bluuebunny/crossref_metadata_2025_split huggingface dataset:
Predictors of survival in patients with refractory metastatic colorectal cancer.
Authors: Kim S. , Lee H. , Baek J. 
Published: February 2017

583 Background: The survival of patients (pts) with metastatic colorectal cancer (mCRC) refractory to three active drugs including fluoropyrimidine, oxaliplatin and irinotecan is very limited but highly variable. Since estimating life expectancy is important for palliative intervention and advanced care planning, we aimed to suggest a model for improved prognostication of pts with mCRC. Methods: We retrospectively reviewed 185 pts with mCRC who had been treated with fluoropyrimidine, oxaliplatin and irinotecan with no response to treatment since 2008. Results: Of 185 pts, there were 104 (56.2%) males and 81 (43.8%) females. The median age was 58 years (range, 23-84 years). Additional cetuximab treatment was given in 43 (23.2%) pts. The median overall survival was 4.82 months. There were seven independent variables with a relationship to survival: performance status (hazard ratio [HR], 1.78; 95% confidence interval [CI], 1.31 to 2.42; p<0.001), resection of primary tumor (HR, 1.55; 95% CI, 1.04 to 2.31; p=0.033), histologic type (HR, 2.54; 95% CI, 1.59 to 4.06; p<0.001), neutrophil/lymphocyte ratio (HR, 1.62; 95% CI, 1.14 to 2.30; p=0.007), serum hemoglobin level (HR, 1.42; 95% CI, 1.02 to 1.96; p=0.035), serum albumin level (HR, 2.33; 95% CI, 1.38 to 3.92; p=0.001) and sum of metastasis site (HR, 2.00; 95% CI, 1.39 to 2.86; p<0.001). By combining these risk factors, pts with mCRC could be categorized into three different groups (Table). There was a significant difference in survival duration between the groups. (p<0.001). Conclusions: Seven prognostic factors predicting survival were identified and used to categorize mCRC Pts who had been treated with fluoropyrimidine, oxaliplatin and irinotecan into three prognostic groups. [Table: see text] No significant financial relationships to disclose.
Effect of the addition of bevacizumab to first-line FOLFOX on efficacy, including response rate, progression-free survival, and overall survival, in patients with metastatic colorectal cancer.
Authors: Suenaga M. , Mizunuma N. , Matsusaka S. , Shinozaki E. , Ogura M. , Kuboki Y. , Watanabe T. , Ozaka M. , Chin K. , Hatake K. 
Published: February 2017

588 Background: Bevacizumab (BV) is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor. Used in combination with chemotherapy, BV has been shown to improve survival in both first- and second-line treatment for metastatic colorectal cancer (mCRC). However, it was reported that addition of BV to FOLFOX conferred only little survival benefit (Saltz et al. JCO2008). The aim of this study was to assess the efficacy of addition of BV to FOLFOX in first-line treatment for patients with mCRC. Methods: Bevacizumab was approved for mCRC in July 2007 in Japan. This study was conducted at a single institution and comprised 217 consecutive patients receiving first-line treatment for mCRC between 2005 and 2009. The primary objective was to compare survival benefit in patients treated with FOLFOX4 (FF) between 2005 and 2007 with that in patients receiving FOLFOX4+BV 5 mg/kg (FF+BV) between 2007 and 2009. Results: Total number of patients in the FF and FF+BV groups was 132 and 85, respectively. Characteristics of patients were as follows (FF vs. FF+B): median age, 62 yrs (range 28-76 yrs) vs. 60 yrs (range16-74 yrs); ECOG PS0, 98.8% vs. 81.8%; and median follow-up time, 20.8 months vs. 24.4 months. Median progression-free survival (PFS) in the FF and FF+BV groups was 10 months (95% CI, 8.7-11.3) and 17 months (95% CI, 10.2-14.1), while median overall survival (OS) was 21 months (95% CI, 17.9-24.1) and not reached, respectively. Response rate was 46% (95% CI, 37- 54) in FF, and 62% (95% CI, 51-73) in FF+BV. Addition of BV to FOLFOX4 significantly improved PFS (p=0.002) and OS (p<0.001). Conclusions: The additive effect of BV for first-line FOLFOX was reconfirmed. These data indicate potential survival benefits from the addition of BV to FOLFOX in first-line treatment of mCRC. In addition, PFS may be a sensitive indicator of outcome prior to post-treatment. No significant financial relationships to disclose.
Observational transversal study to relate functional status and age with the doublet or triplet chemotherapy based on capecitabine in advanced gastric cancer patients.
Authors: Martinez Amores B. , Alsina M. , Jiménez E. , Jorge M. , Martin Valades J. , López P. , Falcó E. , Hinojo C. , Llorca C. , Molins C. 
Published: February 2017

