bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cisplatin/5-fluorouracil (CF) versus carboplatin/paclitaxel (CT) chemoradiotherapy (CRT) for locoregionally advanced esophageal cancer (LAEC).
Authors: Marquardt Michael , Anderson Carryn M. , Mott Sarah L , Furqan Muhammad , Clamon Gerald H. , Parekh Kalpaj , Allen Bryan G. , Buatti John Michael , Watkins John Morgan 
Published: March 2017

140 Background: Disease control and survival outcomes for LAEC are poor despite multimodality treatment with CRT with or without esophagectomy. Without comparative trial data, oncologists select a chemotherapy regimen based on clinical experience and toxicity profile. The present investigation compares LAEC progression free survival (PFS) and overall survival (OS) for CF versus CT. Methods: A retrospective analysis was performed for patients with LAEC from 2003-2012, treated with curative-intent neoadjuvant or definitive concurrent CRT with either CF or CT. Chi-squared tests, Fisher’s exact tests, and t-tests were used to identify significant differences between treatment groups. The Kaplan-Meier method was used to estimate PFS and OS. Results: Of 149 patients with non-metastatic LAEC, 82 met inclusion criteria (n=38 CF, n=44 CT), with 63, 2, and 2 excluded for non-CF/CT CRT, missing data, and <1 month follow-up, respectively. Treatment groups were well balanced, excepting fewer females, lower prior cancer rate, and longer follow-up for the CF group (Table 1). At a median follow-up of 22.7 months (range, 1.8-132.1, median follow-up 58.6 for survivors), 48 patients experienced recurrence (22 CF, 26 CT), and 63 patients died (29 CF, 34 CT). No differences in PFS or OS were demonstrated between treatment groups (Table 1). Conclusions: The present study failed to detect a disease control or survival difference between CF and CT as a component of CRT in neoadjuvant or definitive settings for LAEC. Until randomized trial data are available, oncologists may elect CF or CT based on clinical situations and anticipated sequelae. [Table: see text]
Exclusive chemoradiation with carboplatin-paclitaxel versus FOLFOX-4 in locally advanced esophageal cancer: A matched-pair analysis.
Authors: Miny Joelle , Bertaut Aurelie , Bosset Jean Francois , Boustani Jihane , Rouffiac Magali , Ghiringhelli Francois , Borg Christophe , De Bari Berardino , Crehange Gilles 
Published: March 2017

145 Background: The PRODIGE 5 trial has demonstrated the safety and the efficacy of FOLFOX-4 combined with exclusive 50Gy external RT while the CROSS trial showed an improvement in overall survival with Carboplatin-Taxol (C-TAX) when combined with 41.4Gy before surgery. We sought to determine the feasibility and efficacy of exclusive RT with C-TAX compared to FOLFOX-4 regimen. Methods: 46 patients with locally advanced esophageal cancer who were treated with exclusive chemoradiation were matched 1:1 : 23 patients were treated with FOLFOX-4 regimen (group A) and 23 patients with C-TAX (group B). Comparison between the 2 groups was performed using Mac Nemar test for paired data. All tests were two sided and Pvalues were considered significant when less than 0.05. Results: The mean age in group A was 69.4 years (12.5) and 72.4 years (12.6) in group B (p = ns). In each group, 11 patients had a stage III disease at diagnosis (47.8%) with only 2 stage IV in group A (8.7%) vs none in group B. The median delivered RT doses were 50Gy [14-60] in group A while it was 50Gy [20-70] in group B. 6 courses of chemotherapy were delivered in 12 patients in group A (52.2%) and 14 patients in group B (60.9%) (p = 0.51). After chemoradiation, G1 or higher esophagitis was observed in 5 patients (26.3%) in group A and 3 patients (13.0%) in group B of whom 0 vs 2 G3 were observed in group A and B, respectively. Four patients (21.1%) had a pulmonary infection in group A and 3 in group B (13.0%). Two patients (8.7%) vs 4 patients (17.4%) had G3 neutropenia, with only 0 and 2 neutropenic fever in group A and B, respectively. Neither G3 anemia, nor G3 thrombopenia occured. After a median follow-up of 17.7 months [0.0-46.9], 25 patients had died, 14 in group A (60.9%) and 11 in group B (47.8%). The median PFS rates were 14.0 months in group A [7.7-NR] vs 12.1 months [4.4-NR] in group B (p = 0.32). The median OS rates were 20.3 months in group A [6.2-39.3] vs 17.0 months [4.8-NR] in group B (p = 0.82). Conclusions: Exclusive chemoradiation with C-TAX seems feasible with similar toxicity and survival outcomes than FOLFOX-4. The safety and efficacy of the CROSS regimen needs to be tested prospectively with RT doses > 41.4Gy in a phase II or III trial.
Effect of nodal status compared to tumor response after neoadjuvant radiation on outcomes for patients with esophageal cancer.
Authors: Reddy Sushanth , Swords Jacob A. , Waldrop Mary Glenn , Contreras Carlo M. , Heslin Martin J. , Wei Benjamin , Cerfolio Robert J. , Wang Thomas N. 
Published: March 2017

