bluuebunny/crossref_metadata_2025_split huggingface dataset:
The effect of aroma lymphatic tressage for lower extremity edema associated with the taxane chemotherapy in patients with breast cancer: A phase 2 clinical trial.
Authors: Kim Ju Won , Ha Yang Sun , Lee Ji Yoon , Yang Jae Hee , Lee Min Jae , Lee Eun Young , You Ji Young , Jung Seung Pil , Park Kyong Hwa 
Published: June 2022

e24099 Background: Taxane-associated lower extremity edema is a distinctive adverse effect of taxane, which severely compromise patients’ quality-of-life. Aroma lymphatic tressage (ALT) has been established as a complementary technique that uses a combination of aromatherapy and hand massage to relieve distress and modulate lymphatic drainage in cancer patients. This study aimed to evaluate the symptom-relieving efficacy of a short course ALT on taxane-induced lower extremity edema. Methods: Patients treated with taxane-based chemotherapy for early or advanced stage breast cancer were screened for the study. Patients were enrolled when they presented more than CTCAE G3 of lower-extremity edema. A total of 8 sessions of ALT were applied twice a week for 4 weeks after completing taxane. The primary endpoint was to determine the leg circumference change before and after receiving ALT. Patients’ subjective degree of edema, and quality-of-life were also assessed. Results: A total of 37 patients completed all sessions of planned treatment. All of the participants were female, with the median age of 55.4-years-old. 30.8% of them were premenopausal. The median height of the patients was 157.6cm, median weight was 60.9kg, and median BMI was 1.6kg/m2. Most of the patients received docetaxel (87.2%). The baseline thigh, calf, and ankle circumferences were 56.5cm, 37.4cm, and 22.6cm, each. After 8 sessions of ALT, the median circumferences decreased to 54.7cm, 36.2cm, and 21.9cm. 23 (62.2%) participants experienced a 3% or more reduction in circumference change with a month of ALT. Patients’ subjective degree of edema decreased 56.9% for 4 weeks compared to baseline, while mean body weight decreased from 62.6kg to 61.2kg. All the differences before and after the ALT were statistically significant (p-value < 0.0001) Most of the indicators assessing patients’ quality-of-life improved during the ALT periods, especially physical subscale (from 14.8 to 19.1, p-value < 0.0001). EORTC-QLQ-C30 score also improved from 70.8 to 57.1 (p-value < 0.0001). Conclusions: To our knowledge, this is the first clinical trial to evaluate clinical efficacy of ALT on taxane-associated lower extremity edema. Patients who received ALT after taxane-based chemotherapy presented significant decline of leg circumference and improvement of QoL.
Updated FDA pooled analysis of pain medication use in trial participants with HR+, HER2-negative metastatic breast cancer treated with endocrine therapy and a CDK 4/6 inhibitor.
Authors: Gao Jennifer J , Girvin Andrew , Hodgdon Christine , Osgood Christy , Ison Gwynn , Bhatnagar Vishal , Kluetz Paul Gustav , Pazdur Richard , Amiri-Kordestani Laleh , Beaver Julia A. 
Published: June 2022

e24101 Background: Pain medications (PMs) are commonly used to treat pain in patients with advanced or metastatic breast cancer (MBC). We previously reported an initial analysis of PM prescribing patterns in clinical trial participants with breast cancer receiving CDK 4/6 inhibitor (CDKI)-based treatment. We present an updated analysis here. Methods: We pooled data from 7 randomized controlled trials of CDKI + endocrine therapy (ET) in patients with HR+, HER2-negative MBC. All analyzed patients received at least 1 dose of CDKI/placebo+ET and a concomitant PM with a documented start date. Medications administered during hospitalizations were not included. We looked at PM use in all patients, patients who took PM only before or after the trial started, and those who took PM both before and during the trial. PMs were categorized as opioid (includes codeine-containing), NSAIDS, or other (i.e. bone-directed, antiepileptic, topical PMs). Results: 4200 patients enrolled across the 7 trials who received at least one dose of CDKI/placebo+ET (n = 2616 CDKI, n = 1548 placebo). Of these, 2881 took a PM at any time (n = 1774 CDKI, n = 1107 placebo). Of the 1774 patients who received CDKI+ET, 487 (27%) took at least one opioid and one NSAID at any time, 782 (44%) took at least one NSAID at any time but no opioids, 244 (14%) took at least one opioid at any time but no NSAIDs, and 261 (15%) took only PM that were not opioids or NSAIDs. Of the 1107 patients who received placebo+ET, 297 (27%) took at least one opioid and one NSAID at any time, 490 (44%) took at least one NSAID at any time but no opioids, 153 (14%) took at least one opioid at any time but no NSAIDS, and 167 (15%) took only PM that were not opioids or NSAIDs. Of the 2881 patients who took a PM at any time, 2038 patients (n = 1222 CDKI, n = 816 placebo) had documented start for their PM. Of these, 544 took PM only before the trial started (n = 334 CDKI, n = 210 placebo), 915 took a PM only during the trial (n = 551 CDKI, n = 364 placebo), and 579 took a PM both before and during the trial (n = 337 CDKI, n = 242 placebo). Overall, more patients took NSAIDs only compared to opioids only. Patient characteristics at baseline were balanced between the two arms. Conclusions: Overall, PM prescribing patterns were similar between the arms. NSAID use was higher than opiates in all groups. These findings are hypothesis generating and additional research is needed to determine the impact of PM on participants’ pain and physical function. Further research should include an understanding of the duration of PM needed in patients with MBC.
Palliative specialty care availability for adults in community oncology practices.
Authors: Statler Tiffany M. , Dressler Emily Van Meter , Klepin Heidi D. , Weaver Kathryn E. , Gabbard Jennifer 
Published: June 2022

