Oral oncology · 2025
Neoadjuvant chemoradiation for patients with resectable locally advanced oral cavity squamous cell carcinoma: Results of the prospective INVERT clinical trial.
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Fleischmann Maximilian, Kristen Alexander, Winkelmann Ria, Burck Iris, Weigert Andreas, Issing Christian, Diefenhardt Markus, Martin Daniel, Brandts Christian, Rödel Franz, Balermpas Panagiotis, von der Grün Jens, Thönissen Philipp, Rödel Claus, Ghanaati Shahram
Аннотация
OBJECTIVE: The INVERT trial is a prospective, monocentric, proof-of-principle phase 2clinical trial evaluating the safety and efficacy of neoadjuvant chemoradiation (CRT) inpatients with resectable, locally advanced oral cavity squamous cell carcinoma (LAOCSCC).
METHODS: Eligible patients received intensity-modulated radiotherapy (IMRT) to primarytumor and nodal volumes (60/54/50 Gy in 30 fractions) with concomitant platinumbasedchemotherapy. Surgery was performed 6-8 weeks after CRT. Primary endpointwas the pathological complete response (pCR = ypT0N0) rate. Secondary endpointsincluded R0 resection rate, surgical complications, oncological outcomes, and qualityof life.
RESULTS: Between 02/2012 and 09/2022, 28 UICC Stage (7th edition) IVA-IVB LAOCSCCpatients were enrolled; 92.1 % showed mandibular involvement. All patientsreceived the the full IMRT dose of 60 Gy. For all cisplatin-eligible patients, the mediancumulative dose was 200 mg/m2 BSA. In the intention-to-treat population, the pCR ratewas 46.4 % (n = 13) but did not met the primary endpoint. In total, we recorded 384adverse events (AEs) of any grade and 109 AEs ≥ grade 3 according to CTCAE (nograde 5). Surgical complications were primarily wound healing disorders and postbleeding, with no grade 4 or 5 events. At a median follow-up of 28.5 months,progression-free survival (PFS), local control (LC), freedom from distant failure (DF),and overall survival (OS) were 60.7 %, 89.3 %, 82.1 %, and 64.3 %, respectively. pCRPowered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporationsignificantly correlated with improved PFS (p = 0.010) and OS (p = 0.021).
CONCLUSION: Neoadjuvant CRT is feasible and safe, achieving high pCR rates in LAOCSCC.pCR was associated with improved outcomes.
METHODS: Eligible patients received intensity-modulated radiotherapy (IMRT) to primarytumor and nodal volumes (60/54/50 Gy in 30 fractions) with concomitant platinumbasedchemotherapy. Surgery was performed 6-8 weeks after CRT. Primary endpointwas the pathological complete response (pCR = ypT0N0) rate. Secondary endpointsincluded R0 resection rate, surgical complications, oncological outcomes, and qualityof life.
RESULTS: Between 02/2012 and 09/2022, 28 UICC Stage (7th edition) IVA-IVB LAOCSCCpatients were enrolled; 92.1 % showed mandibular involvement. All patientsreceived the the full IMRT dose of 60 Gy. For all cisplatin-eligible patients, the mediancumulative dose was 200 mg/m2 BSA. In the intention-to-treat population, the pCR ratewas 46.4 % (n = 13) but did not met the primary endpoint. In total, we recorded 384adverse events (AEs) of any grade and 109 AEs ≥ grade 3 according to CTCAE (nograde 5). Surgical complications were primarily wound healing disorders and postbleeding, with no grade 4 or 5 events. At a median follow-up of 28.5 months,progression-free survival (PFS), local control (LC), freedom from distant failure (DF),and overall survival (OS) were 60.7 %, 89.3 %, 82.1 %, and 64.3 %, respectively. pCRPowered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporationsignificantly correlated with improved PFS (p = 0.010) and OS (p = 0.021).
CONCLUSION: Neoadjuvant CRT is feasible and safe, achieving high pCR rates in LAOCSCC.pCR was associated with improved outcomes.