Survival in the real world: A national analysis of patients treated for early-stage breast cancer.

75 Background: Many patient population groups are not proportionally represented in clinical trials, including patients of color, at age extremes, or with comorbidities. It is unclear how treatment outcomes may differ for these patients compared to those well represented in trials. Methods: This retrospective cohort study included women diagnosed with early-stage (I-III) breast cancer (EBC) between 2005-2015 in the CancerLinQ Discovery electronic medical record-based dataset. Patients with comorbidities or concurrent cancer were considered unrepresented in clinical trials. Non-White patients and/or those aged <45 or ≥70 years were considered underrepresented. Patients who were White and aged 45-69 were considered well represented. Overall and EBC subtype-stratified Cox proportional hazards models estimated hazard ratios (HR) and 95% confidence intervals (CI) for five-year mortality by representation group. The overall model was adjusted for cancer stage, subtype, chemotherapy intensity, and year of EBC diagnosis. Stratified models were adjusted for cancer stage, individual treatment regimen (due to lack of chemotherapy intensity variation within subtype), and year of EBC diagnosis. Results: Of 11,770 patients, most were aged 45-69 (71%), White (72%), diagnosed with stage II (51%), or HR+HER2- EBC (56%). Unrepresented patients (7%) were categorized due to comorbidities (76%), concurrent cancer (22%), or both (2%). Underrepresented patients (45%) were categorized based on age (44%), race/ethnicity (39%), or both (17%). The remaining patients were well represented in trials (48%). In adjusted models, unrepresented patients had almost three times the hazard of death than well-represented patients (HR 2.71, 95% CI 2.08-3.52; Table). The hazard of death for underrepresented versus well-represented patients was similar (HR 1.19, 95% CI 0.98-1.45). Comparable results were seen in EBC subtype-specific models. Conclusions: Over half of patients in this study would be considered underrepresented or unrepresented in clinical trials due to age, comorbidity, or race/ethnicity. Patients considered unrepresented in trials experienced poorer survival compared to those well-represented. Trialists should ensure study participants reflect the real-world disease population to support evidence-based decision making for all individuals with cancer.[Table: see text]

166 An audit of Patient Satisfaction after Breast Reconstruction and Presentation of a Novel Decision-Making Aid for Oncological Breast Surgery Patients

Background Breast reconstruction presents women with life-changing decisions at a time of immense pressure due to a concurrent cancer diagnosis. Objectives To assess whether patient satisfaction with breast care teams, patient autonomy in pre-operative consultation and information provision at Ysbyty Glan Clwyd (YGC) met the standards published in the National Mastectomy and Breast Reconstruction Audit (NMBRA), 2011. To use data collected to generate a novel decision-making aid. Method A patient satisfaction questionnaire, ‘Betsi-Q’, was created and sent to 100 mastectomy patients from YGC. Statistical significance was tested using Chi-squared test, T-test (Yates correction) and Z- score. Results Completed questionnaires were returned by 44 respondents (44%). Although shy of the 90% NMBRA recommendation, patient satisfaction with the team was reported high in 35/41 respondents (85%). The audit identified 36 respondents (86%) felt they made an informed decision regarding breast reconstruction, exceeding the 80% NMBRA recommendation. Information regarding the emotional and sexual benefits of breast reconstruction over mastectomy alone, were discussed with 10 respondents (26%), despite recommendations to discuss with all patients. Exploration of more than one option for breast reconstruction was only reported in 29/42 respondents (70%), below the 90% NMBRA recommendation. Conclusions Patient satisfaction with the team at YGC is high but efforts to ensure all patients are making an informed decision should be made. The decision-making tool designed alongside this audit aims to address these recommendations. Early identification and correction of misinformation, along increasing the variety of resources for patient education will be beneficial to manage expectations and enhance patient experience.

