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2. Patritumab deruxtecan in untreated hormone receptor-positive/HER2-negative early breast cancer: final results from part A of the window-of-opportunity SOLTI TOT-HER3 pre-operative study

Author

Oliveira, M., Falato, C., Cejalvo, J.M., Vila, M. Margelí, Tolosa, P., Salvador-Bofill, F.J., Cruz, J., Arumi, M., Luna, A.M., Guerra, J.A., Vidal, M., Martínez-Sáez, O., Paré, L., González-Farré, B., Sanfeliu, E., Ciruelos, E., Espinosa-Bravo, M., Pernas, S., Izarzugaza, Y., Esker, S., Fan, P.-D., Parul, P., Santhanagopal, A., Sellami, D., Villacampa, G., Ferrero-Cafiero, J.M., Pascual, T., and Prat, A.

Published
2023
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4. 189O A phase II study of patritumab deruxtecan (HER3-DXd), in patients (pts) with advanced breast cancer (ABC), with biomarker analysis to characterize response to therapy (ICARUS-BREAST01)

Author

Pistilli, B., primary, Ibrahimi, N., additional, Lacroix-Triki, M., additional, D'Hondt, V., additional, Vicier, C., additional, Frenel, J-S., additional, Dalenc, F., additional, Bachelot, T., additional, Benderra, M-A., additional, Loirat, D., additional, Ducoulombier, A., additional, Mayeur, D., additional, Nachabeh, G.B., additional, Serhal, K., additional, Corcos, N., additional, Sellami, D., additional, Michiels, S., additional, André, F., additional, Mosele, M.F., additional, and Montagnac, G., additional

Published
2023
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6. 204TiP A phase II study of HER3-DXD in patients (pts) with metastatic breast cancer (MBC)

Author

Hamilton, E.P., primary, Bagegni, N.A., additional, Beck, J.T., additional, Cultrera, J.L., additional, Dosunmu, O., additional, Gwin, W.R., additional, Heeke, A.L., additional, Khoury, K., additional, Sellami, D., additional, Shastry, M., additional, Sternberg, D.W., additional, Toppmeyer, D., additional, Wright-Browne, V.M., additional, and Yuan, Y., additional

Published
2022
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13. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study

Author

Lear, J.T. Migden, M.R. Lewis, K.D. Chang, A.L.S. Guminski, A. Gutzmer, R. Dirix, L. Combemale, P. Stratigos, A. Plummer, R. Castro, H. Yi, T. Mone, M. Zhou, J. Trefzer, U. Kaatz, M. Loquai, C. Kudchadkar, R. Sellami, D. Dummer, R.

Abstract

Background: Patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC (mBCC), two difficult-to-treat populations, have had limited treatment options. Sonidegib, a hedgehog pathway inhibitor (HPI), was approved in laBCC based on results from the BOLT trial. Objective: To evaluate long-term efficacy and safety of sonidegib in laBCC and mBCC in the BOLT 18- and 30-month analyses. Methods: BOLT (NCT01327053, ClinicalTrials.gov), a double-blind phase 2 study, enrolled patients from July 2011 until January 2013. Eligible HPI-treatment–naïve patients with laBCC not amenable to curative surgery/radiotherapy or mBCC were randomized 1 : 2 to sonidegib 200 mg (laBCC, n = 66; mBCC, n = 13) or 800 mg (laBCC, n = 128; mBCC, n = 23). Tumour response was assessed per central and investigator review. Results: With 30 months of follow-up, among patients treated with sonidegib 200 mg (approved dose), objective response rates were 56.1% (central) and 71.2% (investigator) in laBCC and 7.7% (central) and 23.1% (investigator) in mBCC. Tumour responses were durable as follows: median duration of response was 26.1 months (central) and 15.7 months (investigator) in laBCC and 24.0 months (central) and 18.1 months (investigator) in mBCC. Five patients with laBCC and three with mBCC in the 200-mg arm died. Median overall survival was not reached in either population; 2-year overall survival rates were 93.2% (laBCC) and 69.3% (mBCC). In laBCC, efficacy was similar regardless of aggressive or non-aggressive histology. Sonidegib 200 mg continued to have a better safety profile than 800 mg, with lower rates of grade 3/4 adverse events (43.0% vs. 64.0%) and adverse events leading to discontinuation (30.4% vs. 40.0%). Conclusion: Sonidegib continued to demonstrate long-term efficacy and safety in these populations. These data support the use of sonidegib 200 mg per local treatment guidelines. © 2017 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.

