Symptomatic Cancer Research Articles

Oral cancer awareness in North-Western Spain: a population-based study.

Background An early diagnosis depends greatly on patient awareness. Thus, the aim of this study was to investigate general awareness of oral cancer and knowledge about its risk factors, signs and symptoms. Material and Methods Cross-sectional population-based survey of randomly selected respondents conducted from March 1, 2015 to 30 June 2016. Results A total of 5,727 people entered the survey (response rate: 53%). When asked what cancers participants had heard about, 20.3% mentioned oral cancer. Regarding risk factors, tobacco was mentioned by 55.3% of the sample (n=3,169), followed by alcohol (12.5%; n=708), poor oral hygiene (10.8%; n=618), diet (6.5%; n=377), and genetics (4.5%; n=248). Conclusions General population has low awareness of oral cancer with poor knowledge of risk factors and main alarm signs. In addition, individuals in the risk group scored lower values in the main variables analysed; even those highly educated showed insufficient awareness and knowledge of oral cancer. In these circumstances, there is clear need for educational interventions tailored to the target audience and aimed at increasing knowledge and awareness of oral cancer to promote primary prevention of oral cancer and minimising the time interval of patients with symptomatic oral cancer in their path to treatment. Key words:Oral cancer, awareness, risk factors, surveys and questionnaires, Spain.

Impact of reverse transcriptase real-time polymerase chain reaction-cycle threshold values on SARS-CoV-2–positive cancer patients undergoing treatment

Introduction: Coronavirus disease 2019 (COVID-19) pandemic, being a novel viral infection, has resulted in disruption of health services, including cancer patient's care and treatment. Hence, there was a need for testing and lateral integration of services for cancer patients with COVID-19. Materials and Methods: A total of 1178 samples were collected from cancer patients for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing before undergoing treatment in a tertiary care cancer center. The realtime reverse transcriptase polymerase chain reaction (RTPCR) was done using the E gene for screening, and for the confirmation, any of the three reactions using RdRp, ORF1bnsp14 and RNasePas were run as internal control. Results: Out of the 1178 samples tested, 211 (17.91%) were positive, and of these patients, 863 (73.25%) were men and 342 (29%) were women. Among the 863 men with cancer, 133 (15.41%) were real-time reverse transcriptase PCR (RT-PCR) positive. Of the 342 women with cancer, 78 (22.80%) were positive. Of the 144 SARS-CoV-2–positive cancer patients with cycle threshold (Ct) <25, 112 (84.2%) were asymptomatic and 32 (41.0%) were symptomatic. Sixty-seven patients showed positive results with a Ct >25. Out of them, 21 (31.3%) were asymptomatic and 46 (68.65%) were symptomatic cancer patients (P < 0.001). Of 144 patients with Ct <25, only 4 (2.8%) patients tested negative within 7–9 days, whereas the rest of the 140 (97.22%) became negative in >9 and up to 28 days. In the 67 cancer patients with Ct >25, within 7–9 days, 50 (74.6%) became RT-PCR negative and the remaining 17 patients mostly >60 years age group became RT-PCR negative in >9–28 days. Conclusions: Ct value of qualitative SARS-CoV-2 reverse transcriptase RT-PCR should be an important tool for an oncologist in designing and implementing patient management guidelines for SARS-CoV-2–positive cancer patients without or with symptoms for COVID-19.

Factors contributing to time to diagnosis in symptomatic colorectal cancer: A scoping review.

