Systemic Therapy Side Effects Research Articles

A systematic review of health-related quality of life outcomes in patients with advanced breast cancer treated with palbociclib.

Aim: To evaluate the impact of palbociclib treatment on health-related quality of life (HRQoL) in patients with hormone receptor-positive, human epidermal growth factor 2-negative advanced breast cancer (HR+/HER2- aBC) or metastatic breast cancer (mBC) in both the clinical and real-world setting. Materials & methods: A systematic literature review was conducted to identify clinical trials and real-world evidence studies up to June 2023 that reported HRQoL outcomes in patients with HR+/HER2- aBC or mBC treated with Palbociclib. Results: 15 unique studies reported across 35 records were identified. Of these, seven were randomized controlled trials (RCTs), three were single-arm clinical trials and five were real-world evidence (RWE) studies. HRQoL was generally found to be maintained in patients with HR+/HER2- aBC or mBC across RCTs, single-arm clinical trials and RWE studies. HRQoL measures across instruments, study types and line of therapy, were largely reported to be at least maintained if not improved from baseline among patients treated with palbociclib and were observed to be comparable or better in the palbociclib group versus monotherapy control arm in RCTs. Similar results were seen for treatment-related outcomes (e.g., sexual functioning, upset by hair loss, systemic therapy side effects etc.), and important individual patient outcomes, including pain, fatigue and physical functioning. Findings were also consistent across key clinical characteristics (visceral metastases, neutropenia), as well as patient populations often underrepresented in clinical trials (Asian patients, older adults). Conclusion: Overall, current evidence suggests that HRQoL is largely preserved with the addition of palbociclib to endocrine therapy in patients with HR+/HER2- aBC or mBC across study types and populations.

Immediate Psychological Implications of Risk-Reducing Mastectomies in Women With Increased Risk of Breast Cancer: A Comparative Study

BackgroundRisk-reducing mastectomy is recommended for high-risk patients but may have significant psychological consequences. This study aimed to determine the differences in anxiety, depressive symptomatology, body image and quality of life in women with an increased risk of breast cancer immediately before and after undergoing risk-reducing mastectomy. MethodsEighty-eight women with an increased risk of breast cancer due to BRCA1/2 mutations or a previous cancer diagnosis participated in this study. Instruments used were the Hospital Anxiety and Depression Scale, Body Image Scale and the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 and Breast 23, administered 15-30 days before and after surgery. ResultsFollowing surgery, there was an immediate and significant worsening in anxiety, depressive symptomatology and body image. There was a significant deterioration in global, physical, role, and social functioning, as well as in body image and sexual enjoyment scales. Additionally, there were increases in fatigue, nausea and vomiting, constipation, dyspnoea, insomnia, appetite loss, perceived financial difficulties, pain, systemic therapy side effects, and breast and arm symptoms. However, there was an improvement in future perspective. These changes occurred independently of whether participants had a cancer diagnosis or BRCA1/2 mutation. ConclusionRisk-reducing mastectomies have immediate psychological consequences. While these procedures improve future health perspective, they increase anxiety and depressive symptomatology and decrease body image and quality of life, regardless of cancer diagnosis or BRCA1/2 mutation. These findings highlight the psychological consequences of such surgical procedures, emphasizing the need for comprehensive psychological interventions both before and after surgery.

Comparison of the efficacy, safety and quality of life of pegylated liposomal doxorubicin-cyclophosphamide versus epirubicin-cyclophosphamide in patients with early stage HER2-negative breast cancer: A prospective, randomized, multicenter, Phase II study.

This multicenter, phase II randomized, non-inferiority study reports from the first prospective two-armed randomized control trial that compared the efficacy, safety and quality-of-life of pegylated liposomal doxorubicin (PLD)-based and epirubicin-based as adjuvant chemotherapy for stage I-II Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer. Patients with stage I/II HER2-negative breast cancer received PLD (37.5mg/m2, Q3W, 5 cycles, LC arm) plus cyclophosphamide (600mg/m2) or epirubicin (90mg/m2, Q3W, 4 cycles, EC arm) plus cyclophosphamide (600mg/m2). Randomization was stratified by lymph node, ER and PR status. The primary endpoint was disease-free survival (DFS), and secondary endpoints were overall survival (OS), safety profiles, and quality of life (QoL). QoL was assessed using the EORTC QLQ-C30 and QLQ-BR23 questionnaires. A total of 256 patients were assigned to LC (n=148) and EC (n=108). There was no difference in 5-year DFS and OS rate between two groups. LC-based adjuvant regimens had significantly less alopecia, less grade 3-4 hematologic adverse events (AEs). Significantly improved QoL was observed in the LC arm during and after treatment for symptoms including fatigue, nausea and vomiting, and systemic therapy side effects. Comparable efficacy and safety between adjuvant PLD and epirubicin for stage I-II HER2-negative breast cancer was observed. There was no difference in 5-year DFS and OS rate between the two treatment arms. However, less grade 3-4 AEs and a trend of favorable QoL symptom scales were observed in the LC arm, suggesting that PLD-containing regimen could become a new standard treatment for early stage HER2-negative breast cancer patients.

