Medical Oncology Unit, University Hospital of Parma, Via Gramsci 14, 43126, Parma, Italy.
Oncology Unit, Oncology Department, ASST Ospedale di Cremona, Cremona, Italy.
Drugs R D. 2017 Dec;17(4):585-596. doi: 10.1007/s40268-017-0209-5.
Standard treatment with sunitinib for patients with metastatic renal cancer provides an 'on-off' schedule (daily administration of a 50-mg capsule for 4 weeks, followed by a 2-week break; consecutive 6-week cycles). We developed an alternative intermittent schedule to reduce the toxicity and symptoms of tumor regrowth during the rest period and to allow prolonged continuation of therapy, maintaining dose intensity.
The objective of this study was to provide a retrospective evaluation of the feasibility, safety, and efficacy of an alternative schedule of sunitinib in patients who did not tolerate classical treatment.
Patients treated with the classical schedule with at least grade 2 toxicity or recurrence of symptoms during the rest period were switched to an alternative schedule (the same daily dose 5 consecutive days per week for 5 weeks and then the same daily dose on days 1, 3, and 5 in the sixth week; consecutive 6-week cycles).
Twenty-five patients were enrolled. The median time from sunitinib initiation to schedule switch was 2.9 months. After the switch, the median therapy duration was 9.2 months. Rate of delay, corrected by cycle number, was 10% for both schedules. After the switch, 48.7% of patients obtained a toxicity reduction (hypertension -82%, stomatitis -71%, cutaneous toxicity -69%). A reduction in 'on-off symptoms' (-86%) was achieved. Overall response rate was 40% and the disease control rate was 80%. Median progression-free survival was 16.4 months and median overall survival was 41.3 months.
Despite the small sample size and retrospective nature, we demonstrated the feasibility, safety, and efficacy of the alternative schedule, allowing prolonged treatment and better quality of life.
转移性肾细胞癌患者的标准治疗方案是使用舒尼替尼，该方案采用“间歇式”给药方案（每日服用 50mg 胶囊，连续服用 4 周，然后停药 2 周；连续 6 周为一个周期）。我们开发了一种替代的间歇性方案，旨在减少休息期间肿瘤复发生长的毒性和症状，并允许延长治疗时间，维持剂量强度。
本研究旨在回顾性评估替代舒尼替尼方案在不能耐受标准治疗的患者中的可行性、安全性和疗效。
至少出现 2 级毒性或在休息期间症状复发的患者，将其从标准方案转换为替代方案（连续 5 周，每周连续 5 天每天服用相同剂量，然后在第 6 周的第 1、3 和 5 天每天服用相同剂量；连续 6 周为一个周期）。
共纳入 25 例患者。从开始使用舒尼替尼到方案转换的中位时间为 2.9 个月。转换后，中位治疗时间为 9.2 个月。两种方案的周期校正延迟率均为 10%。转换后，48.7%的患者毒性减轻（高血压-82%，口腔炎-71%，皮肤毒性-69%），“开-关症状”减轻（-86%）。总缓解率为 40%，疾病控制率为 80%。中位无进展生存期为 16.4 个月，中位总生存期为 41.3 个月。
尽管样本量小且为回顾性研究，但我们证明了替代方案的可行性、安全性和疗效，可延长治疗时间，提高生活质量。
