bluuebunny/crossref_metadata_2025_split huggingface dataset:
Postoperative chemoradiation FOLFOX 4-based for R1 resected gastric cancer: A retrospective mono-institutional study.
Authors: De Vita Ferdinando , Orditura Michele , Laterza Maria Maddalena , Fabozzi Alessio , Savastano Beatrice , Ventriglia Jole , Marano Luigi , Giordano Guido , Petrillo Angelica , Martinelli Erika , Troiani Teresa , Morgillo Floriana , Di Martino Natale , Ciardiello Fortunato 
Published: February 2017

143 Background: Improved DFS and OS were seen in curatively resected patients (pts.) with gastric and gastroesophageal adenocarcinoma treated with the Int0116 protocol of postoperative adjuvant chemoradiotherapy compared to surgery alone. However, there are very limited data about the efficacy of this approach in pts. with R1 resection. To evaluate the efficacy of a combined chemoradiation regimen in this setting, we reviewed our case records from 43 pts. with R1 resection treated between May 2008 and July 2012. Methods: 43 pts. with histologically confirmed gastric adenocarcinoma, received combined adjuvant chemotherapy with FOLFOX-4 for 8 cycles and concomitant radiotherapy (45 Gy in 25 daily fractions over 5 weeks). Radiotherapy was begun after 2 cycles of CT, (reduced by 20% during the period of concomitant radiotherapy). Pts. were followed at 3-month intervals for 2 years, at 6-month intervals for the next 3 years and yearly thereafter. Results: The median age was 62 years (range, 22-74) and the majority of pts. (76.7%) were males. Tumor location was equally distributed in the stomach. Most of the patients had locally advanced disease: 93% had T3-4 tumors and 74.4% had lymph node involvement. There was no treatment related death. Gastrointestinal G3 toxicity was observed in 11.6% of pts., while haematologic G3-4 toxicity was observed in 9.3%. Experienced toxicities led to chemotherapy dose reductions in 9 pts. and dose delay in 11 patients; 7 pts. had a delay in radiotherapy. With a median follow-up of 36 months (range 2-49) for the 43 R1 pts., 74.4% died of gastric cancer, 11.6% are alive with no evidence of recurrence and 13.9% are alive with disease. 66.6% of the relapses in this group occurred at distant sites and 33.3% were locoregional. The estimated 3-year OS was 19%. The median DFS was 14.5 months and the median OS was 16 months. Conclusions: These results seem to imply some benefit for the postoperative treatment, as nearly 19% of the R1 pts. in our study remained free of recurrence at 3 years from surgery. In the absence of phase III data and consequently lack of clear guidelines in this setting, our results support the common practice of adding postoperative chemoradiation after R1 gastrectomy.
Activity of gemcitabine/5-FU combination in refractory esophagogastric (EG) cancer.