Valproic Acid-Like Compounds Enhance and Prolong the Radiotherapy Effect on Breast Cancer by Activating and Maintaining Anti-Tumor Immune Function

Inadequate sustained immune activation and tumor recurrence are major limitations of radiotherapy (RT), sustained and targeted activation of the tumor microenvironment can overcome this obstacle. Here, by two models of a primary rat breast cancer and cell co-culture, we demonstrated that valproic acid (VPA) and its derivative (HPTA) are effective immune activators for RT to inhibit tumor growth by inducing myeloid-derived macrophages and polarizing them toward the M1 phenotype, thus elevate the expression of cytokines such as IL-12, IL-6, IFN-γ and TNF-α during the early stage of the combination treatment. Meanwhile, activated CD8+ T cells increased, angiogenesis of tumors is inhibited, and the vasculature becomes sparse. Furthermore, it was suggested that VPA/HPTA can enhance the effects of RT via macrophage-mediated and macrophage-CD8+ T cell-mediated anti-tumor immunity. The combination of VPA/HPTA and RT treatment slowed the growth of tumors and prolong the anti-tumor effect by continuously maintaining the activated immune response. These are promising findings for the development of new effective, low-cost concurrent cancer therapy.

Focus on the expected quality of reporting in SBRT/radiosurgery prospective studies: how far have we come in 30 years?

Objectives: We aimed at describing and assessing the quality of reporting in all published prospective trials about radiosurgery (SRS) and stereotactic body radiotherapy (SBRT). Methods: The Medline database was searched for. The reporting of study design, patients’ and radiotherapy characteristics, previous and concurrent cancer treatments, acute and late toxicities and assessment of quality of life were collected. Results: 114 articles – published between 1989 and 2019 - were analysed. 21 trials were randomised (18.4%). Randomisation information was unavailable in 59.6% of the publications. Data about randomisation, ITT analysis and whether the study was multicentre or not, had been significantly less reported during the 2010–2019 publication period than before (respectively 29.4% vs 57.4% (p < 0.001), 20.6% vs 57.4% (p < 0.001), 48.5% vs 68.1% (p < 0.001). 89.5% of the articles reported the number of included patients. Information about radiation total dose was available in 86% of cases and dose per fraction in 78.1%. Regarding the method of dose prescription, the prescription isodose was the most reported information (58.8%). The reporting of radiotherapy characteristics did not improve during the 2010 s-2019s. Acute and late high-grade toxicity was reported in 37.7 and 30.7%, respectively. Their reporting decreased in recent period, especially for all-grade late toxicities (p = 0.044). Conclusion: It seems necessary to meet stricter specifications to improve the quality of reporting. Advances in knowledge: Our work results in one of the rare analyses of radiosurgery and SBRT publications. Literature must include necessary information to first, ensure treatments can be compared and reproduced and secondly, to permit to decide on new standards of care.

Multicentre cohort study of the impact of percutaneous coronary intervention on patients with concurrent cancer and ischaemic heart disease

Background The incidence of concurrent cancer and ischaemic heart disease (IHD) is increasing; however, the long-term patient prognoses remain unclear. Methods Five-year all-cause mortality data pertaining to patients in the Osaka Cancer Registry, who were diagnosed with colorectal, lung, prostate, and gastric cancers between 2010 and 2015, were retrieved and analysed together with linked patient administrative data. Patient characteristics (cancer type, stage, and treatment; coronary risk factors; medications; and time from cancer diagnosis to index admission for percutaneous coronary intervention [PCI] or IHD diagnosis) were adjusted for propensity score matching. Three groups were identified: patients who underwent PCI within 3 years of cancer diagnosis (n = 564, PCI + group), patients diagnosed with IHD within 3 years of cancer diagnosis who did not undergo PCI (n = 3058, PCI-/IHD + group), and patients without IHD (n = 27,392, PCI-/IHD- group). Kaplan–Meier analysis was used for comparisons. Results After propensity score matching, the PCI + group had better prognosis (n = 489 in both groups, hazard ratio 0.64, 95% confidence interval 0.51–0.81, P < 0.001) than the PCI-/IHD + group. PCI + patients (n = 282) had significantly higher mortality than those without IHD (n = 280 in each group, hazard ratio 2.88, 95% confidence interval 1.90–4.38, P < 0.001). Conclusions PCI might improve the long-term prognosis in cancer patients with IHD. However, these patients could have significantly worse long-term prognosis than cancer patients without IHD. Since the present study has some limitations, further research will be needed on this important topic in cardio-oncology.

