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ASCO: A mixed bag of positives, negatives, promises for the future
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In years past, I have avoided using my monthly editorial to provide a report from the ASCO Annual Meeting, partly because the content from the meeting is already expertly covered in detail in HemOnc Today.
Reflecting on this year’s meeting, though, caused me to change my mind. This change is based partly on the hematologic malignancies content of the meeting, but more significantly on certain general aspects of the program. Both left me with a sense of important positive and negative takeaways.
Important studies
The hematologic malignancies sessions at this year’s meeting featured several important positive and potentially practice-changing studies.
Perhaps the most remarkable was a prospective trial of CPX-351 (Vyxeos, Celator), a new formulation of cytarabine and daunorubicin that was compared with the standard formulations of these two drugs in a randomized trial of elderly patients with acute myeloid leukemia. This study was the first to show an OS benefit in this difficult-to-treat population.
Studies in multiple myeloma demonstrated the efficacy of oral-only drug combinations and confirmed the utility of autologous stem cell transplantation in patients treated with current induction therapy, an issue that has been controversial for many years.
However, several negative trials also yielded important data.
Two studies of rituximab (Rituxan; Genentech, Biogen) did not meet their primary endpoints, one in which it was used as a maintenance regimen for mantle cell lymphoma, and another in which it was delivered in an intensified dose for diffuse large B-cell lymphoma.
The mantle cell study is particularly important. The PFS advantage previously observed for rituximab maintenance after R-CHOP was not replicated in this study, which used bendamustine (Treanda, Teva Oncology) and rituximab as induction therapy. This study confirms previous observations in many contexts that extrapolating results of one clinical situation to another may have pitfalls.
These results raise the possibility that the same could be true in follicular lymphoma, where the use of rituximab maintenance after bendamustine and rituximab induction is now widespread based on results of the PRIMA trial, which used R-CHOP induction. Ongoing studies hopefully will answer this question.
Another important negative trial reported on the failure of the addition of alemtuzumab (Lemtrada, Sanofi/Genzyme) to CHOP chemotherapy to improve outcomes in patients with peripheral T-cell lymphomas. This was a tough study to conduct but still significant because it effectively puts to bed the idea that alemtuzumab has a role in this disease.
Moonshots and value
In a more general context, the meeting was a mix of positive and negative messages.
Perhaps the most positive was the visit and address from Vice President Joe Biden regarding the cancer moonshot initiative. Although Biden had no new message in his address, his presence at the meeting confirmed his commitment to the effort.
Many different opinions — from the altruistic to the cynical — have been expressed regarding the moonshot; however, I have to believe that the attention brought to the cancer challenge by this initiative will have a positive effect on policy and funding for the prevention, early detection and treatment of cancer.
The increasing attention to value in cancer care was another important positive trend at this year’s meeting.
Although the concept of value was introduced in the 2015 meeting, this largely was centered around drug costs. The approach this year was a little more sophisticated and, particularly in the plenary session, showcased the ASCO Value Framework as a means of measuring the net health benefit of some interventions.
Although this undoubtedly is a positive trend, the approach seems, at the moment, to be a little too formulaic to have real clinical utility.
Several value frameworks for oncology have been proposed in recent years, including those developed by ASCO, the National Comprehensive Cancer Network and the European Society for Medical Oncology. These have been reviewed in JAMA in an excellent commentary by Amitabh Chandra, PhD, and colleagues, as well as an accompanying editorial by Ethan Basch, MD, MSc.
Each framework has limitations, and most have been criticized for the lack of patient-reported data incorporated into the framework.
As Lowell E. Schnipper, MD, and the authors of the recently updated ASCO framework point out, these data are not yet systematically collected. Therefore, it is difficult to build them into a robust model. This is certainly true, and not a good reason to hold up the process of creating usable value frameworks — otherwise, there is a danger that the “perfect becomes the enemy of the good,” and that no progress is made while we wait for robust patient-reported outcome data.
That said, there is a risk in assessing value using a tool still in development and not yet fully validated. The value discussions need to be treated with some circumspection until these models are more mature, easier to use, less arbitrary in their scoring systems — which are still, to a varying extent, subjective — and reproducible.
Exhibit hall lessons
The issue of value also was discussed widely in the context of precision oncology and genomics.
As those of us who are veterans of many ASH and ASCO meetings know, a walk through the exhibit hall gives a pretty accurate impression of the hot areas of research and innovation in oncology at any one time. This year, I was struck by the growth of exhibitors in three areas: immunotherapy (no big surprise), precision oncology and genomics, and “big data” and decision support software.
The intersection of the value proposition and “-omics” is based on the assumption that the molecularly driven choice of the correct targeted treatment upfront will maximize patient benefit by improving the chances for response and PFS, and possibly quality of life and OS, as well. This certainly is a reasonable hypothesis and describes the real potential of genomics in oncology. But for now, it is a hypothesis that needs to be tested prospectively.
The NCI-MATCH study and ASCO TAPUR trial — along with many other big-data projects — are just beginning to evaluate the true clinical impact of drug matching in this way. It is, therefore, disheartening to see some of the marketing around genomics, the frequency of matching drugs to patients, and the claims for improved survival and quality of life already being made well in advance of prospective evaluation of these techniques. It is even more disheartening to see this marketing directed at patients.
The promise of genomics was an important positive message from the meeting. The rush to market and commercialize these platforms before we really understand their clinical utility is disappointing. Hopefully, the impact of this technology on our patients will become clear in the next few years as these studies and datasets mature.
I wonder how different the exhibit hall will look 4 or 5 years from now.
My guess is that immuno-oncology will still be big, but the “feeding frenzy” of genomics and big-data software platforms will have consolidated into a few bigger companies (with bigger booths!).
Those who can most effectively integrate their software into electronic medical records are likely to be the winners. Check back for my ASCO 2020 editorial and we will see how it played out!
References:
Basch E. JAMA. 2016;doi:10.1001/jama.2016.4637.
Chandra A, et al. JAMA. 2016;doi:10.1001/jama.2016.4915.
Salles G, et al. Lancet. 2011;doi:10.1016/S0140-6736(10)62175-7.
Schnipper LE, et al. J Clin Oncol. 2015;doi:10.1200/JCO.2015.61.6706.
Schnipper LE, et al. J Clin Oncol. 2016;doi:10.1200/JCO.2016.68.2518.
The following were presented at the ASCO Annual Meeting; June 3-7, 2016; Chicago:
Cavo M, et al. Abstract 8000.
Lancet JE, et al. Abstract 7000.
Lugtenburg PJ, et al Abstract 7504.
Palumbo A, et al. Abstract LBA4.
Rummel MJ, et al. Abstract 7503.
For more information:
John Sweetenham, MD, is HemOnc Today’s Chief Medical Editor for Hematology. He also is senior director of clinical affairs and executive medical director at Huntsman Cancer Institute at University of Utah. He can be reached at john.sweetenham@hci.utah.edu.
Disclosure: Sweetenham reports no relevant financial disclosures.