bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy of systemic chemotherapy (CT) for the patients (pts) with unresectable liver metastasis (LM) of colorectal cancer (CRC)
Authors: Mera K. , Ohtsu A. , Doi T. , Muto M. , Sano Y. , Takahashi S. , Yoshida S. 
Published: March 2020

13567 Background: Surgical resection of colorectal LM is the only treatment which provides long-term survival for pts with advanced disease confined to the liver. However, most of LM are initially unresectable. The aim of this retrospective study was to evaluate the efficacy of systemic CT for the pts with initially unresectable LM from CRC. Methods: Subjects of this study were advanced CRC with unresectable LM treated by systemic CT at our institution between Aug ’92 and Dec ’03, and fulfilled the following criteria; Age ≤ 75, PS ≤ 2, histologically confirmed colorectal adenocarcinoma, no extrahepatic disease, no prior CT and no serious complication. Results: A total of 349 pts with metastatic CRC were managed by systemic CT between the period. Among these, there were 47 pts who met the recruitment criteria. Their characteristics were; male/female: 32/15, median age (range): 59 (34–75), PS 0/1/2: 33/12/2, primary tumor: colon/rectum: 26/21, sinchronous/metachronous: 26/21, number of LM: 4 ≥ / 5 ≤: 9/38. Regimens of CT were; 5FU/5FU+LV/CPT-11+5FU/CPT-11+5FU+LV/Others: 4/11/7/18/7. In all 47 pts, response rate was 53%, median survival time and 3-year survival rate were 14.6 month and 14.6%, respectively, at a median follow-up of 43.4 month. Seven of 47 (15%) could be secondarily resected after response to CT and all had R0 resection. Estimated 3-year survival rates in resected and non-resected pts were 57.1% and 0%, respectively. Prior CT before liver resection was CPT-11+5FU+LV (IFL)/CPT-11 alone: 6/1. Of the 7 resected pts, 2 pts are alive with no evidence of disease for 38 and 40 month after initiation of CT. Five of 7 pts relapsed (liver 3, liver and lung 2) and all treated with systemic CT for recurrence. Although recurrent disease is persisting, 2 of 5 are still alive for 34 and 48 month by continuing CT. Conclusions: Effective systemic CT allows some pts with unrsectable colorectal LM to be rescued by hepatic resection and provides a chance of long-term survival. No significant financial relationships to disclose.
Outcome of rectal carcinoma patients receiving adjuvant chemoradiotherapy in Marmara University Hospital
Authors: Dane F. , Gumus M. , Iyikesici S. , Yumuk F. , Basaran G. , Atasoy B. M. , Abacioglu U. , Cabuk D. , Teomete M. , Turhal S. 
Published: March 2020

13584 Background: Surgical resection is the cornerstone of curative therapy for rectal cancer. Relapse rate following potentially curative resection is high in patients with stage II/III disease. Thus, chemoradiotherapy is the standard adjuvant treatment in resected stage II/III rectal carcinoma. There are limited studies, if any, analyzing the outcome of rectal cancer patients with stage II/III who received adjuvant chemoradiotherapy after curative resection in Turkey. Therefore, we aimed to analyze the treatment outcome, and the prognostic significance of various parameters in these patients. Methods: 106 patients with stage II/III rectal cancer treated with adjuvant chemoradiotherapy since 1997 until present were analyzed retrospectively. Patients received 5-fluorouracil (370–425mg/m2/day × 5days) and calcium leucovorin (20mg/m2/day × 5days), q4weeks, two courses before and two courses after radiotherapy. The 5-fluorouracil dose was reduced to, 225mg/m2/day given continuously as protracted short-term infusion during radiotherapy. 45–50.4 Gy radiotherapy was given to the pelvic region. Patients were followed-up every 3 months for the first 2 years and every 6 months thereafter. Age, gender, T stage, N stage, histological grade, lymphatic, vascular, and perineural invasion were analyzed as prognostic factors. Results: The median follow-up was 34 months. Median age was 59.5 years. Forty-four percent of the patients were node-negative. Lymphatic, vascular, and perineural invasion rate were 50.5%, 47.3%, and 32.3% respectively. Five-year disease-free and overall survival rates were 68.8% and 72.2%, respectively. Median survival time and median disease free-survival time were not reached at the time of analysis. In multivariate Cox regression analysis; T stage (p: 0.022), nodal stage (0.019), presence of lymphatic invasion (p: 0.0001), and the presence of vascular invasion (p:0.01) were independent prognostic factors. Conclusion: The adjuvant treatment outcome in Turkish patients in our department with stage II/III rectal cancer is similar to those reported in the Western studies. No significant financial relationships to disclose.
