Vismodegib Efficacy in Advanced Basal Cell Carcinoma Maintained with 8-Week Dose Interruptions: A Model-Based Evaluation

Name: Work Video:
Duration: 3 min 30 s
Pascal Chanu; Luna Musib; Xin Wang; Sravanthi Cheeti; Sandhya Girish; René Bruno; Tong Lu; Josina C. Reddy; Jin Y. Jin; Ivor Caro
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[10, 273, 640, 1715], 'in': [11, 91, 145, 151, 157, 189, 195, 311, 398, 439, 518, 547, 610, 641, 712, 840, 892, 923, 931, 946, 983, 993, 1014, 1042, 1142, 1184, 1201, 1225, 1298, 1453, 1469, 1517, 1550, 1559, 1570, 1599, 1609, 1645, 1657, 1676, 1696, 1749, 1785, 1837, 1986, 2007, 2012], 'clinical': [12, 621, 743, 1363, 1901, 1939, 2009], 'trials': [13, 2010], 'patients': [15, 85, 190, 312, 440, 519, 548, 642, 713, 774, 790, 841, 893, 924, 969, 1087, 1180, 1280, 1677, 1786, 1838, 1880, 1993], 'locally': [17], 'advanced': [18, 442, 843, 895, 1788, 1840], 'basal': [19, 25, 402, 443, 523, 844, 896, 1789, 1841], 'cell': [20, 26, 403, 444, 524, 845, 897, 1790, 1842], 'carcinoma': [21, 27, 525], '(laBCC)': [22], 'and': [23, 75, 153, 172, 264, 431, 516, 590, 603, 645, 716, 739, 771, 777, 785, 799, 807, 888, 927, 938, 972, 1008, 1124, 1248, 1255, 1283, 1300, 1303, 1312, 1317, 1354, 1401, 1422, 1477, 1498, 1526, 1538, 1552, 1594, 1601, 1680, 1743, 1756, 1833, 1878, 1932, 1980, 1994, 2002, 2103], 'metastatic': [24], '(mBCC).': [28], 'Treatment': [29], 'interruptions': [30, 64, 180, 283, 692, 1467, 1637], 'have': [31], 'been': [32], 'recommended': [33], 'for': [34, 99, 128, 209, 222, 250, 470, 606, 632, 637, 659, 968, 997, 1420, 1428, 1463, 1496, 1504, 1575, 1614, 1707, 1712, 1728, 1764, 1912, 2024, 2030], 'the': [35, 48, 60, 82, 95, 162, 168, 174, 196, 210, 366, 399, 494, 588, 599, 611, 676, 682, 687, 704, 765, 781, 902, 947, 958, 998, 1046, 1090, 1120, 1127, 1134, 1140, 1143, 1153, 1157, 1162, 1165, 1169, 1172, 1177, 1190, 1197, 1264, 1287, 1319, 1327, 1406, 1482, 1509, 1512, 1518, 1524, 1527, 1533, 1539, 1562, 1565, 1571, 1576, 1585, 1607, 1610, 1618, 1623, 1639, 1693, 1697, 1752, 1758, 1847, 1866, 1900, 1927, 2000, 2008], 'management': [36, 432], 'reactions,': [40], 'but': [41], 'there': [42], 'no': [44], 'clear': [45], 'guidance': [46, 625, 1695], 'on': [47, 65, 359, 693, 764, 797, 1045, 1275, 1337, 1638, 1682, 1761, 1909, 1922, 1926], 'duration': [49, 131], 'those': [51, 794], 'interruptions.': [52, 1690], 'A': [53, 68, 1340], 'model-based': [54, 76, 266, 677, 1309, 1323, 1667], 'evaluation': [55, 267, 678, 1151, 1223], 'was': [56, 73, 514, 696, 762, 955, 979, 991, 1092, 1113, 1130, 1251, 1266, 1306, 1359, 1414, 1490, 1543, 1589, 2033], 'conducted': [57], 'to': [58, 80, 183, 186, 598, 634, 681, 741, 995, 1094, 1132, 1167, 1189, 1196, 1325, 1546, 1555, 1592, 1597, 1709, 1895, 1934, 1937], 'assess': [59, 81, 1326], 'impact': [61, 688, 1328, 1633], 'treatment': [63, 118, 179, 211, 282, 357, 