Symptom network and quality of life of breast cancer patients receiving multimodal cancer treatment: Cross-sectional study

PurposeBreast cancer patients experience symptoms and side effects from multimodal treatments, which often include menopausal symptoms resulting from cytotoxic chemotherapy or estrogen suppression therapy. This study aimed to explore the symptom network and clusters and its relationship to quality of life (QoL) in breast cancer patients who receive multimodal cancer treatment and experience treatment-related menopausal symptoms. MethodsA correlational study was conducted. Breast cancer patients receiving multimodal cancer treatment and experiencing treatment-related menopausal symptoms were included while they were receiving radiation therapy (N = 250). Symptoms, functions and QoL were assessed using the EORTC QLQ-C30 and BR45. Network analysis, principal component analysis, exploratory factor analysis, and multiple linear regression analysis were conducted. ResultsFatigue was the most central symptom in the symptom-only network as well as in the network consisting of symptoms and QoL. Fatigue, systemic therapy side effects, appetite loss, and cognitive symptoms demonstrated significant associations with QoL. The cancer and treatment related symptom cluster consisted of fatigue, cognitive symptoms, emotional symptoms and systemic therapy side effects. Breast cancer therapy-specific symptoms, such as arm symptoms, skin mucosis symptoms, and breast symptoms, formed a cluster with pain. ConclusionFatigue was the most central symptom in breast cancer patients receiving multimodal cancer treatment and experiencing menopausal symptoms. Evaluation of fatigue and providing interventions to manage fatigue would contribute to improvement of QoL of breast cancer patients receiving multimodal cancer treatments. Future network analysis and symptom cluster studies should specify the population of interest and the treatment phase using comprehensive symptom evaluation tools.

Immunotherapy related patient-reported outcomes from five randomized controlled trials in patients with triple negative breast cancer: A systematic review.

e23167 Background: Immunotherapy (IO) has improved clinical outcomes in patients with early-stage Triple Negative Breast Cancer (TNBC) receiving neoadjuvant therapy and certain patient subsets in the metastatic setting. This study aims to evaluate IO-related Patient-Reported Outcomes (PRO) in patients older than 65 years. Methods: We searched Medline ALL (Ovid), Embase (Elsevier), Cochrane Central (Wiley), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. The searches combined terms reflecting (1) the immune checkpoint inhibitors atezolizumab, durvalumab, and pembrolizumab; (2) breast cancer; and (3) randomized controlled trials. Results were limited to items published in English from 2013 through September 2023. We excluded review articles and clinical trial records without results. Two independent reviewers (C.S. and M.L.) screened the studies using the systematic review management tool Covidence, and conflicts were resolved by a third reviewer (W.I.Z.). We included studies that reported on PRO in adults with TNBC receiving any of the three immunotherapies of interest. Results: Five publications composed of two peer-reviewed papers and three abstracts were identified, including 3878 total patients and 3184 with PRO. Three pembrolizumab studies had 2643 total patients (2056 with PRO) and two atezolizumab studies (IMPASSION 130, IMPASSION 031) had 1235 total patients (1128 with PRO). The PRO analysis in KEYNOTE 522 included 1145 patients in the neoadjuvant phase and 847 in the adjuvant phase. The PRO analysis in KEYNOTE 355 included total 847 patients and 317 with Combined Positive Score (CPS) ≥10. No study specified PRO data for patients older than 65 years. Baseline completion rates for all studies were > 80%. All studies used standardized PRO instruments, including the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC- QLQ C30) and its Breast Cancer Module (QLQ-BR23), the Functional Assessment of Cancer-Therapy-General (FACT-G GP5), and the EuroQol-5 Dimension (EQ-D5). All studies showed no statistical difference, or clinical meaningful decline in PRO endpoints between patients who received chemo with IO versus chemo with placebo, during and post treatment follow up. The PRO analysis from KEYNOTE 119, which included total 594 patients of which 187 had CPS ≥10, demonstrated that patients receiving single agent chemotherapy had worse PROs related to systemic therapy side effects and hair loss while the pembrolizumab group had decreased worry about future health. None included subgroup analysis by age, including patients older than 65 years. Conclusions: Our systematic review demonstrates that in both early and advanced TNBC, IO did not worsen PRO. Prospective and retrospective data in IO-related PRO in older patient population are needed.

Uncommon Blepharitis

Blepharitis is a common chronic inflammatory condition affecting the eyelid margins; the pathophysiology of blepharitis is complex and not fully understood. The disease is anatomically divided into anterior (inflammation of eyelashes) and posterior (meibomian gland dysfunction) types. Diagnosis relies on clinical examination, revealing characteristic features like scurf, vascular changes, and meibomian gland dysfunction. The main goals of blepharitis treatment are symptom relief, recurrence prevention, and complication risk minimization. Treatment options include lid hygiene, topical and systemic antibiotics, topical corticosteroids, and omega-3 supplements. However, it is important to highlight reported cases of blepharitis as side effects of systemic therapies, particularly in the context of chemotherapy, bortezomib, cetuximab, TNFα inhibitors, and dupilumab. It is crucial to monitor patients undergoing such treatments regularly and attentively in order to promptly set up adequate supportive therapy. Of even more importance is future research on the pathophysiological mechanisms responsible for the occurrence of these ocular side effects in order to find a nosological cure for the issue.