Colorectal cancer (CRC) is the third most common cancer worldwide (Ferlay et al., 2015, International Journal of Cancer, 136, E359), and delayed diagnosis is associated with mortality (Tørring et al., 2011, British Journal of Cancer, 104, 934; Tørring et al., 2012, Journal of Clinical Epidemiology, 65, 669). The purpose of this review was to determine the factors associated with time to diagnosis in symptomatic CRC using scoping review methods. We performed database and citation searches to identify studies which examine the length of any interval from symptom presentation to diagnosis. Study selection was conducted by two independent reviewers. Factors contributing to time to diagnosis were extracted from selected articles and mapped onto a conceptual framework consisting of four levels: patient and disease factors, provider factors, organisation/setting factors and sectors of influence. From the 31 studies included in this review, we identified 138 unique factors, 17 of which were investigated by at least three studies and 11 of which had consistent results. Patient and disease factors were most commonly studied. Patient perception that their symptoms were benign, a non-urgent referral, female sex and rectal tumour location were each associated with a longer time to diagnosis. Thus far, the literature has focused on patient or disease-related factors, while other levels of influence have been relatively understudied.

Evolving Role of Immunotherapy in Metastatic Castration Refractory Prostate Cancer.

Immunotherapies have shown remarkable success in the treatment of multiple cancer types; however, despite encouraging preclinical activity, registration trials of immunotherapy in prostate cancer have largely been unsuccessful. Sipuleucel-T remains the only approved immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer based on modest improvement in overall survival. This immune evasion in the case of prostate cancer has been attributed to tumor-intrinsic factors, an immunosuppressive tumor microenvironment, and host factors, which ultimately make it an inert ‘cold’ tumor. Recently, multiple approaches have been investigated to turn prostate cancer into a ‘hot’ tumor. Antibodies directed against programmed cell death protein 1 have a tumor agnostic approval for a small minority of patients with microsatellite instability-high or mismatch repair-deficient metastatic prostate cancer. Herein, we present an overview of the current immunotherapy landscape in metastatic castration-resistant prostate cancer with a focus on immune checkpoint inhibitors. We describe the results of clinical trials of immune checkpoint inhibitors in patients with metastatic castration-resistant prostate cancer; either as single agents or in combination with other checkpoint inhibitors, poly (ADP-ribose) polymerase (PARP) inhibitors, tyrosine kinase inhibitors, novel hormonal therapies, chemotherapies, and radioligands. Finally, we review upcoming immunotherapies, including novel monoclonal antibodies, chimeric-antigen receptor (CAR) T cells, Bi-Specific T cell Engagers (BiTEs), therapies targeting the adenosine pathway, and other miscellaneous agents.

Time from presentation to pre-diagnostic chest X-ray in patients with symptomatic lung cancer: a cohort study using electronic patient records from English primary care.

BackgroundNational guidelines in England recommend prompt chest X-ray (within 14 days) in patients presenting in general practice with unexplained symptoms of possible lung cancer, including persistent cough, shortness of breath, or weight loss.AimTo examine time to chest X-ray in symptomatic patients in English general practice before lung cancer diagnosis, and explore demographical variation.Design and settingRetrospective cohort study using routinely collected general practice, cancer registry, and imaging data from England.MethodPatients with lung cancer who presented symptomatically in general practice in the year pre-diagnosis and who had a pre-diagnostic chest X-ray were included. Time from presentation to chest X-ray (presentation–test interval) was determined and intervals classified based on national guideline recommendations as concordant (≤14 days) or non-concordant (>14 days). Variation in intervals was examined by age, sex, smoking status, and deprivation.ResultsIn a cohort of 2102 patients with lung cancer, the median presentation–test interval was 49 (interquartile range [IQR] 5–172) days. Of these, 727 (35%) patients had presentation–test intervals of ≤14 days (median 1 [IQR 0–6] day) and 1375 (65%) had presentation–test intervals of >14 days (median 128 [IQR 52–231] days). Intervals were longer among patients who smoke (equivalent to 63% longer than non-smokers; P<0.001), older patients (equivalent to 7% longer for every 10 years from age 27; P = 0.013), and females (equivalent to 12% longer than males; P = 0.016).ConclusionIn symptomatic primary care patients who underwent chest X-ray before lung cancer diagnosis, only 35% were tested within the timeframe recommended by national guidelines. Patients who smoke, older patients, and females experienced longer intervals. These findings could help guide initiatives aimed at improving timely lung cancer diagnosis.

