Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme: North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 trials

Jan Craig Buckner, Karla V. Ballman, John C. Michalak, Gary V. Burton, Terrence L. Cascino, Paula J. Schomberg, Roland B. Hawkins, Bernd W. Scheithauer, Howard M. Sandler, Randolph Stuart Marks, Judith R. O'Fallon

Research output: Contribution to journalArticle

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Abstract

Purpose: In patients with newly diagnosed glioblastoma multiforme, to determine whether cisplatin plus carmustine (BCNU) administered before and concurrently with radiation therapy (RT) improves survival compared with BCNU and RT and whether survival using accelerated RT (ART) is equivalent to survival using standard RT (SRT). Patients and Methods: After surgery, patients were stratified by age, performance score, extent of surgical resection, and histology (glioblastoma v gliosarcoma) and then randomly assigned to arm A (BCNU plus SRT), arm B (BCNU plus ART), arm C (cisplatin plus BCNU plus SRT), or arm D (cisplatin plus BCNU plus ART). Results: Four hundred fifty-one patients were randomly assigned, and 401 were eligible. Frequent toxicities included myelosuppression, vomiting, sensory neuropathy, and ototoxicity and were worse with cisplatin. There was no difference in toxicity between SRT and ART. Median survival times and 2-year survival rates for patients who received BCNU plus RT (arms A and B) compared with cisplatin, BCNU, and RT (arms C and D) were 10.1 v 11.5 months, respectively, and 11.5% v 13.7%, respectively (P = .19). Median survival times and 2-year survival rates for patients who received SRT (arms A and C) compared with ART (arms B and D) were 11.2 v 10.5 months, respectively, and 13.8% v 11.4%, respectively (P = .33). Conclusion: Cisplatin administered concurrently with BCNU and RT resulted in more toxicity but provided no significant improvement in survival. SRT and ART produced similar toxicity and survival.

Original languageEnglish (US)
Pages (from-to)3871-3879
Number of pages9
JournalJournal of Clinical Oncology
Volume24
Issue number24
DOIs
StatePublished - Aug 20 2006

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Carmustine
Glioblastoma
Cisplatin
Radiotherapy
Neoplasms
Survival
Therapeutics
Survival Rate
Gliosarcoma
Vomiting
Histology

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme : North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 trials. / Buckner, Jan Craig; Ballman, Karla V.; Michalak, John C.; Burton, Gary V.; Cascino, Terrence L.; Schomberg, Paula J.; Hawkins, Roland B.; Scheithauer, Bernd W.; Sandler, Howard M.; Marks, Randolph Stuart; O'Fallon, Judith R.

In: Journal of Clinical Oncology, Vol. 24, No. 24, 20.08.2006, p. 3871-3879.

Research output: Contribution to journalArticle

Buckner, Jan Craig ; Ballman, Karla V. ; Michalak, John C. ; Burton, Gary V. ; Cascino, Terrence L. ; Schomberg, Paula J. ; Hawkins, Roland B. ; Scheithauer, Bernd W. ; Sandler, Howard M. ; Marks, Randolph Stuart ; O'Fallon, Judith R. / Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme : North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 trials. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 24. pp. 3871-3879.
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title = "Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme: North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 trials",
abstract = "Purpose: In patients with newly diagnosed glioblastoma multiforme, to determine whether cisplatin plus carmustine (BCNU) administered before and concurrently with radiation therapy (RT) improves survival compared with BCNU and RT and whether survival using accelerated RT (ART) is equivalent to survival using standard RT (SRT). Patients and Methods: After surgery, patients were stratified by age, performance score, extent of surgical resection, and histology (glioblastoma v gliosarcoma) and then randomly assigned to arm A (BCNU plus SRT), arm B (BCNU plus ART), arm C (cisplatin plus BCNU plus SRT), or arm D (cisplatin plus BCNU plus ART). Results: Four hundred fifty-one patients were randomly assigned, and 401 were eligible. Frequent toxicities included myelosuppression, vomiting, sensory neuropathy, and ototoxicity and were worse with cisplatin. There was no difference in toxicity between SRT and ART. Median survival times and 2-year survival rates for patients who received BCNU plus RT (arms A and B) compared with cisplatin, BCNU, and RT (arms C and D) were 10.1 v 11.5 months, respectively, and 11.5{\%} v 13.7{\%}, respectively (P = .19). Median survival times and 2-year survival rates for patients who received SRT (arms A and C) compared with ART (arms B and D) were 11.2 v 10.5 months, respectively, and 13.8{\%} v 11.4{\%}, respectively (P = .33). Conclusion: Cisplatin administered concurrently with BCNU and RT resulted in more toxicity but provided no significant improvement in survival. SRT and ART produced similar toxicity and survival.",
author = "Buckner, {Jan Craig} and Ballman, {Karla V.} and Michalak, {John C.} and Burton, {Gary V.} and Cascino, {Terrence L.} and Schomberg, {Paula J.} and Hawkins, {Roland B.} and Scheithauer, {Bernd W.} and Sandler, {Howard M.} and Marks, {Randolph Stuart} and O'Fallon, {Judith R.}",
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TY - JOUR

