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Items: 1 to 50 of 109

1.

Sequential or combined designs for Phase I/II clinical trials? A simulation study.

Rossoni C, Bardet A, Geoerger B, Paoletti X.

Clin Trials. 2019 Sep 20:1740774519872702. doi: 10.1177/1740774519872702. [Epub ahead of print]

PMID:
31538815
2.

An alternative trial-level measure for evaluating failure-time surrogate endpoints based on prediction error.

Belhechmi S, Michiels S, Paoletti X, Rotolo F.

Contemp Clin Trials Commun. 2019 Jul 5;15:100402. doi: 10.1016/j.conctc.2019.100402. eCollection 2019 Sep.

3.

An adaptive design for the identification of the optimal dose using joint modeling of continuous repeated biomarker measurements and time-to-toxicity in phase I/II clinical trials in oncology.

Altzerinakou MA, Paoletti X.

Stat Methods Med Res. 2019 Apr 4:962280219837737. doi: 10.1177/0962280219837737. [Epub ahead of print]

PMID:
30945604
4.

Response to comments on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharm Stat 17(5):593-606, Sep/Oct 2018., DOI: https://doi.org/10.1002/pst.1873.

Jaki T, Gordon A, Forster P, Bijnens L, Bornkamp B, Brannath W, Fontana R, Gasparini M, Hampson LV, Jacobs T, Jones B, Paoletti X, Posch M, Titman A, Vonk R, Koenig F.

Pharm Stat. 2019 May;18(3):284-286. doi: 10.1002/pst.1942. Epub 2019 Mar 14. No abstract available.

PMID:
30868716
5.

Cumulative Toxicity in Targeted Therapies: What to Expect at the Recommended Phase II Dose.

Altzerinakou MA, Collette L, Paoletti X.

J Natl Cancer Inst. 2019 Mar 5. pii: djz024. doi: 10.1093/jnci/djz024. [Epub ahead of print]

PMID:
30838405
6.

Intestinal bacterial β-glucuronidase as a possible predictive biomarker of irinotecan-induced diarrhea severity.

Chamseddine AN, Ducreux M, Armand JP, Paoletti X, Satar T, Paci A, Mir O.

Pharmacol Ther. 2019 Jul;199:1-15. doi: 10.1016/j.pharmthera.2019.03.002. Epub 2019 Mar 1. Review.

PMID:
30831128
7.

Multiple recurrences and risk of disease progression in patients with primary low-grade (TaG1) non-muscle-invasive bladder cancer and with low and intermediate EORTC-risk score.

Simon M, Bosset PO, Rouanne M, Benhamou S, Radulescu C, Molinié V, Neuzillet Y, Paoletti X, Lebret T.

PLoS One. 2019 Feb 27;14(2):e0211721. doi: 10.1371/journal.pone.0211721. eCollection 2019.

8.

10PSafety profile of epigenetic therapies in early phase trials: Do epidrugs deserve specific drug development processes?

Leroy L, Satar T, Baldini C, Martin-Romano P, Hollebecque A, Michot JM, Ribrag V, Massard C, Paoletti X, Postel Vinay S.

Ann Oncol. 2019 Feb 1;30(Supplement_1). pii: mdz029.003. doi: 10.1093/annonc/mdz029.003. No abstract available.

PMID:
30810172
9.

Meta-analysis of prognostic and predictive factors: Towards individual participant data?

Faron M, Pignon JP, Paoletti X.

Eur J Cancer. 2018 Nov;104:224-226. doi: 10.1016/j.ejca.2018.09.023. Epub 2018 Oct 26. No abstract available.

PMID:
30454708
10.

Randomized dose-escalation designs for drug combination cancer trials with immunotherapy.

Mozgunov P, Jaki T, Paoletti X.

J Biopharm Stat. 2019;29(2):359-377. doi: 10.1080/10543406.2018.1535503. Epub 2018 Oct 23.

PMID:
30352007
11.

Time to progression ratio in cancer patients enrolled in early phase clinical trials: time for new guidelines?

Watson S, Menis J, Baldini C, Martin-Romano P, Michot JM, Hollebecque A, Armand JP, Massard C, Soria JC, Postel-Vinay S, Paoletti X.

