bluuebunny/crossref_metadata_2025_split huggingface dataset:
Examining perceptions of financial toxicity among cancer patients: The Financial Toxicity 16 Questionnaire.
Authors: Bordonaro Roberto , Castagna Fabrizio , Piazza Dario , Cordio Stefano Sergio , Sergi Concetta , Fassari Giuseppina Emanuela , Martines Concetta , Commendatore Oriana , Sambataro Daniela , Carapezza Luigia , Mattina Marco , Russo Alessia Erika , Gebbia Vittorio 
Published: May 2020

e19389 Background: Financial toxicity (FT) among cancer patients (CP) is multifactorial, arising from both disease-related and non- disease related factors, including socio-cultural, environmental, and psychological attributes. It derives both from costs related to assistance and borne on the patients and its caregivers, and reduction of income capacity also in this case borne on the patients and on the caregivers. Stress levels may escalate to significant proportions in some patient, to present with symptoms of anxiety especially during therapy administration periods. Methods: In order to highlight financial toxicity related to the diagnosis of metastatic pancreatic and lung cancer and to measure its evolution over time and any correlation with the prognosis, we developed a questionnaire called FT16 and we conducted a validation study on a sample of 31 patients. The design of the study involved the development and the psychometric assessment of a scale to measure the perceived sources of FT among CP. Following extensive literature review, a table of specification with the initial items was created to guide item construction for developing the scale. The items related to these FT were converted into an 16-item, multipoint questionnaire, resulting in the FT16. We also monitored quality of life of the patients, using the QlQ C-30 questionnaire, in the aim to capture correlation between FT onset and quality of life deterioration; clinical characteristics of the patients, response to therapy and outcome parameters also have been recorded in the aim to evaluate eventual correlation with FT. Results: The questionnaire was administered to 31 adult patients with lung and pancreatic metastatic cancer, both men and women, who were newly diagnosed and will undergo cancer treatment. Each of them has been informed about the research and written informed consent has been obtained. The internal consistency reliability (Cronbach’s alpha) was 0.77 for the 16 items of the FT16. Analyses of variance (ANOVAs) indicated that there were no significant differences in the mean FT16 score, between sexes, and age groups in the severity score. Conclusions: FT16 questionnaire seems to be an useful tool to capture FT onset in this poor-prognosis subset of patients; the analysis of the data recorded will continue to assess the capability of the FT16 to capture correlations with clinical characteristics at diagnosis and correlations with the prognosis.
Cost-effectiveness of first-line therapy for advanced renal cell carcinoma in the immunotherapy era.
Authors: Parikh Divya Ahuja , Serrato Paul Irvin , Srinivas Sandy , Ryckman Tess Sophie , Salomon Joshua , Goldhaber-Fiebert Jeremy D 
Published: May 2020

e19392 Background: The treatment landscape for advanced renal cell carcinoma (RCC) has transformed in the past two years. Both Nivolumab plus Ipilimumab and Pembrolizumab plus Axitinib are approved regimens for first-line treatment of intermediate to poor-risk patients with advanced RCC. The choice between these immunotherapy-based combinations for first-line therapy is highly debated; no prior study has evaluated the cost-effectiveness of both combinations compared to Sunitinib. Methods: We used a decision analytic Markov model informed by the recent Checkmate-214 and Keynote-426 phase 3 randomized controlled clinical trials to evaluate costs and effectiveness of Nivolumab plus Ipilimumab, Pembrolizumab plus Axitinib, and Sunitinib in the first-line treatment of advanced RCC from a US health payer perspective. We used the model to extrapolate survival beyond the closure of the trials and examined the robustness of our findings with sensitivity analyses. Main outcomes were life expectancy, quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios, all discounted at 3% annually. Results: Nivolumab plus Ipilimumab increased life expectancy by 0.58 years at cost of approximately $190,000 per QALY gained compared to Sunitinib. Pembrolizumab plus Axitinib increased life expectancy by 0.39 years at a cost of approximately $861,000 per QALY gained compared to Nivolumab plus Ipilimumab. The results were not sensitive to reasonable changes in drug costs and quality of life estimates. Both combinations cost more than the traditional willingness-to-pay threshold (WTP) of $150,000 per QALY gained. A 20% price reduction is required for Nivolumab and Ipilimumab to be cost-effective and a 48% price reduction is required for Pembrolizumab plus Axitinib to be cost-effective. Conclusions: Both Nivolumab plus Ipilumumab and Pembrolizumab plus Axitinib provide increased longevity and reduced morbidity relative to Sunitinib. However, the prolonged duration of treatment and doublet-drug pricing results in high-costs. Price reductions are required for both of the immunotherapy-based combinations to be cost-effective. [Table: see text]
Cost effectiveness analysis of additional NK-1 receptor antagonist to olanzapine, ondansetron, and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin.
