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1. A randomized phase III trial comparing trabectedin to best supportive care in patients with pre-treated soft tissue sarcoma: T-SAR, a French Sarcoma Group trial

Author

Le Cesne, A., Blay, J.-Y., Cupissol, D., Italiano, A., Delcambre, C., Penel, N., Isambert, N., Chevreau, C., Bompas, E., Bertucci, F., Chaigneau, L., Piperno-Neumann, S., Salas, S., Rios, M., Guillemet, C., Bay, J.-O., Ray-Coquard, I., Haddag, L., Bonastre, J., Kapso, R., Fraslin, A., Bouvet, N., Mir, O., and Foulon, S.

Published
2021
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2. A single-arm multicentre phase II trial of doxorubicin in combination with trabectedin in the first-line treatment for leiomyosarcoma with long-term follow-up and impact of cytoreductive surgery

Author

Pautier, P., Floquet, A., Chevreau, C., Penel, N., Guillemet, C., Delcambre, C., Cupissol, D., Selle, F., Isambert, N., Piperno-Neumann, S., Saada-Bouzid, E., Bertucci, F., Bompas, E., Alexandre, J., Collard, O., Lebrun-Ly, V., Soulier, P., Toulmonde, M., Le Cesne, A., Lacas, B., and Duffaud, F.

Published
2021
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3. 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

4. A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck †

Author

Seiwert, TY, Fayette, J, Cupissol, D, del Campo, JM, Clement, PM, Hitt, R, Degardin, M, Zhang, W, Blackman, A, Ehrnrooth, E, and Cohen, EEW

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Cancer, Rare Diseases, Dental/Oral and Craniofacial Disease, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Afatinib, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Carcinoma, Squamous Cell, Cetuximab, ErbB Receptors, Female, Head and Neck Neoplasms, Humans, Male, Middle Aged, Quinazolines, Receptor, ErbB-2, Squamous Cell Carcinoma of Head and Neck, Treatment Outcome, Young Adult, afatinib, cetuximab, recurrent HNSCC, metastatic HNSCC, EGFR inhibitor therapy, Receptor, erbB-2, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundAfatinib is an oral, irreversible ErbB family blocker that has shown activity in epidermal growth factor receptor (EGFR)-mutated lung cancer. We hypothesized that the agent would have greater antitumor activity compared with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients, whose disease has progressed after platinum-containing therapy.Patients and methodsAn open-label, randomized, phase II trial was conducted in 43 centers; 124 patients were randomized (1 : 1) to either afatinib (50 mg/day) or cetuximab (250 mg/m(2)/week) until disease progression or intolerable adverse events (AEs) (stage I), with optional crossover (stage II). The primary end point was tumor shrinkage before crossover assessed by investigator (IR) and independent central review (ICR).ResultsA total of 121 patients were treated (61 afatinib, 60 cetuximab) and 68 crossed over to stage II (32 and 36 respectively). In stage I, mean tumor shrinkage by IR/ICR was 10.4%/16.6% with afatinib and 5.4%/10.1% with cetuximab (P = 0.46/0.30). Objective response rate was 16.1%/8.1% with afatinib and 6.5%/9.7% with cetuximab (IR/ICR). Comparable disease control rates were observed with afatinib (50%) and cetuximab (56.5%) by IR; similar results were seen by ICR. Most common grade ≥3 drug-related AEs (DRAEs) were rash/acne (18% versus 8.3%), diarrhea (14.8% versus 0%), and stomatitis/mucositis (11.5% versus 0%) with afatinib and cetuximab, respectively. Patients with DRAEs leading to treatment discontinuation were 23% with afatinib and 5% with cetuximab. In stage II, disease control rate (IR/ICR) was 38.9%/33.3% with afatinib and 18.8%/18.8% with cetuximab.ConclusionAfatinib showed antitumor activity comparable to cetuximab in R/M HNSCC in this exploratory phase II trial, although more patients on afatinib discontinued treatment due to AEs. Sequential EGFR/ErbB treatment with afatinib and cetuximab provided sustained clinical benefit in patients after crossover, suggesting a lack of cross-resistance.

