bluuebunny/crossref_metadata_2025_split huggingface dataset:
Vistonuridine: An orally administered, life-saving antidote for 5-fluorouracil (5FU) overdose
Authors: von Borstel R. , O'Neil J. , Bamat M. 
Published: August 2020

9616 Background: 5FU is widely used to treat solid tumors and is often administered via infusion pump at or near its maximum tolerated dose (MTD). Toxicities and even death can occur in patients over-exposed to 5FU. Uridine is a direct biochemical antagonist of 5FU toxicity; uridine nucleotides dilute intracellular fluorouridine nucleotides derived from 5FU, reducing their lethal incorporation into RNA. However, uridine is poorly bioavailable (7%) and is therefore not a clinically viable antidote. Vistonuridine is an orally administered prodrug of uridine that delivers approximately 8-fold more uridine than administration of uridine itself. Methods: 17 patients overdosed with 5FU have been treated with vistonuridine as an antidote. Patients received vistonuridine (10g q6h for 20 doses) beginning 8 to 96 hours after overdose. Data from 13 patients with similar 5FU overdoses provide the time course and outcomes for patients receiving available supportive care without vistonuridine. A severity score, integrating dose and infusion rate, was calculated for all the patients, and this tool could be used by healthcare workers to determine the expected severity and outcome of a 5FU overdose. Results: All 17 overdose patients treated with vistonuridine recovered fully. Most, especially those for whom vistonuridine treatment was initiated sooner, had relatively modest toxicity. In marked contrast, all 11 of the literature-reported cases of 5FU overdose for which an outcome of death would have been predicted died from the overdose despite receiving available supportive care. Conclusions: These clinical data illustrate the serious, debilitating and life threatening nature of 5FU overdose and the current lack of effective treatments. Vistonuridine appears to be a safe and effective, life-saving antidote to 5FU overdose. [Table: see text]
Early hemoglobin decline and survival prognosis in epoetin alfa studies
Authors: Berlin J. A. , Bowers P. J. , Rao S. , Sun S. , Liu K. , Henry D. H. 
Published: August 2020

9625 Background: When cancer patients (pts) with chemotherapy-induced anemia (CIA) respond to erythropoietic-stimulating agents (ESA), hemoglobin (Hb) typically increases within 4–8 weeks. This exploratory analysis examined whether mortality differs depending on Hb response after 4 or 8 weeks of epoetin alfa (EPO) treatment or depending on transfusion. Methods: Pt-level data were analyzed from 31 randomized studies (7,215 pts) of epoetin alfa vs non-EPO (15 studies) or placebo (16 studies) in pts with CIA. A landmark analysis was used; Hb change was set at a specific time (4 and 8 weeks) and subsequent survival was examined separately for EPO and placebo. Pts were categorized as “Hb increased” (>0.5 g/dL), “Hb decreased” (>0.5 g/dL), or “Hb stable” (within ±0.5 g/dL) compared to baseline. Hb stable was compared to other Hb change categories with Cox proportional hazards models, stratified by study and adjusted for potential confounders. Results: The hazard ratio (HR) for Hb decreased versus Hb stable at 4 weeks was 1.44 for EPO (95% CI: 1.04, 1.99), indicating worse survival for pts with a decline in Hb. This association was weaker for placebo (HR: 1.12; 95% CI: 0.74, 1.67). Increased risk with declining Hb in EPO-treated pts was most pronounced in studies that maintained Hb ≥12 g/dL or treated pts for >12–16 weeks (1,876 pts). Patterns were similar using the 8-week landmark. In both EPO-treated and placebo pts, transfusion increased the rate of on-study death ∼3.5 fold (treating transfusion as a time-dependent variable). Conclusions: These exploratory findings suggest that both decreased Hb after 4 or 8 weeks of EPO treatment and transfusion are associated with increased risk of death. In spite of adjustment for other prognostic factors, it is likely that this association reflects poorer underlying prognosis of pts whose Hb fails to respond. ESAs should be discontinued in the absence of a Hb response. [Table: see text]
Phase III study of sustained release granisetron (APF530) compared to palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV)
Authors: Grous J. J. , Riegel E. , Gabrail N. , Charu V. , Arevalo-Araujo R. , Yanagihara R. , Nguyen A. , Robertson P. , Cooper B. , O'Boyle E. , Barr J. 
Published: August 2020

