bluuebunny/crossref_metadata_2025 huggingface dataset:
Willingness of cancer patients to discuss advance directives with admitting doctor or oncologists
Authors: Dow L. A. , Smith T. J. , Matsuyama R. , Lamont E. B. , Ramakrishnan V. , Kuhn L. , Lyckholm L.
Published: August 2020

9539

Background: Many seriously ill cancer patients do not discuss prognosis or advance directives (ADs), which may lead to aggressive care at end of life (Harrison & Smith, JAMA 2008). Ten years ago, cancer patients did not want to discuss ADs with their oncologist (ONC), but would discuss them with an admitting doctor (Lamont JPM 2000).We assessed if this still held. Methods: We administered semi-structured interviews to cancer inpatients on the VCUHS Hematology-Oncology service. 55/63 consecutive patients accrued. Information was collected regarding ADs and knowledge of hospice/palliative care. Results: Of those enrolled, 22/55 (40%) reported having ADs. Only 2/55 had discussed ADs with their oncologist. Only 12/55 (22%) would want to discuss ADs with their ONC. But when specifically asked, 22/55 (40%) of patients would prefer to discuss ADs with their oncologist, and 40% with their primary care doctor. 86% would discuss ADs with the admitting doctor. There was no difference in doctor preference based upon prior AD completion. The preference not to discuss ADs with the oncologist was often because they felt their family could make the decisions, or that it was only necessary “If it got serious.” There was a common misconception that ADs mean death is imminent and lead to termination of care. Conclusions: Most patients (86%) are willing to discuss ADs with an admitting doctor, but only a small number (22%) want to discuss with their ONC. However, most patients will discuss ADs and 40% actually prefer their ONC if ADs are discussed. We therefore need to train primary care doctors, house staff, hospitalists, and oncologists to have these difficult discussions.

[Table: see text]

No significant financial relationships to disclose.
Sequential (ST) versus combination (CT) chemotherapy in older patients (pts) with advanced colorectal cancer (aCRC): A retrospective analysis of the CAIRO study
Authors: Doornebal J. , Wymenga A. , Antonini N. , van der Graaf W. T. , Koopman M. , Punt C. , Timmer-Bonte J.
Published: August 2020

9542

Background: Although older pts have been underrepresented in clinical trials, studies support the efficacy of chemotherapy in older pts with aCRC. We retrospectively evaluated efficacy, tolerability, and quality of life (QoL, EORTC QLQ C30) of older (group 1: ≥ 70 yrs) vs younger pts (group 2: < 70 yrs) who participated in a randomized phase III trial of ST vs CT in CRC (Koopman et al, Lancet 2007). Moreover, differences between ST vs CT were analyzed in both age groups. Methods: All 803 eligible pts were randomized between ST - 1st line capecitabine (Ca) 1250 mg/m2 bid d1–14 (group 1: n = 104/group 2: n = 297), 2nd line irinotecan (Ir) 350 mg/m2 d1 (1:63/2:189) and 3rd line Ca 1000 mg/m2 bid d1–14 + oxaliplatin 130 mg/m2 d1 ([CAPOX], 1:34/2:119) - and CT - 1stline Ca 1000 mg/m2 bid d1–14 + Ir 250 mg/m2 d1 (1:95/2:307), 2nd line CAPOX (1:33/2:165). Cycles were given q 3 weeks. Results: Baseline characteristics, median number of administered cycles and median relative dose intensities were comparable. Group 1 vs 2: Overall survival (OS) and progression free survival (PFS) were comparable (OS: ST: 17.6 vs 16.0 months, HR 1.127 [0.883 - 1.437], CT: 19.8 vs 16.8 months, HR 0.913 [0.708 - 1.178]). A better RR was observed in 1st line ST for group 1 (30% vs 17%). Grade 3–4 toxicity was more common in 1st and 2nd line ST in group 1 (overall grade 3–4 toxicity 54/59% vs 40/43%). However, significant decreases in overall QoL, fatigue, appetite loss, and diarrhea were only reported in CT for group 1. ST vs CT: OS was comparable (1: 17.6 vs 19.8 months; 2: 16.0 vs 16.8 months). A better RR (17% vs 40%) and longer PFS (5.4 vs 7.8 months) were only observed in CT for group 2. Cumulative overall toxicity over all subsequent lines of treatment was worse for ST in group 1 (85% vs 69%). However, significant decreases in overall QoL, symptomatic appetite loss, nausea and vomiting and diarrhea were only reported in group 1 for CT. Conclusions: Older pts derived comparable benefit from both chemotherapeutic strategies compared to younger pts. CT did not result in any benefit in terms of efficacy in older pts. Despite the higher incidence of grade 3–4 toxicities, both efficacy and QoL results support the preference of ST in fit older aCRC patients.