59 Background: The available evidence suggests that selection of treatment for advanced gastric cancer (AGC) correlates with age and ECOG PS. This study was conducted to analyze whether previously mentioned variables are relevant for the choice of doublet or triplet regimens with capecitabine and determining prognosis. Methods: Multicenter, cross-sectional, observational study in patients with AGC who received at least 2-cycles of capecitabine-based doublet or triplet chemotherapy, with or without measurable disease. The age, as a continuous and categorical (> 64 vs ≤ 64) variable, and ECOG PS were analyzed by logistic regression. Results: A total of 175 patients were evaluated. Median age 65.5 (56-72) years, male: 68% ECOG 0/1/2: 32.7%/55.6%/11.1%. 33% underwent doublet and 67% triplet chemotherapy. Tumour histology: signet-ring cell carcinoma (29%), papillary (13%), mucinous (12%) and tubular (3.5%). Most common sites of metastases: lymph nodes (48%), peritoneum (41%), liver (38%) and lung (12%). Multivariante analysis demonstrated that age ≤ 64 (OR 2.326; p = 0.016) and ECOG 0 (vs 2) (OR 3.937; p = 0.016) were risk factors for the choice of triplet chemotherapy, and failed to show an association between ECOG 1 and regimen. While in patients underwent triplet regimen 51% were aged ≤ 64 and 49% > 64, in those treated with doublet these rates were 32% and 68% respectively; (p = 0.016, Chi-square test). A statistical difference was found for ECOG 0/1/2/4 and regimen chosen. Concretely, among patients who received triplet regimen, 15% had ECOG 2 and 85% ECOG 0 while in case of doublet regimen these rates changed to 43 and 57%; (p = 0.01, Fisher's exact test). Main grade 1/2 capecitabine-related toxicities: diarrhea (10%), mucositis (7%), hand-foot syndrome (5%) and emesis (4%). Most frequent grade 3 were diarrhea in 5% and emesis, asthenia and febrile neutropenia in 2%. No toxicity grade 4 occurred. Conclusions: Age ≤ 64 years and ECOG 0 are risk factors of choice of capecitabine-based triplet chemotherapy in AGC. These results support previous reports showing that age and ECOG PS are associated with treatment choices for AGC. No significant financial relationships to disclose.
Characteristics and treatment effect of senior patients with metastatic colorectal cancer (mCRC): A retrospective analysis.
Authors: Boudreault J. , Aubin F. , Ayoub J. M. , Sylvestre M. , Richard C. S. , Tehfe M. A. 
Published: February 2017

600 Background: Colorectal cancer affects many elderly patients as approximately 50% of cases are diagnosed in patients older than 70 years of age. We retrospectively studied characteristics, presentation, treatment and clinical course of our senior patients with (mCRC). Methods: Medical records of all patients ≥70 years with mCRC treated in our institution from 2006-2009 were reviewed. A multivariate Cox's proportional hazards model was applied to estimate the effect of chemotherapy (CT) on survival, while adjusting for other factors measured at time of diagnosis (age, sex, comorbidity, and number of metastases). Results: Ninety-four patients (48 men and 46 women) ≥70 year-old with mCRC were identified. Abdominal pain, fever, lower GI bleed and anemia were the most common presenting symptoms. Fifty-seven patients didn't receive CT mainly because of patient/family refusal, alteration of general status and presence of comorbidity. CT (N=37) was associated with an improved median survival (13.5 months) compared to non-treated group (2 months), with hazard ratio (0.20; 95% CI, 0.09 to 0.43; p<0.00001). In the multivariate analysis, age (70-74 vs 75-79 vs ≥80 years), sex, comorbidity (0 vs 1 vs 2 vs ≥3), and number of metastatic sites (1 vs ≥2) were not independently associated with survival. ECOG-PS was not mentioned in the medical record of most patients. Sixty- three percent of the 70-74 year-old patients, 34% of the 75-79 year-old group, and only 23% of the ≥80 year-old patients received CT. Treatment benefit was seen with either 5-FU monotherapy (HR: 0.30; 95% CI, 0.12 to 0.77), Irinotecan-based (HR: 0.24; 95% CI, 0.07 to 0.74), or Oxaliplatin-based CT (HR; 0.07; 95% CI, 0.01 to 0.30). None of the patients had geriatric assessment prior to treatment. Conclusions: Most elderly patients with mCRC do not receive CT, yet treatment was associated with a clear survival benefit. The presence of multiple comorbidities did not affect treatment benefit. Although performance status could not be ascertained in this retrospective study, it likely influenced survival and the decision to treat with CT or not. Oncogeriatric assessment may be useful in better selecting elderly patients for systemic treatment. No significant financial relationships to disclose.
Topical application of hangeshashinto (TJ-14) in the management of chemotherapy-induced oral mucositis: A preliminary study.
Authors: Kono T. , Satomi M. , Ebisawa Y. , Chisato N. , Suno M. , Asama T. , Matsubara K. , Furukawa H. 
Published: February 2017