A phase II pilot trial with RP101 in advanced pancreatic carcinoma
Authors: Fahrig R. , Quietzsch D. , Heinemann V. , Liebert A. , Haenel M. 
Published: March 2020

14000 Background: (E)-5-(2-bromovinyl)-2’-deoxyuridine (BVDU, RP101), which supports apoptosis and prevents the acquisition of chemoresistance, was tested in cultured human pancreatic tumor cells. RP101 down-regulated uridine phosphorylase, a marker of poor prognosis, and APEX1, which is involved in DNA repair, and repressed Stat-3 and its target VEGF. Furthermore, RP101 activated antitumor immunity. These results encouraged us to investigate the effect of RP101 in combination with gemcitabine (GEM) and cisplatin (CIS) in patients with advanced pancreatic cancer. Methods: A phase II pilot trial was designed to compare the GEM/CIS/RP101 combination to historical GEM/CIS combination. The primary endpoint was survival. 13 pts with histological documented pancreatic carcinoma received GEM 1.000 mg/m2 plus CIS 50 mg/m2 on days 1 and 15 of a 28-day schedule. RP101 treatment was on the same day and for four days after chemotherapy (500 mg/day). Results: All patients showed at least a stable disease, and 33% of them a PR. As a historical control, 22 pts were selected by random generator from 98 patients enrolled in a previous Phase III study performed in the same centers, 15 with stage IV and 7 with stage III disease, resulting in a similar proportion of stage III to IV patients as in the RP101 co-treatment group (nine stage IV and four stage III). In the RP101-co-treatment group the median survival was significantly longer than that of the historical control group (447 days vs. 186 days, p=0.007). Time to progression (TTP) was also prolonged (280 days vs. 104 days, p=0.004). Ten of the 13 pts lived longer than one year, 4 nearly two years after first treatment. Conclusions: The combined use of GEM/CIS/RP101 prolonged progression-free and overall survival in locally advanced and metastatic pancreatic cancer when compared to all published studies with all combinations of drugs. A repeat study with GEM/RP101 shows similar promising results indicating that the combination of RP101 with GEM should be explored in larger studies in patients with advance pancreatic cancer. [Table: see text]
Long-term outocomes of preoperative chemoradiation therapy with gemcitabine and accelerated hyperfractionated radiation for respectable pancreatic cancer
Authors: Nakamori S. , Nakahira S. , Miyamoto A. , Marubashi S. , Nagano H. , Dono K. , Sakon M. , Monden M. 
