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Top Line: Radiation dose-escalation for esophageal cancer is back.
The Study: But not for long. The Dutch phase 3 ARTDECO trial was reported this week in abstract form at the annual ASCO GI meeting. 260 patients with inoperable esophageal cancer were randomized to definitive treatment with the standard 1.8 Gy x 28 = 50.4 Gy concurrent to weekly carbo/Taxol x 6 versus the same with a simultaneous integrated boost of 2.2 Gy x 28 = 61.4 Gy to the primary tumor. The term “inoperable” was used loosely as it could be due to anatomic or medical reasons or even just patient preference (the case in 44% of enrollees). Importantly—because, as we know, squamous cell carcinomas (SCC) historically have double the complete path response rates of adenos—roughly 60% of enrollees had SCC and 40% adeno. At a median follow-up of nearly 4 years, the primary endpoint of local-progression-free survival was statistically improved with dose-escalation at 3 years for neither SCC (74 → 81%) nor adeno (62 → 65%). Overall survival at 3 years was 40-41% across the board. More disheartening was the leap in grade 5 toxicity from 4% with standard-dose to 10% with dose-escalation. This is in stark contrast to zero reported grade 4-5 toxicities on a similarly-designed phase 1/2 trial at MD Anderson.
TBL: A modern attempt to dose-escalate the esophagus failed to improved survival free from local recurrence, perhaps due to a worrisome number of treatment-related deaths. | Hulshof, ASCO GI 2020