bluuebunny/crossref_metadata_2025_split huggingface dataset:
Stereotactic body radiation therapy and patient-reported quality of life prospectively evaluated in patients with unresectable or recurrent pancreatic cancer.
Authors: Rosati Lauren M. , Cheng Zhi , Robertson Scott P. , Kummerlowe Megan N. , Hacker-Prietz Amy , Wolfgang Christopher Lee , Pawlik Timothy M. , Le Dung T , Zheng Lei , Laheru Dan , Herman Joseph M. 
Published: February 2017

92 Background: The impact of fractionated stereotactic body radiation therapy (SBRT) on patient-reported quality of life (QOL) and physician-reported toxicity in patients with recurrent or locally advanced pancreatic cancer (PCA) was prospectively evaluated. Methods: Forty-two PCA patients were treated with 25-33 Gy using SBRT in 5 fractions on a single-institution study. Both patient- and physician-reported outcomes were evaluated prior to SBRT and 4-6 weeks post-SBRT. Eight outcomes were consistently evaluated among both groups—performance status, fatigue, pain, anorexia, nausea, vomiting, constipation, and diarrhea. Patient-reported QOL metrics were assessed using a 4-point Likert scale on the EORTC QLQ-C30 and QLQ-PAN26, while physician-reported toxicities were graded using the NCI CTCAE version 4.0. Comparisons between those with paired patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT were made using the Wilcoxon signed-rank test. Results: Of the 42 patients currently enrolled onto the study, 29 had both patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT. Fifty-five percent were female and 83% were Caucasian. The median age at diagnosis was 65.6 years (range, 40.8-86.6). There was no significant impairment of any of the 8 physician-reported toxicities, nor were significant changes observed in patient-reported overall health (p = 0.66) or QOL (p = 0.18) scores following SBRT. Patients felt less worried about their future health (mean change [mD] = -0.45, p = 0.02), and an improvement in feeling less attractive as a result of disease and treatment reached borderline significance (mD= 0.31, p = 0.09). However, patients felt limited in planning activities in advance (mD= 0.45, p = 0.02) and were more constipated (mD= 0.38, p = 0.01) 4-6 weeks post-SBRT. Conclusions: Although the numbers are small, patients with unresectable or locally recurrent PCA do not appear to suffer any detriment of overall health or QOL after receiving a five-day course of SBRT. Moreover, this regimen may lead to a more optimistic point of view on future health and/or level of physical attraction. Clinical trial information: NCT01781728.
Quality of life and its correlates after pelvic exenteration for gynecologic cancer.
Authors: Donovan Kristine A. , Albizu-Rivera Alexandra , Chon Hye Sook , Wenham Robert Michael 
Published: February 2017

93 Background: Pelvic exenteration (PE) has been performed historically in women with gynecologic cancer for palliation of recurrent disease. With advances in operative methods, PE in the well-selected patient can produce 5-year survival rates as high as 60%. Despite a recent increase in rate of PE performed with curative intent, there is a paucity of data on its long-term physical and emotional effects. We sought to characterize women’s long-term quality of life (QOL) and its correlates after PE for recurrent gynecologic cancer. Methods: We conducted a mixed methods study combining quantitative measurement of QOL and its demographic, clinical and psychological correlates with concurrent qualitative assessment to probe women’s cognitive and behavioral responses to PE. Results: From 2005 to 2014, 85 women underwent PE at our institution; 44% were still alive at study initiation. Among eligible women, 72% completed their participation. Mean age of the sample at time of study participation was 57.3 (SD = 9.5) years (range = 43 to 75) and median time since surgery was 3.0 years (range = .9 to 8). Women’s self-reported global QOL score was average (54.4 (23); range = 33.3 to 100) and the relationship between QOL and current age or time since surgery was not significant (p > .05). Women reported mild sleep disturbance, mild to moderate pain, moderate fatigue and anxiety and severe depressive symptoms. All of the women exceeded the cut-off for clinically significant depressive symptoms. Qualitatively, women described profound negative changes in their physical and emotional well-being after PE. In nearly all of the women, the extended survival after PE helped to buffer the effects of these changes. Conclusions: Results suggest women’s health-related QOL may return to, or near, pre-surgical levels in long-term survivorship but that symptom control is suboptimal. Findings should facilitate more informed decision making prior to PE and suggest targets for clinical intervention to enhance QOL and improve symptom control after PE. This study highlights the need for more comprehensive assessments pre- and post-PE to examine the effects of disease- and PE-related variables, cultural norms and social support on patient-reported outcomes.
Impact of sleep disturbance in myelodysplastic syndromes (MDS).
Authors: Solis Roxanne M. , Cronin Angel , Watts Corey D. , Steensma David P. , Stone Richard M. , DeAngelo Daniel J. , Owens Robert L. , Wadleigh Martha , Abel Gregory Alan 
Published: February 2017