Published
2014

5. Improved survival using specialized multidisciplinary board in sarcoma patients

Author

Blay, J.-Y., Soibinet, P., Penel, N., Bompas, E., Duffaud, F., Stoeckle, E., Mir, O., Adam, J., Chevreau, C., Bonvalot, S., Rios, M., Kerbrat, P., Cupissol, D., Anract, P., Gouin, F., Kurtz, J. -E., Lebbe, C., Isambert, N., Bertucci, F., Toumonde, M., Thyss, A., Piperno-Neumann, S., Dubray-Longeras, P., Meeus, P., Ducimetière, F., Giraud, A., Coindre, J. -M., Ray-Coquard, I., Italiano, A., and Le Cesne, A.

Published
2017
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6. Prediction of local and metastatic recurrence in solitary fibrous tumor: construction of a risk calculator in a multicenter cohort from the French Sarcoma Group (FSG) database

Author

Salas, S., Resseguier, N., Blay, J.Y., Le Cesne, A., Italiano, A., Chevreau, C., Rosset, P., Isambert, N., Soulie, P., Cupissol, D., Delcambre, C., Bay, J.O., Dubray-Longeras, P., Krengli, M., De Bari, B., Villa, S., Kaanders, J.H.A.M., Torrente, S., Pasquier, D., Thariat, J.O., Myroslav, L., Sole, C.V., Dincbas, H.F., Habboush, J.Y., Zilli, T., Dragan, T., Khanfir, K., Ugurluer, G., Cena, T., Duffaud, F., Penel, N., Bertucci, F., Ranchere-Vince, D., Terrier, P., Bonvalot, S., Macagno, N., Lemoine, C., Lae, M., Coindre, J.M., and Bouvier, C.

Published
2017
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9. 123MO Monalizumab, cetuximab and durvalumab in first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): A phase II trial

Author

Colevas, D.A., primary, Misiukiewicz, K., additional, Pearson, A.T., additional, Fayette, J., additional, Bauman, J.R., additional, Cupissol, D., additional, Saada-Bouzid, E., additional, Adkins, D.R., additional, Marie, D.B., additional, Cornen, S.L., additional, André, P., additional, Carrette, F., additional, Rotolo, F., additional, Boyer Chammard, A., additional, and Cohen, R.B., additional

Published
2021
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11. LBA59 LMS-04 study: A randomised, multicenter, phase III study comparing doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin in non-progressive patients as first-line therapy, in patients with metastatic or unresectable leiomyosarcoma - A French Sarcoma Group study

Author

Pautier, P., primary, Italiano, A., additional, Piperno-Neumann, S., additional, Chevreau, C.M., additional, Penel, N., additional, Cupissol, D., additional, Boudou Rouquette, P., additional, Bertucci, F., additional, Balleyguier, C., additional, Lebrun-Ly, V., additional, Blay, J-Y., additional, Kalbacher, E., additional, Delcambre, C., additional, Bompas, E., additional, Collard, O., additional, Isambert, N., additional, Guillemet, C., additional, Rios, M., additional, Sundqvist, M., additional, and Duffaud, F., additional

Published
2021
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12. LBA58 Results of the randomized, placebo (PL)-controlled phase II study evaluating the efficacy and safety of regorafenib (REGO) in patients (pts) with relapsed advanced or metastatic chordoma, on behalf of the French Sarcoma Group (FSG) and Unicancer

Author

Duffaud, F., primary, Chabaud, S., additional, Chevreau, C.M., additional, Italiano, A., additional, Perrin, C., additional, Isambert, N., additional, Piperno-Neumann, S., additional, Saada-Bouzid, E., additional, Bertucci, F., additional, Cupissol, D., additional, Kalbacher, E., additional, Narciso, B., additional, Schiffler, C., additional, de Sousa Carvalho, N., additional, Monard, L., additional, Bouvier, C., additional, Vidal, V., additional, Blay, J-Y., additional, and Mir, O., additional

Published
2021
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13. 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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14. 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