Authors: Mahaparn Wasamol , Lertanansit Chalermchai , Vinayanuwattikun Chanida , Tanasanvimon Suebpong 
Published: May 2020

e19398 Background: NK-1 receptor antagonist (NK1RA) is a standard anti-emetic agent in chemotherapy-induced nausea and vomiting (CINV) prevention in patients receiving high-dose (HD) cisplatin. However, in limited-resource settings, three-drug regimen including olanzapine, ondansetron and dexamethasone is affordable and effective in CINV prevention in these patients. Objectives: To evaluate cost effectiveness of additional NK1RA for CINV prevention in Thai patients receiving HD cisplatin in 3-cycle horizon, societal perspective. Methods: During January to December 2019, 20 patient receiving HD cisplatin were prospectively enrolled to receive standard three-drug regimen at King Chulalongkorn Memorial Hospital. Total medical resource utility, non-medical cost and clinical outcomes were actually collected and used for establishing decisional-tree model and cost-effectiveness analysis. Three arms decisional-tree model was constructed. First, standard strategy, a real-world practice in Thailand, patients received three-drug regimen in all cycles of chemotherapy. Second, NK1RA-rescue strategy, patients received three-drug regimen in the first cycle and additional NK1RA in subsequent cycles if the patients experienced CINV. Third, NK1RA upfront strategy, patients received four drug NK1RA-containing regimen in all cycles. Complete response (CR) rate was assumed to be 92.5% in NK1RA-containing regimen based on clinical trials. The study endpoint is to compare cost and QALYs in term of incremental cost-effectiveness ratio (ICER). Results: CR rates were 90% and 71% in first and second cycle in patients receiving standard regimen. The NK1RA upfront strategy produced greatest QALYs of 0.0351, followed by 0.0328 and 0.0292 in NK1RA-rescue strategy and standard strategy respectively. Mean total costs were 10420.46, 3332.19 and 2841.30 Thai baht (THB) respectively. The ICER of NK1RA-rescue strategy relative to standard strategy was 135,774 THB per QALY and the ICER of NK1RA upfront strategy relative to NK1RA-rescue strategy was 3,096,654 THB per QALY. Therefore, the ICER of NK1RA-rescue strategy but not NK1RA upfront strategy is considered to be cost effective at the willingness-to-pay level of 160,000 THB per QALY. Conclusions: Our findings suggested that the additional NK1RA as a rescue strategy is cost-effective in patients receiving HD cisplatin in Thai health care.
Cost-effectiveness of filgrastim-sndz as primary prophylaxis (PP) versus secondary prophylaxis (SP) to prevent chemotherapy-induced febrile neutropenia (FN) in non-small cell lung cancer (NSCLC) patients at intermediate risk.
Authors: Li Edward C. , Mezzio Dylan , Spargo Andrew , Campbell Kimberley J. , Lyman Gary H. 