No significant financial relationships to disclose.
Geriatric assessment of older adults with cancer: Baseline data from a 500 patient multicenter study
Authors: Hurria A. , Mohile S. , Lichtman S. , Owusu C. , Klepin H. , Gross C. , Hansen K. , Klapper S. , Togawa K. , Tew W.
Published: August 2020

9546

Background: As the cancer population ages, a brief, comprehensive measure is needed to characterize the “functional age” of a patient, in order to optimize treatment decisions and evaluate outcomes based on factors other than chronological age. A geriatric assessment (GA) evaluates factors other than age that predict morbidity and mortality in older adults. The goals of this study are to describe the results of a GA performed in 500 older adults with cancer from 7 participating institutions and to evaluate the feasibility of completing this assessment in oncology practice. Methods: The GA is comprised of validated measures of functional status, comorbidity, cognition, psychological status, social functioning and support, and nutritional status (Hurria et al, Cancer 2005). The GA was completed prior to the start of a new chemotherapy regimen in patients age ≥ 65 with a solid tumor or lymphoma. Results: 500 patients (mean age 73; range 65–91) completed the GA. The most common tumor types were lung (29%), GI (29%) and breast/gyn (22%) cancer; 57% had stage IV disease. The GA revealed that 41% of patients needed assistance with instrumental activities of daily living despite a mean physician-reported KPS of 85 (range 50–100), 92% had ≥1 comorbid medical conditions (mean 2.5; range 0–9), 95% took ≥ 1 medications (mean 5; range 0–23), 16% had ≥ 1 falls in the past 6 months, 6% had gross cognitive impairment on the Blessed Orientation-Memory-Concentration Test, and 39% had > 5% weight loss in the past 6 months. The mean time to complete the GA was 27 minutes (range 10–80); 94% were satisfied with the GA length and 70% were able to complete the GA without assistance. Multivariate logistic regression identified the following sociodemiographic and disease variables predict the need for assistance with completion of the GA: age ≥ 80 (p=0.02), high school education or less (p<0.01), non-white race (p<0.01), and the presence of metastatic disease (p=0.01). Conclusions: This brief GA is largely self-administered, can be completed by the majority of older patients without assistance, and identifies important deficits and problems that may impact morbidity and mortality. Prospective data are being acquired to identify factors in the GA that predict chemotherapy toxicity in older adults with cancer.

No significant financial relationships to disclose.
Recommendation of adjuvant chemotherapy and trastuzumab in older adults with HER2-positive breast cancer: A survey of oncologists
Authors: Pal S. K. , Naeim A. , Wong F. L. , Chung C. T. , Bhatia S. , Mortimer J. , Somlo G. , Hurvitz S. , Villaluna D. , Hurria A.
Published: August 2020

9547

Background: Though substantial evidence supports the use of adjuvant trastuzumab in patients with HER2-positive breast cancer, a lesser amount of data is available to guide use of this therapy in older adults. The objective of the current study is to understand how patient age and health status impact the oncologists' decision to recommend adjuvant therapy in older women with HER2-positive breast cancer. Methods: Medical oncologists (n=151) participated in an online survey comprised of case scenarios with patients of varying age (70, 75, 80, 85) and health status (good, average, poor) with a T2(4 cm) N2(4+ LN) ER(-), HER2(+) breast cancer. Oncologists could offer the hypothetical patient treatment with chemotherapy and trastuzumab, chemotherapy alone, trastuzumab alone, or no therapy. The influence of age and health status on treatment recommendations was assessed using a generalized linear mixed-effects model. Results: With increasing age and deterioration of health status, the recommendation for chemotherapy with trastuzumab decreased (P<0.0001 for both). In contrast, recommendation for trastuzumab alone or no therapy increased with advancing age (P<0.0001 for both) and deteriorating health status (P<0.0035 and P=0.059, respectively). Chemotherapy alone was not frequently recommended, irrespective of age or health status. Conclusions: Given the relative dearth of evidence-based data for adjuvant treatment of HER2-positive breast cancer in older adults of varying health, oncologists recommend a diverse array of therapeutic approaches for this subgroup. Increasing age and declining health status lead to more frequent recommendation of trastuzumab alone or no therapy, and less frequent recommendation of chemotherapy with trastuzumab.

