bluuebunny/crossref_metadata_2025_split huggingface dataset:
Omission of adjuvant chemotherapy in elderly patients with early stage breast cancer.
Authors: Ma Sung Jun , Oladeru Oluwadamilola Temilade , Singh Anurag K 
Published: May 2020

12032 Background: Breast cancer incidence in elderly population over 70 years is anticipated to grow up to 35% by 2030. However, this elderly population is under-represented in the TAILORx (Trial Assigning Individualized Options for Treatment) with less than 5% of the entire study cohort. As the omission of radiation therapy among the elderly with favorable prognosis is a reasonable alternative option, omission of chemotherapy has not been prospectively investigated. To address this knowledge gap, we conducted an observational cohort study to evaluate the omission of chemotherapy in elderly patients with early breast cancer. Methods: The National Cancer Database (NCDB) was queried for patients above the age of 70 diagnosed with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, pT1-2N0 breast cancer who underwent hormone therapy with or without chemotherapy (2010-2015). Kaplan-Meier method and Cox multivariable analysis (MVA) were performed for survival analysis. Propensity score matching in a 1:1 ratio without any replacement was used to address selection bias. Sensitivity analysis was performed on a subgroup of those with a high 21-gene recurrence score (RS) > 25. Results: A total of 12004 patients were identified, including 10802 and 1202 patients with and without adjuvant chemotherapy, respectively. The median follow up was 38.2 months (IQR 22.5-57.2). On univariate analysis, chemotherapy was not associated with improved overall survival (HR 0.96, p = 0.71), ineligible for inclusion in the final MVA model. On interaction analysis, the use of chemotherapy had no interaction with RS (p = 0.46), age (p = 0.08), tumor size (p = 0.23), tumor grade (p = 0.42), and comorbidity score (p = 0.22). On 1030 and 689 matched pairs for all RS and RS > 25, respectively, there was no association of overall survival with chemotherapy (all RS: HR 0.76, p = 0.08; RS > 25: HR 0.74, p = 0.10). Conclusions: For elderly patients with early stage breast cancer, the addition of adjuvant chemotherapy may not be associated with improved survival even in the setting of high RS > 25. Given the toxicity profile of systemic therapy, shared decision making between clinicians and elderly patients is needed to individualize treatment options.
Factors associated with referral for perioperative geriatric comanagement (GERI-CO) program in 12,398 older adults with cancer.
Authors: Shahrokni Armin , Alexander Koshy , Kim Soo Jung , McMillan Sincere , Downey Robert J. , Korc-Grodzicki Beatriz 
Published: May 2020

12034 Background: At ASCO 2019, we showed that the Memorial Sloan Kettering (MSK) Geriatric Co-management (GERI-CO) program was associated with improvement in 90-day postoperative mortality rate. Now, we present factors associated with the use of such program. Methods: At MSK, patients aged 75+ can be referred for perioperative GERI-CO. We retrospectively reviewed the available data of patients aged 75+ who underwent surgery within two months of their initial visit with the surgeon (2011 to 2019). Patients that were referred for GERI-CO were compared with those who were not: sociodemographic, frailty, comorbid conditions, and surgery characteristics. Frailty level was determined using the MSK Frailty Index (score ranges from 0-11, higher scores suggest more frailty). Multivariable regression analysis was used to assess factors associated with the use of the GERI-CO Program. Results: In total 12,398 patients (4422, 35.7% GERI-CO) were included. Average time from surgical consult to geriatric visit was 9 days. Patients in the GERI-CO program were older (80.7 vs. 79.6), less likely to be non-Hispanic White (87% vs. 91%), have English as primary language (84% vs. 89%), and be fit (12% vs. 17% with MSK-FI 0). They were more likely to have stroke history (5% vs. 4%), have diabetes (DM) (25% vs.20%), hypertension (78% vs. 71%), and peripheral vascular disease (14% vs. 12%), but less likely to have cardiac disease (22% vs. 26%), myocardial infarction (MI) (7% vs. 10%), pulmonary disease (13% vs. 16%). Patients referred for GERI-CO were more likely to undergo 3+ hours surgeries (25% vs. 8%), with 100+ cc intraoperative blood loss (41% vs. 22%), and hospital length of stay (LOS) of 3+ days (42% vs. 19%). In multivariable analysis, being frail (OR = 1.3 and 1.6 for MSK-FI 1-2 and 3+), longer surgery (OR = 2.6 and 3.6 for operation time 1.5-3 and 3+ hours), longer LOS (OR = 1.3 and 1.5 for LOS 1-2 and 3+ days), older age (OR = 1.06), having DM (OR = 1.15) were associated with higher likelihood of GERI-CO while having history of cardiac disease (OR = 0.55), MI (OR = 0.84), pulmonary disease (OR = 0.69) were associated with less likelihood of referral for GERI-CO. Conclusions: Our result shows the unique characteristics of patients managed in the GERI-CO program. This has implications for both implementation of GERI-CO program in other institutions and assessing outcomes of these patients.
Patient controlled analgesia (PCA) vs non-PCA intravenous hydromorphone titration for severe cancer pain: A multi-center, phase III trial, HMORCT09-1.
Authors: Lin Rongbo , Lin Sunzhi , Zhu Jinfeng , Feng Shuitu , Wu Qingyi , Fu Jianqian , Wang Fang , Li Hui , Li Xiaofeng , Zhang Gaowang , Yao Yongzhi , Xin Min , Lai Tianyang , Lv Xia , Chen Yigui , Lin Yubiao , Hong Lixia , Lin Shaowei , Zhao Shen , Huang Cheng 
Published: May 2020

