bluuebunny/crossref_metadata_2025_split huggingface dataset:
Preliminary results of a phase II trial of FOLFOX4 regimen in Chinese patients with unresectable primary liver cancer
Authors: Qin S. K. , Wang Y. J. , Wu Q. , Xing B. C. 
Published: March 2020

14065 Background: Primary liver cancer (PLC) is the 3rd most common cancer in whole China. Development of systemic chemotherapy for the patients not eligible for operation as well as TACE commonly have been required. Oxalipaltin (Eloxatin)+ 5-FU/LV, namely FOLFOX 4 regimen was tried to investigate its efficacy and safety in inoperable PLC. Methods: It was an open-label, single arm and multi-center phase II study to explore RR, DCR,TTP and MST. All the pts had pathologically confirmed inoperable PLC with/without distant metastasis. The pts were treated with the standard FOLFOX 4 regimen, that is OXA 85mg/m2 d1; LV 200mg/m2 IV 2hrs d1,2; 5-FU 400mg/m2 bolus, d1,2 and 5-FU 600mg/m2 CIV 22hrs d1,2; q2w upto 6 cycles or until progression. Tumor evaluation was done every 6 weeks using RECIST criteria. Neurotoxicity was evaluated by Eloxatin specific neurotoxicity criteria (Sanofi-Aventis Co.Ltd) and other toxicities by the NCI CTC AE version 2.0. Results: From July 2004 to Sep. 2005, 27 pts (21 male, 6 female) were recruited from the 4 cancer centers with average age of 56 ±13 years old. 25 patients (92.6%) had hepatocellular carcinoma, and 2 (7.4%) cholangiocellular carcinoma. 15 pts (55.6%) had metastatic disease. 1 pt received liver transplantation before inclusion. The median number of cycles was 4 per pt. 26 pts were evaluable for efficacy and safety. The RR was 19.2% (5/26; 1 CR and 4 PR), and DCR 57.7% (15/26; including 10 SD). 4 of the 5 responsive pts had hepatocellular carcinoma, and 1 had cholangiocarcinoma. Serum AFP level was significantly decreased (mean 131,890.4ug/dl at the baseline and 1,298.6ug/dl after 6 cycles) for the first 16 pts. The first 16 pts’ safety data were available in detail: 11 NCI grade 3/4 events were observed from a total of 76 cycles administered: including 5 neutropenia, 3 leucopenia, 1 thrombocytopenia, 1 infection and 1 liver dysfunction. Grade II & III neurotoxicity was found in 3 & 2 patients respectively. The TTP,MST and further safety data were under follow-up. Conclusions: The preliminary data of the FOLFOX 4 regimen for the advanced Chinese pts with inoperable PLC have shown encouraging results with the better efficacy and favorable safety profile. Further exploration in this area is warranted, especially in hepatocellular carcinoma. No significant financial relationships to disclose.
Retrospective review of patients with adenocarcinoma of the pancreas and ovarian metastasis: Clinical characteristics, treatment strategies, and survival data
Authors: Falchook G. S. , Varadhachary G. R. , Wolff R. A. 
Published: March 2020

14068 Background: Ovarian metastasis from pancreatic adenocarcinoma is rare, and data on clinical features, treatment, and survival are limited. Methods: Charts of 19 patients with pancreatic adenocarcinoma and ovarian metastasis identified by the UTMDACC tumor registry from 1984–2005 were reviewed. Results: Clinical characteristics and survival data are in the Table. Data were limited in patients seen for single-visit second-opinion consultation or for whom only pathology was available. Other synchronous metastatic sites included peritoneum (11), liver (9), lung (5), fallopian tubes (4), uterus (2), colon (2), appendix (1), and brain (1). Ovarian metastasis size varied from “studding” to 20 cm. Among the 12 patients known to have received chemotherapy, 10 underwent resection of the ovarian metastasis. Among these, 5 patients achieved a partial response (PR) in liver metastases, peritoneal metastases, or the pancreatic primary. 3 patients received chemotherapy before resection of the ovarian metastasis, but none demonstrated a response in the ovarian metastasis. Chemotherapy regimens achieving a PR included cisplatin/paclitaxel, gemcitabine/oxaliplatin, gemcitabine/cisplatin, gemcitabine/C225, and gemcitabine/docetaxel/capecitabine. Conclusions: Pancreatic adenocarcinoma with ovarian metastasis is rare, and patients often present with an ovarian mass prior to the pancreatic adenocarcinoma diagnosis. Surgical resection of ovarian metastasis may play a palliative role in symptomatic patients since the survival of these patients appears favorable and response of ovarian metastasis to chemotherapy has not been observed. [Table: see text] No significant financial relationships to disclose.
Gemcitabine + cisplatin (GEM+CIS) in combination with regional hyperthermia (RHT) in second-line therapy of gemcitabine-refractory metastatic pancreatic cancer
Authors: Tschoep K. E. , Milani V. , Schmidt G. , Schiel X. , Abdel-Rahman S. , Kuhlencordt M. F. , Salat C. , Maier V. , Heinemann V. , Issels R. D. 
Published: March 2020