Published: May 2020

e19401 Background: Patients with nonmetastatic NSCLC receiving platinum-based chemotherapy are at an intermediate risk (10-20%) of developing FN; clinical practice guidelines recommend assessing whether these patients have FN risk factors before considering myeloid growth factor (MGF) prophylaxis. Most NSCLC patients receiving chemotherapy have ≥1 FN risk factors, and while PP leads to lower rates of FN across all cycles, it is more costly compared to SP. This study evaluates the cost-effectiveness of PP vs. SP using a biosimilar MGF, filgrastim-sndz, in NSCLC patients at intermediate risk of FN. Methods: A Markov model with a lifetime horizon was constructed to evaluate the total costs and clinical outcomes of using filgrastim-sndz as PP vs. SP in NSCLC patients 61 years old receiving adjuvant carboplatin/paclitaxel every 3 weeks for 4 cycles. Separate analyses were conducted for patients with 0 FN risk factors (0RF) and with ≥1 FN risk factors (1+RF), representing 11.3% and 18% baseline FN risk, respectively. Incremental cost-effectiveness ratios (ICERs) were calculated for cost per FN event avoided, life-year saved (LYS), and quality-adjusted life-year (QALY) gained from a United States payer perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. Results: For patients with 0RF, use of filgrastim-sndz as PP vs. SP provided an additional 0.056 QALYs (0.079 LYS) at an incremental cost of $3,266. The ICERs were $46,815, $41,555, and $58,531 for cost per FN event avoided, cost per LYS, and cost per QALY gained, respectively. For patients with 1+RF, PP vs. SP added 0.090 QALYs (0.127 LYS) at an incremental cost of $1,605. The ICERs were $13,970, $12,644, and $17,805 for cost per FN event avoided, cost per LYS, and cost per QALY gained, respectively. In the PSA, the likelihood of cost-effectiveness at a willingness-to-pay (WTP) threshold of $50,000 per QALY gained was 31.7% for patients with 0RF and 96.6% for 1+RF. Conclusions: For NSCLC patients at intermediate risk of FN receiving adjuvant carboplatin/paclitaxel with 1+RF, PP with filgrastim-sndz compared to SP is cost-effective based on a WTP threshold of $50,000/QALY. [Table: see text]
Financial toxicity and its associated patient and cancer factors among women with breast cancer in China.
Authors: Jing Jingfeng , Feng Ran , Zhang Xiaojun , Li Ming , Gao Jinnan 
Published: May 2020

e19402 Background: The term “Financial toxicity(FT)” is widely used to describe the distress or hardship patients suffering from the financial burden of cancer treatment[1]. Increased evidences have showed that cancer-associated FT is common and has a negative impact on patients’ mental health, quality and length of life[1,2]. The scale of COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) was used to assess the FT of cancer patients, which has been validated and widely used internationally [3] and China [4]. To our knowledge, little is known about the FT of breast cancer patients in China. The aim of this study is to assess the FT and to investigate patients and cancer characteristic that associated with it in patients in central China. Methods: This was a cross-sectional study among 188 patients with stage 0-III women breast cancer admitted in Bethune hospital in Taiyuan, Shanxi province during January - May 2019. FT was self-reported using the COST-FACIT. Patients’ socio-demographic factors, clinical examination, and cancer treatment were collected from questionnaire and hospital record. The financial concern and coping strategy was self-reported. Factors associated with FT was identified using linear regression analysis. Results: One hundred and sixty-six (88.2%) completed the questionnaire. The COST score ranged 0-40 with a mean of 21.2 (median 22.5, standard deviation 8.1). On multivariate linear regression analysis, older age (β coefficient: 0.19, 95% CI: 0.10-0.29, p<0.001), higher household income (β coefficient: 3000-5000 Yuan: 6.48, 95% CI: 2.78-10.17, p =0.001; ≥ 5000 Yuan: 11.17, 95% CI: 7.25-15.09, p<0.001) were positively associated with COST scores. Advanced cancer stage was the strongest predictor of FT among the cancer characteristics (β coefficient: -1.81, 95% CI: -3.17, -0.46, p=0.009). To cope with the FT, 131 (78.8%) patients decreased non-medical expenses, and 56 (33.7%) reduced or quit treatment. Conclusions: FT was significantly associated with patient’s age, income, and cancer stage. Women having financial concerns after diagnosis were more likely to reduce their non-medical expenses and even quit treatments. Clinicians should take into account the FT levels in all patients and work out appropriate treatment strategies for optimal clinical outcome.
