bluuebunny/crossref_metadata_2025_split huggingface dataset:
Radioembolization of unresectable hepatic metastases using yttrium-90 microspheres in heavily pretreated colorectal cancer.
Authors: Hill M. E. , Mulcahy M. F. , Lewandowski R. , Rademaker A. , Salem R. 
Published: February 2017

559 Background: Yttrium-90 (Y90) microsphere liver-directed treatment has previously demonstrated the ability to provide disease stabilization to patients with liver-dominant metastatic colorectal cancer. Methods: We conducted a retrospective analysis of 36 patients with metastatic colorectal cancer who had undergone Y90 liver-directed therapy between November 2001 and March 2009. All patients had previously received 5-fluorouracil, irinotecan, and oxaliplatin and had unresectable hepatic metastases, with or without extrahepatic metastases. Results: Thirty-six patients with a mean age of 58 were included in the analysis. Twenty patients had both hepatic and extrahepatic metastatic disease and 16 had liver-confined metastatic disease at the time of first Y90 treatment. Radiologic response rate with stabilization of liver metastases was 72%. Median survival from time of diagnosis of liver metastases and from time of first Y90 treatment was 31.7 months and 9.4 months, respectively. One patient is still alive. Nine patients received only one Y90 treatment, 20 patients received two treatments, and 7 patients received three treatments. One-year survival from first Y90 treatment was 47%, and 53% of these patients had no extrahepatic metastatic disease prior to therapy, 41% had minimal extrahepatic disease, and 6% had significant extrahepatic disease. Fifty-three percent of patients survived less than one year after the first Y90 treatment. Of these, 36.8% had no evidence of extrahepatic metastatic disease prior to first Y90 therapy, 31.6% had a small volume of extrahepatic disease, and 31.6% had extensive extrahepatic disease. Conclusions: Liver-directed therapy with Y90 was observed to control the growth of unresectable metastatic liver disease in the majority of patients with heavily-pretreated colorectal cancer. A significantly smaller proportion of patients who survived a year or more had extensive extrahepatic mestastatic disease at the time of first Y90 treatment than those who survived less than a year. This suggests a potential survival advantage of Y90 liver-directed treatment in patients with primary liver metastatic disease and minimal extrahepatic disease. [Table: see text]
MFOLFOX6 with oxaliplatin stop-and-go strategy and oral S-1 maintenance therapy in advanced colorectal cancer: CCOG-0704 study.
Authors: Nakayama G. , Kodera Y. , Yokoyama H. , Okuda N. , Fujii T. , Nakao A. 
Published: February 2017

569 Background: In metastatic colorectal cancer (mCRC), a combination of leucovorin and fluorouracil with oxaliplatin (FOLFOX) is one of the standard first-line regimen. The cumulative neurotoxicity of oxaliplatin often requires therapy to be stopped in patients who are still responding. The aim of this study was to evaluate modified FOLFOX6 (mFOLFOX6) with the intermittent oxaliplatin treatment and maintenance therapy with S-1, oral fluoropyrimidine derivative, in the first-line treatment of mCRC. Methods: Thirty patients with untreated mCRC were treated with six cycles of mFOLFOX6 (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, 5-fluorouracil bolus 400 mg/m2 and 5-fluorouracil continuous 2400 mg/m2, every 2 weeks) followed by maintenance therapy with oral S-1 (S-1 80- 120mg/body days 1-28, every 6 weeks). Reintroduction of mFOLFOX6 was scheduled after four cycles of S-1 or tumor progression. The primary study end point was duration of disease control (DDC). Results: Twenty of the 30 patients (66.7%) who achieved responses or stabilizations received S-1 maintenance therapy. mFOLFOX6 was reintroduced in thirteen patients (43.0%). Median DDC was 9.3 months. Median progression-free survival (PFS) was 7.9 months. Overall response rates and disease control rates were 40.0% and 86.6% for the initial mFOLFOX6, 25.0% and 55.0% for S-1 maintenance therapy and 23.1% and 76.9% for mFOLFOX6 reintroduction. Twenty-eight patients (93.3%) had peripheral neuropathy during treatment, but grade 3 neurotoxicity was observed in only 1 patient (3.3%). Conclusions: The planned oxaliplatin stop-and-go strategy with oral S-1 maintenance therapy was feasible first-line treatment for Japanese mCRC patients. Further prospective randamized control study is warranted. No significant financial relationships to disclose.
Adjuvant capecitabine treatment for stage III colon cancer in Japanese patients (KSCC0803).
Authors: Kitazono M. , Emi Y. , Kakeji Y. , Sakaguchi Y. , Samura H. , Ogata Y. , Natsugoe S. , Shirouzu K. , Tokunaga S. , Maehara Y. ,   Kyushu Study Group of Clinical Cancer (KSCC)
Published: February 2017