Understanding Parental Health Literacy for Clean and Healthy Behavior in Early Childhood During the Covid-19 Pandemic

In the COVID-19 pandemic scenario, parents need to be familiar with health literacy by applying clean and healthy living habits to their family members, especially those with early childhood. This study aims to explain parents' perceptions of health literacy for a clean and healthy behavior in their children during the COVID-19 pandemic. The method used in this study is a cross-sectional study involving 22 men and 62 female respondents. Respondent requirements were used in data analysis to determine parents' perceptions of health literacy and the efforts they have made to practice clean and healthy lifestyle in their children. The research findings show that knowing the health awareness of parents has an impact on a child's balanced lifestyle. Based on six measures of clean and healthy behavior for children, three indicators were determined in the category of discipline and high discipline: using clean water, using the toilet, and doing physical activity. The act of washing children's hands with soap indicators has a high discipline score and the use of masks in children has low discipline. If the use of masks is not disciplined by parents, exposure to COVID-19 in early childhood can be disrupted.&#x0D; Keywords: Early Childhood, Parental health literacy, Clean and healthy behaviors&#x0D;

Review of Palliative 223Ra in Metastatic Castration-Resistant Prostate Cancer: Experience at West Virginia University Cancer Center

The ALSYMPCA trial of the α-emitter 223Ra in symptomatic bone-predominant metastatic castration-resistant prostate cancer (mCRPC) reported a median overall survival (OS) of 14.9 mo, versus 11.3 mo for placebo. However, subsequently reported real-world experience with 223Ra in smaller mCRPC patient cohorts has appeared less successful. We performed a retrospective observational study to review our own 223Ra experience at West Virginia University (WVU). Methods: Demographic, clinical, laboratory, and imaging data were reviewed in all bone-predominant mCRPC patients treated with 223Ra at WVU from 2014 to 2019. The number of bone metastases per patient at the start of treatment with 223Ra was quantified via nuclear bone scans (12 scans, 5 of which also included SPECT/CT), body CT scans (8 scans), and PET/CT scans (4 scans). Standard descriptive statistics were used to study institutional review board-exempted, deidentified patient data. Median survival in ALSYMPCA and WVU patients was compared using a 2-sided, 1-sample log-rank test based on the exponential distributions. The primary endpoint was patient OS after initiating 223Ra. Results: Twenty-four patients received 98 infusions of 223Ra; 83% of these patients were referred from outside WVU. Before the first infusion, all 24 had received androgen deprivation therapy. In total, 73 sequential combinations of androgen deprivation therapy were used, 68 of which (93%) preceded the first 223Ra infusion. Also, before 223Ra, 19 (79%) patients had received docetaxel and 19 (79%) had received 33 courses of radiation, 24 of which targeted nonprostatic sites. Eleven patients (46%) completed all 6 planned 223Ra infusions; 13 (54%) stopped early because of clinical deterioration. As of August 2020, only 1 patient remained alive after completing 6 cycles of 223Ra. Median OS from the first 223Ra infusion to the last follow-up or death was 8.3 mo (range, 0-44 mo)-nearly 50% less than the ALSYMPCA median survival of 14.9 mo (P = 0.01). Compared with ALSYMPCA, more WVU patients received bisphosphonates and docetaxel, more had an Eastern Cooperative Oncology Group performance status of at least 2, more used opiates for pain, more had a greater bone metastasis burden by imaging, and more had lower hemoglobin, albumin, alkaline phosphatase, and prostate-specific antigen levels. Conclusion: Although the science supporting the development and clinical use of 223Ra is compelling, optimal clinical benefit will likely require earlier referral for 223Ra, before patients have exhausted most conventional therapies. At WVU, we found that practically all our referred patients had androgen deprivation therapy, radiation, and cytotoxic therapy before starting 223Ra. We continue to offer 223Ra therapy to patients with symptomatic bone-predominant mCRPC but are encouraging earlier patient referral.

