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DATA AVAILABILITY STATEMENT
Data are available upon request.
PMC9939110
REFERENCES
PMC9939110
Background
tissue loss, CLI
CRITICAL LIMB ISCHEMIA
Critical limb ischemia (CLI) is associated with increased risk of tissue loss, leading to significant morbidity and mortality. Therapeutic angiogenesis using cell-based treatments, notably mesenchymal stem cells (MSCs), is essential for enhancing blood flow to ischemic areas in subjects suffering from CLI. The objectiv...
PMC10324209
Methods
CLI
This phase I dose-escalation study investigated P-MSCs in nine CLI patients who were enrolled into each of the two dosage groups (20 × 10
PMC10324209
Results
All dosages of P-MSCs, including the highest tested dose of 60 × 10
PMC10324209
Supplementary Information
The online version contains supplementary material available at 10.1186/s13287-023-03390-9.
PMC10324209
Keywords
PMC10324209
Introduction
DLTs, CLI, PAD, lower-extremity ischemia, toxicities, gangrene, atherosclerotic, pain, extracranial carotids, non-atherosclerotic
PERIPHERAL ARTERY DISEASE, ARTERIAL DISORDERS, GANGRENE, PAD, CRITICAL LIMB ISCHEMIA
Peripheral artery disease (PAD), except for aortic and coronary involvement, includes all arterial disorders. It is mainly associated with extracranial carotids, upper extremity arteries, renal and mesenteric arteries, and lower limb arteries [Critical limb ischemia (CLI), the most severe form of PAD, results in ischem...
PMC10324209
Materials and methods
PMC10324209
Patient recruitment and study design
arterial occlusion, diabetus mellitus, CLI, toxicity, diabetic foot, thromboangiitis
ARTERIAL OCCLUSION, DISEASE, HYPERCHOLESTEROLEMIA, DIABETIC FOOT, THROMBOANGIITIS, BUERGER DISEASE, TAO
Individuals with CLI who participated in the inpatient and outpatient vascular surgery services at Taleghani Hospital, whose primary treating vascular surgeons determined that they were not eligible for surgical or endovascular intervention but were considered suitable candidates, were offered to participate in this tr...
PMC10324209
Preparation of P-MSCs
P-MSCs were harvested from placental tissue acquired from a full-term delivery with written informed consent from a healthy mother and delivered fresh tissue. After successful vaginal birth at a maternity hospital, the placenta was obtained from informed, healthy women (Additional file According to the current GMP (Goo...
PMC10324209
Implant procedure
allergies, pain
ALLERGIES
P-MSCs were administered under spinal anesthesia (3 patients) or IV sedation (6 patients) to relieve pain. P-MSC treatment was administered at two time points, eight weeks apart. The total amount of the suspension was injected intramuscularly using a 30 G needle to a depth of 1–1.5 cm and an area of 10 × 6 cm (30–40 si...
PMC10324209
Outcome measurement and follow-up
ABI, tumor necrosis, TNF-α, CLI, pain, Cancer
ADVERSE EVENT, TUMOR NECROSIS, ADVERSE EVENTS, LIMB ISCHEMIA, ULCERS, ULCERATION, CANCER
To assess the safety and effectiveness of P-MSC injections in the enrolled participants, we assessed medical records, electrocardiogram (ECG) results, vital signs (respiration, heart rate, blood pressure, oxygen saturation, and body temperature), blood chemistry, physical examination reports, digital photographs of wou...
PMC10324209
Statistical analysis
Individual data are described using frequency graphs and tables. Categorical data were summarized as counts and percentages. All data from participants who withdrew prematurely from the study were included in any analysis where possible. The data were transferred to a statistical package for analysis (GraphPad Prism 9....