[Table: see text]

[Table: see text]
NT-ProBNP prediction of major chemotherapy-related toxicity and death in lymphoma patients
Authors: Salar A. , Sanchez-Gonzalez B. , Alvarez-Larran A. , Comin J. , Gonzalez J. R. , Gimeno E. , Gomez M. , Garcia F. , Bruguera J. , Besses C.
Published: August 2020

9569

Background: NT-Pro BNP provides diagnostic and prognostic information in many heart syndromes, but its role in oncologic patients is not established. Methods: We studied the association between NT-ProBNP levels and the risk of major toxicity associated with chemotherapy and death from all causes in 116 consecutive patients with lymphoma treated with curative intent. High resolution ultrasound echocardiography and serum NT-ProBNP levels were prospectively done previous the start of chemotherapy. Charlson Comorbidity Index was retrospectively calculated. A major toxicity event was defined as: when chemotherapy had to be discontinued, when chemotherapy had to be changed to a less intensive regimen, and treatment-related death. Results: High blood levels of NT-proBNP were associated with previous cardiologic history but not with left ventricular ejection fraction. With a median follow-up of 16 moths (0–49 months), 25 patients had a major toxic event with first line chemotherapy and 16 had died at last follow-up. The threshold of NT-ProBNP with better predictive accuracy for major toxicity-free and overall survival was 900 pg/mL. Patients with levels of NT-proBNP greater of 900 pg/mL had an adjusted hazard ratio (HR) for major toxicity after first-line chemotherapy for lymphoma of 6.4 (95%CI, 2.7–15.1). Two additional independent factors predicting higher major toxicity associated with chemotherapy were albumin < 3.5 g/mL (HR 3.5, P=0.008) and number of extranodal sites ≥ 2 (HR 3.1, P<0.007). For prediction of death from all causes, patients with a NT-ProBNP greater of 900 pg/mL had an HR of death of 15.3 (95%CI, 4.8–48.8; P<0.001). ECOG ≥ 2 was also significant for predicting death (HR 3.6; 95%CI, 1.1–11.6; P=0.03). The NT-Pro BNP added prognostic information beyond that provided by conventional risk factors, including IPI, left ventricular ejection fraction and Charlson comorbidity index. Conclusions: NT-ProBNP is the stronger marker for predicting major toxicity after first-line chemotherapy and death from all causes in patients with lymphoma and provides prognostic information beyond that provided by conventional lymphoma risk factors and comorbidity indexes.

No significant financial relationships to disclose.
Exploration of hereditary cancer and feasibility of genetic services at the end of life
Authors: Quillin J. M. , Bodurtha J. N. , Siminoff L. A. , Smith T. J.
Published: August 2020

9578

Background: For families, optimal hereditary cancer assessment begins with an affected relative. End of life could be the last chance for testing or DNA banking. Many palliative care oncologists do not feel qualified to offer genetic services and are rarely doing so (NSGC, 2008). The genetic burden of cancer in palliative care is unknown. Methods: We investigated prevalence of hereditary cancer among dying cancer patients, previous genetic testing or DNA banking, and awareness and intentions regarding these services. In spring/summer 2008 we recruited and interviewed patients (or surrogate decision makers) from the VCUHS Palliative Care Unit. Genetic risk was characterized as “strong” using classification criteria developed by Scheuner et al. (1997) or other consensus diagnostic criteria. Statistics were assessed using SAS 9.1.3. Results: 43 (47%) patients (including 9 surrogates) agreed to participate. The most common diagnoses were leukemias/lymphomas (n=9), and cancers of the lung (n=8), colon (n=5), and breast (n=4). 8 of 43 (18.6%, 95% CI = 7.0% to 30.2%) patients had “strong” genetic risk. Currently available genetic tests could have addressed risk for several patients, especially for HNPCC and hereditary breast/ovarian cancer. None had previous testing or DNA banking. Of strong-risk patients (or surrogates), 7 (87.5%) had heard/read “almost nothing” or “relatively little” about testing. All had heard/read little or nothing about DNA banking. 83% would “probably get tested” if offered, and 72% would “probably” or “definitely” bank DNA. There were no significant differences by race/ethnicity, nor by genetic risk. Conclusions: The genetic burden of cancer may be at least as high in the palliative care population as in other clinical settings and is not being discovered upstream. Patient interest in genetic services is high, but awareness is low.

No significant financial relationships to disclose.
Employment status and work-related difficulties in family caregivers of terminal cancer patients compared with the general population
Authors: Kim S. , Lee J. , Yun Y. , Kim S. , Kim S. , Do Y. , Ro J. , Park S. , Jeong H. , Kang J.
Published: August 2020

