Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib

Paul G. Richardson, Hannah Briemberg, Sundar Jagannath, Patrick Y. Wen, Bart Barlogie, James Berenson, Seema Singhal, David S. Siegel, David Irwin, Michael Schuster, Gordan Srkalovic, Raymond Alexanian, S Vincent Rajkumar, Steven Limentani, Melissa Alsina, Robert Z. Orlowski, Kevin Najarian, Dixie Esseltine, Kenneth C. Anderson, Anthony A. Amato

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Abstract

Purpose: To determine the frequency, characteristics, and reversibility of peripheral neuropathy from bortezomib treatment of advanced multiple myeloma. Patients and Methods: Peripheral neuropathy was assessed in two phase II studies in 256 patients with relapsed and/or refractory myeloma treated with bortezomib 1.0 or 1.3 mg/m2 intravenous bolus on days 1, 4, 8, and 11, every 21 days, for up to eight cycles. Peripheral neuropathy was evaluated at baseline, during the study, and after the study by patient-reported symptoms using the Functional Assessment of Cancer Therapy Scale/Gynecologic Oncology Group-Neurotoxicity (FACT/ GOG-Ntx) questionnaire and neurologic examination. During the study, peripheral neuropathy was also evaluated by investigator assessment. A subset of patients underwent nerve conduction studies (n = 13). Results: Before treatment, 194 (81%) of 239 patients had peripheral neuropathy by FACT/GOG-Ntx questionnaire, and 203 (83%) of 244 patients had peripheral neuropathy by neurologic examination. Treatment-emergent neuropathy was reported in 35% of patients, including 37% (84 of 228 patients) receiving bortezomib 1.3 mg/m2 and 21% (six of 28 patients) receiving bortezomib 1.0 mg/m2. Grade 1 or 2, 3, and 4 neuropathy occurred in 22%, 13%, and 0.4% of patients, respectively. The incidence of grade ≥ 3 neuropathy was higher among patients with baseline neuropathy by FACT/GOG-Ntx questionnaire compared with patients without baseline neuropathy (14% v 4%, respectively). In all 256 patients, neuropathy led to dose reduction in 12% and discontinuation in 5%. Of 35 patients with neuropathy a grade 3 and/or requiring discontinuation, resolution to baseline or improvement occurred in 71%. Conclusion: Bortezomib-associated peripheral neuropathy seemed reversible in the majority of patients after dose reduction or discontinuation. Although severe neuropathy was more frequent in the presence of baseline neuropathy, the overall occurrence was independent of baseline neuropathy or type of prior therapy.

Original languageEnglish (US)
Pages (from-to)3113-3120
Number of pages8
JournalJournal of Clinical Oncology
Volume24
Issue number19
DOIs
StatePublished - Jul 1 2006

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Peripheral Nervous System Diseases
Multiple Myeloma
Therapeutics
Neurologic Examination
Bortezomib
Neural Conduction
Peripheral Nervous System

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Richardson, P. G., Briemberg, H., Jagannath, S., Wen, P. Y., Barlogie, B., Berenson, J., ... Amato, A. A. (2006). Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. Journal of Clinical Oncology, 24(19), 3113-3120. https://doi.org/10.1200/JCO.2005.04.7779

Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. / Richardson, Paul G.; Briemberg, Hannah; Jagannath, Sundar; Wen, Patrick Y.; Barlogie, Bart; Berenson, James; Singhal, Seema; Siegel, David S.; Irwin, David; Schuster, Michael; Srkalovic, Gordan; Alexanian, Raymond; Rajkumar, S Vincent; Limentani, Steven; Alsina, Melissa; Orlowski, Robert Z.; Najarian, Kevin; Esseltine, Dixie; Anderson, Kenneth C.; Amato, Anthony A.

In: Journal of Clinical Oncology, Vol. 24, No. 19, 01.07.2006, p. 3113-3120.