e24110 Background: The American Society of Clinical Oncology recommends integration of palliative care in patients with advanced cancer. Studies have shown the availability of palliative care services, especially in outpatient settings, varies widely across practice sites; factors associated with outpatient palliative care clinic availability remain unknown. Our study describes the presence and characteristics of palliative care resources in community oncology practices. Methods: Analyses used data from the 2015 Cancer Care Delivery Research (CCDR) Landscape Assessment of National Cancer Institute Community Oncology Research Program (NCORP) practices (funding support provided by 2UG1CA189824). Oncology practices were surveyed regarding availability of specialty providers and supportive services, including palliative care, as reported by designated CCDR leads. Descriptive statistics describe availability of providers and services, and logistic regression models identify practice characteristics associated with supportive/palliative care specialist availability. Results: 216 non-pediatric exclusive NCORP practice groups were included in analyses. Characteristics are shown in Table. A majority of practices had palliative care specialists (76%), oncology certified nurses (95%), and advance practice providers (80%); 45% had nurse navigators for oncology. 76% of practices had inpatient palliative care consultation services, but only 36% had a dedicated outpatient palliative care clinic. Multivariable analyses demonstrated practices with Medicaid and/or uninsured patient volumes > 25% (Odds Ratio (OR) = 2.5, p = 0.020), more oncology providers (OR = 1.02, p = 0.025), survivorship clinic availability (OR = 2.5, p = 0.005), and who participated in the Quality Oncology Practice Initiative (QOPI) (OR = 2.0, p = 0.039) were significantly more likely to have an outpatient palliative care clinic. Conclusions: Most community oncology practices reported having palliative care specialists, although only a third had a dedicated outpatient palliative care clinic. Newly discovered factors associated with increased odds of having an outpatient palliative care clinic can inform future efforts to expand the availability of outpatient palliative care clinics within community oncology practices.[Table: see text]
Bone-targeting agent utilization among lung cancer patients with bone metastasis in Taiwan.
Authors: Shih Jin-Yuan , Chen Tom Wei-Wu , Lin Hui-Min Diana , Yang Yea-Harn , Chen Wei-Ju , Chan K. Arnold 
Published: June 2022

