Efficacy and safety of gemcitabine combined with oxaliplatin chemotherapy regimen in cisplatin-intolerant uroepithelial carcinoma
10.3760/cma.j.cn112330-20231129-00156
- VernacularTitle:吉西他滨联合奥沙利铂方案在顺铂不耐受尿路上皮癌患者术后辅助治疗中的疗效和安全性
- Author:
Huaying LIU
1
;
Shun ZHANG
1
;
Ning JIANG
1
;
Yuhao BAI
1
;
Yongming DENG
1
;
Shiwei ZHANG
1
;
Rong YANG
1
;
Hongqian GUO
1
Author Information
1. 南京中医药大学鼓楼临床医学院 南京大学医学院附属鼓楼医院泌尿外科，南京 210008
- Publication Type:Journal Article
- Keywords:
Urologic neoplasms;
Uroepithelial carcinoma;
Cisplatin intolerance;
Oxaliplatin;
Renal insufficiency;
Efficacy;
Safety
- From:
Chinese Journal of Urology
2024;45(11):809-814
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of the gemcitabine combined with oxaliplatin (GEMOX) regimen in the postoperative adjuvant treatment for the patients with cisplatin-intolerant uroepithelial cancer.Methods:The clinical data of 98 patients with uroepithelial carcinoma intolerant to cisplatin chemotherapy who underwent radical surgery from August 2017 to October 2022 at Drum Tower Hospital of Nanjing University School of Medicine were retrospectively analysed. The patients were divided into the adjuvant chemotherapy group and the observation group according to whether or not they underwent adjuvant chemotherapy after surgery. The adjuvant chemotherapy group received postoperative chemotherapy with the GEMOX regimen (gemcitabine 1 000 mg/m 2 intravenously on days 1 and 8, oxaliplatin 130 mg/m 2 intravenously on day 2, every 3 weeks as a cycle), and the observation group did not undergo postoperative adjuvant chemotherapy. In the adjuvant chemotherapy group, there were 33 males and 10 females, the patients’ age was (67.8±7.3) years old, 33 cases with estimated glomerular filtration rate (eGFR) ≤60 ml/(min·1.73m 2), and 10 cases with a Eastern Cooperative Oncology Group (ECOG) functional status score of >1. The postoperative pathology showed 39 cases were in stage T 3, 4 cases in stage T 4, and lymph node positivity (N+ ) was found in 10 cases. There were 55 cases in the observation group, with 42 males and 13 females and the age of (70.7±7.7) years old. Forty-two of them had an eGFR ≤60 ml/(min·1.73m 2), and 13 of them had a ECOG score of >1. The postoperative pathology showed 48 cases were in stage T 3, 7 cases in stage T 4, and 13 cases of N+. The changes in renal function, ECOG scores, and adverse reactions were observed in adjuvant chemotherapy group. Kaplan-Meier method was used to estimate the survival rate, and the log-rank test was used to compare the survival rate between groups. Multifactorial Cox regression was used to analyse the correlation between age, lymph nodes, whether or not to combine with adjuvant chemotherapy and the survival of patients. Results:All patients in this study were followed up for 3 to 75 months, with a median follow-up time of 22 (14, 34) months. The recurrence rates were 83.6%(46/55) and 65.1%(28/43) in the observation and adjuvant chemotherapy groups, respectively, and the disease mortality rates were 52.7%(29/55) and 27.9%(12/43), respectively. The results of the Kaplan-Meier survival analyses showed that the 1-, 2- and 3-year disease-free survival rates in the adjuvant chemotherapy group were 62.8%, 48.6% and 41.1%, respectively, and the 1-, 2- and 3-year overall survival rates were 86.0%, 79.0% and 76.4%, respectively. The 1-, 2- and 3-year disease-free survival rates of the observation group were 58.2%, 22.6% and 9.6%, respectively, and the 1-, 2- and 3-year overall survival rates were 78.2%, 49.4% and 42.8%, respectively. The adjuvant chemotherapy group had an advantage over the observation group regarding disease-free and overall survival rates (all P<0.05). The results of multifactorial Cox regression analysis suggested that the functional status score and the presence or absence of positive lymph nodes, diabetes mellitus, and co-adjuvant chemotherapy were independent risk factors affecting the survival of the patients ( P<0.05). Forty-three cases had 1 to 6 courses of adjuvant chemotherapy, with a median course of 4 (2, 4). In terms of safety, the most common adverse reaction in the gastrointestinal tract was loss of appetite (53.4%, 23/43), the most common grade 1 to 2 adverse reaction in myelosuppression was a decrease in haemoglobin (51.2%, 22/43), and the most common grade 3 to 4 adverse reaction was thrombocytopenia (9.3%, 4/43). The eGFR of 33 patients with renal insufficiency in the adjuvant chemotherapy group was higher after each administration cycle than before ( P<0.05), and renal function did not deteriorate with the increase in administration cycles. Ten patients with a ECOG score of 2 remained with a score of 2 after chemotherapy. Conclusions:In patients with cisplatin-intolerant uroepithelial cancer, gemcitabine in combination with an oxaliplatin regimen improves the overall survival of patients. At the same time, it is well tolerated without increasing nephrotoxicity, making it an optional postoperative adjuvant treatment for patients with cisplatin-intolerant uroepithelial cancer.