PMC10324209
Results
PMC10324209
Characteristic of patients
CLI
From April 2022 to August 2022, 15 patients with CLI were recruited for the clinical trial to determine their eligibility for study enrolment. Of these, 11 patients received treatment with P-MSCs, and eight patients completed the trial. Three patients were excluded from the study because of clinical worsening (Fig. Flo...
PMC10324209
Safety evaluation of P-MSC therapy
TNF-α, tumor necrosis, CLI, diarrhea, pruritus
DISEASE PROGRESSION, MINOR, ADVERSE EVENT, TUMOR NECROSIS
The MTD was not reached after P-MSC treatment, as no cases of DLT or AEs leading to discontinuation of P-MSC treatment were reported in this trial. Intramuscular injection of all doses of P-MSCs, including the maximum tested dose of 60 × 10Two patients experienced moderate post-injection diarrhea a day after cell thera...
PMC10324209
Secondary outcome measures of P-MSC therapy
PMC10324209
Angiogenesis
placenta-derived mesenchymal stem cells (P-MSC).
We evaluated arterial angiography data 6 months after cell injection and classified the degree of collateral vessel development as + 0 (no collateral circulation), + 1 (slight collateral circulation), + 2 (moderate collateral circulation), and + 3 (high collateral circulation) [Changes in collateral artery development ...
PMC10324209
Pain relief and physical functioning
pain
At the beginning of the trial and at the 1-, 3-, and 6-month follow-up visits, the rest pain was assessed using VAS (Table Efficacy parameters: As shown in Fig. In six patients, the treadmill test performed to determine the maximum walking distance improved significantly (The VascuQoL-6 survey was used to subjectively ...
PMC10324209
Ulcer healing and Limb salvage
amputation, Gangrene, gangrene, ulcers, amputations, ulcer/gangrene, TAO, necrosis, ulcer, gangrenes, sores
THROMBOANGIITIS OBLITERANS, MINOR, WOUND INFECTION, GANGRENE, ULCERS, GANGRENE, NECROSIS, ISCHEMIC NECROSIS, SUPERINFECTION, ULCER, GANGRENES, TAO
Ten extremities completed the 6-month follow-up study. At baseline, nine limbs had non-healing sores, necrosis, and gangrene. Throughout the 6-month follow-up period, one limb demonstrated significant healing of the ulcer, and two limbs with ulcers and gangrenes did not progress and remained entirely dry. We performed ...
PMC10324209
Discussion
Pain, non-atherosclerotic PAD, CLI, amputation, amputations, pain, ill, major amputations, ulcer
LIMB ISCHEMIA, DISEASE, MINOR, SECONDARY, ISCHEMIC ULCERS, ULCERATION, ULCER, COMPLICATIONS
In ischemic lesions in CLI patients, normal vascular regeneration mechanisms, including angiogenesis and arteriogenesis, do not take place [No clinical research has documented the safety and effectiveness of utilizing P-MSCs to treat patients with non-atherosclerotic PAD. Therefore, in this primary clinical trial, we a...
PMC10324209
Conclusions
CLI
CRITICAL LIMB ISCHEMIA
In conclusion, our observations from this early clinical trial indicate that intramuscular treatment with high doses of P-MSCs is safe and well tolerated. Despite our encouraging results, we cannot claim that MSC treatment is beneficial and safe for patients with CLI. To fill this knowledge gap regarding the therapeuti...
PMC10324209
Acknowledgements
We deeply appreciate the efforts by Mahmood Bozorgmehr and Faezeh Maghsood for their assistance with data analysis.
PMC10324209
Author contributions
MH, ZSH
This article is a part of the Ph.D. thesis by ZSH at Shahid Beheshti University of Medical Sciences, Tehran, Iran. MS proposed the initial idea. MS designed and supervised the in vitro section, and MH supervised the clinical section of the study. ZSH designed and carried out all laboratory jobs and data analysis, and m...
PMC10324209
Funding
This work was carried out under the grant of School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran, with the ID number of 61342 and ethical code of IRCT20210221050446N1. The funding body played no role in the design of the study and collection, analysis, and interpret...