Contemporary role of palliative cystoprostatectomy or pelvic exenteration in advanced symptomatic prostate cancer.

To access the feasibility of palliative cystoprostatectomy/pelvic exenteration in patients with bladder/rectal invasion due to prostate cancer (PC). Twenty-five men with cT4 PC were retrospectively identified in the institutional databases of six tertiary referral centers in the last decade. Local invasion was documented by CT or MRI scans and was confirmed by urethrocystoscopy. Oncological therapies, local symptoms, previous local treatments, time from diagnosis to intervention and type of surgical procedure were recorded. Patients were divided into groups: ADT group (12 pts) and 13 pts without any history of previous local/systemic treatments for PCa (nonADT groups). Perioperative complications were classified using the Clavien-Dindo system. Overall survival (OS) was defined as the time from surgery to death from any cause. A Cox regression analysis, stratified for ISUP score and previous hormonal treatment (ADT) was also performed for survival analysis. Ileal conduit was the main urinary diversion in both cohorts. For the entire cohort, complication rate was 44%. No significant differences regarding perioperative complications and complication severity between both subgroups were observed (p = 0.2). Median follow-up was 15months (range 3-41) for the entire cohort with a median survival of 15months (95% CI 10.1-19.9). In Cox regression analysis stratified for ISUP score, no statistically significant differences in OS in patients with and without previous ADT before cystectomy or exenteration were observed (HR 3.26, 95% CI 0.62-17.23, p = 0.164). Palliative cystoprostatectomy and pelvic exenteration represent viable treatment options associated with acceptable morbidity and good short-term survival outcome.

Routes to diagnosis of symptomatic cancer in sub-Saharan Africa: systematic review

BackgroundMost cancers in sub-Saharan Africa (SSA) are diagnosed at advanced stages, with limited treatment options and poor outcomes. Part of this may be linked to various events occurring in patients’...

Oncological safety and functional outcomes of testosterone replacement therapy in symptomatic adult-onset hypogonadal prostate cancer patients following robot-assisted radical prostatectomy.

Testosterone replacement therapy (TRT) remains controversial in men with treated prostate cancer. We assessed its safety and functional impacts in patients after definitive surgical treatment with robotic-assisted radical prostatectomy (RARP). We performed a retrospective analysis of 1303 patients who underwent RARP during the years 2006-2019. We identified men with symptoms of andropause and low serum testosterone who received TRT post-RARP; then we divided the cohort into two groups accordingly for comparison. Biochemical recurrence (BCR) was the primary endpoint. Secondary endpoints included functional outcomes. Predictors of BCR, including the effect of TRT on BCR, were evaluated using univariable and multivariable logistic regression. Among the forty-seven men who received TRT, the mean age was 60.83years with a median follow-up of 48months. Three (6.4%) and 157 (12.56%) patients experienced BCR in TRT and non-TRT groups, respectively. Baseline characteristics were similar between both groups except for higher mean BMI in the TRT group (p = 0.03). In the multivariate analysis (MVA), higher pre-RARP prostate-specific antigen (PSA) (p = 0.043), higher International Society of Urological Pathology score (p < 0.001), seminal vesical invasion (p = 0.018) and positive surgical margin (p < 0.001) were predictors of BCR. However, TRT was not (p = 0.389). In addition, there was a significant change in the Sexual Health Inventory for Men (p = 0.022), and serum testosterone level (p < 0.001) before and 6months after initiation of TRT. Our findings suggest that TRT, in well-selected, closely followed, symptomatic men post-RARP is an oncologically safe and functionally effective treatment in prostate cancer patients post-RARP.