e24111 Background: Bone is a common metastatic site among patients with advanced lung cancer. With new treatments available to improve survival of lung cancer and in all likelihood to change the natural history of disease, the diagnosis and management of bone metastasis (BM) may be of increasing clinical relevance. This study aimed to describe the management of BM using bone targeting agents (BTA) among lung cancer patients in Taiwan. Methods: A retrospective cohort of lung cancer patients with BM from 2004 through 2016 was identified using Taiwan National Health Insurance (NHI) data and Taiwan Cancer Registry. Diagnosis codes of International Classification of Disease 9th revision (ICD-9: 198.5) and ICD-10 (C79.51 and C78.03) were used to define BM. Patients were followed from the time of BM diagnosis till death or the end of study period (2017/12/31). We ascertained demographic information and BTA use among these patients. Two classes of BTAs were included: bisphosphonates (zoledronic acid (ZA), pamidronate, and clodronate) and denosumab. Results: A total of 44,800 patients with lung cancer and incident BM diagnosis were identified during the study period. Median age at the time of BM diagnosis was 67 years (25th and 75th percentile: 57-76), with 58.2% male (n = 26,058). The annual number of lung cancer patients with incident BM increased from 2,814 in 2004 to 3,829 in 2016, while the proportion of these patients receiving any BTA during the follow-up ranged from 25.2% to 34.8% annually. Clodronate and pamidronate were the common BTA prescriptions, whereas denosumab became the most frequently prescribed BTA after reimbursement by NHI since 2015. Among patients who initiated BTA after BM diagnosis (n = 10,879), the median time from BM diagnosis to BTA initiation ranged from 31 to 152 days by initial BTA type. More than half of them received more than one dose (56.3%, n = 6,126), with median numbers of doses received as 3, 4, 6 and 6 for ZA, pamidronate, clodronate and denosumab, respectively. Conclusions: A large population of patients with lung cancer were diagnosed with BM every year. However, overall, we observed only a small proportion of eligible patients receiving a BTA and a delayed initiation of BTA, indicating suboptimal treatment for lung cancer patients with BM in Taiwan.[Table: see text]
Feasibility and acceptability of measuring psychosocial outcomes for primary brain tumor patients and caregivers in a neuro-oncology clinical setting.
Authors: Body Anjelica , Ernster Alayna , Quinones Rebecca , Deleyrolle Phuong , Tran David Dinh , Rahman Maryam , Sampson Deborah , St. Clair Jennifer , Ghiaseddin Ashley Parham , Pereira Deidre B. 
Published: June 2022

e24131 Background: A primary brain tumor (PBT) is a distressing diagnosis that impacts the psychosocial well-being of patients and caregivers. Validated questionnaires are useful to assess PBT patient and caregiver psychosocial outcomes. However, it is unknown whether it is feasible to assess these outcomes in a routine clinical setting. This study evaluated the feasibility of assessing psychosocial outcomes for PBT patients and caregivers at the UF Health Neuro-Oncology clinic. Methods: 171 participants (100 PBT patients, 75 with malignant glioma; 71 caregivers) completed a battery of questionnaires to assess psychosocial outcomes during routine clinical appointments. At the end of the battery, a Participant Experience Form (PEF) assessed participant perceptions about the overall experience of completing the battery on a 7-point Likert Scale. Based on criteria from Bowen and colleagues (2009), feasibility and acceptability of assessment procedures were conceptualized and operationalized by assessing: Acceptability (80% of participants will have an average score ≥ 4 on the PEF); Practicality (average time of completion will be < 35 minutes); and Implementation (80% of participants will complete the entire battery). Descriptive statistics were used to assess these outcomes. Results: Patient and caregiver scores of feasibility and acceptability outcomes were as follows: Acceptability (Average PEF score: patients = 5.75 [ SD= 0.95]; caregivers = 5.96 [ SD= 0.83]); Practicality (Average time to complete (minutes): patients = 28.7 [ SD= 11.68]; caregivers = 26.0 [ SD= 12.01]); Implementation (% of participants that completed entire battery: patients = 88.0; caregivers = 84.5). Conclusions: The results indicate that assessing psychosocial outcomes in a routine clinical setting for PBT patients and caregivers was feasible, acceptable, and practical. Future research will use this battery to evaluate longitudinal psychosocial outcomes for this population in a clinical setting.
Exploring the characteristics of dignity loss in patients with cancer in North China.
Authors: Wang Long , Guo Qiaohong , Zuo Jing , Wang Yudong , Feng Li , Zhou Xinliang , Fan Zhisong , Zhang Xue , Han Jing , Liu Jiayin , Li Dan , Hu Xinyan , Liu Wei 
Published: June 2022