Br J Cancer. 2018 Oct;119(8):937-939. doi: 10.1038/s41416-018-0245-0. Epub 2018 Oct 17.

12.

A benchmark for dose finding studies with continuous outcomes.

Mozgunov P, Jaki T, Paoletti X.

Biostatistics. 2018 Aug 24. doi: 10.1093/biostatistics/kxy045. [Epub ahead of print]

PMID:
30165594
13.

A proposal for a new PhD level curriculum on quantitative methods for drug development.

Jaki T, Gordon A, Forster P, Bijnens L, Bornkamp B, Brannath W, Fontana R, Gasparini M, Hampson LV, Jacobs T, Jones B, Paoletti X, Posch M, Titman A, Vonk R, Koenig F.

Pharm Stat. 2018 Sep;17(5):593-606. doi: 10.1002/pst.1873. Epub 2018 Jul 9.

14.

surrosurv: An R package for the evaluation of failure time surrogate endpoints in individual patient data meta-analyses of randomized clinical trials.

Rotolo F, Paoletti X, Michiels S.

Comput Methods Programs Biomed. 2018 Mar;155:189-198. doi: 10.1016/j.cmpb.2017.12.005. Epub 2017 Dec 13. Review.

PMID:
29512498
15.

Phase I-II trial designs: how early should efficacy guide the dose recommendation process?

Paoletti X, Postel-Vinay S.

Ann Oncol. 2018 Mar 1;29(3):540-541. doi: 10.1093/annonc/mdy044. No abstract available.

PMID:
29415188
16.

Revisiting the definition of dose-limiting toxicities in paediatric oncology phase I clinical trials: An analysis from the Innovative Therapies for Children with Cancer Consortium.

Bautista F, Moreno L, Marshall L, Pearson ADJ, Geoerger B, Paoletti X.

Eur J Cancer. 2017 Nov;86:275-284. doi: 10.1016/j.ejca.2017.09.015. Epub 2017 Oct 19.

PMID:
29055843
17.

Repeated measures dose-finding design with time-trend detection in the presence of correlated toxicity data.

Yin J, Paoletti X, Sargent DJ, Mandrekar SJ.

Clin Trials. 2017 Dec;14(6):611-620. doi: 10.1177/1740774517723829. Epub 2017 Aug 2.

18.

Patient-reported tolerability of adverse events in phase 1 trials.

Henon C, Lissa D, Paoletti X, Thibault C, Le Tourneau C, Lanoy E, Hollebecque A, Massard C, Soria JC, Postel-Vinay S.

ESMO Open. 2017 Jun 23;2(2):e000148. doi: 10.1136/esmoopen-2016-000148. eCollection 2017.

19.

A Poisson approach to the validation of failure time surrogate endpoints in individual patient data meta-analyses.

Rotolo F, Paoletti X, Burzykowski T, Buyse M, Michiels S.

Stat Methods Med Res. 2019 Jan;28(1):170-183. doi: 10.1177/0962280217718582. Epub 2017 Jul 6.

PMID:
28681681
20.

Dose-Finding Methods: Moving Away from the 3 + 3 to Include Richer Outcomes.

Paoletti X, Drubay D, Collette L.

Clin Cancer Res. 2017 Aug 1;23(15):3977-3979. doi: 10.1158/1078-0432.CCR-17-1306. Epub 2017 Jun 19.

21.

Outcomes and prognostic factors for relapsed or refractory lymphoma patients in phase I clinical trials.

Michot JM, Benajiba L, Faivre L, Baldini C, Haddag L, Bonnet C, Massard C, Bigot F, Bigenwald C, Verret B, Thomas ZAP, Varga A, Gazzah A, Hollebecque A, Ghez D, Lazarovici J, Balheda R, Jeanson A, Postel-Vinay S, Danu A, Soria JC, Paoletti X, Ribrag V.

Invest New Drugs. 2018 Feb;36(1):62-74. doi: 10.1007/s10637-017-0480-x. Epub 2017 Jun 9.

PMID:
28597151
22.

Early phase clinical trials of anticancer agents in children and adolescents - an ITCC perspective.

Moreno L, Pearson ADJ, Paoletti X, Jimenez I, Geoerger B, Kearns PR, Zwaan CM, Doz F, Baruchel A, Vormoor J, Casanova M, Pfister SM, Morland B, Vassal G; Innovative Therapies for Children with Cancer (ITCC) Consortium.