Authors: Won Elizabeth , Ilson David H. , Chou Joanne F. , Capanu Marinela 
Published: February 2017

147 Background: Systemic chemotherapy has been demonstrated to improve survival and palliate symptoms in metastatic EG cancer. 2ndline (or more) chemotherapy with best supportive care also improves progression free and overall survival. Single-agent gemcitabine did not show activity in EG cancers (Ann Oncol 11:1161, 2000). Addition of gemcitabine to 5-fluorouracil (5FU) has shown modest activity (Oncology 69:130, 2005). To determine the efficacy and tolerability of gemcitabine with 5FU, we reviewed our experience in patients (pts) with metastatic or advanced EG cancers treated with this regimen. Methods: Retrospective review of MSKCC database for pts with metastatic EG cancer treated with gemcitabine/5FU (or capecitabine) between 1/1/2000 - 12/31/2012. Gemcitabine given at 600-1000mg/m2 day1, day 8 of q21 day cycle or 600-1000mg/m2 q2 weeks. 5FU given at 600-1000m2/m2 IV/48 hrs, with bolus 5FU/Leucovorin (200-400mg/m2 IV) on day 1. Capecitabine most commonly given as 1500-4000mg flat dose daily, in two divided doses, 7 days on/7 days off. Results: Of 146 pts, median age was 60; KPS 70 (50-90); 84% adenocarcinoma, 6% squamous (SCC). Sites of disease: 45% liver; 22% bone, 21% peritoneum. 112(77%) had ≥ 2 sites of disease. Pts were heavily pretreated: 42(29%) 2 prior lines of treatment (tx) for metastatic disease, 37(25%) 3 lines of tx, and 7(5%) 4+ lines of tx. Prior tx: 5FU/platinum (37%); Taxanes (56%); Irinotecan (44%). With gemcitabine, 49(34%) received 5FU and 97(66%) received capecitabine. In 144 evaluable pts, partial response rate was 7%, and stable disease was seen in 33%. Median PFS 1.84 months (95% CI,1.38-2.04) and for adenocarcinoma 2.0 months (95%CI,1.2-2.2) vs 1.2 months (95%CI: 0.9-1.51) for SCC (p =0.068). In the PR group, median PFS was 5.0 months (range 3.7-16.3 mo). Grade 3 toxicity was seen in 19 (13%); 1 pt had Grade 4 toxicity. 3(2%) discontinued treatment due to toxicity. Conclusions: Combination gemcitabine/5FU or capecitabine in metastatic EG cancer may have some limited activity and is well tolerated in a previously treated population. This regimen may be an appropriate palliative option for patients with an intact performance status who have progressed on other regimens. Research supported by Foundation 14.
Compliance of MAGIC protocol in patients with resectable gastrosophageal (GO) cancer: Tata Memorial Centre (TMC) experience.
Authors: Sirohi Bhawna , Singh Ashish , Gupta Alok , Deodhar Kedar , Goel Mahesh , Shrikhande Shailesh V 
Published: February 2017

154 Background: The perioperative regimen of ECF significantly improved outcome in MAGIC trial. In pts with advanced gastric cancer, oxaliplatin and capecitabine are non-inferior to cisplatin and 5-FU (Cunningham et al, NEJM 2006, 2008). We analysed the compliance, efficacy and toxicity of perioperative EOX (epirubicin, oxaliplatin, capecitabine) in pts with resectable GO cancer. Methods: This is a retrospective analysis of prospectively maintained database of pts with resectable GO cancer txed at TMC with EOX between Jan 2012 to Aug 2013. Pts were planned to receive 3# of neoadjuvant (NA) and 3# of adjuvant EOX (iv epirubicin 50 mg/m2 D1, oxaliplatin 130 mg/m2, on D1, capecitabiine 1250mg/m2D1-21 every 21 days. On completion of 3# of EOX, pts were planned to undergo gastrectomy and D2 lymphadenectomy (Shrikhande SV, WJSO 2013). Results: 67 pts (53M/14 F, median age 54 y, 32-76) were treated with NA EOX. Median CEA and Ca 19.9 were 2.76( 0.92-135) and 13.85 (<2 -6,308). 37% pts had signet ring histology and 30% poorly differentiated adenocarcinoma. Pre-operatively 92% pts completed EOX (91% in MAGIC trial); 5 pts did not complete 3# -3 due to grade 3 toxicity, 1 died of sepsis and 1 progressed. Treatment-related mortality was 1/67 (1.4%) compared to 2/237 (0.8%) in MAGIC trial. Response to NA tx was SD 22%, PR 64 %,CR 3% and PD in 6%, not assessable in 3 pts. Surgical resection done in 90% pts (88% in MAGIC); being planned in 5 pts; 6 pts did not undergo surgery—1 lost to follow up, 1 died, 2 PD, 2 inoperable. Resection was R0 in 54 pts and R1 in 2 pts. Median number of nodes dissected was 13 (0-37). 3 pts had pCR. The grade 3 and 4 toxicity was 1% intractable hiccups, 3% neuropathy, 9% diarrhea, 4% febrile neutropenia and 5% hand-foot syndrome—slightly higher than MAGIC reported results. 71% pts received adjuvant chemotherapy compared to 58% in MAGIC trial. Conclusions: In pts with operable GO adenocarcinoma, it is possible to deliver the MAGIC-type perioperative chemotherapy with comparable results in an Indian setting. Unlike MAGIC trial, majority of pts underwent D2 lymphadenectomy.
