medwireNews: Patients with resectable or borderline resectable pancreatic cancer who receive neoadjuvant chemoradiotherapy (CRT) have better outcomes than their counterparts who proceed directly to surgery, suggest phase III trial results.
The primary endpoint of overall survival in the intention-to-treat population was a median of 17.1 months for the 119 participants who were randomly allocated to receive preoperative treatment and 13.7 months for the 127 patients who underwent immediate resection, giving a hazard ratio (HR) of 0.74.
Geertjan Van Tienhoven (Academic Medical Center, Amsterdam, the Netherlands) – who presented the PREOPANC-1 findings at the ASCO Annual Meeting 2018 in Chicago, Illinois, USA – noted that the difference between groups was not statistically significant, but stressed the preliminary nature of the current analysis as the anticipated number of events needed for the primary analysis had not been reached at data cutoff.
He added, however, that they had observed significant improvements in other outcomes with the addition of neoadjuvant CRT. Median disease-free survival (DFS) was 9.9 months for the preoperative therapy group and 7.9 months for the immediate surgery group, giving a significant HR of 0.71.
This DFS gain in favor of the preoperative CRT arm was driven by significantly longer distant metastasis-free and locoregional recurrence-free intervals, with corresponding HRs of 0.71 and 0.55.
Moreover, patients who received neoadjuvant CRT were significantly more likely to achieve an R0 resection than those who underwent surgery without prior CRT, at rates of 63% and 31%, respectively. But on the whole a smaller proportion of the preoperative CRT than the immediate surgery group underwent resection, at 60% versus 72%, although this difference was not significant.
The CRT regimen used in the PREOPANC-1 trial consisted of 36 Gy of radiation (given in 15 fractions of 2.4 Gy) alongside gemcitabine 1000 mg/m2 given on days 1 and 8, preceded and followed by one cycle of gemcitabine. All participants were given postoperative gemcitabine, with those in the preoperative CRT group receiving four cycles and those in the immediate surgery group receiving six cycles.
The next step, after the final analysis of the trial, would be “to find even more effective preoperative treatments,” such as FOLFIRINOX alone or with stereotactic body radiation therapy, the presenter noted in a press release. These will need to be tested against the preoperative gemcitabine–radiation regimen in a randomized clinical trial, he said.
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