The value of mammography in women with focal breast complaints in addition to initial targeted ultrasound

PurposeTo determine the added value of mammography in women with focal breast complaints and the utility of initial targeted ultrasound in this setting.MethodsWomen with symptomatic breast disease who were evaluated by breast imaging (mammography/digital breast tomosynthesis and ultrasound) between January 2016 and December 2016 in the Radboud University Medical Centre were included. We retrospectively collected the following data: date of birth, indication of imaging, visibility on mammography/ultrasound, whether biopsy was taken, additional findings, BI-RADS-classification, pathology and follow-up results.ResultsA total of 494 women were included (mean age 46.5, range 30 to 93). In 49 women (9.9%), symptomatic breast cancer was diagnosed, all visible during targeted ultrasound. The negative predictive value of targeted ultrasound was very high (99.8%). Additional findings on mammography were significantly more often malignant when the symptomatic lesion was also malignant (3.8% vs 70%, P < 0.05). In only one patient with symptoms caused by a benign finding, an incidental malignancy was detected on mammography outside the area of complaint (detection rate 2.2/1000 examinations).ConclusionsThe contribution of mammography for cancer detection in women with focal breast complaints is very low when targeted ultrasound is performed. Additional findings are most common in patients with symptomatic breast cancer. Our results suggest that initial targeted ultrasound is a more appropriate initial tool for the evaluation of focal breast complaints. Mammography could be performed on indication only.

Clinicopathological presentation of patients with prostate cancer at Muhimbili National Hospital in Dar es Salaam, Tanzania

Prostate cancer (PC) is the most common type of cancer in men and is of major public health importance worldwide. This study aimed to establish the clinicopathological presentation and its impression in disease progression like to Castrate Resistant Prostate Cancer (CRPC) of patients treated for Prostate Cancer at Muhimbili National Hospital (MNH) in Dar es Salaam.This was a retrospective descriptive hospital based study at Muhimbili National Hospital. Patients who were treated for prostate cancer were identified. Information regarding primary prostatic cancer treatment, clinical disease progression symptoms, and age of the patients were collected. A total of 293 case notes were reviewed of which 189 patients who were treated for prostatic carcinoma with androgen deprivation, 96(50.8%) met the criteria for the diagnoses of Castrate Resistant Prostate Cancer (CRPC) and their mean age was 71.23±4.2. About half of our patients 146(49.7%) presented with history of urine retention necessitating urethral catheterization but also patients had hard, nodulated, grade three prostate though 48.2% had missing documentation of Digital Rectal Examination (DRE) findings. Most of the patients had a poorly differentiated histology with PSA over 100ng/l. Almost all patients had a clinical progression signifying a metastatic disease. Majority of patients presented with symptomatic prostate cancer contrary to the natural history of prostate cancer at its early stage. Urine retention and hard nodulated grade three prostate were the commonest clinical presentation whereas poorly differentiated carcinoma of the prostate was a common pathological finding among patients with prostate cancer MNH in Dar es Salaam, Tanzania.

Symptomatic Breast Cancers and Why Breast Pain May not Always Need Clinical Review.

Breast pain contributes a heavy burden to the symptomatic breast clinic, accounting for a large number of referrals due to patient/clinician subjective anxiety and unclear aetiology. We assess the link between breast pain and cancer with a view to easing the demand on breast services. All new breast cancer diagnoses were identified from the multidisciplinary team outcomes for the 12 months between October 2017 and October 2018. Presenting symptoms were identified from the General Practice referrals and consultant letters. Examination findings were checked with details on imaging requests. 436 new symptomatic cancer diagnoses were made in patients with a median age of 68 (range 25-97). 334 patients were referred by General Practice as two-week waits who formed the cohort selected for analysis (77%). New lumps accounted for 294 ipsilateral cancer diagnoses (88%), nipple symptoms for 28 (8%) and pain with normal examination for 12 (4%, all screening aged patients). All 12 cancers in the patients presenting with pain were correctly identified on mammography, including 4 cancers in the symptomatic breast and 8 Incidental cancers in the contralateral, non-symptomatic breast. Pain does not appear to be frequent symptom of breast cancer presentation. It was more common for patients to have incidental, contralateral asymptomatic cancer than it was for patients with pain alone to have underlying ipsilateral cancer. In such cases, new cancers were identified accurately on mammography. Patients presenting with pain as an isolated symptom, having been carefully assessed in Primary Care, may yield little benefit in repeat clinical examination by a Breast Specialist. Direct to test with mammography could be safe, effective and efficient alternative practice.