Nat Rev Clin Oncol. 2017 Aug;14(8):497-507. doi: 10.1038/nrclinonc.2017.59. Epub 2017 May 16. Review.

PMID:
28508875
23.

Hyperprogression during anti-PD-1/PD-L1 therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.

Saâda-Bouzid E, Defaucheux C, Karabajakian A, Coloma VP, Servois V, Paoletti X, Even C, Fayette J, Guigay J, Loirat D, Peyrade F, Alt M, Gal J, Le Tourneau C.

Ann Oncol. 2017 Jul 1;28(7):1605-1611. doi: 10.1093/annonc/mdx178.

PMID:
28419181
24.

Precision medicine needs randomized clinical trials.

Saad ED, Paoletti X, Burzykowski T, Buyse M.

Nat Rev Clin Oncol. 2017 May;14(5):317-323. doi: 10.1038/nrclinonc.2017.8. Epub 2017 Feb 7. Review.

PMID:
28169302
25.

Randomized phase II trial comparing molecularly targeted therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer: cross-over analysis from the SHIVA trial.

Belin L, Kamal M, Mauborgne C, Plancher C, Mulot F, Delord JP, Gonçalves A, Gavoille C, Dubot C, Isambert N, Campone M, Trédan O, Ricci F, Alt M, Loirat D, Sablin MP, Paoletti X, Servois V, Le Tourneau C.

Ann Oncol. 2017 Mar 1;28(3):590-596. doi: 10.1093/annonc/mdw666.

PMID:
27993804
26.

[New applications for individual participant data meta-analyses of randomized trials].

Lueza B, Lacas B, Pignon JP, Paoletti X.

Bull Cancer. 2017 Feb;104(2):139-146. doi: 10.1016/j.bulcan.2016.10.024. Epub 2016 Nov 28. Review. French.

PMID:
27908441
27.

Patients' perceived tolerance of side effects in phase I cancer clinical trials: A qualitative study.

Brédart A, Bodson S, Le Tourneau C, Flahault C, Bonnetain F, Beaudeau A, Coquan E, Dolbeault S, Paoletti X.

Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12596. Epub 2016 Oct 12.

PMID:
27734561
28.

Prognostic factors of successful on-purpose tumor biopsies in metastatic cancer patients included in the SHIVA prospective clinical trial.

Desportes E, Wagner M, Kamal M, Salomon AV, Deniziaut G, Pierron G, Rouleau E, Jouffroy T, Le Tourneau C, Paoletti X, Servois V.

Oncotarget. 2017 Jan 3;8(1):1760-1773. doi: 10.18632/oncotarget.12051.

29.

Outcome of children with relapsed or refractory neuroblastoma: A meta-analysis of ITCC/SIOPEN European phase II clinical trials.

Moreno L, Rubie H, Varo A, Le Deley MC, Amoroso L, Chevance A, Garaventa A, Gambart M, Bautista F, Valteau-Couanet D, Geoerger B, Vassal G, Paoletti X, Pearson AD.

Pediatr Blood Cancer. 2017 Jan;64(1):25-31. doi: 10.1002/pbc.26192. Epub 2016 Aug 24.

PMID:
27555472
30.

Quelles exigences pour qu'un biomarqueur puisse être un critère de substitution acceptable ?

Paoletti X, Rotolo F, Michiels S.

Bull Cancer. 2016 Jun;103(6 Suppl 1):S63-70. doi: 10.1016/S0007-4551(16)30147-3. Review. French.

PMID:
27494976
31.

An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma.

Anota A, Boulin M, Dabakuyo-Yonli S, Hillon P, Cercueil JP, Minello A, Jouve JL, Paoletti X, Bedenne L, Guiu B, Bonnetain F.

BMJ Open. 2016 Jun 24;6(6):e010696. doi: 10.1136/bmjopen-2015-010696.

32.

Innovations for phase I dose-finding designs in pediatric oncology clinical trials.

Doussau A, Geoerger B, Jiménez I, Paoletti X.

Contemp Clin Trials. 2016 Mar;47:217-27. doi: 10.1016/j.cct.2016.01.009. Epub 2016 Jan 26. Review.