9580

Background: This study was aimed to investigate the employment status and work-related difficulties among family caregiver of terminal cancer patients compared with the general population. Methods: A survey was administered to 381 family caregivers of terminal cancer patients at 11hospitals and 994 general populations aged more than 18 years. Results: Family caregivers of terminal cancer patients were female (66.7%) and the patient's spouse (50.9%), with mean age of 46.8years (SD, 13.5). 212(56.1%) were working before cancer diagnosis, however, only 133(36.3%) continued working currently. Compared with the general population, 233(63.7%)family caregivers of terminal cancer patients were more likely to be not working (adjusted odds ratio [aOR] =2.39; 95% confidence interval [95%CI] = 1.73 to 3.29).Those who continued working reported more easy fatigability (40.6% vs 22.4%) and reduced working hours (20.3% vs 2.1%) than general population. For those doing housework, caregiving itself (56.4%) were identified to be the most common difficulties, followed by easy fatigability (32.3%). Major reasons for not working were providing care to the terminal cancer patients (24.0%). Older age (aOR=10.37; 95%CI=2.80 to 38.41), female sex (aOR=4.28; 95%CI=2.25 to 8.13), lower household income (aOR=2.19; 95%CI=1.19 to 4.06), bearing medical cost by other than spouse (aOR=2.10; 95%CI=1.05 to 4.19), and low performance status of the patients (aOR=2.00; 95%CI=1.01 to 3.95) were significantly associated with not working. Conclusions: When compared to the general population, family caregivers of terminal cancer patients were at risk job loss from their caregiving burden, and caregiving and easy fatigability were the major work-related difficulties. Our study might help make a strategy to reduce job loss for family caregivers' caregiving burden.

No significant financial relationships to disclose.
Parental decisions and outcomes regarding disclosing maternal BRCA1 and 2 test results to children
Authors: Tercyak K. , Peshkin B. , DeMarco T. , Schneider K. , Valdimarsdottir H. , Garber J. , Patenaude A.
Published: August 2020

9582

Background: BRCA1/2 testing is key to hereditary cancer risk management. Though testing is discouraged in children, prior work suggests they are informed of their tested mothers' mutation status; decisions and outcomes of parental disclosure to children remain largely unknown. Methods: We examined predictors of parental disclosure decisions to children ages 8–21 and related outcomes in a large clinical sample (221 tested mothers, 124 untested co-parents). Parents were interviewed prior to mothers' receipt of BRCA1/2 results and 1 and 6 months later. Descriptive analyses were conducted, and bivariate analyses identified candidate predictor variables (demographic, medical, psychosocial) for inclusion in multivariate logistic regression models. Results: 63% of mothers disclosed their results to their children within 1 month of receipt (44% of co-parents also disclosed to children); this increased to 68% by 6 months (55% among co-parents). Within parenting dyads, mothers were significantly more likely than co-parents to disclose to children in the short-term (X2=18.6, p<.0001). Predictors of maternal disclosure to children included not being a BRCA1/2 mutation carrier, older child age, stronger intentions to disclose, more favorable attitudes toward pediatric BRCA1/2 testing, a more open parent-child communication history, and a decisional balance favoring disclosure (all p's<.05). When examined simultaneously, mothers who were not mutation carriers (OR=4.02, 95% CI=1.35, 11.94), mothers of older children (OR=1.30, 95% CI=1.13, 1.49), and those with stronger intentions to disclose (OR=1.39, 95% CI=1.10, 1.76) were more likely to communicate. Other outcomes of maternal disclosure included greater satisfaction with the decision to disclose and more open parent-child communication following disclosure (all p's<.05). Conclusions: This is the largest and most well-characterized study on this topic to date. Short-term rates of parental disclosure to children were high, increasing over time. Parental disclosure decisions are determined by a complex array of both child and parent factors, with some benefits identified with disclosure. Findings indicate a need for additional work, including decision support interventions for communication with children.

No significant financial relationships to disclose.
Survival trends in palliative care patients with cancer: A Mayo Clinic 5-year review
Authors: Kamal A. H. , Swetz K. M. , Liu H. , Ruegg S. R. , Carey E. C. , Whitford K. , Bock F. A. , Creagan E. T. , Moynihan T. J. , Kaur J. S.
Published: August 2020

9592

Background: Palliative care (PC) is an essential part of the continuum of care for cancer (CA) patients (pts). Little is known about the aggregate characteristics and survival of pts receiving inpatient palliative care consultation (PCC). Methods: We reviewed data prospectively collected on patients seen by the Palliative Care Inpatient Consult Service at Mayo Clinic - Rochester from 2003–2008. Demographics, consult characteristics, and survival were analyzed. Kaplan-Meier survival curves and a Cox model of survival were produced. Results: 1794 total patients were seen over the five year period. Cancer is the most common primary diagnosis (47%). Growth in annual PCC has risen dramatically (113 in 2003 vs. 414 in 2007) despite stable total hospital admissions. Patient are predominantly men (52% vs. 48%, p=0.02); median age is 76. General medicine, medical cardiology, and medical intensive care unit services refer most often. Most frequent issues addressed are goals of care, dismissal planning, and pain control (29%, 19%, 17%). PCC in actively dying pts have increased with 27% of all non-operating room, non-trauma in-hospital deaths being seen. Although CA pts have the highest median survival after PCC vs. other diagnoses (17 days, p = 0.018), we observed a five-year trend of decreasing survival from admission to death and PCC to death. Median time from admission to death in CA pts is 36 days in 2003 and 19 days in 2008 (p<0.01). Median time from PCC to death is 33 versus 11.5 days (p<0.01). Despite this, median hospital length of stay and time from PCC to discharge have remained fixed at 8 and 2.5 days, respectively. A Cox model of survival to discharge and <6 months survival (hospice eligibility) shows hospital length of stay, time from consult to discharge, and dismissal location from hospital are all prognostic factors. Conclusions: Survival window for PC intervention for CA pts is lessening. With the trend of shorter survival after PCC, PC professionals have little over two days to implement a comprehensive, ongoing care plan. This highlights the importance of earlier outpatient palliative care involvement with advanced cancer patients and families.

