Functional Assessment Of Cancer Therapy Research Articles

Subjective, but not objective, language functions predict fatigue in patients with lower-grade gliomas during longitudinal follow-up

Purpose To investigate the course of fatigue, subjective and objective language functions in patients with lower-grade gliomas during the first year of disease. Further, to examine if subjective and objective language variables predicted ratings of fatigue. Methods Fatigue was assessed with the Fatigue Severity Scale, subjective language with self-reported word-finding, expression of thoughts, reading and writing from the Functional Assessment of Cancer Therapy – Brain, and objective language with standardized tests. Mixed models were used to investigate changes in variables over time and predictors of fatigue. Results Twenty-three patients with gliomas (WHO 1–3) were included. Average ratings of fatigue did not change significantly, but altering patterns were observed. Subjective concerns about word-finding and expression of thoughts increased significantly during follow-up. The regression analyses showed that concerns about abilities to read and write significantly predicted fatigue. The results indicated that less concerns about reading and writing were associated with lower levels of fatigue. Conclusions Patients with lower-grade gliomas report fatigue and language concerns throughout the first year. Concerns about reading and writing call for careful consideration as they seem to provoke fatigue. The findings underline the importance of the patients’ perspective in treatment and follow-up.

Validity of a single-item indicator of treatment side effect bother in patients with head and neck cancer.

Patients with head/neck squamous cell carcinomas (HNSCC) experience significant tumor- and treatment-related side effects. No efficient summary measure capturing the totality of side effect burdencurrently exists. We examined associations between a single patient-reported outcome (PRO) item evaluating side effect bother (FACT GP5, "I am bothered by side effects of treatment") with overall side effects in HNSCC. We performed a retrospective secondary analysis of development of the Functional Assessment of Cancer Therapy (FACT) Head/Neck Symptom Index (FHNSI-10), which included completing FACT-HN (including Head/Neck Cancer Subscale (HNCS) and Trial Outcome Index (TOI)) and the pain intensity numeric rating scale (NRS). We calculated Spearman's correlations between GP5 and these measures of patient-reported global health, head/neck side effects, and pain intensity NRS. A correlation of > 0.4 was considered sufficient evidence of association. Ninety-seven patients completed baseline and 85 completed 3-month follow-up surveys. GP5 was highly correlated with FACT-HN total score (baseline r = 0.66, 3months r = 0.67) and FHNSI-10 (baseline r = 0.63, 3months r = 0.65). GP5 correlated with multiple FACT-HN subscales including FACT-G, physical well-being, functional well-being, HNCS, and TOI (range baseline r = 0.53-0.77, range 3months r = 0.49-0.77). Worsening GP5 score was associated with worsening overall HNCS (p = 0.002), worsening FHNSI-10 score (p < 0.001), and worsening mean pain intensity (p < 0.001). GP5 exhibited validity within HNSCC, exhibiting substantial correlations with a number of HNSCC-related PRO measures including FACT-HN and FHNSI-10. Worsening GP5 was associated with worsening HNCS, FHNSI summary score, and pain intensity. GP5 has promise as a summary indicator of symptom and side effect bother in HNSCC.

Overall side effect assessment of oxaliplatin toxicity in rectal cancer patients in NRG oncology/NSABP R04.

Regulatory guidance suggests capturing patient-reported overall side effect impact in cancer trials. We examined whether the Functional Assessment of Cancer Therapy (FACT) GP5 item ("I am bothered by side effects of treatment") post-neoadjuvant chemotherapy/radiotherapy differed between oxaliplatin vs. non- oxaliplatin arms in the National Surgical Adjuvant Breast and Bowel Project (NSABP) R-04 trial of stage II-III rectal cancer patients. The R-04 neoadjuvant trial compared local-regional tumor control between patients randomized to receive 5-fluorouracil or capecitabine with radiation, with or without oxaliplatin (4 treatment arms). Participants completed surveys at baseline and immediately after chemoradiotherapy. GP5 has a 5-point response scale: "Not at all" (0), "A little bit" (1), "Somewhat" (2), "Quite a bit" (3), and "Very much" (4). Logistic regression compared the odds of reporting moderate-high side effect impact (GP5 2-4) between patients receiving oxaliplatin or not after chemoradiotherapy, controlling for relevant patient characteristics. We examined associations between GP5 and other patient-reported outcomes reflecting side effects. Analyses were performed among 1132 study participants. Participants receiving oxaliplatin were 1.58 times (95% CI: 1.22-2.05) more likely to report moderate-high side effect bother at post-chemotherapy/radiation. In both arms, worse overall side effect impact was associated with patient-reported diarrhea, nausea, vomiting, and peripheral sensory neuropathy (p < 0.01 for all). This secondary analysis of R-04 found that GP5 distinguished between patients receiving oxaliplatin or not as part of their post-neoadjuvant chemoradiotherapy, adding patient-centric evidence on the reduced tolerability of oxaliplatin and demonstrating that GP5 is sensitive to known toxicity differences between treatments. GOV: NCT00058474.