571 Background: Capecitabine was approved in Japan in 2007 for the adjuvant treatment of stage III colon cancer based on Japanese clinical trial data in advanced and recurrent colorectal and breast cancers as well as data from the Phase III X-ACT trial. For the current study, we aimed to clarify compliance and tolerability of adjuvant treatment with capecitabine in Japanese patients. The study was entered in the UMIN clinical trial registry (UMIN000001444) by the Kyushu Study Group of Clinical Cancer (KSCC). Ethical approval was granted by the institutional review board of each hospital involved. Methods: Based on completion rates from the X-ACT trial we enrolled 97 patients with R0 stage III colon cancer who had histologically confirmed disease and had undergone curative resection (3D2 lymph node dissection). Patients were given oral capecitabine therapy (2,500 mg/m2/day; days 1–14 q3w; eight cycles) within 8 weeks of surgery. The proportion of patients completing eight cycles of treatment per protocol was the primary endpoint, and adverse event (AE) rate was analyzed as a secondary endpoint. Results: Treatment completion in the total patient population was 66.0% (64/97 patients; 95% CI: 55.7–75.3%) and in the per protocol population (PPP) was 70.3% (64/91; 95% CI: 59.8–79.5%). AEs leading to treatment discontinuation included hand-foot syndrome (HFS; n=7), hematotoxicity (n=5) and increased hepatic activity (n=4). Grade 3/4 AEs of note included HFS (22.7%), neutropenia (7.2%), diarrhea (2.1%), and increased bilirubin (0.0%). Of note, any treatment delay >3 weeks in the current trial was considered a withdrawal. In the X-ACT trial, delays of any duration were permitted. Using the X-ACT criteria the completion rate for the PPP in this study was 80.2%, comparable to the figure reported in X-ACT. Conclusions: Our results confirm those of previous global phase III studies and show that capecitabine is well tolerated in both global and Japanese-only populations, with similar high completion rates in both. [Table: see text]
Primary signet ring cell carcinoma of colon: Retrospective analysis of VACCR database.
Authors: Thota R. , Tashi T. , Gonsalves W. , Murukesan V. , Townley P. , Ganti A. , Silberstein P. T. , Subbiah S. 
Published: February 2017

58 Background: Signet ring cell carcinoma accounts for less than 1% of all colon cancers. We examined the clinical pathological features and prognosis of signet ring cell carcinoma of colon and compare it with mucinous and non-mucinous adenocarcinoma of colon. Methods: A total of 206 patients diagnosed with signet ring cell carcinoma from 1995 to 2009 were identified from the VA Central Cancer Registry (VACCR) database. Age, race, histology, grade, lymph node status, stage and type of treatment received data were collected. Results: Out of 206 patients, 173 (83.9%) were white, 31 (15%) were black, and 2 patients were listed as unknown. Median age of diagnosis was 67 years as compared to 70 years for both mucinous and non-mucinous adenocarcinoma of colon. Pathological T-stages were as follows: T1 = 2.9%, T2=5.3%, T3=33.9%, T4= 25.7%, and unknown 32%. Of the total, 22.3% were located in caecum, 21.8% in ascending colon, 15.5% in sigmoid colon, 7.7% in appendix and hepatic flexure of colon, 11.1% in transverse colon, 2.9% in splenic flexure and 4.4% in descending colon. 33.5% were lymph node positive, 34.6% were lymph node negative, and 31.8% were unknown. Histologically grade 3 (55.4%) was most commonly reported followed by grade 2 (7.3%), grade 1 (2.5%), grade 4 (1.9%)and in 33% grade was unknown. 41.3% patients received only surgery while 34% received surgery with adjuvant chemotherapy, 7.3% received chemotherapy alone and 7.8% patients received either chemotherapy, radiation or hormonal therapy alone, 9% did not receive any therapy. 1 year, 3 year and 5 year survivals for signet ring cell cancer compared to adeno carcinoma was 60% vs 80%, 33% vs 60%, and 24% vs 47% respectively. Median survival of signet ring cell carcinoma compared to mucinous and non mucinous adenocarcinoma was 19 months, 48 months and 62 months respectively. Conclusions: Signet ring cell carcinoma of colon has poor survival rates than the other histological subtypes. Signet ring cell carcinoma presents at an earlier age, higher tumor grade and advanced stage at diagnosis when compared to mucinous and non-mucinous adenocarcinoma of colon. Due to rarity of this disease further multi-institute studies are required for in-depth understanding and analysis of this disease. No significant financial relationships to disclose.
Effectiveness of FIr-B/FOx and liver metastasectomies in liver-only metastatic colorectal cancer (MCRC).
Authors: Bruera G. , Cannita K. , Lanfiuti Baldi P. , Santomaggio A. , Marchetti P. , Nuzzo G. , Antonucci A. , Ficorella C. , Ricevuto E. 
Published: February 2017