400, 508, 691, 1001, 1331, 1379, 1394, 1450, 1466, 1535, 1578, 1636, 1689], 'efficacy.': [67, 1339], 'tumor': [69, 92, 581, 706, 747, 953, 977, 1051, 1104], 'growth': [70, 582], 'inhibition': [71, 583], 'model': [72, 701, 761, 942, 1065, 1091, 1111, 1121, 1129, 1155, 1158, 1166, 1265], 'developed,': [74], 'simulations': [77, 1310, 1324, 1668], 'were': [78, 791, 1070, 1365, 1746, 1863, 1888], 'performed': [79, 1114], 'proportion': [83, 96, 1178, 1295, 1407, 1483, 1519, 1572], 'achieving': [86, 1181], '≥30%': [87, 1182], 'reduction': [88, 1183], 'from': [89, 149, 155, 769, 780, 1085, 1186, 1277, 1286, 1548, 1557], 'baseline': [90], 'size': [93, 707], '(i.e.,': [94, 502, 1176], 'responders)': [98], 'various': [100, 1096], 'dosing': [101, 111, 123, 170, 309, 499, 545, 608, 1101, 1336, 1350, 1375, 1445, 1541, 1587], 'schedules.': [102], 'The': [103, 623, 760, 916, 935, 974, 1109, 1260, 1293, 1367, 1399, 1432, 1475, 1631], 'most': [104], 'conservative': [105, 1341, 1368, 1510], 'simulated': [106, 1256, 1513, 1566, 1640], 'scenario': [107, 1369, 1434, 1662], 'compared': [108, 1370, 1435, 1581], 'an': [109, 121, 511, 851, 986, 1270, 1344, 1377, 1392, 1683, 1796], 'intermittent': [110, 169, 307, 498, 543, 1378, 1684], 'schedule': [112, 171, 1380, 1461, 1537, 1580, 1588, 1685], '12': [114, 505, 1386], 'weeks': [115, 137, 185, 286, 506, 636, 1372, 1387, 1442, 1711], 'followed': [119, 509, 1390], 'by': [120, 510, 957, 1115, 1308, 1391, 1523, 1865, 2035], '8-week': [122, 512, 690, 1330, 1393, 1412, 1465, 1488, 1534, 1577, 1635, 1688], 'interruption': [124, 1332, 1395, 1451, 1536, 1579], '(repeated': [125], 'four': [126, 1383], 'times': [127], 'a': [129, 143, 265, 318, 554, 579, 593, 607, 619, 699, 964, 1355, 1436, 1447, 1460, 1649], 'total': [130, 798], '80': [133, 136, 1371, 1441], 'weeks)': [134], 'continuous': [139, 1335, 1348, 1374, 1444, 1540], 'dosing,': [140], 'which': [141, 1358], 'predicted': [142, 1632], 'decrease': [144], 'responders': [146, 1297, 1409, 1485, 1521, 1574, 1613], '−4.7%': [148, 1544], '90.7%': [150, 1415, 1491, 1549], 'laBCC': [152, 192, 216, 644, 715, 776, 926, 971, 1282, 1299, 1421, 1497, 1551, 1600, 1679], '−3.7%': [154, 1553], '63.0%': [156, 1423, 1426, 1499, 1502, 1558], 'mBCC.': [158, 973, 1560], 'These': [159, 575], 'results': [160, 939, 1170], 'demonstrated': [161, 1088, 1161, 1669], 'maintenance': [163], 'efficacy': [166, 289, 695, 889, 1672, 1834], 'support': [173, 2029], 'recently': [175], 'approved': [176, 208, 1864], 'recommendations': [177], 'up': [182, 633, 1708], '8': [184, 503, 635, 1710], 'manage': [187], 'tolerability': [188], 'or': [193, 217, 224, 504, 649, 1103, 1718, 1870], 'mBCC': [194, 218, 646, 717, 928, 994, 1301, 1429, 1505, 1681], 'United': [198, 600, 613, 1698], 'States': [199, 601, 614, 1699], 'prescribing': [200, 615, 1700], 'information.': [201], 'Once-daily': [202], 'oral': [203, 