The impact of CDK4/6 inhibitors on the quality of life of working-age women with metastatic breast cancer: a population-based cohort study from Portugal

Background Breast cancer frequently leads to reduced work capacity and increased absenteeism among working-age women diagnosed with this condition. In this study, we aimed to assess the effect of CDK4/6i combined with aromatase inhibitors (AIs) or fulvestrant on quality of life (QoL) and work activity in a cohort of Portuguese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who started this treatment regimen. Methods This unicentric prospective observational cohort study was conducted in 35 Portuguese women with stage IV HR+/HER2- breast cancer receiving CDK4/6i combined therapy. The objectives of the study were evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 version 3 (QLQ-C30) and the breast cancer-specific Questionnaire (EORTC QLQ-BR23), and the Work Productivity and Activity Impairment questionnaire - General Health (WPAI:GH) questionnaires at four different time points throughout treatment. Results The results obtained revealed a significant improvement in EORTC QLQ-C30 score from baseline in emotional functioning, social functioning, pain, dyspnea, insomnia, and financial difficulties, as well as in future perspective and breast symptoms, as assessed by EORTC QLQ-BR23 score. However, a significant deterioration from baseline in systemic therapy side effects was also observed. Despite the limitations regarding the cohort size, an increase in work absenteeism was also observed, as determined by WPAI:GH scores. This can possibly be attributed to pain-related bone metastases observed in those patients. Conclusions To the best of our knowledge, this is the first study to assess the impact of combined CDK4/6i therapy on the QoL and work activity of Portuguese patients with metastatic breast cancer. Our results indicate that although patients’ QoL did not appear to be affected, there was a significant decrease in work activity, as evidenced by preliminary results of the increased rate on work absenteeism.

Early Recognition and Management of Side Effects Related to Systemic Anticancer Therapy for Advanced Breast Cancer

ObjectivesAdvances in science and technology have meant there are numerous treatment options available for people with advanced breast cancer (ABC). However, each therapeutic approach can cause side effects or adverse events, which can significantly affect the person's quality of life, overall well-being, and, in some instances, safety. This report presents an overview of the common side effects of systemic anticancer therapy and ways to manage them. Data SourcesData sources include peer-reviewed articles sourced in electronic databases and national and international best practice guidelines (ESMO, ASCO, and MASCC guidelines). ConclusionSystemic anticancer therapies have side effects that healthcare professionals need to know about to monitor and manage them in early stages. Nurses play an important role in patient education, early identification, monitoring, and management of treatment side effects. Implications for Nursing PracticePeople with ABC face many challenges during their treatment journey. Oncology nurses, specialist nurses, and nurse practitioners can be of support by providing preventive measures and side effects management at an early stage. Nurses need to have a good understanding of toxicity management but also advanced tumor-specific cancer knowledge of the different subtypes of ABC and holistic assessment skills. They are also key to providing support and enhancing self-management and early recognition of side effects.

Comparison of adverse events in partial- or whole breast radiotherapy: investigation of cosmesis, toxicities and quality of life in a meta-analysis of randomized trials

Purpose/objectiveAdjuvant whole breast radiotherapy and systemic therapy are part of the current evidence-based treatment protocols for early breast cancer, after breast-conserving surgery. Numerous randomized trials have investigated the therapeutic effects of partial breast irradiation (PBI) compared to whole breast irradiation (WBI), limiting the treated breast tissue. These trials were designed to achieve equal control of the disease with possible reduction in adverse events, improvements in cosmesis and quality of life (QoL). In this meta-analysis, we aimed to investigate the differences between PBI and WBI in side effects and QoL.Material/methodsWe performed a systematic literature review searching for randomized trials comparing WBI and PBI in early-stage breast cancer with publication dates after 2009. The meta-analysis was performed using the published event rates and the effect-sizes for available acute and late adverse events. Additionally, we evaluated cosmetic outcomes as well as general and breast-specific QoL using the EORTC QLQ-C30 and QLQ-BR23 questionnaires.ResultsSixteen studies were identified (n = 19,085 patients). PBI was associated with a lower prevalence in any grade 1 + acute toxicity and grade 2 + skin toxicity (OR = 0.12; 95% CI 0.09–0.18; p < 0.001); (OR = 0.16; 95% CI 0.07–0.41; p < 0.001). There was neither a significant difference in late adverse events between the two treatments, nor in any unfavorable cosmetic outcomes, rated by either medical professionals or patients. PBI-technique using EBRT with twice-daily fractionation schedules resulted in worse cosmesis rated by patients (n = 3215; OR = 2.08; 95% CI 1.22–3.54; p = 0.007) compared to WBI. Maximum once-daily EBRT schedules (n = 2071; OR = 0.60; 95% CI 0.45–0.79; p < 0.001) and IORT (p = 0.042) resulted in better cosmetic results grade by medical professionals. Functional- and symptom-based QoL in the C30-scale was not different between PBI and WBI. Breast-specific QoL was superior after PBI in the subdomains of “systemic therapy side effects” as well as “breast-” and “arm symptoms”.ConclusionThe analysis of multiple randomized trials demonstrate a superiority of PBI in acute toxicity as well breast-specific quality of life, when compared with WBI. Overall, late toxicities and cosmetic results were similar. PBI-technique with a fractionation of twice-daily schedules resulted in worse cosmesis rated by patients.

Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer (UK TACT2; CRUK/05/19): quality of life results from a multicentre, phase 3, open-label, randomised, controlled trial

Adjuvant chemotherapy for patients with early breast cancer improves outcomes but its toxicity affects patients' quality of life (QOL). The UK TACT2 trial investigated whether accelerated epirubicin improves time to recurrence and if oral capecitabine is non-inferior to cyclophosphamide, methotrexate, and fluorouracil (CMF) for efficacy with less toxicity. Results showed no benefit for accelerated epirubicin and capecitabine was non-inferior. As part of the QOL substudy, we aimed to assess the effect of chemotherapies on psychological distress, physical symptoms, and functional domains. TACT2 was a multicentre, phase 3, open-label, parallel-group, randomised, controlled trial done in 129 UK centres. Participants were aged 18 years or older with histologically confirmed node-positive or high-risk node-negative invasive primary breast cancer, who had undergone complete excision, and due to receive adjuvant chemotherapy. Patients were randomly assigned (1:1:1:1) to four cycles of 100 mg/m2 epirubicin either every 3 weeks (standard epirubicin) or every 2 weeks with 6 mg pegfilgrastim on day 2 of each cycle (accelerated epirubicin), followed by four 4-week cycles of either CMF (600 mg/m2 cyclophosphamide intravenously on days 1 and 8 or 100 mg/m2 orally on days 1-14; 40 mg/m2 methotrexate intravenously on days 1 and 8; and 600 mg/m2 fluorouracil intravenously on days 1 and 8 of each cycle) or four 3-week cycles of 2500 mg/m2 capecitabine (1250 mg/m2 given twice daily on days 1-14 of each cycle). The randomisation schedule was computer generated in random permuted blocks, stratified by centre, number of nodes involved (none vs 1-3 vs ≥4), age (≤50 years vs >50 years), and planned endocrine treatment (yes vs no). QOL was one of the secondary outcomes and is reported here. All patients from a subset of 44 centres were invited to complete QOL questionnaires (Hospital Anxiety and Depression Scale [HADS] and European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire 30-item core module [QLQ-C30] and Quality of Life Questionnaire breast module [QLQ-BR23]) at baseline, end of standard or accelerated epirubicin, end of CMF or capecitabine, and at 12 and 24 months after randomisation. The QOL substudy prespecified two coprimary QOL outcomes assessed in the intention-to-treat population: overall QOL (reported elsewhere) and HADS total score. Prespecified secondary QOL outcomes were EORTC QLQ-C30 subscales of physical function, role function, and fatigue and EORTC QLQ-BR23 subscales of sexual function and systemic therapy side-effects. This trial is registered with ISRCTN, ISRCTN68068041, and ClinicalTrials.gov, NCT00301925. From Dec 16, 2005, to Dec 5, 2008, 4391 patients (20 [0·5%] of whom were male) were enrolled in TACT2; 1281 (85·8%) of 1493 eligible patients were included in the QOL substudy. Eight (0·6%) participants in the QOL substudy were male and 1273 (99·4%) were female. Median follow-up was 85·6 months (IQR 80·6-95·9). Analysis was performed on the complete QOL dataset (as of Sept 15, 2011) when all participants had passed the 24-month timepoint. Prerandomisation questionnaires were completed by 1172 (91·5%) patients and 1179 (92·0%) completed at least one postrandomisation questionnaire. End-of-treatment HADS depression score (p=0·0048) and HADS total change score (p=0·0093) were worse for CMF versus capecitabine. Accelerated epirubicin led to worse physical function (p=0·0065), role function (p<0·0001), fatigue (p=0·0002), and systemic side-effects (p=0·0001), but not sexual function (p=0·36), compared with standard epirubicin during treatment, but the effect did not persist. Worse physical function (p=0·0048), sexual function (p=0·0053), fatigue (p<0·0001), and systemic side-effects (p<0·0001), but not role functioning (p=0·013), were seen for CMF versus capecitabine at end of treatment; these differences persisted at 12 months and 24 months. Accelerated epirubicin was associated with worse QOL than was standard epirubicin but only during treatment. These findings will help patients and clinicians make an informed choice about accelerated chemotherapy. CMF had worse QOL effects than did capecitabine, which were persistent for 24 months. The favourable capecitabine QOL compared with CMF supports its use as an adjuvant option after neoadjuvant chemotherapy in patients with triple-negative breast cancer. Cancer Research UK, Amgen, Pfizer, and Roche.

Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study

In KEYNOTE-119 (ClinicalTrials.gov, NCT02555657), overall survival (primary end-point) was similar between pembrolizumab and chemotherapy in patients with previously treated metastatic triple-negative breast cancer (TNBC), although the pembrolizumab treatment effect increased with tumour PD-L1 expression. We report results of prespecified health-related quality of life (HRQoL) analyses from KEYNOTE-119. Eligible patients were randomised 1:1 to pembrolizumab 200mg Q3W intravenously for up to 35 cycles or treatment of physician's choice per local/country guidelines. Prespecified exploratory end-points were the change from baseline in HRQoL (EORTC QLQ-C30, QLQ-BR23) and to characterise utilities (EQ-5D-3L). Time to deterioration (TTD) was the time from start of treatment to first onset of a ≥10-point worsening from baseline. HRQoL analyses included 187 patients with tumour PD-L1 combined positive score (CPS) ≥10. Changes from baseline at 6 weeks (primary analysis time point) were directionally better with pembrolizumab versus chemotherapy for QLQ-C30 GHS/QoL (between-group difference in least-squares mean scores of 4.21 [95% CI, -1.38 to 9.80]), QLQ-C30 functional scales (physical, role, cognitive, social), QLQ-C30 symptom scales/items (fatigue, nausea/vomiting, dyspnoea, appetite loss), and QLQ-BR23 symptom scales/items (systemic therapy side-effects, upset by hair loss). Median TTD was directionally longer for pembrolizumab versus chemotherapy for QLQ-C30 QHS/QoL (4.3 versus 1.7 months), QLQ-C30 nausea/vomiting (7.7 versus 4.8 months), and QLQ-BR23 systemic therapy side-effects (6.1 versus 3.4 months). Minimal treatment differences were observed for other HRQoL end-points. HRQoL results were consistent with clinical outcomes and appeared to be driven by results for patients with tumour PD-L1 CPS ≥10.

2127P Long-term yoga reduces the side effects of systemic therapies and improves arm symptoms in the breast cancer patients

2127P Long-term yoga reduces the side effects of systemic therapies and improves arm symptoms in the breast cancer patients

Cross-Cultural Adaptation and Psychometric Properties of the Swahili Version of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR45 among Breast Cancer Patients in Tanzania.

Breast cancer is the most frequent cancer in women in Africa and contributes to premature death and poor quality of life. This study aimed to determine the validity, reliability, and psychometric properties of the Swahili version of EORTC QLQ-BR45 among women with breast cancer in Tanzania. A cross-sectional study design with non-probability convenience sampling was employed. Data were collected in two tertiary hospitals and one national cancer institute; 414 participants completed the EORTC-QLQ-C-30 and EORTC-QLQ-BR45. The reliability of QLQ-BR45 was measured using Cronbach's alpha and McDonald's Omega coefficients. The factor structure of EORTC QLQ-BR45 was assessed using confirmatory factor analysis. The internal consistencies for the five dimensions were all above 0.7 indicating satisfaction, except for systemic therapy side effects with a marginal value of 0.594 and significant correlations between the dimensions of QLQ-C30 and BR45. The final model fit well to the data, with the comparative fit index = 0.953, Tucker-Lewis index = 0.947, root mean square error of approximation = 0.041 (90% CI: 0.035, 0.046), and standardized root mean square residual = 0.072. In conclusion, the QLQ BR45 Swahili version displayed good reliability, validity, and psychometric properties and can be used in Swahili-speaking Sub-Saharan countries.

Effects of letrozole on serum estradiol and estrone in postmenopausal breast cancer patients and tolerability of treatment: a prospective trial using a highly sensitive LC–MS/MS (liquid chromatography–tandem mass spectrometry) method for estrogen measurement

PurposeTo analyze serum estradiol (E2) and estrone (E1) during letrozole treatment and their association to Quality of Life (QoL) and side-effects.MethodsPostmenopausal breast cancer patients starting adjuvant letrozole were eligible. Serum samples were taken at baseline, three, and 12 months. E2 and FSH were measured with routine chemiluminescent immunoassays. E2 and E1 were analyzed after trial completion with a highly sensitive liquid chromatography-tandem mass spectrometry method (LC–MS/MS) with lower limits of quantification (LLOQ) of 5 pmol/L. QoL was measured at baseline and at 12 months with the EORTC QLQ-C30 and QLQ-BR23 and the Women’s Health questionnaires, and menopause-related symptoms with the modified Kupperman Index.ResultsOf 100 screened patients 90 completed the trial. Baseline mean LC–MS/MS E2 and E1 were 12 pmol/L (range < 5–57) and 66 pmol/L (< 5–226), respectively. E2 levels measured by immunoassay and LC–MS/MS showed no correlation. E2 and E1 were completely suppressed by letrozole except for one occasion (E1 11 pmol/L at 3 months). Pain, side effects of systemic therapy, vasomotor symptoms, joint and muscle aches, and vaginal dryness increased during letrozole treatment. A high baseline E2 was significantly associated with increased aching joints and muscles, but not with the other side effects.ConclusionsLetrozole supresses E2 and E1 completely below the LLOQ of the LC–MS/MS in postmenopausal women. High pre-treatment E2 levels were associated with more joint and muscle pain during letrozole. Automated immunoassays are unsuitable for E2 monitoring during letrozole therapy due to poor sensitivity.