Accuracy of faecal immunochemical testing in patients with symptomatic colorectal cancer.

BackgroundThe aim of this study was to determine the diagnostic accuracy of the faecal immunochemical test (FIT) for detecting colorectal cancer in symptomatic patients.MethodsThis was a prospective study of patients with bowel symptoms. Stool samples were collected during rectal examination. The HM‐JACKarc assay (Kyowa Medex, Tokyo, Japan) was used to quantify faecal haemoglobin (Hb); positive results were those with at least 10 μg Hb/g faeces. Two‐by‐two tables and receiver operating characteristic (ROC) curve analysis were used to determine diagnostic accuracy; χ2 and Mann–Whitney U tests were used to compare other parameters.ResultsA total of 928 patients were included (M : F ratio 1 : 1·5; median age 72 (i.q.r. 64–80) years). The overall prevalence of colorectal cancer was 5·1 per cent. The FIT had sensitivity of 85·1 per cent, specificity of 83·5 per cent, positive predictive value of 22·6 per cent and negative predictive value of 99·0 per cent. ROC analysis of FIT for diagnosing colorectal cancer gave an area under the curve value of 0·89 (95 per cent c.i. 0·84 to 0·94). Significant bowel pathology was detected more frequently in FIT‐positive patients (35·1 per cent versus 7·1 per cent in FIT‐negative patients; P < 0·001). There were sex differences in FIT positivity (23·7 per cent in men versus 17·4 per cent in women; P = 0·019); the sensitivity of FIT for colorectal cancer in women was also low. False‐negative FIT results were found mainly in women referred with iron‐deficiency anaemia, who were found to have caecal cancer.ConclusionFIT effectively excluded colorectal cancer in symptomatic patients. Integration of FIT into the diagnostic pathway for colorectal cancer would direct resources appropriately to patients with a greater likelihood of having the disease.

A Study on Acceptance of Mastectomy among Patients Diagnosed with Breast Cancer in Tertiary Hospital in Rivers State, Nigeria

Aim: This study was aimed at ascertaining the acceptance of mastectomy among patients who had breast cancer in a tertiary health facility in Port Harcourt over a 3 year period. Background: The pattern of presentation of breast cancer among Nigerian women is that of prolonged delay, symptomatic breast cancer, advanced breast cancer and poor long-term survival. Seventy percent of cases of breast cancer present in advanced stage. Materials and Methods: The reasons for delayed hospital presentation among patients with breast cancer was assessed using a hospital-based longitudinal study. Data were obtained using a structured proforma. Retrieved data were entered into Microsoft Excel and exported to United States CDC Epi- Info version 7 for statistical analysis. Results: Out of 61 patients counselled for mastectomy, 11 (18%) declined while 50 (82%) accepted. 35 patients with late breast cancer accepted mastectomy while 7patients in the same category did not. Among patients who accepted mastectomy, 15 (30%) were early while 35 (70%) were late breast cancer. Conclusion: The relatively high acceptance of mastectomy seen in this study is tied to patients presenting in late stage of breast cancer. More work is required to improve acceptance of the procedure at early stages of the disease.

Efficacy and Safety of Vandetanib in Progressive and Symptomatic Medullary Thyroid Cancer: Post Hoc Analysis From the ZETA Trial.

