COMPARISON OF FOUR NEUROPATHY ASSESSMENT SCALES IN EVALUATION OF TREATMENT EMERGENT NEUROPATHY IN NEWLY DIAGNOSED PATIENTS OF MULTIPLE MYELOMA TREATED WITH BORTEZOMIB BASED REGIMEN
(Abstract release date: 05/19/16)
EHA Library. Lakshman A. 06/09/16; 132838; E1289
Dr. Arjun Lakshman
Contributions
Contributions
Abstract
Abstract: E1289
Type: Eposter Presentation
Background
Treatment emergent peripheral neuropathy (TEPN) is a distressing and potentially dose limiting side-effect of bortezomib containing regimen for multiple myeloma (MM). The reporting of extent and severity of TEPN is variable due to use of different neuropathy scales. Presently, most investigators use National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) for reporting of TEPN.
Aims
We aimed to compare the utility of different neuropathy scoring scales for detection of TEPN and to evaluate the incidence, severity and electrophysiological characteristics of TEPN after bortezomib based regimen in newly diagnosed patients of MM.
Methods
We prospectively evaluated the incidence of TEPN in treatment naïve patients of MM receiving cyclophosphamide, bortezomib and dexamethasone (CyBorD) on days 1, 8, 15 and 22 of each 28-day cycle, by clinical evaluation, nerve conduction study (NCS) and four different neuropathy scores- NCI CTC v4.0, Total neuropathy score reduced (TNSr) and clinical (TNSc) and Numerical Response Scale (NRS) for neuropathic pain. TNSr includes results of nerve conduction study in addition to the clinical parameters used in TNSc. Post-treatment increment by one grade for NCI-CTC, by score of ≥2 for TNSr and TNSc, and by score of ≥1 for NRS defined TEPN. Informed consent was obtained from each patient and the study was approved by institutional review board.
Results
A total of twenty six patients received CyBorD regimen. Twenty patients completed follow-up. After a median of 7 (range: 3.5-11) months, the rates of occurrence of TEPN differed when the four scales were used; viz. NCI CTC=45% (n=9), TNSr=55% (n=11), TNSc=40% (n=8) and NRS=40% (n=8). All four scales showed worsening following treatment with CyBorD, especially with regard to sensory symptoms (p<0.01 for all scales). TNSr could pick up higher number of cases with TEPN in comparison to any other score, most notably in comparison to NCI CTCAE. Among 12 patients who did not have TEPN by NCI CTC scale, 41.7% (n=5), 16.7% (n=2) and 8.3% (n=1) patients satisfied the criteria for TEPN by TNSr, TNSc and, NRS, respectively. When compared against TNSr, sensitivity for detecting TEPN by NCI CTCAE, TNSc and NRS were 77.8%, 88.9%, and 77.8%, respectively. NCI CTCAE and TNSc, both showed specificity of 63.3% for detection of TEPN. Specificity with NRS was found to be 54.5%. The higher detection rate of neuropathy by TNSr is probably due to wider range of scores given for graded sensorymotor impairment and incorporation of electrophysiological parameters which increases its sensitivity. On NCS, three patients (42.9%) had sensorimotor and four (57.1%) patients had motor nerve conduction abnormalities. Five patients (71.4%) had axonal neuropathy while 2 (28.6%) patients had evidence of demyelination on NCS.
Conclusion
We suggest that, NCI-CTCAE may be suboptimal in comparison to TNSr in assessment of TEPN in patients with MM on bortezomib based therapy. It is desirable to use better scoring systems like TNSr as they may be more sensitive and they improve our understanding of bortezomib induced neuropathy. NRS is a simple screening tool that can be used in routine clinical practice for detecting bortezomib induced neuropathy. Further studies with large sample size including intraepidermal nerve fiber density testing on skin biopsy are required to better define TEPN in patients receiving bortezomib.
Session topic: E-poster
Keyword(s): Bortezomib, Multiple myeloma
Type: Eposter Presentation
Background
Treatment emergent peripheral neuropathy (TEPN) is a distressing and potentially dose limiting side-effect of bortezomib containing regimen for multiple myeloma (MM). The reporting of extent and severity of TEPN is variable due to use of different neuropathy scales. Presently, most investigators use National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) for reporting of TEPN.
Aims
We aimed to compare the utility of different neuropathy scoring scales for detection of TEPN and to evaluate the incidence, severity and electrophysiological characteristics of TEPN after bortezomib based regimen in newly diagnosed patients of MM.