Prognostic Factors for Survival in Patients Undergoing Surveillance After Cytoreductive Nephrectomy.

The clinical course of patients being placed on surveillance in a cohort of systemic therapy-naïve patients who undergo cytoreductive nephrectomy is not well documented. Thus, we evaluated the clinical course of patients placed on surveillance following cytoreductive nephrectomy and identified predictors of survival. In this large single-institution study, we retrospectively analyzed metastatic renal cell carcinoma patients who underwent cytoreductive nephrectomy followed by surveillance. Predictors of survival were evaluated using the Kaplan-Meier method with a log-rank test. Patients were risk stratified based on IMDC (International mRCC Database Consortium) and number of metastatic sites (Rini score), with IMDC score ≤1 and ≤2 metastatic organ sites considered favorable risk. Primary end point was systemic therapy-free survival. Secondary end points included intervention-free survival, cancer-specific survival, and overall survival. Median systemic therapy-free survival was 23.6 months (95% CI: 15.1-40.6), intervention-free survival was 11.8 months (95% CI: 8.0-18.4), cancer-specific survival was 54.2 months (95% CI: 46.2-71.4), and overall survival 52.4 months (95% CI: 40.3-66.8). Favorable-risk patients compared to unfavorable-risk patients had longer systemic therapy-free survival (50.6 vs 11.1 months, P < .01), survival (25.2 vs 7.3, P < .01), and cancer-specific survival (71.4 vs 46.2 months, P = .02). Using risk stratification based on IMDC and number of metastatic sites, surveillance in favorable-risk patients can be utilized for a period without the initiation of systemic therapy. This approach can delay patients' exposure to the side effects of systemic therapy.

MP50-09 CONTEMPORARY OUTCOMES OF PRIMARY EXTRAPERITONEAL RETROPERITONEAL LYMPH NODE DISSECTION FOR STAGE II GERM CELL TUMORS

You have accessJournal of UrologyCME1 Apr 2023MP50-09 CONTEMPORARY OUTCOMES OF PRIMARY EXTRAPERITONEAL RETROPERITONEAL LYMPH NODE DISSECTION FOR STAGE II GERM CELL TUMORS Muhannad Alsyouf, Arman Ashrafi, Sanam Ladi Seyedian, Erika L. Wood, Antoin Douglawi, Hamed Ahmadi, Madeleine Burg, Alireza Ghoreifi, Sumeet Bhanvadia, Anne Schuckman, Hooman Djaladat, and Siamak Daneshmand Muhannad AlsyoufMuhannad Alsyouf More articles by this author , Arman AshrafiArman Ashrafi More articles by this author , Sanam Ladi SeyedianSanam Ladi Seyedian More articles by this author , Erika L. WoodErika L. Wood More articles by this author , Antoin DouglawiAntoin Douglawi More articles by this author , Hamed AhmadiHamed Ahmadi More articles by this author , Madeleine BurgMadeleine Burg More articles by this author , Alireza GhoreifiAlireza Ghoreifi More articles by this author , Sumeet BhanvadiaSumeet Bhanvadia More articles by this author , Anne SchuckmanAnne Schuckman More articles by this author , Hooman DjaladatHooman Djaladat More articles by this author , and Siamak DaneshmandSiamak Daneshmand More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003298.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patients with germ cell tumors (GCT) and clinically low volume retroperitoneal adenopathy have multiple treatment options offering excellent oncologic outcomes. Primary retroperitoneal lymph node dissection (RPLND) is a treatment option that avoids the long term side effects of systemic therapies, however, can be associated with short term morbidity. The objective of this study was to evaluate the perioperative and oncologic outcomes of GCT patients who underwent a primary RPLND via an open extraperitoneal approach (EP RPLND) for the management of clinical stage II (CSII) GCT. METHODS: All GCT patients with marker negative, CSII who underwent a primary EP-RPLND between 2010-2021 were reviewed. The study population included patients with clinical stage (CS)I with retroperitoneal relapse & de-novo CSII patients. Perioperative, ejaculatory function, & oncologic outcomes were evaluated including recurrence rates and patterns. RESULTS: Overall, 45/170 EP-RPLND were performed in the primary setting (20 seminoma, 45 NSGCT). Median radiologic disease size was 1.7cm(IQR 1.3-2.3). Median number of lymph nodes resected was 35(IQR 23–46.5). Three patients (6.7%) experienced a 90-day complication. There were no cases of postoperative ileus, and median hospital stay was 2(IQR 1-3) days. In patients who underwent nerve sparing, 40/44 (91%) maintained antegrade ejaculatory function. pN+ rate was 90% in seminoma and 68% in NSGCT. In seminoma patients, 20 underwent a primary EP-RPLND. At a follow-up of 37.4 months, only 2 patients (10%) with stage IIA developed recurrence: 1 in-field (at 33.3 months follow-up) and 1 outside-field recurrence (at 42.7 months). Both were successfully managed with subsequent surgical resection, with an overall survival (OS) and systemic treatment free survival (STFS) of 100%. In 25 NSGCT patients with a median follow-up of 20.9 months, there were 6 recurrences (24%, 3 stage IIA, 3 stage IIB) at a median time of 3.1 months. All of these recurrences were successfully managed with chemotherapy (OS 100%, STFS 76%). CONCLUSIONS: In CSII GCT, a primary EP RPLND is safe, associated with short hospitalization, and offers excellent oncologic outcomes while minimizing patients morbidity. In this series, all seminoma patients and 76% of NSGCT patients avoided systemic therapy. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e688 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Muhannad Alsyouf More articles by this author Arman Ashrafi More articles by this author Sanam Ladi Seyedian More articles by this author Erika L. Wood More articles by this author Antoin Douglawi More articles by this author Hamed Ahmadi More articles by this author Madeleine Burg More articles by this author Alireza Ghoreifi More articles by this author Sumeet Bhanvadia More articles by this author Anne Schuckman More articles by this author Hooman Djaladat More articles by this author Siamak Daneshmand More articles by this author Expand All Advertisement PDF downloadLoading ...

