Bortezomib-Dexamethasone, Rituximab, and Cyclophosphamide as First-Line Treatment for Waldenström's Macroglobulinemia : A Prospectively Randomized Trial of the European Consortium for Waldenström's Macroglobulinemia
PURPOSE: Rituximab/chemotherapy is a cornerstone of treatment for Waldenström's macroglobulinemia (WM). In addition, bortezomib has shown significant activity in WM. This study evaluated the efficacy and safety of dexamethasone, rituximab, and cyclophosphamide (DRC) as first-line treatment in WM.
METHODS: In this European study, treatment-naïve patients were randomly assigned to DRC or bortezomib-DRC B-DRC for six cycles. The primary end point was progression-free survival. Secondary end points included response rates, overall survival, and safety.
RESULTS: Two hundred four patients were registered. After a median follow-up of 27.5 months, the estimated 24-month progression-free survival was 80.6% (95% CI, 69.5 to 88.0) for B-DRC and 72.8% (95% CI, 61.3 to 81.3) for DRC (P = .32). At the end of treatment, B-DRC and DRC induced major responses in 80.6% versus 69.9% and a complete response/very good partial response in 17.2% versus 9.6% of patients, respectively. The median time to first response was shorter for B-DRC with 3.0 (95% CI, 2.8 to 3.2) versus 5.5 (95% CI, 2.9 to 5.8) months for DRC. This resulted in higher major response rates (57.0% v 32.5%; P < .01) after three cycles of B-DRC compared with DRC. At best response, the complete response/very good partial response increased to 32.6% for B-DRC. Both treatments were well tolerated: grade ≥ 3 adverse events occurred in 49.2% of all patients (B-DRC, 49.5%; DRC, 49.0%). Peripheral sensory neuropathy grade 3 occurred in two patients treated with B-DRC and in none with DRC.
CONCLUSION: This large randomized study illustrates that B-DRC is highly effective and well tolerated in WM. The data demonstrate that fixed duration immunochemotherapy remains an important pillar in the clinical management of WM.
| Errataetall: |
CommentIn: J Clin Oncol. 2023 Aug 20;41(24):4059-4060. - PMID 37348023 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 41(2023), 14 vom: 10. Mai, Seite 2607-2616 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Buske, Christian [VerfasserIn] |
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| Links: |
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| Themen: |
4F4X42SYQ6 |
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| Anmerkungen: |
Date Completed 08.05.2023 Date Revised 21.08.2023 published: Print-Electronic ClinicalTrials.gov: NCT01788020 CommentIn: J Clin Oncol. 2023 Aug 20;41(24):4059-4060. - PMID 37348023 Citation Status MEDLINE |
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| doi: |
10.1200/JCO.22.01805 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM352737069 |
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| 100 | 1 | |a Buske, Christian |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Bortezomib-Dexamethasone, Rituximab, and Cyclophosphamide as First-Line Treatment for Waldenström's Macroglobulinemia |b A Prospectively Randomized Trial of the European Consortium for Waldenström's Macroglobulinemia |
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| 500 | |a Date Completed 08.05.2023 | ||
| 500 | |a Date Revised 21.08.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01788020 | ||
| 500 | |a CommentIn: J Clin Oncol. 2023 Aug 20;41(24):4059-4060. - PMID 37348023 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: Rituximab/chemotherapy is a cornerstone of treatment for Waldenström's macroglobulinemia (WM). In addition, bortezomib has shown significant activity in WM. This study evaluated the efficacy and safety of dexamethasone, rituximab, and cyclophosphamide (DRC) as first-line treatment in WM | ||
| 520 | |a METHODS: In this European study, treatment-naïve patients were randomly assigned to DRC or bortezomib-DRC B-DRC for six cycles. The primary end point was progression-free survival. Secondary end points included response rates, overall survival, and safety | ||
| 520 | |a RESULTS: Two hundred four patients were registered. After a median follow-up of 27.5 months, the estimated 24-month progression-free survival was 80.6% (95% CI, 69.5 to 88.0) for B-DRC and 72.8% (95% CI, 61.3 to 81.3) for DRC (P = .32). At the end of treatment, B-DRC and DRC induced major responses in 80.6% versus 69.9% and a complete response/very good partial response in 17.2% versus 9.6% of patients, respectively. The median time to first response was shorter for B-DRC with 3.0 (95% CI, 2.8 to 3.2) versus 5.5 (95% CI, 2.9 to 5.8) months for DRC. This resulted in higher major response rates (57.0% v 32.5%; P < .01) after three cycles of B-DRC compared with DRC. At best response, the complete response/very good partial response increased to 32.6% for B-DRC. Both treatments were well tolerated: grade ≥ 3 adverse events occurred in 49.2% of all patients (B-DRC, 49.5%; DRC, 49.0%). Peripheral sensory neuropathy grade 3 occurred in two patients treated with B-DRC and in none with DRC | ||
| 520 | |a CONCLUSION: This large randomized study illustrates that B-DRC is highly effective and well tolerated in WM. The data demonstrate that fixed duration immunochemotherapy remains an important pillar in the clinical management of WM | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
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| 650 | 7 | |a Dexamethasone |2 NLM | |
| 650 | 7 | |a 7S5I7G3JQL |2 NLM | |
| 700 | 1 | |a Dimopoulos, Meletios A |e verfasserin |4 aut | |
| 700 | 1 | |a Grunenberg, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Kastritis, Efstathios |e verfasserin |4 aut | |
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| 700 | 1 | |a Hajek, Roman |e verfasserin |4 aut | |
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| 700 | 1 | |a Tournilhac, Olivier |e verfasserin |4 aut | |
| 700 | 1 | |a Aurran, Therese |e verfasserin |4 aut | |
| 700 | 1 | |a Lepretre, Stephane |e verfasserin |4 aut | |
| 700 | 1 | |a Zerazhi, Hacene |e verfasserin |4 aut | |
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| 700 | 1 | |a de Guibert, Sophie |e verfasserin |4 aut | |
| 700 | 1 | |a Brandefors, Lena |e verfasserin |4 aut | |
| 700 | 1 | |a Garcia-Sanz, Ramon |e verfasserin |4 aut | |
| 700 | 1 | |a Gomes da Silva, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Kimby, Eva |e verfasserin |4 aut | |
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| 700 | 1 | |a Morel, Pierre |e verfasserin |4 aut | |
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