582 Background: Effectiveness of liver metastasectomies was evaluated in liver-MCRC patients treated with FIr-B/FOx association in a previous phase II study (Bruera et al, submitted 2010). Methods: Treatment schedule: 12h-timed-flat-infusion/5-Fluorouracil 900 mg/m2 days 1-2, 8-9, 15-16, 22-23; Irinotecan 160 mg/m2, Bevacizumab 5 mg/kg days 1, 15; Oxaliplatin 80 mg/m2 days 8, 22; every 4 weeks. Resection rate, activity, efficacy were analysed and compared in liver-only versus multiple metastatic sites and single versus multiple liver metastases. Results: Liver-MCRC were 33: liver-only 22 patients (67%); multiple metastatic sites 11 patients (33%). Liver metastasectomies were performed in 13 patients (11 R0, 84.6%): 26% of 50 MCRC patients enrolled in the FIr-B/FOx phase II study; 39% of liver-MCRC patients; 54% of liver-only, 6 of 9 (67%) single and 6 of 13 (46%) multiple liver metastases; one liver and lung metastasectomy. Pathologic complete responses (CRs) were 2 (15%); downsizing with modification of surgical resectability, 9 patients (41%); conversion rate of unresectable liver metastases, 83%. Overall activity, including 3 clinical CR, in liver-only patients, 68%. ORR, PFS, OS, respectively: in liver-MCRC patients, 84%, 11 and 23 months; in liver-only metastases, 86%, 17 and 44 months; in liver metastasectomies, 100%, 21 months (PFS from liver surgery 10 months) and 47 months. Significantly increased efficacy: PFS and OS in liver-only versus multiple metastatic sites (p 0.006 and 0.011, respectively) and single versus multiple liver metastasis (p 0.026 and 0.022, respectively). Conclusions: FIr-B/FOx chemotherapy increases resection rate of liver metastases, thus significantly improving efficacy of liver-only MCRC patients. No significant financial relationships to disclose.
Quality-of-life measurements in patients receiving radiation therapy for colorectal malignancies as compared to other gastrointestinal malignancies.
Authors: Samuelson B. T. , Fromme E. K. , Waller J. , Thomas C. R. 
Published: February 2017

587 Background: Therapy for GI malignancies has long been known to have a marked impact on quality of life, yet this relationship remains poorly understood. Methods: A retrospective, IRB-approved chart review was performed of 722 patients receiving RT for any cancer diagnosis between 1/1/2006 and 12/31/2008. Subjects completed the Functional Assessment of Cancer Therapy General (FACT-G) questionnaire before and after RT. Pre- and immediately post-RT course scores were compared using student t-tests with Bonferroni correction for multiple comparisons (5 comparisons, alpha =.01). Results: 722 of 1369 (52.7%) possible patients participated in the database. Complete pre and post RT spirituality data were available for 73 (64.6%) patients with GI malignancies. Average age was 62 years, 58 (79%) were male and 52 (71%) received definitive treatment. 27 (37%) had esophageal or gastric cancer, 22 (30%) had colorectal cancer and 24 (33%) had other GI malignancies such as pancreatic or hepatobiliary. Colorectal cancer patients fared better in overall QOL as compared to esophageal and gastric patients, pancreatic and hepatobiliary patients and patients with GI malignancies as a whole, and were the only group in which decline in overall QOL as measured by the FACT-G (77.22 to 73.08, p=0.216) did not reach or approach significance. This appeared to be largely driven by differences in physical and especially functional well-being, in which colorectal patients demonstrated the smallest decline (16.14 to 15.59, p=0.466) of any group. Colorectal patients did, however, demonstrate a larger decline in physical well-being (22.35 to 18.05, p=0.010) and overall QOL than did all-comers with any primary malignancy (22.1 to 19.4, p<.001) and (81.3 to 78.9, p<.001) respectively. Conclusions: Physical and functional well-being, as well as overall quality of life are known to decline in patients with GI malignancies. Patients with colorectal disease appear to fare better than those with esophageal, stomach, pancreatic or hepatobiliary malignancies by these measures. Additional investigations are warranted to further define these differences. No significant financial relationships to disclose.
What is the benefit for patients suffering from metastatic colorectal cancer (mCRC) after bevacizumab-based regimen (BBR), cetuximab-based regimen (CBR), and panitumumab (P)?
Authors: Metges J. , Ramée J. , Raoul J. , Gourlaouen A. , Porneuf M. , Capitain O. , Achour N. , Egreteau J. , Douillard J. , Grude F. 
Published: February 2017

