bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of crizotinib on patient-reported symptoms and quality of life (QOL) compared with single-agent chemotherapy in a phase III study of advanced ALK+ non-small cell lung cancer (NSCLC).
Authors: Hirsh Vera , Blackhall Fiona Helen , Kim Dong-Wan , Besse Benjamin , Nokihara Hiroshi , Han Ji-Youn , Tassell Vanessa Roberts , Reisman Arlene , Iyer Shrividya , Shaw Alice Tsang 
Published: March 2020

8108 Background: PROFILE 1007 compared the efficacy and safety of the ALK inhibitor crizotinib (N=172) with that of standard-of-care chemotherapy (pemetrexed [PEM; N=99] or docetaxel [DOC; N=72]) in patients with advanced ALK+ NSCLC. The primary endpoint was progression-free survival. The main objective of our present post-hoc analyses was to compare patient-reported outcomes in the crizotinib arm with those of the DOC and PEM subgroups in the chemotherapy arm. Methods: Patient-reported outcomes were assessed at baseline, on day 1 of each cycle, and at the end of treatment using EORTC QLQ-C30 and lung cancer module QLQ-LC13. Higher scores (range 0−100) indicate higher symptom severity or better functioning/QOL. Time to deterioration (TTD) was defined as time from randomization to the earliest time with a ≥10-point increase from baseline for pain in chest, dyspnea, or cough and was compared between groups using an unstratified log-rank test. Repeated measures mixed-effects analyses were performed to compare change from baseline scores, with no adjustment for multiple comparisons. Results: Completion rates at baseline were ≥90% in each group and scores were well balanced. Crizotinib treatment was associated with a significantly longer TTD compared with PEM (median, 5.6 vs. 1.9 mo; HR, 0.66; 95% CI, 0.48−0.92; P=0.013) or DOC (median, 5.6 vs. 0.9 mo; HR, 0.37; 95% CI, 0.26−0.54; P<0.0001). A significantly greater improvement from baseline was observed with crizotinib compared with either the PEM or DOC subgroups for global QOL (P<0.01), cough (P<0.001), dyspnea (P<0.0001), pain in arm or shoulder (P<0.0001), pain in chest (P<0.0001), pain in other parts (P<0.01), fatigue (P<0.05), insomnia (P<0.05), and pain (P<0.0001). A significantly greater improvement was also observed with crizotinib compared with DOC for functioning (P<0.05), alopecia (P<0.0001), and hemoptysis (P<0.0001). Conclusions: Crizotinib treatment showed a significantly greater improvement from baseline in key patient-reported lung cancer symptoms and global QOL compared with DOC and PEM, in addition to improved efficacy previously reported. Clinical trial information: NCT00932893.
Phase II double-blind placebo-controlled study of armodafinil for brain radiation induced fatigue.
