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The Skeptical Oncologist

By BISHAL GYAWALI, MD Why conduct post approval studies at all? Atezolizumab previously received accelerated approval in second-line metastatic or advanced urothelial cancer based on response rates from a single arm trial. The results of post approval confirmatory phase 3 are now published and demonstrate that atezolizumab did not improve survival versus chemotherapy (11.1 v 10.6 months, HR 0.87, p = 0.41). The concept of accelerated approval is to grant early and conditional approval and access to drugs in diseases of unmet need, and that the decision to fully approve or revoke be made based on results of confirmatory phase 3 trials. That means, if the confirmatory larger phase 3 trial shows that the assumed benefit with the drug didn’t exist, the approval be revoked. Naturally, the FDA has decided to revoke the approval. No, I am joking. The post approval studies don’t seem to matter at all. You can improve response rate in a single arm trial, gain an expedited approval and your approval will always remain. Previously, we also saw that a drug that was given accelerated approval based on response rates in a phase 2 received full approval after it failed to improve survival in a subsequent confirmatory phase 3.  Why bother conducting confirmatory studies at all? (Im)precision in precision oncology It goes without question that precision medicine requires precise measurement and validation of biomarkers. So it was very pleas...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Uncategorized Source Type: blogs

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Erin Silverman, 35, of Potomac, Maryland, became a surrogate after her sister, Randi Fishman, 34, was diagnosed with breast cancer. Erin gave birth to her sister's baby in December.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
Abstract BackgroundThe platelet‐to‐lymphocyte ratio (PLR) has been found to predict clinical outcomes in borderline ovarian tumors and the other genital neoplasms. However, its prognostic value in patients with ovarian cancer remains controversial. The aim of this study was to assess its prognostic value in ovarian cancer. MethodsWe searched MEDLINE, EMBASE and the Cochrane databases to identify studies evaluating the prognostic significance of pretreatment PLR in ovarian cancer. The end points were overall survival (OS) and progression‐free survival (PFS). Pooled hazard ratios (HRs) with 95% confidence intervals (CI...
Source: European Journal of Clinical Investigation - Category: General Medicine Authors: Tags: Original Paper Source Type: research
This observational retrospective cross-sectional and case-controlled study measures levels of 25-hydroxy-vitamin D (25-OH-VD) in pediatric cancer survivors at different intervals and assesses the effect of 2 supplementation regimens over a period of 12 months. Sixty-eight patients were included in this quasi-experimental study, of which 32 were boys and 36 were girls. A control group of 30 healthy children were included. It was found that initial 25-OH-VD levels were insufficient (
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Original Articles Source Type: research
This report documents the first observation of HLH associated with thyroid cancer, and illustrates the need to include imaging of the neck while evaluating patients with secondary HLH for an underlying malignancy.
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Original Articles Source Type: research
Conclusions: Our data demonstrate that a significant number of children lose preexisting humoral immunity against MMR and hepatitis B after completion of chemotherapy.
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Original Articles Source Type: research
This report illustrates the value of this molecular assay in establishing the correct diagnosis of a very rare malignancy masquerading as another tumor type.
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Clinical and Laboratory Observations Source Type: research
In children, nasopharyngeal carcinoma (NPC) is a very rare tumor, mostly Epstein-Barr Virus related and quite always diagnosed at a locally advanced stage. With current protocols associating induction cisplatin-based chemotherapy and concomitant chemoradiotherapy, prognosis is excellent with overall survival higher than 85%. However, long-term toxicities are frequent. Improvement in radiation therapy modalities like intensity-modulated radiation therapy and new strategies with radiation dose adaptation to chemotherapy response have been introduced to reduce acute and long-term toxicities. Actually, 2 main questions remain:...
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Review Article Source Type: research
The aims of the current study were to investigate whether SCD incurs an additional risk for poor sleep over and above the influence of sociodemographic factors (ie, race and sex) during adolescence, and to explore the relationships between sociodemographic, physical (ie, age and pubertal status), and disease-related factors (ie, SCD genotype and hydroxyurea use) on sleep problem risk during adolescence. Black adolescents (age, 12 to 17 y) with SCD (n=53) were recruited from regional pediatric SCD clinics in the southeast and a sample of healthy black adolescents (n=160) were recruited from middle and high schools. R...
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Original Articles Source Type: research
A previously healthy 2-year-old female infant presented with pancytopenia and was diagnosed with acute lymphoblastic leukemia. Before the initiation of treatment, she developed symptoms concerning for increased intracranial pressure. Head imaging revealed left parietal hemorrhage, in addition to a right vitreous hemorrhage, which was confirmed on ophthalmology examination later. Terson syndrome, in which intraocular hemorrhage is associated with intracranial hemorrhage, is more commonly reported in adults, although ocular manifestations of leukemia have been reported at presentation and are typically asymptomatic.
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Radiology Corner Source Type: research
No abstract available
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Letters to the Editor Source Type: research
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