17. 81P Monalizumab in combination with cetuximab post platinum and anti-PD-(L)1 in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Updated results from a phase II trial

Author

Fayette, J., primary, Bauman, J., additional, Salas, S., additional, Colevas, D., additional, Even, C., additional, Cupissol, D., additional, Posner, M.R., additional, Lefebvre, G., additional, Saada-Bouzid, E., additional, Bernadach, M., additional, Seiwert, T., additional, Pearson, A., additional, Messouak, S., additional, Cornen, S.L., additional, Andre, P., additional, Rotolo, F., additional, Boyer-Chammard, A., additional, and Cohen, R.B., additional

Published
2020
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21. 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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22. 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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23. 970P MEDINDUCTION: Phase I trial evaluating the safety of durvalumab in combination with docetaxel, cisplatin and 5-FU (DCF) as induction therapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Author

Even, C., primary, Texier, M., additional, Le Tourneau, C., additional, Bahleda, R., additional, Borcoman, E., additional, Vinches, M., additional, Toussaint, P., additional, Marabelle, A., additional, Breuskin, I., additional, Cupissol, D., additional, and Fayette, J., additional

Published
2020
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27. Personalized treatment according to geriatric assessment in first-line recurrent and/or metastatic (R/M) head and neck squamous cell cancer (HNSCC) patients aged 70 or over: ELAN (ELderly heAd and Neck cancer) FIT and UNFIT trials

Author

Guigay, J., primary, Auperin, A., additional, Mertens, C., additional, Even, C., additional, Geoffrois, L., additional, Cupissol, D., additional, Rolland, F., additional, Sire, C., additional, Fayette, J., additional, Peyrade, F., additional, Blot, E., additional, Debourdeau, P., additional, Bozec, L., additional, Capitain, O., additional, Pointreau, Y., additional, Brard, C., additional, Michel, C., additional, Schwob, D., additional, Ortholan, C., additional, and Le Caer, H., additional

Published
2019
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28. Buparlisib (BKM120) in refractory head and neck squamous cell carcinoma harbouring or not a PI3KCA mutation: A phase II multicenter trial

Author

Fayette, J., primary, Digue, L., additional, Ségura-Ferlay, C., additional, Treilleux, I., additional, Wang, Q., additional, Lefebvre, G., additional, Daste, A., additional, Even, C., additional, Couchon Thaunat, S., additional, Guyennon, A., additional, Peyrade, F., additional, Cupissol, D., additional, You, B., additional, Le Tourneau, C., additional, Jaouen, L., additional, Grinand, E., additional, Tabone-Eglinger, S., additional, Garin, G., additional, and Perol, D., additional

Published
2019
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29. Predictive markers of immune mediated adverse events and of treatment response in patients treated with durvalumab monotherapy or in combination with tremelimumab (IOPREDI study)

Author

Marabelle, A., primary, Ghiringhelli, F., additional, Ayyoub, M., additional, Tartour, E., additional, Adotevi, O., additional, Loriot, Y., additional, Lambotte, O., additional, Cupissol, D., additional, Damotte, D., additional, Adam, J., additional, Bonvalet, M., additional, Petre Lazar, B., additional, Licour, M., additional, and Chaput, N., additional

Published
2018
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30. TOPNIVO: A safety study of nivolumab in patients with recurrent and/or metastatic platinum-refractory squamous cell carcinoma of the head and neck (R/M SCCHN): First results on behalf of the UNICANCER Head&Neck Group and the GORTEC

Author

Even, C., primary, Daste, A., additional, Saada-Bouzid, E., additional, Fayette, J., additional, Kaminsky-Forrett, M.-C., additional, Zanetta, S., additional, Prevost, A., additional, Lefebvre, G., additional, Borel, C., additional, Cupissol, D., additional, Huguet, F., additional, Delord, J.-P., additional, Baste Rotllan, N., additional, Delaye, J., additional, Jallut, I., additional, Vintonenko, N., additional, Bourhis, J., additional, Guigay, J., additional, Texier, M., additional, and Auperin, A., additional