251, 660, 1729], '150': [204], 'mg': [205], 'adults': [213], 'symptomatic': [215], 'that': [219, 269, 627, 679, 702, 1089, 1126, 1583, 1622, 1670, 1686, 1702], 'inappropriate': [221], 'surgery': [223], 'radiotherapy': [225], '(European': [226], 'Medicines': [227, 230], 'Agency,': [228], '2019European': [229], 'AgencyErivedge': [231], 'summary': [232], 'product': [234], 'characteristics.https://www.ema.europa.eu/en/documents/product-information/erivedge-epar-product-information_en.pdfDate:': [235], '2019Date': [236], 'accessed:': [237], 'October': [238, 258, 667, 1736], '13,': [239, 259, 668, 1737], '2020Google': [240], 'Scholar;': [241, 338, 375, 413, 453, 869, 1814], 'Genentech': [242], 'et': [243, 291, 305, 340, 354, 377, 391, 415, 429, 455, 527, 541, 652, 722, 737, 824, 838, 871, 885, 1019, 1034, 1206, 1220, 1721, 1769, 1783, 1816, 1830], 'al.,': [244, 292, 341, 378, 416, 456, 528, 653, 723, 825, 872, 1020, 1207, 1722, 1770, 1817], '2019Genentech': [245, 654, 1723], 'USA.': [246, 655, 1724], 'Erivedge': [247, 656, 1725], '(vismodegib)': [248, 657, 1726], 'capsules,': [249, 658, 1727], '[package': [253, 662, 1731], 'insert].': [254, 663, 1732], 'https://www.gene.com/download/pdf/erivedge_prescribing.pdf;': [255, 664, 1733], '2019': [256, 665, 1734], '(accessed': [257, 666, 1735], '2020).Google': [260, 669, 1738], 'Scholar).': [261, 492, 574, 670, 759, 915, 1062, 1739, 1860], 'Clinical': [262, 1766, 1930], 'studies': [263, 1745, 1914], 'suggested': [268], 'low-grade': [270], 'therapy': [277], 'could': [278], 'be': [279, 630, 1674, 1705], 'managed': [280], '4–8': [285], 'without': [287, 617], 'compromising': [288], '(Dréno': [290, 526], '2017Dréno': [293, 529], 'B.': [294, 304, 353, 420, 530, 540, 835, 1780], 'Kunstfeld': [295, 350, 531, 830, 1775], 'R.': [296, 343, 351, 382, 386, 424, 532, 725, 831, 1219, 1776], 'Hauschild': [297, 533, 828, 1773], 'A.': [298, 388, 534, 829, 874, 882, 1774, 1819, 1827], 'Fosko': [299, 535], 'S.': [300, 384, 390, 536], 'Zloty': [301, 537], 'D.': [302, 538, 727, 1217], 'Labeille': [303, 539], 'al.Two': [306, 542], 'regimens': [310, 546], 'multiple': [314, 521, 550], 'basal-cell': [315, 551], 'carcinomas': [316, 552], '(MIKIE):': [317, 553], 'randomised,': [319, 555], 'regimen-controlled,': [320, 556], 'double-blind,': [321, 557], 'phase': [322, 558, 1038, 1049], '2': [323, 559], 'trial.Lancet': [324, 560], 'Oncol.': [325, 370, 405, 561, 1054], '2017;': [326, 406, 562, 857, 908, 1802, 1853], '18:': [327, 563], '404-412Abstract': [328, 564], 'Full': [329, 331, 565, 567, 860, 862, 1238, 1240, 1805, 1807], 'Text': [330, 332, 566, 568, 861, 863, 1239, 1241, 1806, 1808], 'PDF': [333, 569, 864, 1242, 1809], 'PubMed': [334, 409, 449, 488, 570, 755, 865, 911, 1058, 1243, 1810, 1856], 'Scopus': [335, 410, 450, 489, 571, 756, 866, 912, 1059, 1244, 1811, 1857], '(91)': [336, 572], 'Google': [337, 