ASH (American Society of Hematology Annual Meeting) is the largest and most important forum for the presentation of new blood cancer research. Before the ASH 2018 meeting in San Diego got going in earnest, I interviewed Dr. Stephan Stilgenbauer from Ulm, Germany as to what he was most excited about in the CLL research that would be presented over the course of the meeting.
Arguably the most important abstracts at ASH are those presented at the plenary and late-breaking sessions and CLL was strongly represented this year.
There was great anticipation of the ECOG (The Eastern Cooperative Oncology Group) trial, whose results would be presented at the late-breaking session. This trial was important for many reasons, the first of which was that it was a large collaborative trial across many sites.
In allowing for a large number of participants, it gave researchers the ability to definitively answer the pressing question as to which combination was better: ibrutinib + rituximab (IR) or fludarabine, cyclophosphamide and rituximab (FCR) in the frontline setting for healthy fit patients under 70.
This is the research that Dr. Stilgenbauer spoke about with excitement in our interview.
This study excluded 17p-deleted patients, a critical and ethically demanded exclusion, as it has already been proven that ibrutinib-based therapies are better for those with 17p deletion.
CLL patients over age 70 were excluded as well, as they tend to be less tolerant of FCR.
- 529 healthy, fit, treatment naïve patients < 70 were enrolled.
- 2/3 received ibrutinib + rituximab, a combination therapy that has been proven to improve progression free survival (PFS), as well as overall survival (OS), for CLL (Chronic Lymphocytic Leukemia) patients.
- 1/3 received FCR, the “gold standard” chemo-immunotherapy (CIT), which has also been proven to improve PFS and OS in this population.
- This is arguably a battle of the two giants in CLL treatment.
- The clear winner was IR, demonstrating improved PFS and OS.
- Adverse events were also lower with IR, resulting in fewer infections and fewer patients with neutropenia (low neutrophil counts).
- This trial has clear and urgent practice-changing implications.
An obvious question is why was rituximab added to ibrutinib when we now believe that its use is unlikely to add anything to ibrutinib’s efficacy? The answer is that this trial began in 2014 when that was still an unanswered question, again reinforcing the importance of clinical trials and highlighting just how quickly this research is evolving.
We will publish more on this paradigm-shifting trial, including an interview with its principal author Dr. Tait Shanafelt, as it clearly demonstrates that for the vast majority of patients under 70, it has become increasingly difficult to justify CIT under almost any circumstance.
Here is the link to my brief interview with Dr. Stilgenbauer on the first day of ASH 2018 anticipating this exciting research.
Here is a link to the ASH abstract. Exciting times for those of us with CLL! Our mission is now shifting from defining the best therapies to ensuring that all patients have the benefits of the latest research.
As Dr. Stilgenbauer points out there is still research to be done for those patients who cannot tolerate ibrutinib and to examine the options of fixed-duration therapies.
We will publish more from ASH on these topics in the coming weeks.
We are all in this together.
Dr.Brian Koffman, Chief Medical Officer
with help from
Patricia Koffman, Executive Director