Research output: Contribution to journalArticle

Richardson, PG, Briemberg, H, Jagannath, S, Wen, PY, Barlogie, B, Berenson, J, Singhal, S, Siegel, DS, Irwin, D, Schuster, M, Srkalovic, G, Alexanian, R, Rajkumar, SV, Limentani, S, Alsina, M, Orlowski, RZ, Najarian, K, Esseltine, D, Anderson, KC & Amato, AA 2006, 'Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib', Journal of Clinical Oncology, vol. 24, no. 19, pp. 3113-3120. https://doi.org/10.1200/JCO.2005.04.7779
Richardson, Paul G. ; Briemberg, Hannah ; Jagannath, Sundar ; Wen, Patrick Y. ; Barlogie, Bart ; Berenson, James ; Singhal, Seema ; Siegel, David S. ; Irwin, David ; Schuster, Michael ; Srkalovic, Gordan ; Alexanian, Raymond ; Rajkumar, S Vincent ; Limentani, Steven ; Alsina, Melissa ; Orlowski, Robert Z. ; Najarian, Kevin ; Esseltine, Dixie ; Anderson, Kenneth C. ; Amato, Anthony A. / Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 19. pp. 3113-3120.
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abstract = "Purpose: To determine the frequency, characteristics, and reversibility of peripheral neuropathy from bortezomib treatment of advanced multiple myeloma. Patients and Methods: Peripheral neuropathy was assessed in two phase II studies in 256 patients with relapsed and/or refractory myeloma treated with bortezomib 1.0 or 1.3 mg/m2 intravenous bolus on days 1, 4, 8, and 11, every 21 days, for up to eight cycles. Peripheral neuropathy was evaluated at baseline, during the study, and after the study by patient-reported symptoms using the Functional Assessment of Cancer Therapy Scale/Gynecologic Oncology Group-Neurotoxicity (FACT/ GOG-Ntx) questionnaire and neurologic examination. During the study, peripheral neuropathy was also evaluated by investigator assessment. A subset of patients underwent nerve conduction studies (n = 13). Results: Before treatment, 194 (81{\%}) of 239 patients had peripheral neuropathy by FACT/GOG-Ntx questionnaire, and 203 (83{\%}) of 244 patients had peripheral neuropathy by neurologic examination. Treatment-emergent neuropathy was reported in 35{\%} of patients, including 37{\%} (84 of 228 patients) receiving bortezomib 1.3 mg/m2 and 21{\%} (six of 28 patients) receiving bortezomib 1.0 mg/m2. Grade 1 or 2, 3, and 4 neuropathy occurred in 22{\%}, 13{\%}, and 0.4{\%} of patients, respectively. The incidence of grade ≥ 3 neuropathy was higher among patients with baseline neuropathy by FACT/GOG-Ntx questionnaire compared with patients without baseline neuropathy (14{\%} v 4{\%}, respectively). In all 256 patients, neuropathy led to dose reduction in 12{\%} and discontinuation in 5{\%}. Of 35 patients with neuropathy a grade 3 and/or requiring discontinuation, resolution to baseline or improvement occurred in 71{\%}. Conclusion: Bortezomib-associated peripheral neuropathy seemed reversible in the majority of patients after dose reduction or discontinuation. Although severe neuropathy was more frequent in the presence of baseline neuropathy, the overall occurrence was independent of baseline neuropathy or type of prior therapy.",
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T1 - Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib

AU - Richardson, Paul G.

AU - Briemberg, Hannah

AU - Jagannath, Sundar

AU - Wen, Patrick Y.

AU - Barlogie, Bart

AU - Berenson, James

AU - Singhal, Seema

AU - Siegel, David S.

AU - Irwin, David

AU - Schuster, Michael

AU - Srkalovic, Gordan

AU - Alexanian, Raymond

AU - Rajkumar, S Vincent

AU - Limentani, Steven

AU - Alsina, Melissa

AU - Orlowski, Robert Z.

AU - Najarian, Kevin

AU - Esseltine, Dixie

AU - Anderson, Kenneth C.

AU - Amato, Anthony A.

