Procarbazine and high-dose tamoxifen as a second-line regimen in recurrent high-grade gliomas

A phase II study

Alba A. Brandes, Mario Ermani, Sergio Turazzi, Elvira Scelzi, Franco Berti, Pietro Amistà, Antonino Rotilio, Claudio Licata, Mario V. Fiorentino

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Abstract

Purpose: A phase II study was conducted in patients with high-grade gliomas that recurred after surgery plus radiotherapy and a first-line nitrosourea-based regimen. Our aim was to investigate the efficacy of procarbazine (PCB) combined with high-dose tamoxifen in relation to tumor control, toxicity, and time to progression (TTP). Patients and Methods: Fifty-three patients were treated with procarbazine in repeated 30-day courses at 100 mg/m2/d plus tamaxifen 100 mg/d, with a 30-day interval between courses. Thirty-four patients had been pretreated with a first-line nitrosourea-based chemotherapy regimen (group A), and 19 patients had also been pretreated with a second-line chemotherapy regimen consisting of carboplatin and teniposide (group B). Twenty-one of the patients had also been procarbazine pretreated, whereas the remaining 32 patients were not procarbazine pretreated. Results: The response was assessed in 51 patients, 28 of whom had glioblastoma multiforme (GBM) and 23 of whom had anaplastic astrocytoma (AA). There were two complete responses (CR) (4%) and 13 partial responses (PR) (25.5%). The overall response rate (CR + PR) was 29.5% (SE, 6.4; 95% confidence interval [CI], 23 to 35.8). Seventeen patients (32%) had stable disease (SE, 6.2; 95% CI, 21 to 33.6). The median TTP was 13 weeks for patients with GBM and 33 weeks for patients with AA (P = .006). The median survival time (MST) was 27 weeks for patients with GBM and 57 weeks for those with AA (P = .006). Conclusion: Combined PCB and tamoxifen as a second-line regimen gave a reasonably high response rate in patients with heavily pretreated high-grade gliomas. However, although it resulted in an improvement in the patients' quality of life and/or performance status, it was not followed by an increased TTP or MST.

Original languageEnglish
Pages (from-to)645-650
Number of pages6
JournalJournal of Clinical Oncology
Volume17
Issue number2
Publication statusPublished - Feb 1999

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Procarbazine
Tamoxifen
Glioma
Astrocytoma
Glioblastoma
Teniposide
Confidence Intervals
Drug Therapy
Survival
Carboplatin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Brandes, A. A., Ermani, M., Turazzi, S., Scelzi, E., Berti, F., Amistà, P., ... Fiorentino, M. V. (1999). Procarbazine and high-dose tamoxifen as a second-line regimen in recurrent high-grade gliomas: A phase II study. Journal of Clinical Oncology, 17(2), 645-650.

Procarbazine and high-dose tamoxifen as a second-line regimen in recurrent high-grade gliomas : A phase II study. / Brandes, Alba A.; Ermani, Mario; Turazzi, Sergio; Scelzi, Elvira; Berti, Franco; Amistà, Pietro; Rotilio, Antonino; Licata, Claudio; Fiorentino, Mario V.

In: Journal of Clinical Oncology, Vol. 17, No. 2, 02.1999, p. 645-650.

Research output: Contribution to journalArticle

Brandes, AA, Ermani, M, Turazzi, S, Scelzi, E, Berti, F, Amistà, P, Rotilio, A, Licata, C & Fiorentino, MV 1999, 'Procarbazine and high-dose tamoxifen as a second-line regimen in recurrent high-grade gliomas: A phase II study', Journal of Clinical Oncology, vol. 17, no. 2, pp. 645-650.
Brandes, Alba A. ; Ermani, Mario ; Turazzi, Sergio ; Scelzi, Elvira ; Berti, Franco ; Amistà, Pietro ; Rotilio, Antonino ; Licata, Claudio ; Fiorentino, Mario V. / Procarbazine and high-dose tamoxifen as a second-line regimen in recurrent high-grade gliomas : A phase II study. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 2. pp. 645-650.
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title = "Procarbazine and high-dose tamoxifen as a second-line regimen in recurrent high-grade gliomas: A phase II study",
abstract = "Purpose: A phase II study was conducted in patients with high-grade gliomas that recurred after surgery plus radiotherapy and a first-line nitrosourea-based regimen. Our aim was to investigate the efficacy of procarbazine (PCB) combined with high-dose tamoxifen in relation to tumor control, toxicity, and time to progression (TTP). Patients and Methods: Fifty-three patients were treated with procarbazine in repeated 30-day courses at 100 mg/m2/d plus tamaxifen 100 mg/d, with a 30-day interval between courses. Thirty-four patients had been pretreated with a first-line nitrosourea-based chemotherapy regimen (group A), and 19 patients had also been pretreated with a second-line chemotherapy regimen consisting of carboplatin and teniposide (group B). Twenty-one of the patients had also been procarbazine pretreated, whereas the remaining 32 patients were not procarbazine pretreated. Results: The response was assessed in 51 patients, 28 of whom had glioblastoma multiforme (GBM) and 23 of whom had anaplastic astrocytoma (AA). There were two complete responses (CR) (4{\%}) and 13 partial responses (PR) (25.5{\%}). The overall response rate (CR + PR) was 29.5{\%} (SE, 6.4; 95{\%} confidence interval [CI], 23 to 35.8). Seventeen patients (32{\%}) had stable disease (SE, 6.2; 95{\%} CI, 21 to 33.6). The median TTP was 13 weeks for patients with GBM and 33 weeks for patients with AA (P = .006). The median survival time (MST) was 27 weeks for patients with GBM and 57 weeks for those with AA (P = .006). Conclusion: Combined PCB and tamoxifen as a second-line regimen gave a reasonably high response rate in patients with heavily pretreated high-grade gliomas. However, although it resulted in an improvement in the patients' quality of life and/or performance status, it was not followed by an increased TTP or MST.",
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T1 - Procarbazine and high-dose tamoxifen as a second-line regimen in recurrent high-grade gliomas

