Abstract
12090 Background: Clinical guidelines recommend altering chemotherapy treatment by decreasing, delaying, or discontinuing dosing in patients (pts) experiencing chemotherapy-induced peripheral neuropathy (CIPN). There are few data available on clinical use of treatment alteration including the severity of CIPN at the time of alteration. Our objective was to investigate the incidence of oxaliplatin treatment alterations and CIPN severity at that time. Methods: This was a retrospective analysis of pts with colon cancer scheduled to receive oxaliplatin-containing combination chemotherapy on the N08CB trial of intravenous calcium and magnesium for prevention of CIPN. Dose alterations were not mandated by the N08CB protocol. Clinicians assessed CIPN using NCI-CTCAE V.4.0; pts used the sensory subscale of the EORTC-QLQ Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN8). Pts were classified as 1) completed oxaliplatin treatment without alteration, 2) dose reduction or delay due to CIPN, 3) discontinuation due to CIPN, 4) discontinuation due to other AE, or 5) discontinuation for another reason. Comparisons focused primarily on pts with alteration due to CIPN (groups 2 and/or 3) compared with pts completing treatment without alteration (group 1) using chi-squared and Kruskal-Wallis tests. Results: In this analysis of 350 N08CB pts, 135 (39%) completed oxaliplatin without treatment alteration, 70 (20%) had a dose reduction (n=66) or delay (n=4) due to CIPN and 35 (10%) discontinued early due to CIPN. Pts who experienced alterations due to CIPN were younger (p=0.0249) and more likely to be female (p=0.008). Clinician-assessed CIPN severity was greater in pts at the time of dose reduction or delay compared with CIPN severity at the end of treatment in pts with no alteration (p<0.0001). Pt-assessed CIPN severity was not different in pts who completed treatment without alteration compared to pts who had a dose reduction or delay (p=0.88) or a discontinuation (p=0.37). CIPN8 scores at cycle 4 were higher (worse) in pts who eventually had any alteration (i.e., reduction, delay, or discontinuation) compared to pts who completed treatment without any alteration (median CIPN8 11.5 vs. 7.7, p=0.023). Conclusions: Treatment alterations due to CIPN are relatively common in pts receiving adjuvant oxaliplatin for colon cancer and are associated with clinician-assessed but not pt-reported CIPN severity. Rapid CIPN8 increases early in treatment are indicative of increased likelihood of a future oxaliplatin treatment alteration, indicating a potential use of early monitoring and intervention. Support: UG1CA189823; https://acknowledgments.alliancefound.org. Clinical trial information: NCT01099449 (NCCTG N08CB).
Highlights
One of the characteristic side effects of oxaliplatin, a standard component of adjuvant combination chemotherapy treatment of colorectal cancer1,2, is chemotherapy-induced peripheral neuropathy (CIPN).CIPN can present as sensory, motor, and/or painful symptoms in the hands and feet, which can lead to irreversible discomfort and dysfunction in some patients[3]
Treatment alterations due to neuropathy are common in patients receiving oxaliplatin for colon cancer and are associated with clinician-assessed neuropathy severity
Rapid increases in patient-reported neuropathy severity indicate a potential need for monitoring and intervention
Summary
One of the characteristic side effects of oxaliplatin, a standard component of adjuvant combination chemotherapy treatment of colorectal cancer1,2 , is chemotherapy-induced peripheral neuropathy (CIPN).CIPN can present as sensory, motor, and/or painful symptoms in the hands and feet, which can lead to irreversible discomfort and dysfunction in some patients[3]. 2 , is chemotherapy-induced peripheral neuropathy (CIPN). CIPN severity has historically been graded based on clinicianassessment using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). There is an ongoing effort to supplement clinician-assessment in clinical research and practice with patient-reported toxicity collected via questionnaires,[5, 6] which can help detect toxicity earlier; such should, hopefully, improve patient quality of life.[7] Patient-reported toxicities are helpful when assessing subjective toxicities, such as CIPN.[8] Multiple CIPN questionnaires have been developed, including the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 Clinical guidelines recommend altering chemotherapy treatment by decreasing, delaying, or discontinuing dosing in patients who are experiencing chemotherapy-induced peripheral neuropathy. There are few data available on the clinical use of treatment alteration including the severity of CIPN at the time of treatment alteration
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