99 Background: The fatigue of MDS is typically attributed to anemia and inflammatory cytokines expressed by hematopoietic cells. In contrast, the burden and impact of sleep disturbance in MDS has not been well-described. Methods: Starting in January 2006, patients with MDS seen at least twice at the Dana-Farber Cancer Institute (DFCI) were enrolled in a clinical database and underwent baseline administration of the EORTC QLQ-C30. This measure includes a question about sleep disturbance (“have you had trouble sleeping”) as well as a three-item fatigue assessment. For this analysis, we first determined if there were differences in fatigue assessment score by self-reported sleep disturbance, hemoglobin (Hb) and other clinical characteristics (age, gender, cytogenetic category, and blasts) using ANOVA. Next, a multivariable logistic regression model was created to determine the independent contribution of each factor to fatigue score above or below the sample median. Results: 251 patients had complete clinical and QLQ-C30 data. Median age was 68 years; 68% were men. The IPSS distribution was 18% Low, 38% Int-1, 29% Int-2 and 15% High. Median fatigue score was 33 out of 100 (IQR 33-56; reference value for similar-aged cancer patients is 33 with IQR 11-56). The majority (53%) reported trouble sleeping, which was strongly associated with increased fatigue (p<0.001). Among clinical factors, only lower Hb was also associated with fatigue (p<0.001). Sleep disturbance did not vary with IPSS category (p=0.40), and was not strongly correlated with Hb (ρ= 0.10). On multivariable analysis adjusting for age, gender, cytogenetics and blasts, Hb < 10 g/dL and the two highest levels of sleep disturbance independently predicted fatigue score above the median (p=0.003). Conclusions: Poor sleep is prevalent among patients with MDS, and is an independent predictor of fatigue when controlling for Hb. These data suggest that in addition to anemia, sleep disturbance should be addressed to relieve MDS-related fatigue. [Table: see text]
Surgery for solitary pulmonary metastasis after curative gastrectomy for gastric cancer: Contribution to the long-term survival.
Authors: Hayashi Shigeya , Segami Kenki , Kawabe Taiichi , Aoyama Toru , Makuuchi Yousuke , Yamada Takanobu , Sato Tsutomu , Oshima Takashi , Rino Yasushi , Masuda Munetaka , Ogata Takashi , Cho Haruhiko , Yoshikawa Takaki 
Published: February 2017

102 Background: Surgical resection is rarely indicated for pulmonary recurrence after curative gastrectomy for gastric cancer because most tumors recurred as multiple nodules or carcinomatous lymphangitis / pleuritis and prognosis is extremely poor. However, some investigators reported a sporadic case developing a solitary pulmonary metastasis which was surgically resected and resulted in a relatively favorable clinical outcome. The present study aimed to clarify contribution of surgery for solitary pulmonary recurrence to the long-term survival. Methods: We performed a systematic review of the literature by searching the words of “stomach”, “neoplasms”, “lung”, and “metastasis” in the Pubmed and Japanese ICHUSHI database, and analyzed the cases reporting on resection of solitary pulmonary metastasis after curative gastrectomy for gastric cancer together with our cases treated at our hospital. Overall survival was estimated by Kaplan-Meier method. Results: A total of 45 patients, 42 from a systematic review and 3 from our cases, were examined. Median age (range) was 67 years (31–84 years). Primary gastric cancer had the following characteristics; histologically differentiated type in 30 patients, undifferentiated type in 2, and unknown in 13 patients and tumor depth of T1 in 3, T2 in 6, T3 in 13, T4 in 9, and unknown in 6. Surgery for the primary gastric cancer was total gastrectomy in 30 patients and distal one in 15. The median (range) disease-free survival (DFS) between initial gastric resection and the detection of pulmonary metastasis was 28.0 months (5-128 months). Surgery for pulmonary tumor was lobectomies in 20 patients, segmentectomies in 3, wedge resections in 18, and unknown in 4. Only 4 patients received adjuvant chemotherapy after pulmonary resection. The median (range) follow-up period after pulmonary surgery was 20 months (3-98 months). The overall survival after pulmonary resection was 86% at 1-year, 62% at 3-year, and 56% at 5-year with the median (range) survival time of 67 months (3-98 months). Conclusions: Surgery for solitary pulmonary recurrence could contribute to the long-term survival.
Salvage surgery following chemoradiotherapy in management of esophageal cancer: Is it a viable therapeutic option? Results of a multicenter European study.
Authors: Markar Sheraz , Gronnier Caroline , Duhamel Alain , Mabrut Jean-Yves , Bail Jean-Pierre , Carrere Nicolas , Lefevre Jeremie H. , Meunier Bernard , Collet Denis , Mariette Christophe 
Published: February 2017

