bluuebunny/crossref_metadata_2025_split huggingface dataset:
Hyperglycemia treatment is associated with longer length of hospital stay in colorectal cancer surgery patients
Authors: Geraci J. M. , Busaidy N. , Wang J. , Lam T. P. , Skibber J. M. , Freeman J. H. , Goodwin J. S. 
Published: March 2020

6133 Background: Diabetes mellitus (DM) is associated with longer hospital stays in some medical and surgical inpatient populations. Aggressive control of blood sugar may prevent complications and decrease hospital length of stay (LOS). Methods: We conducted a retrospective study of 519 patients at UT MD Anderson Cancer Center (UTMDACC) who had major surgery for colon or rectal cancer in calendar years 2000–2003. Patient data extracted from the UTMDACC Institutional Database included demographics, admission and discharge dates and diagnoses, surgical procedures, and diabetes medication use during the hospitalization. Known DM was defined as present if the patient had a diabetes diagnosis prior to or at admission; hyperglycemia treatment was defined as receipt of a medication for diabetes (insulin or oral medication) during the index hospitalization. Chi-square and t tests were performed to assess associations between patient characteristics and long LOS, and multiple logistic regression was used to identify independent predictors of hospital LOS at or greater than the 75th percentile for the study population (long LOS). Results: The mean age of the study population was 60.4 years (median 61, range 18–91). Known DM was present in 10.4% of cases; the same percentage received hyperglycemia treatment during their hospital stay, although not all were known diabetics. Mean LOS was 8.9 days; median 7 days and the 75th percentile 9 days. 50% of patients treated for hyperglycemia had long LOS (27 of 54 cases, p< 0.0005). In a logistic regression model controlling for patient demographic and clinical characteristics and the occurrence of post-operative complications, hyperglycemia treatment was an independent predictor of long LOS (odds ratio 4.1, 95% confidence interval 1.6, 10.3). Conclusions: Hyperglycemia treatment is associated with longer LOS in patients undergoing surgery for colon or rectal cancer at UTMDACC. Further studies should determine whether patients at risk for long LOS can be identified prospectively such that they might benefit from an intervention to reduce their LOS. [Table: see text]
Prognostic significance of quality of life index in breast cancer
Authors: Gupta D. , Grutsch J. F. , Granick J. , Neelam R. , Vashi P. G. , Daehler M. , Wodek T. , Lis C. G. 
Published: March 2020

6135 Background: Quality of Life (QoL) is a multidimensional construct. There is extensive data showing that QoL tools measuring the activities of daily life provide prognostic information in cancer. However, similar information on QoL tools measuring patient satisfaction with their life is sparse. The Ferrans and Powers Quality of Life Index (QLI) is one such instrument. The goal of this study was to evaluate the statistical strength of association between QLI and survival in breast cancer patients undergoing care in a non-clinical trial setting. Methods: We examined a case series of 251 breast cancer patients treated at Cancer Treatment Centers of America between 04/01 and 11/04. QLI defines QoL in terms of satisfaction with the aspects of life that are important to the patient. QLI measures overall QoL and QoL in four major subscales: health and physical, social and economic, psychological and spiritual, and family. All scores range from 0 to 30 with higher scores indicating better QoL. Study patients were dichotomized into 2 groups based on median scores for all QoL subscales. Kaplan Meier method was used to calculate survival. Log-Rank test was used to study the equality of survival distributions. Results: Of 251 patients, 74 were newly diagnosed and 177 had prior treatment history. The median age was 48 years (range 25 - 74 years). 45 patients had stage I disease, 105 stage II, 38 stage III, and 32 stage IV. The table describes the median survival for all QLI subscales. Health and physical functioning subscale and QLI subtotal subscale were significantly associated with survival. Conclusions: This study shows that baseline levels of patient satisfaction with their QoL provide useful prognostic information in breast cancer. While these findings need to be evaluated further to ascertain which subscales of QoL have a role in predicting patients’ prognosis, they have important implications for patient stratification in clinical trials and may aid decision-making in clinical practice. [Table: see text] No significant financial relationships to disclose.
Elevated preoperative serum level of tumor markers CEA and CA 15–3 in breast cancer patients
Authors: Park B. , Kim H. , Oh J. , Kim S. , Kim K. , Sohn J. 
Published: March 2020

