他莫昔芬治疗老年转移性乳腺癌患者的预后因素：对四项前瞻性临床试验入组患者的分析

Prognostic factors in elderly women with metastatic breast cancer treated with tamoxifen: an analysis of patients entered on four prospective clinical trials.

作者信息

Dhodapkar M V, Ingle J N, Cha S S, Mailliard J A, Wieand H S

机构信息

Division of Medical Oncology, Mayo Clinic and Foundation, Rochester, Minnesota, USA.

出版信息

Cancer. 1996 Feb 15;77(4):683-90. doi: 10.1002/(sici)1097-0142(19960215)77:4<683::aid-cncr14>3.0.co;2-x.

DOI:10.1002/(sici)1097-0142(19960215)77:4<683::aid-cncr14>3.0.co;2-x

PMID:8616760

Abstract

BACKGROUND

Information regarding prognostic factors and survival in elderly women with metastatic breast cancer treated with tamoxifen is limited.

METHODS

The data from 4 prospective clinical trials were analyzed, including information on 396 postmenopausal women with advanced breast cancer who received tamoxifen as initial therapy for metastatic disease. Emphasis was placed on 184 elderly patients (age greater than 65 years) to characterize the response to therapy, time to progression TTP), overall survival (OS), prognostic factors, and treatment-related toxicity.

RESULTS

Among 363 patients with measurable or evaluable disease, the objective response rates were higher in the elderly patients (46% versus 33%, P = 0.06); but age did not achieve significance in a logistic regression analysis (P= 0. 1). The median TTP (10.5 months versus 6.2 months, log rank P = 0.002) and OS (35.7 months versus 28.8 months, log rank P = 0.02) were superior in the elderly cohort. In multivariate analysis, age at diagnosis approached statistical significance (P = 0.055) for TTP but was not significant for OS (P = 0.17). Among elderly patients, disease free interval (DFI) (greater than 5 years), dominant disease site (soft tissue), prior adjuvant chemotherapy, positive estrogen/progesterone receptor (ER/PgR) and performance status (PS) were independent prognostic factors. Hot flashes were common in both younger and older cohorts (25% versus 33%, P = 0.14), while anorexia (14% versus 22%, P = 0.04) and mood changes (2% versus 6%, P = 0.03) were more common in the elderly patients.

CONCLUSIONS

There was no indication that elderly women with metastatic breast cancer treated with tamoxifen have a poorer outcome with regard to response rate, TTP or OS; in fact, they appeared to have a slightly better prognosis although this was not significant after adjustment for other prognostic factors. In elderly patients, DFI, PS, positive ER or PGR, and dominant disease site are independent prognostic factors.

摘要

背景

关于接受他莫昔芬治疗的老年转移性乳腺癌女性患者的预后因素和生存情况的信息有限。

方法

分析了4项前瞻性临床试验的数据，包括396例绝经后晚期乳腺癌女性患者的信息，这些患者接受他莫昔芬作为转移性疾病的初始治疗。重点关注184例老年患者（年龄大于65岁），以描述其对治疗的反应、疾病进展时间（TTP）、总生存期（OS）、预后因素及治疗相关毒性。

结果

在363例可测量或可评估疾病的患者中，老年患者的客观缓解率更高（46%对33%，P = 0.06）；但在逻辑回归分析中年龄未达到显著水平（P = 0.1）。老年队列的中位TTP（10.5个月对6.2个月，对数秩检验P = 0.002）和OS（35.7个月对28.8个月，对数秩检验P = 0.02）更优。在多变量分析中，诊断时年龄对TTP接近统计学显著水平（P = 0.055），但对OS不显著（P = 0.17）。在老年患者中,无病间期（DFI）（大于5年）、主要疾病部位（软组织）、既往辅助化疗、雌激素/孕激素受体（ER/PgR）阳性及体能状态（PS）是独立的预后因素。潮热在年轻和老年队列中都很常见（25%对33%，P = 0.14），而厌食（14%对22%，P = 0.04）和情绪变化（2%对6%，P = 0.03）在老年患者中更常见。