Authors: Shaw Edward G. , Case Doug , Bryant David , Grisell David , Lesser Glenn , Monitto Drew C. , Naughton Michelle Joy , Rapp Stephen R. , Savona Steven R. , Shah Sunjay , Chan Michael D 
Published: March 2020

9505 Background: Armodafinil (ARM), the R-enantiomer of modafinil, is FDA approved for narcolepsy, shift work disorder, and treated sleep-apnea, and has also been shown to reduce fatigue/improve cognitive function in cancer patients. This phase II study estimated the efficacy and toxicity of ARM in primary brain tumor (PBT) patients receiving brain radiation therapy (RT) to determine whether a larger phase III study would be warranted. Methods: Eligibility criteria – adult, PBT, total RT dose >45Gy, KPS>60, no severe headaches, and concurrent chemotherapy allowed. Patients were assessed at baseline, end of RT, then 4 weeks after end RT with the Brief Fatigue Inventory (BFI), Epworth Sleep Scale (ESS), FACT, and FACT brain and FACIT fatigue subscales. Patients were randomized to receive ARM 150mg/day during RT and for 4 weeks after RT or placebo (PLAC). Results: 54 patients enrolled between 9/10-12/12; 26 to ARM, 28 to placebo PLAC. Median age 59; 59% female; 95% White; 41% KPS 90-100, 59% KPS 60-80; 74% malignant glioma, 26% low-grade glioma/benign histology. 83% patients had concurrent chemotherapy. For all randomized patients, there were no statistically significant differences in outcome between ARM and PLAC groups at end-RT vs. baseline or 4 weeks post RT vs. baseline. For patients who had more baseline fatigue (fatigue subscale score <median), ARM-treated patients had significantly/suggestively better outcomes at end-RT vs. baseline compared to PLAC-treated patients: less fatigue (BFI p=0.056, fatigue subscale p=0.0295), less sleepiness (ESS p=0.1034), and better QOL (FACT p=0.0001). Incidence of grade 2/3 toxicities was the same between the two treatment groups: 7% anxiety, 7% nausea, 18% headaches, and 20% insomnia. There were no grade 4 or 5 toxicities. Conclusions: In irradiated PBT patients, fatigue, sleepiness, and reduced QOL occurring at the end of brain RT was less with ARM in those patients who were more fatigued at baseline. Toxicity was minimal. These data support conducting a larger phase III study. Analysis of cognitive function data is ongoing. Support - NIH/NCI grant 2U10 CA 81851 and Teva Pharmaceuticals. Clinical trial information: 95709.
Predictive factors for chemotherapy feasibility in elderly patients with solid tumor: Results of GERCOR old prospective multicenter study.
Authors: Carola Elisabeth , Chibaudel Benoist , Trager Stephanie , Bengrine-Lefèvre Leïla , Chuzel Joelle , Seitz Jean Francois , Dion Patrick , Artru Pascal , Aissat Nasredine , Sarlon Emmanuelle , Woerth Florence , Gauthier Mélanie , Bonnetain Franck , de Gramont Aimery ,   GERCOR
Published: March 2020

9511 Background: One quarter of patients with cancer are 75 year old and over. Previous studies suggested that geriatric parameters improved survival in elderly patients with solid advanced cancer and chemotherapy severe toxicity. A simplified scale would be helpful for oncologist to predict chemotherapy feasibility. The aim was to identify geriatric predictors of chemotherapy feasibility in chemo-naïve elderly patients. Methods: We conducted a prospective multicenter cohort study (NCT00664911). Inclusion criteria were: ≥ 75 years, solid tumor, able to receive at least 2/3 of the standard dose at the first course of treatment. Ten geriatric parameters were recorded at baseline by the oncologist: 1-three words test, 2-date and address for cognitive function, 3-Instrumental Activities of Daily Living (IADL), 4- monopodal stand-up test, 5-hospitalization during the previous year, 6-number of medicines taken for comorbidities, 7-creatinine clearance, 8-albumin serum level, 9-self-rated depressive mood question and 10-presence of a caregiver. The main outcome was chemotherapy feasibility defined by the ability to receive at least 3 months of the planned therapy. Multivariate logistic regression was used. Results: 576 patients were included in 49 centers from 2008 to 2012, 516 (89.6%) were eligible for analysis. Mean age was 81 years, 50.6% had colorectal cancer, 69.5% advanced stage and 83.6% had performance status 0-1. Chemotherapy feasibility was observed in 298 (57.8%) patients. Grade 3-4 toxicity was observed in 26.2% of patients. In multivariate analysis albuminemia < 30g/l (adjusted OR =2.34 CI95% [1.43-3.83]) and depressive mood (adjusted OR=1.55 CI95% [1.02-2.35]) were significantly associated with chemotherapy unfeasibility whereas others geriatrics parameters were not. Conclusions: Albuminemia and self rated depressive mood status were independently predictive for chemotherapy feasibility in elderly patients with solid tumor. Unexpectedly others geriatrics parameters were not independent predictors. Clinical trial information: NCT00664911.
Efficacy of NEPA, a novel combination of netupitant (NETU) and palonosetron (PALO), for prevention of chemotherapy-induced nausea and vomiting (CINV) following highly emetogenic chemotherapy (HEC).