PURPOSEWe conducted a post hoc analysis of the vandetanib phase III trial involving patients with advanced medullary thyroid cancer (MTC) to assess the efficacy and safety of vandetanib in patients with progressive and symptomatic MTC. The primary objective of the analysis was to determine progression-free survival (PFS) of these patients.PATIENTS AND METHODSEligible patients from the ZETA trial were divided into 4 disease severity subgroups: progression and symptoms, symptoms only, progression only, and no progression and no symptoms assessed at baseline. PFS, determined from objective tumor measurements performed by the local investigator, overall survival (OS), time to worsening of pain (TWP), and objective response rate (ORR) were evaluated.RESULTSOf the 331 patients in this trial, 184 had symptomatic and progressive disease at baseline. In this subgroup, results were similar in magnitude to those observed in the overall trial for PFS (hazard ratio [HR], 0.43; 95% CI, 0.28 to 0.64; P < .0001), OS (HR, 1.08; 95% CI, 0.72 to 1.61; P = .71), and TWP (HR, 0.67; 95% CI, 0.43 to 1.04; P = .07), and the observed adverse events were consistent with the known safety profile of vandetanib. In this subgroup, the ORR was 37% in the treatment arm versus 2% in the placebo arm.CONCLUSIONVandetanib demonstrated clinical benefit—specifically, increased PFS—in patients with symptomatic and progressive MTC.

Poor clinical outcomes for patients with cancer during the COVID-19 pandemic.

Poor clinical outcomes for patients with cancer during the COVID-19 pandemic.

Patient demographics and management challenges in an Irish symptomatic breast cancer unit.

Breast cancer is the most common cancer in women. Beaumont Hospital is a nationally designated symptomatic breast cancer unit, independent of the national screening programme, BreastCheck. We hypothesised that patients attending symptomatic breast cancer units differ from national registry data and aimed to characterise this in a retrospective study. A prospective database of patients diagnosed with breast cancer was maintained between 2014 and 2017. Multiple patient and tumour demographics were analysed retrospectively and compared with data from the National Cancer Registry. In total, 944 patients were diagnosed with breast cancer, 379 (40%) were aged < 50, 206 (22%) 50-64, 208 (22%) 65-75 and 151 (16%) > 75years respectively. Expectedly, older patients (≥65years) had a higher proportion of oestrogen receptor-positive, HER2-negative breast cancer (72%). Triple negative breast cancer was relatively more common (17%) among younger patients. These patients received more intensive chemotherapy: 118 (64%) received combination anthracycline-taxane chemotherapy, in comparison with only 14 (21%) of older patients. Patients generally presented at a later stage compared with national registry data: stage II 491 (52%) and stage III 179 (19%) versus stage II (50%) and stage III (13%). Patients attending the symptomatic breast cancer unit Beaumont Hospital have different demographics compared with the national registry data. This presents particular challenges for management.

Asymptomatic versus symptomatic metastatic breast cancer: Potential effects on prognosis and quality adjusted life years (QALYs).