12078 Background: The titration of opioid dosage is necessary for adequate pain relief with acceptable side effects among individuals with cancer pain. The titration process can be achieved by non-patient administration or PCA pump. The aim of this study was to evaluate the efficacy of PCA versus non-PAC titration for severe cancer pain. Methods: Patients with severe cancer pain (NRS ≥ 7/10 at rest) were randomized into PCA or non-PCA titration and stratified by opioid tolerance or intolerance. For PCA, the pump was set as no continuous dose, hydromorphone bolus dose was 10%-20% of the total equianalgesic of past 24h for opioid tolerance, or 0.5 mg for opioid intolerance. The lockout time was 15 min. For non-PCA, initial hydromorphone bolus was the same with PCA. Reassess pain at 15 min. The dose of hydromorphone was increased by 50%-100% if pain unchanged or increased, or repeated if NRS was 4-6, or continue at current dose as needed if NRS≤3. The primary endpoint was the time to successful titration (TST) - time from start to the time of pain controlled at NRS ≤ 3 in two consecutive evaluation with 15-min intervals, which was tested by K-M curve. Results: A total of 214 patients were randomized (106 in PCA, 108 in non-PCA) in 17 study sites. The most common sites of primary cancer were lung (21.03%), stomach (15.89%), colorectal (14.49%) etc. Median TSTs were 0.50h in PCA, 0.79h in non-PCA, HR 1.64 (95% CI 1.23, 2.17, P = 0.00127). In opioid tolerance, 0.50h in PCA, 1.00h in non-PCA (HR 1.92, 95% CI 1.32, 2.78, P = 0.0025). while in opioid intolerance, 0.50h in PCA and 0.50 in non-PCA (HR 1.35, 95% CI 0.88, 2.04, P = 0.162). The median dosage of hydromorphone for TST was 1.00mg (P25, P75 0.50, 2.00) in PCA, 1.50mg (P25, P75 1.00, 2.50) in non-PCA (P = 0.086). In opioid tolerance, 1.00mg (P25, P75 1.00, 2.00) in PCA, 2.00mg (P25, P75 1.00, 4.00) in non-PCA (P = 0.009). In opioid intolerance, 1.00mg (P25, P75 0.50, 2.00) in PCA and 1.00 mg (P25, P75 0.50, 2.00) non-PCA (P = 0.793). Mean patient satisfaction assessed by ESAS score was significantly superior in PCA to non-PCA (0.62±0.67 vs 1.27±0.98 for ITT, 0.66±0.66 vs 1.39±1.00 for opioid tolerance, and 0.56±0.69 vs 1.13±0.95 for opioid intolerance). Adverse events were similar in both PCA/non-PCA groups. Conclusions: PCA IV hydromorphone titration provided quicker analgesic effect, higher patients satisfaction, and a similar tolerability as compared to non-PCA administration in patients with severe cancer pain. Clinical trial information: NCT03375515 .
Value of oncologist generated “surprise question” in predicting survival in metastatic cancer.
Authors: Edge Stephen B. , Liu Lu , Case Amy Allen , O'Connor Tracey L. , Kuvshinoff Boris W. , Murphy Monica L. , McKinney Mishellene 
Published: May 2020