33.

Precision medicine: lessons learned from the SHIVA trial - Authors' reply.

Le Tourneau C, Belin L, Paoletti X, Bièche I, Kamal M.

Lancet Oncol. 2015 Dec;16(16):e581-2. doi: 10.1016/S1470-2045(15)00455-6. No abstract available.

PMID:
26678200
34.

Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials.

Le Tourneau C, Kamal M, Tsimberidou AM, Bedard P, Pierron G, Callens C, Rouleau E, Vincent-Salomon A, Servant N, Alt M, Rouzier R, Paoletti X, Delattre O, Bièche I.

J Natl Cancer Inst. 2015 Nov 23;108(4). doi: 10.1093/jnci/djv362. Print 2016 Apr. Review.

35.

REBECA: a phase I study of bevacizumab and whole-brain radiation therapy for the treatment of brain metastasis from solid tumours.

Lévy C, Allouache D, Lacroix J, Dugué AE, Supiot S, Campone M, Mahe M, Kichou S, Leheurteur M, Hanzen C, Dieras V, Kirova Y, Campana F, Le Rhun E, Gras L, Bachelot T, Sunyach MP, Hrab I, Geffrelot J, Gunzer K, Constans JM, Grellard JM, Clarisse B, Paoletti X.

Ann Oncol. 2015 Nov;26(11):2359. doi: 10.1093/annonc/mdv386. No abstract available.

PMID:
26504187
36.

L'Epidermal Growth Factor Receptor (EGFR) est une cible thérapeutique pour un sous-groupe de tumeurs de vessie agressives de phénotype de type basal.

Neuzillet Y, Rebouissou S, De Reynies A, Lepage M, Krucker C, Chapeaublanc E, Herault A, Kamoun A, Caillault A, Letouze E, Elarouci N, Decoux Y, Molinie V, Vordos D, Laplanche A, Maille P, Soyeux P, Ofualuka K, Reyal F, Biton A, Sibony M, Paoletti X, Southgate J, Benhamou S, Allory Y, Radvanyi F, Lebret T.

Prog Urol. 2014 Nov;24(13):806. doi: 10.1016/j.purol.2014.08.053. Epub 2014 Oct 30. French. No abstract available.

PMID:
26461580
37.

Design and statistical principles of the SHIVA trial.

Paoletti X, Asselain B, Kamal M, Servant N, Huppé P, Bieche I, Le Tourneau C.

Chin Clin Oncol. 2015 Sep;4(3):32. doi: 10.3978/j.issn.2304-3865.2015.02.02. Review.

38.

Designs of preoperative biomarkers trials in oncology: a systematic review of the literature.

Marous M, Bièche I, Paoletti X, Alt M, Razak AR, Stathis A, Kamal M, Le Tourneau C.

Ann Oncol. 2015 Dec;26(12):2419-28. doi: 10.1093/annonc/mdv378. Epub 2015 Sep 14. Review.

PMID:
26371283
39.

Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial.

Le Tourneau C, Delord JP, Gonçalves A, Gavoille C, Dubot C, Isambert N, Campone M, Trédan O, Massiani MA, Mauborgne C, Armanet S, Servant N, Bièche I, Bernard V, Gentien D, Jezequel P, Attignon V, Boyault S, Vincent-Salomon A, Servois V, Sablin MP, Kamal M, Paoletti X; SHIVA investigators.

Lancet Oncol. 2015 Oct;16(13):1324-34. doi: 10.1016/S1470-2045(15)00188-6. Epub 2015 Sep 3.

PMID:
26342236
40.

Dose finding with longitudinal data: simpler models, richer outcomes.

Paoletti X, Doussau A, Ezzalfani M, Rizzo E, Thiébaut R.

Stat Med. 2015 Sep 30;34(22):2983-98. doi: 10.1002/sim.6552. Epub 2015 Jun 24.

PMID:
26109523
41.

Statistical controversies in clinical research: requiem for the 3 + 3 design for phase I trials.

Paoletti X, Ezzalfani M, Le Tourneau C.

Ann Oncol. 2015 Sep;26(9):1808-12. doi: 10.1093/annonc/mdv266. Epub 2015 Jun 18. Review.

42.

The spectrum of clinical trials aiming at personalizing medicine.

