bluuebunny/crossref_metadata_2025_split huggingface dataset:
The effect of tai chi chuan on bone remodeling and cytokines among breast cancer survivors: A feasibility trial
Authors: Peppone L. J. , Mustian K. , Rosier R. N. , Piazza K. M. , Hicks D. G. , Palesh O. G. , Darling T. V. , Purnell J. Q. , Janelsins M. , Morrow G. R. 
Published: August 2020

9610 Background: Weight-bearing exercise may slow the rate of bone loss associated with breast cancer treatment. The purpose of this study is to determine the effect of tai chi chuan (TCC) on bone health, as measured by the changes in the levels of bone resorption and bone formation. This study also aimed to investigate whether changes in bone health were correlated with growth and inflammation markers that serve as regulators of bone cell function. Methods: Female patients (N=16) who completed treatment for breast cancer within the past 30 months were randomly assigned to either the TCC group or the psycho-educational support group without exercise (ST) for 60 minutes, three times a week for a period of 12 weeks. Serum levels of bone resorption (N-telopeptides of type I collagen; NTx) and bone formation (bone specific alkaline phosphatase; BAP) were determined by ELISA at baseline and post-intervention. Using validated methods, a bone remodeling index (BRI) was calculated from levels of NTx and BAP. In addition, pre- and post-intervention levels of insulin-like growth factor binding protein 1 (IGFBP-1) and interleukin-2 (IL-2), markers associated with excessive bone resorption, were measured. Lastly, levels of interleukin-6 (IL-6), believed to enhance bone formation, were measured at both pre- and post-intervention. Results: ANCOVA analyses demonstrated that survivors in the TCC group experienced a greater increase in bone remodeling than those in the ST group (Δ BRITCC=1.6 vs Δ BRIST=0.2; p=0.04). All correlations were determined by Pearson's correlation coefficients. IGFBP-1 was negatively correlated with increasing bone remodeling levels (r=-0.43, p=0.14). IL-2 was also negatively correlated with increasing bone remodeling levels (r=-0.35, p=0.24). IL-6 was positively correlated with increasing bone remodeling levels (r=0.69, p=0.01). Conclusions: This pilot study suggests that TCC has positive effects on bone remodeling through changes in growth and inflammation factors that regulate bone cell function. A larger, more definitive trial examining the influence of TCC on bone remodeling is warranted. Funding: Sally Schindel Cone and R25 CA102618 No significant financial relationships to disclose.
Impact of a psychosocial intervention on performance status and coping
Authors: Lyerly H. K. , Staley T. , Herndon J. E. , Coan A. , Wheeler J. L. , Rowe K. , Horne B. , Abernethy A. P. 
Published: August 2020

9611 Background: Psychosocial distress is a critical cancer comorbidity; new interventions are needed. Pathfinders, a manualized psychosocial care program, provides patient navigation, counseling, coping skills training, mind/body techniques, and lifestyle advice. Methods: This prospective, single-arm, pilot study enrolled adult metastatic breast cancer patients with prognosis ≥6 months. Consenting participants met with a Pathfinder (trained social worker) at least monthly, with interim phone/email contact. Pathfinders worked with patients to identify inner strengths, teach coping skills, engage complementary/alternative providers, employ mind/body techniques, and support healthy lifestyle. At baseline, month 3 and month 6, patients completed surveys including Patient Care Monitor (PCM; a review of systems with 6 subscales and a global quality of life [QOL] score), and Functional Assessment of Chronic Illness Therapy - Fatigue subscale (FACIT-F). Results: Participants (n=50) were: mean age 51.2 years (SD 11.5); 24% non-white; 74% married; 50% did not complete college; the cohort had advanced cancer and short prognosis with 6-month attrition from death, 18%. Scores on the PCM Distress subscale improved from baseline to 3 months with a mean change of -3.42 (n=36; p=0.008) and from baseline to 6 months of -4.11 (n=28; p=0.002). PCM Despair subscale scores also improved: mean change of -4.53 (p=0.006) and -6.93 (p=0.016), respectively. PCM QOL and FACIT-F scores improved from baseline to 3 months; however, the change at 6 months, with smaller sample, was not statistically significant. Mean change in QOL from baseline to 3 and 6 months was 2.88 (n=30; p=0.006) and 2.66 (n=25; p=0.079), respectively. Mean change in FACIT-F from baseline to 3 and 6 months was 2.91 (n=39; p=0.020) and 1.29 (n=32; p=0.407), respectively. Conclusions: Pathfinders had significant positive effect on key psychosocial and QOL outcomes, notably distress and despair, for cancer patients despite advanced disease and worsening symptoms. No significant financial relationships to disclose.
Effect of coping styles on the psychological impact of discussing life expectancy for men with advanced cancer
Authors: Cripe L. D. , Rawl S. , Monahan P. , Tong Y. , Schmidt K. , Rand K. 
Published: August 2020