Authors: Hesketh Paul Joseph , Rossi Giorgia , Rizzi Giada , Palmas Marco , Alyasova Anna , Drobner Igor , Gralla Richard J. 
Published: March 2020

9512 Background: Further progress in preventing CINV will require the introduction of novel agents providing maximal convenience and with efficacy for nausea as well as vomiting. NEPA is a single dose combination of NETU, a novel NK1 receptor antagonist (RA) and PALO, a pharmacologically distinct 5-HT3RA. This study was designed to determine the proper dose of NETU to combine with PALO. Methods: This was a randomized, double-blind, parallel group study in chemotherapy-naïve patients (pts) undergoing cisplatin-based HEC. Four study arms compared 3 oral doses of NEPA (NETU 100, 200, 300mg + PALO 0.50 mg) with oral PALO 0.50 mg, all given on day 1. All pts received oral dexamethasone (DEX) days 1-4. An exploratory aprepitant (APREP) + ondansetron/DEX arm was included. The primary endpoint was complete response (CR: no emesis, no rescue) in the overall (0-120h) phase. Results: 694 pts were enrolled with comparable characteristics across groups: males (57%), median age 55. Common cancers: lung (27%), head and neck (21%). Median cisplatin dose: 75 mg/m2. All NEPA groups showed superior CR rates compared with PALO during the overall and delayed phases, with NEPA300also superior to PALO during the acute phase. NEPA300was also superior to PALO during all phases for no emesis, no significant nausea and complete protection with incremental benefits over lower NEPA doses. AEs were comparable across groups with no dose-response. The % of pts developing ECG changes was comparable across groups. Conclusions: Each NEPA dose resulted in superior CR rates compared with PALO. NEPA300was the best dose studied, with an advantage over lower doses for all efficacy endpoints (including nausea). NEPA doses were well tolerated with similar safety profiles to PALO and APREP. NEPA combined with DEX is superior to PALO plus DEX in prevention of CINV following HEC. [Table: see text]
Caregivers’ perception of advanced cancer patients’ quality of death: Impact on caregiver suicidal ideation in bereavement.
Authors: Abbott Caroline H , Prigerson Holly Gwen , Maciejewski Paul K 
Published: March 2020

9522 Background: Evidence suggests that patients’ quality of life (QOL) at the end of life (EOL), i.e., patients’ quality of death, may affect the health and well-being of informal family caregivers. Here we examine the relationship between family caregivers’ perception of patients’ QOL at the EOL and caregiver suicidal ideation in bereavement. Methods: Our analysis was based on data from a sub-sample of family caregivers (N=112) from the Coping with Cancer Study, an NCI-funded multicenter prospective cohort investigation of advanced cancer patients and their caregivers enrolled September 2002 – February 2008. Caregiver baseline suicidal ideation was assessed using the Yale Evaluation of Suicidality (YES) Scale a median of 4.1 months pre-loss; caregivers’ perception of patients’ overall distress in the last week of life was assessed a median of 1.9 months post-loss; and caregiver suicidal ideation in bereavement was assessed using the YES a median of 6.5 months post-loss. Suicidal ideation was defined as a positive screen on the YES. Multiple logistic regression analysis examined the effect of caregivers’ perception of patients’ quality of death on bereaved caregiver suicidal ideation, adjusting for caregivers’ baseline suicidal ideation and potential demographic confounds. Results: Caregivers’ perception of patients’ overall distress at the EOL was significantly related to caregivers’ suicidal ideation post-loss (AOR=1.26, p=0.022) adjusting for caregivers’ baseline suicidal ideation, relationship to patient, and years of education. Conclusions: The more caregivers’ perceive their loved ones’ quality of death to be poor, the more they are at risk for suicidal ideation in bereavement. Improving QOL at the EOL will not only benefit patients but also protect caregivers from suicidal ideation.