595 Background: Metastatic colorectal cancer (mCRC) management has been clearly improved by targeted therapies such as anti VEGF and /or anti-HER1 drugs. The evaluation of the use of targeted therapies in the real world is strategic to assess health politics. OMIT Bretagne-Pays de la Loire is a network of private and public cancer centers that has been leading cohort studies evaluating Folfiri-bevacizumab treatment, the cost of targeted therapies and the succession of targeted therapies. Methods: The purpose of this study is to evaluate the benefit and safety of three consecutive targeted therapies in patients with KRAS wild-type unresectable mCRC. Sex, age, localization of the primary tumor site, successive chemotherapeutic regimens, toxicities, response rates, progression free survival and overall survival have been studied. Results: 34 patients (22 men, 12 women, median age 63 years [43-82]) have been prospectively recruited between 2003 and 2010. All of them received bevacizumab specially in association with FOLFIRI, cetuximab in association with irinotecan, panitumumab as monotherapy and others chemotherapies than FOLFOX, FOLFIRI, XELOX. The primary tumor site was colon (71%), junction (5%), and rectum (24%). 22 patients had metastatic colorectal tumor, 28 were operated on their primary tumor and 12 underwent resection after one line of treatment. Patients received successively 3 to 8 different lines of treatment for progressive mCRC. Toxicities of targeted therapies were manageable. Objective responses were observed in 38% (13) of the patients treated with BBR, 37% (11) treated with CBR and 25% (6) treated with P. Disease stabilization was achieved in 32% (11) of the patients treated with BBR, in 10% (3) with CBR and in 8% (2) with P. PFS at 80 months is 15%. Median OS from first metastatic line at death was 47.43 months (24.23-70.84). PFS and OS curves will be shown during the meeting. Conclusions: Our study clearly shows that patients receiving successively the three schedules (BBR, CBR, P) have a high overall survival with manageable side effects. No significant financial relationships to disclose.
High linear energy transfer (LET) radiation therapy in recurrent, metastatic, or unresectable rectal adenocarcinoma.
Authors: Paximadis P. , Elliott D. , Shields A. F. , Philip P. A. , Weaver D. W. , Konski A. A. 
Published: February 2017

612 Background: The purpose of this study was to retrospectively analyze the outcomes of patients with recurrent, metastatic, or unresectable rectal adenocarcinoma treated with mixed beam photon and high LET radiotherapy. Methods: Between 1995 and 2005, the high LET database was queried to identify patients with rectal adenocarcinoma. Local control and overall survival (OS) were calculated using the Kaplan-Meier method. Acute and chronic toxicities were graded using the common terminology criteria for adverse events (CTCAE) v4.0 grading system. Biological equivalent dose (BED) was calculated for tumor and normal tissue of both the photon dose and neutron dose for 10 patients. Results: 11 patients with recurrent, metastatic, or unresectable rectal adenocarcinoma were identified as being treated with mixed photon-neutron radiation. The median age of patients in the study was 58 (range: 38-79). There were 8 male patients and 3 female patients. Median follow-up was 6 months (range: 4-76 months). Patients received a median photon dose of 40Gy (range: 26-50.4Gy) and a median neutron dose of 8nGy (range: 6-10nGy). Seven patients received radiation given concurrently with 5-FU. The median OS was 16 months (range: 4-76 months), with 1 and 2-year OS of 56% and 22%, respectively. Local control was achieved in 9 of 11 (82%) patients. Local progression occurring in two patients occurred at 5 months after completion of RT. The median tumor BED in patients achieving local control was 72.5 Gy (range: 57.1-83.5 Gy). There was a nonsignificant difference in median normal tissue BED of patients with grade 3-4 late toxicity of 104.8 Gy (range: 81.1-115.1 Gy), compared with 95.3Gy (range: 89.0-104.6 Gy) for those patients with grade 1-2 late toxicity. Conclusions: Our experience demonstrates that treatment of unresectable rectal tumors with mixed photon-neutron achieved excellent local control. With the added capabilities of intensity modulated neutron radiation therapy (IMNRT), the incidence of treatment-related morbidity may be improved while taking advantage of the superior tumor control that high-LET radiation can impart. No significant financial relationships to disclose.
Phase II study of bevacizumab and cetuximab as neoadjuvant treatment in locally advanced rectal cancer: A preliminary security report.
Authors: Elvira G. , Torrecillas L. , Cervantes G. , Erzao Valle Solis A. A. 
Published: February 2017