374, 412, 452, 491, 573, 758, 868, 914, 1061, 1246, 1813, 1859], 'Dummer': [339, 423], '2015Dummer': [342], 'Basset-Seguin': [344, 425, 877, 1822], 'N.': [345, 426, 827, 878, 1772, 1823], 'Hansson': [346], 'J.': [347, 349, 734, 833, 1213, 1778], 'Grob': [348, 832, 1777], 'Dréno': [352, 419, 834, 1779], 'al.Impact': [355], 'breaks': [358, 1102], 'patient': [361], 'outcomes:': [362], 'exploratory': [363], 'analysis': [364, 848, 1793], 'STEVIE': [367, 786, 1288, 1744], 'study.J': [368], 'Clin': [369, 1053], '2015;': [371], '33:': [372], '9024Crossref': [373], 'Fife': [376, 427], '2017Fife': [379], 'K.': [380, 428, 1033], 'Herd': [381], 'Lalondrelle': [383], 'Plummer': [385], 'Strong': [387], 'Jones': [389], 'al.Managing': [392], 'events': [394, 438], 'carcinoma.Future': [404], '13:': [407], '175-184Crossref': [408], '(19)': [411], 'Lacouture': [414], '2016Lacouture': [417], 'M.E.': [418], 'Ascierto': [421], 'P.A.': [422], 'al.Characterization': [430], 'hedgehog': [434], 'pathway': [435], 'inhibitor-related': [436], 'carcinoma.Oncologist.': [445], '2016;': [446], '21:': [447], '1218-1229Crossref': [448], '(77)': [451], 'Lu': [454], '2020Lu': [457], 'T.': [458], 'Yang': [459], 'Y.': [460, 1969], 'Jin': [461, 1968], 'J.Y.': [462], 'Kågedal': [463], 'M.': [464], 'Analysis': [465], 'longitudinal-ordered': [467], 'categorical': [468], 'data': [469, 768, 796, 922, 1084, 1145, 1276, 1886, 1898, 1903], 'muscle': [471], 'spasm': [472], 'event': [474], 'vismodegib:': [476], 'comparison': [477], 'between': [478, 1253, 1532, 1652], 'different': [479], 'pharmacometric': [480], 'models.CPT': [481], 'Pharmacometrics': [482], 'Syst': [483], 'Pharmacol.': [484], '2020;': [485, 752], '9:': [486], '96-105Crossref': [487], '(2)': [490], 'In': [493, 671, 684, 950, 1149, 1508, 1561, 1664], 'MIKIE': [495], '(NCT01815840)': [496], 'study,': [497, 673, 686], 'interruption)': [513, 1413, 1489], 'effective': [515], 'tolerable': [517], 'nonadvanced': [522], 'data,': [576], 'together': [577], 'recent': [580], '(TGI)': [584], 'model‒based': [585], 'evaluation,': [586], 'supported': [587, 1318], 'submission': [589], 'acceptance': [591], 'supplemental': [594], 'New': [595], 'Drug': [596, 604], 'Application': [597], 'Food': [602], 'Administration': [605], 'update': [609, 900, 1845], 'information': [616, 1701], 'performing': [618], 'new': [620], 'trial.': [622], 'updated': [624, 1694], 'states': [626], 'can': [629, 1704], 'withheld': [631, 1706], 'intolerable': [638, 1713], 'until': [647, 1716], 'improvement': [648, 1717], 'resolution': [650, 1719], '(Genentech': [651, 1720], 'this': [672, 685, 951, 2013], 'we': [674], 'describe': [675], 'contributed': [680], 'approval.': [683], 'assessed': [697], 'using': [698, 746, 1156], 'TGI': [700, 941, 1064, 1128, 1154], 'describes': [703], 'longitudinal': [705], '(TS)': [708], 'change': [709, 1516], 'over': [710, 