bluuebunny/crossref_metadata_2025_split huggingface dataset:
A phase II study of pemetrexed in patients (pts) with advanced neuroendocrine tumors (NETs)
Authors: Bhargava P. , Earle C. C. , Zhu A. X. , Clark J. W. , Vincitore M. , Battu S. , Regan E. , Lawrence C. , Kulke M. H. 
Published: March 2020

15149 Background: Traditional antifolates such as 5-florouracil have been associated with only modest activity in NETs. Pemetrexed is a multitargeted antifolate active in diseases not known to be responsive to other antifolates. We performed a prospective phase II study of pemetrexed in pts with advanced NETs to assess response, toxicity, and survival. Methods: Pts were treated with Pemetrexed administered intravenously at a dose of 500 mg/m2 every 21 days. To reduce toxicity, folic acid and vitamin B12 supplementation were mandatory. Pts were also treated with oral dexamethasone 4 mg twice daily the day prior to, day of, and day after pemetrexed administration. The study utilized a two-step design, with an initial accrual phase of 17. Pts were required to have metastatic neuroendocrine tumors (excluding small cell carcinoma), and preserved hematologic, renal, and hepatic function. Treatment with prior chemotherapy was allowed; pts receiving octreotide remained on octreotide at a stable dose level during study therapy. Results: 17 pts were enrolled with the following characteristics: M: F=4:13. median age 56 (range 38 to 72); ECOG Performance Status 0/1/2=4/12/1. Tumor types included carcinoid n=12(71%) and islet cell n=5(29%). 17 pts received treatment for a median of three, 21-day cycles; the median time on study was 10 weeks. Grade 3–4 toxicities included: fatigue n=8(47%), leukopenia n=7 (41%), neutropenia n=6 (35%), elevated alkaline phosphatase n=4 (23%), thrombocytopenia n=3 (17%), lymphopenia n=3 (17%), pneumonitis n=2 (11%), hyponatremia n=2 (11%), dyspnea n=1 (5%), hyperbilirubinemia n=1 (5%), weight loss n=1 (5%), diarrhea n=1 (5%), elevated ALT/SGPT n=1 (5%), edema n=1 (5%), weakness n=1 (5%), grade 4 proteinuria n=1 (5%). 15 pts were evaluable for response; the best treatment response was stable disease (n=9;), the remaining 6 pts experienced progressive disease as their best response to therapy. Accrual to the study was halted due to lack of observed antitumor activity. Conclusions: Pemetrexed does not have significant antitumor activity in pts with advanced NET. No significant financial relationships to disclose.
First-line physician’s choice (PC1) or standard of care (SOC) then second-line PC2 chemotherapy (CT) in metastatic esophago-gastric adenocarcinoma (MEGA): BC Cancer Agency experience
Authors: Wilson K. S. , Barnett J. B. , Khoo K. , Kollmannsberger C. , Shah A. 
Published: March 2020

15158 Background: The BCCA GI Tumor Group supports 1 CT regimen for MEGA: weekly 5FU-cisplatin [FUC] (Shah, ASCO 1992, A530) for first line SOC CT. All other regimens (PC) require “undesignated” approval for public funding. Reasons for PC requests include prior CT, results of modern CT trials, and contra-indications to FUC. Objectives: to examine response, toxicity and survival in pts. receiving either first-line PC1 CT , or SOC and second line PC2 CT. Methods: BCCA Pharmacy records (Dec. 1999 to April 2006) were searched for PC MEGA pts, charts abstracted, database constructed and KM survival analyses undertaken. Treatment responses, serious toxicities and hospitalizations were recorded. Results: Demographic summary (N = 85): 32 esophageal (10 GEJ), 53 (62%) gastric primary, 61 M, 24 F, median age 56.2 (range 28.7 - 81.8) yrs., 68 Caucasian, 15 Asian, 2 Fijian descent, 55 stage M1 at diagnosis. Prior therapy: 14 CTRT, 3 adjuvant CT, 34 radical surgery. 50 pts received PC1 of whom 25, 9 and 2 received 2nd, 3rd and 4th line CT respectively; of 35 SOC/PC2 pts, 35, 10 and 2 received 2nd, 3rd and 4th line CT for a total of 133 patient-courses of PC (including 4 repeat FUC). Docetaxel and irinotecan regimens accounted for 34% and 36%, 5% and 55%, 16% and 32% of 1st, 2nd and 3rd line PC CT regimens respectively. Partial responses were seen with SOC (11/35) and PC1 (6/50) [chi square p = 0.05]. Four responses were seen with 2nd line CT (2 SOC/PC2, and 2 PC1). Grade 3+ toxicity rates: 19/49 (39%) and 6/36 (17%) with SOC and PC1 with initial CT (p = 0.02). There were 20 hospitalizations with PC and 2 with SOC CT (p = 0.02). Median follow-up time was 8.9 months. Survival analyses are presented below. Multivariate analysis results: primary site, SOC, gender, ethnicity, prior CT, p values were 0.15, 0.23, 0.23, 0.25 and 0.25 resp. Conclusions: Benefits and risks of non-SOC chemotherapy in MEGA need careful consideration before routine adoption as primary or subsequent therapy. [Table: see text] No significant financial relationships to disclose.
Prognostic value of pre-operative serum MUC4 levels for predicting recurrence of pancreatic cancer
Authors: Villanueva M. H. , Stoner J. , Sasson A. , Batra S. K. , Hauke R. J. 
Published: March 2020