Development and psychometric properties of the Functional Assessment of Cancer Therapy-Cutaneous T-Cell Lymphoma (FACT-CTCL).

Patients with Mycosis Fungoides (MF)/Sézary Syndrome (SS) can experience impacted health-related quality of life (HRQoL). To validate the CTCL-S, a novel subscale of the Functional Assessment of Cancer Therapy - General (FACT-G), in patients with MF/SS. Qualitative interviews were conducted with expert clinicians and MF/SS patients. Thematic analysis identified the most common concerns, and 19 items were selected.MF/SS patients were recruited from a single center. FACT-G, CTCL-S (collectively "FACT-CTCL"), Skindex29, and Visual Analogue Scale-Pruritis (VAS itch) were administered. A subset repeated FACT-CTCL and VAS itch after ≈2 weeks. Patient demographics and clinical characteristics were obtained via review of the electronic medical record.Psychometric properties were assessed. Internal consistency was estimated using Cronbach's alpha (α). Convergent and discriminant validity were assessed by comparing CTCL-S to disease stage, age, VAS itch, FACT-G, and SkinDex29. Exploratory factor analysis (EFA) was used to preliminarily assess CTCL-S dimensionality. Test-retest repeatability was summarized using intraclass correlation coefficient (ICC), within-subject standard deviation (wSD), and within-subject coefficient of variation. Seventy-two patients completed the initial survey, and 35 repeated the FACT-CTCL and VAS itch after ≈2 weeks. Two-thirds were male, most were white (78%). The majority (85%) had MF, 15% SS, and 75% early (stage IA-IIA) and 25% advanced (≥ stage IIB) disease. Preliminary EFA found a single predominant factor, supporting a hypothesis of unidimensionality of the CTCL-S. Internal consistency of the CTCL-S was high (α: 0.95 [95% CI: 0.93-0.96]). There was no significant change in CTCL-S average test-retest scores (ICC of 0.93 (p = 0.63)). CTCL-S was significantly lower in advanced vs early stage disease (median[IQR]: 34[26, 48] vs. 59[44, 68], p < 0.001) and strongly correlated with VAS itch (Spearman's r (rs): -0.70, 95% CI: -0.81, -0.55), FACT-G (rs: 0.77, 95% CI: 0.65, 0.85), and Skindex29 (rs: -0.90, 95% CI: -0.94, -0.84), supporting convergent validity. CTCL-S scores had little correlation with age (rs: 0.19, 95% CI: -0.05, 0.41, p = 0.12), supporting discriminant validity. The FACT-CTCL is a disease specific instrument for assessing HRQoL with high reproducibility and good performance in a cohort of patients with MF/SS.

The psychological impact of diagnosis of sinonasal, nasopharyngeal, and laryngeal cancers: a systematic review.

High risk of degraded quality of life and psychological distress is observed in patients diagnosed with sinonasal, nasopharyngeal, and laryngeal cancers, which could be caused by exposure to carcinogens in workplaces. This review aimed to investigate the psychological impact of diagnosis associated with the possible occupational etiology of such neoplasms and to explore the instruments that evaluate the quality of life (QoL), anxiety, and depression in these patients. Studies were considered for the review only if they described aspects of the psychological impact of the diagnosis of sinonasal, nasopharyngeal, and laryngeal cancers and reported results distinguished by the tumor site. The psychological impact was assessed in terms of health-related QoL, anxiety, and depression using reliable psychometric questionnaires administered at the time of diagnosis and 1 year later. In more than 5,900 records identified, 442 studies fulfilled the eligibility criteria and 436 were excluded after full-text screening, resulting in six studies to be finally included in the review. The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30), EORTC QLQ-H&N35, and Functional Assessment of Cancer Therapy (FACT) were used to evaluate the QoL, whereas the Hospital Anxiety and Depression Scale (HADS) and Center for Epidemiologic Studies Depression Scale (CES-D) questionnaires were employed to assess anxiety and depression. QoL scores were similar to those of the general population at the time of diagnosis and remained unchanged or slightly improved at 1 year since diagnosis. In contrast, a higher prevalence of anxiety and depression was observed compared with the general population, although the results were inconsistent across the very few studies identified. No study investigating the association between the potential occupational etiology and QoL or distress was found. Exploring the existing scientific literature on emotional distress in sinonasal, nasopharyngeal, and laryngeal cancer patients was prompted by concerns over the disfiguring nature of treatment and the additional emotional burden resulting from their occupational etiology. Unfortunately, neither a crucial element nor other risk factors (lifestyle, smoking, drinking, etc.) were examined in any study. Patients' employment history should be considered in order to assess the possible impact of believing they are affected by an occupational exposure disease in the evaluation of their psychological distress. This history would support evidence-based recommendations about dedicated psychological interventions.

