Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours
Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bol...
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E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2000 |
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| Umfang: |
7 |
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| Reproduktion: |
Springer Online Journal Archives 1860-2002 |
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| Übergeordnetes Werk: |
in: Journal of cancer research and clinical oncology - 1904, 126(2000) vom: Jan., Seite 41-47 |
| Übergeordnetes Werk: |
volume:126 ; year:2000 ; month:01 ; pages:41-47 ; extent:7 |
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NLEJ205281052 |
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| 520 | |a Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. | ||
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| 700 | 1 | |a Paul, H. |4 oth | |
| 700 | 1 | |a Merkle, K. |4 oth | |
| 700 | 1 | |a Kowalski, R. |4 oth | |
| 700 | 1 | |a Ganser, A. |4 oth | |
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(DE-627)NLEJ205281052 DE-627 ger DE-627 rakwb eng Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours 2000 7 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. Springer Online Journal Archives 1860-2002 Schöffski, P. oth Hagedorn, T. oth Grünwald, V. oth Paul, H. oth Merkle, K. oth Kowalski, R. oth Ganser, A. oth in Journal of cancer research and clinical oncology 1904 126(2000) vom: Jan., Seite 41-47 (DE-627)NLEJ188987657 (DE-600)1459285-x 1432-1335 nnns volume:126 year:2000 month:01 pages:41-47 extent:7 http://dx.doi.org/10.1007/PL00008463 GBV_USEFLAG_U ZDB-1-SOJ GBV_NL_ARTICLE AR 126 2000 1 41-47 7 |
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(DE-627)NLEJ205281052 DE-627 ger DE-627 rakwb eng Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours 2000 7 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. Springer Online Journal Archives 1860-2002 Schöffski, P. oth Hagedorn, T. oth Grünwald, V. oth Paul, H. oth Merkle, K. oth Kowalski, R. oth Ganser, A. oth in Journal of cancer research and clinical oncology 1904 126(2000) vom: Jan., Seite 41-47 (DE-627)NLEJ188987657 (DE-600)1459285-x 1432-1335 nnns volume:126 year:2000 month:01 pages:41-47 extent:7 http://dx.doi.org/10.1007/PL00008463 GBV_USEFLAG_U ZDB-1-SOJ GBV_NL_ARTICLE AR 126 2000 1 41-47 7 |
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(DE-627)NLEJ205281052 DE-627 ger DE-627 rakwb eng Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours 2000 7 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. Springer Online Journal Archives 1860-2002 Schöffski, P. oth Hagedorn, T. oth Grünwald, V. oth Paul, H. oth Merkle, K. oth Kowalski, R. oth Ganser, A. oth in Journal of cancer research and clinical oncology 1904 126(2000) vom: Jan., Seite 41-47 (DE-627)NLEJ188987657 (DE-600)1459285-x 1432-1335 nnns volume:126 year:2000 month:01 pages:41-47 extent:7 http://dx.doi.org/10.1007/PL00008463 GBV_USEFLAG_U ZDB-1-SOJ GBV_NL_ARTICLE AR 126 2000 1 41-47 7 |
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(DE-627)NLEJ205281052 DE-627 ger DE-627 rakwb eng Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours 2000 7 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. Springer Online Journal Archives 1860-2002 Schöffski, P. oth Hagedorn, T. oth Grünwald, V. oth Paul, H. oth Merkle, K. oth Kowalski, R. oth Ganser, A. oth in Journal of cancer research and clinical oncology 1904 126(2000) vom: Jan., Seite 41-47 (DE-627)NLEJ188987657 (DE-600)1459285-x 1432-1335 nnns volume:126 year:2000 month:01 pages:41-47 extent:7 http://dx.doi.org/10.1007/PL00008463 GBV_USEFLAG_U ZDB-1-SOJ GBV_NL_ARTICLE AR 126 2000 1 41-47 7 |
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(DE-627)NLEJ205281052 DE-627 ger DE-627 rakwb eng Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours 2000 7 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. Springer Online Journal Archives 1860-2002 Schöffski, P. oth Hagedorn, T. oth Grünwald, V. oth Paul, H. oth Merkle, K. oth Kowalski, R. oth Ganser, A. oth in Journal of cancer research and clinical oncology 1904 126(2000) vom: Jan., Seite 41-47 (DE-627)NLEJ188987657 (DE-600)1459285-x 1432-1335 nnns volume:126 year:2000 month:01 pages:41-47 extent:7 http://dx.doi.org/10.1007/PL00008463 GBV_USEFLAG_U ZDB-1-SOJ GBV_NL_ARTICLE AR 126 2000 1 41-47 7 |
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Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours |
| abstract |
Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. |
| abstractGer |
Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. |
| abstract_unstemmed |
Abstract Purpose: The cytotoxic agent bendamustine combines a purine-like benzimidazol and bifunctionally alkylating nitrogen mustard group. The drug has clinical antitumour activity in lymphoma, myeloma and breast cancer. In earlier dose-finding studies, the clinically tolerated dose for single-bolus bendamustine was 215 mg/m2; for fractionated therapy on 4 consecutive days it was 85 mg/m2. Anticholinergic symptoms, myelosuppression and cardiac dysrhythmia were dose-limiting. Our trial was designed to define the maximum tolerated dose of a short infusion schedule and to establish a recommended dose for ongoing and future clinical studies. Methods: Patients with refractory malignant tumours qualified for the trial after written informed consent had been obtained. Bendamustine was given as a 30-min iv. infusion on days 1 and 8 of a 4 week cycle, with a starting dose of 100 mg/m2 and an increment per group of 20 mg/m2. Results: Nineteen patients (13 male, 6 female; median age 57 years, range 37–74 years) were treated for one to two cycles with up to 180 mg/m2 bendamustine. At 160 mg/m2, fatigue grade 3 (NCI Common Toxicity Criteria) and dryness of the mouth grade 3 occurred in 2 patients, diarrhoea grade 3 in 1 patient; another patient with a history of myocardial infarction and arrhythmia developed a reversible total atrioventricular block after the first administration of 160 mg/m2 bendamustine. Other events, such as nausea/vomiting, loss of appetite, fever or chills, were not dose-limiting. Haematological toxicity was mild, except for sudden and long-lasting grade 3–4 lymphocytopenia, which occurred in all treatment cycles. Opportunistic infections were not observed. Conclusions: The maximum tolerated dose of a days-1 and -8 schedule of bendamustine, given as a 30-min i.v. infusion, is 160 mg/m2; mouth dryness and fatigue are dose-limiting. The recommended dose for future trials is 140 mg/m2. |
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| title_short |
Repeated administration of short infusions of bendamustine: a phase I study in patients with advanced progressive solid tumours |
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http://dx.doi.org/10.1007/PL00008463 |
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Schöffski, P. Hagedorn, T. Grünwald, V. Paul, H. Merkle, K. Kowalski, R. Ganser, A. |
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Schöffski, P. Hagedorn, T. Grünwald, V. Paul, H. Merkle, K. Kowalski, R. Ganser, A. |
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2024-07-06T03:18:43.966Z |
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