The evolution of financial toxicity in patients with lung cancer.
Authors: Friedes Cole , Hazell Sarah , Fu Wei , Hu Chen , Lee Beverly , Voong K Ranh , Feliciano Josephine Louella , Nicholas Lauren , McNutt Todd R. , Han Peijin , Hales Russell K. 
Published: May 2020

e19406 Background: Financial toxicity (FT), or the cost-related side effect of cancer therapy, has been linked to poor clinical outcomes, greater symptom burden, and worse quality of life. While the repercussions of FT have been thoroughly explored, the longitudinal patient relationship with FT in the initial course of therapy is unknown. Methods: Patients with stage II – IV lung cancer were recruited in a prospective longitudinal non-interventional study between July 2018 and January 2020. FT was measured via the COST score, a validated questionnaire for benchmarking FT, at a) the time of cancer diagnosis and then later at b) 6-month follow up (6MFU). In this model, a lower COST score indicates increased financial hardship. Completed 6MFU data was compared to corresponding baseline data for each patient. Linear regression analysis was used to compare patient characteristics with baseline COST (COSTbase) and 6-month COST (COST6M) scores. Results: At the time of analysis, 209 patients were screened and 194 (95.1%) patients agreed to participate and complete the baseline survey. Subsequently, 93 patients completed the 6MFU survey, 32 patients had died, and 7 patients were lost to follow up. The remaining 62 patients have not met the study end point to date. Of the 93 patients that completed the 6MFU and baseline survey, the median age was 65 (range 35-89), 50.5% were male, and 76.3% were Caucasian. Over the first six months of therapy 36.5% overestimated OOP expenses by > $1000 and 22.5% reported a decrease in total monetary savings, but only 4.3% of patients made decisions about health care based on cost of care. FT was present at both time points but was worse at diagnosis than at 6MFU (median COSTbase 25 [range 1-44] vs. median COST6M 27 [range 0-44]; p = 0.04). Linear regression correlated risk factors with FT at baseline ( < 1 month monetary savings, employed but on sick leave, and inability to afford basic necessities; all p < 0.001) that were different from risk factors at 6MFU (paying much more than expected OOP and sacrificing spending to meet medical costs; p < 0.001). There was no significant difference between estimated OOP costs at baseline (median $2550 [range $0 - $500,000]) and actual OOP costs (median $2496 [range $0 – 25,900]; p = 0.25). Conclusions: FT toxicity is pervasive at both diagnosis and at 6-month follow up, however, the magnitude of toxicity changes with time. Few patients are willing to sacrifice medical care regardless of the cost. Risk factors for FT evolve, suggesting that different groups may benefit from financial intervention at diagnosis versus 6MFU.
Real-world healthcare resource utilization and costs among relapsed/refractory (R/R) mantle cell lymphoma (MCL) patients receiving ibrutinib or chemoimmunotherapy (CIT).