e13073 Background: After radical surgery for breast cancer, routine laboratory or imaging studies for metastases screening are not indicated in the absence of clinical signs and symptoms suggestive of recurrence. While the goal of therapy is the extension of survival and maintenance of quality of life (QOL), therapies themselves could induce adverse events, resulting in deterioration of QOL. We evaluated quality adjusted life years (QALYs), which is survival adjusted by QOL, of the patients with recurrent breast cancer retrospectively and adequate follow-up measures. Methods: Fifty seven patients with recurrent breast cancer who died already were included. Survival curves were partitioned into two health states: time with ≥ grade 2 chemotherapy-related toxicity (TOX) and time without toxicity (TWiST). QALYs were acquired as follows: QALYs = TWiST + 0.7 * TOX. We compared clinical factors in the patients between with (symptomatic group, n = 32) and without symptoms (asymptomatic group, n = 25). Results: The median age of the patient at diagnosis of recurrence was 57 years. Luminal (hormone receptors (HR) - and human epidermal growth factor receptor-2 (HER2) -), HER2 (HER2 +), triple negative (TN) (HR - and HER2 -), and unknown were 29, 7, 15, and 6 cases, respectively. The proportion of HER2 and TN was significantly higher in the symptomatic group than that in the asymptomatic group (58.6, 21.7 %, p &lt; 0.05). 44.6 % of the patients had visceral metastases at diagnosis of recurrence and the proportions were not different between the groups. Although post recurrent survival (PRS) was shorter significantly in the symptomatic group (22.5, 42,0 months, p &lt; 0.01), overall survival from diagnosis of primary breast cancer (OS) was identical (60.5, 91.0 months). Additionally, QALYs after recurrence was shorter in the symptomatic group (23.0, 41.1 months, p &lt; 0.01) and QALYs from diagnosis of primary breast cancer was identical (58.7, 91.0 months). Conclusions: Although there was no significant difference in OS between the both groups, the duration of therapy received was longer in the symptomatic group. In the present study, we acquired limited information due to retrospective manner. Prospective evaluation of QALYs, including patient reported outcome and symptoms derived from cancer itself, would turn out adequate measures of follow-up after radical surgery for primary breast cancer.

Phase Ib study assessing different sequencing regimens of atezolizumab (anti-PD-L1) and sipuleucel-T (SipT)in patients who have asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.

e17564 Background: Combining an immune checkpoint inhibitor with a tumor vaccine may leverage complementary mechanisms of action for treatment of mCRPC. Atezolizumab, a fully human anti–PD-L1 IgG1 antibody, is an approved treatment option in multiple indications; while SipT, an autologous cellular immunotherapeutic, is approved for treatment of metastatic castrate resistant prostate cancer (mCRPC). We present a phase Ib study evaluating safety, tolerability and objective response rate of atezolizumab + SipT in patients with mCRPC (NCT03024216). Methods: Eligible patients who had asymptomatic or minimally symptomatic progressive mCRPC and met standard criteria for sipuleucel-T were randomized to receive either atezolizumab 1200 mg IV every 3 weeks for 2 doses then SipT IV every 2 weeks for a total of three infusions (Arm 1) or SipT IV every 2 weeks for a total of three infusions followed by atezolizumab 1200 mg IV every 3 weeks for 2 doses (Arm 2). The primary endpoint was safety, while secondary endpoints included objective tumor response (PCWG2 and modified RECISTv1.1 criteria) and comparing systemic immune responses after induction between the arms. Results: As of February 6, 2020, 37 pts (median follow-up 7.4 months, median age 75 yrs [range 53.0–86.0]; median number of previous treatments 4 [range 1-8], 75.7% ECOG PS = 0) were enrolled. Three patients did not complete induction therapy (1 – withdrew consent, 1 developed toxicity, and 1 progressed). There were no grade 5 toxicities attributed to study drugs and grade 4 toxicities were noted in 2 patients, 1 in each arm (Arm 1 bronchitis and Arm 2 hypotension). Eight grade 3 toxicities were noted in arm 1 (hyponatremia, pulmonary embolus x3, bone pain, hypophosphatemia, shock, tooth fracture from a fall), while 4 grade 3 toxicities were noted in arm 2 (anemia, hypertension x 2, pneumonia). None of the grade 3 or 4 SAEs were noted to be irAEs. At 6 months, there were 11 SD (7 in Arm 1 and 4 in Arm 2), 18 PD and 7 unevaluable (3 withdrew from study and 4 have yet to reach 6 month evaluation). At this time, PFS was noted to be 8.2 months in Arm 1 and 5.8 months in Arm 2 (p = 0.054). Conclusions: The safety profile of the combination of atezolizumab with sipuleucel-T appears manageable in a heavily pre-treated population and consistent with those agents administered as monotherapy. Responses were seen but no CR. Immune activation studies may shed light on which sequence is optimal. Clinical trial information: NCT03024216 .