9615 Background: Discussions of life expectancy between men and oncologists are limited, in part, because of the potential adverse effect on psychological outcomes. However, appraisal of the cancer threat may enhance coping and improve psychological outcomes for some men with advanced cancer. Methods: We recruited 81 men with advanced cancer to complete surveys including coping (Mini-MAC), post-traumatic growth (PTGI), psychological outcomes (Hospital Anxiety and Depression Scale). Men and oncologists rated extent of discussions about life expectancy. Moderation was assessed with regression interactions and follow-up within group Pearson correlations. Results: Men reported a full (33%), brief (41%), or no (26%) discussion of life expectancy. Concordance was low. Only 23 (28%) agreed with oncologists about the extent of discussion. Among the 34 oncologists who reported having a full discussion, 16 (47%) of their patients reported having a brief discussion and 8 (24%) reported no discussion. Men who reported having a full discussion had significantly lower depression scores (mean = 2.8) than those who reported a brief or no discussion (mean = 4.6; p=.018). As expected, the extent of discussion moderated some of the relationships between coping style and outcomes. Helpless-hopeless coping was associated with greater depression only among patients who reported a full or brief discussion of life expectancy (n=61, r=.56, p<.0001). Interestingly, greater fatalism was associated with greater PTGI spiritual change among men who reported no or brief discussions (n = 54, r = .39, p = .004) and greater PTGI personal strength (n = 20, r = .63, p = .003) and PTGI appreciation of life (n = 20, r = .62, p = .003) among men who reported no discussion compared to men with full and brief or full discussion, respectively. Conclusions: Most men and oncologists reported discussions of life expectancy but there was little agreement on extent. Full discussions were not associated with depression; however this effect was moderated by coping styles. No significant financial relationships to disclose.
Risk of bevacizumab-associated gastrointestinal perforation in patients with colorectal cancer and noncolorectal cancer
Authors: Chu D. T. , Hapani S. , Wu S. 
Published: August 2020

9622 Background: Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor. It is a widely used angiogenesis inhibitor in the treatment of colorectal cancer (CRC) and other solid tumors. Gastrointestinal (GI) perforation is a potentially fatal adverse event associated with bevacizumab, but the risk unclear. This study was conducted to determine the risk of developing GI perforation among CRC and non-CRC patients receiving bevacizumab. Methods: Databases from PUBMED and the Web Science from January 1966 until July 2008 and abstracts presented at the American Society of Clinical Oncology conferences from January 2000 to through July 2008 were searched to identify relevant studies. Eligible studies included prospective phase III clinical trials in which standard anti-neoplastic therapy was administered with and without the use of bevacizumab with available data for GI perforation. Summary incidence rate, relative risk (RR), and 95% confidence interval (CI) were calculated using fixed or random effect models based upon the heterogeneity of the included studies. Results: A total of 12084 patients with various solid tumors from 14 phase III trials were included for analysis. Among patients receiving bevacizumab, the incidence of GI perforation was 0.8% (95% CI: 0.6–1.1%), and RR was 2.0 (95% CI: 1.1–3.8, p = 0.028) in compared with controls. The risk of GI perforation was significantly increased in patients receiving bevacizumab at 5 mg/kg/week (RR 2.6, 95% CI: 1.0–6.6, p=0.04), but not at 2.5 mg/kg/week (RR=1.5, 95%CI: 0.7–3.3, p=0.3). Among 2151 patients with CRC, the incidence of GI perforation was 0.8% (95% CI: 0.5–1.6%); while for 2.999 patients with non-CRC malignancies, the incidence of GI perforation was 0.7% (95% CI: 0.5–1.1%); The relative risk of GI perforation varied with tumor type, with significantly increased risk observed in patients with CRC (RR = 3.1, 95% CI: 1.2–8.2, p<0.023), but not non-CRC (RR=1.5, 95% CI: 0.67–3.4, p=0.3). Conclusions: There is a significant difference in the risk of developing GI perforation in CRC and non-CRC patients receiving bevacizumab with a higher relative risk in patients with CRC. Further investigation into the etiology of this difference is recommended. No significant financial relationships to disclose.
Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: A randomized, double-blind study
Authors: Boice J. A. , Schmoll H. , Brown C. , Taylor A. 
Published: August 2020