Authors: Ghosh Nilanjan , Emond Bruno , Lafeuille Marie-Hélène , Côté-Sergent Aurélie , Lefebvre Patrick , Huang Qing 
Published: May 2020

e19408 Background: Ibrutinib is a targeted oral therapy indicated for MCL patients who received ≥1 prior line of therapy (LOT) (conditional approval on 11/13/2013 in the US). This study compared healthcare resource utilization (HRU) and costs of R/R MCL patients treated with ibrutinib ± rituximab (I±R) or CIT in a US-managed care population. Methods: Optum Clinformatics Extended DataMart De-Identified Databases (05/13/2013-6/30/2019) were used to identify adults with MCL receiving I±R or CIT (index date) following ≥1 prior LOT. Patients’ baseline characteristics were balanced using inverse probability of treatment weighting (IPTW). Monthly HRU and costs (plan paid amount) were evaluated during the first Oncology Care Model (OCM) episode (i.e., first 6 months) post-index and during the observed index I±R or CIT LOT (index LOT); and compared using rate ratios (RRs) and mean monthly cost differences (MMCDs), respectively. Results: A total of 146 I±R and 158 CIT patients were identified. Given the small sample size and to ensure outliers were not driving the results, 2 patients with total healthcare costs ≤0.5th and ≥99.5th percentile were excluded from each cohort. After IPTW, 149 and 151 patients were included in the weighted I±R and CIT cohorts, respectively (mean length of index LOT: 12.0 vs 11.0 months). During the first OCM episode and during the index LOT, the I±R cohort had significantly fewer monthly days with outpatient services compared to the CIT cohort (OCM: RR= 0.63, P<0.001; index LOT: RR= 0.73, P=0.004). The I±R cohort incurred significantly higher monthly pharmacy costs that were offset by lower monthly medical costs, yielding a monthly total cost reduction of $9,435 (p<0.001) during the first OCM episode and $4,628 (p=0.010) during the index LOT, compared to the CIT cohort (Table). Conclusions: In this study, patients with R/R MCL treated with ibrutinib ± rituximab had significantly fewer days with outpatient services and lower total healthcare costs per month versus those treated with CIT during the first OCM episode and the index LOT. [Table: see text]
Post-transplant cyclophosphamide as graft-versus-host disease prophylaxis in HLA matched sibling donor stem cell transplantation for patients with acute leukemia.
Authors: Elshamy Alaa Nabil , Abdelmohsen Essam Ali , Denewer Mai , Mabed Mohamed Nasr 
Published: May 2020

e19523 Background: Graft-versus-host disease (GVHD) is a life-threatening complication of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT). Calcineurin inhibitor (CNI) and methotrexate (MTX) have been used as the standard GVHD prophylaxis in HLA-matched HSCT. Promising clinical trial data using high dose post-transplant Cyclophosphamide (PT-Cy) with or without additional immunosuppressive agents (IS) have shown that it’s an effective, well tolerated alternative. However, experiences are limited with controversial results. Methods: We analyzed 62 patients with Acute Leukemia (39 males, 23 females) with age ranges from 18 to 60 years underwent allogeneic HSCT from matched sibling donors (MSD) using reduced intensity chemotherapy at Maadi Armed Forces Medical Hospital after informed consent. They were randomized into 2 groups according to GVHD prophylaxis regimen. The 1st group (40 patients) received MTX in the following doses; day+2 (15mg), day +4 (10 mg), day +6 (10 mg) with Cyclosporine (5mg/kg) from day -3 till day +90 and Mycophenolate (MMF) (2 -3gm/day) from day +1 till day +30. The 2nd group(22 patients) received PT-Cy (45 mg/kg/day) on days +3 and +4 with Cyclosporine (5mg/kg) from day +5 till day +30 & MMF:(2-3gm /day) from day +5 till +30. Results: At median 1 year Post Allo, PT-Cy was associated with statistically significant lowering of chronic GVHD (cGVHD) incidence compared to MTX group (22.7%, 56.4%) respectively (P = 0.011). Incidence of acute GVHD (aGVHD) at day +100 was (40%, 22.7%) in group 1, 2 respectively (P = 0.169). 92% of patients in group 1 and 86.4 % of patients in group 2 were engrafted with full donor chimerism on day +30 (P = 0.659). The cumulative incidence of relapse at 4 years after transplantation was 17.9 % for group 1 and 36.4 % for group 2 (P > 0.05). Relapse related mortality were 16.2% among MTX group while 27.3% in PT-Cy group (P = 0.10). Transplant related mortality (TRM) in MTX group were; Severe aGVHD (8%), cGVHD (10%), Hepatic Toxicity (8%), Nephrotoxicity (2.7%) & ARDS (5.4%). In PT-Cy group TRM were; septicemia (18%), severe aGVHD (4.5%) & ARDS (4.5%). Cumulative 4 years Disease Free Survival (DFS) & Overall survival (OS) in PT-Cy group were (51.8 %, 46.4%) respectively while (69.3%, 39%) in MTX group which is statistically non-significant (P > 0.05). Conclusions: For GVHD prophylaxis in MSD, PT-Cy is a safe alternative that reduces the risk of cGVHD in comparison with MTx based regimen without affecting Relapse rate, DFS or OS.