Exercise and recovery after surgery in patients with breast cancer: An analysis of the literature

This review explores the impact of exercise on post-surgical recovery in breast cancer patients. Breast cancer, the most prevalent cancer globally, necessitates treatments beyond conventional modalities such as surgery, chemotherapy, radiotherapy, and immunotherapy. While exercise as an adjuvant therapeutic tool is not novel, it is generally accepted for improving cancer outcomes. Yet, it is not included in current treatment guidelines. This study reviews literature using the FACT-B (Functional Assessment of Cancer Therapy – Breast) tool to evaluate quality of life in breast cancer patients undergoing exercise interventions post-surgery. Despite mixed results, with some studies showing significant improvements and others indicating no notable benefits, the general consensus suggests potential advantages of integrating structured exercise programs into recovery protocols. Standardizing the use of quality of life measures like FACT-B could enhance future research and clinical practices, leading to more effective patient care strategies.

Ablative Radiation Therapy to Restrain Everything Safely Treatable (ARREST): A Phase 1 Study of Stereotactic Ablative Radiation Therapy for Polymetastatic Disease

This phase 1 study aimed to assess the safety and feasibility of SABR therapy delivery to all sites of polymetastatic disease (>10 metastases). A 3 + 3 study design was used with 5 dose levels from 6 Gy (6 Gy × 1) to 30 Gy (6 Gy weekly × 5). Dose-limiting toxicity (DLT) was defined as any grade 4 or 5 toxicity or more than 3 grade 3 toxicities within 6 weeks of treatment. The primary endpoint was the maximal tolerated dose, defined as the dose level where ≥2/6 of patients experienced DLT. Secondary endpoints included quality of life (Functional Assessment of Cancer Therapy - General and European Quality of Life 5 Dimension 5 Level) at 6 weeks posttreatment, progression-free survival, and overall survival. Thirteen patients were accrued: 12 Gy (n = 3), 18 Gy (n = 3), 24 Gy (n = 4), and 30 Gy (n = 3), and 207 lesions were treated. Nine patients (69%) had acute toxicity: grade 1 (n = 6, 46%), grade 2 (n = 2, 15%; n = 1 pneumonitis and n = 1 fatigue), and grade 3 (n = 1, 7.7% neutropenia). There were no grade 4 or 5 toxicities. Mean ± SD quality of life (Functional Assessment of Cancer Therapy - General and European Quality of Life 5 Dimension 5 Level health state) was 80.4 ± 21.9 and 77.4 ± 20.9 at baseline versus 76.4 ± 21.8 and 68.0 ± 24.2 at 6-week follow-up, respectively (p = .009 and p = .055, respectively). With a median follow-up of 8.7 months posttreatment (IQR, 2.4-24 months), 8 of 13 patients had disease progression (62%). The median and 12-month progression-free survival were 3.6 months and 11.3%, respectively. The median and 12-month overall survival were 13.8 months and 62%, respectively. In this phase 1 trial, SABR therapy for polymetastatic disease was technically feasible with acceptable acute toxicity at dose levels up to 30 Gy (6 Gy weekly × 5). DLT was not observed.

Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials

AbstractBackgroundHot flashes are a common side effect of endocrine therapy (ET) that contribute to poor quality of life and decreased treatment adherence.MethodsPatients with breast cancer wo were receiving ET and experiencing hot flashes were enrolled through three parallel, randomized trials conducted in the United States, China, and South Korea. Participants were randomized to either immediate acupuncture (IA) or delayed acupuncture control (DAC). IA participants received 20 acupuncture sessions over 10 weeks, whereas DAC participants received usual care, then crossed over to acupuncture with a reduced intensity. The primary end point was a change in score on the endocrine symptom subscale of the Functional Assessment of Cancer Therapy (FACT)‐Endocrine Symptoms between baseline and week 10. Secondary end points included the hot flash score and the FACT‐Breast score. A planned pooled analysis of individual patient data was performed using longitudinal mixed models.ResultsIn total, 158 women with stage 0–III breast cancer were randomized (United States, n = 78; China, n = 40; South Korea, n = 40). At week 10, IA participants reported statistically significant improvements in the endocrine symptom subscale score (mean change ± standard error: 5.1 ± 0.9 vs. 0.2 ± 1.0; p = .0003), the hot flash score (−5.3 ± 0.9 vs. −1.4 ± 0.9; p &lt; .003), and the FACT‐Breast total score (8.0 ± 1.6 vs. −0.01 ± 1.6; p = .0005) compared with DAC participants. The effect of the acupuncture intervention differed by site (p = .005).ConclusionsAcupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer‐specific quality of life in women undergoing ET for breast cancer in the United States, China, and South Korea.