109 Background: Salvage esophagectomy (SE) has traditionally conferred a high rate of mortality and morbidity in small, monocenter, and old publications. The aim of this large multicenter study was to assess the impact of SE following definitive chemoradiotherapy (SALV) on clinical outcomes. Methods: Data from consecutive adult patients undergoing resection for esophageal cancer in 30 European centers from 2000–2010 were collected. Among this population, the first step was to compare SALV (n=308) and neoadjuvant chemoradiotherapy followed by planned esophagectomy (NCRS group, n=540) groups. The second step was to focus on the SALV group and to compare patients that benefited from SE for persistent (PERS group, n=234) versus recurrent (REC group, n=74) disease. Propensity score matching and multivariable analyses were used to compensate for differences in some baseline characteristics. Results: Comparison of SALV and NCRS groups: In-hospital mortality was similar in both groups (8.4% vs. 9.3%). The only significant differences in complications were seen for anastomotic leak (17.2% vs. 10.7%; P=0.007) and surgical site infection, which were both increased in the SALV group. At 3 years, the groups had similar overall (43.3% vs. 40.1%; P=0.542) and disease-free (39.2% vs. 32.8%; P=0.232) survivals, along-with similar overall (46.8% vs. 47.9%; P=0.829), locoregional (18.8% vs. 15.9%; P=0.544), distant (24.3% vs. 28.1%; P=0.949) and mixed (13.0% vs. 13.5%; P=0.888) tumor recurrence. Comparison of PERS and REC groups: There were no significant differences between the groups in the incidence of in-hospital mortality or major complications, apart from reoperation, which was increased in the PERS group (17.9% vs. 8.1%; P=0.042). Overall (23.4% vs 39.2%, p=0.054) and disease free survivals (21.1% vs37.8%, p=0.070) were lower in the PERS group. Conclusions: The results of this large multi-center study suggest that SE can offer acceptable short and long-term outcomes in experienced centers. Randomized controlled trials are required to validate the SE strategy as a viable option in complete esophageal cancer responders.
A randomized 2X2 phase II trial comparing two and four courses of S-1/cisplatin (SC) and paclitaxel/cisplatin (PC) as neoadjuvant chemotherapy for locally resectable advanced gastric cancer: Survival results of COMPASS.
Authors: Yoshikawa Takaki , Tanabe Kazuaki , Nishikawa Kazuhiro , Fujitani Kazumasa , Ito Yuichi , Matsui Takanori , Hayashi Tsutomu , Aoyama Toru , Cho Haruhiko , Morita Satoshi , Miyashita Yumi , Tsuburaya Akira , Sakamoto Junichi 
Published: February 2017

