bluuebunny/crossref_metadata_2025_split huggingface dataset:
Use of intravaginal 17-β estradiol to improve sexual function and menopausal symptoms in postmenopausal women with breast cancer on aromatase inhibitors.
Authors: Goldfarb Shari Beth , Dickler Maura N. , Dnistrian Ann M. , Patil Sujata , Dunn Lara , Chang Kaity , Berkowitz Alyssa Peri , Tucker Noah , Carter Jeanne , Barakat Richard R. , Hudis Clifford , Castiel Mercedes 
Published: March 2020

9610 Background: The majority of women with early stage breast cancer (BC) will become long-term survivors, living with the sequelae of treatment. Attention to symptoms and quality of life (QoL) are therefore of increasing importance both during treatment and survivorship. Aromatase inhibitors (AIs) are used to treat postmenopausal women with hormone-receptor positive (HR+) BC and can lead to profound urogenital atrophy. Atrophic vaginitis in BC survivors is prevalent, its management is complex and it negatively impacts QoL. Methods: A prospective longitudinal IRB-approved study was performed at MSKCC in26 postmenopausal women with stage I-III HR+ BC on adjuvant letrozole or anastrozole for at least 3 months and had urogenital atrophy. All women were initiated on 10µg intravaginal 17-β estradiol. Patients completed the Female Sexual Function Index (FSFI) and Menopausal Symptom Checklist (MSCL) at baseline and wks 12 & 24. Increase in FSFI score means better sexual function and a decrease in MSCL score means improved symptoms. We used the Wilcoxon Signed Rank Sum test to compare QoL measures at baseline to wks 12 and 24. The primary endpoint was change in systemic estradiol level from baseline to wk 12. Serial estradiol/FSH levels were measured at baseline and wks 2, 7, 12, 18 & 24; we used a highly sensitive estradiol radioimmunoassay, ESTR-US-CT, from Cisbio US, Inc. Herein we report the results from the QoL secondary endpoints. Results: During treatment with intravaginal 17-β estradiol 10mcg, improvement in sexual function as measured by the FSFI was seen from a median of 12.4 at baseline to 21.2 at wk 12 (p=.0091) and 21.8 at wk 24 (p=.0271). Improvement was seen from baseline to wk 12 in lubrication (p=.0091), desire (p=.0303), satisfaction (p=.0331) and pain (p=.0005) and from baseline to wk 24 in lubrication (p=.0210), desire (p=.0309) and orgasm (p=.0369). A reduction in menopausal symptoms was also seen from 30.0 at baseline to 23.6 at wk 12 (p=.01) and 22.5 at wk 24 (p=.003). Conclusions: Intravaginal 10μg 17-β estradiol provided relief from menopausal symptoms and improvement in sexual dysfunction in the domains of lubrication, desire, satisfaction, orgasm, and pain.
Complementary and alternative medicine (CAM) use in lung cancer: The impact of control.
Authors: Bauml Joshua , Langer Corey J. , Evans Tracey L. , Garland Sheila N. , Desai Krupali , Mao Jun J 
Published: March 2020

9613 Background: Lung cancer (LC) remains the leading cause of cancer death for both men and women in the U.S., and is associated with significant symptom burden. The diagnosis and treatment of LC can make patients feel a loss of control, and desire for control has been associated with CAM use. While interest in CAM has surged recently, scant literature exists on its use in LC. This study aimed to quantify the prevalence of and identify the factors associated with CAM use in patients (pts) with LC with a specific focus on perceived control. Methods: We performed a cross sectional survey in pts with LC treated at the oncology clinic of an academic medical center. Self-reported CAM use was the primary outcome. Demographic and clinical variables were collected by chart abstraction. Pts’ perception of their degree of control was measured using the Cancer Locus of Control scale. Multivariate logistic regression was performed to determine which factors were independently associated with CAM use. Results: 296 pts were surveyed (77.5% response rate) with a mean age of 63.1 (28-84). 45.6% were male, 83.5% were Caucasian, 21% had never smoked, and 52.4% had Stage IV disease. 50.9% of pts used ≥1 form of CAM, most commonly vitamins (31.5%), herbs (19.3%), relaxation techniques (16%) and special diets (15.7%). In multivariate analysis, CAM use was associated with age≤65 (AOR 1.64, 95% CI 1.01-2.67), college level or greater education (AOR 2.17, 95% CI 1.29-3.64), never having smoked tobacco (AOR 2.39, 95% CI 1.25-4.54), and having a greater feeling of control over the cause of cancer (AOR 2.27, 95% CI 1.35-3.80). Gender and perceived control over treatment outcome were not associated with CAM use. Conclusions: In the largest study evaluating CAM in LC, half of pts surveyed used CAM. CAM use was associated with younger age, increased education, never having smoked tobacco and a greater feeling of control over the cause of cancer. In contrast to prior research, we did not find an association with CAM usage and gender or perceived control over treatment outcome. Since CAM use is common, future research is needed to evaluate how to integrate CAM into clinical care to help patients with LC regain a sense of control and improve their quality of life.