PCR254 Evidence To Support the Use of the Functional Assessment of Cancer Therapy – General Item GP5 (FACT-GP5) To Assess Comparative Tolerability Endpoint: Results From the LIBRETTO-531 Trial

PCR254 Evidence To Support the Use of the Functional Assessment of Cancer Therapy – General Item GP5 (FACT-GP5) To Assess Comparative Tolerability Endpoint: Results From the LIBRETTO-531 Trial

Multi-site randomized trial of a collaborative palliative and oncology care model for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) receiving non-intensive therapy.

LBA6508 Background: Patients with AML and high-risk MDS receiving non-intensive chemotherapy have substantial quality of life (QOL) impairments and often do not engage in timely discussions with their clinicians about their end-of-life (EOL) care preferences. Yet interventions to optimize EOL care delivery and QOL for this population are lacking. Methods: We conducted a multi-site randomized clinical trial of a collaborative palliative and oncology care model compared to usual care in 115 adult patients with AML and high-risk MDS receiving non-intensive therapy at two tertiary care academic hospitals. Patients with a new diagnosis or relapse/ refractory disease were eligible to participate within 30 days of initiating therapy. Patients assigned to the intervention met with a palliative care clinician monthly in the outpatient setting and a minimum of twice weekly during every hospital admission. Patients assigned to usual care were seen by palliative care only upon request. We used Natural Language Processing methods to interrogate the Electronic Health Record (EHR) with a validated algorithm to collect documented EOL care preferences. The primary outcome was to compare time from documentation of EOL care preferences to death between the study arms. Secondary outcomes obtained from the EHR include rates of documentation of EOL care preferences, hospitalization, and hospice utilization at the EOL. Patient-reported secondary outcomes include discussions with clinicians about EOL care preferences, QOL (Functional Assessment of Cancer Therapy – Leukemia), and psychological distress (Hospital Anxiety and Depression Scale) at 3 months after enrollment. Results: We enrolled 51.8% (115/222) of eligible patients. The rate of documented EOL care discussions in the EHR was higher among intervention patients vs. usual care (96.5% vs. 68.4%, P&lt;0.001). Overall, 61.7% (71/115) of patients died, and those receiving the intervention had a longer time from documentation of EOL care preferences to death (41 days vs. 1.5 days, P&lt;0.001). Intervention patients were more likely to report discussing their EOL care preferences with their clinicians (56.9% vs. 14.0%, P&lt;0.001), and less likely to be hospitalized in the last 30 days of life (70.6% vs. 91.9%, P=0.031). There was no difference in hospice utilization at the EOL. At 3 months, patients assigned to the intervention reported better QOL (138.6 vs. 125.5, P=0.010), but no difference in depression or anxiety symptoms compared to those assigned to usual care. Conclusions: Palliative care significantly improved rates of discussion and documentation of EOL care preferences, reduced hospitalization at the EOL, and improved QOL in patients with AML and high-risk MDS. Clinical trial information: NCT03310918 .

Influence of Music Therapy on the Improvement of Perceived Well-Being Indices in Women with Breast Cancer Undergoing Hormonal Treatment

ABSTRACT Background Although there are a growing number of studies investigating the benefits of music therapy interventions with patients diagnosed with cancer, few studies have taken an approach that specifically examines indices of perceived well-being in women with breast cancer. Overcoming these challenges can be an important step in the recovery process. Purpose The purpose of our study was to know the positive influence of responsive music therapy through gong sounds, emitted live, on different areas of well-being of women with breast cancer. Methods Four individual sessions of responsive music therapy with live gong sounds were conducted in which three women (M = 54; SD = 5.57) participated both in the music therapy program and in the completion of the Functional Assessment of Cancer Therapy – Breast (FACT-B) and a semi-structured interview with ad hoc designed questions about perception of qualitative aspects. Results The results showed that the music therapy sessions significantly improved, p = .043 < 0.05, various domains of perceived well-being in women with breast cancer. Discussion This article highlights several key benefits associated with music therapy and various indices of well-being in women with breast cancer, identifies the limitations of the study, and discusses the findings. It is considered necessary to replicate this practice in future studies that include a larger sample and age range over longer follow-up periods. Translation for Health Education Practice The text highlights the importance of considering music therapy as a complementary intervention in comprehensive cancer care programs, which may be relevant to health educators when considering intervention and support approaches for cancer patients. Health education interventions targeting the enhancement of cancer patients’ well-being should incorporate music therapy techniques.

Combined Effects of Physical Activity and Diet on Cancer Patients: A Systematic Review and Meta-Analysis.

