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3 results on '"Sophie Couchon-Thaunat"'

1. NISCAHN: a phase II trial of nivolumab in patients with salivary gland carcinoma (Unicancer ORL-08)

Author

Christian Borel, Caroline Even, Christophe Le Tourneau, Jerome Fayette, Laurence Bozec, Joël Guigay, Sylvie Chabaud, Laurence Digue, Lionnel Geoffrois, Fréderic Rolland, Didier Cupissol, Anne Françoise Dillies, Sylvie Zanetta, Sophie Couchon-Thaunat, Valérie Costes-Martineau, Anne Sudaka-Bahadoran, Isabelle Jallut, Florence Garic, and Audrey Lardy-Cleaud

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Objective Salivary gland cancers (SGC) are rare cancers with currently no standard treatment for recurrent/metastatic disease. Based on checkpoint inhibitors benefit in a broad range of tumours, NIvolumab in Salivary gland CArcinoma of the Head and Neck (NISCAHN) evaluated nivolumab efficacy in SGC.Methods and analysis In this phase II single-stage Fleming design, patients with SGC with a progressive disease progression within 6 months prior to entering the study, were divided into ACC (adenoid cytic carcinoma) and non-ACC. All received nivolumab for a maximum of 12 months. The primary endpoint was the non-progression rate at 6 months (NPR6m) according to Response Evaluation Criteria in Solid Tumors V.1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR), tumour growth rate, safety and quality of life (health-related quality of life).Results 46 patients with ACC and 52 patients without ACC were enrolled over 1 year. Median follow-up was respectively 29.2 months and 16.9 months for patients with ACC and non-ACC. In the ACC cohort, with 15/45 patients non-progressive at 6 months, the primary endpoint was met (33.3%; 95% CI 21.8 to NE). Nivolumab failed to demonstrate efficacy in the non-ACC cohort (NPR6m: 14.0%; 7/50 patients). ORR, PFS and OS were 8.7% (95% CI 2.4 to 20.8), 5.3 (95% CI 3.2 to 5.6) and 17.2 months (95% CI 12.5-NE) in the ACC cohort, and 3.8% (95% CI 0.5 to 13.2), 1.8 (95% CI 1.7 to 3.5) and 11.5 months (95% CI 7.5 to 14.8) in the non-ACC cohort. Nivolumab safety profile was consistent with previous reports.Conclusion Nivolumab has limited efficacy in SGC. Differential results were observed in the two cohorts. The primary endpoint was met in the ACC cohort and no new safety signals were identified.Trial registration number EudraCT number: 2016-001794-32/NCT03132038.

Published
2023
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2. NISCAHN: A phase II, multicenter nonrandomized trial aiming at evaluating nivolumab (N) in two cohorts of patients (pts) with recurrent/metastatic (R/M) salivary gland carcinoma of the head and neck (SGCHN), on behalf of the Unicancer Head & Neck Group

Author

Laurence Digue, Frederic Rolland, Aurélie Guyennon, Sylvie Zanetta, Jérôme Fayette, Didier Cupissol, Christophe Le Tourneau, Jessy Delaye, Isabelle Jallut, Audrey Lardy-Cleaud, Laurence Bozec Lemoal, Valérie Costes, Sophie Couchon-Thaunat, Joël Guigay, Sylvie Chabaud, Anne-Françoise Dillies, Christian Borel, Caroline Even, and Lionnel Geoffrois

Subjects
Cancer Research, medicine.medical_specialty, business.industry, Adenoid cystic carcinoma, Urology, Head neck, medicine.disease, Salivary gland carcinoma, stomatognathic diseases, 03 medical and health sciences, 0302 clinical medicine, Oncology, 030220 oncology & carcinogenesis, medicine, Nivolumab, business, Head and neck, 030215 immunology
Abstract

6083 Background: SGCHN are rare tumors including adenoid cystic carcinoma (ACC) and non-ACC, with no standard systemic treatment for R/M pts. We evaluated N monotherapy in R/M SGCHN pts. Methods: R/M SGCHN pts (ACC or non-ACC) not eligible to local treatment and with centrally confirmed RECIST 1.1 disease progression over the last 6 months were enrolled and received N 3 mg/kg IV, every 2 weeks for a maximum of 12 months (mo). Possibility was given to re-start N in case of progression during the 2-year follow-up phase. Primary endpoint was 6-mo non-progression Rate (NPR6m) as per RECIST 1.1. Secondary endpoints included ORR, PFS, OS, and safety. Considering that N would be uninteresting if NPR6m ≤ 20% and promising if ≥ 40% and using a Fleming’s single-stage design (α: 5% unilateral, power: 90%), at least 14 successes/42 evaluable pts were required for each cohort to be positive. Results: 46 ACC and 52 Non-ACC pts (median age 61 yrs (range 29-81), 43.9% female, 55.1% PS1 and 2.0% PS2) were enrolled and received at least one dose of N. Median treatment duration was 5.5 mo (ACC) and 3.3 (Non-ACC). Median FU was 10.8 mo (ACC) and 8.3 mo (Non-ACC). 95 patients were evaluable for the primary endpoint. NPR6m was 15/45 pts (33.3%, 90%CI :21.8;46.6) and 7/50 pts (14.0%, 90%CI:6.8;24.7) for ACC and non-ACC pts respectively. 4 (8.7%) partial responses (PR) and 26 (56.5%) stable diseases (SD) were observed in ACC cohort while 2 (3.8%) PR and 22 (42.3%) SD were observed in non-ACC. Median PFS was 4.9 mo (95%CI = 3.4;5.6) in ACC pts and 1.8 mo (95%CI = 1.7;3.5) in non-ACC pts. The most common related adverse events (AE) ( > 10% by cohort) were asthenia, hyperthyroidism, diarrhea, rash, pruritus and hypothyroidism. 7/98 pts (7.1%) presented at least one related AE Grade 3-4 (mainly hepatic) and 9 pts (9.2%) prematurely discontinued Nivolumab due to toxicity. Conclusions: Limited efficacy was observed with N in R/M SGCHN pts. N in combination might be of interest and deserves exploration in ACC pts. Clinical trial information: NCT03132038.

Published
2019

3. PIK-ORL: A phase II, multicenter trial aiming to evaluate BKM120 in monotherapy in patients (pts) with metastatic/recurrent head and neck squamous cell carcinoma (HNSCC) after failure of platin and cetuximab or anti-EGFR-based therapy

Author

L. Jaouen, Gwenaelle Garin, M. Matias, Caroline Even, J. Fayette, Qing Wang, Isabelle Treilleux, Audrey Mailliez, Sophie Tartas, L. Digue, C. Le Tourneau, Aurélie Guyennon, Sophie Couchon-Thaunat, Celine Ferlay, M. Degardin, D. Perol, G. Lefebvre, Gilles Clapisson, C. Hebert, and Didier Cupissol

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Metastatic/Recurrent, Cetuximab, business.industry, Hematology, medicine.disease, Head and neck squamous-cell carcinoma, 03 medical and health sciences, 030104 developmental biology, Multicenter trial, Internal medicine, medicine, In patient, business, medicine.drug
Published
2016

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