12082 Background: Treating patients with metastatic cancer (MCA) requires timely integration of palliative and hospice care (PHC). The Surprise Question (SQ-“Would you be surprised if your patient died in the next year?”) may help predict short-term mortality in patients with chronic disease and prompt initiation of PHC. There limited data on the utility of the SQ in oncology and none controlling for age and cancer site (CS). This study evaluates the SQ in MCA. Methods: SQ data were collected using a clinical oncology pathway program (COP) in which the treating oncologist is required to answer the SQ for all patients with MCA. The cohort includes MCA patients with SQ entries from 5-1-2018 to 4-30-2019 providing cohorts with 6- and 12-months follow-up (f/u) from the date of the SQ. Vital status was determined as of 1-15-20. Over 90% of deaths are reported with 3 months of death. Models using SQ response (yes/no), cancer site and age were tested with logistic regression (LR) with Akaike Information Criterion (AIC) for model selection (lower number best model) and ANOVA to assess the value of the SQ in predicting mortality. Results: There were 655 and 1276 patients with MCA in COP with 1 year and 6 months f/u from the SQ, respectively. The proportion with the SQ response “No” (shorter expected survival) varied by cancer site (range 19% – 82% - e.g. breast 42%; pancreas 81%). The SQ was the best predictor compared to cancer site and age for 6 and 12-month mortality (LR Model A – lowest AIC). The odds ratio of death at one year from SQ-No vs. SQ-Yes was 3.8 (95% CI 2.7, 5.4) with a strong association between SQ response and 1-year and 6-month mortality (p < 0.001). See Table. Conclusions: Oncologist assessment of survival expectancy by the SQ in MCA is a strong predictor of mortality beyond cancer site and age. The treating oncologist’s response to SQ can serve as a simple and reliable predictive tool to identify those with MCA likely to die sooner who may benefit from timely referral to PHC. [Table: see text]
Efficacy and safety of direct oral anticoagulants (DOACs) and low molecular weight heparin (LMWH) for primary prevention of venous thromboembolism (VTE) in ambulatory cancer patients.
Authors: Shenouda Mina , Desai Ruchi , Jaglal Michael Vishal 
Published: May 2020

12088 Background: Active malignancy is a well described risk factor for thrombosis. Randomized clinical trials (RCT) have evaluated anticoagulation (AC) with DOACs or LMWH for prevention of VTE in ambulatory cancer patients. This objective of this meta-analysis is to evaluate the efficacy and safety of DOACs and LMWH thromboprophylaxis in adult patients with active solid organ malignancy or lymphoma. Methods: We conducted a search of MEDLINE, EMBASE, and CENTRAL from 10/31/2009-11/31/2019. Data for meta-analysis was extracted from studies that met inclusion criteria (RCT, ambulatory patients age >18 years with active solid organ malignancy or lymphoma, prophylactic AC with DOAC or LMWH). Risk ratio (RR) were calculated for primary (efficacy) end point of VTE occurrence and secondary (safety) end points of major bleeding (MB) and clinically relevant non-major (CRNMB). Subgroup analyses of efficacy and safety endpoints were conducted based on AC and cancer types. Results: Eleven trials met inclusion criteria with total of 7741 participants. Two trials evaluated DOACs and nine trials evaluated LWMH for thromboprophylaxis. Efficacy results are noted in Table. Safety outcomes for MB and CRNMB for AC were RR 1.83 (95% CI 1.26, 2.65), p=0.001 and RR 1.36 (95% CI 1.05, 1.76), p=0.02. Safety outcomes for MB and CRNMB for DOAC were RR 1.95 (95% CI 0.88, 4.30), p=0.10 and RR 1.35 (95% CI 0.80, 2.27), p=0.26. Safety outcomes for MB and CRNMB for LMWH were RR 2.05 (95% CI 1.19, 3.51), p=0.009 and RR 1.44 (95% CI 1.01, 2.05), p=0.04. Conclusions: Both DOACs and LMWH decrease risk for VTE development in ambulatory adult cancer patients. MB and CRNMB were significantly increased in patients taking LMWH but not in patients taking DOACs. A large clinical trial using DOACs for thromboprophylaxis would help elucidate the thrombosis and bleeding event rate in ambulatory cancer patients. [Table: see text]
Inflammatory and clinical risk factors for chemotherapy-induced peripheral neuropathy (CIPN): A nationwide longitudinal study in 143 cancer patients during chemotherapy.
Authors: Kleckner Ian , Jusko Todd , Culakova Eva , Kleckner Amber , Asare Matthew , Inglis Julia Ellen , Loh Kah Poh , Peppone Luke Joseph , Berenberg Jeffrey L. , Conlin Alison Katherine , Ossip Deborah J. , Mustian Karen Michelle 
Published: May 2020