14073 Background: Our completed phase III trial comparing GEM + CIS vs. GEM alone showed good efficacy for the combination arm in 1st-line therapy (ASCO abstr. No. 1003, 2003). Based on the rationale of chemosensitization of CIS by RHT we are performing a prospective phase II study with GEM + CIS combined with RHT. Methods: Until 8/2005 12 pts with metastatic pancreatic adenocarcinoma who failed GEM-based 1st-line-therapy were enrolled in this study. One cycle consisted of GEM (1000mg/m2) on d1 followed by CIS (25mg/m2) on d2 and d4 combined with RHT (BSD system). A total of 2 blocks each of 4 cycles were given biweekly. The main endpoints were time to second progression (TTP2) and 1-year event free survival (1-yr-EFS). TTP2 and EFS were defined as time from start of 2nd-line therapy until progression of disease or death. Response (RECIST) was evaluated after 4 and 8 cycles of therapy. Results: Pt characteristics: median age 60; M:F=8:4. Median time to first progression (TTP1) was 6 months (95% CI:2–7). 8/12 pts received all 8 cycles. No toxic death and no grade 4 toxicity occurred. In 12/2005 10/12 pts were evaluable for this study. Control of disease (1CR, 2MR, 4NC) and progression (3PD) occurred in 70% and 30% respectively. The median TTP2 is 8 months (95% CI: 2–13) and the 1-yr-EFS is 32% (95% CI:3–61). 7 pts are alive at 12/2005. Conclusions: Our ongoing study (EudraCT-No 2005–003855–11) using RHT combined with GEM + CIS shows promising antitumor activity with a very encouraging TTP2 and median 1-yr-EFS in the 2nd-line treatment of GEM-refractory metastatic pancreatic cancer. [Table: see text]
Preliminary results for the combination of docetaxel, oxaliplatin and capecitabine as a first-line treatment for metastatic oesophagogastric cancer
Authors: Viteri S. , Rodríguez J. , González Cao M. , De La Cámara J. , Chopitea A. , Viudez A. , Reyna C. , Olier C. , García-Foncillas J. 
Published: March 2020

14076 Background: Chemotherapy remains the main treatment option for metastatic oesopagogastric cancer (MOC) patients (Pts). First-line regimens have proved a slight but significant increase in quality of life and survival, but a standard regimen has not been defined yet. Several new drugs, as Docetaxel (D), Oxaliplatin (O) and Capecitabine (C) have demostrated activity in MOC. They have shown synergy in preclinical models and activity in previous phase II trials. The purpose of our study is to asses activity and feasibility of the combination of D, O and C as first-line chemotherapy in MOC patients. Methods: MOC patients, with good ECOG performance status and chemonaive are eligible. Pts receive D 60 mg/m2 day 1, O 85 mg/m2 day 1 and oral C 650mg/m2 bid d1–14 every 3 weeks. Primary endpoints are response according to WHO criteria and toxiciy assesment according to NCI.CTCAE v3.0. Results: From November 2004 to December 2005, 17 Pts have been enrolled. Median ECOG PS is 1 (0–2) M/F:9/8. Median age is 57 years (38–68) Primary tumor are gastric carcinomas (82%) and lower oesofagus carcinomas (18%). Metastatic sites included peritoneum 58%, liver 23% and lung 23%. Median number of cycles is 5 (1–7) Treatment is well tolerated with no toxic deaths. NCI grade 3–4 toxicities include 2 Pts (11.8%) with grade 4 neutropenia and one of them developed septic shock; 2 Pts with grade 3 asthenia, 1 Pt with grade 3 vomiting and 1 patient with grade 3 neurotoxicity. Main NCI grade 2 toxicities are dhiarrea (35.3%) and neurotoxicity (23.5%). 13 Pts have been evaluated for response until now: 9 Pts have a confirmed Partial Response (69.2%) and 2 of them underwent salvage surgery; 3 Pts have Stabilized Disease and 1 Pt Progression Disease. Median time to progression and median overall survival have not been reached yet and the study is still ongoing. Conclusions: The combination of D, O and C at the dosses and schedule used in this trial is effective in MOC with a manageable toxicity profile No significant financial relationships to disclose.
Postoperative chemoradiation for resected gastric cancer—The tolerability of the Macdonald regimen in the routine clinical practice setting in Israel
Authors: Kundel Y. , Idelevich E. , Purim O. , Kovel S. , Pfeffer R. M. , Catane R. , Karminsky N. , Stemmer S. M. , Fenig E. , Sulkes A. , Brenner B. 
Published: March 2020