Preliminary results of RTOG 0831, a randomized, double-blinded, placebo-controlled trial of tadalafil in the prevention of erectile dysfunction in patients treated with radiotherapy for prostate cancer.
Authors: Bruner Deborah , Pugh Stephanie L. , Pisansky Thomas Michael , Greenberg Richard Evan , Pervez Nadeem , Reed Daniel R. , Rosenthal Seth A , Mowat Rex B. , Raben Adam , Buyyounouski Mark K. , Kachnic Lisa A. 
Published: March 2020

9525 Background: Determine if prophylactic tadalafil maintains spontaneous (off-drug) erectile function (EF) compared to placebo in patients (pts) treated with radiotherapy (RT) for prostate cancer. Methods: Double-blind 1:1 randomization to tadalafil 5mg daily for 6 mos vs placebo starting with RT. Primary outcomes measured by International Index of Erectile Function (IIEF). Eligibility included pre-RT IIEF Question [Q] 1 response “sometimes/most times/always” able to get an erection. Ps treated with hormones were excluded. Primary outcome was response to IIEF Q1 at 30 wks (6 wks off drug). Pts were stratified by RT modality (external vs. brachytherapy) and age (≤65 vs. >65 years). 182 pts were needed in an intent-to-treat analysis to show a difference from 20% responders with placebo to 40% with tadalafil based on a 2-sided Fishers exact test with α=0.05 and 80% power. Results: We report on 155/222 analyzable/eligible pts. Median age was 63 years, white (73%), and external RT (63%). Mean total dose for external RT was 77.23 Gy and 136.74 Gy for brachytherapy with penile bulb D50 of 24.46 Gy and 31.24 Gy respectively. Most pts completed treatment per protocol (84% tadalafil, 70% placebo). Spontaneous EF at 30 wks from drug start was not different (p=0.99) between arms based on IIEF Q1 response, total IIEF score (52.5 drug vs 52.8 placebo), or score change from baseline (-8.0 drug vs -8.8 placebo). No difference in these outcomes was noted at 1 year. Non-responders at 30 wks were likely to be older (age≥65; p=0.432), but there were no significant predictors at 1 year. About 80% of pts maintained spontaneous EF in both arms. Conclusions: Low-dose daily tadalafil did not preserve EF within the first year of RT for prostate cancer. If tadalafil positively influences delayed RT-induced vasogenic injury, additional time may be needed to observe a benefit to tadalafil as a preventive agent. Alternatively, tadalafil dose modification or altered dosing schedules may be needed to demonstrate a protective effect of this agent when used with RT. Clinical trial information: NCT00951184.
Risk perceptions in localized breast cancer (BC).
Authors: Kumar Pallavi , Sepucha Karen , Chang Yuchiao , Belkora Jeffrey , Lee Clara N , Partridge Ann H. , Feibelmann Sandra , Moy Beverly 
Published: March 2020

9534 Background: Risk perceptions (RP) play an important role in decision making in localized BC. Little is known about RP in the context of adjuvant (adj) therapy decisions. We examined the accuracy of estimate of absolute benefit of adj therapy among patients (pts) with localized BC and sought to identify determinants of accurate RP. Methods: A cross-sectional survey was conducted in localized (Stage I-III) BC pts within 3 months after surgery at 4 U.S. cancer centers. Pts completed the Decision Quality Instrument, which includes items on BC knowledge, numerical estimates of benefit of adj therapy, and communication with providers. We analyzed pts with Stage I/II and calculated objective estimates of benefit of adj therapy using Adjuvant! Online. Based on published data, an estimate that was +/- 5% of the calculated risk was considered correct. We used multivariable (MV) regression to identify determinants of accuracy including tumor stage, age, adj treatment, education, total knowledge score, and decision involvement. Results: 192/249 (77.1%) pts completed the survey; analyses were limited to 166 pts stage I/II with complete risk estimate data. Mean age was 56.4 years (SD 12.1), 83% of respondents were white, and 58.5% were college graduates. 56.3% had stage I and 43.7% had stage II disease. Most (95.6%) had some type of adj therapy, either endocrine therapy only (43.2%), chemotherapy only (15.3%), or both (32%). On average, pts estimated the absolute benefit of adj therapy to be 31.8% (SD24.9), and this varied by stage (28.4 and 35.9 for stage I and II, p=0.06). The overall estimate for this sample from Adjuvant! Online was 11.8% (SD 7.67) and this varied by stage (8.6/16.0 for stage I/II respectively, p<0.001). Few pts (18.1%) had accurate estimates and the majority (68.3%) overestimated the benefit. In MV logistic regression analysis, only BC knowledge score was associated with accurate estimate of benefit (OR 1.36 95%CI 1.04, 1.8). No other factors were significantly associated with accuracy. Conclusions: Pts with localized BC overestimated the absolute benefit of adj therapy by an average of 20 percentage points. Some pts may be taking on risks of adj therapy without accurate knowledge of the benefits, calling into question whether these decisions are truly informed.
