ArticleIn vivo (Athens, Greece)
Safety and Efficacy of SOX Therapy After Preoperative Chemoradiotherapy for Advanced Lower Rectal Cancer: A Phase I Study.
Article in In vivo (Athens, Greece). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND/
aimThis phase 1 study aimed to evaluate the safety and tolerability of S-1 plus oxaliplatin (SOX) as consolidation chemotherapy following chemoradiotherapy (CRT) in total neoadjuvant therapy (TNT) for locally advanced lower rectal cancer. PATIENTS AND
methodsPatients with stage II/III lower rectal adenocarcinoma received long-course CRT followed by two cycles of SOX therapy. A standard 3+3 dose-escalation design was used to determine the recommended dose. The primary endpoint was the incidence of dose-limiting toxicity (DLT) during the first chemotherapy cycle. Secondary endpoints comprised pathological complete response, adverse events, treatment completion, and surgical outcomes.
resultsThe DLT was evaluated in 12 patients. One DLT was observed at dose level 1, while no DLTs were observed at dose level 2. This established the recommended dose as 130 mg/m
conclusionSOX therapy as consolidation chemotherapy after CRT was safe and well tolerated as part of the TNT for lower rectal cancer. To our knowledge, this is the first study to report the use of SOX in TNT. Further trials are warranted to evaluate the efficacy of SOX as consolidation therapy after CRT in larger populations.
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