9627 Background: APF530 is a polymeric formulation of granisetron providing sustained drug release over 5 days. Two doses (5 and 10 mg) of subcutaneous APF530 were evaluated in comparison to 0.25 mg intravenous palonosetron. Efficacy was evaluated in acute (0–24 hrs) and delayed (24–120 hrs) CINV among patients receiving moderate (MEC) or highly (HEC) emetogenic chemotherapy. Methods: Randomized, blinded patients (n=1,395) were stratified into MEC or HEC according to Hesketh et al 1999, and assigned to receive either dose of APF530 or palonosetron. Dexamethasone use was standardized based on the emetogenic strata. Patient diaries recorded emetic episodes, nausea and rescue medications over a 5-day period. Primary endpoint was Complete Response (CR), defined as no emetic episodes and no rescue medication. Non-inferiority to palonosetron was declared if the lower bound of the CI for the difference was above -15%. Results: APF530 was well tolerated. Adverse events were consistent with those previously reported for granisetron. For APF530 Tmax was observed about 24 hrs with sustained levels over 120 hrs. For MEC acute phase CR rates of 74.8% (n=214), 76.9% (n=212) and 75.0% (n=208) were observed for 5 mg, 10 mg APF530 and palonosetron, respectively. Delayed phase CR rates of 51.4%, 59.0% and 57.7% were observed for 5 mg, 10 mg APF530 and palonosetron, respectively. For HEC acute phase CR rates of 77.7% (n=229), 81.3% (n=240) and 80.7% (n=238) were observed for 5 mg, 10 mg APF530 and palonosetron, respectively. Delayed phase CR rates of 64.6%, 68.3% and 66.4% were observed for 5 mg, 10 mg APF530 and palonosetron, respectively. Efficacy was maintained with APF530 over multiple cycles (up to 4). Conclusions: Both doses of APF530 were non-inferior to palonosetron with respect to CR during the acute phase following MEC and HEC. Only the higher dose of APF530 (10 mg granisetron) was non-inferior to palonosetron during the delayed phase of MEC. Both doses of APF530 were comparable to the CR rates of palonosetron during the delayed phase of HEC. [Table: see text]
A phase III randomized prospective trial of the effect of psychotherapy on distress in 287 prostate cancer patients: A URCC CCOP Study
Authors: Palesh O. , Mustian K. , Heckler C. , Purnell J. , Peppone L. , Weiss M. , Atkins J. N. , Dakhil S. R. , Spiegel D. , Morrow G. 
Published: August 2020

9637 Background: Cancer patients suffer from significant psychological distress, including mood and anxiety disorders. Psychiatric disorders are common in cancer and affect 22 to 43% of cancer patients. We previously showed that Supportive Expressive Group Therapy (SET) was effective in reducing distress in women with metastatic breast cancer. The current study expands our earlier research and examines the effect of SET on mood disturbance in prostate cancer patients. Methods: A sample of 318 cancer patients diagnosed with prostate cancer was assessed for mood disturbances by 9 geographically distinct URCC CCOP affiliates. The patients were randomly assigned to receive either 12 weeks of SET or education materials as a control. Patient-reported mood disturbance was assessed using the Profile of Mood States (POMS), a psychometrically valid and reliable measure of mood states, at baseline, 3, 6, 12, 18 and 24 months. Differences between treatment and control groups at follow-up were tested using a mixed-ANOVA model. The dependent variable was individual slopes on the POMS. Results: 287 patients (142 SET and 145 controls) provided complete data. No significant overall effect of intervention on mood was found (p=0.49) and the interaction between baseline mood scores and treatment arm was non-significant (p=0.075). There was a significant main effect for baseline mood (p<0.0001) suggesting that those who have the greatest mood disruption at baseline improve with time independently of treatment arm. Conclusions: This is the first large randomized clinical trial using group psychotherapy among men with prostate cancer. Results suggest that a brief SET intervention does not improve distress among men with prostate cancer. Future studies might consider recruiting patients with particular psychosymptomatology and tailoring interventions. Supported by U10 CA37420 and NCI 1R25CA102618. No significant financial relationships to disclose.
Cumulative risk for a false-positive test using low-dose computed tomography in lung cancer screening
Authors: Croswell J. M. , Baker S. G. , Marcus P. M. , Clapp J. D. , Kramer B. S. 
Published: August 2020