603 Background: Oral mucositis is a common toxicity associated with cytotoxic chemotherapy used for cancer treatment and results in severe discomfort and impairs patients' ability to eat, swallow, and talk. The treatment of chemotherapy-induced oral mucositis is not well established. The cyclooxygenase pathway mediates tissue injury and pain through upregulation of pro-inflammatory prostaglandins. Recent study showed that one of the Japanese traditional medicines (kampo), hangeshashinto (TI-14), may be useful for periodontal disease via downregulation of pro-inflammatory prostaglandins in human. The aim of this study was to evaluate the effect of TJ-14 on chemotherapy- induced oral mucositis. Methods: Fourteen patients with chemotherapy-induced oral mucositis during mFOLFOX6 or FOLFIRI treatment for requiring to the metastasis of advanced colorectal cancer were received topical application of TJ-14. Topical TJ-14 was applied to the oral mucositis three times a day. Patients were asked to make 50 mL of TJ-14 solution (2.5 g) with a tap water and were advised to rinse the TJ-14 solution on the oral mucosa for 10 seconds and then to spill it. Additionally, TJ-14 was topically applied with a cotton pellet on the oral mucositis. The above treatment was advised throughout the course of chemotherapy. Patients were evaluated for the oral mucositis using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 before and after 2-weeks TJ-14 treatment. Results: Thirteen of the fourteen patients (92.8 %) responded to the TJ-14 therapy. There was significant reduction in the grade 3/4 mucositis from 3.2 to 1.8 (p=0.02) as well as in the grade 1/2 mucositis from 1.6 to 0.6 (p=0.034). There is no patient showed worse than before. The compliance of TJ-14-treatment was good. Conclusions: Topical application of TJ-14 may have therapeutic effects on chemotherapy-induced oral mucositis via downregulation of pro-inflammatory prostaglandins. No significant financial relationships to disclose.
Capecitabin (Cap) compared with flurorouracil (5FU)-leucovorin (LV) as concurrent chemotherapy for preoperative chemoradiation (preop CRT) in rectal cancers: A retrospective study.
Authors: Schipman B. , Nguyen T. , Mercier M. , Borg C. , Miny J. , Bosset J. 
Published: February 2017

606 Background: The aim was to compare acute toxicities, compliance to treatment and tumor response after preoperative chemoradiation between two different regimen of concurrent chemotherapy, Cap or 5FU-LV, for the treatment of locally advanced rectal cancers. Methods: Patients with a resectable rectal cancer (T3-4, N0-2) treated from 1993 to 2006 were included. We compared two groups of patients. One treated with preop CRT including 5FU-LV (5FU 350 mg/m2 short IV infusion daily for 5 days - week 1 and 5. LV IV push 20mg/m2 with 5FU. RT 45 Gy 1.8 Gy/F over 5 weeks). The second group received the same RT scheme. 5FU-LV were substitute for Cap 850 mg/m2 twice daily along the RT except week-end. Results: 101 patients received 5 FU-LV and 51 patients Cap. Patients and tumour characteristics were similar. Grade 3-4 acute toxicities rates (especially leucopenia and diarrheas) after chemoradiation were 4 and 9.8% for 5 FU-LV and Cap respectively (p=0.16). Chemotherapy was modified for toxicities (dose reduction or interruption) in 5.9 and 17.6% of patients receiving 5 FU-LV and Cap respectively (p=0.04). Radiotherapy was stopped in 7.9 and 3.9% of patients treated by 5 FU-LV and Cap respectively (p=0.50). Complete histological response rates were 10.3 and 6% (p=0.54), tumour regression (downstaging) rates were 44.3 and 41.2% (p=0.73) for patients treated by 5 FU-LV and Cap respectively. Conclusions: In this retrospective analysis CRT with Cap obtained a similar tumor effect to the 5 FU-LV scheme. However the Cap scheme induced more grade 3-4 toxicities had no impact on the RT compliance but conducted to modify more frequently the chemotherapy scheme. No significant financial relationships to disclose.
Distress in gastrointestinal cancer: Distress thermometer (DT, NCCN)—Validation to Brazilian Portuguese.
Authors: Dettino A. A. , Pontes L. L. , Pagano T. , Fanelli M. F. , Chinen L. T. , Costa C. L. 
Published: February 2017

