Aykan Musa Baris, Yildiran Keskin Gulsema, Erturk İsmail, Acar Ramazan, Kose Ahmet Fatih, Karadurmus Nuri
Department of Medical Oncology, University of Health Sciences, Gulhane School of Medicine, Ankara 06018, Turkey.
Department of Internal Medicine, University of Health Sciences, Gulhane School of Medicine, Ankara 06018, Turkey.
J Clin Med. 2024 Dec 29;14(1):131. doi: 10.3390/jcm14010131.
: Salvage treatment options have not been validated in relapsed or refractory germ cell tumors. Moreover, the study populations including these patients have different heterogeneities. This study aimed to evaluate the efficacy and safety of three cycles of TIP sequential high-dose chemotherapy in patients with testicular non-seminomatous germ cell tumors who relapsed or had a refractory course after first-line platinum-based chemotherapy. : Data of 141 patients who underwent three cycles of TIP followed by HDCT due to relapsed/refractory gonadal NSGCTs after first-line cisplatin-based chemotherapy (BEP/EP) at Gulhane School of Medicine Hospital Medical Oncology Department between January 2017 and May 2024 were evaluated retrospectively. Patients underwent a treatment regimen consisting of two phases. Initially, they received three cycles of induction therapy using a combination known as TIP, which includes paclitaxel, ifosfomide, and cisplatin. Following this, they were given a single cycle of high-dose chemotherapy. Demographic and clinicopathological features of patients and treatment-related complications and survival outcomes were recorded. : Median follow-up for all patients was 35.2 (95% CI, 29.45 to 41.07) months. Complete Response (CR) or marker negative Partial Response (PR) after HDCT was achieved in 84 (59.6%) patients. Median time for PFS not reached (NR) (95% CI, NR) in the entire group. The 2-year PFS rate was 51.8%. Median time for OS not reached (95% CI, NR) and the 2-year OS rate was 72.3%. The most common myelotoxicity observed after HDCT until engraftment was grade 4 neutropenia (100%) and grade 4 thrombocytopenia (96.5%). Transplantation-related mortality occurred in 7.1% of patients. Variables that remained statistically significant in multivariable analysis and were associated with poor prognosis for overall survival were platinum refractory disease and AFP and/or beta HCG elevation. : Significant survival can be achieved after three cycles of TIP consecutive HDCT, while treatment-related mortality was found to be low.
挽救性治疗方案尚未在复发性或难治性生殖细胞肿瘤中得到验证。此外，纳入这些患者的研究人群具有不同的异质性。本研究旨在评估三周期TIP序贯大剂量化疗在一线铂类化疗后复发或病程难治的睾丸非精原生殖细胞肿瘤患者中的疗效和安全性。
回顾性评估了2017年1月至2024年5月在古勒汗医学院医院医学肿瘤科因一线顺铂类化疗（BEP/EP）后复发/难治性性腺非精原生殖细胞肿瘤而接受三周期TIP然后进行大剂量化疗（HDCT）的141例患者的数据。患者接受了包括两个阶段的治疗方案。最初，他们接受了三周期诱导治疗，使用一种称为TIP的联合方案，包括紫杉醇、异环磷酰胺和顺铂。在此之后，他们接受了单周期大剂量化疗。记录患者的人口统计学和临床病理特征以及治疗相关并发症和生存结果。
所有患者的中位随访时间为35.2（95%CI，29.45至41.07）个月。84例（59.6%）患者在HDCT后达到完全缓解（CR）或标志物阴性部分缓解（PR）。全组无进展生存期（PFS）的中位时间未达到（NR）（95%CI，NR）。2年PFS率为51.8%。总生存期（OS）的中位时间未达到（95%CI，NR），2年OS率为72.3%。HDCT后直至植入时观察到的最常见骨髓毒性是4级中性粒细胞减少（100%）和4级血小板减少（96.5%）。7.1%的患者发生了移植相关死亡。在多变量分析中仍具有统计学意义且与总生存预后不良相关的变量是铂难治性疾病以及甲胎蛋白（AFP）和/或β人绒毛膜促性腺激素（β-HCG）升高。
三周期TIP连续HDCT后可实现显著生存，同时发现治疗相关死亡率较低。