15160 Background: The human transmembrane mucin MUC4 is aberrantly expressed in approximately 75% of pancreatic ductal adenocarcinomas, but not in normal pancreatic tissue. Preliminary data suggests serum MUC4 levels may have a diagnostic utility. Hence, we sought to determine if pre-operative MUC4 levels have a prognostic value in pancreatic adenocarcinoma. Methods: A database of MUC4 samples collected under an IRB-approved protocol was queried for subjects with pre-operative MUC4 levels. MUC4 assays were performed using RT-PCR. Descriptive statistics were used to summarize the disease and treatment characteristics of the patients. A level of 0.01 (median) was used to divide patients into high and low MUC4 groups. Kaplan-Meier method was used to summarize the time to event distributions for groups defined by MUC4 levels. Log-rank test was used to compare the time to event distributions between two groups. Results: Seventeen patients (eleven males - 65%) were identified, with a mean age of 65.8 yrs (range: 46 - 76 years) were identified. Pathologic staging was T2/T3 in 95%, 9 pts (53%) had N1 disease, while 15 patients (88%) had stage II disease. All but one received adjuvant therapy with chemotherapy (5FU ± gemcitabine) ± radiation. Patient, disease and treatment characteristics were similar in patients with low MUC4 levels (n=9) and high MUC4 levels (n=8). At a median follow-up of 1.8 years, 13 (77%) experienced disease recurrence and 14 (82%) died. There was no significant association between MUC4 levels and the risk of disease recurrence or death (p>0.9; p = 0.1, respectively). The one- year probabilities for relapse free survival (RFS) and overall (OS) were 0.9 (95% CI: 0.68 - 1.00) and 1 (95% CI: 1 - 1) for patients with low levels and 0.5 (95% CI: 0.15 to 0.85) and 0.63 (95% CI: 0.29 to 0.96) respectively, for subjects with high levels. Conclusions: Although these differences were not statistically significant, the group with high MUC4 levels appears to have higher risk features such as higher stage, regional lymph node disease and older age. Patients with high MUC4 levels had a trend towards higher risk of relapse or death. No significant financial relationships to disclose.
Activity and safety of carboplatin and paclitaxel followed by capecitabine and radiation as adjuvant therapy for gastric cancer (GC)
Authors: Mobayed M. , Philip P. A. , Shields A. F. , Heilbrun L. , Washington T. , Vaishampayan U. , Venkatramanamoorthy R. , El-Rayes B. F. 
Published: March 2020

15162 Background: Adjuvant 5FU based chemo-radiotherapy is considered the standard of care for the treatment of GC. However, the reduction in distant metastases has not been significant indicating the poor systemic effect of this regimen. A regimen of carboplatin and paclitaxel followed by capecitabine and radiation was adopted at the Karmanos Cancer Institute to improve the systemic effects of adjuvant therapy and to utilize the significant antitumor effects of taxanes demonstrated in advanced GC. Methods: We reviewed the outcomes of 21 consecutive patients with GC who were treated with carboplatin (AUC 5 mg/ml x min) and paclitaxel (175–200 mg/m2), followed by concurrent capecitabine (1600–2000 mg/ m2) and radiation (45–50.4 Gy) since January, 1999 for curatively resected GC. Patients received a total of 4–6 cycles of carboplatin and paclitaxel. Results: The median age at diagnosis was 60 years old. Sixteen patients had stage 3 disease and 7 of them had positive margins (R1/R2 resection), 3 patients were stage 2 and 2 patients were stage 1 and both groups had negative margins; all patients had D1/D2 lymph node dissection. Thirteen patients had recurrent disease, 10 of whom had distant metastases. The median recurrence free survival was 12.3 months (90% CI; 9.7–27.7 months). Seven patients are still alive. The median OS was 16.0 months (90% CI; 13.3- 28.8 months). The median follow up for OS was 30.4 months. Grade 3–4 hematologic toxicities were found in 7 patients (33.3 %). Non-hematologic toxicities included grade 3 diarrhea in 3 patients (14%), severe fatigue in 2 patients (10%). No treatment related deaths were observed. Conclusions: Carboplatin and paclitaxel alongside radiation plus capecitabine is a well tolerated regimen in the adjuvant setting. The activity of this regimen in this relatively high risk group of GC patients is of interest for future development. No significant financial relationships to disclose.
Metronomic capecitabine in advanced patients with hepatocellular carcinoma (HCC): Preliminary results
Authors: Brandi G. , Fanello S. , Piscaglia F. , Falanga A. , Bolondi L. , Flori S. , Derenzini E. , Palassini E. , Fedele M. , Biasco G. 
Published: March 2020