The purpose of our systematic review was to examine the effects of any physical activity/exercise intervention combined with any diet/nutrition intervention on any biological/biochemical index, quality of life (QoL), and depression in breast, lung, colon and rectum, prostate, stomach, and liver cancer patients and/or cancer survivors. A systematic review and meta-analysis were undertaken, using PRISMA guidelines and the Cochrane Handbook. The systematic review protocol can be found in the PROSPERO database; registration number: CRD42023481429. We found moderate-quality evidence that a combined intervention of physical activity/exercise and nutrition/diet reduced body mass index, body weight, fat mass, insulin, homeostatic model assessment for insulin resistance, C-reactive protein, triglycerides, and depression, while it increased high-density lipoprotein, the physical component of QoL, and general functional assessment of cancer therapy. We conclude that a combined intervention of physical activity/exercise and diet/nutrition may decrease body weight, fat mass, insulin levels, and inflammation, and improve lipidemic profile, the physical component of QoL, and depression in cancer patients and survivors. These outcomes indicate a lower risk for carcinogenesis; however, their applicability depends on the heterogeneity of the population and interventions, as well as the potential medical treatment of cancer patients and survivors.

Retrospective analysis of peripheral neuropathy in blood cancer survivors evaluated for cellular therapy.

12087 Background: Blood cancer survivors (BCS) sustain peripheral neuromotor decline from toxic therapies but also aging, diabetes and cancer. Peripheral neuropathy (PN) threatens balance and quality of life, and pre-existing nerve deficits raise future PN risk. The evaluation for cellular therapies is an opportunity to identify functional deficits and optimize their management before additional toxic exposures or disease progression. PN is often diagnosed by paresthesias, but toe strength and sensory deficits also impact balance. We aim to quantify the prevalence of these 3 PN manifestations and walking difficulty in BCS evaluated at our center for possible cellular therapies and compare BCS with and without paresthesias. Methods: We retrospectively analyzed clinical data from 5 years of physical therapy (PT) evaluations during the medical assessment for cellular therapy. As count (%) or mean ± SD we described foot paresthesias [Functional Assessment of Cancer Therapy (FACT) Item NTX2], hallux extension weakness (Medical Research Council Grade ≤4 either side), hallux vibration deficit (biothesiometer ≥24.7 V), and reported trouble walking (FACT An6). We then dichotomized the cohort by NTX2 and compared groups with Chi-square, Fisher’s exact or Wilcoxon rank sum tests. Results: 598 (87.6%) of 683 BCS evaluated by PT had FACT data (79.1% White, 5.5% Latinos); 1 in 2 BCS reported paresthesias, 71.2% as moderate-severe. See table for group comparisons. Race (p=.654) &amp; ethnicity (p=.608) were n.s. 506 BCS with FACT (84.6%) had both strength and sensory data; we found ≥ 1 hallux deficit in 396 (78.3%), more commonly with paresthesias (86.3% vs. 69.5%, p&lt;.001). Conclusions: At cellular therapy evaluation, 1 in 2 BCS reported foot paresthesias, and 3 in 4 had strength or sensory hallux deficit. Regardless of the cause, these deficits could contribute to the trouble walking reported by 44%. BCS with paresthesias were older and had more myeloma, diabetes, chemotherapy, hallux deficits, and trouble walking. But trouble walking and hallux deficits were also common without paresthesias. Research is needed to quantify hallux-gait relationships in BCS, and to establish the highest-value rehabilitative approaches to improve strength and walking before further toxic exposures. [Table: see text]

Comparative patient-reported tolerability (PRT): A multiplicity-controlled analysis of LIBRETTO-531, a randomized controlled trial (RCT) in medullary thyroid cancer (MTC).

