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

被引:478
作者
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.
机构
[1] Dana Farber Canc Inst, Boston, MA 02115 USA
[2] Brigham & Womens Hosp, Boston, MA 02115 USA
[3] Millennium Pharmaceut Inc, Cambridge, MA USA
[4] St Vincents Canc Ctr, New York, NY USA
[5] York Presbyterian Hosp, New York, NY USA
[6] Univ Arkansas, Little Rock, AR 72204 USA
[7] Inst Myeloma & Bone Canc Res, W Hollywood, CA USA
[8] Alta Bates Canc Ctr, Berkeley, CA USA
[9] Robert H Lurie Canc Ctr, Chicago, IL USA
[10] Hackensack Univ, Med Ctr, Hackensack, NJ USA
[11] New Sparrow Reg Canc Ctr, Lansing, MI USA
[12] Univ Texas, MD Anderson Canc Ctr, Houston, TX 77030 USA
[13] Mayo Clin & Mayo Fdn, Rochester, MN 55905 USA
[14] Carolinas Hematol Oncol Assoc, Charlotte, NC USA
[15] H Lee Moffit Canc Ctr & Res Inst, Tampa, FL USA
[16] Univ N Carolina, Chapel Hill, NC USA
关键词
D O I
10.1200/JCO.2005.04.7779
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 11 studies in 256 patients with relapsed and/or refractory myeloma treated with bortezomib 1.0 or 1.3 mg/m(2) 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/m(2) and 21% (six of 28 patients) receiving bortezomib 1.0 mg/m(2). Grade 1 or 2, 3, and 4 neuropathy occurred in 22%, 13%, and 0.4% of patients, respectively. The incidence of grade 2 >= 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 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.
引用
收藏
页码:3113 / 3120
页数:8
相关论文
共 20 条
  • [1] Aghajanian C, 2002, CLIN CANCER RES, V8, P2505
  • [2] Efficacy and safety of recombinant human nerve growth factor in patients with diabetic polyneuropathy - A randomized controled trial
    Apfel, SC
    Schwartz, S
    Adornato, BT
    Freeman, R
    Biton, V
    Rendell, M
    Vinik, A
    Giuliani, M
    Stevens, JC
    Barbano, R
    Dyck, PJ
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2000, 284 (17): : 2215 - 2221
  • [3] Safety of prolonged therapy with bortezomib in relapsed or refractory multiple myeloma
    Berenson, JR
    Jagannath, S
    Barlogie, B
    Siegel, DT
    Alexanian, R
    Richardson, PG
    Irwin, D
    Alsina, M
    Rajkumar, SV
    Srkalovic, G
    Singhal, S
    Limentani, S
    Niesvizky, R
    Esseltine, DL
    Trehu, E
    Schenkein, DP
    Anderson, K
    [J]. CANCER, 2005, 104 (10) : 2141 - 2148
  • [4] Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy
    Calhoun, EA
    Welshman, EE
    Chang, CH
    Lurain, JR
    Fishman, DA
    Hunt, TL
    Cella, D
    [J]. INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 2003, 13 (06) : 741 - 748
  • [5] Dumitru D, 2002, Electrodiagnostic medicine, P159
  • [6] Longitudinal assessment of diabetic polyneuropathy using a composite score in the Rochester diabetic neuropathy study cohort
    Dyck, PJ
    Davies, JL
    Litchy, WJ
    OBrien, PC
    [J]. NEUROLOGY, 1997, 49 (01) : 229 - 239
  • [7] How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30
    Fromme, EK
    Eilers, KM
    Mori, M
    Hsieh, YC
    Beer, TM
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (17) : 3485 - 3490
  • [8] Bortezomib therapy alone and in combination with dexamethasone for previously untreated symptomatic multiple myeloma
    Jagannath, S
    Durie, BGM
    Wolf, J
    Camacho, E
    Irwin, D
    Lutzky, J
    McKinley, M
    Gabayan, E
    Mazumder, A
    Schenkein, D
    Crowley, J
    [J]. BRITISH JOURNAL OF HAEMATOLOGY, 2005, 129 (06) : 776 - 783
  • [9] A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma
    Jagannath, S
    Barlogie, B
    Berenson, J
    Siegel, D
    Irwin, D
    Richardson, PG
    Niesvizky, R
    Alexanian, R
    Limentani, SA
    Alsina, M
    Adams, J
    Kauffman, M
    Esseltine, DL
    Schenkein, DP
    Anderson, KC
    [J]. BRITISH JOURNAL OF HAEMATOLOGY, 2004, 127 (02) : 165 - 172
  • [10] Risk factors and kinetics of thrombocytopenia associated with bortezomib for relapsed, refractory multiple myeloma
    Lonial, S
    Waller, EK
    Richardson, PG
    Jagannath, S
    Orlowski, RZ
    Giver, CR
    Jaye, DL
    Francis, D
    Giusti, S
    Torre, C
    Barlogie, B
    Berenson, JR
    Singhal, S
    Schenkein, DP
    Esseltine, DLW
    Anderson, J
    Xiao, H
    Heffner, LT
    Anderson, KC
    [J]. BLOOD, 2005, 106 (12) : 3777 - 3784