147 Background: The CROSS trial established the role of neoadjuvant radiation in the treatment of esophageal adenocarcinoma (EAC). While response to radiation is an important factor in predicting long-term outcomes, the vast majority of patients succumb to systemic disease. The purpose of this study is to assess predictors of survival in patients with EAC following radiation therapy. Methods: All patients who underwent resection after radiation therapy for EAC at a single institution were retrospectively identified from January 2004 to December 2014. Patients who died within 30 days of surgery were excluded. Cox-proportional hazard analyses were performed to identify clinico-pathological factors associated with survival after surgery. Results: In the time period, 334 patients underwent esophagectomy for EAC. Univariable/multivariable analyses are shown in the table. The presence of a pathologic complete response (pCR) did not correlate to survival. The most important factors in predicting outcome were pre-operative albumin and initial lymph node stage by endoscopic ultrasound (EUS). Pre-treatment N0 patients had better survival than N1 patients (median survival 37.2 vs. 16.3 months, P < 0.0001). Patients who remained N0 after radiation had much better outcomes than those that either developed N1 disease after radiation or were initially staged as N1 (stayed N0, N = 126, median survival 52.0 months; N1→N0, N = 85, median survival 22.9 months; N0→N1, N = 30, median survival 15.3 months; persistent N1, N = 44, median survival 11.4 months; P < 0.0001). Conclusions: Pathologic response to radiation does not predict outcomes for patients with EAC. Patients with node positive EAC have poor outcomes even after neoadjuvant radiation therapy. These patients are at an increased risk of distant disease and should be offered additional systemic therapies prior to surgical resection. [Table: see text]
Phase I study of neoadjuvant chemotherapy with xeloda and oxaliplatin (G-XELOX) for locally advanced gastric cancer.
Authors: Satake Hironaga , Kondo Masato , Kotake Takeshi , Okita Yoshihiro , Ogata Takatsugu , Hatachi Yukimasa , Yasui Hisateru , Kaihara Satoshi , Kotaka Masahito , Kato Takeshi , Tsuji Akihito 
Published: March 2017

149 Background: Prognosis for locally advanced gastric cancer, such as clinical T4 disease, bulky nodal involvement, type 4 and large type 3 gastric cancer, remains unsatisfactory, even with D2 gastrectomy followed by adjuvant chemotherapy. Neoadjuvant chemotherapy is a promising approach, and combination chemotherapy with Xeloda and oxaliplatin (G-XELOX) is recognized as a potentially promising regimen for gastric cancer. However, the use of neoadjuvant chemotherapy consisting of G-XELOX for locally advanced gastric cancer has not been reported. The aim of this study was to evaluate the incidence of dose limiting toxicities (DLTs) during the neoadjuvant chemotherapy and to determine the maximum tolerated dose (MTD) and recommended dose of preoperative chemotherapy combined with oxaliplatin with a fixed Xeloda dose for locally advanced gastric cancer. Methods: Patients received two cycles of neoadjuvant chemotherapy with oxaliplatin on day 1, as well as Xeloda (2000 mg/m2/day, b.i.d.) for 14 days, repeatedly every 3 weeks. They then underwent gastrectomy with curative D2/3 lymph-node dissection followed by adjuvant S-1 (80 mg/m2/day, b.i.d.) for one year. A decrease of oxaliplatin dose was planned (starting at level 1, 130 mg/m2). Results: Six patients (5 male, 1 female) with a median age of 72 (range 68-79) were enrolled. MTD was not reached at level 1. Oxaliplatin 130 mg/m2 in combination with Xeloda 2000 mg/m2/day, b.i.d. could be administered with acceptable toxicity. No treatment-related death was observed. Most frequent drug-related AEs during the neoadjuvant chemotherapy period were G1 anemia, G1/2 thrombocytopenia and G1 peripheral neuropathy. One patient refused surgical resection, therefore five received resection with curative intent. Of the five patients, all achieved a pathological downstaging after neoadjuvant G-XELOX therapy. The incidence of operative morbidity was tolerable. Conclusions: Neoadjuvant chemotherapy with G-XELOX regimen was feasible by patients with locally advanced gastric cancer. Clinical trial information: UMIN000015950.
Conversion surgery for unresectable gastric cancer following complete response of distant metastasis by systemic chemotherapy.
Authors: Kobayashi Daisuke , Kanda Mitsuro , Tanaka Chie , Iwata Naoki , Hayashi Masamichi , Yamada Suguru , Nakayama Goro , Sugimoto Hiroyuki , Koike Masahiko , Fujii Tsutomu , Fujiwara Michitaka , Kodera Yasuhiro 
Published: March 2017