Published
2018
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32. Results of the LMS03 phase II study evaluating gemcitabine combined with pazopanib as a 2nd-line treatment for metastatic/relapsed leiomyosarcomas (uterine or soft tissue) after failure of anthracycline-based chemotherapy: The UNICANCER SARCOME 11 study

Author

Pautier, P., primary, Penel, N., additional, Ray-Coquard, I., additional, Italiano, A., additional, Bompas, E., additional, Delcambre, C., additional, Bay, J-O., additional, Bertucci, F., additional, Delaye, J., additional, Chevreau, C., additional, Cupissol, D., additional, Le Moal, L. Bozec, additional, Eymard, J-C., additional, Thyss, A., additional, Isambert, N., additional, Guillemet, C., additional, Rios, M., additional, Piperno-Neumann, S., additional, Chenuc, G., additional, and Duffaud, F., additional

Published
2017
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33. MEDINDUCTION: Phase I trial evaluating the safety of durvalumab in combination with Docetaxel, Cisplatin and 5-FU (DCF) in induction for locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Author

Even, C., primary, Texier, M., additional, Le Tourneau, C., additional, Marabelle, A., additional, Chaput, N., additional, Adam, J., additional, Paci, A., additional, Broutin, S., additional, Ferté, C., additional, Breuskin, I., additional, Cupissol, D., additional, and Fayette, J., additional

Published
2017
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34. The ELAN-ONCOVAL (ELderly heAd and Neck cancer-Oncology eValuation) study: Evaluation of the feasibility of a suited geriatric assessment for use by oncologists to classify patients as fit or unfit

Author

Mertens, C., primary, Le Caer, H., additional, Ortholan, C., additional, Blot, E., additional, Even, C., additional, Rousselot, H., additional, Peyrade, F., additional, Sire, C., additional, Cupissol, D., additional, Pointreau, Y., additional, Debourdeau, P., additional, Rolland, F., additional, Fayette, J., additional, Capitain, O., additional, Sun, X., additional, Debbah, M., additional, Schwob, D., additional, Boulahssass, R., additional, Aupérin, A., additional, and Guigay, J., additional

Published
2017
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35. Second-line afatinib vs methotrexate (MTX) in patients (pts) with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) : subgroup/biomarker analysis of LUX-head and neck 1 (LUX-H&N1)

Author

Tahara, M., Cohen, E. E. W., Haddad, R. I., Fayette, J., Licitra, L. F., Clement, P. M., Vermorken, J. B., Gauler, Thomas, Cupissol, D., Grau, J. J., Guigay, J., del Campo, J. M., Okami, K., Takahashi, S., Burtness, B., Cong, X. J., Gibson, N., Solca, F., Ehrnrooth, E., and Machiels, J. P. H.

Subjects
Medizin
Published
2015

36. 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

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, Clement, P M, Gauler, T, Machiels, Jean-Pascal, Haddad, R I, Fayette, J, Licitra, L F, Tahara, M, Cohen, E E W, Cupissol, D, Grau, J J, Guigay, J, Caponigro, F, de Castro, G, de Souza Viana, L, Keilholz, U, Del Campo, J M, Cong, X J, Ehrnrooth, E, Vermorken, J B, LUX-H&N 1 investigators, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, Clement, P M, Gauler, T, Machiels, Jean-Pascal, Haddad, R I, Fayette, J, Licitra, L F, Tahara, M, Cohen, E E W, Cupissol, D, Grau, J J, Guigay, J, Caponigro, F, de Castro, G, de Souza Viana, L, Keilholz, U, Del Campo, J M, Cong, X J, Ehrnrooth, E, Vermorken, J B, and LUX-H&N 1 investigators

