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Real world impact of treatment-induced peripheral neuropathy (TIPN) on patient reported outcomes (PROs) in patients with multiple myeloma (MM) in the United States.

Abstract

e19531
Background: Some MM treatments can cause TIPN, which is associated with pain, burning, tingling and can impact multiple aspects of patients’ lives. This study examined the PRO impact of TIPN in MM patients using real world data in the US. Methods: Adults with ≥1 disease progression of MM and ≥1 Patient Care Monitor (PCM) records from the Vector Oncology Data Warehouse were included. Index scores (General Physical Symptoms, Treatment Side Effects, Acute Distress, Despair, Impaired Ambulation, and Impaired Performance) and 4 individual items (numbness/tingling; burning sensation in hands or feet; physical pain; and weakness of body parts) (0 not a problem –10 as bad as possible) were compared before and after the 1st TIPN occurrence using fixed effect models accounting for nesting within subjects. Results: 304 patients were included (mean age: 63.5; 50.3% male; ≥1 comorbidity conditions: 50.0%; renal disease: 24.3%; diabetes: 21.1%; cerebrovascular accident: 9.2%; congestive heart failure: 7.2%), 39.1% of whom had ≥1 TIPN during follow up. After the 1st TIPN occurrence, 2 index scores (General Physical Symptoms and Impaired Performance) and all 4 individual items investigated worsened statistically significantly in unadjusted analysis. Increased problems in Impaired Performance, numbness/tingling, and burning in hands or feet were clinically relevant (Table). Conclusions: Following TIPN events, MM patients experienced significant and clinically meaningful worsening of symptoms and performance in daily activities. Novel MM agents with lower TIPN rates might provide better patient quality of life and persistence.
Unadjusted change in PCM results after 1st TIPN.
 MeanStandard Error
Index Score
General Physical Symptoms0.91Ɨ0.27
Treatment Side Effects-0.120.25
Acute Distress-0.570.37
Despair0.160.31
Impaired Ambulation-1.29Ɨ0.52
Impaired Performance1.69*Ɨ0.47
Individual Item
Numbness/tingling1.03*Ɨ0.10
Burning in hands or feet1.60*Ɨ0.10
Physical pain0.290.12
Weakness of body parts0.64Ɨ0.13
*A ≥1.5-3 change in index score or ≥1.0 change in items are considered clinically relevant. Ɨp<0.05

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Journal of Clinical Oncology
Pages: e19531

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Published online: May 20, 2015
Published in print: May 20, 2015

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Mark S. Walker
Vector Oncology, Memphis, TN
Ze Cong
Onyx Pharmaceuticals, Inc., South San Francisco, CA
Kevin B. Knopf
California Pacific Medical Center, San Francisco, CA
Sanjay Kumar Aggarwal
Onyx Pharmaceuticals, Inc., South San Francisco, CA
Jiandong Kerr
Vector Oncology, Memphis, TN
Arthur C. Houts
Vector Oncology, Memphis, TN
Vector Oncology, Memphis, TN; Onyx Pharmaceuticals, Inc., South San Francisco, CA; California Pacific Medical Center, San Francisco, CA

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Mark S. Walker, Ze Cong, Kevin B. Knopf, Sanjay Kumar Aggarwal, Jiandong Kerr, Arthur C. Houts
Journal of Clinical Oncology 2015 33:15_suppl, e19531-e19531

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