621 Background: Serological tumor markers: Cancer Antigen 15–3 (CA 15–3), Carcinoembryonic Antigen (CEA), have been investigated as useful markers for monitoring of response to treatment and for predicting outcome in breast cancer patients. Methods: A total of 820 breast cancer patients, treated over the period April 1999 through December 2003, had preoperative CA15–3 and CEA concentrations measured. The stage of the primary tumor ranged from 0 to IV. The median age of the patients was 47years (range 20–88 years old). The concentration of markers was investigated with regard to clinico-pathological parameters and patients outcome by both univariate and multivariate analysis. We determined the range of normality by the mean + 2 standard deviations of the markers distribution in populations of healthy females, who took an annual health screening program. Survival curves for disease free survival and death from disease were estimated by the method of Kaplan-Meier method and differences between groups in survival were tested using the log-rank test. All statistical analyses were carried out using SPSS statistics software (ver 10.5). Results: Among 820 patients, elevated preoperative level of CA15–3 and CEA was identified in 100 (12.2%) and 83 (10.1%) patients, respectively. Tumor size (>5cm), lymph node metastases (≥4), advanced stage (stage III and IV) were associated with significantly higher level of both preoperative CA15–3 and CEA. Elevated preoperative values of CA15–3 and CEA were associated with poor disease free survival (DFS, p=0.0019, p=0.0001, respectively) and distant relapse-free survival (DRFS, p=0.011, p=0.0034), but the level was marginal for overall survival (OS, p=0.0848, p=0.0895). By Cox’s multivariate analysis, younger age (<35 years), larger tumor size(>2cm), axillary node metastases, negative ER expression, elevated preoperative values of CA15–3 and CEA were independent prognostic factors for DFS and DRFS. Conclusions: High level of preoperative CA 15–3 and CEA might reflect a tumor burden, and is associated with advanced disease condition and disease-free survival. Measuring preoperative levels of CA 15–3 and CEA might be helpful for predicting the outcome and for planning the adjuvant therapy in breast cancer patients. No significant financial relationships to disclose.
Analysis of the pathological response to primary chemotherapy in patients with locally advanced breast cancer (LABC) grouped according to ER, PR and HER2 status
Authors: Fernandez-Morales L. A. , Dalmau E. , Martinez S. , Arcusa A. , Pericay C. , Lain J. M. , Font J. , Tortajada L. , Saigi E. , Segui-Palmer M. A. 
Published: March 2020

626 Background: The determination of ER and PR has a considerable importance when evaluating the prognosis and the response to treatment in breast cancer (BC). Assessment of HER2 status is also a standard for the management of BC. Hormone receptors (HR), HER2, and increasingly, genomic profiles distinguish at least four major classes of BC: HER2+; HER2-HR+, which can be divided into two classes, favorable and unfavorable; and basal-like that express neither HER2 nor HR. In the clinical practice is possible to divided BC according to ER, PR and HER2: ER-PR-HER2+, ER-PR-HER2-, ER+PR+HER2-, ER+RP+HER2+; and less frequently ER+PR-HER2-, ER+PR-HER2+, ER-PR+HER2+ and ER-PR+HER2-. In the neoadjuvant setting the pathological complete response (pCR) to primary chemotherapy (PC) is associated to negativity for ER and PR receptors, and in patients (pts) with HER2 + BC, the addition of trastuzumab to PC increasing the rate of pCR. The aims of this study were to determine the pCR of PC with anthracyclines (A) and taxanes (T) in pts with LABC grouped according to ER, PR and HER2 status. Methods: Pts with LABC treated with PC including A and T were grouped according to ER, PR and HER2 status, and the pCR rate were analyzed using the chi-squared test and correlations with a p value of ≤0,05 were considered statistically significant. Results: A total of 103 pts were treated. There were 14.6% of ER-PR-HER2+ BC, 23.3% ER-PR-HER2-, 35.0%ER+PR+HER2-, 8.7% ER+PR+HER2+, 11.7% ER+PR-HER2-, 2.9% ER+PR-HER2+, 1.9% ER-PR+HER2+, and 1.9% ER-PR+HER2-. For the analysis of pCR only 100 pts were included. There were18 pts who achieved a pCR. Of these pts, 9/18 (50.0%) were RE-RP-HER2-, 5/18 (27.8%) ER-PR-HER2+, 3/18 (16.7%) ER+PR+HER2+, and 1/18 (5.6%) ER+PR+HER2- (p≤0.01). The table 1 show the pCR rate for each subgroup of BC. Conclusions: In patients with LABC to group BC according to ER, PR and HER2 status can help to predict pCR to PC. [Table: see text] No significant financial relationships to disclose.
Early switch with aromatase inhibitors as adjuvant hormonal therapy for postmenopausal breast cancer: Pooled-analysis of 8,794 patients
Authors: Ciccarese M. , Bria E. , Giannarelli D. , Cuppone F. , Nuzzo C. , Nistico’ C. , Terzoli E. , Cognetti F. , Carlini P. 
Published: March 2020

