Takeaways From the Latest Clinical Trial Data

Ripal Gandhi, MD, practices interventional oncology at the Miami Cardiac and Vascular Institute and Miami Cancer Institute and is a Course Director for the Symposium on Clinical Interventional Oncology (CIO). Dr. Gandhi closely follows the latest research in the field and shared his thoughts on data recently presented at the American Society of Clinical Oncology (ASCO).

What did you learn from data presented at ASCO?

Some important clinical trials assessing yttrium 90 (Y-90) radioembolization have been released at ASCO and The International Liver Congress. The SIRFLOX, FOXFIRE, and FOXFIRE global combined data were presented at the ASCO meeting and evaluated combining first-line chemotherapy treatment with selective internal radiotherapy (SIRT) using Y-90 for colorectal cancer in patients with metastatic liver disease. The results showed that the overall survival results were not different between patients treated with Y-90 plus chemotherapy versus  systemic chemotherapy alone. However, the study has not been published yet in a peer-reviewed journal, so we don’t know all the details. We do know that Y-90 radioembolization clearly has a role in the treatment of liver dominant, chemorefractory patients, and SIR-spheres have been recently included as a Category 2A recommended treatment per the latest National Comprehensive Cancer Network (NCCN) guidelines, which is the same designation for systemic chemotherapy.    However, we’re still trying to determine its role in first-line patients.

When interpreting these data, it’s important to keep in mind that patients with right-sided colon cancer have a much worse prognosis than patients with left-sided colon cancer. According to the Alliance trial, which was presented last year, the median overall survival for patients with right-sided colon cancer is about 19.4 months versus about 33.3 months for left-sided tumors. That’s a marked, significant difference, and those differences are reflected in NCCN guidelines for chemotherapeutic regimens.

The difference may also be seen in the recently presented SIRFLOX/FOXFIRE/ FOXFIRE global data I already mentioned. According to a subset analysis of these data, there was a 4.9-month improvement in median overall survival in patients with right-sided colon cancer who were treated with selective internal radiotherapy (SIRT) compared with chemotherapy, which translates into about a 36% reduction in risk of death.

What are the implications of this subset analysis?

I don’t think we know that until we really look at the data. It’s important to note that I have not seen details of the study outside of the presentation, and the study has not yet been published. At this point though, the data seem promising, especially for patients with right-sided colon cancer.

Are there any other trials that you wish to highlight?

Other major trials that were recently presented were the SIRveNIB trial and the SARAH trial. Both of those studies looked at head-to-head sorafenib vs Y-90 in hepatocellular carcinoma (HCC). In both of those studies, the overall survival was not significantly different between the 2 regimens. However, patients who underwent Y-90 radioembolization had fewer side effects and better quality of life.

I think this difference has the ability to eventually change the Barcelona Clinic Liver Cancer (BCLC) staging system, which is the most accepted algorithm in the management of HCC. In my opinion, Y-90 should be considered an acceptable treatment option for patients with both BCLC intermediate stage B and advanced stage C disease.  In my personal experience, many patients have difficulty tolerating sorafenib, so I think Y-90 is a very viable treatment option.  I believe that there is likely synergy of combining radioembolization with sorafenib and eagerly await the results of additional studies.