PY - 2006/7/1

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N2 - Purpose: To determine the frequency, characteristics, and reversibility of peripheral neuropathy from bortezomib treatment of advanced multiple myeloma. Patients and Methods: Peripheral neuropathy was assessed in two phase II studies in 256 patients with relapsed and/or refractory myeloma treated with bortezomib 1.0 or 1.3 mg/m2 intravenous bolus on days 1, 4, 8, and 11, every 21 days, for up to eight cycles. Peripheral neuropathy was evaluated at baseline, during the study, and after the study by patient-reported symptoms using the Functional Assessment of Cancer Therapy Scale/Gynecologic Oncology Group-Neurotoxicity (FACT/ GOG-Ntx) questionnaire and neurologic examination. During the study, peripheral neuropathy was also evaluated by investigator assessment. A subset of patients underwent nerve conduction studies (n = 13). Results: Before treatment, 194 (81%) of 239 patients had peripheral neuropathy by FACT/GOG-Ntx questionnaire, and 203 (83%) of 244 patients had peripheral neuropathy by neurologic examination. Treatment-emergent neuropathy was reported in 35% of patients, including 37% (84 of 228 patients) receiving bortezomib 1.3 mg/m2 and 21% (six of 28 patients) receiving bortezomib 1.0 mg/m2. Grade 1 or 2, 3, and 4 neuropathy occurred in 22%, 13%, and 0.4% of patients, respectively. The incidence of grade ≥ 3 neuropathy was higher among patients with baseline neuropathy by FACT/GOG-Ntx questionnaire compared with patients without baseline neuropathy (14% v 4%, respectively). In all 256 patients, neuropathy led to dose reduction in 12% and discontinuation in 5%. Of 35 patients with neuropathy a grade 3 and/or requiring discontinuation, resolution to baseline or improvement occurred in 71%. Conclusion: Bortezomib-associated peripheral neuropathy seemed reversible in the majority of patients after dose reduction or discontinuation. Although severe neuropathy was more frequent in the presence of baseline neuropathy, the overall occurrence was independent of baseline neuropathy or type of prior therapy.

AB - Purpose: To determine the frequency, characteristics, and reversibility of peripheral neuropathy from bortezomib treatment of advanced multiple myeloma. Patients and Methods: Peripheral neuropathy was assessed in two phase II studies in 256 patients with relapsed and/or refractory myeloma treated with bortezomib 1.0 or 1.3 mg/m2 intravenous bolus on days 1, 4, 8, and 11, every 21 days, for up to eight cycles. Peripheral neuropathy was evaluated at baseline, during the study, and after the study by patient-reported symptoms using the Functional Assessment of Cancer Therapy Scale/Gynecologic Oncology Group-Neurotoxicity (FACT/ GOG-Ntx) questionnaire and neurologic examination. During the study, peripheral neuropathy was also evaluated by investigator assessment. A subset of patients underwent nerve conduction studies (n = 13). Results: Before treatment, 194 (81%) of 239 patients had peripheral neuropathy by FACT/GOG-Ntx questionnaire, and 203 (83%) of 244 patients had peripheral neuropathy by neurologic examination. Treatment-emergent neuropathy was reported in 35% of patients, including 37% (84 of 228 patients) receiving bortezomib 1.3 mg/m2 and 21% (six of 28 patients) receiving bortezomib 1.0 mg/m2. Grade 1 or 2, 3, and 4 neuropathy occurred in 22%, 13%, and 0.4% of patients, respectively. The incidence of grade ≥ 3 neuropathy was higher among patients with baseline neuropathy by FACT/GOG-Ntx questionnaire compared with patients without baseline neuropathy (14% v 4%, respectively). In all 256 patients, neuropathy led to dose reduction in 12% and discontinuation in 5%. Of 35 patients with neuropathy a grade 3 and/or requiring discontinuation, resolution to baseline or improvement occurred in 71%. Conclusion: Bortezomib-associated peripheral neuropathy seemed reversible in the majority of patients after dose reduction or discontinuation. Although severe neuropathy was more frequent in the presence of baseline neuropathy, the overall occurrence was independent of baseline neuropathy or type of prior therapy.

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