Vrdoljak J, Boban T, Petrić Miše B, Boraska Jelavić T, Bajić Ž, Tomić S, Vrdoljak E
University of Split, Medical School, Šoltanska 2, 21000 Split, Croatia.
Department of Oncology, Clinical Hospital Center Split, Spinčićeva 1, 21000 Split, Croatia.
Jpn J Clin Oncol. 2019 Apr 1;49(4):347-353. doi: 10.1093/jjco/hyz011.
The optimal first-line therapy of advanced ovarian cancer still remains questionable: standard paclitaxel-carboplatin (TC), dose-dense TC, intraperitoneal chemotherapy or TC plus bevacizumab. In this study, we present the real-life results of dose-dense treatment of the single-institution on Caucasian population.
A retrospective cohort study was used on consecutive samples of 74 patients treated with the conventional 3-weekly TC protocol (2008-11) and on 70 treated with TC dose-dense protocol (2012-16). The primary endpoint of this study was overall survival (OS). Secondary endpoints were progression free-survival (PFS) and toxicity. We made adjustments for age, pathohistological type, tumor grade, stage and postoperative residual disease by Cox regression.
After adjustment for pre-planned clinical and sociodemographic factors, patients treated with dose-dense protocol showed a significantly lower hazard for dying from any cause, than patients treated with conventional protocol (HR = 0.50; 95% CI 0.26-0.98; P = 0.042). Median OS, at 60 months follow-up had not been reached in the dose-dense group, while in the standard treatment group was 48 months (95% CI 33-62). Unadjusted PFS was significantly longer in the dose-dense group (HR = 0.58; 95% CI 0.38-0.88; P = 0.011), but not after the adjustment (P = 0.096). Generally, the level of toxicity was similar in both groups of patients. The need for blood transfusions and usage of filgrastim was significantly higher in the TC dd group. The incidence of neutropenia and thrombocytopenia Grade 3 or 4 were not significantly different in both regimens.
Our retrospective study has shown the superior efficacy and comparable toxicity of dose-dense chemotherapy regimen over the conventional regimen in treatment of ovarian cancer on Caucasian population at a single-institution.
晚期卵巢癌的最佳一线治疗方案仍存在争议：标准的紫杉醇-卡铂（TC）方案、剂量密集型TC方案、腹腔内化疗或TC联合贝伐单抗。在本研究中，我们展示了单机构对白种人群进行剂量密集治疗的实际结果。
采用回顾性队列研究，连续纳入74例接受传统3周一次TC方案治疗的患者（2008 - 2011年）和70例接受剂量密集型TC方案治疗的患者（2012 - 2016年）。本研究的主要终点是总生存期（OS）。次要终点是无进展生存期（PFS）和毒性。我们通过Cox回归对年龄、病理组织学类型、肿瘤分级、分期和术后残留疾病进行了调整。
在对预先计划的临床和社会人口统计学因素进行调整后，接受剂量密集方案治疗的患者因任何原因死亡的风险显著低于接受传统方案治疗的患者（风险比[HR] = 0.50；95%置信区间[CI] 0.26 - 0.98；P = 0.042）。在60个月的随访中，剂量密集组未达到中位总生存期，而标准治疗组为48个月（95% CI 33 - 62）。未调整的无进展生存期在剂量密集组显著更长（HR = 0.58；95% CI 0.38 - 0.88；P = 0.011），但调整后无显著差异（P = 0.096）。总体而言，两组患者的毒性水平相似。TC剂量密集组输血需求和非格司亭的使用显著更高。两种方案中3级或4级中性粒细胞减少和血小板减少的发生率无显著差异。
我们的回顾性研究表明，在单机构对白种人群治疗卵巢癌时，剂量密集化疗方案比传统方案具有更好的疗效和相当的毒性。