Comparison of toxicity experienced by elderly (E) and younger (Y) patients in breast cancer (BC) clinical trials.
Authors: Mariano Caroline Joy , Francl Mia Ivy , Lim Howard John , Pope Janice , Wong Linda , Lohrisch Caroline A. 
Published: March 2020

9542 Background: E patients (pts), age 65 and older, form a large percent of BC pts, but are under-represented in trials, due to actual/perceived frail health, or actual/perceived greater potential toxicity from therapy (rx). With ethics approval, we examined whether E pts had more toxicity than Y pts (< 65 years) in clinical trials. Methods: All BC phase II and III drug trials open from 1999 to 2012 at British Columbia Cancer Agency Vancouver Center were reviewed, excluding trials with only premenopausal pts. Adverse events (AE) were captured from case report forms and charts. The primary endpoint was meaningful toxicity (MTOX), defined as any grade 3 or 4 AE; any AE with dose delay or reduction; or premature discontinuation of rx. Frequencies of MTOX were compared using chi-square tests, means were compared with T-tests. Results: Among 46 trials enrolling 799 pts, rx types were chemotherapy ([CT], 18% of pts), hormone ([HT] 40%), skeletal ([ST] 14%), targeted ([T] 14%]) and CT + T (14%). Pts were 19% E (age range 65-84) and 81% Y (age range 25-64). E pts were more likely to enroll in HT and ST trials; Y pts were evenly distributed among all rx types. Toxicity data (Table) was available for 778 pts (97%). Conclusions: In non CT trials, E and Y pts had similar frequency and number of MTOX. Few E (5%) enrolled in CT trials, but with no more MTOX than Y pts. Discontinuation of rx was equal in E and Y, considering all rx types. Appropriate selection of E pts by eligibility criteria, self selection, and/or clinician assessment allows safe participation of E pts in BC trials. Fear of increased MTOX should not exclude fit E pts from trial participation. [Table: see text]
Local tumor control and survival outcomes of percutaneous radiofrequency ablation plus post-ablation chemotherapy for lung tumors in nonsurgical patients: A meta-analysis.
