OncoPharm

MSI-high/MMRd rectal cancer treatment guidelines are being re-written. A brief synopsis of why treatment guidelines are changing so quickly in this space. Also, listeners helped out in explaining the ribociclib storage & stability change. Hint: https://www.novartis.com/news/novartis-implements-manufacturing-adjustments-ribociclib-ensure-alignment-latest-regulatory-standards-ebc-end-q2

FDA has been busy the last week approving: -ribociclib x 3 years in high risk stage II & III breast cancer based on the NATALEE trial as well as a new storage requirement -osimertinib indefinitely following chemoradiation in stage III EGFR-mutated NSCLC -amivantamab + chemotherapy following progression on osimertinib (Mariposa-2) -a subcutaneous formulation of atezolizumab -isatuximab + VRD for multiple myeloma -pembrolizumab + chemotherapy for metastatic pleural mesothelioma

Recapping just some of the notable data coming out of ESMO 2024: -Final OS results from Keynote-522 (perioperative pembrolizumab in TNBC) -AMBASSADOR (adjuvant pembrolizumab in bladder cancer) -NIAGRA (perioperative durvalumab in bladder cancer) -ADRIATIC (discussed on ASCO recap Pod, but publication now available) -LEANOX (impact of lean body mass adjustment on oxaliplatin dose)

LMS04 final OS results are published for doxorubicin + trabectedin in Leiomyosarcoma. Plus, a natural experiment of what happens in small cell lung cancer during an IV etoposide shortage. Finally, a nice paper provides some examples of how oncology pharmacists can bridge the care gap between oncology and primary care. LMS04: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2403394 IV etoposide shortage: https://doi.org/10.1200/OP.24.00394 Primary care - oncology pharmacy collaboration: https://doi.org/10.1177/10781552241279303

This is chapter 1 of a keynote address from summer 2024 on putting together the pieces of oncology pharmacy - with an emphasis on how our knowledge of drug dosing changes with time. Video/slides available at YouTube: https://youtu.be/1Oae8AV5Af4

We all know we aren't supposed to make cross-trial comparisons, but it happens anyway. So, let's compare FLARUA2 (osimertinb + chemo) and the newly FDA-approved MARIPOSA regimen (lazertinib + amivantamab) to see what we can (and can't) take away from such a dangerous cross-trial comparison.

A mixed bag of Phase III results for using olanzapine with moderately emegotenic chemotherapy (MEC). Inui, et al: https://doi.org/10.1200/JCO.24.00278 Ostwal, et al: doi:10.1001/jamanetworkopen.2024.26076

A new cellular therapy is approved for synovial sarcoma and the anticipated approval has occurred for the dual IDH1/IDH2 inhibitor, vorasidenib.

FDA appears to change its stance on evaluating perioperative (adjuvant followed by neoadjuvant) ICI study designs in NSCLC. Also, a simple blood test is approved to detect colorectal cancer, but there are several limitations compared to colonoscopy.

Did you know high-dose chemotherapy with autologous stem cel rescue was a "standard" breast cancer treatment ~30 years ago? This story involves changing practices based on Phase II data and outright clinical trial fraud, and retractions of publications. On-site review of Bezwoda study: https://doi.org/10.1016/S0140-6736(00)90024-2 Oral History: https://cancerhistoryproject.com/institutions/nccns-bob-carlson-talks-about-the-day-he-stormed-out-of-a-meeting-with-transplanters/