14077 Background: Postoperative chemoradiation as per the Intergroup 116 trial (“the MacDonald regimen”) is considered standard for completely resected high risk gastric cancer. However, concerns remain with regards to the toxicity of this regimen. To evaluate the safety and tolerability of this regimen in a routine clinical practice setting, we analyzed retrospective date of several Oncology Institutes in Israel. As we did not expect a different toxic profile in patients (pts) with positive margins (R1 resection), these were studied together with pts that underwent complete resection (R0). Methods: Treatment was administered according to the original Macdonald report. Overall and disease free survival rates were calculated using the Kaplan-Meier method. Results: Between 6/2000 and 9/2005 100 pts who had R0 (81%) or R1 (19%) resection of locally advanced gastric adenocarcinoma received post-operative chemoradiation; 62% were male and the median age was 64 years (range, 25–78); 77% had T≥3 tumors and 85% had N+ disease; 91% of the pts completed radiotherapy and 62% completed the entire chemoradiation plan. Reason for discontinuation was toxicity in all cases; 48% of the pts had grade ≥ 3 toxicity (30% grade 3 and 23% grade 4), 32% were hospitalized at least once for supportive care .Three patients (3%) died of toxicity: grade 4 diarrhea (1), neutropenic sepsis (1), and neutropenic sepsis complicated by small bowel gangrene (1).The most common hematological toxicity was neutropenia, which was grade ≥3 in 30% of the pts and was complicated by infection in 17%. The most common non-hematological toxicities were nausea, diarrhea and fatigue. With a median follow-up of 24 months (range, 3–64 months), 68% of the R0 patients remain alive and 64% are free of disease. Median disease free survival is 54 months and median overall survival has not been reached. Conclusions: In our experience, postoperative chemoradiation as per Intergroup 116 seems to be highly toxic, with a mortality rate higher than reported in that trial. Preliminary efficacy data seems comparable to the original report. No significant financial relationships to disclose.
Is hyperglycemia a prognostic factor in pancreatic cancer?
Authors: Mekan S. F. , Safa M. M. , Komrokji R. S. , Nahleh Z. A. , Jazieh A. R. 
Published: March 2020

14078 Background: Pancreatic hyperglycemia is one of the manifestations of pancreatic cancer.The purpose of this study is to explore the prevalence and significance of hyperglycemia at the time of diagnosis of pancreatic cancer. Methods: We reviewed retrospectively cases presenting to our institution with diagnosis of pancreatic carcinoma between 1999–2003. Hyperglycemia was defined as a blood sugar of greater than 140mg/dL. Results: There were 155 cases diagnosed with pancreatic cancer. Out of these, 67 (43.2%) were males and 71(45.8%) were females. The mean age was 63 years. Staging was reported in 134 patients: 19 patients (14%) were stage I, 23 (17%) stage II, 40 (30%) stage III and 52 (39%) stage IV. Median survival time was 8 months. Thirty-four (22%) patients had prior history of diabetes mellitus and were excluded from subsequent analysis. Sixty-four patients out of 121 patients (53%) were found to be hyperglycemic. These patients had no prior history of diabetes mellitus or were diagnosed with diabetes within six months. There was no difference between hyperglycemic patients and normoglycemic patients regarding age, sex, race, tumor location, smoking history, history of pancreatitis and hypertension. Hyperglycemic patients were more likely to have history of alcohol use compared to normoglycemic patients (p value = 0.005, OR = 4.07). Hyperglycemic patients were less likely to present with stage IV disease as compared to normoglycemic patients (25% vs. 55%) (p-value 0.002). The median survival in hyperglycemic patients was significantly longer than in normoglycemic patients (12 vs. 6 months, p-value = 0.02).There was a trend towards better survival among stage IV hyperglycemic patients as compared to normoglycemic patients (13 months vs 3 months) (p-value 0.38). Conclusions: In this retrospective analysis, 53% of pancreatic cancer patients without diabetes had hyperglycemia at presentation. These patients presented at an earlier stage compared to normoglycemic patients and had significantly longer survival. The impact of hyperglycemia on survival could be related to earlier presentation or difference in the tumor biology. The clinical significance of hyperglycemia in pancreatic cancer should be further studied in prospective fashion. No significant financial relationships to disclose.
Phase II study of irofulven in recurrent or metastatic gastric cancer: A Cancer Therapeutic Research Group (CTRG) study
Authors: Chung H. C. , Yeo W. , Rha S. Y. , Boyer M. , Ong S. Y. , Lim R. , Zee B. , Roh J. K. , Goh B. C. , Chan A. T. 
Published: March 2020