635 Background: The magnitude of the survival benefit of aromatase inhibitors (AIs) after 2–3 years of tamoxifen as adjuvant hormonal therapy for early breast cancer is still unclear. We performed a pooled-analysis of phase III trials, to look how much advantages adjuvant the “early switch” strategy add over standard tamoxifen for 5 years. Methods: All phase III trials were considered eligible. A pooled analysis was accomplished, and event-based relative risk ratios (RR) with 95% confidence interval (CI) were derived. Significant differences in primary outcome (EFS and RFS, event- and relapse-free survival), and secondary outcomes (OS, overall survival, deaths in absence of progression, other cancers and toxicities), were explored. Magnitude outcome measures were: absolute benefits (AB) and number of patients needed to treat (NNT). Heterogeneity test was applied as well. Results: Four trials designed to look if AIs after 2–3 yrs of TAM improve EFS (8794 patients) were gathered. Conclusions: Considered all the available phase III trials, the early switch strategy improves survival over standard tamoxifen for 5 years, with a different toxicity profile. The lack of significant heterogeneity in the analysis underscores the homogenous effect across all trials. [Table: see text] No significant financial relationships to disclose.
Internet based double-blind cross-over clinical trial to test efficacy of high dose isoflavone soy in controlling breast cancer survivor hot flashes
Authors: Dooley W. C. , Hendricks C. , Gusev Y. , Shockney L. 
Published: March 2020

636 Background: Severe hot flashes are common after completion of allopathic breast cancer treatment. Hot flashes are rare in the Orient where high isoflavone soy diets are common. Methods: We enrolled breast cancer survivors experiencing hot flashes after the completion of surgery, radiation and chemotherapy into a 16 week double blind cross-over casein placebo controlled trial of a 160 mg isoflavone soy dietary supplement. Hot flash frequency, severity, and time of day, exercise time and patient journaling was recorded by an internet diary placed on a HIPPA compliant server with password access. Results: Of 168 patients enrolled, 117 actually participated in taking supplementation and completing internet diaries giving adequate data for analysis. Of this group 13 patients dropped out of study for failure to finish all dietary supplements throughout the study period. The hot flash data during the last 4 weeks on each supplement was compared to determine benefit. There was no statistical difference in hot flash frequency, intensity or duration between either supplement independent of exercise level. Interestingly, 82% of patients reported a decrease in hot flashes in the first 4 weeks of study independent of which supplement they were randomized to receive. The journal entries report during this “induction” period that the majority of patients had identified emotional or dietary or other triggers for their hot flashes. The avoidance of the triggers seemed to substantially reduce their reported menopausal symptoms. Conclusions: High dose soy isoflavone dietary supplementation is ineffective in reducing breast cancer survivor hot flashes. Journaling may have a benefit in allowing survivors to find their individual triggers for the most severe hot flashes. Internet patient data entry provides a unique and highly compliant tool for obtaining direct patient reporting in survivorship clinical trials. [Table: see text]
Is tamoxifen prevention in younger women underutilized? Analysis of competing causes of mortality
Authors: Ragaz J. , Spinelli J. J. , Coldman A. , Mihalcioiu C. 
Published: March 2020

