目的·探究单周紫杉醇联合顺铂（weekly paclitaxel+cisplatin，DP）作为转移性乳腺癌（metastatic breast cancer，MBC）一线治疗方案，相比其他医师选择方案（treatment of physician's choices，TPC）的疗效和安全性。方法·选取2008年7月—2021年6月在上海交通大学医学院附属仁济医院肿瘤科住院治疗的MBC患者共117例，根据是否使用DP方案作为一线治疗方案分为DP组（55例）和TPC组（62例）。DP组接受紫杉醇80 mg/m²联合顺铂25 mg/m²，分别在第1、8、15日给药，每28 d为1个周期，共6个周期治疗。TPC组使用其他一线化疗方案，包括卡培他滨、吉西他滨、多西他赛等药物的单药或联合治疗。收集患者年龄、月经状态、原发灶病理和分子分型等临床特征；根据实体瘤疗效评价标准（Response Evaluation Criteria in Solid Tumors，RECIST）1.1版评估患者治疗反应，并分别计算客观缓解率（objective response rate，ORR）和临床获益率（clinical benefit rate，CBR）；根据美国国家癌症研究所常见不良反应分级标准5.0（National Cancer Institute's criteria for common adverse effect 5.0，NCI CTC 5.0）评估不良反应，并将NCI Ⅲ/Ⅳ级不良反应作为严重不良反应；收集患者复发进展病灶数量和累及部位作为复发进展模式。使用χ²检验比较2组患者临床特征、治疗效果、严重不良反应的差异；使用Kaplan-Meier生存分析比较2组患者一线无进展生存期（first-line progression-free survival，PFS1）的差异，并分别分析临床特征、接受治疗情况等因素对PFS1的影响，对筛选出的可能影响因素进行单因素Cox回归分析。结果·2组患者的临床特征中，除孕激素受体（progesterone receptor，PR）表达这一指标的差异有统计学意义（P=0.048）外，其他指标的差异均无统计学意义（P>0.05）。DP组的ORR和CBR均显著高于TPC组（47.3% vs 22.6%，P=0.009；78.2% vs 41.9%，P=0.002）；DP组的中位PFS1为12.0个月（95%CI 10.0~15.0个月），TPC组的中位PFS1为6.0个月（95%CI 5.0~9.0个月），差异具有统计学意义（Log-rank P=0.000）。仅接受DP方案一线治疗为MBC进展的保护因素（HR=0.419，95%CI 0.271~0.649，P=0.000）。2组患者复发进展模式除骨转移存在统计学意义（P=0.006）外，其他部位转移情况的差异未见统计学意义（P>0.05）。2组患者不良反应可耐受，组间严重不良反应比例差异无统计学意义（P>0.05）。结论·晚期一线DP方案较同期TPC方案具有更好的疗效，能延长PFS1，临床可根据MBC患者的病情选择使用。

Objective ·To investigate the efficacy and safety of weekly paclitaxel in combination with cisplatin (DP) as first-line regimen compared with other treatment of physician's choices (TPC) for metastatic breast cancer (MBC). Methods ·The clinical data of 117 MBC patients who were hospitalized in the Department of Oncology, Renji Hospital, Shanghai Jiao Tong University School of Medicine from July 2008 to June 2021 were retrospectively analyzed. Fifty-five patients were divided into DP group and 62 patients were divided into TPC group, according to whether the DP regimen was used as first-line chemotherapy. The DP group received paclitaxel 80 mg/m² combined with cisplatin 25 mg/m², administered on the 1st, 8th and 15th day, respectively, every 28 d as a cycle, a total of 6 cycles of treatment. TPC group received other first-linechemotherapy regimens, including single or combined regimens of capecitabine, gemcitabine, docetaxel and other regimens.Clinicopathologic characteristics including age, menopausal status, pathological results and molecular subtypes were collected and analyzed. Objective response rate (ORR) and clinical benefit rate (CBR) were used to evaluate the efficacy of different regimens based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The adverse effects (AEs) were assessed in accordance with National Cancer Institute's criteria for common adverse effect 5.0 (NCI CTC 5.0), and NCI Ⅲ/Ⅳ AEs were analyzed as severe AEs. The numbers and sites of MBC relapses were analyzed as progression pattern. The differences of clinicopathologic characteristics, efficacy and severe AEs between the two groups were compared by χ² test. Kaplan-Meier survival analysis was used to compare the difference of first-line progression free survival (PFS1) between the two groups, and the factors with probable influence on PFS1, including clinicopathologic characteristics, treatments and other factors were analyzed. The univariate Cox regression analysis was further applied to analysis of the possible influencing factors screened above. Results ·Except the progesterone receptor (PR) expression (P=0.048), there was no significant difference in clinicopathologic characteristics between the two groups (P>0.05). The ORR (47.3% vs 22.6%, P=0.009) and CBR (78.2% vs 41.9%, P=0.002) in the DP group were significantly higher than those in the TPC group. The median PFS1 was 12.0 months (95%CI 10.0?15.0 months) in the DP group, while the median PFS1 was 6.0 months (95%CI 5.0?9.0 month) in the TPC group, demonstrating significant difference (Log-rank P=0.000). Only the factor "receiving DP regimen as first-line chemotherapy" was recognized as a protective factor for MBC progression by univariate Cox analysis (P=0.000, HR=0.419, 95%CI 0.271?0.649). There was no significant difference (P>0.05) in the progression pattern between the two groups except for fewer bone metastasis (P=0.006). The AEs of the two groups were tolerable, and there was no significant difference in the proportion of severe AEs between the two groups (P>0.05). Conclusion ·The first-line DP regimen demonstrates better efficacy and prolonged PFS1 than TPC regimens. It could be an effective selection and should be considered for MBC according to the clinical situations.