PMC10324209
Availability of data and materials
All data generated or analyzed during this study are included in this published article.
PMC10324209
Declarations
PMC10324209
Ethics approval and consent to participate
CLI
CRITICAL LIMB ISCHEMIA
This project under the title “Safety assessment for transplantation of adaptive human placental mesenchymal stem cells in patients with Critical limb ischemia (CLI): clinical trial phase 1” was approved by Ethical Committee of Shahid Beheshti University of Medical Sciences (IR.SBMU.REC.1400.025) (Approval date: 12/12/2...
PMC10324209
Consent for publication
Not relevant.
PMC10324209
Competing interests
The authors declare that they have no competing interests.
PMC10324209
References
PMC10324209
Background
bullous disorder, pemphigoid
BULLOUS DISORDER, PEMPHIGOID
Edited by: Vinay Keshavamurthy, Post Graduate Institute of Medical Education and Research (PGIMER), IndiaReviewed by: Yuval Tal, Hadassah Medical Center, Israel; Daisuke Tsuruta, Osaka City University, JapanBullous pemphigoid (BP) is a common subepidermal bullous disorder that lacks adequate treatment alternatives. Dup...
PMC10399451
Methods
hyperpigmentation, eczematous lesion, pruritus, urticarial, various disease severities
HYPERPIGMENTATION, ERUPTIONS, REMISSION, URTICARIAL, DISEASE
BP patients with various disease severities and comorbidities were included in this case series. All patients received dupilumab alone or in combination with immunosuppressants in a real-world setting. Complete remission (CR) was defined as the absence of pruritus symptoms and previous BP eruptions, with only hyperpigm...
PMC10399451
Findings
Pruritus, eosinophilia
PRURITUS, ERUPTIONS, EOSINOPHILIA
Ten individuals were enrolled in this case series. Pruritus symptoms and BP eruptions improved significantly in nine patients (90%). Seven patients (70%) attained CR, including all mild-to-moderate (100%) cases and three of six (50%) severe BP cases. At the dupilumab monotherapy stage, eosinophilia was observed in two ...
PMC10399451
Conclusion
Eosinophilia, mild-to-moderate disease
EOSINOPHILIA
Treatment of BP with diverse comorbidities with anti-IL-4 receptor α antibody provides further credentials to a prospective randomized study. More impressive efficacy and safety profiles were observed in patients with mild-to-moderate disease after 1 year of follow-up. Eosinophilia may occur in patients receiving dupil...
PMC10399451
Introduction
autoimmune subepidermal bullous disorder, Dupilumab, atopic dermatitis, Bullous pemphigoid, pruritus, AD
BULLOUS PEMPHIGOID, ATOPIC DERMATITIS, PATHOGENESIS
Bullous pemphigoid (BP) is a common autoimmune subepidermal bullous disorder that primarily affects older people, with tense bullae and pruritus as its characteristic clinical manifestations (The importance of T helper 2 (Th2) cells and the Th2 molecule milieu in the pathogenesis of BP has been demonstrated. Dupilumab ...
PMC10399451
Methods
blisters, pruritus, ONFH, MP
INFILTRATION, OSTEONECROSIS OF THE FEMORAL HEAD, BULLOUS PEMPHIGOID, DISEASE, ADVERSE EFFECTS, BULLOUS PEMPHIGOID, DISEASE
Patients from the Department of Dermatology, Peking Union Medical College Hospital (PUMCH), were recruited in the case series. All patients were diagnosed with BP using at least three of the following methods: (i) hematoxylin and eosin staining demonstrating subepidermal blisters and eosinophil infiltration; (ii) direc...
