ABSTRACT
Background: DT combination has shown efficacy in the adjuvant setting for BRAF-mutated melanoma (BMM) patients (pts) in clinical trials. Previous reports from DESCRIBE-AD resulted in promising overall survival (OS) rates at 12 months. Methods: An observational retrospective study was carried out in 25 GEM sites in Spain. Histologically confirmed and resected BMM pts previously treated with DT according to standard clinical practice in the adjuvant setting were included. Only surgical resection was allowed as a prior treatment to DT. DT discontinuation rate and time to treatment discontinuation were the primary objective. Secondary objectives included safety and efficacy of the combination. Here, we report 3-year results for OS. Results: From 10/2020 to 03/2021, 65 pts were included. Median age was 58 years, 55% were male and 60%, 25%, and 14% had an ECOG PS 0/1/Uk respectively, one patient presented ECOG 3. Allocation of stage IIIA, IIIB and IIIC according to TNM AJCC 7th edition was 29%, 26% and 32%, respectively. There were 3 pts diagnosed at stage I/II but considered of risk, and 2 pts with stage IV but completely resected, all considered for adjuvant DT. Ulceration was present in 40%, Breslow ≥2 mm in 71%, and nodes were microscopically and macroscopically affected in 39% and 22% of pts, respectively. Only 9.2% of pts discontinued DT prematurely due to toxicity and 21.2% had dose reductions to manage toxicity. After a median follow-up of 36.2 m (range: 13-51.1), the overall OS rate at 3-years was 83.5% (95% CI: 74.5-93.5). According to AJCC 7 stage at diagnosis, the 3-years OS rate was 95.2% (95% CI: 86.6-100), 75% (56-100), and 76.8% (60.7-97.2) for stage I-II-IIIA, IIIB, and IIIC-IV respectively. Throughout the study period 11 (16.9%) pts died, of which 10 died due to disease progression and one due to COVID-19 infection. Conclusions: Adjuvant treatment with DT for melanoma achieved good treatment compliance and has proven efficacy in the real world. Adjuvant DT has a clinical impact in survival in line with previous clinical trial COMBI-AD. Editorial acknowledgement: We acknowledge Mfar Clinical Research staff for their assistance in the development of this . Legal entity responsible for the study: Grupo Español Multidisciplinar en Melanoma (GEM). Funding: Grupo Español Multidisciplinar en Melanoma (GEM) as Sponsor with Industry partner NOVARTIS. Disclosure: P. Cerezuela-Fuentes: Financial Interests, Personal, Other, Consultancy, conference,congress attendance/infrastructure: BMS, MSD, Pierre Fabre, Roche, Sanofi, SunPharma. J. Martín-Liberal: Financial Interests, Personal, Other, Lecture fees: Astellas, MSD;Financial Interests, Personal, Other, Lecture fees, advisory fees: Bristol Myers Squibb, Novartis, Pierre Fabre, Pfizer, Roche, Sanofi;Non-Financial Interests, Personal, Member, membership or affiliation: ASCO, ESMO, SEOM, GEM, EORTC, SOGUG, GEIS. L.A. Fernández-Morales: Financial Interests, Personal, Invited Speaker, Speak at sponsored meetings: BMS, MSD, Pierre-Fabre, Roche;Financial Interests, Personal, Other, Speak at sponsored meetings and advisory role: Novartis. J. Medina Martinez: Financial Interests, Personal, Other, Speaker, consultancy or advisory role or similar activity: Novartis, Roche, Pierre Fabre, BMS, MSD, Sanofi. M. Quindós: Financial Interests, Personal, Other, speaker, consultancy and advisory: AstraZeneca, GSK, Merck Sharp & Dohme, Novartis, PharmaMar, Roche, Bristol Myers Squibb, Pierre Fabre;Financial Interests, Institutional, Other, Clinical trials: Merck Sharp & Dohme, Roche, Bristol Myers Squibb. A. García Castaño: Non-Financial Interests, Advisory Role: Bristol, MSD, Novartis. T. Puértolas: Financial Interests, Personal, Invited Speaker, Speaker and advisory role: BMS, Novartis;Financial Interests, Personal, Invited Speaker: Roche, MSD, Sun-Pharma;Financial Interests, Personal, Other, Speaker and advisory role: Pierre-Fabre;Financial Interests, Personal, Advisory Role: Sanofi;Financial Interests, Institutional, Other, Clinical trial: Roche, BMS, Apexi en Inc, Aduro Biotech, Alkermes Inc;Non-Financial Interests, Institutional, Other, congresses inscriptions: Lilly, Sun-Pharma, Novartis, Roche, MSD;Non-Financial Interests, Institutional, Leadership Role, Vocal: GEM (Grupo Español Multidisciplinar de Melanoma);Non-Financial Interests, Institutional, Affiliate: SEOM (Sociedad Española de Oncología Médica), GEM (Grupo Español Multidisciplinar de Melanoma). P. Ayala de Miguel: Financial Interests, Personal, Invited Speaker, Public speaking: Novartis, Merck Sharp & Dohme, Sanofi, Pierre-Fabré. B. Campos: Financial Interests, Personal, Other, Speaker or advisory role: Roche, BMS, Sanofi, Novartis, Pierre-Fabre, Sun Pharma;Financial Interests, Personal, Other, Speaker role: AstraZeneca, Merck, ROVI, Leo Pharma. E. Espinosa: Financial Interests, Personal, Advisory Role, Advisory: BMS, MSD;Financial Interests, Personal, Other, Advisory, educational activities: Novartis;Financial Interests, Personal, Invited Speaker, Advisory, educational activities: Pierre Fabre;Financial Interests, Personal, Funding, Funding for translational investigation: Roche;Non-Financial Interests, Personal, Member, Vicepresident: Grupo Español Multidisciplinario de Melanoma. A. Rodríguez-Lescure: Financial Interests, Personal, Advisory Role: Pfizer, Novartis, ROCHE, AstraZeneca, Daiichi Sankyo, Seagen;Financial Interests, Personal, Invited Speaker, Public speaking: Pierre-Fabre;Financial Interests, Institutional, Research Grant, Grant for Clinical Trials: BMS, Lilly, Roche, Novartis, Amgen, Pzifer, Zimeworks, AstraZeneca, G1 Therapeutics, Bayer. L. Espasa Font: Financial Interests, Personal, Full or part-time Employment: Novartis. G. Belaustegui Ferrández: Financial Interests, Personal, Full or part-time Employment: Novartis. All other authors have declared no conflicts of interest.