11111 Background: In cancers with longer natural histories, progression free survival (PFS) alone may not adequately capture the impact of treatment side effects (SE) and may, therefore, be complemented by robust measures of patient-reported tolerability (PRT) to quantify overall SE burden. Here, we pioneer the use of a novel, scalable, quantitative PRT metric as a key secondary endpoint to support the regulatory review and inform clinical decision-making of selpercatinib use in LIBRETTO-531 (NCT04211337), an RCT that demonstrated the PFS benefit (HR=0.28) of selpercatinib over vandetanib/cabozantinib (control) in RET-mutant MTC. Methods: We first assessed PRT using the single Functional Assessment of Cancer Therapy (FACT) item GP5, asking patients to rate “bothered by treatment side effects” from 0 to 4. Patients who reported “3=quite a bit” or “4=very much” on GP5 were classified as “high SE bother,” a validated meaningful cutoff for treatment SE burden. In a second pre-specified step, PRT was defined as the proportion of time on treatment (PTOT) with “high SE bother” and was compared between selpercatinib vs. control arms in the tolerability evaluable population. PRT was tested at a 1-sided significance level of 0.025, conditional on achieving statistical significance for PFS and treatment failure-free survival by BICR. To complement PRT, other patient-reported outcomes including health-related quality of life (HRQoL, using EORTC QLQ-C30) and symptomatic adverse events (AEs; using PRO-CTCAE) were evaluated. We calculated the PTOT that patients reported clinically meaningful impairment of HRQoL (using pre-specified cutoff scores) and highly symptomatic AEs (scores of 3 or 4). Results: Patients on selpercatinib (n=161) had a significantly better PRT (lower PTOT with high SE bother) than control (n=81) (8% vs. 24%, p&lt;.0001). Sensitivity analyses using different cutoffs for high SE bother showed consistent results (p&lt;.0001). On QLQ-C30, patients on selpercatinib reported significantly less PTOT with HRQoL impairment across physical (36% vs. 52%), role (2% vs. 11%), cognitive (4% vs. 8%), emotional (6% vs. 11%), and social (2% vs. 8%) functions (all p&lt;0.01) vs. control. On PRO-CTCAE, patients on selpercatinib reported significantly less PTOT with diarrhea (5% vs. 38%), fatigue (6% vs. 21%), taste change (3% vs. 15%), decreased appetite (2% vs. 15%), hand/foot syndrome (2% vs. 9%) (all p&lt;.001) vs. control. Conclusions: Through the incorporation of a novel, single question and quantifiable metric that measured time on treatment under high SE bother into the LIBRETTO-531 study, we demonstrated superior PRT and improved PFS for selpercatinib in patients with RET-mutant MTC versus vandetanib/cabozantinib. This simplified PRT metric deserves further adoption as a quantitative endpoint to complement PFS in future RCTs.

Fulvestrant with or without the cyclin-dependent kinase 7 (CDK7) inhibitor samuraciclib in advanced hormone receptor positive (HR+) breast cancer after CDK4/6 inhibition: Phase II SUMIT-BC study.

TPS1126 Background: CDK7 enhances oncogene transcription and upregulates anti-apoptotic genes, accelerates the cell cycle via CDK phosphorylation, and activates estrogen receptors (ERs) that can drive resistance to hormonal therapy in cancer. CDK7 inhibition therefore represents a potential anticancer strategy in cancer. Samuraciclib (CT7001) is a small molecule, ATP competitive, selective oral inhibitor of CDK7 that inhibits these key effects of CDK7. Samuraciclib had a favorable safety profile and showed clinical activity when combined with fulvestrant in a phase I study in patients with HR+/HER2− advanced breast cancer (BC) who had previously been treated with a CDK4/6 inhibitor. Patients with no detectable TP53 mutation in ctDNA at baseline and those without baseline liver metastases appeared to have better outcomes. The instant release capsule formulation of samuraciclib used in this study released large amounts of samuraciclib high in the gastrointestinal (GI) tract, which may have contributed to the observed low grade GI adverse events, which were managed with prophylaxis and counselling (1). Methods: A phase 2 open-label randomized study has been designed to evaluate the efficacy, safety, pharmacokinetics (PK), and quality of Life (QoL) of samuraciclib combined with fulvestrant compared to fulvestrant monotherapy (SUMIT-BC; NCT05963984). Eligible patients (n=60) are ≥18 years, have histologically or cytologically confirmed ER+/HER2− advanced or metastatic BC not amenable to resection or radiotherapy of curative intent, have received an aromatase inhibitor combined with a CDK4/6 inhibitor in the adjuvant or advanced setting, are receiving a luteinizing hormone-releasing hormone agonist if pre/perimenopausal, and have RECIST v1.1 evaluable disease. Prior SERD, mTOR inhibition, or chemotherapy for advanced BC are not permitted. All patients undergo baseline Guardant360 ctDNA analysis to establish TP53 and other mutation status. Patients are randomized 1:1:1 to fulvestrant alone (500 mg IM administered on days 1, 15 and 29 and then monthly), fulvestrant and samuraciclib 240 mg QD, or fulvestrant and samuraciclib 360 mg QD. In preparation for phase 3 development, a novel single tablet formulation of samuraciclib is used, which may enhance GI tolerability. Patients undergo RECIST v1.1 evaluation at baseline, every 8 weeks until week 48, and every 12 weeks thereafter. The primary endpoint is clinical benefit response at 24 weeks. Secondary endpoints are tolerability, progression free survival, overall response rate, duration of response, and PK of fulvestrant and samuraciclib. QoL (Functional Assessment of Cancer Therapy - Breast questionnaire [FACT-B]) and correlations between TP53 mutation and efficacy/safety will be assessed. 1. Coombes et al. Nature Comms 2023. Clinical trial information: NCT05963984 .