981, 1003], 'time': [711, 918, 982, 1004, 1641], 'treated': [718], '(Bruno': [721], '2020Bruno': [724], 'Bottino': [726], 'de': [728], 'Alwis': [729], 'D.P.': [730], 'Fojo': [731], 'A.T.': [732], 'Guedj': [733], 'Liu': [735], 'C.': [736, 880, 1825], 'al.Progress': [738], 'opportunities': [740], 'advance': [742], 'cancer': [744, 1016, 1044], 'therapeutics': [745], 'dynamic': [748], 'models.Clin': [749], 'Cancer': [750], 'Res.': [751], '26:': [753], '1787-1795Crossref': [754], '(21)': [757], 'developed': [763], 'basis': [766, 1047], '129': [770], '27': [772], 'evaluable': [773, 1279], 'mBCC,': [778, 1602], 'respectively,': [779], 'ERIVANCE': [782, 904, 1741, 1849], 'BCC': [783, 905, 1742, 1850], '(NCT00833417)': [784], '(NCT01367665)': [787], 'studies.': [788], 'Evaluable': [789], 'defined': [792], 'as': [793, 1012, 1137, 1139, 1655, 1997, 1999], 'unbound': [800, 961], 'concentrations,': [802], 'plasma': [803], 'alpha-1-acid': [804], 'glycoprotein': [805], 'levels,': [806], 'TS': [808, 921, 1083, 1185, 1644], '(sum': [809], 'longest': [811], 'diameters': [812], '≤5': [814], 'target': [815], 'lesions)': [816], '(model': [817], 'development': [818, 943, 1122, 1159], 'dataset;': [819], 'Supplementary': [820, 932, 948, 1009, 1658, 2122], 'Table': [821, 1006, 1068, 1291], 'S1)': [822], '(Basset-Séguin': [823, 1768], '2017Basset-Séguin': [826, 1771], 'Mortier': [836, 1781], 'L.': [837, 1022, 1782], 'al.Vismodegib': [839, 1784], 'carcinoma:': [846, 898, 1791, 1843], 'primary': [847, 1792], 'STEVIE,': [850, 1795], 'international,': [852, 1797], 'open-label': [853, 1798], 'trial.Eur': [854, 1799], 'J': [855, 1233, 1800], 'Cancer.': [856, 907, 1234, 1801, 1852], '86:': [858, 1803], '334-348Abstract': [859, 1804], '(131)': [867, 1812], 'Sekulic': [870, 1815], '2017Sekulic': [873, 1818], 'Migden': [875, 1820], 'M.R.': [876, 1821], 'Garbe': [879, 1824], 'Gesierich': [881, 1826], 'Lao': [883, 1828], 'C.D.': [884, 1829], 'al.Long-term': [886, 1831], 'safety': [887, 1832], 'final': [899, 1844], 'pivotal': [903, 1848], 'study.BMC': [906, 1851], '17:': [909, 1854], '332Crossref': [910, 1855], '(168)': [913, 1858], 'individual': [917, 1896], 'courses': [919], 'are': [929, 944, 1626, 1915, 1977], 'shown': [930, 1252, 1656], 'Figure': [933, 1010, 1107, 1147, 1397, 1659], 'S1.': [934], 'key': [936], 'details': [937, 1908, 1921], 'described': [945], 'Materials.': [949], 'model,': [952], 'shrinkage': [954, 978], 'driven': [956], 'concentration': [959], 'vismodegib,': [962], 'similar': [965], 'rate': [966, 975], 'used': [967, 992, 2011], 'constant': [980, 989], 'laBCC;': [984], 'however,': [985], 'exponential': [987], 'decay': [988], '(λ)': [990], 'account': [996], 'loss': [999, 1569], 'effect': [1002], '(Supplementary': [1005, 1067, 1106, 1146, 1290, 1396], 'S2': [1007], 'S2),': [1011], 'seen': 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