Le Tourneau C, Kamal M, Alt M, Verlingue L, Servois V, Sablin MP, Servant N, Paoletti X.

Chin Clin Oncol. 2014 Jun;3(2):13. doi: 10.3978/j.issn.2304-3865.2014.05.02.

43.

Statistical evaluation of surrogate endpoints with examples from cancer clinical trials.

Buyse M, Molenberghs G, Paoletti X, Oba K, Alonso A, Van der Elst W, Burzykowski T.

Biom J. 2016 Jan;58(1):104-32. doi: 10.1002/bimj.201400049. Epub 2015 Feb 12. Review.

PMID:
25682941
44.

[The role of the expansion cohort in phase I trials in oncology: guidelines of the phase I HUB].

Ezzalfani M, Dugué A, Mollevi C, Pulido M, Bonnetain F, Filleron T, Gal J, Gauthier M, Le Deley MC, Le Tourneau C, Médioni J, Nguyen JM, Chabaud S, Teixeira L, Thivat E, You B, Kramar A, Paoletti X.

Bull Cancer. 2015 Jan;102(1):73-82. doi: 10.1016/j.bulcan.2014.10.001. Epub 2015 Jan 2. Review. French.

PMID:
25609488
45.

Optimal cut points for quality of life questionnaire-core 30 (QLQ-C30) scales: utility for clinical trials and updates of prognostic systems in advanced hepatocellular carcinoma.

Diouf M, Bonnetain F, Barbare JC, Bouché O, Dahan L, Paoletti X, Filleron T.

Oncologist. 2015 Jan;20(1):62-71. doi: 10.1634/theoncologist.2014-0175. Epub 2014 Dec 26.

46.

Designs of drug-combination phase I trials in oncology: a systematic review of the literature.

Riviere MK, Le Tourneau C, Paoletti X, Dubois F, Zohar S.

Ann Oncol. 2015 Apr;26(4):669-74. doi: 10.1093/annonc/mdu516. Epub 2014 Nov 17. Review.

PMID:
25403591
47.

A new approach to integrate toxicity grade and repeated treatment cycles in the analysis and reporting of phase I dose-finding trials.

Doussau A, Thiébaut R, Geoerger B, Schöffski P, Floquet A, Le Deley MC, Mathoulin-Pélissier S, Rizzo E, Fumoleau P, Le Tourneau C, Paoletti X.

Ann Oncol. 2015 Feb;26(2):422-8. doi: 10.1093/annonc/mdu523. Epub 2014 Nov 17.

PMID:
25403589
48.

Predictive gene signature of response to the anti-TweakR mAb PDL192 in patient-derived breast cancer xenografts.

de Plater L, Vincent-Salomon A, Berger F, Nicolas A, Vacher S, Gravier E, Thuleau A, Karboul N, Richardson M, Elbaz C, Marangoni E, Bièche I, Paoletti X, Roman-Roman S, Culp PA, Asselain B, Diéras V, Decaudin D.

PLoS One. 2014 Nov 6;9(11):e104227. doi: 10.1371/journal.pone.0104227. eCollection 2014.

49.

Long-term follow-up of TaG1 non-muscle-invasive bladder cancer.

Olivier Bosset P, Neuzillet Y, Paoletti X, Molinie V, Botto H, Lebret T.

Urol Oncol. 2015 Jan;33(1):20.e1-20.e7. doi: 10.1016/j.urolonc.2014.09.001. Epub 2014 Oct 2.

PMID:
25282704
50.

REBECA: a phase I study of bevacizumab and whole-brain radiation therapy for the treatment of brain metastasis from solid tumours.

Lévy C, Allouache D, Lacroix J, Dugué AE, Supiot S, Campone M, Mahe M, Kichou S, Leheurteur M, Hanzen C, Dieras V, Kirova Y, Campana F, Le Rhun E, Gras L, Bachelot T, Sunyach MP, Hrab I, Geffrelot J, Gunzer K, Constans JM, Grellard JM, Clarisse B, Paoletti X.

Ann Oncol. 2014 Dec;25(12):2351-6. doi: 10.1093/annonc/mdu465. Epub 2014 Oct 1. Erratum in: Ann Oncol. 2015 Nov;26(11):2359.

PMID:
25274615

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