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阴茎癌患者辅助和/或新辅助化疗中使用的化疗方案的疗效和毒性比较。

Comparison of efficacy and toxicity of chemotherapeutic regimens used as adjuvant and/or neoadjuvant chemotherapy in penile cancer patients.

作者信息

Dhasthakeer Usman, Jha Ambika Nand, Gupta Ashok Kumar

机构信息

National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, 844102, India.

School of Pharmacy, Sharda University, Knowledge Park-III, Greater Noida, U.P., 201306, India.

出版信息

Curr Probl Cancer. 2025 Apr;55:101185. doi: 10.1016/j.currproblcancer.2025.101185. Epub 2025 Feb 1.

Abstract

OBJECTIVE

To compare the efficacy and toxicity of different chemotherapeutic regimens used as adjuvant or neoadjuvant chemotherapy in penile cancer patients.

METHODOLOGY

This observational study was carried out at Mahavir Cancer Sansthan & Research Centre (MCSRC), Patna, involving 112 patients who received various chemotherapy regimens: 5-Fluorouracil with Cisplatin (FP), Paclitaxel with Carboplatin (TP), Paclitaxel with Cisplatin (TP), and Paclitaxel with Ifosfamide and Cisplatin (TIP). Efficacy was assessed based on tumor response after Neoadjuvant Chemotherapy (NACT) using RECIST v1.1, and Disease-Free Survival (DFS) was calculated with the Kaplan-Meier method. Chemotherapy toxicity was evaluated using CTCAE v4.03, and statistical analysis was performed with SPSS v22.

RESULTS

The mean age of the penile cancer patients was found to be 53.5 years. The most of the patients comes under stage-IIIb (62 patients - 55.4%). Out of 88 FP received patients, 28 were treated with NACT in which 24 had partial response (PR) and 4 had progressive disease (PD). The objective response rate (ORR) for this group was found to be 85.71%. Out of 21 TP received patients, 9 were treated with NACT in which 6 had CR and 3 had PR, therefore ORR was found to be 100%. Only one Patient received TIP as NACT had PR. The median DFS rate was found to be 6 months for ACT and 7 months for NACT in FP chemotherapy, whereas 10 months was found to be for ACT and NACT of TP combinations. The patients received TP combinations, had more than 6 months of DFS rate. The grade I-III haematological toxicity of anaemia, lymphocytopenia and thrombocytopenia was observed more in FP than TP and TP combinations. The grade I-III non-haematological toxicity was showed for all chemotherapy combinations.

CONCLUSION

Overall, the TP regimen stands out as the most effective and well-tolerated chemotherapy regimen for penile cancer, demonstrating both superior survival outcomes and a more favourable toxicity profile compared to the FP regimen.

摘要

目的

比较不同化疗方案作为阴茎癌患者辅助或新辅助化疗的疗效和毒性。

方法

本观察性研究在巴特那的玛哈维尔癌症中心及研究中心(MCSRC)进行,纳入了112例接受各种化疗方案的患者:氟尿嘧啶联合顺铂(FP)、紫杉醇联合卡铂(TP)、紫杉醇联合顺铂(TP)以及紫杉醇联合异环磷酰胺和顺铂(TIP)。使用RECIST v1.1基于新辅助化疗(NACT)后的肿瘤反应评估疗效,采用Kaplan-Meier方法计算无病生存期(DFS)。使用CTCAE v4.03评估化疗毒性,并使用SPSS v22进行统计分析。

结果

阴茎癌患者的平均年龄为53.5岁。大多数患者处于IIIb期(62例患者 - 55.4%)。在88例接受FP方案的患者中,28例接受了NACT治疗,其中24例有部分缓解(PR),4例有疾病进展(PD)。该组的客观缓解率(ORR)为85.71%。在21例接受TP方案的患者中,9例接受了NACT治疗,其中6例完全缓解(CR),3例PR,因此ORR为100%。仅1例接受TIP方案作为NACT治疗的患者有PR。在FP化疗中,辅助化疗(ACT)的中位DFS率为6个月,NACT为7个月,而TP联合方案的ACT和NACT的中位DFS率为10个月。接受TP联合方案的患者DFS率超过6个月。与TP及TP联合方案相比,FP方案中I - III级血液学毒性如贫血、淋巴细胞减少和血小板减少更为常见。所有化疗方案均显示出I - III级非血液学毒性。

结论

总体而言,TP方案是阴茎癌最有效且耐受性良好的化疗方案,与FP方案相比,其生存结局更优,毒性特征更有利。

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