PMC10399451
Results
itching, bullae, hypertension, erythema, herpes, reduction in skin lesion, eosinophilic leukemia, parasite infection, eosinophilia, pruritus, hyperkalemia, blisters, herpes zoster, coronary heart disease, skin lesions, allergic diseases
VIRUS, OEDEMA OF THE LOWER LIMBS, RECURRENCE, HYPERTENSION, DISEASE, ERYTHEMA, HERPES, KIDNEY INSUFFICIENCY, EOSINOPHILIC LEUKEMIA, EOSINOPHILIA, CARDIAC INSUFFICIENCY, ERUPTIONS, REMISSION, ADVERSE EVENT, HERPES ZOSTER, CORONARY HEART DISEASE, SKIN LESIONS
Nine patients (90%) receiving dupilumab therapy showed notable improvements in their pruritus symptoms and BP eruptions. Seven patients (70% of the total) obtained CR. On average, it took 8.3 weeks (58 days) for seven patients to achieve CR. In our case series, 100% of mild-to-moderate cases attained CR. Of the severe...
PMC10399451
Discussion and overview of literature
Eosinophilia, bullae, hypereosinophilia, inflammation, asthma, AD, MP
RECURRENCE, EOSINOPHILIA, BULLOUS PEMPHIGOID, PROLIFERATION, HYPEREOSINOPHILIA, DISEASE, DISEASE, INFLAMMATION, ADVERSE EVENT, BULLOUS PEMPHIGOID, ASTHMA, CHRONIC EOSINOPHILIC PNEUMONIA, REMISSION, SEPARATION, PATHOLOGY, PATHOGENESIS, COMPLICATIONS
BP, the most prevalent autoantibody-mediated cutaneous blistering disorder, is characterized by pruritic vesicles or bullae and primarily affects older people. Pathogenic B and T cells, autoantibodies, and inflammatory cytokines/chemokines are significant in the characteristic pathology of BP (The pathogenesis and emer...
PMC10399451
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
PMC10399451
Ethics statement
This study was approved by the ethics committee of Peking Union Medical College Hospital (ethics document number: JS-3132). The patients/participants provided their written informed consent to participate in this study.
PMC10399451
Author contributions
DISEASE, BULLOUS PEMPHIGOID
S-HW wrote the manuscript with significant contributions from Y-GZ. S-ZL and YS assessed the Bullous Pemphigoid Disease Area Index. Y-GZ collected clinical pictures and revised the article critically. All authors contributed to the article and approved the submitted version.
PMC10399451
Acknowledgments
PMC10399451
Conflict of interest
Y-GZ served as a speaker for Sanofi, but this was not associated with this study.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
PMC10399451
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ...
PMC10399451
References
PMC10399451
Supplementary Information
endometrial cancer
ENDOMETRIAL CANCER
Second-line treatment of endometrial cancer is an unmet medical need. Lurbinectedin showed promising antitumor activity in a phase I study in combination with doxorubicin in advanced endometrial cancer. This phase 2 Basket trial evaluated lurbinectedin 3.2 mg/mThe online version contains supplementary material availabl...
PMC10560193
Keywords
PMC10560193
Introduction
cancer, endometrial cancer, TCGA, Endometrial cancer
CANCER, ENDOMETRIAL CANCER, ENDOMETRIAL CANCER
Endometrial cancer is the sixth most common cause of cancer in females with 417,000 cases every year [Lurbinectedin (ZEPZELCAThis report focuses on the outcomes of the endometrial cancer cohort. In addition, retrospective biomarker analysis based on TCGA and PromiSe molecular subtypes was explored. This cohort was eval...
PMC10560193
Methods
The study protocol was approved by the Independent Local Ethics Committee of each participating center and was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and local regulations for clinical trials. Signed informed consent was obtained from all patients prior to any study...
PMC10560193
Patient selection
Tumors, endometrial cancer
DISEASE, ENDOMETRIAL CANCER, ENDOMETRIAL CARCINOMA, TUMORS
Seventy-three patients with endometrial cancer were treated at 19 investigational sites in Belgium (n = 3), France (n = 17), Germany (n = 2), Spain (n = 23), Switzerland (n = 2), the United Kingdom (n = 9), and the USA (n = 17). Eligibility criteria included patients ≥ 18 years old with pathologically proven diagnosis ...
