Phase I study of concurrent selective lymph node late-course accelerated hyperfractionated radiotherapy and S-1 plus cisplatin for locally advanced oesophageal squamous cell carcinoma

Abstract

). In the initial five patients, two patients developed DLTs. As MTD was not reached, five additional patients were treated with the same dose level, and DLTs occurred in only one patient. Similar results were found in the last five patients. After CCRT, the objective response rates were 100% for primary tumours and 86.2% for metastatic lymph nodes, respectively. Totally, the observed Grade 3 toxicities during CCRT were leukopenia (20%), neutropenia (20%) and dermatitis (13.3%), and no Grade 4 toxicity occurred. The Kaplan-Meier-estimated overall and progression survival rates were 86.7% and 66.7% (1 year), 73.3% and 60% (2 years) and 73.3% and 60% (3 years). Conclusion:The concurrent SLN LCAF IMRT and chemotherapy with S-1 and CDDP was well tolerated and showed promising efficacy. The dose of S-1 in this regimen was recommended with 80 mg m 22 orally twice daily on Days 1-14 and Days 22-35. Advances in knowledge: CCRT with S-1 plus CDDP exhibited encouraging results with milder toxicities, high objective response rates and ideal overall survival time.

Comparison of concurrent chemoradiotherapy with radiotherapy alone for locally advanced esophageal squamous cell cancer in elderly patients: A randomized, multicenter, phase II clinical trial

“…Given the toxicity of standard platinum with fluorouracil chemotherapy in elderly patients, we chose the fixed‐dose combination medication of tegafur, gimeracil and oteracil (or S‐1 for short), which is an oral fluorouracil drug with reduced side effects 20 and has been adopted in many clinical trials for ESCC patients 21‐23 . In addition, we have preliminarily verified the mild toxicities and encouraging outcomes of CCRT with S‐1 in our previous study 24 . We designed this randomized controlled two‐arm multicenter phase II clinical trial (ChiCTR‐IPR‐17010668) to assess the safety and efficacy of CCRT with S‐1 or RT alone in elderly ESCC patients.…”

“…[21][22][23] In addition, we have preliminarily verified the mild toxicities and encouraging outcomes of CCRT with S-1 in our previous study. 24 We designed this randomized controlled two-arm multicenter phase II clinical trial…”

Long term results of different radiotherapy techniques and fractions for esophageal squamous cell carcinoma

“…And these have been identified by some reviews and meta-analyses as potentially advantageous compared to conventional fraction ( 5 , 6 ). To avoid severe mucous membrane toxicities after altered fractionated schedules, a variant of accelerated treatment, referred to as ‘concomitant boost’ or ‘late course accelerated hyperfractionated fraction (LCAF)’ technique, was devised ( 7 , 8 ).…”