bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prognostic value of routine biomarkers in older patients with cancer: Pooled analysis of three prospective cohorts.
Authors: Paillaud Elena , Soubeyran Pierre , Oubaya Nadia , Brain Etienne , Fonck Marianne , Reinald Nicoleta , Heitz Damien , Allain Mylene , Zebachi Sonia , Rousselot Hubert , Laurent Marie , Dauba Jérôme , Caillet Philippe , Bastuji-Garin Sylvie , Rainfray Muriel , Bringuier Michael , Grellety Thomas , Bellera Carine A. , Mathoulin-Pélissier Simone , Canoui-Poitrine Florence 
Published: March 2020

11551 Background: To assess prognostic value of routine biomarkers in older patients with cancer. Methods: A pooled analysis of three prospective multicentre cohorts, ELCAPA, PHRC Aquitaine and ONCODAGE was conducted. Patients aged 70 years or older, with cancer were included. Biomarkers collected were plasmatic C-reactive protein, albumin and a combined score: Glasgow Prognostic Score (GPS). The GPS comprised three categories (0: CRP≤10 mg/L, albumin≥35 g/L; 1: CRP≤10 mg/L and albumin < 35 g/L, or CRP > 10 mg/L and albumin≥35 g/L; 2: CRP > 10 mg/L and albumin < 35 g/L).The primary endpoint was overall survival at 12 months. Multivariable Cox models were used, adjusting for age, sex, localisation, metastatic status, performance status, frailty screening index, the G8. Discriminative properties were assessed using Harrell C index and NRI (Net Reclassification Improvement). Results: Overall 1800 patients were analyzed (ELCAPA: N = 543, PHRC Aquitaine: N = 253, ONCODAGE: N = 1004; mean age: 78.5±5.5 years; 61.7% of men; 37% metastatic; most frequent localisations: breast (34.9%) and colon-rectum (17.7%); 70.7% of patients screened at risk of frailty with G8). Overall survival was 71.1%. GPS was independently associated with death (among normal G8: GPS 1: Hazard Ratio (HR) = 4.48; 95% Confidence Interval (95% CI) = [2.03; 9.89], GPS 2: 11.64 [4.54; 29.81], among abnormal G8: GPS 1: 2.45 [1.79; 3.34], GPS 2: 3.97 [2.93; 5.37]. The addition of GPS to the clinical model (Harell C: 0.82 [0.80; 0.83]) improved discrimination (Harell C: 0.84 [0.82; 0.85], NRI: 11% [5; 19]). Conclusions: GPS could be used in older patients with cancer to help decision-making and prognosis assessment.
Role of the oncological-multidimensional prognostic index in older patients with metastatic colorectal cancer treated in a real-world setting.
Authors: Procaccio Letizia , Brunello Antonella , Fiduccia Pasquale , Lettiero Annunziata , Tierno Giuseppina , Pusole Grazia , Bergamo Francesca , Schirripa Marta , Manai Chiara , Zagonel Vittorina , Lonardi Sara 
Published: March 2020

11552 Background: About 50% of diagnoses of colorectal cancer (CRC) occur in patients (pts) older than 70 years. Though a comprehensive geriatric assessment (CGA) is recommended for proper management of older cancer pts, there is still no consensus on the best form of geriatric assessment. We investigated possible prognostic factors in elderly metastatic (m)CRC pts in a real-world setting, focusing on the role of the oncological-multidimensional prognostic index (onco-MPI). Methods: Pts aged ≥ 70 years with mCRC referred to the Medical Oncology 1 Unit from May 2010 to May 2017 were assessed by a multidisciplinary team and received a basal CGA. Onco-MPI was calculated by a validated algorithm as a weighted linear combination of the CGA domains, as previously described. The following 3 different prognostic groups were identified: low (scores 0.0-0.46), medium (scores 0.47-0.63) and high risk (scores 0.64-1.0). Results: A total of 206 mCRC pts were included, 123 males. Mean age was 76.1 years (69.2-90.8). ECOG PS was < 2 in 90% and mini-mental state examination was ≥ 24 in 85% of pts. Primary tumor was located in rectum, left and right side in 18%, 42% and 40% of pts, respectively. RAS and BRAF mutations were detected in 44% and 9% of pts, respectively. According to onco-MPI score, 32%, 39% and 28% of cases were low, medium and high risk, respectively. According to CGA as per Balducci’s criteria, 56% of pts were classified as fit, 31% vulnerable and 13% frail. Median overall survival (OS) was 26 months (95% CI 19.7-32.4). The following factors were significantly associated with OS: ECOG PS (0-1 vs > 1, 31% vs 15%, p = 0.004); onco-MPI score (low vs medium vs high risk, 29% vs 38% vs 19%, p = 0.005), treatment (monotherapy vs doublet vs triplet, 20% vs 31% vs 30%, p = 0.01). No significant difference in OS was observed in CGA-based groups (p = 0.15). In high onco-MPI score, doublet-regimen correlated with higher OS compared to monotherapy (79% vs 51%, p = 0,03). Conclusions: Onco-MPI emerged as a significant prognosticator in mCRC elderly pts. It may be useful in daily clinical practice for driving decision-making in this age group. Thanks to its marked standardization it may be also applied in clinical trials.
Physiological and psychosocial effects of a highly structured exercise program on breast cancer survivorship.
Authors: Tjoe Judy A. , Piacentine Linda B. , Yin Jun , Papanek Paula , Ng Alexander V. 
Published: March 2020

11558 Background: Exercise after breast cancer treatment improves cancer-related outcomes, although the mechanism of action is unclear. Engagement in healthy active lifestyles after cancer treatment may also impact overall survival. We aimed to determine effectiveness of a highly structured, clinically overseen, goal oriented, group triathlon training program on improving physiological and psychosocial outcomes in female breast cancer survivors (BCS). Methods: After stage appropriate local and systemic breast cancer treatment, 53 female BCS were recruited to participate in this study. The 14-week group triathlon training program was individually adjusted for treatment side effects. 28 similar BCS who did not participate in the training served as controls. Pre- and post-exercise training measures included: Functional endurance (Timed 6MWT), quality of life (QOL, FACT-B), cancer-related fatigue (CRF, FACIT-F), exercise self-efficacy (ESE) via questionnaires, estradiol, and inflammatory biomarkers (C-reactive protein, TNFr1, leptin and adiponectin). Results: Complete data were obtained from 41 [mean age 51 (7) yr, mean BMI 29.5 (6.2)] triathlon finishers and 16 [mean age 56 (10) yr, mean BMI 31.5 (8.0)] controls. 6MWT improved (26 m) more in the triathlon group (p < 0.05). FACT-B, FACIT-F, and ESE all improved compared to controls (all p < 0.05). Body mass and BMI decreased in the training group compared to controls (p = 0.01, p = 0.04 respectively). Arm circumference decreased in the trained group but increased in controls (p < 0.05). Estradiol and leptin positively correlated with initial body weight in both groups but did not change after training. Adiponectin significantly decreased in the triathlon group (p = 0.01), perhaps due to selection bias of controls. No significant changes were seen in other serological markers. Conclusions: A highly structured, clinically overseen, moderate intensity exercise program can improve endurance, QOL, CRF, body mass, and possibly improve survival after breast cancer treatment. Furthermore, improvements in ESE may provide tools for patients to continue adherence to regular exercise guidelines that may lower obesity and its related comorbidities, including arm lymphedema.
The CAROLE (CArdiac Related Oncologic Late Effects) Study: A Phase II, single-arm feasibility trial.