ABSTRACT
Introduction: A better understanding of the reality for cancer patients during COVID-19 will help us readapt current predication models. To further inform future clinical guidelines, we need a deep dive into rich data sources from apex Cancer Centres. We report on the outcomes of cancer patients receiving radical surgery between March-September 2020 (as well as 2019) in the European Institute of Oncology (EIO) in Milan and the South East London Cancer Alliance (SELCA). Methods: IEO is one of the largest cancer hospitals in Italy. SELCA includes 3 major hospital trust, treating about 8,000 new cancer patients per annum. Both institutions implemented a COVID-19 minimal pathway, whereby patients were required to shield for 14 days prior to admission and were swabbed for COVID-19 within 3 days of surgery. Positive patients had surgery deferred until a negative swab. Surgical outcomes assessed were: ASA grade, surgery time, theatre time, ICU stay>24h, pneumonia, length of stay (LOS), and admissions. For COVID-19, we focused on infection rate and mortality. Results: At IEO the number of radical surgeries (270 for gynaecological, 339 for head and neck, 377 for thoracic, and 491 for urological cancers) declined by 6% as compared to the same period in 2019 (n=1477 vs 1560). The main decline was observed for thoracic surgery (377 vs 460, i.e. -18%). Age, sex, SES, ethnicity, comorbidities, and performance status were all comparable between both periods (e.g. 58% male, 38% aged 70+, 48% high SES, 15% with existing cardiovascular diseases). Readmissions were required for 39%, and <1% (n=9) developed COVID-19, of which only 1 had severe disease and died. 11 died of other causes during follow-up (1%). At SELCA, the number of radical surgeries (321 for breast, 129 for colorectal, 114 for gynaecological, 152 for head and neck, 92 for liver, 56 for plastics/skin, 305 for thoracic, 72 for upper gastrointestinal, and 312 for urology) declined by 29% (n=1553 vs 2182). Even though a different geographical setting, characteristics were fairly comparable with the IEO: 58% males, 30% aged 70+, 34% high SES, 16% with existing cardiovascular diseases. Readmissions were required for 22%, <1% (n=7) developed COVID-19, and none died from it. 19 died of other causes within 30 days (1%). Conclusion: Milan and London were both at the epicentre of the first COVID-19 wave. Whilst a decline in number of surgeries was observed, the implemented COVID-19 minimal pathways have shown to be safe for cancer patients requiring radical treatment, with limited complications and almost no COVID-19 infections.
ABSTRACT
OBJECTIVES: Tracheostomy for coronavirus disease 2019 pneumonitis patients requiring prolonged invasive mechanical ventilation remains a matter of debate. This study analysed the timing and outcomes of percutaneous tracheostomy, and reports our experience of a dedicated ENT-anaesthetics department led tracheostomy team. METHOD: A prospective single-centre observational study was conducted of patients undergoing tracheostomy, who had been diagnosed with coronavirus disease 2019 pneumonitis, between 21st March and 20th May 2020. RESULTS: Eighty-one patients underwent tracheostomy after a median (interquartile range) of 16 (13-20) days of invasive mechanical ventilation. Median follow-up duration was 32 (23-40) days. Of patients, 86.7 per cent were successfully liberated from invasive mechanical ventilation in a median (interquartile range) of 12 (7-16) days. Moreover, 68.7 per cent were subsequently discharged from hospital. On univariate analysis, there was no difference in outcomes between early (before day 14) and late (day 14 or later) tracheostomy. The mortality rate was 8.6 per cent and no deaths were tracheostomy related. CONCLUSION: Outcomes appear favourable when patients are carefully selected. Percutaneous tracheostomy performed via a multidisciplinary approach, with appropriate training, was safe and optimised healthcare resource utilisation.
ABSTRACT
OBJECTIVE: The global coronavirus disease 2019 (COVID-19) pandemic has necessitated rapid alterations to diagnostic pathways for head and neck cancer patients that aim to reduce risk to patients (exposure to the hospital environment) and staff (aerosol-generating procedures). Transoral fine needle aspiration cytology offers a low-risk means of rapidly diagnosing patients with oral cavity or oropharyngeal lesions. The technique was utilised in selected patients at our institution during the pandemic. The outcomes are considered in this study. METHOD: Diagnostic outcomes were retrospectively evaluated for a series of patients undergoing transoral fine needle aspiration cytology of oral cavity and oropharyngeal lesions during the COVID-19 pandemic. RESULTS: Five patients underwent transoral fine needle aspiration cytology, yielding lesional material in 100 per cent, with cell blocks providing additional information. In one case, excision biopsy of a lymphoproliferative lesion was required for final diagnosis. CONCLUSION: Transoral fine needle aspiration cytology can provide rapid diagnosis in patients with oral cavity and oropharyngeal lesions. Whilst limitations exist (including tolerability and lesion location), the technique offers significant advantages pertinent to the COVID-19 era, and could be employed in the future to obviate diagnostic surgery in selected patients.