Patient care and clinical outcomes for patients with COVID-19 infection admitted to African high-care or intensive care units (ACCCOS): a multicentre, prospective, observational cohort study
Publication Date
2021Author
Bruce M Biccard, Pragasan Dean Gopalan, Malcolm Miller, William Lance Michell, David Thomson, Adesoji Ademuyiwa, Ernest Aniteye, Greg Calligaro, Maman Sani Chaibou, Hailu Tamiru Dhufera, Mohamed Elfagieh, Mahmoud Elfiky, Muhammed Elhadi, Maher Fawzy, David Fredericks, Meseret Gebre, Abebe Genetu Bayih, Anneli Hardy, Ivan Joubert, Fitsum Kifle, Hyla-Louise Kluyts, Kieran Macleod, Zelalem Mekonnen, Mervyn Mer, Atilio Morais, Vanessa Msosa, Wakisa Mulwafu, Andrew Ndonga, Zipporah Ngumi, Akinyinka Omigbodun, Christian Owoo, Fathima Paruk, Jenna Lynn Piercy, Juan Scribante, Yakob Seman, Elliott Taylor, Dawid van Straaten, Ahmed Awad, Hend Hussein, Mahmoud Shaban, Merihan Elbadawy, Ahmed O Elmehrath, Ahmed Cordie, Mohamed Elganainy, Mostafa El-Shazly, Mahmoud Essam, Omar A Abdelwahab, Aboubakr Ali, Aliae Mohamed Hussein, Fatma A Monib, Islam Ahmed, Mahmoud M Saad, Mohammed Ali Al-Quossi, Nashwa Rafaat, Islam Galal, Dalia Omran Omran, Ahmed Azzam, Mohammed Azab, Ahmed Tawheed, Mahmoud Gamal, Mohamed El Kassas, Aml Azzam, Neama Ahmed, Yasmin NasrEldin, Omar Abdewahab, Omar Elmandouh, Meseret MeGebre, Abebe Addisie, Akine Eshete, Kokeb Desita, Hiruy Araya, Yared Agidew, Addisu Desalegn Andabo, Emnet Tesfaye, Elias Ali Yesuf, Gelaw Hailemariam, Menbeu Sultan Mohammed, Yemane Gebremedhin, Yoseph Taye, Tamiru Assefa Mebrate, Tirunesh Busha Gemechu, Tigist Tesfaye Bedane, Elias Tewabe Abera, Ayele Teshome, Ernest Aniteye Ernest Aniteye, Christian Owoo Christian Owoo, Alfred Doku, Jane Sandra Afriyie-Mensah, Aba Lawson, Daniel Akwanfo DYaw Sottie, Emma Addae, Ernest Ofosu-Appiah Ernest Ofosu-Appiah, William Obeng William Obeng, Anne Mugera, Caesar Bitta, Mohammed Abdalraheem Huwaysh, Mohammed Mahdi Ali Yahya, Alsnosy Abdullah Khalefa Mohammed, Amrajaa Alsalihin Mohammed Majeed, Amkhatirah Emad Mousay Mohammed, Elsalhein Majeed, Abdurraouf A Abusalama, Ehab Altayr, Taha Abubaker, Akram Mohammed Alkaseek, Butaina Abdulhafith, Zainab Alziyituni, Marwa F Gamra, Mohamed Muftah Anaiba, Samer Khel, Mohammed Abdelkabir, Saedah Abdeewi, Safia Adam, Abdulmueti Alhadi, Ahmed Alsoufi, Muhannad Hassan, Ahmed Msherghi, Ahmad Elmabri Mohammad Bouhuwaish, Francis Masoo, Singatiya stella Chikumbanje, Delia Mabedi, Antonio Carlos, Cesaltina Lorenzoni, Jorge Mambo, Isabel Isabel Chissaque, Mouzinho Mouzinho Saide, Maikassoua Mamane, Foumakoye Amadou, Adesoji Ademuyiwa Adesoji Ademuyiwa, Akinyinka Omigbodun Akinyinka Omigbodun, Ademola Adeyeye, Akinola Akinmade, Yakubu Momohsani, John Bamigboye, Donald Orshio, Erdoo Suckie Isamade, Henry Embu, Samuel Nuhu, Samuel Ojiakor, Ahmed Nuhu, Adeola Fowotade, Arinola Sanusi, Babatunde Osinaike, Olusola Idowu, Abdullahi Oteikwu Amali, Sanusi Ibrahim, Adamu Abba Adamu, Ibrahim Kida, Job Otokwala, Olubusola Alagbe-Briggs
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Show full item recordAbstract/ Overview
Background
Molecular imaging is increasingly used to guide treatment decisions and planning in prostate cancer. We aimed to evaluate the role of 18F-fluciclovine-PET/CT in improving cancer control compared with conventional imaging (bone scan and either CT or MRI) alone for salvage postprostatectomy radiotherapy.
Methods
In EMPIRE-1, a single-centre, open-label, phase 2/3 randomised controlled trial, patients with prostate cancer with detectable PSA after prostatectomy and negative conventional imaging (no extrapelvic or bone findings) were randomly assigned in a 1:1 ratio to radiotherapy directed by conventional imaging alone or to conventional imaging plus 18F-fluciclovine-PET/CT. Computer-generated randomisation was stratified by PSA concentration, adverse pathology indicators, and androgen deprivation therapy intent. In the 18F-fluciclovine-PET/CT group, radiotherapy decisions were rigidly determined by PET findings, which were also used for target delineation. The primary endpoint was 3 year event-free survival, with events defined as biochemical or clinical recurrence or progression, or initiation of systemic therapy, using univariate and multivariable analyses in patients who received radiotherapy. This trial is registered with ClinicalTrials.gov, NCT01666808 and is closed to new participants.
Findings
From Sept 18, 2012, to March 4, 2019, 165 patients were randomly assigned, with median follow-up of 3·52 years (95% CI 2·98–3·95). PET findings resulted in four patients in the 18F-fluciclovine-PET/CT group having radiotherapy aborted; these patients were excluded from survival analyses. Median survival was not reached (95% CI 35·2–not reached; 33% of 81 patients had events) in the conventional imaging group compared with not reached (95% CI not reached–not reached; 20% of 76 patients) in the 18F-fluciclovine-PET/CT group, and 3 year event-free survival was 63·0% (95% CI 49·2–74·0) in the conventional imaging group versus 75·5% (95% CI 62·5–84·6) for 18F-fluciclovine-PET/CT (difference 12·5; 95% CI 4·3–20·8; p=0·0028). In adjusted analyses, study group (hazard ratio 2·04 [95% CI 1·06–3·93], p=0·0327) was significantly associated with event-free survival. Toxicity was similar in both study groups, with the most common adverse events being late urinary frequency or urgency (37 [46%] of 81 patients in the conventional imaging group and 31 [41%] of 76 in the PET group), and acute diarrhoea (11 [14%] in the conventional imaging group and 16 [21%] in the PET group).
Interpretation
Inclusion of 18F-fluciclovine-PET into postprostatectomy radiotherapy decision making and planning significantly improved survival free from biochemical recurrence or persistence. Integration of novel PET radiotracers into radiotherapy decisions and planning for prostate cancer patients warrants further study.
Funding
National Institutes of Health/National Cancer Institute, Blue Earth Diagnostics, and Winship Cancer Institute of Emory University.
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