bluuebunny/crossref_metadata_2025 huggingface dataset:
Assessment of executive function (EF) among pediatric survivors of acute lymphoblastic leukemia (ALL).
Authors: Balsamo Lyn M , Sint Kyaw J , Neglia Joseph Philip , Kadan-Lottick Nina
Published: March 2020

9584

Background: Childhood ALL survivors are at increased risk of impaired EF. Both parent ratings and performance-based measures are used to identify vulnerable patients. We seek to assess the association between these modalities to 1) each other, and 2) need for special education and stimulants. Methods: This 22-site cross-sectional study included 256 children in remission for standard-risk precursor-B ALL previously enrolled on legacy Children's Oncology Protocols from 1993 - 2000. Patients had no history of CNS leukemia, cranial radiation, or pre-existing neurodevelopmental disorders; were ≥1 year off-therapy; and were 6-16 years at evaluation. Patients were administered performance-based measures of working memory, Digit Span (DS) and Letter-Number Sequencing (LNS) comprising the Working Memory Index (WMI) from the Wechsler Intelligence Scales for Children - Fourth Edition. Patients completed the Controlled Oral Word Association Test (COWAT). Parents completed demographic surveys and a Likert-scale assessment of executive processes, Behavior Rating Inventory of Executive Function (BRIEF). Results: There were modest correlations between BRIEF-WM scale and WMI (r=-0.20, p<0.01) and subscales, DS (r=-0.17, p<0.01) and LNS (r=-0.19, p<0.01). BRIEF-Initiate and COWAT (r=-0.22, p<0.01) were correlated. However, impaired classification based on performance-based measures was a poor predictor of parent assessment classification. The WMI and BRIEF-WM independently predicted receipt of special education (p=0.0017 and 0.0003). The BRIEF-WM and Initiate scales predicted stimulant medication use (p<0.0001 and p=0.0037); however, performance-based measures did not. Conclusions: Rater and performance-based measures provide related, but different information about EF indicating the need for both. Both measurement modalities capture educational difficulties; however, only parent ratings are associated with stimulants. This may reflect the medication's success in modifying cognition in controlled environments and the BRIEF's sensitivity to the child's ability to execute tasks in the real-world setting.
Thromboembolic events in breast cancer patients: A large series.
Authors: Reboucas Danilo Souza , Thuler Luiz Claudio Santos , Costa Maria Eduarda Ferro , Garces Alvaro Henrique Ingles , Aquino Luciana Carla Martins de , Bines Jose
Published: March 2020

9589

Background: Breast cancer is frequently associated with thromboembolic events (TEE). TEE may result in significant morbidity, a substantial economic burden and they represent a leading cause of death. Methods: We conducted a case-control study to analyze patients’ baseline and treatment characteristics in predicting TEE occurrence as well as the prognosis of breast cancer patients with thromboembolic events. We identified all breast cancer patients with a TEE at INCA (Brazilian National Cancer Institute), between January 2007 and December 2011. The control group consisted of breast cancer patients that had a doppler ultrasound with normal findings during the same period. Variables found to be significant (P <0.10) by univariate analysis were subsequently entered into a multivariate logistic regression model. We used Kaplan-Meier and Cox regression for survival analysis. Results: Overall, 225 patients that developed TEE were compared to 225 matched controls. The majority of events were deep vein thrombosis of the lower extremity (78.7%) and unilateral (94.2%). Most TEE occurred within the first 3 years after the diagnosis of cancer (66.2%), with the highest incidence observed in the initial 6 months. Factors associated with the development of TEE were: age above 50 years (OR 1.85, 95% CI: 1.16 to 2.95), ECOG performance status (PS) equal to or above 3 (OR 2.01, CI 95%: 1.24 to 3.26) and the presence of a central venous catheter (CVC) (OR 2.56, 95% CI: 1.42 to 4.62). The occurrence of TEE led to systemic treatment changes (44.9%) and, most importantly, it was associated with decreased survival (HR = 1.34, 95% CI: 1.01 to 1.77, p = 0.041). Conclusions: This large retrospective analysis of TEE in breast cancer patients confirms that most events occur early in the treatment course. The incidence of TEE was associated with patients’ age, PS, and the presence of CVC. Prospective studies are needed to evaluate outpatient thromboprophylaxis for selected groups of patients.
Five-year trajectories of financial recovery in low-income breast cancer survivors.
Authors: Blinder Victoria Susana , Patil Sujata , Gany Francesca , Maly Rose C.
Published: March 2020