Real-world symptom burden and early treatment discontinuation in first-line metastatic breast cancer (MBC).
Authors: Walker Mark S. , Masaquel Anthony , Kerr Jiandong , Lalla Deepa , Abidoye Oyewale O. , Ogbata Obiageli Uchenna , Schwartzberg Lee Steven 
Published: March 2020

9619 Background: Treatment options in 1st line metastatic breast cancer (MBC) vary and may include chemotherapy, targeted, and hormone therapy. Some patients (pts) do not complete therapy as planned, perhaps due to treatment related toxicities. The current study examined the association of symptom burden with early treatment discontinuation (ETD) of 1st line therapy of MBC in real-world settings. Methods: Data were abstracted from medical records of pts at 9 community oncology practices. Eligible pts had stage IV breast cancer with start of 1st line therapy on 1/2004 to 6/2012, were ≥ 18 years, and had ≥ 1 Patient Care Monitor (PCM) survey during 1st line. The PCM is an 86-item survey of cancer-related symptoms collected as part of routine clinical care. Age, race, HER2 status, hormone status, oral and infused agents, dates of diagnosis, treatment, progression, and death were recorded. ETD was defined by direct indication of early stopping in the medical record, or by treatment duration ≤ 6 weeks without evidence of disease progression. Cox regression of ETD with time varying covariates was used to examine the impact of 23 separate symptoms as well as an overall composite symptom burden score based on pt responses on each symptom. Results: 797 pts were included, with mean age of 58.4 years, 62.1% White; with 340 on Chemotherapy (CT), 349 on CT + Targeted therapy (T) and 108 on Hormone therapy only (H). Overall, ETD occurred in 95 (11.9%) pts, with rates highest among CT (15.3%), followed by T (10.0%) and H (7.4%). Cox regression showed that 21 of 23 symptoms each increased the risk of ETD. In the composite symptom burden score (median 7.1; range 0 - 21) analysis, overall symptom burden was found to be significant (HR = 1.124, p < 0.0001), indicating a 12.4% increased risk of ETD with each additional symptom. Pts with 10+ symptom score had a significantly increased risk of ETD (HR = 3.09, p < 0.0001) compared to pts with < 5 symptom score. Pts with 15+ symptom score had the highest risk of ETD (HR = 5.75, p < 0.0001). Conclusions: Pts treated with CT for 1st line MBC had the highest rate of ETD. The likelihood of ETD increased as the number of symptoms increased. Future research is needed to evaluate ETD on pt outcomes, including overall survival.
Palonosetron (PALO) versus granisetron (GRA) in the triplet regimen with dexamethasone (DEX) and aprepitant (APR) for preventing chemotherapy-induced nausea and vomiting (CINV) in patients (pts) receiving highly emetogenic chemotherapy (HEC) with cisplatin (CDDP): A randomized, double-blind, phase III trial.