Abstract

BACKGROUND: In 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 <65 years. PATIENTS AND METHODS: Patients were randomized (2:1) to 40 mg/day oral afatinib or 40 mg/m(2)/week intravenous methotrexate. PFS was the primary end point; overall survival (OS) was the key secondary end point. Other end points included: objective response rate (ORR), patient-reported outcomes, tumor shrinkage, and safety. Disease control rate (DCR) was also assessed. RESULTS: Of 483 randomized patients, 27% (83 afatinib; 45 methotrexate) were aged ≥65 years (older) and 73% (239 afatinib; 116 methotrexate) <65 years (younger) at study entry. Similar PFS benefit with afatinib versus methotrexate was observed in older {median 2.8 versus 2.3 months, hazard ratio (HR) = 0.68 [95% confidence interval (CI) 0.45-1.03], P = 0.061} and younger patients [2.6 versus 1.6 months, HR = 0.79 (0.62-1.01), P = 0.052]. In older and younger patients, the median OS with afatinib versus methotrexate was 7.3 versus 6.4 months [HR = 0.84 (0.54-1.31)] and 6.7 versus 6.2 months [HR = 0.98 (0.76-1.28)]. ORRs with afatinib versus methotrexate were 10.8% versus 6.7% and 10.0% versus 5.2%; DCRs were 53.0% versus 37.8% and 47.7% versus 38.8% in older and younger patients, respectively. In both subgroups, the most frequent treatment-related adverse events were rash/acne (73%-77%) and diarrhea (70%-80%) with afatinib, and stomatitis (43%) and fatigue (31%-34%) with methotrexate. Fewer treatment-related discontinuations were observed with afatinib (each subgroup 7% versus 16%). A trend toward improved time to deterioration of global health status, pain, and swallowing with afatinib was observed in both subgroup

Published
2016

38. 1110O - Personalized treatment according to geriatric assessment in first-line recurrent and/or metastatic (R/M) head and neck squamous cell cancer (HNSCC) patients aged 70 or over: ELAN (ELderly heAd and Neck cancer) FIT and UNFIT trials

Author

Guigay, J., Auperin, A., Mertens, C., Even, C., Geoffrois, L., Cupissol, D., Rolland, F., Sire, C., Fayette, J., Peyrade, F., Blot, E., Debourdeau, P., Bozec, L., Capitain, O., Pointreau, Y., Brard, C., Michel, C., Schwob, D., Ortholan, C., and Le Caer, H.

Published
2019
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40. Randomized trial of treatment with cisplatin and interleukin-2 either alone or in combination with interferon-?-2a in patients with metastatic melanoma

Author

Vinke J, de Peuter R, Sylvie Negrier, D. Baume, Christine Chevreau, M. F. Avril, Bernard Escudier, Oskam R, A. Herrera, Thierry Dorval, and Cupissol D

Subjects
Cisplatin, Cancer Research, medicine.medical_specialty, Chemotherapy, Randomization, business.industry, medicine.medical_treatment, Parallel study, Cancer, medicine.disease, Gastroenterology, law.invention, Surgery, Regimen, Oncology, Randomized controlled trial, law, Internal medicine, Toxicity, medicine, business, medicine.drug
Abstract

BACKGROUND The objective of the current study was to evaluate the response rate, survival, and toxicity of treatment with cisplatin and high dose intravenous continuous infusion interleukin-2 (IL-2) with or without interferon-α-2a (IFN) in patients with metastatic melanoma. METHODS One hundred and seventeen patients with metastatic melanoma randomly were assigned to receive cisplatin, 100 mg/m2, followed after a 3-day rest period by IL-2, 18 × 106 IU/m2, on Days 3-6 and Days 17-21 (Arm 1) or cisplatin and IL-2 using an identical schedule plus subcutaneous IFN, 9 × 106 U, 3 times a week during IL-2 administration (Arm 2). In the absence of disease progression or undue toxicity, the cycle could be repeated on Day 29. Patients who responded after two cycles eventually could receive a third cycle. One hundred and one patients were evaluable for toxicity and efficacy. RESULTS On treatment Arm 1, 3 patients (6%) achieved a complete response (CR) and 5 patients (10%) achieved a partial response (PR) with a median response duration of 3.8 months for the CRs and 8.7 months for the PRs. On treatment Arm 2, 2 patients (3%) achieved a CR (durations of 5.9 and 33.1 months, respectively) and 11 patients (21%) a PR with a median response duration of 8.3 months. The median durations of overall survival were 10.4 months (range, 1.1-39.7+ months) and 10.9 months (range, 0.5-38.1+ months) for treatment Arms 1 and 2, respectively. The toxicity profile was consistent with the known side effects of this IL-2 intravenous regimen combined with cisplatin chemotherapy and IFN. Toxicity was more pronounced in treatment Arm 2 compared with treatment Arm 1. There were 2 and 4 patients, respectively, in treatment Arms 1 and 2 who died within 28 days after completion of treatment. CONCLUSIONS The observed overall response rates of 16% and 25% in treatment Arms 1 and 2, respectively, is lower than that expected with biochemotherapy; despite the fact that the objective of the trial was not to show any difference between the 2 treatment arms, our results indicate that the addition of IFN, at the dose and schedule used in this trial, fails to improve the activity of a cisplatin/IL-2 regimen significantly in patients with metastatic melanoma. Although response rates were relatively low, the median overall survival was nearly 1 year in both groups. Cancer 1999;85:1060–6. © 1999 American Cancer Society.

