Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced recta
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RESEARCH
Efficacy and safety‑in analysis of short‑course radiation followed by mFOLFOX‑6 plus avelumab for locally advanced rectal adenocarcinoma Ali Shamseddine1*†, Youssef H. Zeidan2†, Ziad El Husseini1, Malek Kreidieh1, Monita Al Darazi1, Rim Turfa3, Joseph Kattan4, Ibrahim Khalifeh5, Deborah Mukherji1, Sally Temraz1, Kholoud Alqasem3, Rula Amarin3, Tala Al Awabdeh3, Samer Deeba6, Faek Jamali6, Issa Mohamad7, Mousa Elkhaldi7, Faiez Daoud8, Mahmoud Al Masri8, Ali Dabous8, Ahmad Hushki9, Omar Jaber10, Maya Charafeddine1 and Fady Geara2
Abstract Background: Neoadjuvant chemotherapy and short-course radiotherapy followed by resection has been gaining recognition in the treatment of rectal cancer. Avelumab is a fully human immunoglobulin that binds Programmed Death-Ligand 1 (PD-L1) and prevents the suppression of the cytotoxic T cell immune response. This phase II trial evaluates the safety and pathologic response rate of short-course radiation followed by 6 cycles of mFOLFOX6 with avelumab in patients with locally advanced rectal cancer (LARC). Methods: This study is prospective single-arm, multicenter phase II trial adopting Simon’s two-stage. Short-course radiation is given over 5 fractions to a total dose of 25 Gy. mFOLFOX6 plus avelumab (10 mg/kg) are given every 2 weeks for 6 cycles. Total mesorectal excision is performed 3–4 weeks after the last cycle of avelumab. Follow up after surgery is done every 3 months to a total of 36 months. Adverse event data collection is recorded at every visit. Results: 13 out of 44 patients with LARC were enrolled in the first stage of the study (30% from total sample size). All patients met the inclusion criteria and received the full short-course radiation course followed by 6 cycles of mFOLFOX6 plus avelumab. 12 out of the 13 patients completed TME while one patient had progression of disease and was dropped out of the study. The sample consisted of 9 (69%) males and 4 (31%) females with median age of 62 (33–73) years. The first interim analysis revealed that 3 (25%) patients achieved pathologic complete response (pCR) (tumor regression grade, TRG 0) out of 12. While 3 (25%) patients had near pCR with TRG 1. In total, 6 out of 12 patients (50%) had a major pathologic response. All patients were found to be MMR proficient. The protocol regimen was well tolerated with no serious adverse events of grade 4 reported. Conclusion: In patients with LARC, neoadjuvant radiation followed by mFOLFOX6 with avelumab is safe with a promising pathologic response rate.
*Correspondence: [email protected] † Ali Shamseddine and Youssef H. Zeidan: Equal contributors 1 Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute ‑ NKBCI, American University of Beirut Medical Center, Beirut, Lebanon Full list of author information is available at the end of the article © The Author(s) 2020. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and
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