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2. X-ray Fourier ptychographic microscopy

Author

Simons, H., Poulsen, H. F., Guigay, J. P., and Detlefs, C.

Subjects
Physics - Instrumentation and Detectors, Physics - Optics
Abstract

Following the recent developement of Fourier ptychographic microscopy (FPM) in the visible range by Zheng et al. (2013), we propose an adaptation for hard x-rays. FPM employs ptychographic reconstruction to merge a series of low-resolution, wide field of view images into a high-resolution image. In the x-ray range this opens the possibility to overcome the limited numerical aperture of existing x-ray lenses. Furthermore, digital wave front correction (DWC) may be used to charaterize and correct lens imperfections. Given the diffraction limit achievable with x-ray lenses (below 100 nm), x-ray Fourier ptychographic microscopy (XFPM) should be able to reach resolutions in the 10 nm range., Comment: 9 pages, 1 figure

Published
2016

3. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer

Author

Cohen, EEW, Licitra, LF, Burtness, B, Fayette, J, Gauler, T, Clement, PM, Grau, JJ, del Campo, JM, Mailliez, A, Haddad, RI, Vermorken, JB, Tahara, M, Guigay, J, Geoffrois, L, Merlano, MC, Dupuis, N, Krämer, N, Cong, XJ, Gibson, N, Solca, F, Ehrnrooth, E, and Machiels, J-PH

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Dental/Oral and Craniofacial Disease, Rare Diseases, Cancer, Clinical Research, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Administration, Intravenous, Administration, Oral, Afatinib, Antimetabolites, Antineoplastic, Biomarkers, Tumor, Biopsy, Carcinoma, Squamous Cell, Disease-Free Survival, Head and Neck Neoplasms, Humans, Methotrexate, Neoplasm Metastasis, Neoplasm Recurrence, Local, Predictive Value of Tests, Quinazolines, Squamous Cell Carcinoma of Head and Neck, afatinib, methotrexate, HNSCC, biomarker, phase III, EGFR, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundIn the phase III LUX-Head & Neck 1 (LUX-H&N1) trial, second-line afatinib significantly improved progression-free survival (PFS) versus methotrexate in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Here, we evaluated association of prespecified biomarkers with efficacy outcomes in LUX-H&N1.Patients and methodsRandomized patients with R/M HNSCC and progression following ≥2 cycles of platinum therapy received afatinib (40 mg/day) or methotrexate (40 mg/m2/week). Tumor/serum samples were collected at study entry for patients who volunteered for inclusion in biomarker analyses. Tumor biomarkers, including p16 (prespecified subgroup; all tumor subsites), EGFR, HER2, HER3, c-MET and PTEN, were assessed using tissue microarray cores and slides; serum protein was evaluated using the VeriStrat® test. Biomarkers were correlated with efficacy outcomes.ResultsOf 483 randomized patients, 326 (67%) were included in the biomarker analyses; baseline characteristics were consistent with the overall study population. Median PFS favored afatinib over methotrexate in patients with p16-negative [2.7 versus 1.6 months; HR 0.70 (95% CI 0.50-0.97)], EGFR-amplified [2.8 versus 1.5 months; HR 0.53 (0.33-0.85)], HER3-low [2.8 versus 1.8 months; HR 0.57 (0.37-0.88)], and PTEN-high [1.6 versus 1.4 months; HR 0.55 (0.29-1.05)] tumors. Afatinib also improved PFS in combined subsets of patients with p16-negative and EGFR-amplified tumors [2.7 versus 1.5 months; HR 0.47 (0.28-0.80)], and patients with p16-negative tumors who were EGFR therapy-naïve [4.0 versus 2.4 months; HR 0.55 (0.31-0.98)]. PFS was improved in afatinib-treated patients who were VeriStrat 'Good' versus 'Poor' [2.7 versus 1.5 months; HR 0.71 (0.49-0.94)], but no treatment interaction was observed. Afatinib improved tumor response versus methotrexate in all subsets analyzed except for those with p16-positive disease (n = 35).ConclusionsSubgroups of HNSCC patients who may achieve increased benefit from afatinib were identified based on prespecified tumor biomarkers (p16-negative, EGFR-amplified, HER3-low, PTEN-high). Future studies are warranted to validate these findings.Clinical trial registrationNCT01345682.