T2 - A phase II study

AU - Brandes, Alba A.

AU - Ermani, Mario

AU - Turazzi, Sergio

AU - Scelzi, Elvira

AU - Berti, Franco

AU - Amistà, Pietro

AU - Rotilio, Antonino

AU - Licata, Claudio

AU - Fiorentino, Mario V.

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N2 - Purpose: A phase II study was conducted in patients with high-grade gliomas that recurred after surgery plus radiotherapy and a first-line nitrosourea-based regimen. Our aim was to investigate the efficacy of procarbazine (PCB) combined with high-dose tamoxifen in relation to tumor control, toxicity, and time to progression (TTP). Patients and Methods: Fifty-three patients were treated with procarbazine in repeated 30-day courses at 100 mg/m2/d plus tamaxifen 100 mg/d, with a 30-day interval between courses. Thirty-four patients had been pretreated with a first-line nitrosourea-based chemotherapy regimen (group A), and 19 patients had also been pretreated with a second-line chemotherapy regimen consisting of carboplatin and teniposide (group B). Twenty-one of the patients had also been procarbazine pretreated, whereas the remaining 32 patients were not procarbazine pretreated. Results: The response was assessed in 51 patients, 28 of whom had glioblastoma multiforme (GBM) and 23 of whom had anaplastic astrocytoma (AA). There were two complete responses (CR) (4%) and 13 partial responses (PR) (25.5%). The overall response rate (CR + PR) was 29.5% (SE, 6.4; 95% confidence interval [CI], 23 to 35.8). Seventeen patients (32%) had stable disease (SE, 6.2; 95% CI, 21 to 33.6). The median TTP was 13 weeks for patients with GBM and 33 weeks for patients with AA (P = .006). The median survival time (MST) was 27 weeks for patients with GBM and 57 weeks for those with AA (P = .006). Conclusion: Combined PCB and tamoxifen as a second-line regimen gave a reasonably high response rate in patients with heavily pretreated high-grade gliomas. However, although it resulted in an improvement in the patients' quality of life and/or performance status, it was not followed by an increased TTP or MST.

AB - Purpose: A phase II study was conducted in patients with high-grade gliomas that recurred after surgery plus radiotherapy and a first-line nitrosourea-based regimen. Our aim was to investigate the efficacy of procarbazine (PCB) combined with high-dose tamoxifen in relation to tumor control, toxicity, and time to progression (TTP). Patients and Methods: Fifty-three patients were treated with procarbazine in repeated 30-day courses at 100 mg/m2/d plus tamaxifen 100 mg/d, with a 30-day interval between courses. Thirty-four patients had been pretreated with a first-line nitrosourea-based chemotherapy regimen (group A), and 19 patients had also been pretreated with a second-line chemotherapy regimen consisting of carboplatin and teniposide (group B). Twenty-one of the patients had also been procarbazine pretreated, whereas the remaining 32 patients were not procarbazine pretreated. Results: The response was assessed in 51 patients, 28 of whom had glioblastoma multiforme (GBM) and 23 of whom had anaplastic astrocytoma (AA). There were two complete responses (CR) (4%) and 13 partial responses (PR) (25.5%). The overall response rate (CR + PR) was 29.5% (SE, 6.4; 95% confidence interval [CI], 23 to 35.8). Seventeen patients (32%) had stable disease (SE, 6.2; 95% CI, 21 to 33.6). The median TTP was 13 weeks for patients with GBM and 33 weeks for patients with AA (P = .006). The median survival time (MST) was 27 weeks for patients with GBM and 57 weeks for those with AA (P = .006). Conclusion: Combined PCB and tamoxifen as a second-line regimen gave a reasonably high response rate in patients with heavily pretreated high-grade gliomas. However, although it resulted in an improvement in the patients' quality of life and/or performance status, it was not followed by an increased TTP or MST.

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