A prospective multicenter observational study for chemotherapy-induced nausea and vomiting in gastric cancer in Japan.
Authors: Iwagami Shiro , Baba Hideo , Hirabayashi Naoki , Sugiyama Yoichi , Nakajima Go , Tsuji Yasushi , Kunisaki Chikara , Tsuburaya Akira , Goto Masahiro , Maehara Yoshihiko , Takeda Koji , Yoshida Kazuhiro , Aiba Keisuke 
Published: February 2017

155 Background: There has been no nationwide survey on CINV or validation of the guideline in Japan. The aim of the study was to investigate the occurrence of CINV in gastric cancer patientstreated with chemotherapy for the first time. Methods: A nationwide survey on CINV was conducted by the CINV study group of Japan. 108 institutions participated in the study. A 7-day diary for CINV was provided to the patients prior to chemotherapy to record the daily occurrence and severity of CINV and the amount of food intake. Acute and delayed CINV was defined as nausea and vomiting which developed within or later than 24 hours after the start of chemotherapy, respectively. We evaluated the frequency and the risk factors of CINV. The medical staff also filled out questionnaires about their patients’ CINV. Results: A total of 154 patients were registered during the period from April 2011 to December 2012. There were 109 males and 45 females with a median age of 65 (range: 25-82). HEC was given to 152 and MEC was administered to 2 patients. CDDPwas included in all of HEC regimens. For preventing CINV, a three-drug regimen of aprepitant, 5-TH3 receptor antagonist (5- TH3 RA ), and dexamethasone was applied in 131 cases and a two-regimen of 5- TH3 RA and dexamethasone in 23. Acute nausea (AN) was ovserved in 19 patients (12.3%), while delayed nausea (DN) was experienced by 74 patients (48%). Acute vomiting (AV) occurred in 1 case (0.6%), while delayed vomiting (DV) was observed 15 cases (9.7%). The risk factors of CINV in gastric cancer were female and motion sickness. The age, pregnancy or morning sickness didn’t show any correlation with an occurrence of CINV. The staff predicted an occurrence of AN and DN in 96 patients (62.3%) and 132 (85.7%). However only experienced 19 (12.3%) and 74 (48.1%) patients showed symptoms of AN and DV, respectively. Conclusions: CINV in patients with gastric cancer seems to be under control with a management according to the guideline, however delayed CINV remains to be high and needs to be targeted by further investigation. Clinical trial information: UMIN000005971.
Detection of multidrug-resistant, gene-related proteins for postoperative individualized chemotherapy of gastric cancer.