No significant financial relationships to disclose.
Is patient self-reporting more accurate than clinician reporting of symptoms for predicting survival in patients with cancer? Meta-analysis of 30 closed EORTC randomized controlled trials
Authors: Bottomley A. , Coens C. , King M. , Osoba D. , Taphoorn M. J. , Reeve B. , Ringash J. , Schmucker-Von Koch J. , Weis J. , Quinten C.
Published: August 2020

9597

Background: This study investigated whether patient self-reporting of symptoms improved prediction of survival as compared to clinician reporting or whether it provided an additive value when taken together with clinician assessment of the same symptoms. Methods: Patients with advanced cancer from 30 European Organisation for Research and Treatment of Cancer (EORTC) Randomized Controlled Trials were included in this retrospective pooled analysis. Clinician [Common Toxicity Criteria (CTC)] and patient (EORTC QLQ-C30) symptom assessment were reported at entry into the study. Data were obtained for six symptoms: pain, fatigue, vomiting, nausea, diarrhea and constipation. The prognostic accuracy for survival was assessed by modeling the contrast in reporting using the Harrell's discrimination c-index (c). Results: Data were available from patient and clinician assessment for pain [number of trials (t) =8, number of patients (n) =1214], fatigue [t=5, n=1237], vomiting [t=5, n=824], nausea [t=6, n=1393], diarrhea [t=6, n=815] and constipation [t=4, n=751]. Fatigue (c=0.59 vs 0.55, p<.01) and constipation (c=0.57 vs 0.52, p=0.03) as reported by patients (vs clinicians) were significantly higher in predicting survival. Patient reported pain (c=0.59 vs 0.58, p=0.17), nausea (c=0.54 vs 0.52, p=0.51), vomiting (c=0.55 vs 0.52, p=0.21) and diarrhea (c=0.51 vs 0.52, p=0.49) did not predict survival any more accurately than clinician assessment. Patient and clinician assessment combined (vs clinicians alone) improved the prognostic accuracy for fatigue (c=0.61 vs 0.55, p=0.01), pain (c=0.60 vs 0.58, p<0.01), nausea (c=0.54 vs 0.52, p=0.04), vomiting (c=0.56 vs 0.52, p=0.04) and constipation (c=0.5 vs 0.52, p=0.01), but not for diarrhea (c=0.52 vs 0.52, p=0.44). Conclusions: Our results suggest that patients’ ratings of their own fatigue and constipation have more prognostic value than clinicians’ ratings of these symptoms. Further, the prognostic value of clinicians's ratings can be improved by combining them with patients’ assessments for the symptoms pain, fatigue, constipation, nausea and vomiting.

No significant financial relationships to disclose.
A patient-level pooled analysis of the prognostic significance of baseline fatigue for overall survival (OS) among 3,915 patients participating in 43 North Central Cancer Treatment Group (NCCTG) and Mayo Clinic Cancer Center (MC) oncology clinical trials
Authors: Sloan J. A. , Liu H. , Sargent D. J. , Satele D. , Schaefer P. L. , Halyard M. Y. , Grothey A. , Garces Y. I. , Brown P. D. , Loprinzi C. L. , Buckner J. C.
Published: August 2020

9599

Background: We have previously identified overall a single-item measure for baseline quality of life (QOL) as a strong prognostic factor for survival (Tan, ASCO 2008), and that fatigue was an important component of patient QOL (Sloan, 2007). To explore whether patient-reported fatigue was supplemental or redundant to the prognostic information of overall QOL, we performed a patient-level pooled analysis of 43 NCCTG and MCCC oncology clinical trials of the effect of baseline fatigue on OS. Methods: 3,915 patients participating in 43 trials provided data at baseline for fatigue on a single-item 0–100 point scale. OS was tested for association with clinically deficient fatigue (CDF, score 0–50, n=1,497) vs not clinically deficient fatigue (nCDF, score 51–100, n=2,418). Cox proportional hazards models adjusted for the effects of overall QOL, performance score, race, disease site, age and gender. Results: Baseline fatigue was a strong predictor of OS for the entire patient cohort (CDF vs. nCDF: 31.5 mos vs >83.9 mos, p<0.0001). The effect sizes were consistent across different disease sites (GI, esophageal, head and neck, prostate, lung, breast and others). After controlling for covariates, including performance status and overall QOL, baseline fatigue remained a strong prognostic factor in multivariate models (CDF vs. nCDF: HR=1.23, p=0.02). Conclusions: Fatigue is a strong prognostic factor for OS independent of overall QOL and PS in a wide variety of oncology patient populations. Single-item measures of overall QOL and fatigue can help to identify vulnerable subpopulations among cancer patients.

