medwireNews: Total neoadjuvant therapy with FOLFIRINOX followed by individualized chemoradiotherapy results in a high margin-negative (R0) resection rate in patients with borderline resectable pancreatic cancer, phase II trial data show.
In addition, Janet Murphy (Harvard Medical School, Boston, Massachusetts, USA) and colleagues note that the 2-year median progression-free survival (PFS) and overall survival (OS) with this more active regimen “appear substantially better than in historical controls where only adjuvant chemotherapy was used.”
The study – published in JAMA Oncology – included 48 patients (median age 62 years, 56% men) with newly diagnosed, previously untreated, localized pancreatic cancer that was classed as borderline resectable.
The patients received eight cycles of FOLFIRINOX (fluorouracil, irinotecan, and oxaliplatin) followed by short-course chemoradiotherapy (25.0 Gy in five fractions with protons or 30.0 Gy in 10 fractions with photons) with capecitabine for patients with resolution of vascular involvement upon restaging (n=27) or by long-course chemoradiotherapy (50.4 GY in 28 fractions) with fluorouracil or capecitabine for those with persistent vascular involvement (n=17).
Overall, the R0 resection was 65% among the 48 eligible patients.
However, not all patients underwent resection and among the 32 participants that did, the R0 resection rate was 97%.
At study completion, 30 patients were still alive, with a median follow-up period of 18 months.
Median PFS was 14.7 months overall, with a 2-year PFS rate of 43%, while median OS was 37.7 months, with a 2-year OS rate of 56%.
When just the patients who underwent resection were considered, median PFS was 48.6 months with a 2-year PFS rate of 55%, while median OS had not been reached and the 2-year OS rate was 72%.
Murphy and co-authors note that previous retrospective studies have described R0 resection rates of 23.0–25.2% in patients with borderline and locally advanced disease, with median PFS and OS times of 11.7 and 24.2 months, respectively.
However, they caution that “varying definitions of R0 resection in the United States and Europe make it a challenge to benchmark the success of this approach to historical controls.”
The team concludes that their findings support ongoing phase III trials, including the Alliance trial for borderline pancreatic cancer.
By Laura Cowen
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