Published
1999

41. Results of a prospective randomized phase III T-SAR trial comparing trabectedin vs best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS)

Author

Le Cesne, A., primary, Blay, J.-Y., additional, Cupissol, D., additional, Italiano, A., additional, Delcambre, C., additional, Penel, N., additional, Isambert, N., additional, Chevreau, C., additional, Bompas, E., additional, Bertucci, F., additional, Chaigneau, L., additional, Piperno-Neumann, S., additional, Salas, S., additional, Rios, M., additional, Guillemet, C., additional, Bay, J.-O., additional, Ray-Coquard, I.L., additional, Mir, O., additional, Haddag, L., additional, and Foulon, S., additional

Published
2016
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42. Pazopanib in patients with progressive recurrent or metastatic (R/M) salivary gland carcinoma (SGC): Further evaluation of efficacy including tumor growth rates (GR) analysis. H&N Unicancer Group PACSA trial with the REFCOR

Author

Guigay, J., primary, Bidault, F., additional, Fayette, J., additional, Even, C., additional, Cupissol, D., additional, Rolland, F., additional, Peyrade, F., additional, Laguerre, B., additional, Le Tourneau, C., additional, Zanetta, S., additional, Bozec Le Moal, L., additional, Borel, C., additional, Digue, L., additional, Delaye, J., additional, Diffetocq, S., additional, Costes, V., additional, Auperin, A., additional, and Faivre, L., additional

Published
2016
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43. 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

Fayette, J., primary, Digue, L., additional, Ferlay, C., additional, Treilleux, I., additional, Garin, G., additional, Wang, Q., additional, Hebert, C., additional, Even, C., additional, Cupissol, D., additional, Couchon-Thaunat, S., additional, Jaouen, L., additional, Guyennon, A., additional, Le Tourneau, C., additional, Lefebvre, G., additional, Mailliez, A., additional, Matias, M., additional, Degardin, M., additional, Tartas, S., additional, Clapisson, G., additional, and Perol, D., additional

Published
2016
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44. The nationwide cohort of 26,883 patients with sarcomas treated in NETSARC reference network between 2010 and 2015 in France: major impact of multidisciplinary board presentation prior to 1st treatment

Author

Blay, J.-Y., primary, Le Cesne, A., additional, Penel, N., additional, Bompas, E., additional, Chevreau, C., additional, Duffaud, F., additional, Rios, M., additional, Kerbrat, P., additional, Cupissol, D., additional, Anract, P., additional, Kurtz, J.-E., additional, Lebbe, C., additional, Bertucci, F., additional, Piperno-Neumann, S., additional, Rosset, P., additional, Isambert, N., additional, Dubray-Longeras, P., additional, Ducimetière, F., additional, Coindre, J.-M., additional, and Italiano, A., additional

Published
2016
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45. 314O_PR Second-line afatinib vs methotrexate (MTX) in patients (pts) with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC): subgroup/biomarker analysis of LUX-head and neck 1 (LUX-H&N1)

