An FDA expert panel voted 16-0, with one abstention, recommending that future FDA approvals of PI3K inhibitors be supported by randomized data. The four currently-approved PI3K inhibitors for treating hematologic malignancies received FDA approval based on single-arm data. Although these drugs have offered durable ORR and improvements in PFS, randomized data presented at the hearing showed they are associated with higher rates of serious adverse events, including fatality.

Compared to chemotherapy alone, adebrelimab plus chemotherapy nearly doubled 2-year OS and more than tripled 1-year PFS in patients with extensive-stage SCLC, according to results presented earlier this month at the AACR Annual Meeting 2022. The phase 3 CAPSTONE-1 study evaluated adebrelimab in combination with carboplatin plus etoposide, as first-line treatment for ES-SCLC.

The recent 2022 ASCO GU Cancers Symposium provided important new data for the management of advanced prostate cancer. Presentations covered in this review of symposia highlights include androgen receptor (AR) inhibitors in patients with metastatic hormone-sensitive prostate cancer, combinations of PARP inhibitors with abiraterone acetate in metastatic castration-resistant prostate cancer, 177Lu-PSMA-617 in metastatic CRPC, some novel therapies, and even a look at an artificial intelligence pathology predictive biomarker.

According to Dr. Keshav Khanijow, a hospitalist and an instructor of medicine at Johns Hopkins University School of Medicine in Baltimore: “Research has shown that using appropriate pronouns and terminology with transgender youth can be lifesaving. And I would posit that using appropriate pronouns and terminology for all LGBTQ people helps to build and foster trust with a medical provider, and that ultimately saves lives. It’s not the patient’s job to teach us while they’re battling illness. Rather, the onus is on us to learn it.”

In this case-control registry study of 63,828 patients with 14 common cancer types and 37,086 controls, pathogenic variants in BRCA1 were associated with biliary tract cancer, BRCA2 was associated with esophageal cancer, and combined BRCA1/2, with gastric cancer.

In an integrated analysis of mutations and clinical outcomes, comprising 2,200 patients with TP53-mutated myelodysplastic syndrome (MDS) with excess blasts (EB) or TP53-mutated acute myeloid leukemia (AML), the authors state that mutant TP53 AML and MDS-EB “do not differ with respect to molecular characteristics and survival” and argue these entities should be considered a single molecular disease entity. In a commentary to the above paper, TP53 and the star-crossed lovers MDS and AML, John Welch, MD, PhD of Washington University School of Medicine writes, “As a junior Hematology/Oncology fellow, I was told there were two types of physicians: splitters and mergers. That is, clinicians either seek to diagnose increasingly homogenously narrow groups of patients based on increasingly refined, shared characteristics, or they seek to find broad, overarching patterns that unite diagnostic classifications. Hematologic malignancies have been fertile ground for the diagnostic splitters of the world. On the other hand, there have been some noteworthy exceptions. Sometimes it is a technological advance that allows for the synthesis of disparate diagnoses.”