CRA1502 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. No significant financial relationships to disclose.
Impact of sentinel lymph node biopsy on staging of early cervical cancer: Results of a prospective, multicenter study
Authors: Lecuru F. , Bats A. , Mathevet P. , Querleu D. , Leblanc E. , Morice P. , Darai E. , Marret H. , Collin C. , Chatellier G. , Gilaizeau F. 
Published: August 2020

CRA5506 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. No significant financial relationships to disclose.
A phase III study comparing concurrent gemcitabine (Gem) plus cisplatin (Cis) and radiation followed by adjuvant Gem plus Cis versus concurrent Cis and radiation in patients with stage IIB to IVA carcinoma of the cervix
Authors: Dueñas-González A. , Zarba J. J. , Alcedo J. C. , Pattarunataporn P. , Beslija S. , Patel F. , Casanova L. , Barraclough H. , Orlando M. 
Published: August 2020

CRA5507 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]
Cancer screening in adult survivors of childhood cancer: A report from the Childhood Cancer Survivor Study (CCSS)
Authors: Nathan P. C. , Ness K. K. , Hudson M. M. , Mahoney M. , Ford J. S. , Landier W. , Armstrong G. , Henderson T. , Robison L. L. , Oeffinger K. C. 
Published: August 2020

CRA6501 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. No significant financial relationships to disclose.
Incidence of arthralgia syndrome (AS) related to aromatase inhibitors (AIs) in postmenopausal women with early breast cancer (EBC)
Authors: Maisano R. , Maisano R. , Azzarello D. , Del Medico P. , Giannicola R. , Giuffrè C. , Panuccio V. , Raffaele M. , Zavettieri M. , Falzea A. , Nardi M. 
Published: August 2020

e11603 Background: Anastozole (A) and letrozole (L) are standard drugs in up-front adjuvant endocrine therapy in postmenopausal hormone positive EBC. AIs have a higher incidence of osteoporosis, bone fractures and musculoskeletal symptoms, particularly joint pain and stiffness (AS) respect to tamoxifen. The real incidence of AS can be underestimated respect to data derived from clinical trials. Methods: From 1/07 to 12/07 we registered all patients (pts) taking A or L as adjuvant therapy for at least 3 months. We screened 47 pts, 3 pts refused to participate at the study and 2 resulted metastatic. A total of 42 pts were enrolled. The median age was 67 yrs (range 51–89), the median time since menopause was 11 yrs (range 1–48). 30 pts had natural menopause, 7 surgical menopause and 5 reported chemo-induced menopause. 25 pts took A and 17 pts took L. The median duration on therapy was 19 months (range 3–68) and 31 pts had received chemotherapy (9 CMF, 17 anthra-based, 5 anthra-taxane based). Results: 11 pts (26%) did not report AS, 19 pts (45%) had new-onset AS and 12 (29%) had worsening of prior joint pain after starting adjuvant AIs therapy. Most pts reported moderate to severe AS requiring occasional use of nonsteroidal anti-inflammatory drugs (75%), 15% used oral supplements and 10% used opiates, only 4 women used exercise to relieve joint stiffness. 17 pts interrupted the therapy from 7 to 20 days in order to reduce the symptoms and 7 obtained a partial improvement. 11 pts (35%) suffered from AS declared the worsening of quality of life. In univariate analysis presence of AS was not associated with age, entry into menopause, years since menopause, duration of AI therapy or previous chemotherapy. Conclusions: Our data show a higher incidence of AS in clinical practice respect to literature data, which caused worsening of quality of life and could be reason of discontinuation of effective therapy. The exact mechanism of AIs-related arthralgia is unclear, but is believed to be related to estrogen deprivation, however further studies are needed to define the pathogenesis in order to find an effective therapy. No significant financial relationships to disclose.
The patterns of care studies for operable breast cancer in China
Authors: Tian Y. , Hua D. , Ji Y. , Li X. , Liu J. , Wang B. , Yu D. 
Published: August 2020