Authors: Yu Pengfei 
Published: February 2017

156 Background: Postoperative adjuvant chemotherapy was beneficial for some patients,however, it may increase the treatment burden and reduce the immunity of other patients. Screening appropriate patients based on molecular markers for individualized adjuvant chemotherapy was necessary. Methods: Between June 2002 to June 2004, 119 patients who underwent radical gastrectomy were retrospectively analyzed. 61 patients had adjuvant chemotherapy based on platinum and 5-FU for 4 to 6 cycles. ToPo II negative, MRP positive and GST-π positive were regarded as three risk factors which may be associated with chemotherapy resistance and poor prognosis. Patients were divided into two groups: high-risk group (≥2 risk factors) and the low-risk group (<2 risk factors), and the tumor recurrence and patients’ survival time of the two groups were analyzed. Results: The average recurrence time of the low-risk group was significantly longer than that of the high-risk group (21.29 ± 11.10 VS 15.16 ± 8.05 months ,p<0.01).The 3-year and 5-year survival rate of the high-risk group was 57.4% and 42.6%, however, it had no significant difference compared to 66.2% and 58.5% of the low-risk group (P> 0.05). In the high-risk group, the 3-year survival rate of patients with/without chemotherapy were 62.1% and 52.0%, 5-year survival rates were 44.8% and 40.0%, but the difference was not statistically significant (P> 0.05). In the low-risk group, the 3-year survival rate of patients with/without chemotherapy were 81.2% and 51.5%, 5-year survival rates were 71.9% and 45.5%, and the difference was statistically significant (p<0.05). Conclusions: Combined determination of MDR-related proteins ToPo II, MRP and GST-π may be prospectively valuable for optimizing the chemotherapy regimes, and further predicting the outcomes of gastric cancer patients.
Interim safety analysis from a randomized, open-label, multicenter, phase III trial of capecitabine plus oxaliplatin (XELOX) versus capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer (AGC).
Authors: Hwang In Gyu , Kang Jung Hun , Lee Soonil , Lee Hyo Rak , Lee Hui Young , Ji Jun Ho , Lee Jeeyun , Park Se Hoon , Park Joon Oh , Park Young Suk , Lim Ho Yeong , Kang Won Ki 
Published: February 2017

158 Background: While combination chemotherapy involving fluoropyrimidines and platinum is currently considered a standard regimen in AGC, there has been a price to pay in terms of toxicity. Since the main goal of treatment in AGC remains palliation, the current multi-center phase III trial compares efficacy and safety of XELOX combination with those of X monotherapy in elderly patients with AGC. Methods: AGC Patients aged 70 years or older were randomized 1:1 to receive X (capecitabine 1000 mg/m2 bid po on D1-D14) or XELOX (capecitabine 1000 mg/m2 bid po on D1-D14 plus oxaliplatin 110 mg/m2 iv on D1). Treatment was repeated every 21 days until disease progression, unacceptable toxicity, or patient’s refusal. Primary endpoint was overall survival, and the target sample size was 200 eligible patients. This interim safety analysis contains toxicity data from the first 27 randomized patients. Results: Among the 27 patients (X: 13, XELOX 14), median age was 77 (range, 70-84) years and 24 patients had symptomatic (ECOG PS 1-2) disease. The arms of the study were balanced with respect to baseline characteristics. No treatment-related serious adverse events (SAEs) or unexpected toxicities were observed. The most frequent toxicities were anorexia, fatigue, anemia, and hand-foot skin reactions. Fatigue and sensory neuropathy were more common in XELOX than X patients. QOL data showed no significant differences between the two arms. Conclusions: Our data indicate that the addition of oxaliplatin does not add to the toxicity of single agent capecitabine as first-line chemotherapy in elderly (age ≥70 years) AGC patients. The accrual is currently ongoing (ClinicalTrials.gov, NCT01470742). Clinical trial information: NCT01470742.
Pretreatment skeletal muscle depletion as an adverse prognostic factor in metastatic gastric cancer.