9626 Background: Aprepitant (A) has been shown in a previous trial to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving cyclophosphamide and anthracycline. This study assessed A in patients with a variety of tumors receiving a broad range of MEC regimens. Methods: This Phase III, randomized, gender-stratified, double-blind, trial enrolled female and male patients ≥18 years old with confirmed malignancies naïve to MEC or highly emetogenic chemotherapy and scheduled to receive a single dose of 1 or more MEC agent. Patients received A triple-therapy regimen (A 125 mg, ondansetron [O] 8 mg b.i.d., and dexamethasone [D] 12 mg on Day 1 of chemotherapy, A 80 mg q.d. on Days 2–3) or a control regimen (O 8 mg b.i.d. and D 20 mg on Day 1, and O 8 mg q12h on Days 2–3) all administered orally. Episodes of vomiting, nausea, and rescue medication use were recorded in a patient diary. Tolerability was assessed by physical and lab examinations, and adverse event (AE) reporting. Primary and key secondary efficacy endpoints were proportions of patients with No Vomiting and Complete Response (no vomiting and no rescue medication use), respectively, during the 120 hours postchemotherapy. Results: Among 848 randomized patients, 77% were female while 52, 20, 13, and 5% of patients had breast, colorectal, lung, or ovarian cancer, respectively. Significantly more patients in the A group achieved No Vomiting and Complete Response (a difference of 14.1 &12.4 percentage points vs. control, respectively). The incidences of AEs were generally similar in the aprepitant (61.9%) and control groups (66.5%). Conclusions: The aprepitant regimen provided superior efficacy over the control regimen in the treatment of CINV in a broad range of patients receiving MEC in both No Vomiting and Complete Response endpoints. Aprepitant was generally well tolerated. [Table: see text] [Table: see text]
Hot flash placebo responses: Related to baseline hot flash frequency?
Authors: Jones J. M. , Loprinzi C. L. , Qin R. , Barton D. L. 
Published: August 2020

9628 Background: As multiple treatments have been studied for the management of hot flashes in randomized, controlled trials, hot flash placebo responses have been quite variable across trials. Based on observations of trial reports, it was hypothesized that the magnitude of placebo effect might correlate with the number of baseline hot flashes in different studies. The current project examines the effect of the baseline hot flash frequency required for study participation and also the actual number of baseline hot flashes observed as these individually relate to the eventual reductions of hot flash frequency observed in patients receiving placebos. Methods: Data were collected from placebo-controlled, double-blinded, randomized trials, identified by a PubMed search, which reported hot flash frequency at baseline, 4–6 weeks and 12 weeks. Trials were excluded if they had less than 20 participants completing the placebo arm. Data gathered, in each study, included the number of hot flashes required to enroll in the study, the average hot flash number during the baseline period, and the hot flash changes in the placebo arms of each study (percent reduction from the baseline period). A simple statistical analysis was conducted in a descriptive fashion since standard deviation was not available in many trials. Scatter plots and Pearson's correlation coefficients demonstrated the relationships between the placebo hot flash percent reduction from baseline and both the minimum required number of hot flashes at baseline, and the mean number of hot flashes at baseline. Results: 45 trials with 49 placebo arms were included in this analysis. A significant positive correlation was seen between the number of hot flashes required to enroll in a study and the percent reduction of hot flashes from baseline at 4–6 weeks (Rho = 0.481, p = 0.003). There was also a significant positive correlation between the number of hot flashes at baseline and the percent reduction of hot flashes from baseline at 4–6 weeks (Rho = 0.481, p= 0.002) and at 12 weeks (Rho = 0.573, p= 0.003). Conclusions: These data support that higher baseline hot flash enrollment requirements and also higher baseline hot flash frequencies are associated with an increased placebo response. No significant financial relationships to disclose.
Differential time course of action of 5-HT3 and NK1 antagonists when used with highly and moderately emetogenic chemotherapy (HEC and MEC)
Authors: Hesketh P. J. , Warr D. G. , Street J. C. , Carides A. D. 
Published: August 2020