152 Background: In case of gastric cancer (GC), conversion surgery (CS) can be defined as resection of the primary cancer by gastrectomy which had not been originally planned but was indicated after confirming complete response (CR) in the distant metastasis (DM) by chemotherapy. In the present study, we looked at prognostic significance of CS, which is intended to cure originally unresectable GC. Methods: From 2004 to Feb in 2016, 24 GC patients who were treated by chemotherapy and achieved CR in DM underwent CS among 909 patients with gastrectomy in our department. 10 out of 24 patients who had peritoneal metastases (P) as a single non-curative factor underwent intraperitoneal chemotherapy (IP) in addition to systemic chemotherapy. CR was confirmed by CT and/or laparoscopic examination. Results: 15 patients had P, 13 had distant lymph node metastases (LYM), 2 had liver metastases, and 2 had lung metastases. Chemotherapeutic regimens consisted of systemic chemotherapy plus IP of taxane in 10 patients, S-1/CDDP in 7, capecitabine/CDDP/trastsuzumab in 3, and others in 4. Median duration of chemotherapy before surgery was 7.3 months (2.3-17.5). Total gastrectomy was performed in 18 patients and distal gastrectomy in 6, achieving R0 resection in 21 patients and R1 in 3. 10 patients with P who underwent IP relapsed within 12 months postoperatively except for 2 and had significantly shorter overall survival time than those with other DM except for P (median: 20 vs. 42 months, P = 0.004). Among 14 patients who had DM other than P as target lesions, 9 are disease-free with postoperative median follow up time of 35 months (6.8-82), and 5 patients had recurrence (LYM in 4 and P in 1) with postoperative median survival time of 25 months (4.8-45). DM of the patients without recurrence had achieved CR within shorter period (median: 3.6 vs. 6.7 months) and had higher pathological response rate of the primary lesion (89% vs. 40%) compared to patients with recurrence. Conclusions: Outcome of GC patients who underwent CS after achieving CR in DM was promising, especially in those without P. Further issues such as appropriate chemotherapeutic period, and prognostic factors to decide on the indication for CS need to be solved.
Feasibility and acceptability of implementing an electronic patient reported outcome (e-PRO) dysphagia screening tool for routine multidisciplinary care.
Authors: Shani Kishan , Borean Michael , Chen Judy , Li Yuchen , Brown M. Catherine , Vennettilli Ashlee , Lau Anthea , Zheng Dennis , Kuang Qin , Boyd Kevin , Leung Yvonne , Cella David , Mackay Helen , Darling Gail Elizabeth , Wong Rebecca , Patel Deval , Xu Wei , Liu Geoffrey , Howell Doris 
Published: March 2017