e24132 Background: Patients with cancer experience different degrees of loss of dignity. Exploring the characteristics of dignity loss for patients with cancer is rare in China, but it is of great significance for patients and their families in the whole anti-cancer trajectory. Methods: Inpatients and outpatients with cancer from the Fourth Hospital of Hebei Medical University were enrolled in this study. The Patient Dignity Inventory(PDI) and EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) was used for measuring patients’ dignity loss and quality of life. Spearman’s correlation analysis was conducted to analyze the correlation factors of dignity loss, and the correlation among dignity loss, quality of life and its dimensions. Results: A total of 403 patients with cancers were included in this study. In terms of loss of dignity, 20 patients (4.96%) didn’t report loss of dignity, 295 patients (73.20%) had mild loss of dignity, 78 (19.35%) had moderate and 10(2.48%) had severe loss of dignity. The three most prevalent PDI problems of patients were “experiencing physically distressing symptoms”(146, 36.23%), “Feeling that I am a burden to others” (126，31.27%) and “worrying about future” (114, 28.29%) . Companionship(r = 0.167, P = 0.001), PS(r = 0.392, P < 0.001), diagnosis to investigation time (r = 0.107, P = 0.031), stage of disease (r = 0.279, P < 0.001), stage of treatment (r = 0.333, P < 0.001), surgery and recurrence (r = 0.158, P = 0.001), anxiety (r = 0.612, P < 0.001), depression (r = 0.603, P < 0.001), psychological distress (r = 0.453, P < 0.001), symptom burden (r = 0.421, P < 0.001) and impact on life (r = 0.450, P < 0.001) were positive correlated with loss of dignity. Age (r = -0.134, P = 0.007), occupation (r = -0.124, P = 0.013) were negative correlated with loss of dignity. Loss of dignity and quality of life are significant correlated with each other. Dignity existential distress showed moderate negative correlation with emotional function (r = -0.513, P < 0.001). Dignity symptom distress showed moderate negative correlation with emotional function (r = -0.675, P < 0.001) and social function (r = -0.515，P < 0.001). Dignity symptom distress showed moderate positive correlation with fatigue symptoms (r = 0.541, P < 0.001). Conclusions: Most cancer patients’ dignity were impaired slightly or moderately in North China. Dignity of cancer patients showed significant association with quality of life. Anxiety and depression were more consistent with dignity than other factors. Improving the quality of life and dignity of patients is vital.
Levering internet-based discussion data from gynecological cancer survivors to inform survivorship care: A mixed methods thematic analysis approach.
Authors: Adams Elizabeth , Tallman David , Haynam Marcy , Nekhlyudov Larissa , Lustberg Maryam B. 
Published: June 2022

e24143 Background: Internet and social media platforms offer insight into the experience of survivorship, but the volume of narrative data is often cumbersome for thorough thematic analysis. We present a semi-automated mixed methods approach to analyze web-based discussions and demonstrate its utility on American Cancer Society (ACS) Discussion Board posts from gynecologic cancer survivors. Methods: Posts from the ACS Ovarian Cancer, Uterine Cancer, and Other Gynecological Cancer Discussion Boards were analyzed for psychosocial themes described in the Cancer Survivorship Care Framework. Quantitative analysis was facilitated by verified keywords created for each theme of interest and was completed via custom Python scripts and R packages. Qualitative analysis was expedited by theme keywords and completed on a subset of posts. Results: A total of 125,498 posts made by 6,436 gynecological cancer survivors and caregivers between July 2000 and February 2020 were evaluated. Of all posts, 23,458 were related to psychosocial aspects of survivorship and were analyzed. Quantitative analysis revealed that survivors frequently discussed the role of friends and family in care, fatigue, health insurance issues, and the effect of cancer on loved ones. The most frequently used psychosocial-related words were “family,” “hope,” and “help.” Qualitative analysis demonstrated that survivors frequently discussed coping and caregiver relationships, where survivors sought advice on topics including spousal emotional adjustment, financial toxicity, and confronting mortality. Conclusions: Online platforms offer great opportunity to learn about patient experiences of survivorship care. Candid conversations between survivors may be leveraged to inform survivorship practices and improve future survivorship initiatives. Our novel methodology expedites thematic analysis of such robust narrative data and its translation into survivorship settings.
Automated assessment of illness and treatment understanding (ITU) via the Memorial Sloan Kettering Patient Portal.
Authors: Epstein Andrew S. , Bernal Camila , Romano Danielle R. , Goldberg Jessica , Desai Anjali V. , Nelson Judith Eve 
Published: June 2022

