Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.
Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.
Indian J Cancer. 2022 Jul-Sep;59(3):387-393. doi: 10.4103/ijc.IJC_850_19.
There is limited access to 1 year of adjuvant trastuzumab in resource-constrained settings. Most randomized studies have failed to prove non-inferiority of shorter durations of adjuvant trastuzumab compared to 1 year However, shorter durations are often used when 1 year is not financially viable. We report the outcomes with 12 weeks of trastuzumab administered as part of curative-intent treatment.
This is a retrospective analysis of patients treated at Tata Memorial Centre, Mumbai, a tertiary care cancer center in India. Patients with human epidermal growth factor receptor (HER2)-positive early or locally advanced breast cancer who received 12 weeks of adjuvant or neoadjuvant trastuzumab with paclitaxel and four cycles of an anthracycline-based regimen in either sequence, through a patient assistance program between January 2011 and December 2012, were analyzed for disease-free survival (DFS), overall survival (OS), and toxicity.
A total of 102 patients were analyzed with a data cutoff in September 2019. The median follow-up was 72 months (range 6-90 months), the median age was 46 (24-65) years, 51 (50%) were postmenopausal, 37 (36%) were hormone receptor-positive, and 61 (60%) had stage-III disease. There were 37 DFS events and 26 had OS events. The 5-year DFS was 66% (95% Confidence Interval [CI] 56-75%) and the OS was 76% (95% CI 67-85%), respectively. Cardiac dysfunction developed in 11 (10.7%) patients.
The use of neoadjuvant or adjuvant 12-week trastuzumab-paclitaxel in sequence with four anthracycline-based regimens resulted in acceptable long-term outcomes in a group of patients, most of whom had advanced-stage nonmetastatic breast cancer.
在资源有限的情况下，可获得的辅助曲妥珠单抗治疗时长仅为 1 年。大多数随机研究未能证明与 1 年相比，较短时间的辅助曲妥珠单抗治疗（例如 12 周）非劣效。然而，当 1 年的治疗方案在经济上不可行时，通常会采用较短的治疗时长。我们报告了在印度塔塔纪念中心（Mumbai 的一家三级癌症治疗中心）使用曲妥珠单抗 12 周作为治愈性治疗的一部分的结果。
这是一项对 2011 年 1 月至 2012 年 12 月期间通过患者援助计划接受曲妥珠单抗辅助或新辅助治疗、12 周紫杉醇治疗，且序贯接受 4 周期蒽环类药物为基础的方案的人表皮生长因子受体（HER2）阳性早期或局部晚期乳腺癌患者的回顾性分析。无病生存期（DFS）、总生存期（OS）和毒性分析。
对 2019 年 9 月截止时的 102 例患者进行了分析。中位随访时间为 72 个月（范围 6-90 个月），中位年龄为 46（24-65）岁，51 例（50%）绝经后，37 例（36%）激素受体阳性，61 例（60%）疾病分期为 III 期。有 37 例发生 DFS 事件，26 例发生 OS 事件。5 年 DFS 为 66%（95%CI 56-75%），OS 为 76%（95%CI 67-85%）。11 例（10.7%）患者出现心脏功能障碍。
在一组大多数为非转移性晚期乳腺癌患者中，序贯使用新辅助或辅助 12 周曲妥珠单抗-紫杉醇联合 4 周期蒽环类药物为基础的方案治疗，可获得可接受的长期结果。