Authors: Hashimoto Hironobu , Yamanaka Takeharu , Shimada Yasuhiro , Arata Koji , Matsui Reiko , Goto Koichi , Takiguchi Tomomi , Ohyanagi Fumiyoshi , Kogure Yuki , Nogami Naoyuki , Nakao Masahiko , Takeda Koji , Azuma Kanako , Nagase Seisuke , Hayashi Toshinobu , Fujiwara Kimiko , Shimada Toshikazu , Seki Nobuhiko , Suzuki Kenichi , Yamamoto Nobuyuki 
Published: March 2020

9621 Background: Standard antiemetic care for preventing CINV due to HEC is a combination of 5-HT3 receptor antagonist (RA), DEX, and APR. This study compared the efficacy of two 5-HT3drugs, PALO and GRA, in the triplet regimen. Methods: Pts with a malignant solid tumor who were receiving HEC containing 50 mg/m2or more CDDP were enrolled. They were randomly assigned to either Arm A (PALO 0.75 mg, i.v.) or Arm B (GRA 1 mg, i.v.), 30 min before chemotherapy on day 1, both arms with DEX (9.9 mg on day 1 and 6.6 mg on day 2-4, i.v.) and APR (125 mg on day 1 and 80 mg on day 2–3, p.o.). Primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medications) at the overall (0-120 hours) phase. Secondary endpoints included CR at the acute (0-24 h) and delayed (24-120 h) phases, and total control (TC; no emetic episodes, no rescue medications, and no nausea) at the overall, acute, and delayed phases. The planned sample size of 840 provided 90% power to detect a 10% improvement in the CR at 0-120 h with two-sided alpha of 0.05. Primary analysis was conducted with exact Cochran-Mantel-Haenszel (CMH) test. Results: Between July 2011 and June 2012, 842 pts were enrolled and 827 were evaluable. The median CDDP dose was 76.1 mg/m2 in Arm A and 75.7 mg/m2in Arm B. Baseline factors were well-balanced. Efficacy results are summarized in the Table. Conclusions: The present study did not meet its primary endpoint. However, it has shown that the clinical utility of PALO exceeds that of GRA. PALO is a more preferable 5-HT3RA in the triplet regimen than GRA in the prevention of CINV due to HEC. Clinical trial information: 000004863. [Table: see text]
A randomized multicenter phase II trial on efficacy of a hydrocolloid dressing containing ceramide with a low-friction external surface for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma.
Authors: Shinohara Nobuo , Nonomura Norio , Kimura Go , Eto Masatoshi , Minami Hironobu , Yamazaki Naoya , Naito Seiji ,   Japanese Society of Renal Cancer
Published: March 2020

9623 Background: Hand-foot skin reaction (HFSR) is the most clinically significant and dose-limiting dermatologic toxicity in metastatic renal cell carcinoma (mRCC) patients who receive sorafenib (SOR). At present, evidence-based management strategy is not completely established. Since HFSR may be attributed to keratinous disorders of the skin and tends to develop in areas on the soles of the feet subject to strong pressure, a hydrocolloid dressing containing ceramide (a protective dressing against pressure ulcer) may prevent the development and worsening of HFSR. The purpose of the study is to investigate the usefulness of this material for HFSR on the soles of the feet in mRCC patients treated with SOR. Methods: Patients with grade 1 HFSR on the soles of the feet were randomly assigned 1:1 to receive a hydrocolloid dressing containing ceramide (Arm A) or 10% urea cream (Arm B). The detailed protocol of this study was presented in ASCO 2011 (Trial in Progress; TPS 233). A hydrocolloid dressing containing ceramide was applied to affected sites on the soles of the feet, but not to the hands. The primary endpoint was the incidence of Grade 2 or 3 HFSR on the soles of the feet in the first 4 weeks. Results: Thirty-three patients were evaluated; 17 patients in Arm A and 16 patients in Arm B. There were no significant differences in baseline characteristics between two arms. Over the 4 weeks period of this study, the incidence of Grade 2 or 3 HFSR on the soles of the feet was significantly lower in Arm A than Arm B; 5 (29%) patients in Arm A versus 11 (69%) in Arm B, p=0.03. On the other hand, the incidence of HFSR on the hands was similar between two arms. The median time to Grade 2 or 3 HFSR on the soles of the feet was significant longer in Arm A compared with Arm B; not reach (95%CI 13-28+) in Arm A versus 22 days (95%CI 15-27), p=0.03. Regarding the pain levels on the soles, Arm A was superior to Arm B (p=0.05). Conclusions: These results indicate that a hydrocolloid dressing containing ceramide with a low-friction external surface is effective in preventing the worsening of HFSR caused by SOR in mRCC patients. Clinical trial information: UMIN000002016.