e24146 Background: Patient-reported outcome (PRO) technology offers opportunities to address research questions and unmet clinical needs of cancer patients’ ITU. We tested the feasibility of PRO assessment of ITU. Methods: With the same 5-item questionnaire (2 open- [about expectations of cancer outcome and treatment intent] and 3 validated [Weeks JC NEJM 2012] closed-ended items) administered by medical oncology nurses in clinic in a previous pilot (Shin P ASCO 2020), we used the electronic patient portal in our cancer center to elicit responses from all gastrointestinal medical oncology patients scheduled for clinic follow-up. Patients registered on the portal received this questionnaire automatically the day before the second follow-up visit and then quarterly, with a brief explanation that it applied to all patients for quality improvement. Responses were available for review in the electronic health record by all oncology team members, who were offered a 20-minute Zoom introduction to this initiative. Workflow and content of communications about prognosis, treatment intent, and goals of care stayed within clinicians’ discretion. Results: From 5/2021 through 12/2021, 5000 questionnaires were sent to 3852 patients (1-3 times per patient, quarterly), of which all but one was returned, including 3863 with open- and closed-ended responses and 1135 with closed answers only. Patients: 55% male, 83% white, median age 64 (range, 15-96). Most common cancers: colorectal (54%) and pancreatic (21%). In patients with stage data (78%), 35% had stage IV disease. In closed-ended responses, patients receiving treatment (n = 2637 questionnaires) reported that based on the most recent discussions with the oncology team, they thought the treatment was at least a little likely to cure the cancer (66%), prolong life (98%), and/or help with cancer-related problems (92%). Open-ended answers ranged in length from 0-1013 words (median, 6; IQR, 10). Conclusions: Almost all patients in this large, heterogeneous cancer center cohort participated in an automatic assessment system via electronic patient portal addressing questions about their understanding of prognosis and treatment goals. PROs, traditionally focused on symptoms, represent a promising mechanism for scaling structured assessment of patients’ understanding of the prognosis and intent of their treatment. Our future research will address: effects in other cancer types/care settings; temporal changes in sequential responses: associations with clinical factors (e.g., stage, symptoms, treatment, oncologist documentation of prognosis/treatment intent, healthcare delivery and outcomes including patient reports of the quality of clinician communication); open vs. closed-ended questions for assessing ITU; administration in-person vs. via portal; and perspectives of patients and clinicians on our assessment process.
EPIK-B5: A phase III, randomized study of alpelisib (ALP) plus fulvestrant (FUL) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA-mutated advanced breast cancer (ABC) progressing on/after an aromatase inhibitor (AI) with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i).
Authors: De Laurentiis Michelino , Costa Luis , Gligorov Joseph , Knop Ann , Senkus-Konefka Elzbieta , García-Sáenz José A. , Schmid Peter , Heniquez Aurelia , Serra Paolo , Reising Albert , Kuemmel Sherko 
Published: June 2022

TPS1109 Background: Endocrine therapy (ET) + CDK4/6i is standard of care for HR+, HER2− ABC; however, CDK4/6i resistance, in which the phosphatidylinositol-3-kinase (PI3K) pathway has a key role, remains challenging. Progression-free survival (PFS) for ≥ 2nd-line ET monotherapy post CDK4/6i is poor; prognosis may be worse in patients with a PI3KCA mutation. ALP (PI3K-α selective inhibitor and degrader) + FUL is approved by the European Medicines Agency (EMA) for HR+, HER2–, PIK3CA-mutated ABC after ET monotherapy. Outside the EMA, ALP + FUL approval includes post-CDK4/6i use. ALP + FUL has shown clinical activity and consistent safety in a small subpopulation in SOLAR-1 with prior CDK4/6i treatment (n = 9) and in BYLieve Cohort A (CDK4/6i + AI as immediate prior treatment; n = 121). The EPIK-B5 study aims to confirm the efficacy and safety of ALP + FUL in a larger population with HR+, HER2–, PIK3CA-mutated ABC with prior CDK4/6i + AI treatment. Methods: EPIK-B5 is a Phase III, randomized (1:1), double-blind, placebo-controlled study assessing the efficacy and safety of ALP (300 mg/d orally starting Cycle 1 Day 1 [C1D1]) + FUL (500 mg intramuscularly on C1D1 and C1D15, and D1 of subsequent cycles) in patients (N ≈ 234) with HR+, HER2–, PIK3CA-mutated ABC progressing on/after CDK4/6i + AI. Patients randomized to placebo + FUL can cross over to ALP + FUL after progression. Randomization is stratified by presence of lung and/or liver metastasis and prior CDK4/6i setting. Adult men or postmenopausal women with confirmed HR+, HER2–, PIK3CA-mutated ABC and ≥ 1 measurable lesion are eligible. The primary endpoint is PFS per blinded independent review committee assessment. Secondary endpoints include overall survival, overall response and clinical benefit rates, duration of and time to response, PFS by PIK3CA-mutation status in circulating tumor DNA, PFS on next-line treatment, time to definitive deterioration of ECOG status, quality of life (QoL), and safety and tolerability. Exploratory endpoints include biomarker analyses, additional QoL endpoints, and time to subsequent chemotherapy. Recruitment is ongoing, with enrollment planned over 2 years in 18 countries; completion of primary data collection is anticipated in 2026. Clinical trial information: NCT05038735; EUDRACT2021-001966-39.