Extended follow-up of a Phase II trial in relapsed, refractory multiple myeloma: Final time-to-event results from the SUMMIT trial

Paul G. Richardson, Bart Barlogie, James Berenson, Seema Singhal, Sundar Jagannath, David H. Irwin, S Vincent Rajkumar, Gordan Srkalovic, Melissa Alsina, Kenneth C. Anderson

Research output: Contribution to journalArticle

131 Citations (Scopus)

Abstract

BACKGROUND. Bortezomib, a first-in-class proteasome inhibitor, has shown clinical activity in relapsed, refractory multiple myeloma in a pivotal Phase II trial, SUMMIT. METHODS. Patients received bortezomib 1.3 mg/m2 on Days 1, 4, 8, and 11 followed by a 10-day rest period for up to 8 cycles. Dexamethasone 20 mg on the day of and the day after bortezomib was permitted for suboptimal response. Extended treatment beyond 8 cycles was offered to patients whose physicians felt they would benefit from additional therapy. Follow-up was conducted in all patients for a median of 23 months, an additional 13 months from the original report. RESULTS. Of 202 patients enrolled in SUMMIT, 193 were evaluable for response. Seven (4%) patients achieved a complete response, 12 (6%) achieved a nearly complete response, 34 (18%) achieved a partial response, and 14 (7%) had a minimal response while on bortezomib. The updated median duration of response to bortezomib alone was 12.7 months. The median overall time to progression for all SUMMIT patients was 7 months. For responding patients, the median time to progression was 13.9 months, whereas for those with progressive disease (PD) or who were not evaluable, the median time to progression was 1.3 months. The median overall survival (OS) for all SUMMIT patients was 17.0 months. Whereas the median OS for patients with PD or who were not evaluable was 8 months, the median OS for responding patients was not reached at 23 months of follow-up. CONCLUSIONS. These data demonstrate that treatment with bortezomib results in meaningful long-term benefit for patients with relapsed and refractory myeloma.

Original languageEnglish (US)
Pages (from-to)1316-1319
Number of pages4
JournalCancer
Volume106
Issue number6
DOIs
StatePublished - Mar 15 2006

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Multiple Myeloma
Survival
Proteasome Inhibitors
Dexamethasone
Bortezomib
Therapeutics
Physicians

Keywords

  • Bortezomib
  • Dexamethasone
  • Multiple myeloma
  • Proteasome inhibitor

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Richardson, P. G., Barlogie, B., Berenson, J., Singhal, S., Jagannath, S., Irwin, D. H., ... Anderson, K. C. (2006). Extended follow-up of a Phase II trial in relapsed, refractory multiple myeloma: Final time-to-event results from the SUMMIT trial. Cancer, 106(6), 1316-1319. https://doi.org/10.1002/cncr.21740

Extended follow-up of a Phase II trial in relapsed, refractory multiple myeloma : Final time-to-event results from the SUMMIT trial. / Richardson, Paul G.; Barlogie, Bart; Berenson, James; Singhal, Seema; Jagannath, Sundar; Irwin, David H.; Rajkumar, S Vincent; Srkalovic, Gordan; Alsina, Melissa; Anderson, Kenneth C.

In: Cancer, Vol. 106, No. 6, 15.03.2006, p. 1316-1319.

Research output: Contribution to journalArticle

Richardson, PG, Barlogie, B, Berenson, J, Singhal, S, Jagannath, S, Irwin, DH, Rajkumar, SV, Srkalovic, G, Alsina, M & Anderson, KC 2006, 'Extended follow-up of a Phase II trial in relapsed, refractory multiple myeloma: Final time-to-event results from the SUMMIT trial', Cancer, vol. 106, no. 6, pp. 1316-1319. https://doi.org/10.1002/cncr.21740
Richardson, Paul G. ; Barlogie, Bart ; Berenson, James ; Singhal, Seema ; Jagannath, Sundar ; Irwin, David H. ; Rajkumar, S Vincent ; Srkalovic, Gordan ; Alsina, Melissa ; Anderson, Kenneth C. / Extended follow-up of a Phase II trial in relapsed, refractory multiple myeloma : Final time-to-event results from the SUMMIT trial. In: Cancer. 2006 ; Vol. 106, No. 6. pp. 1316-1319.
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abstract = "BACKGROUND. Bortezomib, a first-in-class proteasome inhibitor, has shown clinical activity in relapsed, refractory multiple myeloma in a pivotal Phase II trial, SUMMIT. METHODS. Patients received bortezomib 1.3 mg/m2 on Days 1, 4, 8, and 11 followed by a 10-day rest period for up to 8 cycles. Dexamethasone 20 mg on the day of and the day after bortezomib was permitted for suboptimal response. Extended treatment beyond 8 cycles was offered to patients whose physicians felt they would benefit from additional therapy. Follow-up was conducted in all patients for a median of 23 months, an additional 13 months from the original report. RESULTS. Of 202 patients enrolled in SUMMIT, 193 were evaluable for response. Seven (4{\%}) patients achieved a complete response, 12 (6{\%}) achieved a nearly complete response, 34 (18{\%}) achieved a partial response, and 14 (7{\%}) had a minimal response while on bortezomib. The updated median duration of response to bortezomib alone was 12.7 months. The median overall time to progression for all SUMMIT patients was 7 months. For responding patients, the median time to progression was 13.9 months, whereas for those with progressive disease (PD) or who were not evaluable, the median time to progression was 1.3 months. The median overall survival (OS) for all SUMMIT patients was 17.0 months. Whereas the median OS for patients with PD or who were not evaluable was 8 months, the median OS for responding patients was not reached at 23 months of follow-up. CONCLUSIONS. These data demonstrate that treatment with bortezomib results in meaningful long-term benefit for patients with relapsed and refractory myeloma.",
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T2 - Final time-to-event results from the SUMMIT trial