14105 Background: Cytotoxic chemotherapy has been widely used in patients (pts) with advanced or metastatic gastric cancer, but the reported high response rates in phase II settings have not been confirmed by randomized trials. Moreover, the therapeutic impact on survival has been modest. The purpose of this study was to evaluate Irofulven, a DNA interacting acylfulvene analog, as first line therapy for pts with recurrent or metastatic gastric cancer. Methods: The main eligibility criteria were: Histologically or cytologically confirmed disease; age > 18 yrs; ECOG ≤ 2; measurable disease; no prior chemotherapy for recurrent or metastatic disease; life expectancy > 3 months. Irofulven was given at 0.45 mg/kg i.v. over 30-min infusion (max. 50 mg), on Day 1 and 8, every 3 weeks. The primary endpoint was treatment response and toxicity; the secondary end-point was survival. A 2-stage phase II design was used. In the first stage, the target enrollment was 20, if ≤ 2 responses were observed, the study would be stopped and the treatment concluded to be ineffective; if ≥ 6 responses were observed, the study drug would be concluded to be active. Otherwise, another 15 pts would be entered into the second stage. Survival was constructed using the Kaplan-Meier method. All patients entering the trial were included in the survival analysis. Results: 23 pts were entered into the first stage. The median no. of cycles per pt was 2 (range: 1–6). 2 pts (9%) had ≥ 1 week delay in administration of subsequent cycle of chemotherapy. For the day 8 chemotherapy, 7 pts (30%) required dose reductions; 5 (22%) had dose omitted. 22% and 17% pts developed grade 3/4 anemia and neutropenia respectively. There was no grade 4 thrombocytopenia or neutropenic fever. Of the 20 evaluable pts, no responses was observed, 3 pts had stable disease after 2 cycles of treatment which was not confirmed by a further assessment. Median overall survival was 6.05 months (95% CI 4.55–9.39). Conclusions: Irofulven was tolerated at the described dose but showed no evidence of antitumor activity in patients with advanced gastric cancer. Acknowledgement: The study was sponsored by the Division of Cancer Treatment and Diagnosis, National Cancer Institute, U.S.A, and its collaborator MGI Pharma, Inc. No significant financial relationships to disclose.
mTOR inhibition affects primary liver cancer
Authors: Rizell M. , Cahlin C. , Olausson M. , Hafstrom L. , Andersson M. , Lindner P. 
Published: March 2020

14106 Background: Due to extent of tumour and underlying liver disease primary liver cancer, hepatocellular(HCC) as well as cholangiocellular(CCC), has extremely poor prognosis. The tyrosinekinase and mTOR inhibitor sirolimus, is registered for preventing allograft rejection. It retard experimental liver tumours in rats, and has antiangiogenic effects as well. Methods: Patients with a nonoperable HCC or CCC, with a Karnofsky >70, and the diagnosis confirmed by biopsy or alfa-fetoprotein (>700ug/ml) were eligible. Ethic committee approved the study and informed consent was signed. The daily Sirolimus dose was adjusted to a 6–10 μg/L through-concentration.Twenty patients were to be enrolled in a nonrandomized study. The primary endpoint was to detect a radiological tumor response rate, defined by RECIST criteria, and secondary endpoint was to study the safety profile. CT or MRI were repeated every third month. The study was approved by the Etic Committee of Göteborg University. Results: Eleven patients with HCC and nine with CCC were included. Overall respone rate was 5%, which ocurred in a patient patient with HCC. The PR lasted for 15 months (RR 9% for HCC). Four patients with HCC had SD for median 7 months (range 5–18). Of the patients with CCC four had SD. Median duration of SD was 4 months (range 1 - 7). Median survival for patients with HCC was 7 months (range 2–20) and CCC 4 months (range 2–24) Discussion: There is low evidence supporting the use of chemotherapy for primary liver cancer. For HCC, one PR and 4 SD in this pilot study indicate that sirolimus might be of interest to study in a phase II trial, since the toxicity of sirolimus was low. In the european SILVER study,the impact of sirolimus for patients transplanted for HCC will be clarified. Experimentally, the antiangiogenetic effects of sirolimus has been boosted by combining with 5-FU and gemcitabine. This might translate to impoved response rate also for liver cancer. Conclusions: This pilot study suggests that sirolimus have a tumour effect in patients with HCC. No significant financial relationships to disclose.
Chemotherapy with FOLFOX IV in advanced gastric cancer
Authors: Garrido. M. A. , Melgoza G. , Galindo H. , Madrid J. , Sanchez C. , Alvarez M. G. , Orellana E. 
Published: March 2020