Abstract PD8-04: The role of Yoga as a complementary therapy in women undergoing treatment for breast cancer: A randomized controlled trial

Abstract Background: Yoga has been tested in multiple small-randomized studies for its impact on quality of life (QOL) on breast cancer (BC). We conducted a randomized controlled trial, to study the effect of yoga on disease free survival as the primary endpoint in women with operable breast cancer. (NCT02161900). Methods: Women with non-metastatic BC during and after standard treatment, were randomized to yoga and conventional exercise(YCE) versus conventional exercise only(CE). The primary endpoint was disease free survival (DFS) with secondary endpoints of overall survival (OS) and QOL, which was assessed using the EORTC QLQC30, BR23, Brief fatigue inventory (BFI), Visual pain scores (VPS) and a spirituality questionnaire (SQ). EORTC QLQ was assessed at baseline (BL), 6-9 months (mo), 18-21 mo. BFI and VPS at BL, 6-8 mo and 12-15 mo and SQ at BL and 12-15 mo. We report the final analysis of DFS, OS and QOL in 850 women randomized to the study. The groups were balanced for clinic-pathologic factors in both arms. Results: Of the 850 women randomized on the study, 426 were on YCE arm and 424 on CE arm. The median age was 47 versus (vs) 48 years, median pT size was 3 vs 2.85cm, grade 3 tumors were 82.7 vs 82.1%, hormone receptor positive was in 69% vs 69.4% and HER2neu positive was in 14.4 vs13.7% in YCE and CE arms respectively. At a median follow-up of 80 months the disease fee survival was 80% vs 76.7% (HR= 0.85, 95% CI= 0.64 – 1.14, p=0.28), and overall survival was 85.4% vs 83.1% (HR= 0.86, 95%CI = 0.61 – 1.21, p=0.38) in YCE and CE respectively. Physical(p=0.043) and emotional function (0.017), fatigue (p=0.002), pain (p=0.031), appetite loss (&amp;lt; 0.001) arm symptoms (0.035) and systemic therapy side effects (0.036) reduced at 6-9mo in YCE, with sustained improvements in physical (p=0.036) and emotional function (p=0.008) at 54mo. The median score of fatigue after adjuvant therapy measured by QLQ C30 was lower in YCE compared to CE (11.11vs 22.22, p = 0.002). Similarly, in BFI the baseline median scores of severity of fatigue were 5 in YCE and 6 in CE which reduced to 3 at one year in both groups. A further reduction to 0 was observed in the YCE arm at 2 years and then sustained till 4 years compared to the median score of fatigue in CE which stayed at 3. (p=0.04, 0.03 2 and 4 years respectively). In VPS the number of patients experiencing severe pain in YCE group were less than CE group with specific reduction noted in pain over the breast/chest wall (p=0.018 at 24mo). Lastly SQ assessed spirituality and showed no difference, but less deterioration compared to baseline scores were noted in YCE. Fifty-three percent women on YCE showed an improvement in QOL from baseline compared to 47% in CE, however the global score of QOL did not differ significantly between the two arms. This cohort had overall compliance of 61% to yoga and physiotherapy in YCE with 91.75% compliance among those who did yoga for 6-9mo and 85% to physiotherapy alone in CE. Conclusions: Yoga resulted in a 15% relative improvement in DFS and 14% in OS, that did not reach statistical significance in this trial. Yoga is a low-risk, low-cost therapy that improves day-to-day activity, including pain, fatigue and quality of life in women with breast cancer.This is the first study where the long term benefits in quality of life have been noted with the addition of yoga for women undergoing treatment for breast cancer. Citation Format: Nita S. Nair, Nishu S. Goel, Vani Parmar, Ashwini Dewade, Shabina Siddique, Aarti Pandey, Rohini Hawaldar, Rajendra Badwe. The role of Yoga as a complementary therapy in women undergoing treatment for breast cancer: A randomized controlled trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD8-04.