9597

Background: Breast cancer may have devastating consequences on the financial stability of low-income families due to its impact on employment and limited duration of emergency Medicaid coverage. Methods: A consecutive sample of 921 low-income, uninsured/underinsured, English/Spanish-speaking women diagnosed with breast cancer through the California Breast and Cervical Cancer Treatment Program was surveyed 6 months after diagnosis. Previously uninsured women were enrolled in MediCal. Follow-up surveys were administered at 18, 36, and 60 months. Our primary outcome was self-reported adequacy of financial resources. Trajectories of financial adequacy were compared by ethnicity and by trajectories of employment and insurance status. Results: 6 months after diagnosis, 38% said they had adequate financial resources to meet their needs, compared to 39%, 49%, and 55% at 18, 36, and 60 months, respectively. Trajectories of financial adequacy varied by ethnicity and by trajectories of employment and insurance status (Table). Of 549 who reported on financial resources in all 4 surveys the most common trajectory was inadequate resources in all surveys (n=120) followed by adequate resources in all surveys (n=83). Of 208 who had adequate resources at 6 months, 60% reported inadequate resources in ≥1 subsequent survey. Of 341 who had inadequate resources at 6 months, 87% reported inadequate resources in ≥1 subsequent survey. Conclusions: Low-income breast cancer survivors are at risk of long-term financial instability. Latinas and survivors who are not working and/or are uninsured are at highest risk. Additional research is needed to better understand the factors that impact financial recovery after treatment. [Table: see text]
Young adult cancer survivors' (CS) follow-up care expectations of their primary care providers (PCPs) and oncologists.
Authors: Kumar Divjot Singh , Moghaddamjou Ali , Cheung Winson Y.
Published: March 2020

9598

Background: The delivery of cancer survivorship care can be complicated by a lack of clarity surrounding physician roles during follow-up. This can be particularly challenging for young adult CS who face unique needs. Our aim was to characterize young CS’ follow-up care expectations of their PCPs and oncologists. Methods: A self-administered survey was mailed to all CS diagnosed with cancer from 2005 to 2009, aged 20 to 39 years at the time of diagnosis, evaluated at any 1 of 5 regional cancer centers in British Columbia, and lived beyond 2 years. The questionnaire focused on demographics, prior treatment, and CS attitudes regarding physician responsibilities during survivorship, specifically their views about their PCPs’ and oncologists’ roles. Descriptive statistics and regression analyses were used to summarize these expectations and to determine if they differed based on physician type. Results: A total of 426 patients were included (response rate 59%): current median age was 40 years (range 24-45) and 301 (71%) were women. Common tumor sites were breast (48%), testicular (27%), and gynecological (18%). Most patients (63 and 65%, respectively) expected PCPs to be responsible for following their most recent cancer and screening for future cancers. Nearly all (85 and 93%, respectively) indicated that PCPs should also provide preventive care and manage their co-morbidities. Conversely, a significant proportion (65%) felt that oncologists should remain responsible for addressing side effects of cancer treatments throughout survivorship. In terms of fertility discussions, half of patients viewed this as a role for oncologists whereas the remainder perceived this to be more suitable for PCPs. Interestingly, neither PCPs nor oncologists were seen to have any significant role in addressing social reintegration, interpersonal relationships, or sexual function, with <30% of respondents expecting these to be discussed by either physician. Conclusions: Young adult CS expect PCPs to be responsible for most aspects of their ongoing care. More clarity regarding physician roles is required with respect to specific survivorship issues, such as fertility, sexual function and psychosocial health.
Discriminatory power of a 25-item distress screening tool CancerSupport Source: A cross-sectional study of 251 cancer survivors.
Authors: Miller Melissa F , Mullins C. Daniel , Onukwugha Ebere , Gayer Christopher , Golant Mitch , Buzaglo Joanne S.
Published: March 2020