Effects of a pilot 12-week exercise program on breast cancer survivors’ quality of life.

e12525 Background: Previous studies have demonstrated that breast cancer survivors commonly experience a decrease in quality of life including an increased risk of depression, insomnia, cancer-related fatigue, and negative body image. Several studies have shown that exercise interventions, such as yoga, Pilates, water aerobics, and strengthening exercises can improve survivors’ quality of life. We implemented a 12-week exercise program in breast cancer survivors and evaluated quality of life changes. Here we discuss our findings evaluating 13 quality of life questionnaires. Methods: We evaluated 46 participants who completed a baseline and post 12-week questionnaire assessment. All participants underwent an exercise program 3 times/week for 90 minutes/session. We calculated differences in baseline and post 12-week quality of life through 13 questionnaires: Functional Assessment of Cancer Therapy - General (FACT-G) Physical, Social/Family, Emotional, and Functional, Social Support, Insomnia Severity Index, Brief Fatigue Inventory, Patient Health Questionnaire, and Body Image after Breast Cancer (BIBCQ) Vulnerability Scale (VS), Body Stigma Scale (BSS), Limitations Scale (LS), Body Concerns Scale (BCS), Transparency Scale (TS), and Arm Concerns Scale (ACS) and assessed the intervention's efficacy by comparing the baseline and post 12-week scores using paired t-tests. Results: The difference between baseline and post 12-week quality of life are presented in the Table. 7/13 questionnaires showed statistical significance: FACT-G Physical and Functional, Insomnia Severity Index, Brief Fatigue Inventory, Patient Health Questionnaire, and BIBCQ LS and BCS. Conclusions: Our study showed improvement in metrics evaluated in breast cancer survivors who underwent the personalized exercise program. Specifically, body image was improved with exercise which further exemplifies the impact of lifestyle changes on quality of life measures and is an important adjunct to future cancer survivorship studies. Clinical trial information: NCT04013568 . [Table: see text]

Physical activity and dexamethasone for cancer related fatigue: A preliminary placebo controlled randomized control trial.

12050 Background: Despite high frequency and significant impact on quality of life, there are limited treatment options available for cancer related fatigue (CRF) in patients with advanced cancer. The primary aim of the study was to determine the feasibility (adherence, safety, and satisfaction) of the combination therapy, physical activity (PA) plus Dexamethasone (Dex); and PA plus placebo (Pl) for CRF. The secondary aim was to explore the effects of PA+Dex, and PA+Pl on CRF as assessed by Functional Assessment of Cancer Illness Therapy–fatigue (FACIT-F). Methods: In this phase 2, randomized, double blind, placebo controlled trial, patients with advanced cancer with CRF ≥ 4/10 on Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks plus either 4mg of Dex (PA+Dex arm), or Pl (PA+PL arm) BID for the first 7 days. Changes in FACIT-F scores from baseline to Day 8, and Day 29 were assessed. Other outcomes included change in quality-of-life scores. Results: A total of64 (89%) patients were evaluable. The median (IQR) changes in FACIT-F scores at Day 8 and Day 29 from baseline were 9 (2,16), P&lt; 0.001; 5.75 (0,12.5), P=0.015 for PA+ Dex arm, and 3.5 (-2.13, 10), P=0.054; 6.50 (2.5, 15.5), P=0.006 for PA+ Pl arm respectively. Exploratory Linear Mixed Model (LMM) analysis showed significant treatment effect of PA +Dex, with treatment having improvement of 5.63 units for FACIT-F scores (95% Cl 1.74,9.52), P=0.005. Effect sizes for improvement of FACIT-F scores at Day 8 and Day 29 were -3.49, -2.43 in PA+Dex arm; and -1.93, -2.72 in PA+Pl arm, respectively. Effect sizes for change in fatigue related symptoms and quality of life scores as assessed by Patient-Reported Outcome Measurement Information System-Fatigue T-scores, Multidimensional Fatigue Symptom Inventory-Short Form total, and Functional Assessment of Cancer Therapy -General scores at Day 8, and Day 29 in PA+ Dex arm were 2.93 (P=0.005), 2.82 (P=0.005); 2.27 (P=0.023), 2.68 (P=0.007); -2.39 (P=0.017), -3.26 (P=0.001) respectively. Adherence to Dex and Pl were 91% and 92%, respectively, Satisfaction rates with PA+Dex and PA+Pl arms were 98% and 79%, respectively. There was no significant difference in grade ≥3 adverse events between the two arms (P = 0.36). Conclusions: Satisfaction, and tolerability to the combination therapy, and medication adherence was excellent.PA + Dex significantly improved CRF at day 8 and 29. The improvement was sustained 3 weeks after discontinuation of Dex. Further larger studies are justified. Clinical trial information: NCT03583255 .

