|The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Neoadjuvant treatment with either GEMCAP, FOLFIRINOX, or capecitabine-based radiotherapy (CRT) prolonged overall survival (OS), but did not increase the resection rate, compared with immediate surgery among patients with borderline-resectable pancreatic cancer, according to results from a phase 2 trial presented at the ASCO20 Virtual Scientific Program.
“We conclude that neoadjuvant therapy should be considered for patients with borderline resectable pancreatic cancer,” said Paula Ghaneh, MD, of the University of Liverpool in the United Kingdom, who is the lead author and presenter of the study.
The international, multicenter, phase 2 ESPAC-5F trial (Clinical trial information: 89500674) randomly assigned 90 patients with borderline-resectable pancreatic cancer as defined by the National Comprehensive Cancer Network criteria to receive neoadjuvant therapy with either 2 cycles of GEMCAP, 4 cycles of FOLFIRINOX, 50.2 Gy CRT in 28 daily fractions over 5.5 weeks, or immediate surgery.
Restaging was performed at 4 to 6 weeks and surgical exploration was performed if the disease was deemed borderline resectable. All patients received physician’s choice adjuvant therapy. The primary endpoints were recruitment rate and resection rate, and the secondary endpoints included R0 resection margin rate, OS, and toxicity.
At baseline, the median age was 64 and 45% of patients were men. Patients had a World Health Organization performance status of 0 (45%) or 1 (55%). The median CA19-9 value was 583 kU/L.
“This was a challenging trial to recruit due to the patient population with borderline resectable disease, and also having to be fit for all lines of therapy,” Dr Ghaneh explained. Among the 88 patients included in the full analysis set, the recruitment rate was 21 patients per year.
There were 52 patients who underwent surgical exploration. The resection rate was similar between groups, at 55% with neoadjuvant therapy and 62% with immediate surgery (P =.668). Among patients who underwent resection, the R0 rate was 23% with neoadjuvant treatment and 15% with immediate surgery (P =.721).
Neoadjuvant therapy significantly prolonged OS, with a 1-year OS rate of 77% (95% CI, 66%-89%) compared with 42% (95% CI, 27%-64%) with immediate surgery (hazard ratio, 0.28; 95% CI, 0.14-0.57; P <.001). In the neoadjuvant groups, the 1-year OS rate was 79% with GEMCAP, 84% with FOLFIRINOX, and 64% with CRT.
Of the patients who received neoadjuvant therapy, 18% experienced a serious grade ≥3 adverse events, including 26% in the FOLFIRNOX group, 21% in the CRT group, and 6% in the GEMCAP group.
Dr. Ghaneh concluded by saying that although the resection rate was similar between arms, “there was a significant survival advantage at 1 year for neoadjuvant therapy.” She also noted that FOLFIRINOX resulted in the highest OS rate compared with the other neoadjuvant therapies, albeit with a higher rate of toxicity.
Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2021 meeting by visiting the conference page.
Ghaneh P, Palmer DH, Cicconi S, et al. ESPAC-5F: Four-arm, prospective, multicenter, international randomized phase II trial of immediate surgery compared with neoadjuvant gemcitabine plus capecitabine (GEMCAP) or FOLFIRINOX or chemoradiotherapy (CRT) in patients with borderline resectable pancreatic cancer. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 4505.