9599

Background: Distress screening and integrated psychosocial care is imperative for cancer patients, yet no tools are specifically tailored for the community provider setting where the majority of US patients are treated. Any screening tool must be validated and effective at discriminating those at risk for greater distress and the associated poorer health outcomes. The study objective was to test the discriminatory power of a 25-item distress screening tool CancerSupportSource for use among cancer survivors. Methods: A total of 251 members (90% female, median age 57 years; mixed diagnoses, 46% breast, 9% gynecologic, 7% blood, 6% colorectal, 32% other) of a community-based cancer support network completed a web-based distress screening tool. Participants were asked to rate each of 25 items according to the question “Today, how concerned are you about…?” using a five-point scale (0 not at all to 4 very seriously concerned). A summary score was calculated as the count of items rated ≥2 and the item discrimination index (IDI) as the difference between proportions of high and low scorers rating an item≥2. Cut-points at 13 and 4 yielded equal-sized groups and were used to classify participants as high (n=59) and low scorers (n=60). Results: Items with the greatest discriminatory power (IDI≥0.8) were: changes or disruptions in work, school or home life; worrying about the future and what lies ahead; feeling too tired to do the things you need or want to do; feeling sad or depressed; ability to exercise or be physically active; and feeling nervous or afraid. Conversely, items with the lowest IDI included: eating and nutrition; tobacco or substance use; transportation to treatment and appointments; considering taking your own life. Conclusions: The results highlight, among 25 items of a distress screening tool, those items with the greatest discriminatory power to identify cancer survivors with psychosocial distress. Results suggest priority areas for distress screening and referral for support services.
Bridging to survivorship in breast cancer: Learning how treatment impacts mental health among early-stage breast cancer survivors.
Authors: Patt Debra A. , Espirito Janet L. , Turnwald Brian , Harrell Robyn K. , Bhowmik Debajyoti , Hoverman J. Russell , Brooks Barry Don , Denduluri Neelima , Beveridge Roy A.
Published: March 2020

9604

Background: Depression (D) and anxiety (A) complicate survivorship in breast cancer (BC) patients (pts). The prevalence of D and A after BC treatment (Tx) in the community and concordance with BC Tx type is poorly described, but vitally important to characterize risks of Tx and optimize support for BC pts and goals for survivorship care planning. Methods: We queried the electronic health record (EHR), iKnowMed, from a a large network of community oncology practices for pts treated with stage I-III breast cancer from 2007-2010 with at least 5 visits and follow up through 2012 for our retrospective study. We excluded pts who developed metastatic disease or died. We stratified pts by chemotherapy (CT) utilization (yes/no),hormone receptor (HR) status, age, and documented body mass index (BMI) at diagnosis, and post diagnosis development of D (y/n), A (y/n) or utilization of venlafaxine (E) like antidepressants (Ads), non-E like Ads or anti-A medications within the study period. Time to onset of A or D was analyzed using Cox proportional hazard methodology. Results: We identified 8,506 patients with a documented BMI at 1, 2, and 3 years (yrs) post diagnosis. 4369(51%) of patients received adjuvant CT and 4137 (49%) did not. Baseline characteristics were similar between tx groups, and active D or A was low at the time of dx, but as a whole rose to 41% during the study period. Pts with pre-existing D or A at the time of diagnosis were excluded. CT increases the risk of D or A (HR: 1.23, CI: 1.15-1.33). HR+ status also increases the risk of D or A (HR: 1.21, CI:1.11-1.32). Age conveyed a small diminished risk of D or A (HR: 0.98, CI: 0.98-0.99) while baseline BMI conveyed a small increased risk (HR: 1.02, CI 1.01-1.3). When excluding E like compounds that are often used to treat hot flashes in BC pts, CT was still found to have an increased risk of D or A (HR: 1.28, CI: 1.18-1.39), and HR+ was still associated with higher risk of D or A as well (HR: 1.11, CI: 1.01-1.22). Conclusions: Mental health disorders such as D and A are common among BC survivors, and more prevalent among BC survivors who received CT and have HR+ disease. This warrants further investigation on how to evaluate and support the mental health needs of BC survivors.
Who is receiving survivorship care plans? Findings from the 2012 Livestrong survey.
Authors: Rechis Ruth , Bann Carla , Nutt Stephanie , Squiers Linda , Rao Naveen
Published: March 2020