Published
2017

4. Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial †

Author

Clement, PM, Gauler, T, Machiels, JP, Haddad, RI, Fayette, J, Licitra, LF, Tahara, M, Cohen, EEW, Cupissol, D, Grau, JJ, Guigay, J, Caponigro, F, de Castro, G, de Souza Viana, L, Keilholz, U, del Campo, JM, Cong, XJ, Ehrnrooth, E, and Vermorken, JB

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Dental/Oral and Craniofacial Disease, Cancer, Clinical Trials and Supportive Activities, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Afatinib, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Disease-Free Survival, Female, Head and Neck Neoplasms, Humans, Male, Methotrexate, Neoplasm Metastasis, Neoplasm Recurrence, Local, Platinum, Quinazolines, Squamous Cell Carcinoma of Head and Neck, Treatment Outcome, LUX-H&N 1 investigators, HNSCC, afatinib, methotrexate, older, phase III, second-line, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundIn the phase III LUX-Head & Neck 1 (LHN1) trial, afatinib significantly improved progression-free survival (PFS) versus methotrexate in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients progressing on/after platinum-based therapy. This report evaluates afatinib efficacy and safety in prespecified subgroups of patients aged ≥65 and

Published
2016

9. Pembrolizumab versus cetuximab concurrent with radiotherapy in patients with locally advanced squamous cell carcinoma of head and neck unfit for cisplatin (GORTEC 2015-01 PembroRad): a multicenter, randomized, phase II trial

Author

Tao, Y., primary, Biau, J., additional, Sun, X.S., additional, Sire, C., additional, Martin, L., additional, Alfonsi, M., additional, Prevost, J.B., additional, Modesto, A., additional, Lafond, C., additional, Tourani, J.M., additional, Miroir, J., additional, Kaminsky, M.C., additional, Coutte, A., additional, Liem, X., additional, Chautard, E., additional, Vauleon, E., additional, Drouet, F., additional, Ruffier, A., additional, Ramee, J.F., additional, Waksi, G., additional, Péchery, A., additional, Wanneveich, M., additional, Guigay, J., additional, Aupérin, A., additional, and Bourhis, J., additional

Published
2023
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11. Guidelines (short version) of the French Otorhinolaryngology – Head and Neck Surgery Society (SFORL) on patient pathway organization in ENT: The therapeutic decision-making process

Author

Deneuve, S., Babin, E., Lacau-St-Guily, J., Baujat, B., Bensadoun, R.-J., Bozec, A., Chevalier, D., Choussy, O., Cuny, F., Fakhry, N., Guigay, J., Makeieff, M., Merol, J.-C., Mouawad, F., Pavillet, J., Rebiere, C., Righini, C.-A., Sostras, M.-C., Tournaille, M., and Vergez, S.

Published
2015
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13. Recommandation de la SFORL sur l’organisation du parcours de soins en cancérologie des voies aéro-digestives supérieures (version courte). Prise en charge précoce des patients porteurs d’un cancer de la tête et du cou

Author

Cuny, F., Babin, E., Lacau Saint Guily, J., Baujat, B., Bensadoun, R., Bozec, A., Chevalier, D., Choussy, O., Deneuve, S., Fakhry, N., Guigay, J., Makeieff, M., Merol, J.-C., Mouawad, F., Pavillet, J., Rebiere, C., Righini, C., Sostras, M.-C., Tournaille, M., and Vergez, S.

Published
2015
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17. 478P Metronomic oral vinorelbine (MOV) combined with tremelimumab (T) + durvalumab (D): Results of the tumor mutational burden-high (TMB-h) and/or microsatellite instability-high (MSI-h) cohort of the MOVIE study

Author

Hervieu, A., primary, Guigay, J., additional, Borcoman, E., additional, Lavaud, P., additional, Coquan, E., additional, Frenel, J-S., additional, De La Motte Rouge, T., additional, Augereau, P., additional, Cropet, C., additional, Legrand, F., additional, and Goncalves, A., additional

Published
2022
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18. 695P Effectiveness and quality-of-life (QoL) data from real-world study (ProNiHN) in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN) treated with nivolumab (nivo) in France

Author

Le Tourneau, C., primary, Salas, S., additional, Pointreau, Y., additional, Ceruse, P., additional, Babin, E., additional, Rondeau, V., additional, Guigay, J., additional, Rotarski, M., additional, Chehimi, M., additional, Toullec, C., additional, Marie, G., additional, Sire, C., additional, Darut Jouve, A., additional, Theron, A., additional, Calderon, B., additional, Houessinon, A., additional, Cotté, F-E., additional, Lavignon, M., additional, Even, C., additional, and Fayette, J., additional

Published
2022
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19. 675P Patterns of radiological responses to anti-PD1 in patients (pts) with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in TOPNIVO (T) study