155 Background: In Ontario, Canada, longitudinal patient self-reporting of 9 common cancer symptoms and a global health scale (Edmonton Symptom Assessment System, ESAS) is mandated and used clinically as a screening tool for multidisciplinary precision care (chemo/rads/surg). However, a common GI symptom, dysphagia, is not assessed in the same setting. Methods: Mostly gastro-esophageal cancer outpatients (some head and neck and lung cancer patients undergoing radiation were also included for generalizability) received one of two versions (V1, V2) of the dysphagia screening tool based on PRO-CTCAE-derived language. The tool included two screening questions, which when answered affirmatively, led to more comprehensive dysphagia/odynophagia questioning. The survey was introduced on iPads with V1. An assessment of acceptability through patient survey was additionally included in V2, and the duration of survey completion was recorded. Exploratory in-depth interviews were conducted with oncologists to assess usability in the clinic setting. Results: Of 101 approached and eligible, 79 consented, and 66 completed the survey. Median completion time was 2.12 ± 0.80 min. 95% were happy to complete survey on a touchscreen tablet, 88% did not find completion of survey time-consuming, and 91% found completion of survey useful in order to tell the clinician how they feel physically and emotionally. The prevalence of dysphagia based on screening question #1 (“difficulty upon swallowing?”) was 38% (25/66), while for screening question #2 (“pain upon swallowing?”) prevalence was 18% (12/66). Five interviewed physicians found the survey to be clinically informative, not burdensome in terms of time consumption, and felt it would be a valuable addition to outpatient clinics. One recurring suggestion was to combine the two screening questions into one. Results were similar across GI, head and neck, and lung cancer sites. Conclusions: The e-PRO dysphagia screening tool is acceptable and feasible for patients, and useful for clinicians. Next, a modified one-question dysphagia tool will be assessed in the multidisciplinary care of gastro-esophageal cancer patients.
Impact of a pre- and postoperative chemotherapy (Ctx) on overall survival (OS) and progression free survival (PFS) in locally advanced gastric cancer (LAGC).
Authors: Manth Ricarda , Schaefer H , Schroeder J , Spiessl G , Nuessler N , Karthaus Meinolf 
Published: March 2017

156 Background: Perioperative Ctx has become standard of care for LAGC. Duration of pre- and post-op Ctx is a matter of debate. Our study evaluated effects of varying durations of pre- and post-op Ctx on PFS and OS. Secondary endpoints were toxicity, reasons for cessation of Ctx and response. We compared the outcome to a group of pts receiving no perioperative Ctx as an internal control. Methods: Pts with LAGC were included in a prospective cohort trial from a single institution from 2007 to 2015. Inclusion criteria were T1-T4, N0-3, M0, AEG (n=27) or gastric cancers (n=65). Initial therapy decisions were made by an interdisciplinary tumor board for all pts. Pts received DDP/5-FU (qw d28 mod FFCD-Protocol, Ychou et al. JCO 2011) for 2 mo, and a 3rd mo of pre-op Ctx in case of non-progression after 2 mo and proceeded to Ctx after surgery for a planned total of six mo of Ctx. Results: 92 pts (53 m; 39 f pts) with a median age of 69 ys (range 33-96) were included. A total of 74 pts were recommended periop Ctx and 18 primary surgery (S). A total of 67 (91%) of the periop Ctx received pre-op Ctx (NA) of which 47 (64%) received 3 mo of pre-op Ctx, 19 (26%) two mo, 1 pt (1%) one mo, and 7 pts refused preop Ctx (9%) of which only 3 proceeded to surgery. Only 53 pts (72 %) received post-op Ctx; 25 pts (34%) received three mo, 9 pts (12 %) two mo, and another 10 pts (14 %) one mo of postop Ctx. Nine pts (13%) in the NA group and 20 pts (39%) in the post-op Ctx group had to stop Ctx due to toxicity after 1 (n=11) and <2 (n=9) mo of Ctx. Only 23 pts (31%) received the planned pre- and postop Ctx of 6 mo in total. Up to 07/2016 a total of 36 deaths were observed (39%). 5 yr PFS was 49% in the group of periop Ctx vs 14% in the S group. PFS in pts receiving a total of < 4 mo of Ctx was 36% vs. 61% in pts receiving 6 mo of Ctx. 3 yr OS was 19% in the S group vs 48% in the Ctx group. The OS in pts receiving < 4 mo was 34% vs.43% in pts with 6 mo Ctx. A pCR after preop Ctx was observed in 2 pts, a PR in 47 pts, a SD in 12 pts, while a PD occurred in 3 pts only. Conclusions: Pre-op Ctx was considerably better tolerated than post-op Ctx and led to fewer Tx cessations. We found a better PFS for pts with >4 mo of periop Ctx, as well as OS was affected by a shorter duration of periop Ctx.
A multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with advanced gastric cancer.
Authors: Terazawa Tetsuji , Iwasa Satoru , Sasaki Yusuke , Okazaki Shunsuke , Goto Masahiro , Kojima Yasushi , Naganuma Atsushi , Nagashima Kengo , Hirano Hidekazu , Honma Yoshitaka , Takashima Atsuo , Kato Ken , Hamaguchi Tetsuya 
Published: March 2017