e11607 Background: To present the results of clinical practices for operable breast cancer (BC) in the developed areas of China during the past decade. Methods: Four academic levels of radiotherapy (RT) departments, located in the Southeast coast of China, were selected. A pattern of care study, about women with operated BC and post-operative RT during 1999 and 2006, was conducted. The recruited samples were evaluated for their medical files completeness at first. For qualified documentations, data collected included patient characteristics, clinical and pathologic features, and treatment course received. Frequencies and corresponding percentages were calculated and analyzed for comparisons between 1999 and 2006. Results: 97 in 1999 and 271 in 2006 were identified as qualified files. Patient's diagnosis median age were 48 (1996) and 46 (2006) years. The clinical staging with I, II, and III (UICC 1997) were in 11%, 69%, 13% of 1999 patients and 15%, 74%, 7% of the 2006. The pathological characteristics were clearly defined in 78% (1999) and 84% (2006), but hormonal receptors and Her2neu were performed in 59% and 0% in the 1999 vs. 73% (p < 0.05) and 1% in 2006 survey. As type and extent of surgery and RT, the percentage of conservative treatment was increased from 4% in 1999 to 12% in 2006 (p< 0.05), postmastectomy RT was done for all the others. The time interval from operation to initiation of RT were longer in 2006, the mean was delayed from 23.8 to 43.4 days. The axillary operation pattern including lymph node dissection, level I/II dissection, and sentinel lymph node biopsy (SLNB), were documented in 61%, 24%, and 8% of patients in 2006. For patients of 1999, no SLNB was performed and 16% with level I/II operation (p< 0.05). Systemic chemotherapy (CT) and/or hormonal therapy were used in 74% (1999) and 98% (2006) of patients respectively (p< 0.05). Anthracyclines and paclitaxel-based CT regimens use significantly increased between 1999 and 2006 (31% vs. 52% and 12% vs. 36%). Conclusions: The practice patterns established in this study provide a baseline data. The present results demonstrate a low level of compliance with Western guidelines of clinical practices with current BC standards and continued improvement in many categories. Establishment and widespread use of international guidelines in China are desirable. No significant financial relationships to disclose.
Toxicities and adherence rates of hormone treatment in male breast cancer patients treated at a tertiary care center
Authors: Visram H. , Dent S. F. 
Published: August 2020

e11613 Background: Male breast cancer (BC) comprises approximately 1% of all breast cancer cases, and over 80% of male BC tumours express the estrogen receptor (ER). Male BC patients (pts) are often offered hormonal treatment (HT) with tamoxifen (T), or more recently aromatase inhibitors (AI's). There is a paucity of information in the literature on the toxicities (Tx) and adherence rates of HT in this population. Methods: We conducted a retrospective chart review of 24 pts diagnosed with male BC at the Ottawa Regional Cancer Centre from 1986–2003. Data collected included pt age, ER status, progesterone receptor (PR) status, systemic chemotherapy, HT, and Tx of treatment. Results: Median age of 24 male BC pts was 70.0 years (r: 46–83 years). The majority (16/24) of pts had ER/PR testing: 12 (75.0%) ER/PR +, 1 (6.3%) ER +/PR-, 2 (12.5%) ER +/PR unknown, and 1 (6.3%) ER/PR-. Of the 15 pts who were ER +, 13 received T and 5 received anastrozole (A) monotherapy during their treatment. One ER - pt received adjuvant T. Three pts with ER status unknown received T. Median duration of treatment with T (17 pts) was 38.0 months (r: 2–79 months). Hot flashes (23.5 %) was the most common reported Tx. Decreased libido, weight gain, rash, and malaise were reported in 2 pts (11.8%) each. Increased liver enzymes, pulmonary embolism, and erectile dysfunction were reported in 1 pt (5.9%) each. Five pts (29.4%) terminated treatment early due to T toxicity (median treatment 15 months; r: 2–54 months). Five pts were treated with A (median 10 months; r: 3–60 months), 4 of whom received prior T treatment. One pt reported loss of libido, and 1 significant depression /suicidal ideation requiring psychiatric treatment. Conclusions: This study provides contemporary data on toxicities and adherence rates of HT in male BC pts in a non-clinical trial setting. Approximately 30 % of male BC pts discontinued T therapy due to Tx, potentially having a negative impact on clinical outcome. Future studies will examine differences in adherence rates and outcomes between T and A in male BC pts. No significant financial relationships to disclose.
Prognostic factors for patients with invasive ductal carcinoma of the breast who received neoadjuvant chemotherapy
Authors: Tamura N. , Tamura N. 
Published: August 2020