Published: March 2020

14004 Background: Gemcitabine (GEM) is recognized as an effective chemotherapeutic agent for non-curative pancreatic cancer and has an activity for radiosensitizer. Although preoperative chemoradiation therapy (preCRT) with GEM is one of the promising adjuvant therapies for potentially curative pancreatic cancer, the clinical significance of the treatment remains to obscure. Methods: Potentially resectable pancreatic cancer patients were recruited in this study from September 2001 through August 2004. Patients were randomly divided into preCRT group and a control group. Patients in preCRT group received GEM (400 mg/m2 or 800 mg/m2 on day 1 and 7) and concomitant accelerated hyperfractionated irradiation (1.5 Gy ×2/day, 5 days/weeks, total dose 30Gy or 36 Gy). After 3–4 weeks’ rest of the preCRT, patients were re-evaluated for resectability. Patients who underwent R0 resection did not received any postoperative adjuvant treatment until recurrence. Results: There were 23 patients in preCRT group and were 19 patients in control group. After re-evaluation, 4 patients (17%) were considered as unresectable due to the progressed disease. 19 patients (83%) in preCRT group and 19 patients (100%) in control group underwent laparotomy. Sixteen patients (70%) in preCRT group and 17 patients (89%) in control group underwent R0 resection. Median survival times were 17.6 months in preCRT group and 16.7 months in control group, respectively (p=0.65). Among patients underwent R0 resection, one and three-years survival rate were 81.2% and 27.1% in preCRT group, while these were 70.6% and 15.4% in the control group (p=0.26). Local recurrence was observed in 4 (25%) of 16 patients who underwent R0 resection in preCRT group and in 7 (41%) of 17 patients who underwent R0 resection in control group, while recurrence at distant organs (liver, lung, peritoneum, bone) were observed in 8 patients (50%) of preCRT group and 8 patients (47%) in control group. Conclusions: Although the preoperative chemoradiation therapy with GEM and accelerated hyperfractionated radiation for potentially curative pancreatic cancer is likely to be promising against local recurrence after R0 resection, survival benefit of the therapy was unsatisfactory. No significant financial relationships to disclose.
Pre-operative chemotherapy with epirubicin, cisplatin and 5FU/capecitabine in patients with operable oesophageal cancer
Authors: Boleti E. , Sharland D. , Weeden D. , Bailey I. , Bateman A. , Geldart T. , Crabb S. , Copson E. , Darby A. , Iveson T. 
Published: March 2020

14011 Background: The MRC OE02 study demonstrated pre-operative chemotherapy in patients with potentially operable oesophageal cancer improved survival. Pre-operative chemotherapy has been widely adopted in the UK. At our institution for the past 5 years patients with operable oesophageal cancer have routinely been given pre-operative chemotherapy with 3 cycles of Epirubicin, Cisplatin and Protracted Venous Infusion (PVI) 5FU (ECF). Recently, PVI 5FU has been replaced by Capecitabine (ECX). Methods: From March 2000 to October 2005, patients with operable oesophageal carcinoma have received 3 cycles of ECF or ECX (Epirubicin 50mg/m2, Cisplatin 60mg/m2, and PVI 5FU 200mg/m2 per day or Capecitabine 625mg/m2 po bd for 21 days). Disease response was assessed by CT scan and surgery was performed 4–6 weeks after completion of chemotherapy. Results: 59 patients received neo-adjuvant chemotherapy (48 received ECF, 11 ECX). Median age was 64. Fifty-three patients (89.8%) completed the planned 3 cycles of chemotherapy. WHO grade 3 or 4 toxicity occurred in 7 patients (11.8%): 6 haematological with 1 toxic death among them (1.7%) and 1 mucositis. Forty-four of 49 patients (89.7%) with dysphagia reported improvement of their symptoms as a result of chemotherapy. Fifty-two patients (88.1%) proceeded to surgery of which 47 (90.3%) underwent complete tumour resection, 4 patients (7.7%) were found to have inoperable/metastatic disease and 1 patient had incomplete excision (1.9%). Median follow-up was 26.8 months with overall median survival of 36.2 months and a 2-year survival of 63.2%. Thirty-four (57.6%) patients remain alive to date of which, 30 are disease-free and 4 are alive with recurrent disease. Conclusions: These encouraging results demonstrate that 3 cycles of preoperative ECF/ECX chemotherapy in patients with operable oesophageal cancer allow surgery to be safely performed in the vast majority of patients and our 2-year survival compare favourably with previously reported series. These results suggest that 3 cycles of pre-operative treatment with ECF/ECX chemotherapy may improve survival in this group of patients and is worthy of further research. No significant financial relationships to disclose.