Authors: Puckett Lindsay , Saba Shahryar , Henry Sonia , Rosen Stacey , Rooney Elise , Laxer Alison , Gilbo Philip , Pappas Karalyn , Eacobacci Katherine , Kapyur Amitha , Robeny Justin , Filosa Samaria , Musial Samantha , Chaudhry Anisha , Chaudhry Rahul , Lesser Martin , Riegel Adam , Charlton Jessica , Ramoutarpersaud Sariah , Lee Lucille 
Published: March 2020

11569 Background: Long-term breast cancer survivors are at risk of late effects from cardiotoxic (tox) radiation (RT) and chemotherapy (chemo). However, there is a paucity of data to recommend appropriate cardiac screening for those ~10 years (yrs) after diagnosis (dx). This phase II, single arm study assessed multimodality screening in a heterogeneous cohort of long-term survivors. Methods: Our prospective, single center pilot study enrolled 201 (of 200 planned) eligible patients (pts): age 18-65 at dx, with treatment (tx) for breast cancer (any stage/tx) in 2004-2011 (≥6 yrs prior), with no cardiac disease (dz) at dx. The primary endpoint was presence of any cardiac dz (preclinical or clinical) on electrocardiogram (EKG), echocardiogram (echo), or coronary artery calcium CT (CAC CT); secondary endpoint included clinical (clin) dz alone. Subgroups assessed were: no tox chemo or RT (no tox), tox RT (left-sided) alone, tox chemo (anthracycline) alone, and both tox chemo and tox RT (tox chemoRT). Results: After enrollment (6/2017-7/2018), 200 pts had sufficient data for analysis. Median age was 50 (29-65) at dx, 63 (37-77) at imaging, and interval (dx to imaging) was 11.5 (6.7-14.5) yrs. There were 44% no tox, 31.5% tox RT, 16% tox chemo, and 8.5% tox chemoRT pts. Among all pts, 77.6% displayed evidence of any cardiac dz, 51.5% had clin dz. Per modality, rates of any and clin dz were: 27.1%/10% EKG, 50.0%/25.3% echo, and 50.8%/45.8% CAC CT. Among subgroups, these rates were: 73.9%/53.4% no tox, 82.5%/58% tox RT, 75%/38.7% tox chemo, and 82.4%/35.3% tox chemoRT (NS on χ2 test, p = .58/p = .15). Multivariable logistic regression with tox RT, tox chemo, and age as covariates, showed no significant tox RT (NS) or tox chemo effect (NS), however, increasing age was significantly associated with higher incidence of cardiac dz (p < 0.01; OR = 1.12 per yr, 95% CI: 1.07-1.18). Conclusions: Among pts with a median of > 10 yrs post breast cancer tx, multimodality CAROLE screening was feasible and showed high rates of cardiac dz (any/clin = 77.6%/51.5%) among all subgroups, including those without tox tx. This study provides evidence for long-term cardiac screening in a diverse group of breast cancer survivors and provides a novel pathway for evaluation. Clinical trial information: NCT03235427.
Cardiorespiratory fitness and cardiovascular mortality after prolonged androgen deprivation therapy for prostate cancer.