12099 Background: CIPN is a common dose-limiting side effect of taxane and platinum chemotherapy. It is difficult for clinicians to predict who will experience CIPN before initiating chemotherapy, partly because the etiology of CIPN is poorly understood. Specifically, although inflammation putatively plays a role in CIPN, there is limited evidence of the role of inflammation in CIPN in humans. Here, we identified the strongest predictors of CIPN using variables measured before taxane or platinum chemotherapy, including serum inflammation. Methods: 143 sedentary patients with cancer (81% breast, 7% colon, 5% lung; 7% other; mean age 56 years) receiving taxane or platinum chemotherapy rated the severity of (a) numbness and tingling, and (b) hot/coldness in hands/feet on 0-10 point scales before and after their first 6 weeks of chemotherapy. Linear regression models were fit to predict CIPN symptom severity at 6 weeks using variables related to inflammation (serum IL-1β, IL-6, IL-8, IL-10, IFN-γ, sTNFR1; 69 patients who gave blood), clinical factors (cancer stage, baseline neuropathy, fatigue, anxiety, depression, using diabetes medications), behavior (daily pedometer steps), and demographics (age, race) measured before chemotherapy. The final model was identified by the smallest AIC goodness of fit. Results: The strongest pre-chemotherapy predictors of numbness and tingling after 6 weeks of taxane and/or platinum chemotherapy were worse patient-reported fatigue/anxiety/depression (explaining 25% of variance), platinum chemotherapy (7%), and older age (5%). The strongest predictors of hot/coldness in hands/feet included worse baseline neuropathy (13%), platinum chemotherapy (8%), and fatigue/anxiety/depression (6%). In the 69 patients with serum data, a more pro-inflammatory state was a risk factor for CIPN as higher levels of pro-inflammatory IL-1β (7%) predicted numbness/tingling, and lower levels of anti-inflammatory IL-10 (7%) predicted hot/coldness in hands/feet. Conclusions: The strongest pre-chemotherapy predictors of CIPN included worse fatigue/anxiety/depression and platinum chemotherapy in this sedentary population of cancer patients (mostly breast). A pro-inflammatory state before chemotherapy may also increase risk for CIPN, suggesting that inflammation may underlie the etiology of CIPN in humans. Clinicians should consider assessing these factors to inform the patient’s risk for CIPN. Funding: NCI UG1CA189961, NCI K07 K07CA221931, T32CA102618. Clinical trial information: NCT00924651 .
Impact of embedded palliative care providers compared to externally available palliative care services on the number of patients receiving palliative care referrals in a large community oncology practice.
Authors: Young Garrett , Lyss Aaron J. , Blakely Johnetta , Owens Leah , Dickson Natalie R. , Schleicher Stephen Matthew 
Published: May 2020

12103 Background: Palliative care improves quality of life and may increase overall survival in patients with solid tumor malignancies. Despite having the ability to refer patients to in-home and external palliative care services, we observed low palliative care referral rates in our practice of 90 oncologists across 30 clinics. We tested whether embedding palliative care providers directly in clinic would improve palliative care referral rates for solid tumor patients. Methods: Between 2017 and 2020, we embedded an independent palliative care provider into five clinics across middle Tennessee. Access to external palliative care services was present both before and after the intervention. Using data from our EHR and billing systems, we performed a pre-post analysis measuring palliative care referrals in the six-month periods immediately before (pre-intervention period) and after (post-intervention period) a palliative care provider was embedded in each clinic. Statistical significance was assessed using Welch’s two sample t-test. Results: 8,636 unique solid tumor patients were seen in the five clinics during the study periods (Table). Despite having the ability to refer patients to external palliative care services in the pre-intervention period, the placement of a palliative care provider into clinic increased the number of solid tumor patients that received a palliative care referral per month at all clinics (min.: 200%; max.: 990%; median: 600%). Four of the five increases were statistically significant (p-values < 0.05). Conclusions: Even when external palliative care services are available, embedding palliative care providers into community oncology clinics significantly increases the rate of palliative care referrals for solid tumor patients. [Table: see text]
A highly effective and practical desensitization regimen: Results in comparable clinical outcomes for multiple myeloma patients with skin rash after immunomodulatory drugs.
Authors: Firoozmand Amin , Ali Naveed , Ahmed Nausheen , Fu Pingfu , Cao Shufen , Brown George , Schmikla Hannah , Driscoll James Joseph , O' Brien Timothy , Caimi Paolo Fabrizio , De Lima Marcos J.G. , Malek Ehsan 
Published: May 2020

