Supplementary Data from Results and Molecular Correlates from a Pilot Study of Neoadjuvant Induction FOLFIRINOX Followed by Chemoradiation and Surgery for Gastroesophageal Adenocarcinomas
posted on 2023-03-31, 23:14authored byJennifer Y. Wo, Jeffrey W. Clark, Christine E. Eyler, Mari Mino-Kenudson, Samuel J. Klempner, Jill N. Allen, Florence K. Keane, Aparna R. Parikh, Eric Roeland, Lorraine C. Drapek, David P. Ryan, Ryan B. Corcoran, Emily Van Seventer, Isobel J. Fetter, Heather A. Shahzade, Melin J. Khandekar, Michael Lanuti, Christopher R. Morse, Rebecca S. Heist, Christine A. Ulysse, Benjamin Christopher, Christian Baglini, Beow Y. Yeap, John T. Mullen, Theodore S. Hong
Supplemental Appendix 5. Acute toxicity related to chemotherapy and chemoradiation.
Funding
NIH Proton Beam NCI
Federal Share Program
NCI
History
ARTICLE ABSTRACT
We performed a NCI-sponsored, prospective study of neoadjuvant FOLFIRINOX followed by chemoradiation with carboplatin/paclitaxel followed by surgery in patients with locally advanced gastric or gastroesophageal cancer.
The primary objective was to determine completion rate of neoadjuvant FOLFIRINOX × 8 followed by chemoradiation. Secondary endpoints were toxicity and pathologic complete response (pCR) rate. Exploratory analysis was performed of circulating tumor DNA (ctDNA) to treatment response.
From October 2017 to June 2018, 25 patients were enrolled. All patients started FOLFIRINOX, 92% completed all eight planned cycles, and 88% completed chemoradiation. Twenty (80%) patients underwent surgical resection, and 7 had a pCR (35% in resected cohort, 28% intention to treat). Tumor-specific mutations were identified in 21 (84%) patients, of whom 4 and 17 patients had undetectable and detectable ctDNA at baseline, respectively. Presence of detectable post-chemoradiation ctDNA (P = 0.004) and/or postoperative ctDNA (P = 0.045) were associated with disease recurrence.
Here we show neoadjuvant FOLFIRINOX followed by chemoradiation for locally advanced gastroesophageal cancer is feasible and yields a high rate of pCR. ctDNA appears to be a promising predictor of postoperative recurrence.See related commentary by Catenacci, p. 6281