Literal results.

Top Line: We learned in abstract form at ASCO 2018 that neoadjuvant chemoradiation improves overall survival when compared to upfront surgery for resectable / borderline resectable pancreatic cancer.
The Study: The full manuscript is now in print, and it pulls back on some of the punches. As a reminder, 246 patients with resectable or borderline resectable pancreatic cancer were randomized to [1] preop 2.4 Gy x 15 = 36 Gy concurrent to 3 cycles of gemcitabine followed by surgery then gem x 4 versus [2] upfront surgery then gem x 6. Unfortunately, unlike at the time of abstract reporting (13.5 → 17 months), this analysis demonstrates no statistical improvement in the primary endpoint of overall survival among all enrollees (14 → 16 months). But it’s not all lackluster. The secondary endpoint of disease-free survival was statistically improved. More importantly, a number of enrollees never made it to surgery in either arm after staging laparoscopy, washing out distinctions in the primary intention-to-treat analysis. In fact, only 72 of 119 (61%) went to surgery in arm [1] and 92 of 127 (72%) in arm [2]. Among this predefined subgroup (n=164), the rate of R0 resection remained significantly improved (40 → 71%) as well as overall survival (20 → 35 months). In other words, if this trial had specified a negative staging laparoscopy as an inclusion criterion, we’d be seeing bigger headlines. A more global lesson from this chain of events is to take abstract results for what they are—provocative concepts that need to be fleshed out in full-length finalized analyses.
TBL: Among patients with health and disease amenable to pancreatic cancer resection, pre-op chemoradiation improves disease-free and overall survival—and laparoscopy remains a crucial component of staging. | Versteijne, J Clin Oncol 2020


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