15163 Background: No standard therapies are available for HCC patients (pts) ineligible for curative treatments. HCC has a rich neovasculature and neoangiogenesis is a negative prognostic factor: a high density of microvessels and hyperexpression of VEGF correlates with an increased propensity for invasion and metastatization and with a decreased DFS after resection. High level of circulating endothelial progenitors cells (CEPc) are related with insurgence and progression of HCC. Phase II trials with antiangiogenic agents in monotherapy had a response rate lower than 10% but stable disease (SD) is encouraging ranging between 30 and 60%. Retrospective analysis of standard capecitibine showed a response of 11% and similar SD rate. Experimental data on solid tumors suggest that metronomic CT prolongs inibihition of tumor growth, avoiding CEPc mobilization. Methods: Starting in september 2006, twenty-two patients were started on treatment (19 male; median age 63.7, range 47–82 ). BCLC (Barcelona Consensus Liver Cancer): 5 pts = B; 17 pts = C; Child: 12 pts =A, 8=B, 2=C. 14 pts had portal thrombosis. 15 pts were treated in front line, 7 in second line (4 pts previously treated with Sorafenib and 3 with experimental protocol of CPT-11 HAI; ASCO 2006 Abs 14061 ). The first cycle was carried out with standard capecitabine (2000 mg/sq.mt; 14 over 21 days), followed by metronomic capecitabine (1300 mg) without interruption. To compare the angiogenic role of metronomic capecitabine versus standard administration, VEGF and trombospondine have been dosed at baseline and after the first cycle of standard capecitabine and after one month of metronomic capecitabine. The response has been assessed by CT scan every three months. Results: Five out of 22 patients have been dismissed for toxicity (liver failure) during the standard capecitabine treatment. Among the 17 remaining patients, two have discontinued the treatment due to toxicity (liver failure) during the metronomic treatment and 10 have accomplished at least the first month of metronomic schedule. 6 patients have been evaluated for response: 2 PR (one second line), 3 SD (all in second line), 1 PD (second line). Conclusions: Metronomic capecitabine seems to have a better tolerability than standard schedule and promises good efficacy. No significant financial relationships to disclose.
Prognostic factors in metastatic gastric cancer patients (pts) treated with second-line chemotherapy
Authors: Catalano V. , Graziano F. , Santini D. , Baldelli A. M. , Giordani P. , Vincenzi B. , Rossi D. , Alessandroni P. , Tonini G. , Catalano G. 
Published: March 2020

