Dressler L G, Eudey L, Gray R, Tormey D C, McGuire W L, Gilchrist K W, Clark G M, Osborne C K, Mansour E G, Abeloff M D
University of New Mexico School of Medicine, UNM Cancer Center, Albuquerque 87131.
J Natl Cancer Inst Monogr. 1992(11):167-72.
An ancillary study (INT 0076) to the Intergroup clinical trial of node-negative breast cancer patients (INT 0011) was performed to retrospectively evaluate DNA flow cytometry measurements of ploidy (DNA content) and proliferative capacity (S-phase fraction) for their ability to predict time to recurrence. Of the 915 patients eligible for the clinical trial, 788 were registered for the ancillary flow cytometry study (INT 0076). Four hundred and three of these patients [estrogen receptor (ER)-positive, tumor size less than 3 cm] had been registered to the observation arm of the clinical trial and 385 (ER-negative and/or tumor size greater than or equal to 3 cm) had been randomly assigned to adjuvant chemotherapy (cyclophosphamide, methotrexate, fluorouracil, and prednisone for six cycles) or to observation. Paraffin blocks from 95% (748 of 788) of these patients were obtained, 712 of which had sufficient cancer tissue to be evaluable for the flow cytometric assay. DNA ploidy status (DNA diploid vs DNA aneuploid) was evaluable for 565 (79%) specimens, 64% of which were aneuploid. Proliferative capacity was estimated by the percentage of cells having an S-phase DNA content, using a trapezoidal modeling algorithm(s) as previously described. The median S-phase value for the entire group (both registered and randomly assigned patients) was 6.97%, which defined the cutoff for interpretation of high or low S-phase values. With a median follow-up time of 4.55 years, S-phase fraction, but not ploidy status, is a significant predictor for time to recurrence in both the randomly assigned and the untreated population (observed registered group and observed randomly assigned group).(ABSTRACT TRUNCATED AT 250 WORDS)
针对淋巴结阴性乳腺癌患者的组间临床试验（INT 0011）开展了一项辅助研究（INT 0076），以回顾性评估DNA流式细胞术对倍性（DNA含量）和增殖能力（S期分数）的测量结果预测复发时间的能力。在符合该临床试验条件的915例患者中，788例登记参加了辅助流式细胞术研究（INT 0076）。其中403例患者[雌激素受体（ER）阳性，肿瘤大小小于3 cm]登记进入临床试验的观察臂，385例（ER阴性和/或肿瘤大小大于或等于3 cm）被随机分配接受辅助化疗（环磷酰胺、甲氨蝶呤、氟尿嘧啶和泼尼松，共六个周期）或观察。获取了这些患者中95%（788例中的748例）的石蜡块，其中712例有足够的癌组织可用于流式细胞术检测。565例（79%）标本可评估DNA倍性状态（DNA二倍体与DNA非整倍体），其中64%为非整倍体。使用先前描述的梯形建模算法，通过具有S期DNA含量的细胞百分比来估计增殖能力。整个组（登记和随机分配的患者）的S期值中位数为6.97%，该值定义了高或低S期值的解释临界值。中位随访时间为4.55年，S期分数而非倍性状态是随机分配组和未治疗人群（观察登记组和观察随机分配组）复发时间的显著预测指标。（摘要截短于250字）