Authors: Andrew Peter , Jerat Sandra , Valdes Mario , Lee-Ying Richard M. , O'Connor Stephen 
Published: March 2020

9550 Background: Local recurrence is a frequent outcome post radiofrequency ablation (RFA) for local control of lung tumors. We sought to examine local tumor control and survival benefits of RFA plus post-ablation chemotherapy versus RFA alone for management of lung tumors in non-surgical patients. Methods: Search strategy: MEDLINE, the Cochrane Library, and EMBASE databases from January 2000 to December 2012. Inclusion criteria: RFA +/- post-ablation chemotherapy in non-surgical patients with solid lung tumors. Exclusion criteria: Post-RFA radiation therapy, biologics, brachytherapy, or other ablation modalities. Outcomes: Local tumor progression (LTP), overall survival (OS), and disease-free survival (DFS) at 12 month follow-up. Statistical analysis: Fixed effect analyses, bias assessment, and sensitivity analyses (BioStat Inc., NJ, USA). Results: RFA plus post-ablation chemotherapy group: 11 clinical studies, 684 patients (mean age 64 years [range 50 to 74]; 434 men, ECOG ≤2), ablation of 1,314 lung tumors, with a 4:1 ratio being <3cm versus ≥3cm in diameter, and a 1:4 ratio being primary versus metastatic. RFA alone group: 38 clinical studies, 1,874 patients (mean age 65 years [range 49 to 75]; 1,041 men, ECOG ≤2), ablation of 2,604 lung tumors, with a 2.1:1 ratio being <3cm versus ≥3cm in diameter, and a 1:1 ratio being primary versus metastatic. RFA plus post-ablation chemotherapy versus RFA alone: LTP of 15% over median follow-up of 31 months [range 12 to 59]) versus 19% over median follow-up of 21 months [range 12 to 29]); OR 0.73 (95% CI: 0.61-0.86, p<0.05) at 12 month follow-up. OS was 89% versus 78%, respectively, at 12 month follow-up; OR 1.52 (95% CI: 1.16-2.00, p=0.003). DFS was 90% versus 82%, respectively, at 12 month follow-up; OR 3.18 (95% CI: 2.04-4.96, p<0.05). Sensitivity analyses were robust, publication bias relatively narrow, and heterogeneity within acceptable limits; Q statistic<21; p>0.13 for all outcomes. Conclusions: This meta-analysis reveals that RFA plus post-ablation chemotherapy of lung tumors yields improved outcomes in terms of LTP, OS, and DFS compared with RFA alone.
Gender differences in comprehensive geriatric assessment (CGA): Results from the IN-GHO registry.
Authors: Honecker Friedemann , Bokemeyer Carsten , Kallischnigg Gerd , Huschens Susanne , Wedding Ulrich ,   on behalf of the IN-GHO Advisory Board
Published: March 2020

9553 Background: Elderly cancer patients (pts) are a heterogeneous population. As chronological age does not provide sufficient information on individual limitations and resources, a CGA helps to describe the heterogeneity in a structured way. Assessment instruments might be sensitive to gender differences. We therefore analyzed the IN-GHO registry for gender associated differences in results of CGA. Methods: The internet based IN-GHO registry prospectively collects data of elderly cancer pts from > 100 centres in Germany and Austria. Data from 1,580 pts aged 70+ years were analyzed comparing results between female (n=883) and male (n=697) pts by Chi-square or Mann-Whitney U test. Analyses included results from CGA, physicians´ rating (fit vs. compromised vs. frail) and pts´ self rating of fitness for treatment (Likert scale 1 = very fit to 6 = very unfit), type (combination vs. monotherapy vs. no), and dosage (full vs. adapted) of treatment. Results: Mean age was 76.7 years (range 70-97), 71.5% had a solid tumor, and 28.5% a hematological malignancy. Mean age was slightly but significantly higher in women than in men (76.9 vs. 76.4; p=0.02), reflected in a higher number of pts. aged 80+ (26.5% vs. 21.1%; p=0.013). No gender differences were observed in physicians´ rating and pts´ self rating of fitness for therapy, or in type or dosage of treatment. Furthermore, no gender associated differences were noted in Karnofsky-Performance-Scale, comorbidity (Charlson-Comorbidity-Score), polypharmacy, and cognition (Mini-Mental-Status-Examination). Gender associated differences, however, were noted in body mass index (more women in categories <19 and >35), mean ADL (91.7 vs. 93.4, p=0.03), mean IADL (6.9 vs. 6.7 (p=0.049), and timed-up-and-go test (< 10 seconds 36.1% vs. 43.6%, p=0.005). The main differences between women and men in ADL and IADL scores were noted in the item bathing (ADL) and food preparation, housekeeping, and laundry (IADL). Conclusions: The internet based registry is a valuable tool to gain data on prognostic factors, treatment, and outcome in old cancer pts. In several items of CGA, significant differences exist between women and men.