111 Background: The prognosis for stage III gastric cancer is not satisfactory even by S-1 adjuvant chemotherapy. Neoadjuvant chemotherapy is a promising approach but its optimal duration and regimen have not been established yet. Methods: We conducted a randomized phase II trial to compare two or four courses and regimen of SC or PC using a two-by-two factorial design.Key eligibility criteria was (i) T2-3/N+ or T4aN0 in case of schirrhous or junctional tumors, T2-3 with N+ to the major branched artery, T4aN+, T4b, para-aortic nodal metastases, or resectable minimal peritoneal metastases confirmed by laparoscopy and (ii) no other distant metastasis. Patients received S-1 (80 mg/m2 for 21 days with 1 week rest) / cisplatin (60 mg/m2 at day 8) or paclitaxel / cisplatin (80 mg/m2 and 25 mg/m2, respectively, on days 1, 8, and 15 with 1 week rest) as neoadjuvant chemotherapy. Then, patients received D2 gastrectomy with curative intent. The primary endpoint was 3-year overall survival. The planned sample size was 80 eligible patients in total so that the treatment group with the superior observed 3-year OS rate by 10% increase was to be selected with a probability of 88% or higher. Results: Eighty-three patients were assigned to SC (n=41, two courses in 21 and four courses in 20) and PC (n=42, two courses in 21 and four courses in 21). Pathological response rate was 42% (17/41) in SC and 33% (14/42) in PC, and 36% (15/42) in the two courses and 39% (16/41) in the four courses. Pathological CR was 0% (0/42) in the two courses and 10% (4/41) in the four courses. Grade 3/4 adverse events by chemotherapy and grade 3/4 surgical morbidities defined by Clavien-Dindo classification were both less than 10% in each arm without treatment-related death. The 3-year OS was 60.9% (95% CI, 44.3-73.9%) in SC and 64.3% (95% CI, 47.9-76.7%) in PC, and 64.3% (95% CI, 47.9-76.7%) in the two courses and 61.0% (95% CI, 44.4-74.0%) in the four courses. Conclusions: Two courses of SC as neoadjuvant chemotherapy is recommended for a test arm of future phase III study for patients with locally resectable advanced gastric cancer. Clinical trial information: UMIN000002595.
A phase II study of systemic chemotherapy with docetaxel, cisplatin, and S-1 (DCS) followed by gastrectomy with D2 plus para-aortic lymph node (PAN) dissection for gastric cancer with extensive lymph node metastasis (ELM): Japan Clinical Oncology Group Study JCOG1002.
Authors: Ito Seiji , Sano Takeshi , Katayama Hiroshi , Mizusawa Junki , Takahari Daisuke , Sasako Mitsuru , Katai Hitoshi , Tanaka Yoichi , Kinoshita Takahiro , Terashima Masanori , Nashimoto Atsushi , Yamaue Hiroki , Fukushima Norimasa , Yamada Makoto , Fujiwara Yoshiyuki , Kimura Yutaka , Azuma Takeshi , Yoshimura Tsunehiro 
Published: February 2017

116 Background: Gastric cancer with ELM is commonly regarded as unresectable with poor prognosis. We previously reported the safety and efficacy of cisplatin and S-1 (CS) followed by D2 gastrectomy with PAN dissection for this target (JCOG0405, Br J Surg 2014). Methods: Eligibility criteria included histologically proven gastric adenocarcinoma; bulky nodal involvement around major branched arteries to the stomach (Bulky N) and/or PAN metastases; cM0 (except PANs); negative lavage cytology; neither Borrmann type 4 nor large (8cm or more) type 3; PS 0 or 1. Patients received two or three cycles of induction chemotherapy of docetaxel (40mg/m2 day1), cisplatin (60mg/m2 day1), and S-1 (80mg/m2from day 1 to 14) every 4 weeks, and then underwent D2 gastrectomy with PAN dissection. After R0 resection, postoperative chemotherapy with S-1 was given for one year. The primary endpoint is response rate (RR) of NAC by central peer review. The planned sample size was 50 patients, provided 80% power under the hypothesis of primary endpoint as the expected RR of 80% and threshold RR of 65% with a one-sided alpha of 10%. Results: Between 07/2011 and 05/2013, 53 patients were enrolled and 1 patient was ineligible: 30 had Bulky N, 14 had PAN metastases, and 9 had both. 51of 52 patients (98.1%) completed a planned NAC. The clinical RR was 57.7% (30/52) (80%CI [47.9%-67.1%], one-sided p=0.89). The R0 resection rate was 84.6% (45/52). During DCS chemotherapy, grade 3/4 neutropenia occurred in 39.6% and grade 3/4 non-haematological adverse events in 20.8%. The incidence of grade 3/4 adverse events related to surgery was 30.6%. There was no treatment-related death. The pathological finding revealed minor response (residual tumor <1/3) was achieved in 50.0% (26/52) and major response (residual tumor <2/3) in 34.6% (18/52). The long-term survival is still under follow-up. Conclusions: Preoperative DCS revealed feasible but could not show sufficient efficacy. Preoperative CS is still being considered a standard treatment for this population. Clinical trial information: UMIN000006069.
Is linitis plastica a contraindication for surgical resection? A 7-institution study of the U.S. Gastric Cancer Collaborative.
Authors: Blackham Aaron Udell , Swords Doug S. , Levine Edward Allen , Fitzgerald Nora , Squires Malcolm Hart , Poultsides George A. , Fields Ryan C. , Bloomston Mark , Weber Sharon M. , Pawlik Timothy M. , Jin Linda X. , Spolverato Gaya , Winslow Emily , Schmidt Carl Richard , Kooby David A. , Worhunsky David J. , Saunders Neil , Cho Clifford Suhyun , Maithel Shishir Kumar , Votanopoulos Konstantinos Ioannis 
Published: February 2017