Published
2018

14. Abstract GS3-08: Alpelisib + fulvestrant for advanced breast cancer: Subgroup analyses from the phase III SOLAR-1 trial

Author

Juric, D, primary, Ciruelos, E, additional, Rubovszky, G, additional, Campone, M, additional, Loibl, S, additional, Rugo, HS, additional, Iwata, H, additional, Conte, P, additional, Mayer, IA, additional, Kaufman, B, additional, Yamashita, T, additional, Lu, Y-S, additional, Inoue, K, additional, Takahashi, M, additional, Pápai, Z, additional, Longin, A-S, additional, Mills, D, additional, Wilke, C, additional, Sellami, D, additional, and Andre, F, additional

Published
2019
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18. Abstract P5-21-06: Alpelisib plus letrozole in estrogen receptor-Positive (ER+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (aBC): Safety and preliminary efficacy analysis from a phase 1b trial

Author

Juric, D, primary, Gonçalves, A, additional, Hamilton, E, additional, Boni, V, additional, Mayer, IA, additional, Turri, S, additional, Wang, Y, additional, Vogl, FD, additional, Sellami, D, additional, and Campone, M, additional

Published
2018
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19. Abstract PD5-12: Buparlisib (BUP) or placebo (PBO) plus fulvestrant (FUL) in postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Overall survival (OS) results from BELLE-2, a randomized, phase III study

Author

Campone, M, primary, Im, S-A, additional, Iwata, H, additional, Clemons, M, additional, Ito, Y, additional, Awada, A, additional, Chia, S, additional, Jagiełło-Gruszfeld, A, additional, Pistilli, B, additional, Tseng, L-M, additional, Hurvitz, S, additional, Masuda, N, additional, Cortés, J, additional, De Laurentiis, M, additional, Arteaga, CL, additional, Jiang, Z, additional, Jonat, W, additional, Sellami, D, additional, El-Hashimy, M, additional, Le Mouhaër, S, additional, Sankaran, B, additional, Bourdeau, L, additional, and Baselga, J, additional

Published
2018
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21. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study

Author

Lear, J.T., primary, Migden, M.R., additional, Lewis, K.D., additional, Chang, A.L.S., additional, Guminski, A., additional, Gutzmer, R., additional, Dirix, L., additional, Combemale, P., additional, Stratigos, A., additional, Plummer, R., additional, Castro, H., additional, Yi, T., additional, Mone, M., additional, Zhou, J., additional, Trefzer, U., additional, Kaatz, M., additional, Loquai, C., additional, Kudchadkar, R., additional, Sellami, D., additional, and Dummer, R., additional

Published
2017
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22. The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma

Author

Dummer, R. Guminski, A. Gutzmer, R. Dirix, L. Lewis, K.D. Combemale, P. Herd, R.M. Kaatz, M. Loquai, C. Stratigos, A.J. Schulze, H.-J. Plummer, R. Gogov, S. Pallaud, C. Yi, T. Mone, M. Chang, A.L.S. Cornélis, F. Kudchadkar, R. Trefzer, U. Lear, J.T. Sellami, D. Migden, M.R.

