Phase III study of Enzastaurin compared with Lomustine in the treatment of recurrent intracranial glioblastoma
Purpose - - This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4). - - Patients and Methods - - Patients were randomly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d (1,125-mg loading d...
Gespeichert in:
| Hauptverfasser: | , , , , , , , , , , , , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
[March 1, 2010]
|
| In: |
Journal of clinical oncology
Year: 2010, Jahrgang: 28, Heft: 7, Pages: 1168-1174 |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.2009.23.2595 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2009.23.2595 Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2009.23.2595 
|
| Verfasserangaben: | Wolfgang Wick, Vinay K. Puduvalli, Marc C. Chamberlain, Martin J. van den Bent, Antoine F. Carpentier, Lawrence M. Cher, Warren Mason, Michael Weller, Shengyan Hong, Luna Musib, Astra M. Liepa, Donald E. Thornton, and Howard A. Fine |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1876447575 | ||
| 003 | DE-627 | ||
| 005 | 20240311120519.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231219s2010 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1200/JCO.2009.23.2595 |2 doi | |
| 035 | |a (DE-627)1876447575 | ||
| 035 | |a (DE-599)KXP1876447575 | ||
| 035 | |a (OCoLC)1425872682 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Wick, Wolfgang |d 1970- |e VerfasserIn |0 (DE-588)120297736 |0 (DE-627)080586929 |0 (DE-576)186221320 |4 aut | |
| 245 | 1 | 0 | |a Phase III study of Enzastaurin compared with Lomustine in the treatment of recurrent intracranial glioblastoma |c Wolfgang Wick, Vinay K. Puduvalli, Marc C. Chamberlain, Martin J. van den Bent, Antoine F. Carpentier, Lawrence M. Cher, Warren Mason, Michael Weller, Shengyan Hong, Luna Musib, Astra M. Liepa, Donald E. Thornton, and Howard A. Fine |
| 264 | 1 | |c [March 1, 2010] | |
| 300 | |b Diagramme | ||
| 300 | |a 7 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Gesehen am 19.12.2023 | ||
| 520 | |a Purpose - - This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4). - - Patients and Methods - - Patients were randomly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d (1,125-mg loading dose, day 1) or lomustine (100 to 130 mg/m2, day 1). Assuming a 45% improvement in progression-free survival (PFS), 397 patients were required to provide 80% power to achieve statistical significance at a one-sided level of .025. - - Results - - Enrollment was terminated at 266 patients (enzastaurin, n = 174; lomustine, n = 92) after a planned interim analysis for futility. Patient characteristics were balanced between arms. Median PFS (1.5 v 1.6 months; hazard ratio [HR] = 1.28; 95% CI, 0.97 to 1.70), overall survival (6.6 v 7.1 months; HR = 1.20; 95% CI, 0.88 to 1.65), and 6-month PFS rate (P = .13) did not differ significantly between enzastaurin and lomustine, respectively. Stable disease occurred in 38.5% and 35.9% of patients and objective response occurred in 2.9% and 4.3% of patients, respectively. Time to deterioration of physical and functional well-being and symptoms did not differ between arms (HR = 1.12; P = .54). Four patients discontinued enzastaurin because of drug-related serious adverse events (AEs). Eleven patients treated with enzastaurin died on study (four because of AEs; one was drug-related). All four deaths that occurred in patients receiving lomustine were disease-related. Grade 3 to 4 hematologic toxicities were significantly higher with lomustine (46 events) than with enzastaurin (one event; P ≤ .001). - - Conclusion - - Enzastaurin was well tolerated and had a better hematologic toxicity profile but did not have superior efficacy compared with lomustine in patients with recurrent glioblastoma. | ||
| 700 | 1 | |a Puduvalli, Vinay K. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Chamberlain, Marc C. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Bent, Martin J. van den |e VerfasserIn |4 aut | |
| 700 | 1 | |a Carpentier, Antoine F. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Cher, Lawrence M. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mason, Warren |e VerfasserIn |4 aut | |
| 700 | 1 | |a Weller, Michael |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hong, Shengyan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Musib, Luna |e VerfasserIn |4 aut | |