Author

Tahara, M., primary, Cohen, E.E.W., additional, Haddad, R.I., additional, Fayette, J., additional, Licitra, L.F., additional, Clement, P.M., additional, Vermorken, J.B., additional, Gauler, T., additional, Cupissol, D., additional, Grau, J.J., additional, Guigay, J., additional, del Campo, J.M., additional, Okami, K., additional, Takahashi, S., additional, Burtness, B., additional, Cong, X.J., additional, Gibson, N., additional, Solca, F., additional, Ehrnrooth, E., additional, and Machiels, J.-P.H., additional

Published
2015
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46. 1065P - TOPNIVO: A safety study of nivolumab in patients with recurrent and/or metastatic platinum-refractory squamous cell carcinoma of the head and neck (R/M SCCHN): First results on behalf of the UNICANCER Head&Neck Group and the GORTEC

Author

Even, C., Daste, A., Saada-Bouzid, E., Fayette, J., Kaminsky-Forrett, M.-C., Zanetta, S., Prevost, A., Lefebvre, G., Borel, C., Cupissol, D., Huguet, F., Delord, J.-P., Baste Rotllan, N., Delaye, J., Jallut, I., Vintonenko, N., Bourhis, J., Guigay, J., Texier, M., and Auperin, A.

Published
2018
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47. High-dose chemotherapy consolidation for chemosensitive advanced soft tissue sarcoma patients: an open-label, randomized controlled trial

Author

Bui-Nguyen, B., Ray-Coquard, Isabelle, Chevreau, C., Penel, N., Bay, J. O., Coindre, J. M., Cupissol, D., Italiano, A., Bonichon, F., Lotz, J. P., Thyss, A., Jimenez, M., Mathoulin-Pélissier, S., Blay, J. Y., Renseigné, Non, Institut Bergogné, Department of Medical Oncology, Centre Léon Bérard [Lyon], Institut Claudius Regaud, CRLCC Institut Claudius Regaud, Centre Régional de Lutte Contre le Cancer Oscar Lambret, Centre Jean Perrin, CRLCC Jean Perrin, Institut bergogné, Centre Val d'Aurelle-Paul Lamarque, Plateforme de génétique moléculaire des cancers d'Aquitaine, Institut Bergonié - CRLCC Bordeaux, Service d'oncologie Médicale, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz, Centre Antoine Lacassagne, CRLCC Antoine Lacassagne, Unité Matériaux et Transformations - UMR 8207 (UMET), Centre National de la Recherche Scientifique (CNRS)-Université de Lille-Ecole Nationale Supérieure de Chimie de Lille (ENSCL)-Institut National de la Recherche Agronomique (INRA), Centre d'Investigation Clinique - Epidemiologie Clinique / Essais Cliniques Bordeaux, Institut National de la Santé et de la Recherche Médicale (INSERM), Eq 11, Centre Léon Bérard [Lyon]-Centre de Recherche en Cancérologie de Lyon (CRCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Institut Bergonié [Bordeaux], UNICANCER-UNICANCER, Service d'Oncologie Médicale [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Institut de Chimie du CNRS (INC)-Institut National de la Recherche Agronomique (INRA)-Centre National de la Recherche Scientifique (CNRS)-Université de Lille-Ecole Nationale Supérieure de Chimie de Lille (ENSCL), Centre Léon Bérard [Lyon]-Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lille-UNICANCER, Institut National de la Recherche Agronomique (INRA)-Ecole Nationale Supérieure de Chimie de Lille (ENSCL)-Institut de Chimie du CNRS (INC)-Université de Lille-Centre National de la Recherche Scientifique (CNRS), and Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL)

