX pts. While there was no difference in PFS in pts with -ve vs. persistently +ve cytology at repeat DL following CTX (15.5 vs. 4.7 months, p = 0.3), median OS was improved in pts who cleared cytology (29 vs. 8 months, p = 0.01). Median PFS and OS were 7 and 13.5 months respectively in CTX only pts. Conclusions: Surgery and IP CTX may have a role in highly select pts with GC and +ve cytology or small-volume gross dz. While survival was encouraging, no pt had OS > 5 years. Surgery and IP CTX may be considered in pts who have a -ve repeat DL after initial CTX. Survival in CTX only pts is comparable with stage IV pts enrolled on clinical trials.
Impact of radiation dose during neoadjuvant chemoradiation on postoperative complications in esophageal (EC) and gastroesophageal junction cancers (GEJC).
Authors: Kastelowitz Noah , Marsh Megan D. , McCarter Martin , Meguid Robert A. , Schefter Tracey E. , Rooke Douglas A. , Stumpf Priscilla , Leong Stephen , Messersmith Wells A. , Lieu Christopher Hanyoung , Leal Alexis Diane , Davis S. Lindsey , Purcell William T. , Mitchell John D. , Weyant Michael J. , Scott Christopher , Goodman Karyn A. 
Published: January 2019

119 Background: Neoadjuvant chemoradiation (nCRT) followed by resection is standard of care for operable stage II-III EC and GEJC; however, it can be associated with significant risk of postoperative complications (POC). The CROSS study group reported no increase in POC severity with nCRT using 41.4 Gy compared to surgery alone as defined by the Comprehensive Complication Index (CCI). We applied the CCI metric to evaluate the impact of nCRT radiation dose of < 50 Gy vs. ≥ 50 Gy on POC rates and compared to the CROSS rates. Methods: We retrospectively reviewed 82 pts (2004-2016) with EC or GEJC treated with nCRT followed by resection at our institution. 29 (35%) pts were treated with < 50 Gy (range 39.6-46.8 Gy) and 53 (65%) were treated with ≥ 50 Gy (range 50.0-52.5 Gy) delivered using IMRT/VMAT (41%), 3D-CRT (46%), or tomotherapy IMRT (12%). Concurrent chemotherapy were carboplatin/paclitaxel (59%), cisplatin/5-FU (17%), or other (24%). Resection was performed by Ivor Lewis esophagectomy (67%), esophagogastrectomy (14%), or trans-hiatal approach (11%). POC within 30 days were graded using the Clavien-Dindo scale and CCI scores were computed and compared between the two dose groups and with the CROSS nCRT group. Results: CCI scores and complication rates between our < 50 Gy and ≥ 50 Gy groups were not significantly different. Assuming a normal distribution of the CROSS CCI scores, there was no significant difference in CCI scores between the CROSS study nCRT, < 50 Gy, or ≥ 50 Gy groups. Rates of pulmonary complications were greater in the CROSS study. Conclusions: In highly selected EC and GEJC pts, definitive nCRT radiation doses do not appear to increase POC rates. Thus, 50 Gy can likely be delivered without increasing toxicity while also achieving a definitive dose for pts not able or willing to undergo subsequent surgery. [Table: see text]
The impact of infectious complications on long-term prognosis after curative resection for gastric cancer.
Authors: Maezawa Yukio , Aoyama Toru , Tamagawa Hiroshi , Sato Tsutomu , Ogata Takashi , Cho Haruhiko , Oshima Takashi , Yukawa Norio , Yoshikawa Takaki , Rino Yasushi , Masuda Munetaka 
Published: January 2019

122 Background: Several studies have reported that postoperative complications such as anastomotic leakage affect long-term prognosis after gastric cancer surgery. This study aimed to determine whether or not long-term outcomes were affected by the postoperative inflammatory complications in patients who underwent curative resection for gastric cancer. Methods: The patients were retrospectively selected from the medical records of consecutive patients who underwent curative gastrectomy with nodal dissection for gastric cancer at Yokohama City University and Kanagawa Cancer Center from January 2000 to August 2015. Inflammatory complications were evaluated according to the Clavien-Dindo classification. Overall survival (OS) was compared between postoperative inflammatory complications (IC) and no-complication (NC) groups. Results: A total of 2,254 patients were eligible for inclusion in the present study. One hundred seventy-five patients had IC group, while 2,079 patients had not. Operation time (p < 0.001), blood loss (p < 0.001) was significantly greater in the IC group. The incidence of postoperative inflammatory complication grade 2 or higher was 8.5% in which, pancreatic fistula (2.8%), anastomotic leakage (1.8%) were occurred. The mortality rate was 0.18%. The five-year OS rates of the IC and NC groups were 74.9% and 83.2%, respectively. The difference was statistically significant (p = 0.015). Multivariate Cox’s proportional hazard analyses demonstrated that the postoperative inflammatory complications were a significant prognostic factor for OS. Conclusions: Postoperative inflammatory complications have an obvious impact on the OS in curatively resected gastric cancer patients. It is necessary to reduce the incidence of postoperative complications.
Oncologic outcomes after laparoscopic and open distal gastrectomy for advanced gastric cancer: A propensity score matching analysis.
Authors: Chung Yoona , Choi Sung Il , Hong Kyungpyo , Kim Sanghyun 
Published: January 2019

135 Background: The aim of this study is to investigate the oncologic outcomes as well as short-term outcomes of laparoscopic distal gastrectomy compared with open distal gastrectomy for advanced gastric cancer using propensity-score matching analysis. Methods: A total of 384 patients underwent distal gastrectomy for advanced gastric cancer from July 2006 to November 2016. Data on short- and long-term outcomes were collected prospectively and reviewed. Propensity-score matching was applied at a ratio of 1:1 comparing the laparoscopic distal gastrectomy (LDG) group and open distal gastrectomy (ODG) groups. Results: The LDG group showed longer operative time than the ODG group. However, resumption of diet and length of hospital stay were shorter in the LDG group than in the ODG group (4.7 vs. 5.6 days, p= 0.049 and 9.6 vs. 11.5 days, p= 0.035, respectively).The extent of lymph node dissection in the LDG group was more limited than in the ODG group ( p= 0.002), although there was no difference in the number of retrieved lymph nodes between the two groups. The 3-year overall survival rates were 98% and 86.9% ( p= 0.018), whereas the 3-year recurrence-free survival were 86.3% and 75.3%, p= 0.259) in the LDG and the ODG groups. Conclusions: Laparoscopic distal gastrectomy is safe and feasible for advanced gastric cancer in terms of earlier recovery after surgery and long-term oncologic outcomes.