Authors: Gong Jingyi , Payne David , Caron Jesse Pittard , Bay Camden , McGregor Bradley Alexander , Hainer Jon , Partridge Ann H. , Neilan Tomas G. , Di Carli Marcelo , Nohria Anju , Groarke John 
Published: March 2020

11576 Background: Androgen deprivation therapy (ADT) plays a pivotal role in management of prostate cancer (PC), with prolonged ADT favored over short-term use in the definitive treatment of high risk PC with radiation. Objectives: To compare cardiorespiratory fitness (CRF) and cardiovascular (CV) mortality among patients with PC with and without ADT exposure, and to explore how duration of ADT exposure influences CRF and CV mortality risk. Methods: This is a retrospective study of patients referred for exercise treadmill testing (ETT) after a diagnosis of PC. PC risk classification was based on Gleason score (GS) at diagnosis: high risk GS ≥ 8, intermediate risk GS= 7, and low risk GS ≤ 6. CRF was categorized according to metabolic equivalents (METs): METs ≥ 8 defined as good CRF and METs < 8 as reduced CRF. ADT exposure was grouped as short-term (≤ 6 months) versus prolonged (> 6 months). Results: 616 patients underwent an ETT a median of 4.8 years (interquartile range: 2.0-7.9) after diagnosis of PC. 150 patients (24.3%) received ADT prior to ETT; 51 with short-term versus 99 with prolonged exposure. 524 (85.1%) patients had ≥ 2 CV risk factors, and 28 CV deaths occurred over 4.2 (interquartile range: 2.3-7.1) years following the ETT. Reduced CRF was more frequent among ADT-exposed versus ADT-naive patients (48.7 versus 32.6%, p< 0.001). Prolonged ADT was associated with reduced CRF (odds ratio (OR): 2.71; 95% confidence interval (CI): 1.31-5.61; p=0.007) and increased CV mortality (hazard ratio (HR): 3.87; 95% CI: 1.16-12.96; p=0.03) in adjusted analyses. In contrast, short-term ADT exposure was not independently associated with either reduced CRF (OR 1.71; 95% CI: 1.00-2.94); p=0.05) or CV mortality (HR: 1.60; 95% CI: 0.51-5.01; p=0.42). Conclusions: Among patients with PC and high baseline CV risk, > 6 months ADT exposure but not less was associated with reduced CRF and increased CV mortality. Reduced CRF may in part mediate increased CV mortality risk. Exercise interventions concurrent with prolonged ADT warrants investigation to potentially offset risk.
Clinical impact of neutropenia and febrile neutropenia in mCRC pts treated with FOLFOXIRI/bevacizumab (bev): A pooled analysis of TRIBE and TRIBE2 studies.
Authors: Rossini Daniele , Sbrana Andrea , Bergamo Francesca , Manai Chiara , Santini Daniele , Ghidini Michele , Antoniotti Carlotta , Moretto Roberto , Marmorino Federica , Urbano Federica , Ronzoni Monica , Noventa Silvia , Randon Giovanni , Carlomagno Chiara , Latiano Tiziana Pia , Cordio Stefano Sergio , Granetto Cristina , Cremolini Chiara , Falcone Alfredo , Antonuzzo Andrea 
Published: March 2020

11591 Background: FOLFOXIRI/bev is a valid option as first-line therapy for unresectable mCRC. TRIBE and TRIBE2 trials reported better activity and efficacy of the triplet/bev when compared with doublets/bev at the price of a higher incidence of chemo-related toxicities, including neutropenia (N). Here we aim at providing a detailed description of this adverse event, including the occurrence of febrile neutropenia (FN) and the use of granulocyte-colony stimulating factors (G-CSFs), in order to estimate the clinical relevance of N during FOLFOXIRI/bev. Methods: Safety data of 1175 pts enrolled in the TRIBE and TRIBE2 studies were reviewed. The incidence of N, the incidence and severity of FN, and the use of G-CSF in the triplet/bev and in the doublets/bev arms were compared using the Chi-square or the Fisher exact test as appropriate. Results: Out of 1175 pts included in the final analysis, 586 (49.8%) were treated with FOLFOXIRI/bev. Five pts (0.8%) in the doublets/bev arms and 29 (4.9%) in the triplet/bev arms received a primary prophylaxis with G-CSF. Among other pts, 118 (20.2%) in the doublets/bev arms and 276 (49.9%) in the triplet/bev arms experienced ≥ G3 N (p < 0.001). FN occurred in 25 (4.3%) and 41 (7.4%) cases respectively (p=0.041). Out of 78 FN episodes, 4 (13.3%) out of 30 in the doublets/bev arms and 13 out of 48 (27.1%) in the triplet/bev arms were associated with a poor MASCC score (<21) (p=0.17). G-CSF was used in 1069 (10.8%) cycles, 270 (5.3%) in doublets/bev and 799 (16.6%) in triplet/bev arms. In both arms, the majority of N and FN episodes were observed in the first two months (318 ≥ G3 N episodes out of 675 (47.1%), and 54 FN episodes out of 78 (69.2%)). Conclusions: FOLFOXIRI/bev was associated with a higher risk of N and FN than doublets/bev. However, the risk of FN was lower than 10%, thus not requiring a systematic use of primary G-CSF prophylaxis. The majority of FN episodes was associated with a good MASCC score, thus having a limited clinical impact. The vast majority of FN episodes occurred in the first two months of treatment, suggesting a closer monitoring of this adverse event during the first courses of therapy.