PMC10560193
Lurbinectedin treatment
All patients were treated with lurbinectedin 3.2 mg/m
PMC10560193
Efficacy and safety assessments
tumor, Toxicity, Cancer
ADVERSE EVENT, TUMOR, ADVERSE EVENTS, DISEASE, CANCER
The primary objective of this study was to assess the antitumor activity of lurbinectedin in terms of ORR, primary endpoint, assessed by the investigators. Radiological tumor evaluation was performed every six weeks (two cycles) until Cycle 6, and every nine weeks (three cycles) thereafter. Objective response was to be...
PMC10560193
Translational study
cancer, tumor, tumors
CANCER, TUMOR, TUMORS, PATHOGENESIS
Fifty of 73 treated patients (68.5%) had available archived formalin-fixed paraffin-embedded tumor samples and consented to participate in an optional translational study. In order to characterize patients’ tumors, a next generation sequencing (NGS) custom gene panel was performed, targeting 151 genes involved in cance...
PMC10560193
Statistical methods
REGRESSION, RECRUITMENT
Up to 50 evaluable patients were to be recruited to test the null hypothesis that 10% or less patients get a response (p ≤ 0.10) Initially, 15 patients were to be included in a first stage. If one confirmed response occurred in the first 15 evaluable patients, recruitment had to continue up to 25 evaluable patients. Tw...
PMC10560193
Results
PMC10560193
Lurbinectedin treatment
neutropenia, leukopenia, febrile neutropenia, hematological toxicity, anemia
LEUKOPENIA, NEUTROPENIA, ANEMIA, FEBRILE NEUTROPENIA
A total of 378 cycles were administered to the 73 treated patients. The median number of cycles per patient was 4 (range, 1–22 cycles), with 31.5% of patients having received ≥ 6 cycles. The median relative dose intensity was 97.7% (range, 64.9–102.9%). Twenty patients had treatment-related dose delays, being hematolog...
PMC10560193
Discussion
carcinosarcoma, endometrial cancer, tumor, endometrioid tumors, endometrial carcinoma
CARCINOSARCOMA, ENDOMETRIAL CANCER, TUMOR, ENDOMETRIAL CARCINOMA, ENDOMETRIOID TUMOR
This cohort from a phase 2 exploratory Basket study included 73 patients with pretreated endometrial cancer who received therapy with single-agent lurbinectedin. ORR according to RECIST v.1.1 was 11.3% (95%CI, 5.0–21.0%). Responses were mostly observed in patients with endometrioid tumors and the median of prior lines ...
PMC10560193
Acknowledgements
Cancer
CANCER
We gratefully acknowledge the patients, their families and the investigator teams. Vivek Subbiah is an Andrew Sabin Family Foundation Fellow at The University of Texas MD Anderson Cancer Center. Vivek Subbiah acknowledges support of The Jacquelyn A. Brady Fund.
PMC10560193
Author contributions
Pierre
Rebecca Kristeleit: Investigation, Resources, Writing – review & editing. Alexandra Leary: Investigation, Resources, Writing – review & editing. Jean Pierre Delord: Investigation, Resources, Writing – review & editing. Victor Moreno: Investigation, Resources, Writing – review & editing. Ana Oaknin: Investigation, Resou...
PMC10560193
Funding
Anderson Cancer, Cancer
CANCER
The study was funded by Pharma Mar S.A, including partial funding by grants from the Centro para el Desarrollo Tecnológico Industrial (CDTI) during the conduct of the study (grant number IDI-20150006). VS is supported by a US National Institutes of Health (NIH) grant (no. R01CA242845 and R01CA273168); MD Anderson Cance...