Subjects
integumentary system
Abstract

Background The hedgehog pathway inhibitor sonidegib demonstrated meaningful tumor shrinkage in more than 90% of patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC in the BCC Outcomes with LDE225 Treatment study. Objective This report provides long-term follow-up data collected up to 12 months after the last patient was randomized. Methods In this multicenter, randomized, double-blind phase II study, patients were randomized 1:2 to sonidegib 200 or 800 mg. The primary end point was objective response rate assessed by central review. Results Objective response rates in the 200- and 800-mg arms were 57.6% and 43.8% in locally advanced BCC and 7.7% and 17.4% in metastatic BCC, respectively. Among the 94 patients with locally advanced BCC who responded, only 18 progressed or died and more than 50% had responses lasting longer than 6 months. In addition, 4 of 5 responders with metastatic BCC maintained an objective response. Grade 3/4 adverse events and those leading to discontinuation were less frequent with sonidegib 200 versus 800 mg (38.0% vs 59.3%; 27.8% vs 37.3%, respectively). Limitations No placebo or comparator arms were used because sonidegib demonstrated efficacy in advanced BCC in a phase I study, and the hedgehog pathway inhibitor vismodegib was not yet approved. Conclusion With longer follow-up, sonidegib demonstrated sustained tumor responses in patients with advanced BCC. © 2016 American Academy of Dermatology, Inc.

Published
2016

23. Abstract S4-07: BELLE-3: A phase III study of buparlisib + fulvestrant in postmenopausal women with HR+, HER2–, aromatase inhibitor-treated, locally advanced or metastatic breast cancer, who progressed on or after mTOR inhibitor-based treatment

Author

Di Leo, A, primary, Seok Lee, K, additional, Ciruelos, E, additional, Lønning, P, additional, Janni, W, additional, O'Regan, R, additional, Mouret Reynier, M-A, additional, Kalev, D, additional, Egle, D, additional, Csoszi, T, additional, Bordonaro, R, additional, Decker, T, additional, Tjan-Heijnen, VC, additional, Blau, S, additional, Schirone, A, additional, Weber, D, additional, El-Hashimy, M, additional, Dharan, B, additional, Sellami, D, additional, and Bachelot, T, additional

Published
2017
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24. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): A multicentre, randomised, double-blind phase 2 trial

Author

Migden, M.R. Guminski, A. Gutzmer, R. Dirix, L. Lewis, K.D. Combemale, P. Herd, R.M. Kudchadkar, R. Trefzer, U. Gogov, S. Pallaud, C. Yi, T. Mone, M. Kaatz, M. Loquai, C. Stratigos, A.J. Schulze, H.-J. Plummer, R. Chang, A.L.S. Cornélis, F. Lear, J.T. Sellami, D. Dummer, R.

Abstract

Background: Patients with advanced basal cell carcinoma have limited treatment options. Hedgehog pathway signalling is aberrantly activated in around 95% of tumours. We assessed the antitumour activity of sonidegib, a Hedgehog signalling inhibitor, in patients with advanced basal cell carcinoma. Methods: BOLT is an ongoing multicentre, randomised, double-blind, phase 2 trial. Eligible patients had locally advanced basal cell carcinoma not amenable to curative surgery or radiation or metastatic basal cell carcinoma. Patients were randomised via an automated system in a 1:2 ratio to receive 200 mg or 800 mg oral sonidegib daily, stratified by disease, histological subtype, and geographical region. The primary endpoint was the proportion of patients who achieved an objective response, assessed in the primary efficacy analysis population (patients with fully assessable locally advanced disease and all those with metastatic disease) with data collected up to 6 months after randomisation of the last patient. This trial is registered with ClinicalTrials.gov, number NCT01327053. Findings: Between July 20, 2011, and Jan 10, 2013, we enrolled 230 patients, 79 in the 200 mg sonidegib group, and 151 in the 800 mg sonidegib group. Median follow-up was 13·9 months (IQR 10·1-17·3). In the primary efficacy analysis population, 20 (36%, 95% CI 24-50) of 55 patients receiving 200 mg sonidegib and 39 (34%, 25-43) of 116 receiving 800 mg sonidegib achieved an objective response. In the 200 mg sonidegib group, 18 (43%, 95% CI 28-59) patients who achieved an objective response, as assessed by central review, were noted among the 42 with locally advanced basal cell carcinoma and two (15%, 2-45) among the 13 with metastatic disease. In the 800 mg group, 35 (38%, 95% CI 28-48) of 93 patients with locally advanced disease had an objective response, as assessed by central review, as did four (17%, 5-39) of 23 with metastatic disease. Fewer adverse events leading to dose interruptions or reductions (25 [32%] of 79 patients vs 90 [60%] of 150) or treatment discontinuation (17 [22%] vs 54 [36%]) occurred in patients in the 200 mg group than in the 800 mg group. The most common grade 3-4 adverse events were raised creatine kinase (five [6%] in the 200 mg group vs 19 [13%] in the 800 mg group) and lipase concentration (four [5%] vs eight [5%]). Serious adverse events occurred in 11 (14%) of 79 patients in the 200 mg group and 45 (30%) of 150 patients in the 800 mg group. Interpretation: The benefit-to-risk profile of 200 mg sonidegib might offer a new treatment option for patients with advanced basal cell carcinoma, a population that is difficult to treat. © 2015 Elsevier Ltd.