No significant financial relationships to disclose.
The effect of tai chi chuan on bone remodeling and cytokines among breast cancer survivors: A feasibility trial
Authors: Peppone L. J. , Mustian K. , Rosier R. N. , Piazza K. M. , Hicks D. G. , Palesh O. G. , Darling T. V. , Purnell J. Q. , Janelsins M. , Morrow G. R.
Published: August 2020

9610

Background: Weight-bearing exercise may slow the rate of bone loss associated with breast cancer treatment. The purpose of this study is to determine the effect of tai chi chuan (TCC) on bone health, as measured by the changes in the levels of bone resorption and bone formation. This study also aimed to investigate whether changes in bone health were correlated with growth and inflammation markers that serve as regulators of bone cell function. Methods: Female patients (N=16) who completed treatment for breast cancer within the past 30 months were randomly assigned to either the TCC group or the psycho-educational support group without exercise (ST) for 60 minutes, three times a week for a period of 12 weeks. Serum levels of bone resorption (N-telopeptides of type I collagen; NTx) and bone formation (bone specific alkaline phosphatase; BAP) were determined by ELISA at baseline and post-intervention. Using validated methods, a bone remodeling index (BRI) was calculated from levels of NTx and BAP. In addition, pre- and post-intervention levels of insulin-like growth factor binding protein 1 (IGFBP-1) and interleukin-2 (IL-2), markers associated with excessive bone resorption, were measured. Lastly, levels of interleukin-6 (IL-6), believed to enhance bone formation, were measured at both pre- and post-intervention. Results: ANCOVA analyses demonstrated that survivors in the TCC group experienced a greater increase in bone remodeling than those in the ST group (Δ BRITCC=1.6 vs Δ BRIST=0.2; p=0.04). All correlations were determined by Pearson's correlation coefficients. IGFBP-1 was negatively correlated with increasing bone remodeling levels (r=-0.43, p=0.14). IL-2 was also negatively correlated with increasing bone remodeling levels (r=-0.35, p=0.24). IL-6 was positively correlated with increasing bone remodeling levels (r=0.69, p=0.01). Conclusions: This pilot study suggests that TCC has positive effects on bone remodeling through changes in growth and inflammation factors that regulate bone cell function. A larger, more definitive trial examining the influence of TCC on bone remodeling is warranted. Funding: Sally Schindel Cone and R25 CA102618

No significant financial relationships to disclose.
Impact of a psychosocial intervention on performance status and coping
Authors: Lyerly H. K. , Staley T. , Herndon J. E. , Coan A. , Wheeler J. L. , Rowe K. , Horne B. , Abernethy A. P.
Published: August 2020

9611

Background: Psychosocial distress is a critical cancer comorbidity; new interventions are needed. Pathfinders, a manualized psychosocial care program, provides patient navigation, counseling, coping skills training, mind/body techniques, and lifestyle advice. Methods: This prospective, single-arm, pilot study enrolled adult metastatic breast cancer patients with prognosis ≥6 months. Consenting participants met with a Pathfinder (trained social worker) at least monthly, with interim phone/email contact. Pathfinders worked with patients to identify inner strengths, teach coping skills, engage complementary/alternative providers, employ mind/body techniques, and support healthy lifestyle. At baseline, month 3 and month 6, patients completed surveys including Patient Care Monitor (PCM; a review of systems with 6 subscales and a global quality of life [QOL] score), and Functional Assessment of Chronic Illness Therapy - Fatigue subscale (FACIT-F). Results: Participants (n=50) were: mean age 51.2 years (SD 11.5); 24% non-white; 74% married; 50% did not complete college; the cohort had advanced cancer and short prognosis with 6-month attrition from death, 18%. Scores on the PCM Distress subscale improved from baseline to 3 months with a mean change of -3.42 (n=36; p=0.008) and from baseline to 6 months of -4.11 (n=28; p=0.002). PCM Despair subscale scores also improved: mean change of -4.53 (p=0.006) and -6.93 (p=0.016), respectively. PCM QOL and FACIT-F scores improved from baseline to 3 months; however, the change at 6 months, with smaller sample, was not statistically significant. Mean change in QOL from baseline to 3 and 6 months was 2.88 (n=30; p=0.006) and 2.66 (n=25; p=0.079), respectively. Mean change in FACIT-F from baseline to 3 and 6 months was 2.91 (n=39; p=0.020) and 1.29 (n=32; p=0.407), respectively. Conclusions: Pathfinders had significant positive effect on key psychosocial and QOL outcomes, notably distress and despair, for cancer patients despite advanced disease and worsening symptoms.