608 Background: Distress is psychological suffering, and DT is its efficient screening scale. Objectives: 1) Translate,culturally adapt,and validate DT to Brazilian Portuguese. 2) Evaluate distress in gastrointestinal cancer patients. Methods: Inclusion: >=200 patients with advanced gastrointestinal cancer, age>=18. Exclusion criteria: uncontrolled psychiatric disorder, not knowing diagnosis, difficulty in understanding informed consent. They answered Brazilian Portuguese translated version of DT, and Hospital Anxiety and Depression Scale (HADS). Obtained data used to calculate validity and reliability of the DT (cutoff <=4 represents significant distress), using HADS as gold-standard evaluation of distress (cutoff <=14, and 7 for subscales). Results: Preliminary relevant results (n=85) shown in the table. Conclusions: Data confirm importance of emotional assistance to patients with oncologic diseases and need of interdisciplinary palliative care. We plan to present updated data in ASCO GI Meeting, and be able to show validation of DT to Brazilian Portuguese. [Table: see text] [Table: see text]
Completion and toxicity rates of adjuvant chemotherapy in rectal cancer patients previously treated with neoadjuvant therapy and resection.
Authors: Oxner C. R. , Choi S. , Hein M. J. , Lim D. , Shibata S. , Pigazzi A. 
Published: February 2017

609 Background: Adjuvant chemotherapy is recommended after rectal cancer surgery. Yet the success and complication rates of this adjuvant treatment are poorly studied. The purpose of this study is to determine the success rate and define the toxicity profile of adjuvant chemotherapy in rectal cancer patients previously treated with neoadjuvant chemotherapy. Methods: Study design is a retrospective review of patients from December 2002-December 2007 from the City of Hope database. Data is available with 66 patients diagnosed with locally advanced rectal cancer treated with neoadjuvant chemo radiation and resection. Data points analyzed included demographics, chemotherapy-related toxicity and survival. Results: Adjuvant chemotherapy was started in 35/66 (53%) of patients. In 31 cases chemotherapy was not given because of patient refusal or physician preference. 9 patients were lost to follow-up. Follow-up ranged from 9-59 months with median follow-up of 27 months. In the 26 patients with adequate follow up there were a total of 165 episodes of toxic events 3a grade 1. Most of the events were mild to moderate grade 1-2. In 10 patients (28%) 22 major toxicities 3a grade 3 episodes were observed. The median Karnofsky performance scale (KPS) showed no significant difference in patients before and after adjuvant chemotherapy (p = 0.071). The rates of 1-year, 3-year and 5-year survival were 100%, 90%, and 60%, respectively; corresponding disease-free survival was 88%, 83%, and 69% respectively. Conclusions: These preliminary data suggest that only a fraction of rectal cancer patients previously treated with neoadjuvant CRT complete a full course of adjuvant chemotherapy. Future studies will help confirm these preliminary findings and generate an outcome comparison between patients receiving and not receiving adjuvant therapy. No significant financial relationships to disclose.
A novel approach to manage skin toxicity caused by cetuximab and panitumumab.
Authors: Berardi R. , Campanati A. , Onofri A. , Bittoni A. , Pierantoni C. , Giuliodori K. , Ganzetti G. , Scartozzi M. , Offidani A. , Cascinu S. 
Published: February 2017