Predictors and trajectories of fatigue in ovarian and uterine cancer.
Authors: Poort Hanneke , de Rooij Belle Hadewijch , Weng Shicheng , Ezendam Nicole , van de Poll-Franse Lonneke V , Wright Alexi A. 
Published: March 2020

11603 Background: Fatigue is one of the most common and distressing symptoms reported by patients with gynecological cancers, but few studies have empirically examined whether it resolves without intervention. The aims of this study were to identify: 1) clinically-distinct subgroups of patients with fatigue over time and 2) medical and psychological predictors of clinically-significant fatigue one-year post-diagnosis. Methods: Secondary analysis of a prospective cohort study. Symptoms of fatigue, depression, and anxiety were assessed at diagnosis, 6-months, and 12-months with the 10-item Fatigue Assessment Scale (FAS), and the Hospital Anxiety and Depression Scale (HADS), respectively. Group-based trajectory modeling was used to classify patients by their fatigue scores over time, and logistic regression models were fit to examine associations between clinically-significant fatigue and demographic, clinical, and psychosocial characteristics. Patients with recurrent or primary progressive cancers were excluded from the primary analysis. Results: Among 312 participants with newly diagnosed ovarian (n = 112) or endometrial (n = 200) cancers, the median age was 66 years (IQR = 60-72 years), 36% had ovarian cancer, and 79% had early stage disease. At baseline, 49% reported clinically significant fatigue and one year later, 42% had persistent fatigue. During the year after diagnosis, there were three distinct trajectories of fatigue that persisted: (1) severe fatigue (15%), (2) moderate fatigue (45%), and (3) no fatigue (41%). Patients with ≥2 comorbid conditions (odds ratio [OR] 2.52, 95% confidence interval [CI] = 1.21-5.27, P = 0.01), clinically significant fatigue at baseline (OR 5.47, 95% CI = 2.71-11.03, P < .0001), and those reporting depressive symptoms at baseline (OR 3.45, 95% CI = 1.13-10.55, P = 0.03) were more likely to report clinically-significant fatigue at 12 months. Conclusions: Half of women with gynecologic cancers have clinically-significant fatigue at diagnosis and 42% of survivors have persistent fatigue one year later, suggesting spontaneous regression of symptoms is rare. Importantly, depressive symptoms contribute to persistent fatigue and are modifiable with psychological interventions. Future studies should test scalable psychological interventions to address depressive symptoms, reduce fatigue, and improve quality of life in women with gynecologic cancers.
A phase II, double-blinded, randomized study using a proprietary amino acid mixture as diarrhea prevention in patients undergoing autologous stem cell transplantation (AST) for multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).