Cross-cultural adaptation and psychometric properties of the Indonesian version for quality of life among breast cancer patients.

Breast cancer is one of the most important health problems worldwide. Quality of life (QoL) is an important indicator to evaluate symptoms in cancer patients, including those with breast cancer. Culturally suitable, valid, reliable, and appropriate instruments to measure the QoL of breast cancer patients are needed, which is still rare in Indonesia. This study aimed to translate the EORTC QLQ-BR45 instrument into Indonesian and evaluate its psychometrics. A cross-sectional study was performed on 635 patients conveniently selected from the oncology department in referral hospital. The first phase of this study involved translation of the existing EORTC QLQ-BR45 into Indonesian, and in the second phase, we evaluated its psychometric properties. Construct validity was evaluated using confirmatory factor analysis (CFA). Criterion validity was examined according to the association between disease stage and Karnofsky Performance Scale (KPS). A total of 635 (99.00%) completed the EORTC QLQ-BR45 successfully. The instrument indicated good readability and high content validity. All Cronbach's alpha coefficients were satisfactory (overall value, 0.87). For construct validity, patients with KPS ≥80% did better than those with KPS ≤70% as did two multi-item scales in functional scales (body image and breast satisfaction) and five multi-item scales in symptom scales (systemic therapy side effects, endocrine therapy, and arm, breast, and endocrine sexual symptoms). Body image score of late-stage patients was significantly higher. CFA indicated that the nine-factor structure of the Indonesian EORTC QLQ-BR45 was a good fit for the data. The Indonesian EORTC QLQ-BR45 questionnaire is reliable and valid with good psychometric properties, thus can be used for breast cancer patients in Indonesia.

Surgical Treatment for Advanced Oropharyngeal Cancer: A Narrative Review

Background and Objectives: to describe current scientific knowledge regarding the treatment options in advanced oropharyngeal cancer. The standard care for advanced oropharyngeal cancer (OPSCC) has been chemoradiotherapy, although surgical approaches followed by adjuvant treatment have been proposed. The best therapy for each patient should be decided by an interdisciplinary tumour-board. Different strategies should be considered for the specific patient's treatment: surgery, chemotherapy and radiation therapy or combinations of them. The treatment choice is influenced by tumour variability and prognostic factors, but it also depends on cancer extension, extranodal extension, nervous invasion, human papilloma virus (HPV) presence, making the decisional algorithm not always clear. HPV-related OPSCC is strongly associated with a favourable overall survival (OS) and disease-free survival rate (DSS); by contrast, HPV-negative OPSCC often flags a worse prognosis. Consequently, the American Joint Committee on Cancer (AJCC) differentiates OPSCC treatment and prognosis based on HPV status. Methods: we carried out a review of current scientific literature to analyze the different indications and limitations of surgical treatment options in OPSCC stage III and IV. Conclusion: robotic surgery or open approaches with reconstructive flaps can be considered in advanced stages, resulting in the de-intensification of subsequent systemic therapy and fewer related side effects. Furthermore, in the event of the primary failure of systemic therapy or disease recurrence, the surgical approach constitutes an additional therapeutic option which lengthens patient survival functions.

Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial.

In the FLIPPER trial, palbociclib/fulvestrant significantly improved progression-free survival (PFS) compared with placebo/fulvestrant in postmenopausal women with HR+/HER2- advanced breast cancer (ABC). We assessed health-related quality of life (QoL) using patient-reported outcomes (PROs). In this phase II double-blinded study, PROs were assessed at baseline after every three cycles and at the end of the treatment using the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23. Time to deterioration (TTD) in global health status (GHS)/QoL was defined as a decrease of ⩾10 points. Changes from baseline (CFB) and TTD were analysed using linear mixed-effect and Cox regression models, respectively. Of the 189 randomised (1:1) patients, 178 (94%) completed ⩾1 post-baseline assessment; 50% received ⩾22 cycles of study treatment, with a questionnaire compliance >90%. Mean baseline scores were comparable between arms. GHS/QoL scores were maintained throughout the palbociclib/fulvestrant treatment. CFB showed significant differences for GHS/QoL, appetite loss, constipation and systemic therapy side effect scores favouring placebo/fulvestrant. TTD in GHS/QoL was delayed in placebo/fulvestrant versus palbociclib/fulvestrant [30.3 versus 11.1 months; adjusted hazard ratio (aHR): 1.57, 95% CI: 1.03-2.39, p = 0.036]; this difference was not significant in patients with progressive disease (aHR: 1.2, 95% CI: 0.6-2.2, p = 0.658). No statistically significant differences in TTD were found for the other QLQ-C30 and QLQ-BR23 scales. Although TTD in GHS/QoL was prolonged with placebo/fulvestrant, no differences were observed on other functional or symptom scales. This finding and the improvement in PFS support the combination of palbociclib/fulvestrant as a beneficial therapeutic option for HR+/HER2- ABC. Sponsor Study Code: GEICAM/2014-12EudraCT Number: 2015-002437-21ClinTrials.gov reference: NCT02690480.