Methods
We prospectively evaluated the incidence of TEPN in treatment naïve patients of MM receiving cyclophosphamide, bortezomib and dexamethasone (CyBorD) on days 1, 8, 15 and 22 of each 28-day cycle, by clinical evaluation, nerve conduction study (NCS) and four different neuropathy scores- NCI CTC v4.0, Total neuropathy score reduced (TNSr) and clinical (TNSc) and Numerical Response Scale (NRS) for neuropathic pain. TNSr includes results of nerve conduction study in addition to the clinical parameters used in TNSc. Post-treatment increment by one grade for NCI-CTC, by score of ≥2 for TNSr and TNSc, and by score of ≥1 for NRS defined TEPN. Informed consent was obtained from each patient and the study was approved by institutional review board.
Results
A total of twenty six patients received CyBorD regimen. Twenty patients completed follow-up. After a median of 7 (range: 3.5-11) months, the rates of occurrence of TEPN differed when the four scales were used; viz. NCI CTC=45% (n=9), TNSr=55% (n=11), TNSc=40% (n=8) and NRS=40% (n=8). All four scales showed worsening following treatment with CyBorD, especially with regard to sensory symptoms (p<0.01 for all scales). TNSr could pick up higher number of cases with TEPN in comparison to any other score, most notably in comparison to NCI CTCAE. Among 12 patients who did not have TEPN by NCI CTC scale, 41.7% (n=5), 16.7% (n=2) and 8.3% (n=1) patients satisfied the criteria for TEPN by TNSr, TNSc and, NRS, respectively. When compared against TNSr, sensitivity for detecting TEPN by NCI CTCAE, TNSc and NRS were 77.8%, 88.9%, and 77.8%, respectively. NCI CTCAE and TNSc, both showed specificity of 63.3% for detection of TEPN. Specificity with NRS was found to be 54.5%. The higher detection rate of neuropathy by TNSr is probably due to wider range of scores given for graded sensorymotor impairment and incorporation of electrophysiological parameters which increases its sensitivity. On NCS, three patients (42.9%) had sensorimotor and four (57.1%) patients had motor nerve conduction abnormalities. Five patients (71.4%) had axonal neuropathy while 2 (28.6%) patients had evidence of demyelination on NCS.
Conclusion
We suggest that, NCI-CTCAE may be suboptimal in comparison to TNSr in assessment of TEPN in patients with MM on bortezomib based therapy. It is desirable to use better scoring systems like TNSr as they may be more sensitive and they improve our understanding of bortezomib induced neuropathy. NRS is a simple screening tool that can be used in routine clinical practice for detecting bortezomib induced neuropathy. Further studies with large sample size including intraepidermal nerve fiber density testing on skin biopsy are required to better define TEPN in patients receiving bortezomib.
Session topic: E-poster
Keyword(s): Bortezomib, Multiple myeloma
Abstract: E1289
Type: Eposter Presentation
Background
Treatment emergent peripheral neuropathy (TEPN) is a distressing and potentially dose limiting side-effect of bortezomib containing regimen for multiple myeloma (MM). The reporting of extent and severity of TEPN is variable due to use of different neuropathy scales. Presently, most investigators use National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) for reporting of TEPN.
Aims
We aimed to compare the utility of different neuropathy scoring scales for detection of TEPN and to evaluate the incidence, severity and electrophysiological characteristics of TEPN after bortezomib based regimen in newly diagnosed patients of MM.
Methods
We prospectively evaluated the incidence of TEPN in treatment naïve patients of MM receiving cyclophosphamide, bortezomib and dexamethasone (CyBorD) on days 1, 8, 15 and 22 of each 28-day cycle, by clinical evaluation, nerve conduction study (NCS) and four different neuropathy scores- NCI CTC v4.0, Total neuropathy score reduced (TNSr) and clinical (TNSc) and Numerical Response Scale (NRS) for neuropathic pain. TNSr includes results of nerve conduction study in addition to the clinical parameters used in TNSc. Post-treatment increment by one grade for NCI-CTC, by score of ≥2 for TNSr and TNSc, and by score of ≥1 for NRS defined TEPN. Informed consent was obtained from each patient and the study was approved by institutional review board.
Results
A total of twenty six patients received CyBorD regimen. Twenty patients completed follow-up. After a median of 7 (range: 3.5-11) months, the rates of occurrence of TEPN differed when the four scales were used; viz. NCI CTC=45% (n=9), TNSr=55% (n=11), TNSc=40% (n=8) and NRS=40% (n=8). All four scales showed worsening following treatment with CyBorD, especially with regard to sensory symptoms (p<0.01 for all scales). TNSr could pick up higher number of cases with TEPN in comparison to any other score, most notably in comparison to NCI CTCAE. Among 12 patients who did not have TEPN by NCI CTC scale, 41.7% (n=5), 16.7% (n=2) and 8.3% (n=1) patients satisfied the criteria for TEPN by TNSr, TNSc and, NRS, respectively. When compared against TNSr, sensitivity for detecting TEPN by NCI CTCAE, TNSc and NRS were 77.8%, 88.9%, and 77.8%, respectively. NCI CTCAE and TNSc, both showed specificity of 63.3% for detection of TEPN. Specificity with NRS was found to be 54.5%. The higher detection rate of neuropathy by TNSr is probably due to wider range of scores given for graded sensorymotor impairment and incorporation of electrophysiological parameters which increases its sensitivity. On NCS, three patients (42.9%) had sensorimotor and four (57.1%) patients had motor nerve conduction abnormalities. Five patients (71.4%) had axonal neuropathy while 2 (28.6%) patients had evidence of demyelination on NCS.