Single-institution experience of allogeneic stem cell transplantation for diffuse large B-cell lymphoma.
Authors: Puliafito Benjamin , Afshar Solmaz F. , Galitzeck Zachary , Steinberg Amir S. 
Published: May 2020

e19524 Background: Given the promising results of novel therapies such as CAR-T, there is heightened scrutiny on the long-term outcomes of allogeneic stem cell transplant (alloHCT) in diffuse large B cell lymphoma (DLBCL). We present the characteristics and long-term follow-up of DLBCL patients (pts) who underwent alloHCT at our institution over the past 10 years. Methods: Adult pts who underwent an initial alloHCT for DLBCL at our institution from 2008 to 2018 (n = 18) were included. Pt, disease, transplant (tx), and GVHD history were retrospectively collected from reports to CIBMTR and chart review. Outcomes of progression-free survival (PFS) and overall survival (OS) were analyzed in February 2020. Results: Eighteen pts underwent an alloHCT for DLBCL at a median of 19.5 months post-diagnosis (range, 6 – 83 mo). The median age at the time of tx was 53 years old (range, 30 – 67 yrs). The median Karnofsky score was 70 (range, 30 – 100). The majority of the pts (78%) had stage IV disease. The median number of prior chemotherapy regimens was 3 (range, 1 – 6). Disease was chemosensitive in 11 pts (61%), chemoresistant in 4 pts (22%), and undetermined in 3 pts (16%). Eleven pts (61%) had a previous autoHCT with a median time between txs of 8 months (range, 4 – 28 mo). The disease status at time of tx included CR1 (n = 2), CR3+ (n = 2), PR (n = 4), PIF-resistant (n = 3), PIF-sensitive (n = 1), REL1-resistant (n = 1), and REL3+-sensitive (n = 3). Fifteen patients received PBSC and 3 patients received cord blood. Donors were HLA-identical siblings (n = 5), monozygotic twins (n = 1), and unrelated (n = 12). Conditioning regimens were Flu/Mel (n = 10), Flu/Mel/ATG (n = 2), Flu/TBI (n = 2), Flu/Cy/TBI (n = 1), Cy/TBI (n = 2), and BEAM (n = 1). Acute GVHD developed in 16 pts (89%) with max grades of III or IV in 10 pts despite 94% of pts receiving GVHD prophylaxis. Chronic GVHD developed in 5 pts (28%; 3 pts with limited disease and 2 pts with extensive disease). PFS rates were 56% at 6 months, 33% at 1 year, and 24% at 3 years. OS rates were 72% at 6 months, 39% at 1 year, and 24% at 3 years. The median time to death was 7.5 months (range, 1 – 74; mean 12.9 mo) with primary disease as the most common cause of death (5/18 pts; 28%). At the time of analysis, 4 pts (22%) were alive with a maximum survival of 58 months (range, 28 – 58 mo). Conclusions: A significant portion of DLBCL patients had durable responses after alloHCT with 24% of patients alive at 3 years, despite high rates of GVHD and a broad range of disease status. As novel therapies continue to emerge, alloHCT should still be considered in specific populations of relapsed and refractory DLBCL.