Hi ,

Welcome back to the Oncology Insights Newsletter which fosters your continuous growth in oncology pharmacy practice

Last time you learned about training people well enough to leave but treating them well enough so they don't want to, infusion reactions with obinutuzumab in CLL, and expecting the unexpected

This week you'll learn a fun analogy to remember the types of statistical errors, MRD testing in myeloma, and drama surrounding generic paclitaxel's approval back in the day

Have a great week!

Kelley

🧠 IPS (Insight, Pearl, Sundry)

Insight

The difference between a type 1 and type 2 statistical error is easy to get confused if you’re not knee deep in stats on the regular.

A type 1 error is when you reject a TRUE null hypothesis

A type 2 error is when you accept a FALSE null hypothesis

A fun analogy to help you remember these is to think of the “boy who cried wolf” fable

The people in the community commit a type 1 error when they DO believe the boy who cried wolf, but there was not actually a wolf there

They commit a type 2 error when they DON’T believe the boy who cried wolf, but there was in fact a wolf 🐺

Pearl

Biological monitoring can be tricky in some cancers. For example, in myeloma, is the best marker to measure disease IgG levels, M-protein, or MRD (measurable residual disease)? 

And how do we use these markers to adjust treatment - how much change in MRD levels or M-protein equates to a need to change therapy? We don’t have a good answer for this right now.

In April 2024, the FDA’s ODAC committee supported the use of MRD status as a surrogate endpoint in accelerated approval for myeloma studies. This has the potential to dramatically shape myeloma trials and treatment but we’ll need to see how it shakes out in future clinical trial design.

The use of MRD as a biomarker has opened up a new question about autologous transplant, historically a very common treatment of myeloma.

Today, myeloma is not curable, even with transplant, but if we can achieve a deep and durable response with available off-the-shelf therapies, do patients truly need to go to transplant?

One argument is to still collect stem cells (because it gets harder the longer they are on marrow toxic drugs), but to hold off on transplant in favor of continued therapies that offer the same or better outcomes with less toxicity risk.

A lot more to come in myeloma in the future!

Sundry

Do you say paclitaxel or Taxol? 🤔

There was quite the drama over generic paclitaxel - if you like drug history, take a quick read

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