Gemcitabine and oxalipaltin (Gemox) in advanced/unresectable gall baldder cancer: A phase II study
Authors: Sharma A. , Raina V. , Shukla N. K. , Deo S. V. 
Published: March 2020

14027 Background: Adenocarcinoma of gall bladder is common in females in northern part of India with rising incidence. In Delhi incidence is 5.5 per 1,00,000 population in females (4th most common cancer in females after breast, cervix, and ovary). Majority of patients present in unresectable stage and are offered palliative treatment by placing a stent and/or using chemotherapy. Gemcitabine and Oxaliplatin as single agents or in combinations with others have shown some activity in adenocarcinoma of pancreas, gall bladder, and biliary tracts. There is in vitro evidence about synergism between gemcitabine and oxalipaltin. To investigate efficacy of this combination in advanced/ inoperable gall bladder cancer this study was started. Method: A phase II study. Eligible patients were started on Gemcitabine and oxaliplatin combination as: Inj Gemcitabine 900 mg/m2 IV 30 minutes infusion day 1 and 8, Inj Oxaliplatin 80 mg/m2 2 hours infusion in Dextrose 5% Day 1 and 8 All every 3 weeks. For a maximum of 6 cycles/ disease progression which ever is early. Protocol was approved by local ethics committee. Results: Thirty two recurrent/ unresectable patients, twenty two of them females, with an age range of 31–72 years (median 48 years) were enrolled for the study after obtaining written consent. With median of 3 total of 98 cycles (range 1–6) have been delivered. 3 patients received 6 cycles and another 8 are at various stages of therapy. Grade III/IV toxicity was seen in 4 patient; no toxic death. Responses have been assessed on intent to treat basis using RECIST criteria: CR 2 (6.3%) including one pathological, PR 3 (9.4%), SD 10 (31.3%), 13 (40.6%) progressed (PD) on chemotherapy, and in 4 (12.5%) patients response evaluation is being done. Even in a worst case scenario about 16% patient had documented response and another 31% stable disease. On follow up 18 (56.2%) patients have died. Median survival is 6 months and 10 patients survived more than 6 months and 10 months survival is 12% (4 patients). Updated results will be presented during meeting. Conclusion: This combination is feasible, well tolerated and may be viable option in treatment of such patients where otherwise median survival is about 3 months. These results warrant further evaluation in a large trial. No significant financial relationships to disclose.
Immunological evaluation of personalized peptide vaccination with gemcitabine for advance pancreatic cancer patients
Authors: Yanagimoto H. , Mine T. , Yamamoto K. , Satoi S. , Honma S. , Mizoguchi J. , Yamada A. , Oka M. , Kamiyama Y. , Itoh K. , Takai S. 
Published: March 2020

14029 Background: A phase I clinical study was performed to determine safety and immunogenicity of personalized peptide vaccination with gemcitabine (GEM) in advanced pancreatic cancer patients (APC). Methods: Thirteen human histocompatibility leukocyte antigen (HLA)-A24+ or A2+ patients with unresectable (n=10) or recurrent (n=3) pancreatic cancer were treated with GEM plus up to four peptides that were positive for pre-vaccination measurement of peptide-specific IgG antibodies and/or cytotoxic T lymphocyte (CTL) precursors in the circulation (personalized peptide vaccine). GEM was administered at 1000mg/m2 as a 30-min intravenous infusion once a week for three week, followed by 1 week of rest. All patients were treated on outpatient basis. The cycle was repeated every 8 weeks. Results: Peptide doses of vaccination per week were planned as follows: level 1, 1mg; level 2, 2mg; and level 3, 3mg. The main grade 3 toxicities observed during the first cycle in each level were neutropenia (15%), anemia (23%) and thrombocytopenia (15%). No significant differences in the toxicities were found between each level. There was no dose limiting toxicity (DLT) observed in each level. Augmentation of peptide-specific CTL responses in the post-vaccination peripheral blood mononuclear cells was observed in each level, while increased titer of peptide-specific IgG antibodies was observed in the post-vaccination plasma in level 2 and level 3. Applicable responses were no complete response, two partial responses (15%), and 7 stable diseases (55%). Nevertheless 7 patients of them (54%) were under the second-line chemotherapy, disease control rate was 70%, the median TTP (time to progression) was 18.5 weeks and the MST (median survival time) was 7.6 months in this study. Conclusions: The combination therapy of personalized peptide vaccination with GEM for APC patients is feasible and safe. Because of positive immune responses under a full dose of GEM, the peptide vaccination of 3 mg is recommended. No significant financial relationships to disclose.