Risk of arterial (ATE) and venous thromboembolism (VTE) in a population-based cohort of bevacizumab-treated metastatic colorectal cancer (mCRC) patients.
Authors: Yu Irene S. , Chen Leo , Cheung Winson Y. 
Published: March 2020

9624 Background: Bevacizumab potentiates the risk of ATE and VTE in cancer patients who are in a prothrombotic state. Whether there are specific factors that add to this risk and how bevacizumab-related thromboembolisms are best managed remain unclear. Our objectives were to 1) characterize the incidence of ATE and VTE in a population-based cohort of mCRC patients, 2) describe patient and treatment factors associated with thromboembolisms, and 3) examine how ATE and VTE are managed in routine practice. Methods: All patients diagnosed with mCRC from 2006 to 2008, evaluated at 1 of 5 regional cancer centers in British Columbia, and offered bevacizumab were included. Multivariate regression models were constructed to explore the associations between clinical factors and thromboembolisms. Results: A total of 541 mCRC patients were identified: 27 never started bevacizumab and 14 were lost to follow-up. Of the 500 remaining patients: median age was 61 years (IQR 53-67), 297 (59%) were men, 309 (62%) had ECOG 0/1, and 39 (8%) reported prior ATE or VTE. Median number of bevacizumab cycles was 11 (IQR 7-15). After receiving bevacizumab, 91 (18%) patients developed 12 ATE and 88 VTE, with 8 patients experiencing >1 event. Baseline characteristics, such as median age (61 vs 61 years), gender distribution (61 vs 58% men), and ECOG 0/1 (66 vs 58%) were similar between patients with and without thromboembolisms, respectively (all p>0.05). In regression models, individuals who experienced ATE or VTE were more likely to have a prior history (14 vs 6%, p=0.02), reported greater pre-existing cardiac comorbidities (42 vs 32%, p=0.05), and received a higher median number of bevacizumab cycles (13 vs 9, p<0.01), suggesting a potential dose-related effect. Following the development of ATE or VTE, management varied: bevacizumab was discontinued in 46%, held temporarily in 14%, and continued in 40% of patients. Conclusions: In this population-based cohort, the thromboembolism risk is high, especially in patients with pre-existing risk factors and those heavily treated with bevacizumab. Management of bevacizumab-related ATE and VTE appears variable, underscoring the need for guidelines.
Sustainability of antiemetic responses with APF530 (sustained-release granisetron) during multiple cycles of moderately (MEC) and highly (HEC) emetogenic chemotherapy regimens: Results of a randomized phase III trial.