Authors: Hasegawa Hiroko , Fujitani Kazumasa , Yamaoka Yusuke , Hirao Motohiro , Nakazuru Shoichi , Sekimoto Mistugu , Mita Eiji 
Published: February 2017

161 Background: Body composition has emerged as an important prognostic factor in cancer patients. Especially, skeletal mass depletion has been associated with poor performance status, toxicity of chemotherapy and shortened survival in cancer patients. However, the impact of pre-treatment skeletal muscle index on survival or toxicity in metastatic gastric cancer patients remains uncertain. Methods: In this retrospective study, we reviewed 98 metastatic gastric cancer (mGC) patients who received S-1 based combination chemotherapy as first-line treatment from April 2006 to March 2013. Pre-treatment skeletal muscle mass was quantified by CT cross sectional area at the third lumbar vertebrae and evaluated as lumbar skeletal muscle index (SMI) (cm2/m2) after normalization for stature (m2). Patients were categorized into 2 groups depending on initial SMI: 35 patients with SMI ≤ 40 and 63 patients with SMI > 40. Results: Median overall survival was significantly shorter in the SMI ≤ 40 group than in the SMI >40 group (439 days versus 565 days; p= 0.03). Progression free survival was also better in the SMI> 40 group without statistical significance (175 days versus 151 days; p= 0.17). Toxicity (grade 3 or 4) was more common in the SMI ≤ 40 group than in the SMI >40 group. (41.1% versus 11.1%; p=0.001). In multivariate analysis, performance status of 2 (HR 4.711, 95%CI 1.065 to 20.832, p=0.04), presence of primary tumor (HR 2.322, 95%CI 1.007 to 5.357, p=0.04) and pre-treatment SMI (HR 2.525, 95%CI 1.145 to 5.568, p=0.02) were independent prognostic factors for OS. Conclusions: The present study suggests that skeletal muscle depletion at the initiation of first-line chemotherapy might be an independent prognostic factor for mGC patients.
A restrospective analysis of toxicities encountered with palliative epirubicin, oxaliplatin, and capecitabine (EOX) chemotherapy for advanced esophagogastric cancer.
Authors: Khakoo Shelize Sadrudin , Georgiou Alexandros , Waters Justin S. 
Published: February 2017

162 Background: Palliative chemotherapy for advanced gastric and gastro-oesophageal junctional (GEJ) carcinoma improves tumour related symptoms and overall survival compared to best supportive care alone. EOX has been established as one of the most effective regimens in randomised clinical trials, but produced significant toxicity. We wished to examine the tolerability of EOX in everyday practice. Methods: A retrospective search was conducted to identify patients with advanced gastric or GEJ cancer, treated at our institution with at least one cycle of first line palliative EOX between 2009 and 2012. Patient baseline characteristics, toxicities (graded according to CTCAEv.4), dose reductions, treatment interruptions and discontinuations were analysed. Results: We identified 60 patients, 83% were male, and the median age was 64 years (age range18-82 years). 85% had a baseline performance status (PS) of 1, 10% PS of 2 and 5% PS of 0. 75% had GEJ cancer and the remainder had gastric cancer. 82% were commenced on standard EOX (1250mg/m2 capecitabine, 130mg/m2 oxaliplatin and 50mg/m2). 80% of patients experienced grade 3 or worse toxicity. 27% discontinued treatment due to excessive toxicity and 37% due to progressive disease. Significant toxicities (at least grade 3) were: 28% neutropenia, 27% diarrhoea, 23% fatigue, 10% vomiting, 10% anaemia, 8% neutropenic sepsis, 8% nausea, 5% thrombocytopenia, 5% peripheral neuropathy, 3% mucositis and 3% chest pain. 47% of patients required a dose reduction of at least 1 drug. 66% of patients completed 3 cycles, 35% completed 6 cycles and 18% completed 8 cycles. The mean progression free survival for patients completing 8 cycles was 4.6 months. Conclusions: EOX improves tumour related symptoms and overall survival but the benefits are often short-lived and in some patients it is associated with unacceptable toxicity, given their limited life expectancy. More thought needs to be given to prophylactic measures and modification of the EOX regimen to improve tolerability without compromising efficacy.
Matched pair analysis to examine the effects of a planned preoperative exercise program in early gastric cancer patients with metabolic syndrome to reduce operative risk: The Adjuvant Exercise for General Elective Surgery (AEGES) study group.