Author

Even, C., primary, Bernard-Tessier, A., additional, Texier, M., additional, Ben Said, O., additional, Iacob, M., additional, Daste, A., additional, Fayette, J., additional, Zanetta, S., additional, Lefebvre, G., additional, Vinches, M., additional, Johnson, A.C., additional, Bozec Le Moal, L., additional, Saada, E.B., additional, Jallut, I., additional, Garic, F., additional, Monard, L., additional, Bourhis, J., additional, Guigay, J., additional, Auperin, A., additional, and Ammari, S., additional

Published
2022
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20. 854MO Avelumab-cetuximab-radiotherapy (RT) versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Final analysis of randomized phase III GORTEC 2017-01 REACH trial

Author

Tao, Y., Auperin, A., Sun, X., Liem, X., Sire, C., Martin, L., Pointreau, Y., Borel, C., Kaminsky-Forrett, M-C., Miroir, J., Rolland, F., Coutte, A., Clatot, F., Sinigaglia, L., Thariat, J., Even, C., Saada, E.B., Guigay, J., and Bourhis, J.

Published
2024
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28. 916P Impact of sarcopenia (S) on efficacy and toxicity of nivolumab (N) in patients (pts) with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in TOPNIVO (T) study

Author

Muratori, L., primary, Texier, M., additional, Mayache-Badis, L., additional, Bidault, F., additional, Iacob, M., additional, Daste, A., additional, Fayette, J., additional, Lefebvre, G., additional, Saada-Bouzid, E., additional, Zanetta, S., additional, Toullec, C., additional, Cupissol, D., additional, Salas, S., additional, Kaminsky-Forrett, M-C., additional, Johnson, A.C., additional, Ferrand, F.R., additional, Aupérin, A., additional, Guigay, J., additional, Raynard, B., additional, and Even, C., additional

Published
2021
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29. LBA35 Avelumab-cetuximab-radiotherapy versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Randomized phase III GORTEC-REACH trial

Author

Bourhis, J., primary, Tao, Y., additional, Sun, X., additional, Sire, C., additional, Martin, L., additional, Liem, X., additional, Coutte, A., additional, Pointreau, Y., additional, Thariat, J., additional, Miroir, J., additional, Rolland, F., additional, Kaminsky, M-C., additional, Borel, C., additional, Maillard, A., additional, Sinigaglia, L., additional, Guigay, J., additional, Saada-Bouzid, E., additional, Even, C., additional, and Aupérin, A., additional

Published
2021
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33. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial

Author

Guigay, J, Auperin, A, Fayette, J, Saada-Bouzid, E, Lafond, C, Taberna, M, Geoffrois, L, Martin, L, Capitain, O, Cupissol, D, Castanie, H, Vansteene, D, Schafhausen, P, Johnson, A, Even, C, Sire, C, Duplomb, S, Evrard, C, Delord, JP, Laguerre, B, Zanetta, S, Chevassus-Clement, C, Fraslin, A, Louat, F, Sinigaglia, L, Keilholz, U, Bourhis, J, Mesia, R, Gallego, O, López Pousa A., and Vazquez Fernandez, Silvia