Published
2015

26. Change in Fatigue and Correlations with Clinical Outcome in Patients with Advanced Basal Cell Carcinoma Treated with Sonidegib in the Bolt Study

Author

Guminski, A, primary, Stull, D, additional, Houghton, K, additional, Gutzmer, R, additional, Migden, MR, additional, Dirix, L, additional, Lewis, KD, additional, Combemale, P, additional, Herd, RM, additional, Kudchadkar, R, additional, Trefzer, U, additional, Sellami, D, additional, Lear, J, additional, and Dummer, R, additional

Published
2016
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28. 3347 BOLT 18-month analysis: efficacy and safety of sonidegib in patients with locally advanced basal cell carcinoma (laBCC) and evaluation of tumor response using 2 sets of composite assessment criteria

Author

Dummer, R., primary, Sondak, V., additional, Grichnik, J., additional, Schwartz, L., additional, Guminski, A., additional, Gutzmer, R., additional, Yi, T., additional, Trylesinski, A., additional, Sellami, D., additional, and Migden, M., additional

Published
2015
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30. Randomized, Double-Blind Study of Sonidegib (Lde225) in Patients (Pts) with Advanced Basal Cell Carcinoma (Bcc)

Author

Dummer, R., primary, Guminski, A., additional, Gutzmer, R., additional, Dirix, L., additional, Lewis, K., additional, Combemale, P., additional, Herd, R., additional, Kaatz, M., additional, Loquai, C., additional, Stratigos, A., additional, Schulze, H., additional, Plummer, R., additional, Yi, T., additional, Chang, A.L.S., additional, Cornélis, F., additional, Kudchadkar, R., additional, Trefzer, U., additional, Lear, J., additional, Sellami, D., additional, and Migden, M.R., additional

Published
2014
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31. Patient-Reported Quality of Life (Qol) with Sonidegib (Lde225) in Advanced Basal Cell Carcinoma (Bcc)

Author

Dummer, R., primary, Gutzmer, R., additional, Migden, M.R., additional, Dirix, L., additional, Lewis, K., additional, Combemale, P., additional, Higuchi, K., additional, Gogov, S., additional, Yi, T., additional, Herd, R., additional, Kudchadkar, R., additional, Trefzer, U., additional, Lear, J., additional, Sellami, D., additional, and Guminski, A., additional

Published
2014
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32. Phase I study investigating everolimus combined with sorafenib in patients with advanced hepatocellular carcinoma.

Author

Finn, R.S., Poon, R.T., Yau, T., Klumpen, H.J., Chen, L.T., Kang, Y.K., Kim, T.Y., Gomez-Martin, C., Rodriguez-Lope, C., Kunz, T., Paquet, T., Brandt, U., Sellami, D., Bruix, J., Finn, R.S., Poon, R.T., Yau, T., Klumpen, H.J., Chen, L.T., Kang, Y.K., Kim, T.Y., Gomez-Martin, C., Rodriguez-Lope, C., Kunz, T., Paquet, T., Brandt, U., Sellami, D., and Bruix, J.

