METHODS: This was a retrospective analysis of patients receiving oxaliplatin on the NCCTG N08CB trial. Neuropathy severity was assessed at each cycle by clinicians and patients. Patients were classified as (1) completed treatment without alteration, (2) dose reduction or delay due to neuropathy, (3) discontinuation due to neuropathy, (4) discontinuation for other toxicity, or (5) discontinuation for another reason (5). Comparisons focused primarily on patients with alteration due to neuropathy (groups 2 and/or 3) compared with patients who completed treatment without alteration (group 1).
RESULTS: In 350 participants, 135 (39%) completed treatment without alteration, 70 (20%) had a dose reduction or delay due to neuropathy, and 35 (10%) discontinued early due to neuropathy. Clinician-assessed neuropathy severity was greater in patients at the time of dose reduction or delay compared with severity at the end of treatment in patients without alteration (p < 0.0001). Patient-reported neuropathy severity at cycle 4 was worse in patients who eventually had a reduction or delay as compared with patients who completed treatment without alteration (p = 0.017).
CONCLUSIONS: 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.
BACKGROUND: Clinicaltrials.gov Identifier: NCT01099449 (NCCTG N08CB).
方法:这是NCCTGN08CB试验中接受奥沙利铂的患者的回顾性分析。临床医生和患者在每个周期评估神经病变的严重程度。患者被分类为(1)完成治疗而没有改变,(2)由于神经病变而导致的剂量减少或延迟,(3)因神经病而停药,(4)因其他毒性而停止,或(5)因其他原因而终止(5)。比较主要集中在由于神经病变(第2和/或第3组)的患者与完成治疗而没有改变的患者(第1组)的比较。
结果:在350名参与者中,135(39%)完成治疗而没有改变,70(20%)由于神经病变而剂量减少或延迟,35(10%)由于神经病而早期停药。临床医师评估的神经病变严重程度在剂量减少或延迟时的患者比在治疗结束时没有改变的患者的严重程度更大(p<0.0001)。与完成治疗而没有改变的患者相比,最终减少或延迟的患者在第4周期的患者报告的神经病变严重程度更差(p=0.017)。
结论:在接受奥沙利铂治疗结肠癌的患者中,由于神经病变引起的治疗改变是常见的,并且与临床医生评估的神经病变严重程度相关。患者报告的神经病变严重程度的快速增加表明可能需要监测和干预。
背景:Clinicaltrials.gov标识符:NCT01099449(NCCTGN08CB)。