No significant financial relationships to disclose.
Effect of coping styles on the psychological impact of discussing life expectancy for men with advanced cancer
Authors: Cripe L. D. , Rawl S. , Monahan P. , Tong Y. , Schmidt K. , Rand K.
Published: August 2020

9615

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

No significant financial relationships to disclose.
Risk of bevacizumab-associated gastrointestinal perforation in patients with colorectal cancer and noncolorectal cancer
Authors: Chu D. T. , Hapani S. , Wu S.
Published: August 2020

9622

Background: Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor. It is a widely used angiogenesis inhibitor in the treatment of colorectal cancer (CRC) and other solid tumors. Gastrointestinal (GI) perforation is a potentially fatal adverse event associated with bevacizumab, but the risk unclear. This study was conducted to determine the risk of developing GI perforation among CRC and non-CRC patients receiving bevacizumab. Methods: Databases from PUBMED and the Web Science from January 1966 until July 2008 and abstracts presented at the American Society of Clinical Oncology conferences from January 2000 to through July 2008 were searched to identify relevant studies. Eligible studies included prospective phase III clinical trials in which standard anti-neoplastic therapy was administered with and without the use of bevacizumab with available data for GI perforation. Summary incidence rate, relative risk (RR), and 95% confidence interval (CI) were calculated using fixed or random effect models based upon the heterogeneity of the included studies. Results: A total of 12084 patients with various solid tumors from 14 phase III trials were included for analysis. Among patients receiving bevacizumab, the incidence of GI perforation was 0.8% (95% CI: 0.6–1.1%), and RR was 2.0 (95% CI: 1.1–3.8, p = 0.028) in compared with controls. The risk of GI perforation was significantly increased in patients receiving bevacizumab at 5 mg/kg/week (RR 2.6, 95% CI: 1.0–6.6, p=0.04), but not at 2.5 mg/kg/week (RR=1.5, 95%CI: 0.7–3.3, p=0.3). Among 2151 patients with CRC, the incidence of GI perforation was 0.8% (95% CI: 0.5–1.6%); while for 2.999 patients with non-CRC malignancies, the incidence of GI perforation was 0.7% (95% CI: 0.5–1.1%); The relative risk of GI perforation varied with tumor type, with significantly increased risk observed in patients with CRC (RR = 3.1, 95% CI: 1.2–8.2, p<0.023), but not non-CRC (RR=1.5, 95% CI: 0.67–3.4, p=0.3). Conclusions: There is a significant difference in the risk of developing GI perforation in CRC and non-CRC patients receiving bevacizumab with a higher relative risk in patients with CRC. Further investigation into the etiology of this difference is recommended.

No significant financial relationships to disclose.
Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: A randomized, double-blind study
Authors: Boice J. A. , Schmoll H. , Brown C. , Taylor A.
Published: August 2020

9626

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

[Table: see text]
Hot flash placebo responses: Related to baseline hot flash frequency?
Authors: Jones J. M. , Loprinzi C. L. , Qin R. , Barton D. L.
Published: August 2020

9628

Background: As multiple treatments have been studied for the management of hot flashes in randomized, controlled trials, hot flash placebo responses have been quite variable across trials. Based on observations of trial reports, it was hypothesized that the magnitude of placebo effect might correlate with the number of baseline hot flashes in different studies. The current project examines the effect of the baseline hot flash frequency required for study participation and also the actual number of baseline hot flashes observed as these individually relate to the eventual reductions of hot flash frequency observed in patients receiving placebos. Methods: Data were collected from placebo-controlled, double-blinded, randomized trials, identified by a PubMed search, which reported hot flash frequency at baseline, 4–6 weeks and 12 weeks. Trials were excluded if they had less than 20 participants completing the placebo arm. Data gathered, in each study, included the number of hot flashes required to enroll in the study, the average hot flash number during the baseline period, and the hot flash changes in the placebo arms of each study (percent reduction from the baseline period). A simple statistical analysis was conducted in a descriptive fashion since standard deviation was not available in many trials. Scatter plots and Pearson's correlation coefficients demonstrated the relationships between the placebo hot flash percent reduction from baseline and both the minimum required number of hot flashes at baseline, and the mean number of hot flashes at baseline. Results: 45 trials with 49 placebo arms were included in this analysis. A significant positive correlation was seen between the number of hot flashes required to enroll in a study and the percent reduction of hot flashes from baseline at 4–6 weeks (Rho = 0.481, p = 0.003). There was also a significant positive correlation between the number of hot flashes at baseline and the percent reduction of hot flashes from baseline at 4–6 weeks (Rho = 0.481, p= 0.002) and at 12 weeks (Rho = 0.573, p= 0.003). Conclusions: These data support that higher baseline hot flash enrollment requirements and also higher baseline hot flash frequencies are associated with an increased placebo response.