Relationship between hope and quality of life in patients with advanced cancer in Uruguay: An observational analysis.

e24055 Background: International research suggests a beneficial effect of hope on quality of life in advanced-stage cancer patients. Specific evidence for Latin America and Uruguay is limited, highlighting the need to explore this relationship for regional clinical strategies. Objective: To evaluate the correlation between hope and quality of life in Uruguayan patients with advanced cancer. Methods: This observational, analytical-descriptive, and cross-sectional study used the Herth Hope Index (HHI) and the Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life questionnaire. It included 59 patients aged 18 or older, diagnosed with advanced, non-curable cancer. Results: There was a positive but non-significant correlation between HHI and FACT-G scores (Pearson coefficient of 0.05). Hope significantly correlated with support from oncology services (p = 0.044), family support (p = 0.003), and spiritual beliefs (p = 0.029). Factors like bone metastases, diagnostic delay, and being accompanied at consultations significantly impacted quality of life (p = 0.041, p = 0.035, p = 0.012). Conclusions: The study observed a positive association between hope and quality of life, but the lack of statistical significance indicates the need for more research. Clinically, results highlight the importance of comprehensive care addressing spiritual and emotional needs, in addition to medical treatment. It also underscores the potential impact of supportive services on patient well-being. Future research should include larger sample sizes and consider longitudinal designs to better understand hope's effects over time in advanced cancer patients.

Sexual satisfaction and its predictors in patients with advanced cancer and their family caregivers in six European countries: Baseline data from the DIAdIC study.

To identify predictors of sexual satisfaction in patients with advanced cancer and their family caregivers. Cross-sectional study using baseline survey data from a randomized controlled trial in six European countries. Patients with advanced cancer and their family caregiver completed measures on sexual satisfaction (one item from Functional Assessment of Cancer Therapy - General questionnaire for patients and Caregiver Quality of Life Index-Cancer scale for family caregivers) and health-related characteristics. Multivariable linear regressions were performed for all predictors (identified based on literature) with sexual satisfaction as dependent variable. The sample comprised 431 patient-family caregiver dyads. Patients with prostate or gynecological cancer reported lower sexual satisfaction (respectively B=-0.267 95% CI: -1.674, -0.594 and B=-0.196, 95% CI -2.103, -0.452). Higher emotional (B=0.278, 95% CI 0.024, 0.057) physical (B=0.305, 95% CI 0.012, 0.025) and social functioning (B=0.151, 95% CI 0.001, 0.013), global health (B=0.356, 95% CI 0.007, 0.013) and social wellbeing (B=0.161, 95% CI 0.013, 0.082) among patients were associated with higher sexual satisfaction. Among family caregivers, sexual satisfaction was lower with increased age (B=-0.142, 95% CI -0.022, -0.004). Higher emotional functioning (B=0.027, 95% CI 0.011, 0.043) and quality of life (B=0.165, 95% CI -0.165, 0.716) were associated with higher sexual satisfaction in family caregivers. The results underscore that sexual wellbeing of patients and family caregivers is related to health related factors in physical, emotional, and social domains. Patients and family caregivers could benefit from a dyadic approach to address sexual wellbeing.

An evidence-based breathing exercise intervention for chronic pain management in breast cancer survivors: A phase II randomized controlled trial

ObjectiveExplore the preliminary effects of a breathing exercise (BE) intervention on chronic pain among breast cancer survivors. MethodsThis two-parallel-arm, open-label pilot randomized controlled trial recruited 72 breast cancer survivors who were randomly allocated to either the control or intervention group (n = 36 each). Both groups received usual care and a pain information booklet, while the intervention group received 4 weeks of additional BE. The primary clinical outcome was measured using the Brief Pain Inventory (BPI), with secondary clinical outcomes measured by the Hospital Anxiety and Depression Scale (HADS), Quality of Life Patient/Cancer Survivor Version in Chinese (QOLCSV-C), and Functional Assessment of Cancer Therapy- Breast (FACT-B) immediately post-intervention and at 4-week follow-up. Both adjusted and unadjusted Generalized Estimating Equation models were utilized to assess the BE's potential effects, with safety assessed through participant self-report. ResultsSixty-eight participants completed the study. Statistical significance was observed in BPI in both adjusted and unadjusted models at post-intervention and follow-up (p < 0.05). BE demonstrated positive effects on anxiety, depression and quality of life improvement across all measures and timepoints in both adjusted and unadjusted models (p < 0.05). The effect sizes were smaller in the adjusted model. Three mild transient discomforts were reported associated with BE practice including dizziness, tiredness and yawning, without requirement of medical treatment. No severe adverse events occurred. ConclusionThis BE intervention appears effective in alleviating chronic pain, anxiety and depression, and improving quality of life for breast cancer survivors. Fully powered large-scale studies are required to confirm its effects.