AU - Richardson, Paul G.

AU - Barlogie, Bart

AU - Berenson, James

AU - Singhal, Seema

AU - Jagannath, Sundar

AU - Irwin, David H.

AU - Rajkumar, S Vincent

AU - Srkalovic, Gordan

AU - Alsina, Melissa

AU - Anderson, Kenneth C.

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N2 - BACKGROUND. Bortezomib, a first-in-class proteasome inhibitor, has shown clinical activity in relapsed, refractory multiple myeloma in a pivotal Phase II trial, SUMMIT. METHODS. Patients received bortezomib 1.3 mg/m2 on Days 1, 4, 8, and 11 followed by a 10-day rest period for up to 8 cycles. Dexamethasone 20 mg on the day of and the day after bortezomib was permitted for suboptimal response. Extended treatment beyond 8 cycles was offered to patients whose physicians felt they would benefit from additional therapy. Follow-up was conducted in all patients for a median of 23 months, an additional 13 months from the original report. RESULTS. Of 202 patients enrolled in SUMMIT, 193 were evaluable for response. Seven (4%) patients achieved a complete response, 12 (6%) achieved a nearly complete response, 34 (18%) achieved a partial response, and 14 (7%) had a minimal response while on bortezomib. The updated median duration of response to bortezomib alone was 12.7 months. The median overall time to progression for all SUMMIT patients was 7 months. For responding patients, the median time to progression was 13.9 months, whereas for those with progressive disease (PD) or who were not evaluable, the median time to progression was 1.3 months. The median overall survival (OS) for all SUMMIT patients was 17.0 months. Whereas the median OS for patients with PD or who were not evaluable was 8 months, the median OS for responding patients was not reached at 23 months of follow-up. CONCLUSIONS. These data demonstrate that treatment with bortezomib results in meaningful long-term benefit for patients with relapsed and refractory myeloma.

AB - BACKGROUND. Bortezomib, a first-in-class proteasome inhibitor, has shown clinical activity in relapsed, refractory multiple myeloma in a pivotal Phase II trial, SUMMIT. METHODS. Patients received bortezomib 1.3 mg/m2 on Days 1, 4, 8, and 11 followed by a 10-day rest period for up to 8 cycles. Dexamethasone 20 mg on the day of and the day after bortezomib was permitted for suboptimal response. Extended treatment beyond 8 cycles was offered to patients whose physicians felt they would benefit from additional therapy. Follow-up was conducted in all patients for a median of 23 months, an additional 13 months from the original report. RESULTS. Of 202 patients enrolled in SUMMIT, 193 were evaluable for response. Seven (4%) patients achieved a complete response, 12 (6%) achieved a nearly complete response, 34 (18%) achieved a partial response, and 14 (7%) had a minimal response while on bortezomib. The updated median duration of response to bortezomib alone was 12.7 months. The median overall time to progression for all SUMMIT patients was 7 months. For responding patients, the median time to progression was 13.9 months, whereas for those with progressive disease (PD) or who were not evaluable, the median time to progression was 1.3 months. The median overall survival (OS) for all SUMMIT patients was 17.0 months. Whereas the median OS for patients with PD or who were not evaluable was 8 months, the median OS for responding patients was not reached at 23 months of follow-up. CONCLUSIONS. These data demonstrate that treatment with bortezomib results in meaningful long-term benefit for patients with relapsed and refractory myeloma.

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KW - Dexamethasone

KW - Multiple myeloma

KW - Proteasome inhibitor

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