Jean-Yves Blay, MD, PhD
A subgroup analysis from a phase III, open-label, randomized study showed that eribulin (Halaven) had comparable activity to dacarbazine (DTIC) in patients with leiomyosarcoma. These results were presented at the recent 2016 ESMO Congress.
In the subgroup of 309 patients with leiomyosarcoma, the median overall survival (OS) was 12.7 months with eribulin versus 13 months with DTIC (HR = 0.93; 95% CI, 0.71-1.20).
Based on previously reported results from the phase III trial, eribulin was approved in January 2016 for unresectable or metastatic liposarcoma in patients who had received a prior anthracycline-containing regimen.
“Even though the drug is not approved for leiomyosarcoma, this proves that we need to work more and further explore the activity of this agent in this very specific patient population,” said lead study author Jean-Yves Blay, MD, PhD.
In an interview with OncLive
, Blay, a professor of Medicine at the Université Claude Bernard, Lyon, France, and the scientific director of the Canceropole Lyon Rhône Alpes, discussed the key points of this subgroup analysis, as well as the current and future state of the treatment landscape for sarcoma and its many subtypes.
OncLive: Could you provide an overview of your presentation at ESMO?
: I presented a subgroup analysis of a pivotal phase III trial, which tested eribulin versus DTIC in patients with advanced soft tissue sarcoma progressing after a doxorubicin-based regimen. This clinical trial was actually already reported and published some months ago and led to the approval of eribulin for the treatment of liposarcoma in this clinical situation.
Now, what I’m presenting here is a subgroup analysis of the L-sarcoma, which is leiomyosarcoma, which is a complex and difficult-to-treat patient population. Eribulin was found to be equivalent to DTIC in terms of OS and progression-free survival (PFS). This is important because leiomyosarcoma is quite a challenging disease, and DTIC is well known to be an active agent in this setting and is actually incorporated in many first-line chemotherapy regimens, while other regimens are using it more in later stages.
So the observation that eribulin was equivalent in terms of OS, antitumor activity, PFS, and response is very interesting. Even though the drug is not approved for leiomyosarcoma, this proves that we need to work more and further explore the activity of this agent in this very specific patient population.
The activity of the drug was also associated with quite a good tolerance. There were slightly more incidents of neutropenia, less thrombopenia, slightly more alopecia. Overall, it was a very well tolerated treatment, and it was easy to administer.
It’s important to remember that there are very few clinical trials in this space. In fact, this is the biggest one demonstrating improvement in OS in patients with advanced sarcoma. So these findings are very important, and this new treatment certainly adds something to treatment of patients with advanced L-sarcoma.
What makes sarcoma such a difficult disease to treat?
Eribulin was tested in L-sarcoma, which represents about 15% of all sarcomas, including advanced sarcoma. There’s a large group of other sarcomas, which probably includes more than 80 different histological subtypes, for probably more than 200 molecular subtypes or something like that, for which we have not yet explored eribulin. And that’s something we should probably do in the future, considering the activity of the agent in L-sarcoma.