9608

Background: There are more than 14 million cancer survivors in the US – a number that is on the rise. Care coordination resources will be essential to provide support to this growing population. Key stakeholders, including the Commission on Cancer (CoC) and the Institute of Medicine, have proposed survivorship care plans (SCPs) as a way to extend support. However, limited research has been conducted to date on SCPs. Methods: In 2012, the LIVESTRONG Foundation (LIVESTRONG) administered a survey to understand the role of a treatment summary (TS) and SCPs and how they fit into survivors’ care. Logistic regression models were conducted to identify factors associated with receiving SCPs or TS. Results: 5,303 survivors responded to these questions (Table). While 92% of these respondents received information about where to return to for cancer check-ups, only 51% reported receiving a TS and 17% reported receiving a SCP. Survivors who were more likely to receive SCPs if they had a navigator (p<.001) and if they were male, Black, had finished treatment within the past year, or received care at a university-based medical center or community cancer center (p < 0.05). Also, those receiving a SCP were significantly more likely to have had a detailed discussion with a provider regarding long-term side effects, emotional needs, and lifestyle recommendations. Specifically, 60% of those with a SCP discussed long-term effects compared to 39% who did not. Conclusions: Results here indicate that few survivors receive SCPs but survivors reported benefits from receiving them. Currently many workflow barriers impede delivering SCPs, and LIVESTRONG is working with key stakeholders including the CoC to automate the LIVESTRONG Care Plan powered by Penn Medicine’s OncoLink through a registry and EMR system to understand how to address this issue. [Table: see text]
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]
A pilot intervention addressing sexual dysfunction after risk-reducing oophorectomy.
Authors: Bober Sharon , Garber Judy , Recklitis Christopher J , Patenaude Andrea Farkas
Published: March 2020

9644

Background: Women at high risk for ovarian cancer due to BRCA1 or BRCA2 mutation or family history are recommended to undergo prophylactic bilateral salpingo-oophorectomy (PBSO) after age 35 or completion of childbearing. This potentially life-saving surgery leads to premature menopause, frequently resulting in profound sexual dysfunction. We developed and piloted the first psychoeducational intervention for managing sexual dysfunction in young women after PBSO. Methods: This single-arm multi-modal pilot intervention study included a single half day session with educational modules about sexual health education, relaxation training, and cognitive behavioral therapy (CBT) skills to manage symptoms, followed by tailored telephone counseling. Self-report assessments, including the 19-item Female Sexual Function Index (FSFI) and a 10-item measure of sexual knowledge after PBSO were completed at baseline and two months post-intervention. Eligible women had PBSO for risk-reduction, current age ≤ 49, and endorsed at least one symptom of sexual dysfunction. Study endpoints include feasibility and effectiveness. Results: 36 women enrolled and completed pre- and post- assessments. Median age was 44 years (range 36-49) and median time since PBSO was 3.2 years (range 0.75-12.3). FSFI scores improved significantly from baseline to post-intervention for the desire (p = 0.003), arousal (p = 0.001), and satisfaction (p = 0.031) domains, as well as on the full scale score (p = 0.005). In addition, 60% of participants demonstrated improved knowledge scores about managing sexual dysfunction after PBSO following the intervention. Conclusions: The current intervention builds upon recent advances in CBT and sexual health education to address this much-neglected problem after PBSO. Results from this promising pilot intervention provide compelling preliminary data to move toward conducting a randomized clinical trial. Reducing post-PBSO distress, a valuable goal in its own right, may ultimately improve uptake of this potentially life-saving procedure in a high-risk population, as loss of sexual functioning is one of the reasons mutation carriers give for rejecting surgical risk-reduction.
Impact of oncology drug shortages.
Authors: Emanuel Ezekiel J. , Shuman Katie , Chinn Derek , Gogineni Keerthi
Published: March 2020