14112 Background: Gastric cancer is the first cause of mortality for cancer in Chile. 65% is observed in advanced form and the median survival without surgery is 5,4 months. We hypothesised that chemotherapy and specially FOLFOX IV is an active regimen and has low toxicity in patient with advanced gastric cancer. The main evaluated objectives were: response, toxicity and survival of patient with advanced gastric cancer. Methods: Patients with gastric adenocarcinoma, stage IV that accepted chemotherapy with FOLFOX IV in any time of evolution were included. The evaluation of response was obtained with CT scan every two month. The characteristics of patients, chemotherapy responses, toxicity and global survival were analysed. Results: Between November 2003 and October 2005, 20 patients were included, the median age was 51,5 years (range 28–67), 80% male. Hepatic, peritoneal and lung metastases were the principal places of dissemination. The response rate in first line was: PR 66%, SD 17%, with overall response of 83% (12 patients). In second line the response was: PR 37%, SD 63% (8 patients). The average of treatment was 5,5 months. The median of response was 5 months (2–12). The median overall survival was 12 months. 50% of patients showed toxicity; digestive grade 2 in 2 patients, neurological grade 2 in 4 patients and only 1 patient showed grade 3 toxicity. Conclusions: FOLFOX IV is an active chemotherapy regiment with low toxicity profile in advanced gastric cancer. With these results we propose a Phase III trial would be feasible to perform. No significant financial relationships to disclose.
Combination of irinotecan, oxaliplatin and cetuximab for patients with metastatic pancreatic cancer
Authors: Roach M. , Lee F. , Rabinowitz I. , Parasher G. , Heywood G. 
Published: March 2020

14135 Background: Gemcitabine-based chemotherapy is considered standard approach for patients with metastatic pancreatic cancer but the results remain unsatisfactory with survival averaging about 6 to 10 months. Cell line study indicates more than 90% of pancreatic cancer cells express EGFR receptor. We therefore explore the use of non-gemcitabine-containing regimen and add an EGFR inhibitor. Method: We initiated a regimen with irinotecan 120 mg/m2, oxaliplatin 85 mg/m2, and cetuximab 400 mg/m2 first dose followed by 250 mg/m2 for all subsequent doses delivered every 14 days for patients with metastatic pancreatic cancer. Results: From 1/2005 to 12/2005, a total of 5 patients were treated. Two males and three females, age 59 to 78. Three presented with metastatic disease. One had Whipple’s procedure then had disease recur 2 months post-surgery. One had locally advanced disease and progressed 10 months after concurrent chemoradiation. Grade III/IV neutropenia, anemia developed in 1/5 patients. Grade III/IV diarrhea and nausea/vomiting developed in 3/5 patients. Grade III/IV fatigue, anorexia developed in 4/5 patients. The non-hematologic toxicity was the main reason for dose reduction. 4 had CT scan for response evaluation. The fifth patient completed first cycle of treatment on 1/3/2006 and had CA19–9 dropped from 15,900 to 9,398 u/ml (40% decline). By CT scan, partial response rate is 75% as shown in the table. So far, two patients have died, 5 and 10 months since initiating treatment, one from recurrent hepatic abscess and one from fungus infection. Conclusions: This combination delivered every other week appears promising for patients with metastatic pancreatic cancer. The planned phase II trial will adopt a lower dose approach with irinotecan 90 mg/m2, oxaliplatin 60 mg/m2, and cetuximab 250 mg/m2. [Table: see text] No significant financial relationships to disclose.