Authors: Boccia Ralph V. , Cooper William , O'Boyle Erin 
Published: March 2020

9626 Background: Patients receiving MEC or HEC were administered subcutaneous (SC) APF530 500 mg, a sustained delivery formulation of granisetron (10 mg). The complete antiemetic response rates (CR; no emetic episodes and no rescue medication) were non-inferior to those of palonosetron in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) (Grous et al. ASCO 2009, #9627). We report on sustainability of CR with APF530 (10 mg) during multiple chemotherapy cycles in this study. Methods: 1428 patients scheduled to receive single doses of MEC or HEC were randomized to APF530 SC (5 or 10 mg granisetron) or 0.25 mg palonosetron intravenously (IV) prior to cycle 1 (C1). In C2-4, patients who received palonosetron in C1 were randomized to APF530 5 or 10 mg; those who received APF530 continued with their C1 APF530 dose. Treatment cycles were separated by 7-28 days. CR rates were compared between cycles using McNemar’s test. Results: No significant differences in within-cycle CR occurred between APF530 doses during acute and delayed phases in C2-4 for MEC and HEC, but a trend toward higher CR rates was seen in successive cycles. For the 2 doses, CR was sustained across all 4 cycles in 56.5-62.6% and 68.4-71.7% in acute phase, and 41.8-42.4% and 57.5-57.9% in delayed phase with MEC and HEC, respectively. Examination of CR rates in C2, C3, or C4 compared with the rate in C1 showed that CR rates were sustained and that the proportion of patients with no CR in C1 but CR in later cycles was consistently higher than that of patients with CR in C1 but no CR later. For illustration, the table shows C4 CR and C1 CR for patients who received APF530 10 mg in C1 and C4. Conclusions: CR rates achieved with APF530 during acute and delayed phases of CINV in MEC and HEC were maintained over multiple cycles. Clinical trial information: NCT00343460. [Table: see text]
Final results of a phase I trial of fasting prior to platinum-based chemotherapy.
Authors: Quinn David I. , Groshen Susan G. , Shah Manali , Tsao-Wei Denice D , Garcia Agustin A. , Pham Huyen , Lin Yvonne Gail , Ketchens Charlean , Massopust Kristy , Wei Min , Longo Valter , Dorff Tanya B. 
Published: March 2020

9632 Background: Fasting confers dramatic protection against chemotherapy toxicity in mice (PNAS 2008). We studied safety and feasibility of escalated fasting duration prior to platinum doublet chemotherapy in cancer patients (pts). Insulin, glucose, ketones and insulin-like growth factor (IGF) were measured as potential biomarkers of the fasting state. Methods: 3 fasting cohorts were evaluated: 24, 48 and 72 hours (hr) (48 pre/24 post chemotherapy). Subjects recorded all calories consumed during the fast period. Feasibility was defined as 4/6 subjects in each cohort consuming < 200 kCal/24 hr without excess fasting toxicity (using CTCAE v4.0). Results: Primary cancer: Urothelial 5, breast 5, ovarian 7, uterine 1, NSCLC 1. Regimens: gemcitabine+ cisplatin 6, docetaxel + carboplatin (C) + trastuzumab 5, C + paclitaxel 8. Median age: 61y (31-73). 4/6 pts, 5/7 pts and 4/6 pts in the 24, 48 and 72 hr groups were fasting compliant <200 kCal/24 hr with no significant toxicities. Median weight change was 0 after 1 cycle of fasting (-3.8% to +3.1%); 1 pt failed to regain 25% of lost weight prior to second cycle and per protocol did not fast again. Reasons for failure included forgetting and inability to maintain fast. Worst symptoms during the 48 and 72 hr fast: grade 1 hypoglycemia and hyponatremia; grade 2 headache, fatigue and dizziness; there were no grade 3 or 4 fasting-related toxicities. After fasting, insulin levels fell by medians of 69% in 24hr pts and 60% in 48hr pts (p=0.014). Median IGF1 levels Δ by -18.3% (p=0.012), interestingly 3 pts who fasted 72 hr had further Δ -19% to -59% from 48 to 72 hr. Conclusions: Fasting for up to 72 hr around chemotherapy is safe and feasible for cancer pts and resulted in significant decline in insulin and IGF1 levels. The randomized phase II portion of the trial commenced with 72 hr fast, seeking to delineate insulin and IGF1 as potential biomarkers of chemotherapy toxicity reduction. Clinical trial information: NCT00936364.
Symptom clusters and demographic characteristics in advanced cancer.