PMC10560193
Data availability
Individual participant data are not publicly available since this requirement was not anticipated in the study protocol considering that this trial started patient enrolment in 2015. Clinical trial summary results were placed in the European Clinical Trials Database (EudraCT;
PMC10560193
Declarations
PMC10560193
Ethical approval
All procedures performed were in accordance with the ethical standards of the institutional and/or national research committees, and with the Declaration of Helsinki or comparable ethical standards.
PMC10560193
Informed consent
Written informed consent was obtained from all patients included in the study.
PMC10560193
Competing interests
Cancer
ONCOLOGY, EVENTS, CANCER, EMD
Alexandra Leary has grants or contracts from Agenus, Astra Zeneca, BMS, GSK, Iovance, MSD, OSE Immuno, Roche as principal investigator in clinical trials and from ARCAGY-GYENCO, AZ, Sanofi for translational research; has payment as invited speaker from Astra Zeneca, Clovis, GSK, Kephren publishing, Medscape; payment fo...
PMC10560193
References
PMC10560193
Background
malaria
MALARIA
A better understanding of vector distribution and malaria transmission dynamics at a local scale is essential for implementing and evaluating effectiveness of vector control strategies. Through the data gathered in the framework of a cluster randomized controlled trial (CRT) evaluating the In2Care (Wageningen, Netherla...
PMC10288776
Methods
infection
MAY, INFECTION
From May 2017 to April 2019, adult mosquitoes were collected monthly using human landing catches (HLC) in twenty villages in Gbêkê region. Mosquito species wereidentified morphologically. Monthly entomological inoculation rates (EIR) were estimated by combining the HLC data with mosquito sporozoite infection rates meas...
PMC10288776
Results
Overall,
PMC10288776
Conclusion
malaria
MALARIA, DISEASE
These results demonstrate that the intensity of malaria transmission is extremely high in Gbêkê region, especially during the rainy season. The study highlights the risk factors of transmission that could negatively impact current interventions that target indoor control, as well as the urgent need for additional vecto...
PMC10288776
Keywords
PMC10288776
Background
diagnosisof, AIDS, malaria, Tuberculosis, deaths
MALARIA, AIDS, TUBERCULOSIS, MAY, MALARIA
Malaria is still a major public health problem in sub-Saharan Africa despite improvements in the diagnosisof the pathogens and large-scale deployment of vector control tools, such as long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS). According to the World Malaria Report 2021, a slight upward tr...
PMC10288776
Methods
PMC10288776
Study area and trial design
malaria
MALARIA
The study was carried out in the Gbêkê region in central Côte d’Ivoire. This region is characterized by wet savannah with a single annual rainy season (April to November) followed by a long dry season (December to March). There was an average annual rainfall of 1223 mm and an average temperature of 26.3  C during the s...
PMC10288776
Mosquito sampling
MAY
Each month between May 2017 and April 2019, mosquitoes were sampled using human landing catches (HLC) both indoors and outdoors for one night at four randomly selected houses in the 20 study villages (Fig. A map of study area, showing sampling villagesMonthly rainfall and temperature data during the study period was ob...
PMC10288776
Determining
A random subset of 59,901 captured
PMC10288776
Data analysis
Human landing catch captures were done monthly and then the data were pooled every two months for analysis. The human biting rate (HBR, the number of Anopheles vectors collected per person per night), the sporozoite rate (SR, the number of vectors positive for sporozoites over the number of vectors tested) and the ento...
PMC10288776
Results
PMC10288776
Species composition and vector distribution
malaria
MALARIA, MAY
A total of 157,645 mosquitoes belonging to four genera were collected over 4,880 sampling person-nights using HLC methods (Table Diversity and abundance of mosquito species from 20 villages in Gbêkê region from May 2017 to April 2019Overall, Entomological outcomes by season and collection location for SR: Sporozoite ra...