| 700 | 1 | |a Liepa, Astra M. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Thornton, Donald E. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Fine, Howard A. |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of clinical oncology |d Alexandria, Va. : American Society of Clinical Oncology, 1983 |g 28(2010), 7 vom: März, Seite 1168-1174 |h Online-Ressource |w (DE-627)313116962 |w (DE-600)2005181-5 |w (DE-576)090887018 |x 1527-7755 |7 nnas |a Phase III study of Enzastaurin compared with Lomustine in the treatment of recurrent intracranial glioblastoma |
| 773 | 1 | 8 | |g volume:28 |g year:2010 |g number:7 |g month:03 |g pages:1168-1174 |g extent:7 |a Phase III study of Enzastaurin compared with Lomustine in the treatment of recurrent intracranial glioblastoma |
| 856 | 4 | 0 | |u https://doi.org/10.1200/JCO.2009.23.2595 |x Verlag |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u https://ascopubs.org/doi/10.1200/JCO.2009.23.2595 |x Verlag |z lizenzpflichtig |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20231219 | ||
| 993 | |a Article | ||
| 994 | |a 2010 | ||
| 998 | |g 120297736 |a Wick, Wolfgang |m 120297736:Wick, Wolfgang |d 910000 |d 911100 |e 910000PW120297736 |e 911100PW120297736 |k 0/910000/ |k 1/910000/911100/ |p 1 |x j | ||
| 999 | |a KXP-PPN1876447575 |e 444102424X | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"name":{"displayForm":["Wolfgang Wick, Vinay K. Puduvalli, Marc C. Chamberlain, Martin J. van den Bent, Antoine F. Carpentier, Lawrence M. Cher, Warren Mason, Michael Weller, Shengyan Hong, Luna Musib, Astra M. Liepa, Donald E. Thornton, and Howard A. Fine"]},"origin":[{"dateIssuedKey":"2010","dateIssuedDisp":"[March 1, 2010]"}],"type":{"media":"Online-Ressource","bibl":"article-journal"},"id":{"eki":["1876447575"],"doi":["10.1200/JCO.2009.23.2595"]},"recId":"1876447575","person":[{"role":"aut","family":"Wick","display":"Wick, Wolfgang","given":"Wolfgang"},{"family":"Puduvalli","role":"aut","display":"Puduvalli, Vinay K.","given":"Vinay K."},{"given":"Marc C.","display":"Chamberlain, Marc C.","role":"aut","family":"Chamberlain"},{"given":"Martin J. van den","display":"Bent, Martin J. van den","family":"Bent","role":"aut"},{"role":"aut","family":"Carpentier","display":"Carpentier, Antoine F.","given":"Antoine F."},{"display":"Cher, Lawrence M.","role":"aut","family":"Cher","given":"Lawrence M."},{"role":"aut","family":"Mason","display":"Mason, Warren","given":"Warren"},{"display":"Weller, Michael","role":"aut","family":"Weller","given":"Michael"},{"given":"Shengyan","display":"Hong, Shengyan","role":"aut","family":"Hong"},{"given":"Luna","family":"Musib","role":"aut","display":"Musib, Luna"},{"given":"Astra M.","role":"aut","family":"Liepa","display":"Liepa, Astra M."},{"family":"Thornton","role":"aut","display":"Thornton, Donald E.","given":"Donald E."},{"given":"Howard A.","family":"Fine","role":"aut","display":"Fine, Howard A."}],"language":["eng"],"note":["Gesehen am 19.12.2023"],"title":[{"title_sort":"Phase III study of Enzastaurin compared with Lomustine in the treatment of recurrent intracranial glioblastoma","title":"Phase III study of Enzastaurin compared with Lomustine in the treatment of recurrent intracranial glioblastoma"}],"physDesc":[{"noteIll":"Diagramme","extent":"7 S."}],"relHost":[{"type":{"bibl":"periodical","media":"Online-Ressource"},"recId":"313116962","language":["eng"],"part":{"issue":"7","pages":"1168-1174","year":"2010","extent":"7","volume":"28","text":"28(2010), 7 vom: März, Seite 1168-1174"},"physDesc":[{"extent":"Online-Ressource"}],"corporate":[{"display":"American Society of Clinical Oncology","role":"isb"}],"origin":[{"publisher":"American Society of Clinical Oncology ; Lippincott Williams & Wilkins","dateIssuedKey":"1983","publisherPlace":"Alexandria, Va. ; Baltimore, Md. [u.a.]","dateIssuedDisp":"1983-"}],"disp":"Phase III study of Enzastaurin compared with Lomustine in the treatment of recurrent intracranial glioblastomaJournal of clinical oncology","id":{"issn":["1527-7755"],"eki":["313116962"],"zdb":["2005181-5"]},"note":["Fortsetzung der Druck-Ausgabe","Gesehen am 22.05.23"],"titleAlt":[{"title":"official journal of the American Society of Clinical Oncology"},{"title":"JCO"},{"title":"Journal of clinical oncology legacy archive (ASCO)"}],"pubHistory":["1.1983 -"],"title":[{"title":"Journal of clinical oncology","subtitle":"JCO : an American Society of Clinical Oncology journal","title_sort":"Journal of clinical oncology"}]}]} | ||
| SRT | |a WICKWOLFGAPHASEIIIST1201 | ||