Hanrahan Emer O, Broglio Kristine R, Buzdar Aman U, Theriault Richard L, Valero Vicente, Cristofanilli Massimo, Yin Guosheng, Kau Shu-Wan C, Hortobagyi Gabriel N, Rivera Edgardo
Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.
Cancer. 2005 Sep 15;104(6):1158-71. doi: 10.1002/cncr.21305.
In three prospective, single-arm studies, the authors previously showed an improved outcome for anthracycline-naïve patients with isolated sites of recurrent breast carcinoma (BC) who were treated with doxorubicin-based chemotherapy after local therapy (surgery and/or radiotherapy). In the current report, the initial results are presented from a Phase II trial of docetaxel (100 mg/m(2) every 21 days for 6 cycles) given after local therapy for recurrent BC (Stage IV BC with no evidence of clinically measurable disease) in patients who received prior adjuvant anthracycline-based chemotherapy, and the authors provide an update of the 3 previous studies. An analysis of prognostic factors for these patients also is presented.
Eligibility criteria for all studies included histologic proof of recurrent BC that had been resected and/or irradiated with curative intent. Survival was calculated using the Kaplan-Meier method. Univariate survival analyses were performed to test for associations between patient characteristics and outcome (log-rank test). Cox proportional hazards models were used to determine the multivariable correlations between patient characteristics and outcome.
The median follow-up for the docetaxel-based trial (n = 26 patients) was 45 months. Early outcomes for this study are promising. The median disease-free survival (DFS) was 44 months, and the 3-year DFS and overall survival (OS) rates were 58% and 87%, respectively. In the 3 doxorubicin-based studies, the median follow-up was 121.5 months for all living patients, and the estimated 20-year DFS and OS rates were both 26%. On multivariable analysis of patients from all 4 studies, the only significant prognostic factor for DFS and OS (P = 0.0006) was the number of involved axillary lymph nodes at initial diagnosis.
A proportion of patients with isolated BC recurrences achieved prolonged DFS with combined-modality treatment. Patients who receive anthracycline-based chemotherapy at primary diagnosis may benefit from local treatment followed by docetaxel-based chemotherapy for isolated recurrences. The only significant independent prognostic factor was the number of involved axillary lymph nodes at initial diagnosis.
在三项前瞻性单臂研究中,作者先前表明,对于局部治疗(手术和/或放疗)后接受基于阿霉素化疗的初治蒽环类药物的孤立性复发性乳腺癌(BC)患者,其预后有所改善。在本报告中,呈现了一项多西他赛II期试验的初步结果,该试验为接受过基于蒽环类药物辅助化疗的复发性BC(IV期BC且无临床可测量疾病证据)患者在局部治疗后给予多西他赛(每21天100mg/m²,共6个周期),作者还提供了之前三项研究的更新情况。此外,还对这些患者的预后因素进行了分析。
所有研究的纳入标准包括经组织学证实的复发性BC,且已进行根治性切除和/或放疗。采用Kaplan-Meier法计算生存率。进行单因素生存分析以检验患者特征与预后之间的关联(对数秩检验)。使用Cox比例风险模型确定患者特征与预后之间的多变量相关性。
基于多西他赛的试验(n = 26例患者)的中位随访时间为45个月。该研究的早期结果很有前景。中位无病生存期(DFS)为44个月,3年DFS和总生存期(OS)率分别为58%和87%。在三项基于阿霉素的研究中,所有存活患者的中位随访时间为121.5个月,估计20年DFS和OS率均为26%。对所有四项研究的患者进行多变量分析时,DFS和OS的唯一显著预后因素(P = 0.0006)是初始诊断时受累腋窝淋巴结的数量。
一部分孤立性BC复发患者通过综合治疗实现了延长的DFS。在初次诊断时接受基于蒽环类药物化疗的患者,对于孤立性复发,可能从局部治疗后再进行基于多西他赛化疗中获益。唯一显著的独立预后因素是初始诊断时受累腋窝淋巴结的数量。