Authors: Cho Haruhiko , Yoshikawa Takaki , Oba Mari Saito , Hirabayashi Naoki , Shirai Junya , Aoyama Toru , Hayashi Tsutomu , Yamada Takanobu , Oba Koji , Tsuburaya Akira , Sakamoto Junichi 
Published: February 2017

166 Background: Since obesity is a risk factor during surgery, the effects of a preoperative exercise program to reduce the incidence of peri- and postoperative complications in patients with a high BMI (> 25) and metabolic syndrome were investigated. An assessment of the effects of prospectively planned preoperative exercise was performed in a prospective matching study comparing an exercise testing group and a usual preoperative preparation group who underwent gastrectomy for gastric cancer in Japan. Methods: Stage I gastric cancer patients with metabolic syndrome diagnosed according to the criteria of the Japanese Ministry of Health, Labour and Welfare were enrolled in a surgery after preoperative exercise group. The control group was selected from a database using an individual matching approach for surgery, sex, weight, BMI, volume of visceral fat and institution. The primary end point was the frequency of postoperative complications (cardiovascular events, pneumonia, surgery-related abdominal complications, etc.). Results: A total of 72 patients (54 in the surgery alone group, 18 in the preoperative exercise group) were analyzed. The median operative time and amount of bleeding were 208 min and 130 ml in the surgery alone group and 248 min and 105 ml in the exercise group, respectively. Postoperative complications occurred in one case (5.5%) in the exercise group and 22 (40.7%) cases in the surgery alone group. Conclusions: Preoperative exercise is safe, and its benefits in reducing postoperative complications are promising and therefore warrant further investigation.
Exploratory analysis to investigate clinical factors that may influence trastsuzumab efficacy in patients with HER2-positive gastric cancer.
Authors: Wakatsuki Takeru , Chin Keisho , Matsusaka Satoshi , Ogura Mariko , Ozaka Masato , Suenaga Mitsukuni , Shinozaki Eiji , Nakayama Izuma , Mizunuma Nobuyuki 
Published: February 2017

169 Background: ToGA study showed significant survival benefit of trastuzumab in patients with HER2 positive gastric cancer (GC); however, clinical factors which can impact its efficacy prior to treatment are still unknown. Hence, we conducted this exploratory analysis whether clinical factors could influence trastuzumab efficacy in patients with HER2 positive GC. Methods: Thirty-three HER2 positive GC patients, who were treated by trastuzumab with chemotherapy in our institute from 2011 March to 2012 December, were enrolled. Clinical factors according to ToGA study and tumor markers were examined. We retrospectively analyzed whether these clinical factors were associated with progression-free survival (PFS) and overall survival (OS). These endpoints were estimated using by Kaplan-Meier methods and compared by the log-rank test. The Cox regression analysis including only clinical factors of which p-value was less than 0.02 was done. Results: Median follow-up period was 10.8 months. Median age was 63 y.o. and 64% of the patients were male. PS 0-1, GEJ cancer, visceral metastasis (lung or liver), previous gastorectomy, previous chemotherapy, number of metastatic site (1-2), and number of metastatic lesion (1-4) were found in 97%, 27%, 58%, 36%, 21%, 76%, and 27% of the patients, respectively. Sixty-seven% and 94% of the patients were differentiated type and HER2 3+ by IHC, respectively. Baseline median CEA and CA19-9 levels were 5.2 ng/ml and 109.4 U/ml, respectively. Median PFS was 9.5 months (95% CI: 5.5-13.5) and median OS was not reached. Overall response rate by RECIST was 71.4%. Lower CA19-9 levels were associated with longer PFS in univariate analysis. Patients who had lower CA 19-9 levels showed a median PFS of 12.2 months vs. 6.9 months for patients who had higher CA19-9 levels (HR: 0.41 [95%CI: 0.17-1.00], p=0.042), however this result was not conserved in multivariate analysis. No clinical factors were associated with OS. Conclusions: Lower CA19-9 levels were associated with favorable PFS in the patients with HER2 positive GC upon when treated by trastuzunab. External clinical validations and further molecular analyses are needed to validate this result.