Multicentre Cohort Study of the Impact of Percutaneous Coronary Intervention on Patients With Concurrent Cancer and Ischaemic Heart Disease

Background: The incidence of concurrent cancer and ischaemic heart disease (IHD) is increasing; however, the long-term patient prognoses remain unclear.Methods: Five-year all-cause mortality data pertaining to patients in the Osaka Cancer Registry, who were diagnosed with colorectal, lung, prostate, and gastric cancers between 2010 and 2015, were retrieved and analysed together with linked patient administrative data. Patient characteristics (cancer type, stage, and treatment; coronary risk factors; medications; and time from cancer diagnosis to index admission for percutaneous coronary intervention (PCI) or IHD diagnosis), were adjusted for propensity score matching. Three groups were identified: patients who underwent PCI within 3 years of cancer diagnosis (n=564, PCI+ group), patients diagnosed with IHD within 3 years of cancer diagnosis who did not undergo PCI (n=3058, PCI-/IHD+ group), and patients without IHD (n=27,392, PCI-/IHD- group). Kaplan-Meier analysis was used for comparisons. Results: After propensity score matching, the PCI+ group had better prognosis (n=489 in both groups, hazard ratio 0.64, 95% confidence interval 0.51–0.81, P<0.001) than the PCI-/IHD+ group. PCI+ patients (n=282) had significantly higher mortality than those without IHD (n=280 in each group, hazard ratio 2.88, 95% confidence interval 1.90–4.38, P<0.001). Conclusions: PCI might improve the long-term prognosis in cancer patients with IHD. However, these patients could have significantly worse long-term prognosis than cancer patients without IHD.

Elective staged proctocolectomy and living donor liver transplantation for colon cancer with sclerosing cholangitis-related ulcerative colitis: a case report

Background Primary sclerosing cholangitis (PSC) is a well-known complication of ulcerative colitis (UC), but it is rare to encounter patients requiring both living donor liver transplantation (LDLT) and proctocolectomy. We report a case of elective two-stage surgery involving proctocolectomy performed after LDLT for a patient with early colon cancer concurrent with PSC-related UC. To our knowledge, this is the first report of concurrent cancer successfully treated with both LDLT and proctocolectomy. Case presentation A 32-year-old Japanese man with colon cancer associated with UC underwent restorative proctocolectomy at 3 months after living donor liver transplantation (LDLT) for PSC. He was diagnosed with PSC and UC when he was a teenager. Conservative therapy was initiated to treat both PSC and UC. He had experienced recurrent cholangitis for years; therefore, a biliary stent was placed endoscopically. However, his liver function progressively deteriorated. Colonoscopic surveillance revealed early colon cancer; hence, surgical treatment was considered. PSC progressed to cirrhosis and portal hypertension; hence, LDLT was performed before restorative proctocolectomy. Three months after LDLT, we performed restorative proctocolectomy with ileal pouch–anal anastomosis. The postoperative course was uneventful. The patient was well, with good liver and bowel functions and without tumor recurrence, more than 1 year after proctocolectomy. Conclusions With strict patient selection and careful patient management and follow-up, elective proctocolectomy may be performed safely and effectively after LDLT for concurrent early colon cancer with PSC-related UC. There are no previous reports of the use of both LDLT and proctocolectomy for the successful treatment of PSC-related UC and concurrent cancer.

Contemporary Management of Acute Lower Limb Ischemia: Determinants of Treatment Choice

The role of endovascular procedures in the treatment of acute lower limb ischemia (ALI) is expanding. For treatment, the choice between surgical or endovascular is still debated. The aim of this study was to identify factors that determine the selection of treatment. This study included 307 ALI patients (209 with thrombosis). Patient details, factors affecting the procedure choice, and outcomes were analyzed. The majority of patients were operated on (52.4%). Surgery was more frequent in embolic patients with embolus (odds ratio (OR) 33.85; 95% confidence interval (CI) 6.22–184.19, p < 0.0001), severe ischemia (OR 1.79; 95% CI 1.2–2.66, p = 0.0041), and active cancer (OR 4.99; 95% CI 1.26–19.72, p = 0.02). Tibial arteries involvement was negatively related to surgery (OR 0.25; 95% CI 0.06–0.95, p = 0.04). The complications and amputation rates were comparable. Reinterventions were more common in the endovascular group (19 (20.2%) vs. 17 (8.9%), p = 0.007). The six-month mortality was higher in the operated patients (12.6% vs. 3.2%, respectively, p = 0.001). The determinants of the treatment path are ischemia severity, concurrent cancer, embolus, and peripheral lesion location. Modification of the Rutherford acute lower limb ischemia classification is required to improve the decision-making in patients with profound ischemia.