PMC10288776
Dynamics of malaria transmission
PMC10288776
Seasonal abundance and biting patterns of Anopheles mosquitoes
malaria
MALARIA
The monthly abundance of human-biting Monthly abundances of human-biting Anopheles species in Gbêkê regionDuring the sampling period, more vectors (of the Mean density of Abundance of malaria vectors varied from one year to the other (Table Entomological outcomes for [95% CI]: 95% Confidence intervalHourly catches of A...
PMC10288776
Parity and sporozoite infection rate
We dissected 71,951 Anopheles for determination of parous rate. Overall, A total of 14,490 When considering the collection years, the sporozoite rate of
PMC10288776
Entomological inoculation rate (EIR)
malaria
MALARIA
In Gbêkê region, malaria transmission occurred all year long (Fig. Monthly variation of entomological inoculation rate for Anopheles species from may 2017 to april 2019
PMC10288776
Discussion
malaria
MALARIA
This study was conducted to characterize The study of malaria transmission revealed that three common African This study demonstrated that the malaria vector species and abundance and malaria transmission intensity in the Gbêkê region varied significantly according to the season. High risk of malaria transmission was r...
PMC10288776
Conclusions
MALARIA
Malaria transmission in the Gbêkê area was mainly due to
PMC10288776
Acknowledgements
We thank all participants of the study, especially technicians at the VCPEC-IPR for their technical assistance. We are also, grateful to the villagers of all sites for their kind collaboration.
PMC10288776
Author contributions
RN, AAK, EDS, MBT, JC and LPAA conceived and designed the study. LPAA, RZW, EDS, IZT, WAO, FHAY and SC participated in the data collection, laboratory and data management work. RN, AAK, EDS and LPAA supervised the study. SC and LPAA analysed the data. SC and AAK wrote the manuscript. All authors revised the manuscript....
PMC10288776
Funding
This study was made possible by the support of the Pennsylvania State University from the Bill & Melinda Gates Foundation (OPP1131603).
PMC10288776
Availability of data and materials
The datasets used and/or analysed during the current study are available At Intitut Pierre Richet/Institut national de santé Publique and will be made available on reasonable request.
PMC10288776
Declarations
PMC10288776
Ethics approval and consent to participate
malaria, yellow fever
MALARIA, YELLOW FEVER
The trial was reviewed and approved by the Côte d’Ivoire Ministry of Health ethics committee (039/MSLS/CNER-dkn). We also obtained written and verbal informed consent from all trial participants. Mosquito collectors were immunized against yellow fever and medical supervision was provided during the trial. Confirmed mal...
PMC10288776
Consent for publication
Not applicable.
PMC10288776
Competing interests
The authors declare that they have no competing interests.
PMC10288776
References
PMC10288776
Subject terms
The bevacizumab (bev)/olaparib (ola) maintenance regimen was approved for
PMC10673712
Introduction
ovarian cancer, HRD
OVARIAN CANCER
Homologous recombination deficiency (HRD) associated with inactivation of mainly PARPi have been extensively tested in patients with ovarian cancer. Six phase III clinical trials have demonstrated that maintenance with a PARPi, with or without bevacizumab (bev), following platinum-based therapy in patients with newly d...
PMC10673712
Kaplan–Meier Estimates of Progression-free Survival and Overall survival according to ShallowHRDv2 or Mychoicetest in PAOLA-1 trial.
tumors, scars
TUMORS
Kaplan–Meier estimates of (Importantly, The main advantage of detecting HRD by genomic scars is to identify tumors deficient for HRR pathway in the absence of
PMC10673712
Discussion
tumor, HRD
TUMOR
Assessment of HRD status is mandatory to balance benefit and risks of PARPi maintenance in newly diagnosed AOC patients. We report here clinical validation of Analysis of the discordant cases between The clinical value of HRD testing may not be restricted to the question of ola in AOC. Contrary to ola, which has not be...
PMC10673712