157 Background: The incidence of gastric cancer increases gradually in individuals aged ≥ 75 years who account for about 40% of all patients. From the SPIRITS study, comparing S-1 monotherapy with S-1 and cisplatin (CDDP) combination therapy (median overall survival [OS]: 11.0 versus 13.0 months, p=0.04), S-1 and CDDP chemotherapy (SP regimen) is recognized as one of the standard first-line regimens for patients with advanced gastric cancer in Japan. However, patients in this trial were aged < 75 years. Methods: The aim of this phase II study was to evaluate the efficacy and safety of SP regimen in elderly patients with chemotherapy-naive advanced gastric cancer. Patients aged ≥ 76 years were given oral S-1 twice daily for 21 days, followed by 14 days rest; CDDP was intravenously infused at day 8, repeated every 35 days, for up to eight cycles. The dose of S-1 (50–120 mg/body) and CDDP (30–60 mg/m2) was adjusted depending on the patient’s body surface area and creatinine clearance (Ccr-adjusted SP regimen). The primary endpoint was OS. The threshold and expected OS were estimated at 8 and 14 months, respectively. Secondary endpoints included response rate (RR), progression-free survival (PFS), time to treatment failure (TTF) and adverse events. Results: From December 2012 to October 2014, 40 patients were enrolled at 15 institutions. Patient characteristics were: gender (M/F) 29/11; median age 78 (range, 76–89); ECOG PS0/1, 13/27; and unresectable/recurrence 30/10. The median cycle for each patient was four (range, 1–8). The median OS was 12.3 months (80% confidence interval, 10.2–14.4 months). The median PFS and TTF were 7.8 and 4.3 months, respectively. The RR was 54%. A dose reduction of S-1 and CDDP was made for 30% and 35% of patients, respectively. The protocol was discontinued in 17 patients (43%) for disease progression, 10 patients (25%) for adverse events and 7 patients (17%) for patient refusal. The main adverse events at a grade 3 or higher were anorexia (25%), neutropenia (23%), hyponatremia (20%) and anemia (18%). Treatment-related deaths did not occur. Conclusions: Ccr-adjusted SP regimen showed promising activity and was tolerated well by elderly patients with advanced gastric cancer. Clinical trial information: UMIN000009349.
Quality of life and self-management strategies after gastroesophageal cancer surgery.
Authors: Sun Virginia , Kim Jae Y. , Ruel Nora , Kim Joseph , Raz Dan , Erhunmwunsee Loretta , Melstrom Laleh Golkar , Chao Joseph , Woo Yanghee , McCorkle Ruth 
Published: March 2017

159 Background: Gastroesophageal cancer surgery can result in significant morbidity and decreased quality of life (QOL). The profound physical changes and symptoms that affect eating/digestion can substantially alter psychological and social well-being. We aimed to describe QOL and dietary/behavioral self-management strategies after gastroesophageal cancer surgery. Methods: Patients who were 6-12 months post-resection completed surveys for QOL (EORTC-QLQ-C30), symptoms (EORTC-QLQ-OES18 or QLQ-STO22), diet modifications, and behavioral adjustments. Scores for validated measures were calculated according to guidelines, and summarized using descriptive statistics. Results: 31 patients (11 esophagectomy, 20 gastrectromy) participated in the study. Surgical approach was 71% minimally invasive (laparoscopic, robotic). Patients reported clinically meaningful (≥10 point difference) worse mean scores compared to reference population means for physical (73.3/100 esophagectomy, 78.3/100 gastrectomy vs. 89.8/100 reference populations), role (63.6/100, 73.3/100 vs. 84.7/100), and social functioning (62.1/100, 75.0/100 vs. 87.5/100). Eating problems (48.5/100) was the worst symptom for esophagectomy patients. Thereafter, problems with taste, cough, reflux, and dysphagia were reported frequently. For gastrectomy patients, eating problems was also the worst symptom (28.2/100), followed by body image disturbance, dry mouth, and pain. Time to comfort with eating after surgery was between 3-12 months. The most common behavioral adjustments include chewing food completely (96%), eating multiple meals per day (90%), controlling meal portions (87%), staying or sitting upright after meals (71%), staying at or close to home more (64%), and eating out less (55%). Conclusions: QOL is greatly reduced after gastroesophageal cancer surgery. Eating problems and associated symptoms persist 6-12 months after surgery. Patients used multiple self-management strategies to control eating problems and symptoms. These strategies varied greatly, suggesting that personalized interventions are necessary to help patients adjust to eating after surgery and improve QOL.