647 Background: Our past work on Tamoxifen impacting overall mortality outcome among survivors of the 1st breast cancer (JCO, 1998, 16:2018–24) introduced methodology permitting analyses of competing cause mortality, adjustable as new data emerge. This analysis estimates Tamoxifen impact on four conditions among BrCa survivors known to be affected by Tamoxifen, i.e. contralateral breast cancer; uterine cancer, cardiovascular (CVS) mortality, and thromboembolism (TE). Updated RR rates of Tamoxifen impacting the four conditions were obtained from recent literature (Lancet, 2005, 365:1687–1717; JNCI,2005, 97:1652–62; 97:1609–10). Methods: The effect of Tamoxifen was calculated by applying Relative Risk Rates (RR) to the respective underlying Canadian age-specific mortality figures, separately for each condition. The final mortality impact was the “net mortality”, defined as differences of deaths, from each condition, between 1,000 Tamoxifen users vs 1,000 non-users (Dif N/1,000), expressed for ages <50 and >50. (i.e sum of avoidances [-] vs hazards[+]) Results: see Table below. Conclusion: Our results show a favorable Tamoxifen impact on overall mortality, particularly evident for women age <50, in whom the breast cancer mortality reduction significantly outweighs the hazards. These data are applicable to Tamoxifen prevention in population-women who are at high risk for BrCa. Their outcome profiles affected by Tamoxifen mirror those of the survivors of the 1st BrCa. While for women >50, other chemoprevention alternatives exist (i.e. trials of Aromatase Inhibitors), for younger women no chemoprevention trials are presently in existence. Our data indicate that in those, routine use of Tamoxifen may save substantial numbers of lives. [Table: see text] No significant financial relationships to disclose.
Dendritic cell (DC) reconstitution is associated with less opportunistic infections (OI) after allogeneic hematopoetic stem-cell transplantation (HSCT)
Authors: Dunbar E. M. , Levine J. B. , Schold J. D. , Samantha G. S. , Meier-Kriesche H. , Marchand E. , Mahmood S. S. , Reddy V. S. 
Published: March 2020

6539 Background: Dendritic cells are key antigen presenting cells which coordinate immune responses against infections. We investigated the correlation between DC reconstitution after HSCT and the onset of OI. Methods: We prospectively studied immune reconstitution of DC in 124 patients with predominantly high-risk hematopoetic malignancies. Peripheral blood underwent flow cytometry analysis for DC, defined as lineage negative, HLA-DR+, CD11c+ and CD123+. Cluster analysis demonstrated patients at engraftment with high DC (>6.92/mm3) (n =68), low DC (n=56), and at 60 days with high DC (>3.95/mm3) (n=48), and low DC (n=43). Primary study endpoint was onset of OI, defined as viral and invasive fungal (proven and probable) OI within 6 months of HSCT. A cox proportional hazard multivariate model was adjusted for important covariates, including age, transplant conditioning (myeloablative vs. non-myeloablative), graft source (peripheral blood vs. bone marrow), donor-type (HLA-matched related vs. unrelated), and ANC. Results: Patients with low DC at engraftment had significantly increased onset of acute grade II-IV GVHD by Kaplan-Meier analysis (p=0.004). Patients with onset of GVHD prior to day 60 were less likely to have high DC (32% with GVHD, 72% without GVHD) (p=0.001). Furthermore, low DC at 60 days was adversely associated with: time to viral OI (p=0.04), time to composite of viral OI and death (p=0.02), time to viral or fungal OI (p=0.009), and time to composite of viral or fungal OI and death (p=0.02). In the Cox model, low DC at 60 days, was associated with a 3.7 relative risk (RR) (1.2, 11.8) for onset of OI. Patients with onset of OI prior to day 60 were significantly less likely to have high DC (41% with OI, 61% without OI) (p=0.05). Conclusions: This study emphasizes the clinical importance of measuring DC after transplant. Patients with low DC reconstitution are at an increased risk of OI and death. Measuring DC, and further understanding of the likely complex factors involved in DC reconstitution, may provide rationale towards future therapeutic immune interventions. No significant financial relationships to disclose.
Sequential imatinib and chemotherapy yield reverse-transcriptase polymerase chain reaction (RT-PCR)-negative peripheral stem cell collections in Philadelphia (Ph) chromosome positive acute lymphoblastic leukemia (ALL)—Preliminary results of CALGB 10001
Authors: Wetzler M. , Stock W. , Owzar K. , Sher D. A. , Hoke E. E. , Linker C. A. , Bloomfield C. D. , Larson R. A. 
Published: March 2020