e11617 Background: Neoadjuvant chemotherapy (NAC) for patients with invasive ductal carcinoma (IDC) of the breast is performed as a standard therapy in many hospitals for improving outcomes of IDC patients. The purpose of this study is to identify important prognostic clinicopathological factors for 115 IDC patients who operated in our hospital (1997 to 2002) followed by NAC. Methods: The multivariate analyses with an assessment of pathological effect of NAC, grading system for lymph vessel tumor emboli (LVTE), and histological factors of tumors in lymph nodes in addition to well-known prognostic clinicopathological factors were performed in IDC patients with nodal metastasis and in those of pTNM stage III as well as IDC patients as a whole. Results: Multivariate analyses demonstrated that grading system for LVTE was a significant prognostic factor for IDC patients in the both group. Severe tumor stroma in nodal metastatic tumors significantly increased the HRs of tumor recurrence of IDC patients in the both group. Number of mitotic figures in nodal metastatic tumors significantly increased the HRs of tumor death in IDC patients with nodal metastasis. Tumor necrosis in primary-invasive-tumors was a significant factor for tumor recurrence of patients in the both. Conclusions: The study clearly demonstrated that grading system for LVTE, and characteristics of nodal metastatic tumors as well as the presence of tumor necrosis in primary-invasive tumors are very important prognostic factors for IDC patients who received NAC. Since we already reported a prognostic significance of the factors in IDC patients who did not receive NAC in previous studies, we concluded that the factors are also very important for IDC patients who received NAC to accurately assess their outcome. No significant financial relationships to disclose.
Male breast cancer: Prognostic factors evaluation in a 35-year service
Authors: Botan R. D. , Alvares M. N. , Hassan A. 
Published: August 2020

e11618 Background: Treatment for male breast cancer is based on the results of large clinical trials for female breast cancer. Although peculiar differences do exist between men and women, very little is known about the prognostic factors in male breast cancer, even though female breast cancer practical conducts are widely used in male breast cancer. The rarity of this condition makes very difficult to produce randomized trials. Methods: This study is populational and epidemiological and evaluated male breast cancer patients from January 1974 to December 2001 about its prognostic characteristics. Data were collected retrospectively and the sample has been described using descriptive statistics methods. Survival curve was built using Kaplan-Meier method. Staging system was standardized as in the sixth edition of American Joint Committee on Cancer, independently on when the diagnose was made. Due to differences throughtout 35 years on therapeutic on breast cancer, treatment options were categorized in groups to make the survival evaluation possible. Results: From 45 patients with male breast cancer, 91% presented ductal histology, 26% were negative axillary, 9.1% were T1, 25% were T2, 4.5% were T3, 50% were T4 and 12.12% presented with distant metastasis at diagnose. Seventy nine percent were submitted to radical local treatment, while 34% had not been submitted to any kind of systemic treatment (neoadjuvant, adjuvant e hormone therapy). Forty percent of patients have not presented distant recurrence, while 58.3% have not presented local recurrence. A median survival of 126 months has been observed to the analyzed population, ranging from 69–182 months. Five-year survival was 72% and 10-year survival was 54%. These data agreed with the available data in the published literature. Conclusions: Male breast cancer appears to behave biologically and clinically very similar to female breast cancer, but differences do exist and need to be elucidated. Randomized multi-center clinical trials become necessary, as systematic reviews, to build higher statistic power studies. No significant financial relationships to disclose.