616 Background: Inhibition of the EGFR represents one of the most important fields for research and development in cancer therapy. Skin rash has been documented as one of the most common adverse reactions in patients receiving EGFR inhibitors. Several approaches have been attempted to manage skin toxicity. Nicotinamide has been shown to be an effective treatment for skin inflammation in various conditions, since nicotinamide inhibits IL-8 production through the NF-kB and MAPK pathways in an in vitro keratinocytes/P. acnes model of inflammation. Furthermore green tea polyphenols could be useful in attenuation of solar UVB light-induced oxidative stress-mediated and MAPK-caused skin disorders in humans. Methods: Therapy protocol for skin toxicity consisted of: topic applications of green tea and a mostouizer and orally given nicotinamide. Patients were monitored weekly and data regarding skin toxicity (NCI-CTC grade, the Dermatology Life Quality Index (DLQI), a global score evaluating all the parameters) were recorded. Results: Between September 2009 and September 2010, 13 colorectal cancer patients receiving anti-EGFR monoclonal antibodies (cetuximab or panitumumab) and developing skin toxicity, were treated by a multidisciplinary team including oncologists, dermatologists, a pathologist, and a nurse. All the patients experienced a significative eduction of erythema, papulo-pustular rash, paronychia, fissuring, xerosis, and itching. A significative improvement of the global score and of DLQI was evident. No toxicity related to the treatment of skin toxicity was observed. Conclusions: Treatment with nicotinamide, green tea, and moisturizer represents a novel effective approach to manage skin toxicity caused by cetuximab and panitumumab. No significant financial relationships to disclose.
Combination of cetuximab and chemotherapy in the first-line treatment of metastatic colorectal cancer: Slovakian experience.
Authors: Salek T. , Sebo E. , Mazalova D. , Chovanec J. , Stresko M. , Thomkova A. , Andrasina I. , Barilla R. , Hlavata Z. , Mego M. 
Published: February 2017

622 Background: Cetuximab is an EGFR-targeting IgG1 monoclonal antibody that is active against EGFR-expressing Kras wild type metastatic colorectal cancer (mCRC) in monotherapy or in combination with chemotherapy. Here, we report efficacy and safety of combination of cetuximab and chemotherapy in patients (pts) with mCRC treated in major cancer centers in Slovakia from 01/2009 to 07/2010. Methods: Forty consecutive pts (28F/12M) with EGFR expressing Kras wild type mCRC (14 pts-rectal cancer, 26 pts-colon cancer) treated with irinotecan-based (29 pts-73%) and oxaliplatin-based (11 pts-27%) chemotherapy were evaluated. Median age was 59 years (44-77).17 pts were pretreated with adjuvant therapy. No of metastatic sites: 1 mts -22 pts (55%), 2 mts-13 pts (32.5%), 3 mts -5pts (12.5%). Median CEA level before therapy 13.5 (1-1,800). Results: 10 pts achieved complete remission (25%), 21 pts partial remission (52.5%), 8pts disease stabilization, 1pt disease progression. Median progression-free survival (mPFS) was 16 months, 1 year survival 65%-95% CI (50-80), median follow-up was 13 months (range 4-20m). The main Gr 3-4 toxicity was skin rash 2pts (5%) and diarrhea 2 pts (5%). Any grade toxicity: rash 32 pts (80%), diarhea 8pts (20%), neuropathy 8pts (20%), weakness 3pts (7.5%), neutropenia 2pts (5%), trombocytopenia 2pts (5%). Conclusions: Our experience confirms the efficacy and acceptable safety profile of combination chemotherapy and cetuximab in first line mCRC patients. No significant financial relationships to disclose.
Early outcome of a phase II study of yttrium-90 radioactive resin microspheres in the treatment of colorectal adenocarcinoma metastatic to the liver after failure of first-line combination chemotherapy (inSIRT Trial).
Authors: Roeland E. , Shimabukuro K. A. , Fanta P. T. , Rose S. C. , Reid T. R. 
Published: February 2017

626 Background: Liver metastases develop in at least half of the cases of colorectal cancer (CRC) and the liver is often either the dominant or the only site of metastases. It is estimated that up to 90% of patients with metastatic CRC die as a consequences of their hepatic metastases and resultant liver failure. We are evaluating the aggressive management of liver metastases through the incorporation of Yttrium-90 radioactive microspheres after evidence of progressive disease following a first-line FOLFOX based regimen with or without bevacizumab. Optimal timing for microsphere treatment relative to chemotherapy has not yet clearly been established. In this abstract, we present preliminary data of a phase II study evaluating tumor and biochemical response rates. Methods: Patients with disease progression despite first-line FOLFOX based therapy with or without bevacizumab are eligible for the inSIRT trial. Interventional radiology and nuclear medicine assess the liver lesions and the patient receives selective internal radiation therapy (SIRT) microspheres therapy. Bilobar hepatic disease requires a second treatment. 4-6 weeks after the final microspheres therapy, patients proceed to second-line chemotherapy with FOLFIRI. Results: To date, 3 metastatic CRC patients have been treated on this protocol and a total of 5 patients enrolled. No significant adverse events have been noted. Preliminary results for 3 patients show stable disease after failure of first-line combination chemotherapy up to 160 days after treatment. No significant financial relationships to disclose.