ABSTRACT
Goals: Wire-guided localisation (WGL) has been the standard technique for pre-operative localisation of non-palpable breast cancer (NPBC) for almost 40 years. However,WGL has several pitfalls including peri-operative scheduling challenges and patient discomfort. Savi Scout localisation (SSL) is a novel FDA-approved potential alternative, that utilises an implantable wireless non-radioactive reflector. A systematic review and meta-analysis was performed to compare the surgical outcomes of SSL versus WGL in NPBC surgery. Methods: Embase, MEDLINE, PubMed and the Cochrane Library (1946 to December 2020)were searched using PRISMA guidelines for studies comparing SSL andWGL in NPBC surgery. Outcome measures including operative duration, positive margins and re-excision were analysed. Results were pooled into meta-analyses using a Mantel- Haenszel Random-Effects model as Odds Ratios for dichotomous data and Mean Difference for continuous data with a 95% Confidence Interval. Results: Four eligible peer-reviewed studies involving 808 patients were identified comparing SSL (n = 462) andWGL (n = 346), including one prospective and three retrospective cohort studies. Therewas no significant difference between SSL and WGL in operative duration (minutes) (95% CI -0.27, -7.89 to 7.34, p = 0.94), positive margins (OR 0.73, 0.36 to 1.45, p = 0.36) and re-excision (OR 0.62, 0.33 to 1.16, p = 0.13). Inclusion of two excluded non-peer-reviewed retrospective cohort studies (additional SSL n = 143,WGL n = 424) altered statistical significance for re-excision in favour of SSL (OR 0.55, 0.36 to 0.83, p = 0.004). Conclusion(s): This study provides evidence that SSL is a safe and effective alternative to conventional WGL for NPBC surgery. SSL has the advantage of uncoupling pre-operative localisation from surgery, reducing scheduling challenges. This is particularly useful in the current COVID-19 climate, with pre-operative elective surgery patient self-isolation requirements. SSL may decrease the need for reexcision however further studies including randomised controlled trials are required to investigate this further. Conflict of Interest: No significant relationships
ABSTRACT
Aims: Wire-guided localisation (WGL) has been the standard technique for localisation of non-palpable breast cancers (NPBC) for almost 40 years. However, WGL has disadvantages including peri-operative scheduling challenges and patient discomfort. Savi Scout localisation (SSL) is a novel alternative that utilises an implantable wireless nonradioactive reflector. A systematic review and meta-analysis was performed to compare outcomes of SSL versus WGL in NPBC surgery. Methods: Embase, MEDLINE, PubMed and the Cochrane Library (1946 to December 2020) were searched using PRISMA guidelines for studies comparing SSL and WGL in NPBC surgery. Outcome measures analysed were operative duration, positive margins and re-excision. Results were pooled into meta-analyses using a Mantel-Haenszel Random- Effects model as Odds Ratios for dichotomous data and Mean Difference for continuous data. Results: Four eligible peer-reviewed cohort studies involving 808 patients were identified comparing SSL (n=462) and WGL (n=346). There was no significant difference between SSL and WGL in operative duration (95% CI -0.27, -7.89 to 7.34, p=0.94), positive margins (OR 0.73, 0.36 to 1.45, p=0.36) and re-excision (OR 0.62, 0.33 to 1.16, p=0.13). Inclusion of two non-peer-reviewed cohort studies (additional SSL n=143, WGL n=424) altered statistical significance for re-excision in favour of SSL (OR 0.55, 0.36 to 0.83, p=0.004). Conclusions: This study demonstrates that SSL is a safe and effective alternative to WGL. SSL uncouples pre-operative localisation from surgery, reducing scheduling challenges. This is particularly useful in the current COVID-19 climate, with pre-operative patient self-isolation requirements. SSL may decrease re-excision rates. Randomised controlled trials are required to investigate this further.
