Phase I dose-escalation study of NBTXR3 in HNSCC

Eur J Cancer, 2021, Hoffmann C. et al.

Authors

Caroline Hoffmann1, Valentin Calugaru2, Edith Borcoman3, Victor Moreno4, Emiliano Calvo5, Xavier Liem6, Sébastien Salas7, Bernard Doger4, Thomas Jouffroy1, Xavier Mirabel 6, Jose Rodriguez1, Anne Chilles2, Katell Bernois8, Mikaela Dimitriu8, Nicolas Fakhry9, Stéphanie Wong Hee Kam7, Christophe Le Tourneau10

1 – Department of Surgery, Institut Curie, Paris, France
2 – Department of Radiation Oncology, Institut Curie, Paris, France
3 – Department of Drug Development and Innovation (D3i), Institut Curie, Paris, France
4 – START – Fundación Jiménez Díaz, Madrid, Spain
5 – START – Hospital Sanchinarro, Madrid, Spain
6 – Oscar Lambret Center, Lille, France
7 – Hôpital Timone, Marseille, France
8 – Nanobiotix, SA, France
9 – Hôpital Conception, Aix-Marseille University, Marseille, France
10 – Department of Drug Development and Innovation (D3i), Institut Curie, Paris, France; INSERM U900 Research Unit, Saint-Cloud, France; Paris-Saclay University, Paris, France

Summary

Background: Locally advanced soft tissue sarcoma (STS) management may include neoadjuvant or adjuvant treatment by radiotherapy (RT), chemotherapy (CT) or chemoradiotherapy (CRT) followed by wide surgical excision. While pathological complete response (pCR) to preoperative treatment is prognostic for survival in osteosarcomas, its significance for STS is unclear. We aimed to evaluate the prognostic significance of pCR to pre-operative treatment on 3-year disease-free survival (3y-DFS) in STS patients.

Methods: This is an observational, retrospective, international, study of adult patients with primary non-metastatic STS of the extremities and trunk wall, any grade, diagnosed between 2008 and 2012, treated with at least neoadjuvant treatment and surgical resection and observed for a minimum of 3 years after diagnosis. The primary objective was to evaluate the effect of pCR. (≤5% viable tumor cells or ≥95% necrosis/fibrosis) on 3y-DFS. Effect on local recurrence-free survival (LRFS), distant recurrence-free survival (MFS) overall survival (OS) at 3 years was also analyzed. Statistical univariate analysis utilized chi-square independence test and odds ratio confidence interval (CI) estimate, multivariate analysis was performed using LASSO.

Results: A total of 330 patients (median age 56 years old, range:19–95) treated by preoperative RT (67%), CT (15%) or CRT (18%) followed by surgery were included. pCR was achieved in 74/330 (22%) of patients, of which 56/74 (76%) had received RT. 3-yr DFS was observed in 76% of patients with pCR vs 61% without pCR (p < 0.001). Multivariate analysis showed that pCR is statistically associated with better MFS (95% CI, 1.054–3.417; p = 0.033), LRFS (95% CI, 1.226–5.916; p = 0.014), DFS (95% CI, 1.165–4.040; p = 0.015) and OS at 3 years (95% CI, 1.072–5.210; p = 0.033).

Conclusions: In a wide, heterogeneous STS population we showed that pCR to preoperative treatment is prognostic for survival.

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