Conclusion
We suggest that, NCI-CTCAE may be suboptimal in comparison to TNSr in assessment of TEPN in patients with MM on bortezomib based therapy. It is desirable to use better scoring systems like TNSr as they may be more sensitive and they improve our understanding of bortezomib induced neuropathy. NRS is a simple screening tool that can be used in routine clinical practice for detecting bortezomib induced neuropathy. Further studies with large sample size including intraepidermal nerve fiber density testing on skin biopsy are required to better define TEPN in patients receiving bortezomib.
Session topic: E-poster
Keyword(s): Bortezomib, Multiple myeloma
Type: Eposter Presentation
Background
Treatment emergent peripheral neuropathy (TEPN) is a distressing and potentially dose limiting side-effect of bortezomib containing regimen for multiple myeloma (MM). The reporting of extent and severity of TEPN is variable due to use of different neuropathy scales. Presently, most investigators use National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) for reporting of TEPN.
Aims
We aimed to compare the utility of different neuropathy scoring scales for detection of TEPN and to evaluate the incidence, severity and electrophysiological characteristics of TEPN after bortezomib based regimen in newly diagnosed patients of MM.
Methods
We prospectively evaluated the incidence of TEPN in treatment naïve patients of MM receiving cyclophosphamide, bortezomib and dexamethasone (CyBorD) on days 1, 8, 15 and 22 of each 28-day cycle, by clinical evaluation, nerve conduction study (NCS) and four different neuropathy scores- NCI CTC v4.0, Total neuropathy score reduced (TNSr) and clinical (TNSc) and Numerical Response Scale (NRS) for neuropathic pain. TNSr includes results of nerve conduction study in addition to the clinical parameters used in TNSc. Post-treatment increment by one grade for NCI-CTC, by score of ≥2 for TNSr and TNSc, and by score of ≥1 for NRS defined TEPN. Informed consent was obtained from each patient and the study was approved by institutional review board.
Results
A total of twenty six patients received CyBorD regimen. Twenty patients completed follow-up. After a median of 7 (range: 3.5-11) months, the rates of occurrence of TEPN differed when the four scales were used; viz. NCI CTC=45% (n=9), TNSr=55% (n=11), TNSc=40% (n=8) and NRS=40% (n=8). All four scales showed worsening following treatment with CyBorD, especially with regard to sensory symptoms (p<0.01 for all scales). TNSr could pick up higher number of cases with TEPN in comparison to any other score, most notably in comparison to NCI CTCAE. Among 12 patients who did not have TEPN by NCI CTC scale, 41.7% (n=5), 16.7% (n=2) and 8.3% (n=1) patients satisfied the criteria for TEPN by TNSr, TNSc and, NRS, respectively. When compared against TNSr, sensitivity for detecting TEPN by NCI CTCAE, TNSc and NRS were 77.8%, 88.9%, and 77.8%, respectively. NCI CTCAE and TNSc, both showed specificity of 63.3% for detection of TEPN. Specificity with NRS was found to be 54.5%. The higher detection rate of neuropathy by TNSr is probably due to wider range of scores given for graded sensorymotor impairment and incorporation of electrophysiological parameters which increases its sensitivity. On NCS, three patients (42.9%) had sensorimotor and four (57.1%) patients had motor nerve conduction abnormalities. Five patients (71.4%) had axonal neuropathy while 2 (28.6%) patients had evidence of demyelination on NCS.
Conclusion
We suggest that, NCI-CTCAE may be suboptimal in comparison to TNSr in assessment of TEPN in patients with MM on bortezomib based therapy. It is desirable to use better scoring systems like TNSr as they may be more sensitive and they improve our understanding of bortezomib induced neuropathy. NRS is a simple screening tool that can be used in routine clinical practice for detecting bortezomib induced neuropathy. Further studies with large sample size including intraepidermal nerve fiber density testing on skin biopsy are required to better define TEPN in patients receiving bortezomib.
Session topic: E-poster
Keyword(s): Bortezomib, Multiple myeloma
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