Authors: Aktas Aynur , Walsh Declan , Rybicki Lisa A. , Fitz Anne 
Published: March 2020

9638 Background: Little is known about demographic variations in cancer symptom clusters (SC). Our objective was to determine whether SC are associated with age, gender, race, performance status (PS), or primary cancer site. Methods: Symptoms from 1000 advanced cancer patients referred to a palliative medicine program were recorded prospectively. Among 922 patients with complete symptom data, hierarchical cluster analysis identified 7 SC. A SC was considered present if the patient had ≥50% of the symptoms in the cluster. Comparisons were made between patients with and without each cluster using the chi-square test (age <65 vs. ≥65 years; gender female (F) vs. male (M); race Caucasian (C) vs. African American (AA); 10 primary site groups (PSG), or Wilcoxon rank sum test (ECOG PS 0-4). A p value <0.05 indicated statistical significance. Results: 83% of patients were C, 52% ≥65 years, 56% M, and 55% had ECOG PS 3-4 Most common PSG were lung (25%), genitourinary (18%), and gastrointestinal (GI) (11%). Fatigue/anorexia-cachexia cluster was associated with race (58% AA vs. 68% C, p=0.032) and PSG (range 47% melanoma to 83% pancreas, p=0.012); Neuropsychological cluster was associated with older age (29% ≥65 vs. 39% <65, p<0.001) and race (22% AA vs. 36% C, p=0.001). Upper GI cluster was associated with female gender (16% M vs. 22% F, p=0.035) and PSG (range 8% Head & Neck to 32% pancreas, p=0.035). Nausea/Vomiting cluster was associated with younger age (35% ≥65 vs. 43% <65, p=0.010) and female gender (33% M vs. 47% F, p<0.001). Aerodigestive cluster was associated with male gender (36% F vs. 44% M, p=0.010) and PSG (range 24% pancreas to 58% Head & Neck, p<0.001). Debility cluster was associated with race (33% AA vs. 44% C, p=0.016) and poor PS (range 17% PS0 to 54% PS4, p<0.001). Pain cluster was associated with younger age (88% ≥65 vs. 92% <65, p=0.028). Conclusions: We identified 7 SC whose prevalence were influenced by age, gender, race, PS, or primary cancer site. This supports the clinical relevance of the cluster concept in palliative and supportive care. Demographic characteristics may warrant different clinical approaches to patient care. Identification of these differences may help develop more effective cancer treatment and management strategies.
High-dose Asian ginseng (Panax ginseng) for cancer-related fatigue (CRF): A preliminary report.
Authors: Yennurajalingam Sriram , Reddy Akhila Sunkepally , Tannir Nizar M. , Lee Richard T. , Lopez Gabriel , Escalante Carmen , Manzullo Ellen F. , Frisbee-Hume Susan , Tarleton Kenneth , Williams Janet L. , Palla Shana L. , Cohen Lorenzo , Bruera Eduardo 
Published: March 2020

9642 Background: CRF is a common and severe symptom in patients with cancer. There are limited useful treatments available. The objective of this preliminary study was to assess the safety of high-dose Panax ginseng (PG) on CRF. Methods: In this prospective open labeled study, 30 patients with cancer and fatigue ≥4/10 (0=no fatigue, 10=worst possible fatigue) received high dose PG 800mg orally daily for 29 days. Functional Assessment of Cancer Therapy-fatigue (FACIT-F), Edmonton Symptom Assessment System (ESAS) (0=best, 10=worst), and Hospital Anxiety Depression Scale (HADS) were assessed at baseline and day 29. Results: 24/30 (80%) patients were evaluable. The median age was 58yrs, 50% were females, 84% were white. The most common cancer type was genitourinary cancer (31%). Table shows the changes in fatigue, anxiety, depression scores. ESAS well-being improved from 4.67 (2.04) to 3.50 (2.34) (p=0.01374), appetite improved from 4.29 (2.79) to 2.96 (2.46) (p=0.0097). 21/24 (87%) patients had an improved FACIT-F fatigue score by day 15. Global Symptom Evaluation score of PG for fatigue was better in 15/24 patients (63%) with median improvement of 5 (1=hardly any better, 7= very great deal better). No ≥ grade 3 adverse events related to the study drug were reported. Conclusions: 1) PG is safe and rapidly improved ESAS fatigue and FACIT-F fatigue scores; 2) Overall quality of life (FACIT-General), appetite, and sleep at night also improved. Randomized controlled trials of PG are justified in CRF. Clinical trial information: NCT01375114. [Table: see text]