ABSTRACT
BACKGROUND Cellular therapies (allogeneic hematopoietic cell transplantation, allo-HCT, autologous hematopoietic cell transplantation, auto-HCT, and chimeric antigen receptor T cell therapy, CAR T) render patients severely immunocompromised for extended periods post-therapy. Emerging data suggest reduced immune responses to COVID-19 vaccines among patients with hematologic malignancies, but data for cellular therapy recipients are sparse. We therefore assessed immune responses to mRNA COVID-19 vaccines among patients who underwent cellular therapies at our center to identify predictors of response. PATIENT AND METHODS In this observational prospective study, anti-SARS-CoV-2 spike IgG antibody titers and circulating neutralizing antibodies were measured at 1 and 3 months after the 1 st dose of vaccination. CD4, CD19, mitogen, and IgG levels from patient samples collected prior to initiation of vaccination in a subset of patients were used to assess immune recovery and association with response. A concurrent healthy donor (HD) cohort provided control response rates. RESULTS Allo-HCT (N=149), auto HCT (N=61), and CAR T (N=7) patients vaccinated between 12/22/2020- 2/28/2021 with mRNA vaccines and 69 HD participated in this study. At 3 months, 188 pts (87%) had a positive anti-SARS-CoV-2 spike IgG levels (median 5,379 AU/mL, IQR 451-15,750), and 139 (77%) had a positive neutralization Ab assay (median 93%, IQR 36-96%). All HD (100%) had a positive anti-SARS-CoV-2 spike IgG and a positive neutralization Ab assay with median levels of 8,011 AU/mL (IQR 4573-11,159) and 96% (IQR 78- 96%), respectively. Time from vaccination to cellular therapy was associated with response;67% of patients vaccinated in the first 12 months post-cellular therapy (N=42) mounted a serologic response, compared with patients vaccinated between 12-24 (89%) (N=45), 24-36 (91%) (N=32) and >36 (93%) (N=98) months post-treatment, p= 0.001 (figure 1). Patients with immune parameters below the recommended threshold for vaccinations post-cellular therapies were also less likely to mount a response (figure 2): CD4+ T-cell count < 200 vs >200 cells/μL, 66% vs 87% (p=0.012);CD19+ B-cell count <50 vs >50 cells/μL;33% vs 95% (p<0.001), phytohemagglutinin mitogen response <40% vs >40%, 42% vs 89% (p<0.001), and IgG <500 vs >500 mg/dl, 71% vs 91% (p=0.003). Patient age, gender, prior COVID-19 infection, treatment with IVIG, and type of mRNA COVID-19 vaccine were not associated with the likelihood of serologic response. CONCLUSION This largest cohort to date, demonstrates that COVID-19 vaccine responses of cellular therapy recipients are reduced compared to healthy control and response varies based on time interval from cellular therapy and immune function at the time of vaccination, underscoring the importance of monitoring immune status parameters, as well as qualitative measures (neutralizing Ab) of vaccine response, in informing clinical decisions, including the indication for booster vaccines. [Formula presented] Disclosures: Politikos: Merck: Research Funding;ExcellThera, Inc: Other: Member of DSMB - Uncompensated. Vardhana: Immunai: Membership on an entity's Board of Directors or advisory committees. Perales: Equilium: Honoraria;Cidara: Honoraria;Sellas Life Sciences: Honoraria;Miltenyi Biotec: Honoraria, Other;Celgene: Honoraria;MorphoSys: Honoraria;Takeda: Honoraria;Incyte: Honoraria, Other;Karyopharm: Honoraria;Kite/Gilead: Honoraria, Other;Merck: Honoraria;NexImmune: Honoraria;Novartis: Honoraria, Other;Medigene: Honoraria;Omeros: Honoraria;Servier: Honoraria;Bristol-Myers Squibb: Honoraria;Nektar Therapeutics: Honoraria, Other. Shah: Amgen: Research Funding;Janssen Pharmaceutica: Research Funding.
ABSTRACT
Background: The Joint Committee on Intercollegiate Examinations (JCIE- domestic) is responsible for the supervision of standards, policies, regulations and professional conduct of the UK/Ireland Specialty Fellowship Examinations. The Joint Surgical Colleges’ Fellowship Examination (JSCFE- International) is organised by the JSCFE Committee in five specialities, and one of them is General Surgery. The syllabus for the examination is extensive and needs rigorous preparation. The Specialty Trainees (ST) get supervised structured training and regular assessments, and hence their pass rate is not only comparatively higher, but they are better prepared for the challenge. However, trainee surgeons who are outside the UK training programmes find the examination difficult. The COVID-19 pandemic has impacted surgical training and education by limiting access to conventional teaching methods and available resources. We have been running a teaching and formative assessment platform since May 2017. This teaching resource has helped several trainees in passing the examination and has proven to be a valuable learning resource in the pandemic. Materials and Methods: We provided examination support, guidance and supervision by running Skype/ Microsoft Teams sessions and weekend courses. We emphasised five critical steps in all our sessions and used our course website- WWW.PHOENIXFRCSCOURSE.COM for material 1- Using Landing Sentences to start at the MRCS level 2- 0- 60 mph concept - a safe but quick pace to move from the MRCS zone onto the FRCS zone 3- The MISTER-model of simulation and learning 4- Maintaining pace and grace under pressure 5- Interleaving- revising, rehearsing and consolidating difficult topics The sessions included model scenarios, table viva, academic reading, virtual clinics and peer to peer learning (Examiners’ Drills). The faculty were recent examination graduates and had attended such sessions before their exam success. We followed the JCIE marking descriptors for formative assessment and timely feedback. Results: The first such course was organised in May 2017 and since then (over 40 months) a total of 100 attendees: 90 candidates (domestic FRCS and International FRCS) and 10 observers went through our sessions and workshops. Some 50 virtual sessions and 8 courses (16 days of simulation workshops) have been held so far. 66 (15 CCT and 51 non-CCT) candidates took the examination and 54 passed (82%). Sum 23 candidates have either deferred their examination dates or have been delayed because of the COVID-19 pandemic and are being regularly supported. Conclusions: Simulation-based virtual teaching supplemented with weekend inhouse courses has the potential to improve FRCS Section-2 examination preparation and the success rate during COVID-19 pandemic.