Late toxicity after adjuvant radiochemotherapy for gastric adenocarcinoma
Authors: Wysocka B. , Kassam Z. , Lockwood G. , Brierley J. , Dawson L. , Ringash J. 
Published: March 2020

14042 Background: There is limited late toxicity data following adjuvant radiochemotherapy for resected gastric cancer. Methods: We reviewed radiation dose volume histograms (DVHs) and toxicity outcomes for gastric cancer patients (stage Ib to IV) who received adjuvant conformal radiochemotherapy between November 2000 and May 2005. Charts were reviewed to determine survival, late clinical toxicity, and biochemical markers of renal or hepatic toxicity (creatinine, bilirubin, ALP, AST, ALT). DVHs for kidneys and liver were correlated with toxicity outcomes. Overall (OS), disease-free (DFS) and event (death or late toxicity) -free (EFS) survival were calculated. Results: 80 of 88 patients’ DVHs were available for review. Mean age was 58 years (range: 22 - 75), with 53 (66%) males and 27 (34%) females. Stage distribution was: IB - 13 (16%), II - 32 (40%), IIIA - 24 (30%), IIIB - 4 (9%) and IV - 7 (9%). 3D conformal radiotherapy (45 Gy/25 fractions) was used. In 69 patients, chemotherapy was standard as per the INT-116 study; 11 study patients received infusional 5FU (200mg/m2/day for 12 weeks) and cisplatin in escalating dose (4 cycles q 2 weeks, 0–30 mg/m2). All treatment was completed in 56 (70%) patients; 9 (11%) did not complete radiotherapy and 22 (27.5%) had chemotherapy dose omissions. Median follow up is 30 months (range 6–62). At 2 years, OS was 84% (95% CI 73%-90%), DFS was 66% (95% CI 53%-75%) and EFS was 61% (95% CI 49–72%). Clinical late toxicity occurred in 6 patients 9 to 53 months following treatment: bowel obstruction/perforation (2) and anastomotic stricture (4), in volumes treated to 45 Gy. No clinical symptoms of renal or hepatic toxicity were reported. Grade 1 (CTCAE v3.0) elevation of creatinine was observed in 8 (10%) patients; at least one liver test was altered in 22 (27.5%) patients, (grade 1–17; 2–4; 3–1). Abnormal bloodwork occurred 9 days to 55 months following treatment and did not correlate with higher kidney and liver doses. Conclusions: In our cohort of patients treated with conformal radiochemotherapy, small bowel and anastomotic toxicity was most common, with no clinical renal or hepatic toxicity observed. Biochemical renal and hepatic changes were not related to clinical toxicity or dose delivered. Further assessment with longer follow-up in a larger sample is planned. No significant financial relationships to disclose.
Usefulness of FDG-PET in predicting the prognosis of advanced pancreatic carcinoma with chemotherapy
Authors: Ueno M. , Ohkawa S. , Miyakawa K. , Amano A. , Masaki T. 