15169 Background: Currently, there is no established second-line chemotherapy for pts with advanced gastric cancer who failed to respond or progressed after a first-line chemotherapy. Many of these pts still have a good performance status or have symptoms to be palliated at the time of first-line failure and are candidates for second-line chemotherapy. However, phase II trials demonstrate divergent results about pts more likely to benefit from second-line chemotherapy. We retrospectively analyzed the influence of various clinicopathologic factors on the survival of pts treated with second-line chemotherapy. Methods: Analysis is based on the data of 169 pts consecutively treated at 3 oncology department with a second-line chemotherapy. Univariate and multivariate analyses were performed to determine prognostic factors of survival. The variable used for analysis were: sex, age, ECOG performance status, a weight loss > 5 Kg in the last month; site of primary tumor, histopathology; hemoglobin, serum albumin, and CEA levels, number and site of metastatic disease, response to and time-to-progression (TTP) with the first- line chemotherapy. Results: The variables predictive of better survival were: ECOG PS 0–1 (p<0.001), no weight loss (p=0.001), hemoglobin level > 10 g/dl (p=0.01), CEA level <50 U/ml (p<0.02), number of metastatic sites = 2 (p=0.002), TTP of the first-line chemotherapy > 4 months (p=0.008). Peritoneal carcinomatosis was predictive of poor survival only when associated with one or more signs or symptoms as vomiting, anorexia, abdominal pain, ascites(p=0.03). Four factors were independently associated with better overall survival: ECOG PS 0–1 (p=0.002; HR 0.46; CI 95%, 0.29–0.75), CEA level <50 U/ml (p=0.008; HR 0.54; CI 95%, 0.35–0.85), one or two metastatic sites of disease (p=0.01; HR 0.58; CI 95%, 0.39–0.88), and TTP of the first-line chemotherapy > 4 months (p=0.02; HR 0.66; CI 95%, 0.45–0.95). Conclusions: In the absence of data deriving from randomized, controlled, clinical trials, this analysis suggests that some clinical factors may help clinicians to better select groups of pts with gastric cancer more likely to benefit from a second-line chemotherapy. No significant financial relationships to disclose.
Treatment of locally advanced esophageal carcinoma with induction cisplatin-paclitaxel-5FU (PTF) before local therapy
Authors: Fernandez-Rodriguez R. , Ancizar N. , Lopez de Argumedo G. , Ruiz de Lobera A. , Lopez Vivanco G. , Gil Negrete A. , Sancho A. , Carrera S. , Munoz A. , Mane J. M. 
Published: March 2020

15174 Background: We analyse induction therapy with PTF before local definitive therapy in terms of response, resectability, toxicity and survival. Methods: Patients (pts) with locally advanced esophageal carcinoma were included. Treatment: Paclitaxel 175 mg/m2 and CDDP 75 mg/m2 on day 1 and 5FU 800 mg/m2/day, days 1–4, every 21 days. After 2–3 cycles surgery is considered. If unresectable, Radiotherapy (64 Gy) and concomitant Carboplatin (60 mg/m2, d 1–5 during 1st and 4th week of RT) are planned. Results: From May-02 to October-06 31 pts were treated (28M, 3F) Age: 55 (32–70) PS 0–1: 6–25. Location: Upper 10, Middle 13, Distal 7, Whole 1. Pathology: Squamous 29, Adenocarcinoma 2. T3/4:14/17 N0/1:8/23 M1a: 3. Weight loss >10 kg 12 pts. 87 cycles have been delivered. Range: 2–4. Mean 2,83. Median 3. Toxicity (episodes): hematological 3/4: no episodes. Emesis 3: 2. Mucositis 3: 2. Asthenia 2/3: 8. 2 pts died in remission due to gastrostomy complications and esophago-tracheal fistula, treatment related. Response: CR 5, PR 9, SD 13, PD 4. Treatment after PTF: Surgery 10 pts (1 upper, 5 middle, 4 distal). 1 distal unresectable at surgery, 2 middle not resected because of liver cirrhosis and liver metastases at surgery. pCR: 1. pPR 6 (R0: 3, R1: 3) Chemoradiation with concomitant Carboplatin: 19, making 3 SD in PR, 2 PR in CR and 1 SD in CR. One PR and 4 SD progressed after chemoradiation. Progression: 21 (local 7, systemic 7, both 7). Died: 19 (16 of disease, 2 of complications of gastrostomy, 1 unrelated) Median PFS: 48,28 weeks (95% CI 32,80 - 63,77). Median OS: 51,14 weeks (95% CI 28,81 - 73,47). Conclusions: This schedule has a good toxicity profile. Surgical rescue is possible in almost a half of middle and distal tumours. Chemoradiation is the best approach for unresectable tumours. Considering stage at diagnosis, survival curves are promising. No significant financial relationships to disclose.
Repeat 90Y-microsphere radioembolization for hepatic malignancies: Safety and patient selection issues
Authors: Kennedy A. S. , Dezarn W. A. , McNeillie P. , England M. , Overton C. , Sailer S. 
Published: March 2020