9629 Background: Cisplatin-based HEC displays a biphasic pattern of emesis with both an early and delayed period. In contrast, MEC has a monophasic pattern. The objective of this analysis was to investigate the time course of action of the 5-HT3antagonist ondansetron (OND) and the NK1 antagonist aprepitant (APR) in trials with HEC and MEC. Methods: Phase III HEC and MEC trials of APR were included. In 2 HEC studies, patients (pts) scheduled to receive cisplatin- based chemotherapy were randomized to an active-control group (OND + dexamethasone [DEX] Day 1, DEX bid Days 2–4) or an APR group (APR + OND + DEX Day 1; APR + DEX qd Days 2–3; and DEX Day 4). In a third HEC study, control pts also received OND on Days 2- 3. For the MEC study, breast cancer pts receiving anthracycline + cyclophosphamide-based chemotherapy were randomized to an active- control group (OND + DEX pre chemotherapy and OND 8 hours (h) later; OND bid Days 2–3) or an APR group (APR + OND + DEX pre chemotherapy and OND 8 h later; APR qd Days 2–3). In a post-hoc analysis, multivariate logistic regression models were used to assess the impact on emesis at different time intervals using a modified intent-to-treat approach. No multiplicity adjustment was planned, so nominal p-values are reported. Results: 1,527 pts and 856 pts were randomized and assessed for efficacy in the HEC and MEC trials respectively. For HEC, APR reduced risk of emesis beginning 15–18 h after cisplatin and extending to 48 h by 45–77% compared to control and by 45–67% compared to the OND control. For MEC, APR markedly reduced emesis from 6–9 h by 61% compared to control (p=0.0012). Conclusions: Time of onset (15 h vs. 6 h) and time course (15–48 h vs. 6–9 h) for the enhanced control of emesis with the addition of APR differs between HEC and MEC respectively. With HEC these results suggest that 5-HT3 dependent mechanisms are most important in the first 12 h after HEC with NK1-dependent mechanisms having a key role later. With MEC both 5-HT3 and NK1 mechanisms appear to be important early and the greatest impact of the NK1 antagonist occurs in the first 9 h. These results provide a rationale for maximizing NK1-antagonist exposure early on with MEC as a means to improve emesis control. [Table: see text]
Non-small cell lung cancer and estrogen plus progestin use in postmenopausal women in the Women's Health Initiative randomized clinical trial
Authors: Chlebowski R. T. , Schwartz A. , Wakelee H. , Anderson G. L. , Stefanick M. L. , Manson J. E. , Chien J. W. , Chen C. , Wactawski-Wende J. , Gass M. 
Published: August 2020

CRA1500 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]
Final STEPP results of prophylacatic versus reactive skin toxicity (ST) treatment (tx) for panitumumab (pmab)-related ST in patients (pts) with metastatic colorectal cancer (mCRC)
Authors: Mitchell E. P. , Lacouture M. , Shearer H. , Iannotti N. , Piperdi B. , Pillai M. , Xu F. , Yassine M. 
Published: August 2020

CRA4027 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]
A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of CTEP-sponsored studies
Authors: Cheng S. , Dietrich M. , Finnigan S. , Sandler A. , Crites J. , Ferranti L. , Wu A. , Dilts D. 
Published: August 2020