No significant financial relationships to disclose.
Differential time course of action of 5-HT3 and NK1 antagonists when used with highly and moderately emetogenic chemotherapy (HEC and MEC)
Authors: Hesketh P. J. , Warr D. G. , Street J. C. , Carides A. D.
Published: August 2020

9629

Background: Cisplatin-based HEC displays a biphasic pattern of emesis with both an early and delayed period. In contrast, MEC has a monophasic pattern. The objective of this analysis was to investigate the time course of action of the 5-HT3antagonist ondansetron (OND) and the NK1 antagonist aprepitant (APR) in trials with HEC and MEC. Methods: Phase III HEC and MEC trials of APR were included. In 2 HEC studies, patients (pts) scheduled to receive cisplatin- based chemotherapy were randomized to an active-control group (OND + dexamethasone [DEX] Day 1, DEX bid Days 2–4) or an APR group (APR + OND + DEX Day 1; APR + DEX qd Days 2–3; and DEX Day 4). In a third HEC study, control pts also received OND on Days 2- 3. For the MEC study, breast cancer pts receiving anthracycline + cyclophosphamide-based chemotherapy were randomized to an active- control group (OND + DEX pre chemotherapy and OND 8 hours (h) later; OND bid Days 2–3) or an APR group (APR + OND + DEX pre chemotherapy and OND 8 h later; APR qd Days 2–3). In a post-hoc analysis, multivariate logistic regression models were used to assess the impact on emesis at different time intervals using a modified intent-to-treat approach. No multiplicity adjustment was planned, so nominal p-values are reported. Results: 1,527 pts and 856 pts were randomized and assessed for efficacy in the HEC and MEC trials respectively. For HEC, APR reduced risk of emesis beginning 15–18 h after cisplatin and extending to 48 h by 45–77% compared to control and by 45–67% compared to the OND control. For MEC, APR markedly reduced emesis from 6–9 h by 61% compared to control (p=0.0012). Conclusions: Time of onset (15 h vs. 6 h) and time course (15–48 h vs. 6–9 h) for the enhanced control of emesis with the addition of APR differs between HEC and MEC respectively. With HEC these results suggest that 5-HT3 dependent mechanisms are most important in the first 12 h after HEC with NK1-dependent mechanisms having a key role later. With MEC both 5-HT3 and NK1 mechanisms appear to be important early and the greatest impact of the NK1 antagonist occurs in the first 9 h. These results provide a rationale for maximizing NK1-antagonist exposure early on with MEC as a means to improve emesis control.

[Table: see text]
Non-small cell lung cancer and estrogen plus progestin use in postmenopausal women in the Women's Health Initiative randomized clinical trial
Authors: Chlebowski R. T. , Schwartz A. , Wakelee H. , Anderson G. L. , Stefanick M. L. , Manson J. E. , Chien J. W. , Chen C. , Wactawski-Wende J. , Gass M.
Published: August 2020

CRA1500

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

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

CRA4027

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

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

CRA6509

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

No significant financial relationships to disclose.
MSH2 and adjuvant cisplatin-based chemotherapy in non-small cell lung cancer
Authors: Fouret P. , Planchard D. , Mendiboure J. , Kamal N. S. , Olaussen K. A. , Bertrand P. , Pirker R. , Dunant A. , Le Chevalier T. , Soria J. C.
Published: August 2020

CRA7502

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

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

CRA9011

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

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

e11609

Background: Impact of the mode of estrogen receptor determination on breast cancer prognosis Abstract Background: We examined if the mode of estrogen receptor (ER) determination and expression in primary breast cancer impact on patient's prognosis. Methods: We conducted an analysis on a prospective cohort of 1012 patients treated for stage I-III Breast Cancer at Conception Hospital, Marseille, France between 1984 to 2003. ER was determined according to enzyme immuno-assay (EIA) and immunohistochemistry (IHC). Disease-free and overall survivals were evaluated according to the mode of ER quantification and in function of qualitative or quantitative ER expression. Results: ER was a strong predictor of overall survival in the whole population whatever method used for the status determination (p<0.001); however when stratifying the analysis on ER quantitative expression, ER was still a prognostic indicator in the EIA group for OS (p= 0.004) and DFS (p<0.001), group but not in the IHC group for OS (p=0.58) and DFS (p= 0.195). Conclusions: ER determination in breast cancer is strongly associated with a better prognosis, but the level of influence of ER varies with the assay and ER expression.

No significant financial relationships to disclose.