CRA6510

The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Monday, June, 3, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News.
Efficacy of different anti-HER2 drugs in first-line therapy for advanced breast cancer: Systematic review and meta-analysis.
Authors: Sasse Andre Deeke , Carcano Flavio Mavignier , dos Santos Lucas Vieira , Lima Joao Paulo Da S.N.
Published: March 2020

e11500

Background: Anti-HER2 therapy has brought major gains to therapy of advanced breast cancer (ABC), however it is still not know if there are difference in efficacy between trastuzumab and lapatinib. We execute a systematic review and meta-analysis in order to measure the impact of anti-HER2 therapy on ABC outcome and to assess if any particular drug is more effective in this scenario. Methods: Randomized controlled trials comparing first-line antineoplastic drug plus minus antiHER2 therapy (either trastuzumab or lapatinib) in ABC patients were searched in major meeting proceedings and databases. The outcomes were overall survival (OS), progression-free survival (PFS), tumor response and safety. Meta-analyses were performed using random-effects model and outcomes measured by hazard ratio (HR) and pertinent 95% confidence intervals were calculated. Subgroup analyses and meta-regression were undertaken to compare and measure the impact of anti-HER2 drug used over the estimated effect size. Results: eight trials (1848 patients) were included, two trials used lapatinib whereas six used trastuzumab. In two trials, anti-HER2 therapy was combined to hormone therapy. All trials, except the one by Slamon, demanded tumors to be ISH+ or IHC 3+. The methodological quality of included trials was moderate to good. Either trastuzumab or lapatinib improved overall survival (HR 0.79; 95% CI 0.69-0.91; P=0.0008; I2=0%) with no difference bet drugs (test for difference P=0.75). PFS was also increased with antiHER2 addition with similar activity of trastuzumab and lapatinib (HR = 0.58; 95% CI 0.51-0.66; P<0.0001; I2=0%, test for difference P= 0.42). Conclusions: The present meta-analysis confirmed the role of antiHER2 drugs as a valid first-line therapy for ABC. Furthermore, we failed to show any difference in efficacy between lapatinib and trastuzumab when combined to systemic therapy, both being acceptable options for antiHER2 therapy for ABC.
Health economic analysis of breast cancer index in patients with ER+, LN- breast cancer.
Authors: Gustavsen Gary , Schroeder Brock , Kennedy Patrick , Pothier Kristin Ciriello , Schnabel Catherine A. , Erlander Mark G.
Published: March 2020

e11504

Background: Numerous studies have demonstrated the cost utility of gene expression-based assessment of recurrence risk in breast cancer. Cost savings rely primarily on decreased use of adjuvant chemotherapy in patients predicted to be low-risk. Breast Cancer Index (BCI) is a gene expression-based test that significantly predicts overall risk of recurrence, late (≥5y) recurrence and likelihood of benefit from extended (≥5y) endocrine therapy in patients with ER+, LN- breast cancer. This study evaluated the potential cost utility of BCI from a US third-party payer perspective. Methods: A fact-based economic model was developed which projected the cost and effectiveness of BCI in a hypothetical population of patients with ER+, LN- breast cancer compared to standard clinicopathologic diagnostic modalities. Patients flowed through the model based on patterns of care and BCI data. Costs associated with adjuvant chemotherapy, toxicity, follow-up, endocrine therapy, and recurrence were modeled over 10 yrs. Model inputs were based primarily on published literature, and supplemented by interviews with disease experts and payers. Sensitivity analyses were performed around key inputs to estimate effects on the model. Results: Use of BCI is projected to be cost saving in this patient population, with a net cost savings of $4,005 per patient tested after accounting for BCI cost. Gross cost savings were projected to be achieved through targeted use of adjuvant chemotherapy ($5,785), reduced recurrence in patients receiving extended endocrine therapy based on BCI ($2,350), and reduced recurrence in previously non-compliant patients ($370). Sensitivity analyses demonstrated that results were most sensitive to chemotherapy utilization in low- and intermediate-risk patients, cost of adjuvant chemotherapy, cost of recurrence, and percentage of patients classified as low risk. Conclusions: BCI is projected to be cost saving in an ER+, LN-, breast cancer patient population. Cost savings are achieved through projected impact on adjuvant chemotherapy use, extended endocrine therapy use, and endocrine therapy compliance. These findings require validation in additional cohorts, including studies of real-world clinical practice.