I wanted to share this recent communication from our colleagues at Sennewald Medizintechnik.
There are only a few weeks to go until the ESHO Meeting in Berlin and it is not too late to register via ESHO Congress website, if you have not already done so. We asked Dr. Pirus Ghadjar (ESHO 2018 Congress Organization) to outline the main highlights of the event.
Since the hyperthermia department at the Charité Universitätsmedizin in Berlin is one of the nine centers that contributed to the long-term results of the EORTC 62961-ESHO 95 trial recently published in JAMA Oncology Journal, we also asked Dr. Ghadjar some
more detailed questions about the trial. You will find his answers below.The hyperthermia systems used in the trial were provided by BSD/Pyrexar Medical, so we are pleased to point out that as a Diamond Sponsor of the ESHO Meeting, we are holding a Lunch Symposium on May 17 on “Pyrexar Innovations 2018”.
DR. GHADJAR ABOUT - ESHO 2018
Dr. Ghadjar, could you please summarize the highlights of the ESHO 2018 program?
I am pleased to say that the program of this year’s ESHO is very interesting and includes several highlights. For instance, the "abdominal tumor" session providing information on the latest treatment for pancreatic cancer and liver tumors and the use of hyperthermia to improve current treatment standards for abdominal tumors. The session on "MR-guided thermal therapies and applications" will summarize recent developments in MR thermometry as well as MR-based heat treatments. Another highlight -- among others -- will be the session on "Immune effects of hyperthermia and novel drug combinations" where the combination of hyperthermia and checkpoint inhibitors will be discussed.
The 2018 ESHO program also includes a one-day nurse/radiation therapist symposium, as well as a Patient Information Day, which will be held in German.
INTERVIEW DR. GHADJAR JAMA ONCOLOGY JOURNAL PUBLICATION
1. The EORTC 62961-ESHO 95 Trial was completed in November 2006. Why is JAMA Oncology only reporting now and what is the significance?
Long term data of the EORTC 62961-ESHO 95 trial comparing neoadjuvant chemotherapy vs. neoadjuvant regional hyperthermia plus chemotherapy for patients with localized high-risk soft tissue sarcoma was published by Issels et al. in February 2018 based on a median follow-up of 11.3 years. The recruitment of the total number of 341 patients was conducted from July 1997 to November 2006. The database for this analysis was closed in December 2014. The long follow-up duration is necessary to analyze potential differences in the secondary trial endpoint of overall survival. The significance of the results is that the addition of regional hyperthermia did not only improve local progression-free survival but also significantly improved overall survival as compared to neoadjuvant chemotherapy alone.
2. But why has it taken so long to publish the results?
Issels et al. closely analyzed their data after the database was closed. Due to the unique and convincing data, the manuscript was then submitted to high-impact medical journals and the process of manuscript review, re-submission and revision took time until the manuscript was accepted for publication by JAMA Oncology.
3. Is it true the study was prematurely halted? Were there negative results?
No, the predefined analysis plan as stated in the trial protocol was followed. The early trial results were published in Lancet Oncology in 2010, reporting that the primary trial endpoint local progression-free survival was significantly improved by neoadjuvant regional hyperthermia plus chemotherapy vs. neoadjuvant chemotherapy alone based on a median follow-up of 34 months. As the primary trial endpoint was significantly improved (as far back as 2010) the trial had to be regarded as a positive one. In 2010 the follow-up duration was not sufficient to detect potential differences in overall survival. Eight years later this has changed, and a significant overall survival benefit could be detected in favor of regional hyperthermia.