T1 - Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme

T2 - North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 trials

AU - Buckner, Jan Craig

AU - Ballman, Karla V.

AU - Michalak, John C.

AU - Burton, Gary V.

AU - Cascino, Terrence L.

AU - Schomberg, Paula J.

AU - Hawkins, Roland B.

AU - Scheithauer, Bernd W.

AU - Sandler, Howard M.

AU - Marks, Randolph Stuart

AU - O'Fallon, Judith R.

PY - 2006/8/20

Y1 - 2006/8/20

N2 - Purpose: In patients with newly diagnosed glioblastoma multiforme, to determine whether cisplatin plus carmustine (BCNU) administered before and concurrently with radiation therapy (RT) improves survival compared with BCNU and RT and whether survival using accelerated RT (ART) is equivalent to survival using standard RT (SRT). Patients and Methods: After surgery, patients were stratified by age, performance score, extent of surgical resection, and histology (glioblastoma v gliosarcoma) and then randomly assigned to arm A (BCNU plus SRT), arm B (BCNU plus ART), arm C (cisplatin plus BCNU plus SRT), or arm D (cisplatin plus BCNU plus ART). Results: Four hundred fifty-one patients were randomly assigned, and 401 were eligible. Frequent toxicities included myelosuppression, vomiting, sensory neuropathy, and ototoxicity and were worse with cisplatin. There was no difference in toxicity between SRT and ART. Median survival times and 2-year survival rates for patients who received BCNU plus RT (arms A and B) compared with cisplatin, BCNU, and RT (arms C and D) were 10.1 v 11.5 months, respectively, and 11.5% v 13.7%, respectively (P = .19). Median survival times and 2-year survival rates for patients who received SRT (arms A and C) compared with ART (arms B and D) were 11.2 v 10.5 months, respectively, and 13.8% v 11.4%, respectively (P = .33). Conclusion: Cisplatin administered concurrently with BCNU and RT resulted in more toxicity but provided no significant improvement in survival. SRT and ART produced similar toxicity and survival.

AB - Purpose: In patients with newly diagnosed glioblastoma multiforme, to determine whether cisplatin plus carmustine (BCNU) administered before and concurrently with radiation therapy (RT) improves survival compared with BCNU and RT and whether survival using accelerated RT (ART) is equivalent to survival using standard RT (SRT). Patients and Methods: After surgery, patients were stratified by age, performance score, extent of surgical resection, and histology (glioblastoma v gliosarcoma) and then randomly assigned to arm A (BCNU plus SRT), arm B (BCNU plus ART), arm C (cisplatin plus BCNU plus SRT), or arm D (cisplatin plus BCNU plus ART). Results: Four hundred fifty-one patients were randomly assigned, and 401 were eligible. Frequent toxicities included myelosuppression, vomiting, sensory neuropathy, and ototoxicity and were worse with cisplatin. There was no difference in toxicity between SRT and ART. Median survival times and 2-year survival rates for patients who received BCNU plus RT (arms A and B) compared with cisplatin, BCNU, and RT (arms C and D) were 10.1 v 11.5 months, respectively, and 11.5% v 13.7%, respectively (P = .19). Median survival times and 2-year survival rates for patients who received SRT (arms A and C) compared with ART (arms B and D) were 11.2 v 10.5 months, respectively, and 13.8% v 11.4%, respectively (P = .33). Conclusion: Cisplatin administered concurrently with BCNU and RT resulted in more toxicity but provided no significant improvement in survival. SRT and ART produced similar toxicity and survival.

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