Abstract

1 december 2013, Item does not contain fulltext, BACKGROUND & AIMS: Sorafenib is the only therapy shown to improve overall survival in advanced hepatocellular carcinoma (HCC). Combination therapy targeting multiple signaling pathways may improve outcomes. This phase I study was designed to determine the maximum tolerated dose (MTD) of everolimus given with sorafenib 400mg twice daily in patients with advanced HCC of Child-Pugh class A liver function who were naive to systemic therapy. METHODS: Everolimus was initiated at 2.5mg once daily and increased per a Bayesian sequential dose-escalation scheme based on the dose-limiting toxicities experienced within the first 28days of treatment. Adverse events were assessed continuously. Efficacy was evaluated using the best overall response rate per RECIST. RESULTS: Thirty patients were enrolled; 25 were evaluable for MTD determination. One out of 12 patients treated with everolimus 2.5mg once daily and 6 out of 13 patients treated with everolimus 5.0mg once daily experienced a dose-limiting toxicity, most commonly thrombocytopenia (n=5). All patients experienced 1 adverse event, most commonly diarrhea (66.7%), hand-foot skin reaction (66.7%), and thrombocytopenia (50.0%). Best overall response was stable disease (62.5% and 42.9% in the 2.5-mg and 5.0-mg cohorts, respectively). Median time to progression and overall survival in the 2.5-mg cohort were 4.5months and 7.4months, respectively, and 1.8months and 11.7months, respectively, in the 5.0-mg cohort. CONCLUSIONS: In patients with advanced HCC, the everolimus MTD in combination with standard-dose sorafenib was 2.5mg once daily. The inability to achieve a biologically effective everolimus concentration at the MTD precluded phase II study of this combination.

Published
2013

36. Les démodécidoses : à propos de 719 cas

Author

Neji, S., primary, Cheikhrouhou, F., additional, Trabelsi, H., additional, Sellami, H., additional, Boudaya, S., additional, Sellami, D., additional, Makni, F., additional, Fki, J., additional, Turki, H., additional, and Ayadi, A., additional

Published
2012
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37. Phase I study of everolimus in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC).

Author

Finn, R. S., primary, Poon, R. T. P., additional, Yau, T., additional, Klumpen, H., additional, Chen, L., additional, Kang, Y., additional, Kim, T., additional, Gomez-Martin, C., additional, Rodriguez-Lope, C., additional, Kunz, T., additional, Paquet, T., additional, Asubonteng, K., additional, Winkler, R. E., additional, Anak, O., additional, Sellami, D. B., additional, and Bruix, J., additional

Published
2011
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38. [Conservative treatment of cancer of the breast in Tunisia]

Author

Mesedi W, Farouk Benna, Gamoudi A, Bouaouina N, Sellami D, Rahal K, Ben Youssef R, Ben Romdhane K, Ben Abdallah M, and Maalej M

Subjects
Adult, Survival Rate, Chemotherapy, Adjuvant, Humans, Lymph Node Excision, Breast Neoplasms, Female, Middle Aged, Mastectomy, Segmental, Combined Modality Therapy, Aged, Follow-Up Studies, Neoplasm Staging
Published
1993

40. 608 Génodermatoses et manifestations palpébrales

Author

Feki, J., primary, Neifar, H., additional, Kharrat, W., additional, Nemria, J., additional, Hamdi, S., additional, Ouazani, S., additional, Sayedi, I., additional, Sellami, D., additional, Trigui, A., additional, Turki, K., additional, and Ben Zina, Z., additional

Published
2009
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41. 622 Euryblépharon : à propos de deux cas

Author

Oualha, A., primary, Ben Zina, Z., additional, Kammoun, S., additional, Fetoui, F., additional, Khabou, A., additional, Kharrat, W., additional, Sellami, D., additional, Kammoun, B., additional, and Feki, J., additional

Published
2009
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42. 613 Les atteintes palpébrales dans la lèpre

Author

Aloulou, Y., primary, Kamoun, B., additional, Ouazani, S., additional, Bouassida, W., additional, Barkia, I., additional, Khabou, A., additional, Neifar, H., additional, Nemria, J., additional, Ben Salah, Y., additional, Fetoui, F., additional, Sellami, D., additional, and Feki, J., additional

Published
2009
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