Abstract

Background Results from a phase 2 trial of the TPEx chemotherapy regimen (docetaxel-platinum-cetuximab) showed promising results, with a median overall survival of 14.0 months in first-line recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). We therefore aimed to compare the efficacy and safety of the TPEx regimen with the standard of care EXTREME regimen (platinum-fluorouracil-cetuximab) in this setting. Methods This was a multicentre, open-label, randomised, phase 2 trial, done in 68 centres (cancer centres, university and general hospitals, and private clinics) in France, Spain, and Germany. Eligible patients were aged 18-70 years with histologically confirmed recurrent or metastatic HNSCC unsuitable for curative treatment; had at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; and had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. Participants were randomly assigned (1:1) using the TenAlea website by investigators or delegated clinical research associates to the TPEx regimen or the EXTREME regimen, with minimisation by ECOG performance status, type of disease evolution, previous cetuximab treatment, and country. The TPEx regimen consisted of docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2), both intravenously on day 1, and cetuximab on days 1, 8, and 15 (intravenously 400 mg/m(2) on day 1 of cycle 1 and 250 mg/m(2) weekly subsequently). Four cycles were repeated every 21 days with systematic granulocyte colony-stimulating factor (G-CSF) support at each cycle. In case of disease control after four cycles, intravenous cetuximab 500 mg/m(2) was continued every 2 weeks as maintenance therapy until progression or unacceptable toxicity. The EXTREME regimen consisted of fluorouracil 4000 mg/m(2) on day 1-4, cisplatin 100 mg/m(2) on day 1, and cetuximab on days 1, 8, and 15 (400 mg/m(2) on day 1 of cycle 1 and 250 mg/m(2) weekly subsequently) all delivered intravenously. Six cycles were delivered every 21 days followed by weekly 250 mg/m(2) cetuximab as maintenance therapy in case of disease control. G-CSF support was not mandatory per the protocol in the EXTREME regimen. The primary endpoint was overall survival in the intention-to-treat population; safety was analysed in all patients who received at least one dose of chemotherapy or cetuximab. Enrolment is closed and this is the final analysis. This study is registered at ClinicalTrials.gov, NCT02268695. Findings Between Oct 10, 2014, and Nov 29, 2017, 541 patients were enrolled and randomly assigned to the two treatment regimens (271 to TPEx, 270 to EXTREME). Two patients in the TPEx group had major deviations in consent forms and were not included in the final analysis. Median follow-up was 34.4 months (IQR 26.6-44.8) in the TPEx group and 30.2 months (25.5-45.3) in the EXTREME group. At data cutoff, 209 patients had died in the TPEx group and 218 had died in the EXTREME group. Overall survival did not differ significantly between the groups (median 14.5 months [95% CI 12.5-15.7] in the TPEx group and 13.4 months [12.2-15.4] in the EXTREME group; hazard ratio 0.89 [95% CI 0.74-1.08]; p=0.23). 214 (81%) of 263 patients in the TPEx group versus 246 (93%) of 265 patients in the EXTREME group had grade 3 or worse adverse events during chemotherapy (p

Published
2021

39. 920P Avelumab (anti-PD-L1) in patients with platinum-refractory/ineligible recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Results from a phase Ib cohort

Author

Guigay, J., primary, Lee, K-W., additional, Patel, M.R., additional, Daste, A., additional, Wong, D.J., additional, Goel, S., additional, Gordon, M., additional, Gutierrez, M., additional, Balmanoukian, A., additional, Le Tourneau, C., additional, Mita, A., additional, Vansteene, D., additional, Keilholz, U., additional, Schöffski, P., additional, Grote, H.J., additional, Zhou, D., additional, Bajars, M., additional, and Penel, N., additional

Published
2020
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40. 946P Germinal immunogenetics and response to nivolumab in recurrent/metastatic head and neck squamous cell carcinoma (RM HNSCC) patients (pts): TopNIVO ancillary study

Author

Saada, E.B., primary, Koudou, Y., additional, Daste, A., additional, Fayette, J., additional, Lefebvre, G., additional, Zanetta, S., additional, Toullec, C., additional, Cupissol, D., additional, Salas, S., additional, Kaminsky-Forrett, M-C., additional, Johnson, A.C., additional, Vauleon, E., additional, Ebran, N., additional, Schmidt, M., additional, Texier, M., additional, Peyrade, F., additional, Milano, G., additional, Guigay, J., additional, Even, C., additional, and Etienne-Grimaldi, M-C., additional

Published
2020
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41. 917MO TOPNIVO - A safety study of nivolumab in patients with recurrent and/or metastatic platinum-refractory squamous cell carcinoma of head and neck (R/M SCCHN): Final analysis

Author

Even, C., primary, Daste, A., additional, Fayette, J., additional, Lefebvre, G., additional, Saada-Bouzid, E., additional, Zanetta, S., additional, Toullec, C., additional, Cupissol, D., additional, Salas, S., additional, Kaminski, M.C., additional, Johnson, A.C., additional, Vauleon, E., additional, Le Tourneau, C., additional, Sire, C., additional, Prevost, A., additional, Jallut, I., additional, Bourhis, J., additional, Guigay, J., additional, Aupérin, A., additional, and Texier, M., additional

Published
2020
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42. LBA38 Pembrolizumab versus cetuximab, concomitant with radiotherapy (RT) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC): Results of the GORTEC 2015-01 “PembroRad” randomized trial

Author

Bourhis, J., primary, Sire, C., additional, Tao, Y., additional, Martin, L., additional, Alfonsi, M., additional, Prevost, J.B., additional, Rives, M., additional, Lafond, C., additional, Tourani, J.M., additional, Biau, J., additional, Geoffrois, L., additional, Coutte, A., additional, Liem, X., additional, Vauleon, E., additional, Drouet, F., additional, Pechery, A., additional, Guigay, J., additional, Wanneveich, M., additional, Aupérin, A., additional, and Sun, X., additional