Authors: Luque Laura , Soiffer Robert , Glotzbecker Brett , Kim Haesook , DeFilipp Zachariah Michael , Keefe Dorothy Mary Kate 
Published: March 2020

11607 Background: Melphalan, remains the mainstay of conditioning for autologous hematopoietic stem cell transplantation (HSCT) in multiple myeloma (MM) and non-Hodgkin lymphoma (NHL) patients. Gastrointestinal symptoms represent the most significant non-hematologic toxicities following high-dose melphalan conditioning, with approximately 40% of patients experiencing CTCAE grade 2 or higher diarrhea following conditioning regimens containing melphalan. Enterade is a proprietary blend of electrolytes and five amino-acids that can facilitate retention of the absorbing capacity of the small intestine by rebuilding the villi and reduce antigenic translocation by tightening the mucosal barrier. In a study of irradiated mice, enterade improved survival and improved body weight following irradiation. The goal was to investigate the effectiveness of enterade to reduce GI toxicities after high-dose melphalan chemotherapy. Methods: The trial was designed as a Phase 2, multi-center, double-blinded, 2-arm randomized study. 114 MM or NHL patients were enrolled between October 2016 and October 2017. Patients received either two 8oz bottles/day of enterade or placebo starting on the day of admission through Day +14. GI toxicity was scored by the CT-CAE 4.0 system from admission through Day + 14. Compliance was arbitrarily set at consumption of 2 bottles daily for 11+ days. Results: Of the 114 enrolled patients, 99 (61 MM, 38 NHL) attempted to consume at least 1 dose of enterade/placebo. Compliance overall was much lower than anticipated; with no MM patients achieving compliance compared to 34.2% in the NHL group. Compliance in NHL patients was 31.6% in the enterade group versus 36.8% in the placebo group. Analysis of primary endpoint in NHL patients showed a 16% incidence of diarrhea ≥ grade 2 in enterade compliant patients versus 86% in the placebo group (p= 0.02). Conclusions: Eleven days of two 8oz bottles of liquid is a difficult task during ASCT, especially for MM with nausea, altered taste and poor appetite. For those NHL patients, compliant per protocol (who consumed ≥11 days), enterade significantly reduced diarrhea. The use of enterade to prevent diarrhea following high-dose chemotherapy should be explored further in populations capable of reasonable oral intake. Clinical trial information: NCT02919670.
Therapy discontinuation processes in a gynecologic oncology population.
Authors: Watson Catherine H. , Puechl Allison , Truong Tracy , Lim Stephanie , Havrilesky Laura Jean , Davidson Brittany Anne 
Published: March 2020

11611 Background: The decision to discontinue anti-cancer therapies in oncology patients is a complex one and may occur in several unique ways. We sought to understand the processes of therapy discontinuation in a gynecologic oncology population and to discern possible changes in the distribution of these processes after implementation of a palliative care (PC) quality improvement project. Methods: Women with incurable gynecologic malignancies seen in the outpatient setting at an academic center were identified with the recommendation for ‘goals of care’ discussion within 3 visits following identification. Processes of discontinuing chemotherapy for this population were assessed and categorized into 1 of 4 categories: definitive outpatient decision, definitive inpatient decision, interruption by hospitalization, treatment holiday, and “no decision.” Retrospective chart review identified a similar cohort of women prior to the implementation of our PC intervention. Univariate analyses were conducted to determine associations between characteristics and binary outcome of definitive outpatient decision versus all other decision processes. Results: 90/102 (88%) pre-intervention subjects and 83/157 (53%) post-intervention subjects had died at time of analysis. Of the total deceased cohort, 59/173 (34%) made a definitive decision to stop therapy in the outpatient setting. After implementation of the PC initiative, there was a trend towards fewer women identified as having made “no decision” (18.1% vs 30%). Those who made a definitive outpatient decision were less likely to die within 30 days of hospitalization than those who did not (OR 0.16 [95% CI 0.07,0.390], p < 0.0001). Conclusions: Discontinuation of therapy is a nuanced concept in gynecologic oncology patients that can be stratified into several processes. While our data demonstrates a possible increase in active decision-making with the PC initiative, a majority of patients near the end of life still did not make definitive therapy cessation decisions. This reveals an urgent need for the development of initiatives to enhance patient engagement and shared decision making for women near the end of life.