15177 Background: Liver tolerance to reirradiation with multiple doses of 90Y-microspheres is not known. Many patients (pts) have also received external beam radiotherapy to the liver or through the liver and are surviving long enough to be considered for a second and third liver treatments with internal radiation. Methods: The experience of a single center treating liver tumors with resin 90Y-microspheres was used. Pts that received liver radiation prior to or after resin microsphere therapy were studied. Endpoints were toxicity, tumor response, disease type, latency period between radiation treatments, shunting to lung, and effects on liver volume and function. The delivery activity of microspheres selected was not reduced below that which was typically chosen for patients without prior liver radiation which was 25% reduced from the manufacturer’s BSA dose calculation method. All patients received bilobar microsphere delivery during a single session. Results: A total of 40 pts were identified; 14 women, 26 men, treated 6/2003 to 12/2006, with 35 pts receiving 2 courses and 5 pts with 3 courses of liver radiation. Retreatment with resin microspheres 26 pts, prior external beam radiation in 7 pts, prior glass microspheres in 2pts, prior systemic radiotherapy in 2 pts, and prior stereotactic liver radiation in 1 pt. Liver function was stable and adequate in all patients after additional liver radiation, and no pts developed radiation-induced liver dysfunction (RILD) or veno-occlusive disease (VOD). The percentage of shunting to the lung decreased with retreatment. Tumors treated: 14 carcinoid, 11 colorectal, 6 hepatocellular and cholangiocarcinoma, 2 sarcoma, 3 unknown primary, 1 each of breast, esophagus, and head and neck primaries. Conclusions: Repeated radiation to the liver with 90Y-microspheres appears safe in patients that have sufficient normal liver function and reserve based on known laboratory parameters already used for selection of microsphere therapy. No acute life-threatening, fatal, or late liver damage was observed, i.e. RILD or VOD. No specific dose reduction is recommended for retreatment of the liver. No significant financial relationships to disclose.
Survival outcomes of advanced pancreatic cancer in an integrative treatment setting: The Cancer Treatment Centers of America experience
Authors: Lis C. G. , Levin R. D. , Neelam R. , Vashi P. G. , Lammersfeld C. A. , Alschuler L. , Grutsch J. F. , Daehler M. , Neelam R. , Granick J. , Gupta D. 
Published: March 2020

15188 Background: In this study, we report the survival outcomes of patients with advanced pancreatic cancer who underwent intra- arterial mitomycin/cisplatin therapy at Cancer Treatment Centers of America (CTCA), a community hospital comprehensive cancer center combining conventional and integrative medical therapies. Methods: At our center, all patients undergo a comprehensive program of nutritional, spiritual, physical, naturopathic, and emotional support while receiving an aggressive conventional treatment protocol. Using data collected by the cancer registry, we identified 114 consecutively treated newly diagnosed cases of invasive pancreatic cancer who underwent definitive treatment between Jan 01 and Dec 05. Results: 26 patients were stage III and 88 were stage IV. The median age was 58 years (range 31 to 81 years). 55 patients were selected for intra-arterial therapy with mitomycin/cisplatin. These patients had a PS of 2 or better and either had no metastatic lesions or a single localized liver metastasis. 16 patients in this cohort received radiotherapy. The 59 other patients underwent a variety of therapies. Intra-arterially treated patients had a median survival of 369 days and a 2-year cumulative survival of 19%. Patients not treated with intra-arterial therapy had a median survival of 249 days and a 2-year survival of 11%. Univariate survival analysis found that patients undergoing intra-arterial therapy had significantly better survival outcomes compared to patients undergoing different therapies (Log rank test P = 0.04). The table compares the survival outcomes of recent phase III investigations on first line therapies for pancreatic cancer with those at CTCA. Conclusion: Currently, the published clinical trial data in advanced pancreatic indicates a one-year survival ranging from less than 10% to 28%. Consequently, the survival outcomes of patients undergoing therapy at our center warrant further investigation. [Table: see text] No significant financial relationships to disclose.
The validity of complex breast cysts after surgery
Authors: Tea M. M. , Grimm C. , Bikas D. , Kroiss R. , Fink-Retter A. , Kubista E. , Wagner T. M. 
Published: March 2020

1519 Objective: Breast cysts are the most common cause of benign breast masses. Simple breast cysts do not need further evaluation, but complex breast cysts require additional assessment due to the potential presence of malignancy. However these complex cysts have rarely been examined and quantified according the associated cancer detection rate. Our study is the first investigation that evaluates the malignancy rate of complex breast cysts identified by histo-pathological results. Material and Methods: Imaging findings of complex cysts were correlated retrospectively with clinical and pathologic outcomes. Results: 150 complex breast cysts were found in 132 women. We detected a high malignancy rate of 14%. Sonographic criteria of a complex cyst such as thick cyst wall (p=0.0006), lobulation (p=0.01) or hyperechogenicity (p=0.04) were predictive of neoplasm. Two or more criteria combined were associated with a 13.6 - fold higher risk of malignancy (p<0.0001). Menopause status, family history or personal history of breast cancer did not influence the detection rate of neoplasm. Conclusion: Based on our results we raise the issue for the need of surgical intervention, compared to observation by ultrasound of complex breast cysts to prevent a missed or delayed diagnosis of breast cancer. No significant financial relationships to disclose.