627 Background: Concurrent chemoradiotherapy is the standard treatment in locally advanced rectal cancer. Bevacizumab and cetuximab are accepted today in the treatment of metastatic colorrectal cancer. We evaluate the activity and security of these drugs in the neoadyuvante setting. Methods: Ten patients have been included so far. Treatment consists in a first phase with induction treatment with capecitabine 2,000 mg/m2 D1-14, oxaliplatin 130 mg/m2 and bevacizumab 7.5 mg/kg every 3 weeks for two cycles. In sequential form a second phase that consist in external beam radiation therapy that was given at 50.4 Gy in 28 sesions concurrently with capecitabine 1,300 mg/m2 /d continuous during radiotherapy with cetuximab 400 mg/m2 every two weeks in patients with k-ras wild type. Results: 10 patients completed induction treatment and eight patients completed the concurrent phase. As of today, two patients are still on treatment. At this point, four patients have been operated; three patients are still waiting for surgery, and one avoided surgery. During induction treatment the main toxicity was disesthesias in eight patients, four patient presented grade 2 emesis, two presented grade 2 altered liver function test, two had grade 2 hand foot syndrome. One patient presented grade 3 hemorrhage. During the second phase, eight patients received cetuximab and presented rash grade 1-2, diarrhea grade 1 in five patients, emesis grade 1 in four patients, anemia grade 2 in two patients, proctitis grade 2 in four patients, and grade 3 in one patient. From four patients who were operated two presented complete pathological response and two have tumor persistence. Conclusions: The combination of chemoradiation with bevacizumab and cetuximab seems to be secure with no increment in toxicity and those presented are acceptable and manageable. No significant financial relationships to disclose.
Preoperative chemoradiation with S-1 plus oxaliplatin in patients with locally advanced rectal cancer: Results of a phase II study and the role of apparent diffusion coefficient (ADC) by diffusion-weighted magnetic resonance imaging (DW MRI) for prediction of pathologic responses.
Authors: Lee E. M. , Hong J. L. , Lee J. L. , Kim S. Y. , Park Y. S. , Kim J. H. , Yu C. S. , Kim J. C. , Kim A. Y. , Kim T. W. 
Published: February 2017

629 Background: We conducted a phase II study of preoperative chemoradiation (CRT) with S-1, a novel oral fluoropyrimidine, plus oxaliplatin in patients (pts) with locally advanced rectal cancer. Tumor ADCs were measured by DW-MRI and were evaluated as a predictive marker for pathologic responses. Methods: Radiotherapy was delivered to a total 50.4 Gy. The recommended doses were determined by a previous phase I study; oxaliplatin 50 mg/m2/week on D1, 8, 22 and 29, and S-1 80 mg/m2/day on D1-14 and D22-35. Total mesorectal excision was performed within 6 ± 2 weeks. Primary endpoint was pathologic complete response (pCR) rate. The value of tumor ADCs by DW-MRI was measured before and after CRT, and was correlated with pathologic responses after surgery. Results: A total of 38 patients were enrolled; 22 (57.9%) were men and the median age was 54 years (range, 28-67). Of 35 patients who underwent curative surgery, 28 patients underwent sphincter-saving operations. There was no grade 4 toxicity, and grade 3 toxicities included leukopenia (2.7%), neutropenia (2.7%), anorexia (2.7%), nausea (2.7%) and diarrhea (8.8%). The pCR rate was 25.7% (8/35, 95% CI [10.9-42.1]) and additional 10 patients (28.6%) showed near total regressions of tumor. Tumor ADCs by DW-MRI were calculated in 38 patients (including phase I part). The post-CRT ADC and the ADC changes (ΔADC) were significantly correlated with pCR rate (post-CRT ADC: 1.52±0.46 vs. 1.07±0.58, p=0.037, ΔADC: 44.5% vs. -7.6%, p=0.026). Conclusions: Preoperative CRT with S-1 plus oxaliplatin showed promising results in pathologic responses and favorable toxicities profiles. Tumor ADC by DW-MRI seems to be a useful method for predicting responses. No significant financial relationships to disclose.