Subjects
Male, MESH: Combined Modality Therapy, MESH: Consolidation Chemotherapy, MESH: Peripheral Blood Stem Cell Transplantation, Kaplan-Meier Estimate, Carboplatin, chemistry.chemical_compound, 0302 clinical medicine, MESH: Mesna, MESH: Carboplatin, Antineoplastic Combined Chemotherapy Protocols, Etoposide, Mesna, MESH: Etoposide, MESH: Aged, Ifosfamide, MESH: Middle Aged, Soft tissue sarcoma, Sarcoma, Hematology, Middle Aged, Chemotherapy regimen, Combined Modality Therapy, 3. Good health, Dacarbazine, MESH: Antineoplastic Combined Chemotherapy Protocols, Oncology, MESH: Young Adult, 030220 oncology & carcinogenesis, Female, medicine.drug, Adult, medicine.medical_specialty, Adolescent, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH: Dacarbazine, Disease-Free Survival, 03 medical and health sciences, MESH: Doxorubicin, Young Adult, medicine, Humans, Progression-free survival, MESH: Ifosfamide, MESH: Kaplan-Meier Estimate, Aged, MESH: Adolescent, Peripheral Blood Stem Cell Transplantation, MESH: Humans, business.industry, MESH: Adult, medicine.disease, MESH: Male, Surgery, Consolidation Chemotherapy, chemistry, Doxorubicin, MESH: Sarcoma, MESH: Disease-Free Survival, business, MESH: Female, 030215 immunology
Abstract

International audience; BACKGROUND: Metastatic soft tissue sarcoma (STS) prognosis remains poor and few cytotoxic agents offer proven efficacy. This randomized open phase III study examines whether high-dose (HD) chemotherapy with peripheral blood stem cells (PBSCs) could improve overall survival (OS) of chemosensitive patients. PATIENTS AND METHODS: Advanced STS patients aged 18-65 years received four courses of standard mesna, adryamycin, ifosfamide and dacarbazine (MAID) treatment. Chemotherapy-responding patients and patients with at least stable disease amenable to complete surgical resection were randomized to receive standard dose (SD) with two successive MAID cycles or HD treatments of one MAID then MICE intensification: mesna (3.6 g/m(2), day 1-5), ifosfamide (2.5 g/m(2), day 1-4), carboplatin [area under the curve (AUC) 5/day 2-4] and etoposide (300 mg/m(2), day 1-4) with PBSC reinjection at day 7. RESULTS: From 2000 to 2008, 207 patients received four cycles of MAID and 87 assessable patients were randomly assigned to receive the following: 46 SD, 41 HD, with 45 and 38 maintained for analyses after secondary centralized histological review. Futility analyses led to study closure in November 2008. Three-year OS was 49.4% for the SD group versus 32.7% for HD arm, hazard ratio= 1.26, 95% confidence interval 0.70-2.29; progression-free survival was 32.4% and 14.0%, respectively. HD treatment led to higher grades 3-4 toxicity. CONCLUSION: This study failed to show an OS advantage for advanced STS patients treated with dose-intensified chemotherapy with PBSC.

Published
2011

48. LBA57 - Results of the LMS03 phase II study evaluating gemcitabine combined with pazopanib as a 2nd-line treatment for metastatic/relapsed leiomyosarcomas (uterine or soft tissue) after failure of anthracycline-based chemotherapy: The UNICANCER SARCOME 11 study

Author

Pautier, P., Penel, N., Ray-Coquard, I., Italiano, A., Bompas, E., Delcambre, C., Bay, J-O., Bertucci, F., Delaye, J., Chevreau, C., Cupissol, D., Le Moal, L. Bozec, Eymard, J-C., Thyss, A., Isambert, N., Guillemet, C., Rios, M., Piperno-Neumann, S., Chenuc, G., and Duffaud, F.

Published
2017
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50. 1050PD - The ELAN-ONCOVAL (ELderly heAd and Neck cancer-Oncology eValuation) study: Evaluation of the feasibility of a suited geriatric assessment for use by oncologists to classify patients as fit or unfit

Author

Mertens, C., Le Caer, H., Ortholan, C., Blot, E., Even, C., Rousselot, H., Peyrade, F., Sire, C., Cupissol, D., Pointreau, Y., Debourdeau, P., Rolland, F., Fayette, J., Capitain, O., Sun, X., Debbah, M., Schwob, D., Boulahssass, R., Aupérin, A., and Guigay, J.

Published
2017
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