Published: March 2020

14043 Background: 18F-fluorodeoxyglucose (FDG) PET is a new diagnostic imaging technique that takes advantage of increased glucose metabolism by the tumor cells. High uptake of FDG is reportedly associated with poor survival in head and neck cancer (Heikki et al., 1997, Nuclear Oncology). FDG uptake diminishes with elevated levels of plasma glucose. We herein evaluated the usefulness of FDG-PET in predicting the prognosis of advanced pancreatic carcinoma (APC). Methods: FDG-PET was performed on 32 consecutive patients with APC between July 2001 and April 2004. The patients fasted for at least 5 hr before the study. The plasma glucose level was controlled under 150 mg/dl by using oral antidiabetic or insulin therapy in advance. FDG-PET images were acquired 45 min after intravenous injection of FDG. We did not measure the plasma glucose level directly before imaging. The FDG uptake in the primary tumor was quantitated as the standardized uptake value (SUV), and the maximum SUV (SUVmax) was measured in the regions of interest. All of the 32 APC patients received chemotherapy (26: gemcitabine, 1: gemcitabine + UFT, 5: TS-1). We analyzed the correlation between SUVmax and the overall survival. Then, we excluded the diabetics (n = 8) and compared SUV in the non-diabetic patients (n = 24). The overall survival curve was plotted according to the method of Kaplan and Meier. The difference in the overall survival was calculated using the log-rank test, and a multivariate analysis was conducted. Results: 32 patients were examined. All cases showed FDG uptake in the pancreatic tumor (SUVmax ranged from 2.73 to 9.67). The overall survival ranged from 38 to 945 days with a median of 261 days.These patients were classified into two groups at a median SUVmax value of 4.81. There was no significant difference in the overall survival between these two groups (p > 0.05). The non-diabetic patients (n = 24) were classified into two groups at a median SUVmax value of 5.51. The high SUVmax group had shorter overall survival than the low SUVmax group (p = 0.039). The multivariate analysis using Cox hazard model also revealed that SUVmax was a significant, independent factor that influenced the survival (p = 0.043) in the non-diabetic patients. Conclusions: FDG-PET may be a useful modality in determining the prognosis of APC. No significant financial relationships to disclose.
A phase I/II study of oxaliplatin, docetaxel, and capecitabine in advanced carcinoma of the esophagus and stomach
Authors: Evans D. L. , Miner T. , Ng T. , Akerman P. , Harrington D. , Martel D. , Maia C. , Benton D. , Saba N. , Safran H. 
Published: March 2020

14046 Background: The Brown University Oncology Group has attempted to modify the regimen of docetaxel, cisplatin and fluorouracil (DCF) to reduce toxicity, simplify administration and maintain efficacy. We have a completed a phase I/II study of weekly doxetaxel, carboplatin and capecitabine for patients with advanced esophagogastric cancer (Safran et al, Am J Clin Oncol, 2006). In this phase I study we have substituted oxaliplatin for carboplatin to determine the maximum tolerated dose (MTD) of weekly docetaxel and oxaliplatin with capecitabine. Methods: Patients with metastatic esophageal and gastric cancers received docetaxel and oxaliplatin on days 1 and 8 and capecitabine in divided doses, twice daily, on days 1–10, with each cycle repeated every 21 days. Patients were treated at 4 dose levels as shown in the table. Results: Fourteen patients have been enrolled. The median age was 58.5 years. Eight patients had esophageal cancer and six had gastric cancer. Grade 3/4 dose limiting toxicities (DLTs) of diarrhea, nausea, and febrile neutropenia occurred in three of four patients at dose level 3. An intermediate dose level was added (2A), reducing the capecitabine dose. Conclusion: Oxaliplatin 50 mg/m2 and docetaxel 35 mg/m2 day 1 and 8 with capecitabine 750 mg/m2 BID × 10 days in 21 day cycles may represent a promising, easily administered regimen for metastatic esophageal and gastric cancer. Enrollment continues at dose level 2A. [Table: see text] [Table: see text]