Global Retinoblastoma Study Group IMPORTANCE Early diagnosis of retinoblastoma, the most common intraocular cancer, can save both a child's life and vision. However, anecdotal evidence suggests that many children across the world are diagnosed late. To our knowledge, the clinical presentation of retinoblastoma has never been assessed on a global scale.OBJECTIVES To report the retinoblastoma stage at diagnosis in patients across the world during a single year, to investigate associations between clinical variables and national income level, and to investigate risk factors for advanced disease at diagnosis. DESIGN, SETTING, AND PARTICIPANTSA total of 278 retinoblastoma treatment centers were recruited from June 2017 through December 2018 to participate in a cross-sectional analysis of treatment-naive patients with retinoblastoma who were diagnosed in 2017. MAIN OUTCOMES AND MEASURESAge at presentation, proportion of familial history of retinoblastoma, and tumor stage and metastasis. RESULTSThe cohort included 4351 new patients from 153 countries; the median age at diagnosis was 30.5 (interquartile range, 18.3-45.9) months, and 1976 patients (45.4%) were female. Most patients (n = 3685 [84.7%]) were from low-and middle-income countries (LMICs). Globally, the most common indication for referral was leukocoria (n = 2638 [62.8%]), followed by strabismus (n = 429 [10.2%]) and proptosis (n = 309 [7.4%]). Patients from high-income countries (HICs) were diagnosed at a median age of 14.1 months, with 656 of 666 (98.5%) patients having intraocular retinoblastoma and 2 (0.3%) having metastasis. Patients from low-income countries were diagnosed at a median age of 30.5 months, with 256 of 521 (49.1%) having extraocular retinoblastoma and 94 of 498 (18.9%) having metastasis. Lower national income level was associated with older presentation age, higher proportion of locally advanced disease and distant metastasis, and smaller proportion of familial history of retinoblastoma. Advanced disease at diagnosis was more common in LMICs even after adjusting for age (odds ratio for low-income countries vs upper-middle-income countries and HICs, 17.92 [95% CI,, and for lower-middle-income countries vs upper-middle-income countries and HICs, 5.74 [95% CI,). CONCLUSIONS AND RELEVANCEThis study is estimated to have included more than half of all new retinoblastoma cases worldwide in 2017. Children from LMICs, where the main global retinoblastoma burden lies, presented at an older age with more advanced disease and demonstrated a smaller proportion of familial history of retinoblastoma, likely because many do not reach a childbearing age. Given that retinoblastoma is curable, these data are concerning and mandate intervention at national and international levels. Further studies are needed to investigate factors, other than age at presentation, that may be associated with advanced disease in LMICs.

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a world-wide pandemic. Internationally, because of availability, accessibility, and distribution issues, there is a need for additional vaccines. This study aimed to: establish the feasibility of personal dendritic cell vaccines to the SARS-CoV-2 spike protein, establish the safety of a single subcutaneous vaccine injection, and determine the antigen-specific immune response following vaccination. In Phase 1, 31 subjects were assigned to one of nine formulations of autologous dendritic cells and lymphocytes (DCL) incubated with 0.10, 0.33, or 1.0 µg of recombinant SARS-CoV-2 spike protein, and admixed with saline or 250 or 500 µg of granulocyte-macrophage colony-stimulating factor (GM-CSF) prior to injection, then assessed for safety and humoral response. In Phase 2, 145 subjects were randomized to one of three formulations defined by incubation with the same three quantities of spike protein without GM-CSF, then assessed for safety and cellular response. Vaccines were successfully manufactured for every subject at point-of-care. Approximately 46.4% of subjects had a grade 1 adverse event (AE); 6.5% had a grade 2 AE. Among 169 evaluable subjects, there were no acute allergic, grade 3 or 4, or serious AE. In Phase 1, anti-receptor binding domain antibodies were increased in 70% of subjects on day-28. In Phase 2, in the 127 subjects who did not have high levels of gamma interferon-producing cells at baseline, 94.4% had increased by day 14 and 96.8% by day 28. Point-of-care personal vaccine manufacturing was feasible. Further development of such subject-specific vaccines is warranted.

Latar belakang. Terapi transfusi adalah salah satu terapi kunci dalam pengelolaan kanker dan penyakit darah pada anak. Hanya sedikit laporan tentang kuantitatif aspek transfusi sel darah merah dan trombosit pada penyakit leukemia limfoblastik akut (LLA). Fase induksi sangat berbahaya pada terapi LLA, karena sumsum tulang mengalami supresi yang diakibatkan oleh kemoterapi intensif. Fase induksi meliputi pemberian obat-obat methotrexate, vincristine, L-asp, daunorubicin, dan kortikosteroid selama 6 minggu. Protokol Indonesia 2006 terdiri dari 3 fase (induksi, konsolidasi, pemeliharaan) pada kelompok risiko standar (standard risk/SR) dan ditambah fase re-induksi untuk kelompok risiko tinggi (high risk/HR).Kuantitas transfusi dikaitkan dengan masalah efek samping dan biaya.Tujuan. Menilai perbedaan kebutuhan transfusi darah pasien LLA risiko standar dan tinggi yang diterapi dengan Protokol Indonesia 2006. Metode. Studi retrospektif dilakukan selama bulan Juli 2006 sampai Desember 2010 tentang kebutuhan transfusi selama fase induksi pada pasien baru LLA yang mendapat terapi dengan Protokol Indonesia 2006 di RS Dr Kariadi Semarang. Pasien diklasifikasikan menjadi kelompok risiko standar dan tinggi menurut kriteria NCI. Dibandingkan jumlah transfusi packed red cell(PRC) dan thrombocyte concentrate(TC) per luas permukaan tubuh (basal surface area/BSA).Analisis statistik menggunakan chi square(X2).Hasil. Subyek 160 pasien, namun hanya 119 (74,3%) pasien yang dapat dievaluasi. Perbandingan kelompok SR:HR 59,7:40,3. Rerata BSA pada kelumpok SR dan HR berturut turut 0,66 (SD±0,19)m2dan 0,77/m2 (SD±0,22), p<0,001. Selama fase induksi didapatkan rerata pemakaian PRC per pasien pada kelompok SR dan HR berturut turut 530 ml dan 420ml (p=0,79), pada TC 13 dan 11 unit (p= 0,19).Rasio penggunaan komponen PRC/BSA berturut turut untuk SR: HR 843:543 ml/m2untuk komponen TC 21:15 unit/m2.Kesimpulan. Tidak terdapat perbedaan bermakna antara kebutuhan kelompok risiko standar dan tinggi terhadap kebutuhan transfusi komponen darah PRC dan TC selama fase induksi.

Purpose Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B in South-East Asia require maintaining its capacity of monovalent hepatitis B production to keep up with both the national immunization program and global needs. To keep the sustainability of the vaccine, a new bulk is needed to be made available. This study aims to evaluate the immunogenicity and safety of Bio Farma newly formulated recombinant hepatitis B vaccines, which came from different sources of bulk, compared to the already registered hepatitis B vaccine. Materials and Methods An experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three recombinant hepatitis B vaccines from different bulk sources, with Bio Farma registered hepatitis B vaccine as the control group. A total of 536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments. The subject’s safety was monitored for 28 days after each vaccination. Results Of 536 enrolled participants, 521 finished the vaccination and serology assessments. The investigational products were proven not to be inferior to the control. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the investigational products and control. No serious adverse event was found to be related to the investigational vaccines. Conclusion Investigational vaccines are shown to be equally immunogenic and safe as the control vaccine.