Published
2020
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50. Integrating artificial intelligence into lung cancer screening: a randomised controlled trial protocol

Author

Paul Hofman, Sylvie Leroy, Jonathan Benzaquen, Bernard Padovani, Charles Hugo Marquette, Fontas Eric, Eric Fontas, Stephanie Lopez, Nesrine Rouis, Jacques Boutros, Allegra Maryline, Amamou-Elhani Faten, ARFI Thierry, Baque Jean, Baque-Juston Marie, Barel Remy, Barrios Baretto Deisy, Baudin Guillaume, Beck Camille, Bellmann Laurent, Benchetrit Maxime, Benkirane Mohamed-Taib, Benyoussef Sid Ali, Benzaquen Jonathan, Berthet Jean Philippe, Bonnard Eric, Bordone Olivier, Boutros Jacques, Boyer Guy-René, Bulsei Julie, Caillon Cynthia, Castelnau Olivier, Chalmin Jérémy, Chebib Ralph, Cohen Charlotte, Cruzel Coralie, Degoutte Aurélien, Delin Margot, Diascorn Yann, Doux Nathalie, Durand Lorraine, Duval Yannick, El Hemweh Omar, Fayada Julien, Felderhoof Eric, Feliciello Stéphane:, Femenia Richard, Ferrari Victoria, Francisci Marc Paul, Ghalloussi Hannah, Gomez-Caro-Andres Abel, Gora Assia, Griffonnet Jennifer, Gubeno Marie Christine, Guigay Joël, Hamila Marame, Harrathi Mohamed-Ali, Henaut Quentin, Herin Edouard, Hofman Paul, Hofman Véronique, ILIE Marius, Korzeniewski Sylvia, Lalvee Salomé, Lassalle Sandra, Le Heron Charles, Leray Loïc, Leriche Julien, Lerousseau Lionel, Leroy Sylvie, Lespinet Fabre Virginie, Lestrez Roxane, Leyssalle Axelle, Long Mira Elodie, Lopez Stephanie, Mahler Valentin, Maniel Charlotte, Marcano Xavier, Marco Roucayrol Sabine, Marquette Charles-Hugo, Martin Nicolas, Mistri Aurélie, Nicolle Isabelle, Novellas Sébastien, Oddo Frédéric, Otto Josiane, Padovani Bernard, PERQUIS Marie Pierre, Philibert Lorène, Pop Daniel, Pottier Héloïse, Raguin Olivier, Rolland Fabien, Rouis Nesrine, Rousset Johanna, Ruitort Frédéric, Sanfiorenzo Céline, Selva Eric, Tanga Virginie, Tardy Magalie, Thomas Olivier, Varenio Sophie, Verdoire Paul, Vigny Isabelle, Washetine Kévin, Zurlinden Olivier, Tarhini Adam, and Perrotin Cédric

Subjects
Medicine
Abstract

Introduction Lung cancer (LC) is the most common cause of cancer-related deaths worldwide. Its early detection can be achieved with a CT scan. Two large randomised trials proved the efficacy of low-dose CT (LDCT)-based lung cancer screening (LCS) in high-risk populations. The decrease in specific mortality is 20%–25%.Nonetheless, implementing LCS on a large scale faces obstacles due to the low number of thoracic radiologists and CT scans available for the eligible population and the high frequency of false-positive screening results and the long period of indeterminacy of nodules that can reach up to 24 months, which is a source of prolonged anxiety and multiple costly examinations with possible side effects.Deep learning, an artificial intelligence solution has shown promising results in retrospective trials detecting lung nodules and characterising them. However, until now no prospective studies have demonstrated their importance in a real-life setting.Methods and analysis This open-label randomised controlled study focuses on LCS for patients aged 50–80 years, who smoked more than 20 pack-years, whether active or quit smoking less than 15 years ago. Its objective is to determine whether assisting a multidisciplinary team (MDT) with a 3D convolutional network-based analysis of screening chest CT scans accelerates the definitive classification of nodules into malignant or benign. 2722 patients will be included with the aim to demonstrate a 3-month reduction in the delay between lung nodule detection and its definitive classification into benign or malignant.Ethics and dissemination The sponsor of this study is the University Hospital of Nice. The study was approved for France by the ethical committee CPP (Comités de Protection des Personnes) Sud-Ouest et outre-mer III (No. 2022-A01543-40) and the Agence Nationale du Medicament et des produits de Santé (Ministry of Health) in December 2023. The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations.Trial registration number NCT05704920.

Published
2024
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