6549 Background: Ph+ ALL has a short complete remission duration and survival. Allogeneic stem cell transplantation (SCT) is recommended. We hypothesized that imatinib plus sequential chemotherapy will result in greater leukemia cell cytoreduction than previously achieved with chemotherapy alone, allowing collection of large numbers of normal hematopoietic stem cells uncontaminated by residual t(9;22) lymphoblasts and thus reduce the likelihood of relapse after autologous SCT for patients without donors. Methods: Treatment consisted of a 4–5 drug induction regimen followed by imatinib 400 mg BID for 4 weeks, CNS prophylaxis with high-dose methotrexate, another month of imatinib, and ideally allogeneic SCT following fractionated total body irradiation (FTBI) and etoposide. Those without donors received high-dose cytarabine, etoposide, and G-CSF for stem cell mobilization, leukapheresis, and autologous SCT after FTBI, etoposide and cyclophosphamide. Imatinib maintenance continues until RT-PCR negative for 12 months. Patients had to be < 60 years old. Results: 18 patients have enrolled to date; so far 3 underwent allogeneic SCT and 5 completed peripheral stem cell collections of whom 4 have undergone autologous SCT. Median stem cell yield was 55.74×106/kg (range, 34.8–94.4). Peripheral stem cells were assayed from 3 patients for RT-PCR with a sensitivity of 1:105-106. All 3 samples were negative for BCR-ABL. Of the 3 patients who underwent allogeneic SCT, 1 failed to engraft and died, 1 died due to respiratory failure on day 70, and 1 relapsed on day 113. Of the 4 patients who underwent autologous SCT, all achieved neutrophil engraftment (> 0.5×109/L) between days 8–10 and platelet engraftment (> 50×109/L) between days 7–17. Two patients relapsed (simultaneous CNS and marrow) on days 164 and 309, and 2 patients are alive in continuous remission on days +297 and +359 following autologous SCT. Conclusions: Sequential imatinib and chemotherapy can achieve RT-PCR negativity in Ph+ ALL, allowing autologous SCT. Ongoing accrual will evaluate the efficacy of this approach in adults with Ph+ ALL. [Table: see text]
Pretreatment pulmonary function tests predict risk of mortality following fractionated total body irradiation without lung dose reduction prior to stem cell transplant
Authors: Mansueti J. R. , Singh A. K. , Karimpour S. E. , Guion P. , Ning H. , Savani B. , Wu C. , Altemus R. , Barrett J. 
Published: March 2020

6550 Background: Peripheral blood stem cell transplantation (PBSCT) is a key component in the treatment of various malignancies. Preparatory regimens for PBSCT often include total body irradiation (TBI). Pulmonary toxicity is often prominent, and is felt to be related to total lung dose and dose rate. The Radiation Oncology Branch of the National Institute of Health initially administered TBI without lung shielding, however shielding was added in 2002. Pulmonary function testing (PFT) was undertaken both before and after stem cell transplant and TBI for all patients. The PFT results were analysed to test the hypothesis that TBI patients with pre-treatment combined ventilation/diffusion capacity deficits, defined as both FEV1 and DLCO below 100% predicted, would benefit most from reduction of lung dose. Methods: From 1997–2004, 146 consecutive patients with hematologic malignancies received fractionated TBI before PBSCT. The first 85 patients were treated without lung dose reduction to 13.6 Gray (Gy). Thereafter, total body dose was decreased to 12 Gy (1.5 Gy BID for 4 days). Initially, lung dose was limited to 9 Gy by use of lung shielding. Later lung dose was reduced to 6 Gy. All patients received PFTs prior to treatment, 90 days after treatment, and annually. Results: Median F/U was 44 months (range 12–90 months). Sixty-one patients had combined ventilation/diffusion capacity deficits defined as both a forced expiratory volume in the first second (FEV1) and a diffusion capacity of carbon dioxide (DLCO) less than 100% predicted. Of these 61, 27 had lung dose reduction and 34 did not. One-year survival was 71% versus 50% with and without lung dose reduction respectively (log rank test p=0.042). Eighty-five patients had FEV1 and/or DLCO greater than or equal to 100% predicted; 34 were treated with lung dose reduction and 51 without. In both groups, 1 year survival was 70%. Conclusions: Among patients treated without lung dose reduction, survival was significantly worse among those with pretreatment combined ventilation/diffusion capacity deficits. Among those with combined ventilation/diffusion capacity deficits, lung dose reduction significantly improved survival. No significant financial relationships to disclose.