118 Background: Linitis plastica (LP) describes a diffusively infiltrative gastric adenocarcinoma that portends poor prognosis. Current treatment guidelines do not differentiate between LP and non-LP cancers and it is not known if the same staging system should be applied to both situations. Methods: Using the multi-institutional U.S. Gastric Cancer Collaborative database, 869 patients with gastric adenocarcinoma who underwent resection between 2000-2012 were identified. Clinicopathologic, perioperative and survival outcomes of the 58 patients with LP were compared to the 811 patients without LP. Results: Advanced disease (stage III/IV) at presentation was more common in patients with LP compared to non-LP patients (90 vs 44%, p<0.01). Despite the fact that most LP patients underwent total gastrectomy (88% vs 57%, p<0.01), positive margins were more common in LP patients (33 vs 7%, p<0.01). There was no difference in perioperative complications (48 vs 43%, p=0.45) or mortality (7 vs 3%, p=0.12) between LP and non-LP patients. While survival correlated with stage in non-LP patients, there was no difference in median overall survival (OS) of LP patients based on stage (I/II, 17.3 mos; III, 10.6 mos; IV, 12.0 mos; p=0.46). Median OS was significantly worse in patients with LP (11.6 vs 37.8 months, p<0.01) when margin status and extent of lymphadenectomy were not factored in the analysis. However, when analyzing only patients with optimal resections (R0, D2 lymphadenectomy), the median OS for stage III LP (n=22) and non-LP (n=185) patients was nearly identical (26.8 vs 25.3 mos, p=0.69). There were no independent prognostic factors identified to predict survival in LP patients undergoing curative resection. Conclusions: The poor prognosis of LP gastric cancer is due primarily to its advanced stage at diagnosis. However, LP patients who undergo optimal resections can expect similar long term survival compared to optimally resected non-LP patients with advanced stage disease. Patient selection and multidisciplinary management are paramount when considering surgical resection in patients with gastric LP.
An assessment of feeding jejunostomy tube placement at the time of resection for gastric adenocarcinoma: A seven-institution analysis of 837 patients from the U.S. Gastric Cancer Collaborative.
Authors: Dann Gregory C. , Squires Malcolm Hart , Postlewait Lauren McLendon , Kooby David A. , Poultsides George A. , Weber Sharon M. , Bloomston Mark , Fields Ryan C. , Pawlik Timothy M. , Votanopoulos Konstantinos Ioannis , Schmidt Carl Richard , Ejaz Aslam , Acher Alexandra W. , Jin Linda X. , Cho Clifford Suhyun , Winslow Emily , Russell Maria C. , Cardona Kenneth , Staley Charles A. , Maithel Shishir Kumar 
Published: February 2017

120 Background: A recent single institutional study demonstrated that jejunostomy feeding tubes (J-tubes) placed during resection of gastric adenocarcinoma (GAC) are associated with increased complications and no change in receipt of adjuvant therapy. Our aim was to validate these findings in a large multi-institutional cohort. Methods: All patients who underwent resection for GAC at 7 institutions participating in the U.S. Gastric Cancer Collaborative from 2000-2012 were identified. Patients with metastatic disease were excluded. Univariate and multivariate logistic regression were performed to assess the association of J-tubes with postoperative complications and receipt of adjuvant therapy. Subset analysis of patients who underwent total vs subtotal gastrectomy was also performed. Results: Of 965 patients, 837 were included for analysis, of whom 265 (32%) received a J-tube. Patients receiving J-tubes demonstrated greater incidence of preoperative weight loss, lower BMI, greater extent of resection, and more advanced TNM stage. J-tube placement was associated with increased infectious complications (36% vs 19%;p<0.001), including surgical site infections (14% vs 6%;p<0.001) and deep intra-abdominal infections (11% vs 4%;p<0.001). On multivariate analysis, J-tubes remained independently associated with increased risk of infectious complications (HR=1.93;p=0.001), surgical site infections (HR=2.85;p=0.001), and deep intra-abdominal infections (HR=2.13;p=0.04). J-tubes were not associated with increased receipt of adjuvant therapy (HR=0.82;p=0.34). Subset analysis of patients undergoing total and subtotal gastrectomy similarly demonstrated an association of J-tubes with increased risk of infectious outcomes andno association with increased receipt of adjuvant therapy. Conclusions: J-tubes placed during resection of gastric adenocarcinoma are independently associated with increased postoperative infections and are not associated with increased receipt of adjuvant therapy, despite being placed in patients with advanced TNM stage tumors. Selective use of J-tubes is recommended.