CRA6509 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.
MSH2 and adjuvant cisplatin-based chemotherapy in non-small cell lung cancer
Authors: Fouret P. , Planchard D. , Mendiboure J. , Kamal N. S. , Olaussen K. A. , Bertrand P. , Pirker R. , Dunant A. , Le Chevalier T. , Soria J. C. 
Published: August 2020

CRA7502 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]
A phase III multi-institutional randomized study of immunization with the gp100: 209–217(210M) peptide followed by high-dose IL-2 compared with high-dose IL-2 alone in patients with metastatic melanoma
Authors: Schwartzentruber D. J. , Lawson D. , Richards J. , Conry R. M. , Miller D. , Triesman J. , Gailani F. , Riley L. B. , Vena D. , Hwu P. 
Published: August 2020

CRA9011 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]
Impact of the mode of estrogen receptor determination on breast cancer prognosis
Authors: Martin P. , Mazouni C. , André F. , Bonnier P. 
Published: August 2020

e11609 Background: Impact of the mode of estrogen receptor determination on breast cancer prognosis Abstract Background: We examined if the mode of estrogen receptor (ER) determination and expression in primary breast cancer impact on patient's prognosis. Methods: We conducted an analysis on a prospective cohort of 1012 patients treated for stage I-III Breast Cancer at Conception Hospital, Marseille, France between 1984 to 2003. ER was determined according to enzyme immuno-assay (EIA) and immunohistochemistry (IHC). Disease-free and overall survivals were evaluated according to the mode of ER quantification and in function of qualitative or quantitative ER expression. Results: ER was a strong predictor of overall survival in the whole population whatever method used for the status determination (p<0.001); however when stratifying the analysis on ER quantitative expression, ER was still a prognostic indicator in the EIA group for OS (p= 0.004) and DFS (p<0.001), group but not in the IHC group for OS (p=0.58) and DFS (p= 0.195). Conclusions: ER determination in breast cancer is strongly associated with a better prognosis, but the level of influence of ER varies with the assay and ER expression. No significant financial relationships to disclose.
Dose-dense epirubicin with paclitaxel as preoperative treatment in locally advanced breast cancer: Phase II trial
Authors: Bautista Aragón Y. L. , Silva J. , Gonzalez Avila G. , Gutierrez A. , Pluma-Jiménez M. 
Published: August 2020

e11633 Background: Treatment of locally advanced breast cancer (LABC) with anthracycline-based regimens have pathological complete response (pCR) of 10–15%, and with anthracyclin-taxane therapy have pCR 18–30%. Combined or sequential are both acceptable with the most important agents. Methods: We use a dose- dense regimen epirubicin and paclitaxel for 12 weeks to determine the effectiveness in the neoadjuvant setting could increase pCR and safety of the regimen. This phase II study investigated women with untreated locally advanced breast cancer assigned to receive epirrubicina 25 mg/m2 and paclitaxel 70 mg/m2 for twelve weeks. Results: 21 patients were enrolled at median follow up of eight months. The median age was 55 years old (28–67). The distribution by TNM was IIB (15%), IIIA (52%), IIIB (24%) y IIIC (9%) and tumor type was lobular (24%) and ductal (76%). The mean tumor size was 8 cm (5 -14 cm). Ninety percent completed twelve cycles of chemotherapy with a two hundred forty five cycles administered. In six patients had dose reduction by 10–20% in subsequent doses and one patient withdrawn from de study because of chemotherapy related toxicity. In 9 percent of patients we use G-SCF. Surgery was performed in 18 patients. Eleven patients (52%) achieved a clinical response (PR o CR) after twelve cycles. Complete pathological response and partial was 11% y 14%. Subset analysis of the effect of Independent predictors included receptor status, Her2 neu, tumor size, and histology was no statistically significant (p.68). Treatment was generally well tolerated. Grade 3/4 non-hematologic adverse events (neurotoxicity, nauseas and palmar plantar dysesthesia) events occurred in 5% of patients. No cardiac toxicity was found. Conclusions: Despite the small sample size, it was representative of our population of LABC. These data indicate that the combined regimen in dose-dense epirubicin and paclitaxel is a regimen with acceptable toxicity. However we have low percent of cPR, maybe we have a high percent of patients with stage IIIA and IIIB with large diameter of tumor size. No significant financial relationships to disclose.