12104 Background: Immunomodulatory drugs (IMiDs) are backbone of myeloma therapy for patients with Multiple Myeloma (MM). The incidence of IMiD-associated rash is up to 27% in some reports impeding maximal benefit of this agent. The optimal management of IMiDs-associated skin is unclear. The concurrent weekly Dexamethasone (Dex) does not diminish the incidence of skin eruptions with IMiDs (Sviggum, et al. 2006), therefore we designed a low dose daily and tapering corticosteroid regimen to tame this immune response upon restarting IMiDs and allow desensitization and reinstitution of the same IMiD. Furthermore, we assessed the impact of this desensitization regimen on clinical outcome. Methods: A total of 160 patients were evaluated. The incidence of rash was found to be 13% (n = 21). A cohort of age- and gender-matched without rash (n = 39) was randomly selected. The effects of rash on overall and progression free survival (OS and PFS) were further estimated using Cox regression controlling the effects of age and gender. Results: Median time to development of rash after IMiD initiation was 28 days (range, 2-232). Rashes were graded as low (I-II) in 89% (n = 17) and high (III-IV) in 19% of pts. All pts were managed by temporary treatment interruption and upon clearance of rash, re-institution of the same IMiD concomitantly with a standardized 3-week steroid rash prophylaxis protocol (prednisone at 10 mg daily for 10 days, followed by 5 mg daily for 10 days, followed by 5 mg on alternate days for 10 days). As a result, all patients were able to restart the same IMiD with none re-experiencing any dermatologic adverse effect afterward. Comparing to no-rash controls, there was no significant difference in PFS (0.13) or OS (p = 0.12) in multivariate regression model. Conclusions: Proposed 3-week corticosteroid regimen showed 100% success rate in reinstituting IMiDs in our cohort. It may provide a highly effective and practical short term immunosuppression required to enable patients to restart IMiDs and enjoy comparable outcome to pts without skin rash.
Health and cancer concerns among siblings of childhood cancer survivors: A report from the Childhood Cancer Survivor Study (CCSS).
Authors: Morales Sonia , Mirzaei Salehabadi Sedigheh , Srivastava Deokumar , Gibson Todd M. , Leisenring Wendy M. , Lown Anne , Zeltzer Lonnie K. , Armstrong Gregory T. , Krull Kevin R. , Buchbinder David Kyle 
Published: May 2020

12117 Background: Siblings of long-term survivors of childhood cancer can be at risk for persistent concerns regarding their future health and risk for cancer. We examined self-perceived future health and cancer risk concerns among such siblings. Methods: 3,969 siblings (median age 29 [range 18–56] years) of 5+ year matched pair cancer survivors (n= 3,969; age 25 [6–48] years; time since diagnosis 19.6 [9.6-33.8] years) in the CCSS self-reported physical/psychosocial problems, including concerns regarding future health and cancer risk (dichotomized as concerned vs not concerned). Chronic health conditions (CHC) were graded using the Common Terminology Criteria for Adverse Events system: mild (grade 1), moderate (grade 2), severe/disabling (grade 3),or life-threatening (grade 4). Sibling demographics, their matched survivor’s diagnosis, era and treatment components, complications (death, relapse, disfigurement) as well as self-reported health status and CHCs for siblings and survivors were examined as potential risk factors for concern using multivariable logistic regression. Adjusted odds ratios (OR) and 95% confidence intervals (CI) are reported. Results: The prevalence of siblings reporting concerns regarding health and cancer risk decreased based on decades of matched survivor diagnosis: 1970-79 (73.3%; 63.9%), 1980-89 (67.2%; 62.6%), 1990-99 (45.7%; 52.3%). Risk factors for concerns included sibling poor/fair current health (future health OR 3.65, 95% CI 2.37-5.62; cancer risk OR 1.54, 1.12-2.13) compared to good/very good/excellent health. Sibling grade 2 (future health OR 1.46, 1.23-1.74; cancer risk OR 1.20, 1.01-1.42) or grade 3-4 CHCs (future health OR 1.37, 1.09-1.71; cancer risk OR 1.28, 1.03-1.58) were associated with greater concerns compared to those with less than grade 2 CHCs. Survivor treatment with chemotherapy/radiation was associated with elevated cancer risk concerns (OR 1.51, 1.13-2.02) compared to surgery/no therapy. Siblings of survivors with grade 3-4 CHCs (OR 1.35, 1.12-1.63) had greater future health concerns compared to those with less than grade 2 CHCs. Sibling bereavement was a risk factor for future health (OR 1.45, 1.04-2.03) and cancer risk (OR 1.44, 1.05-1.99) concerns. Conclusions: The prevalence of sibling concerns regarding future health and cancer have diminished in more recent decades. Subgroups of siblings are at-risk for concerns over future health and cancer risk, partially determined by medical characteristics of their survivor and their own health status.