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Cynthia Z. Qi, Min Huang, Amin Haiderali, Jipan Xie, Zheng-Yi Zhou, Eric Q. Wu and Peter Fasching

Objective: Pathological complete response (pCR) has been a commonly used endpoint in neoadjuvant trials for breast cancer (BC). A pooled analysis of 12 neoadjuvant BC trials by Cortazar et al (2014) reported a positive association between pCR and long-term survival outcomes among patients with general BC and certain subtypes including triple negative BC (TNBC). To update and extend the evidence to assess the association of pCR and survival outcomes in TNBC, this study reviewed and summarized cohort studies and recent clinical trials in the literature. Methods: English publications reporting association between pCR and survival outcomes among TNBC patients receiving neoadjuvant chemotherapy were searched in MEDLINE, EMBASE, Cochrane CENTRAL, and Northern Light Sciences Conference Abstracts. Full-text publications from all years and conference abstracts since year 2016 were identified. Relevant clinical trials, real-world evidence (RWE) studies, and meta-analyses were included for review and extraction. Results: Of total 1,880 publications retrieved, 35 reported association between pCR and survival outcomes for neoadjuvant TNBC (9 clinical trials, 21 RWE studies, and 5 pooled/meta-analyses). The sample size of TNBC patients varied between 25 and 1,645. Different pCR definitions were used across studies, of which absence of tumor in the breast and axillary nodes was most common (N=29). The prognostic impact of pCR was evaluated for multiple survival outcomes: overall survival (OS; N=19), disease-free survival (DFS; N=14), relapse-free survival (RFS; N=7), event-free survival (N=5), distant DFS (N = 4), and local RFS (N=2). Kaplan-Meier analysis was used to assess the association between pCR and these outcomes in 31 studies. Clear separation of survival curves in favor of pCR was observed in all the studies. Log-rank tests were conducted in 18 studies, and statistically significant association was reported in majority of them, except for 1 RWE study with small sample size (N=35) and 1 pooled analysis with a different pCR definition (absence of tumor in the breast) than most of the others. Cox proportional hazards model was used in 17 studies, wherein hazard ratios of survival outcomes comparing pCR vs non-pCR ranged from 0.08 to 0.53. Conclusions: Despite divergent study designs and pCR definitions, evidence from both clinical and real-world settings consistently suggest that pCR is a strong predictor of OS and other survival outcomes among TNBC patients.

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Ying Zhou, Chenchen Zhu, Zhen Shen, Yanhu Xie, Wei Zhang, Jing Zhu, Tianjiao Zhang, Min Li, Jiwei Qin, Shuai Yin, Rongzhu Chen, Wei Wei, Sinan Sun, Guihong Wang, Zheng Zhou, Hanhui Yao, Dabao Wu and Björn Nashan

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Zheng Zhou, Alfred W. Rademaker, Leo I. Gordon, Ann S. LaCasce, Allison Crosby-Thompson, Ann Vanderplas, Gregory A. Abel, Maria A. Rodriguez, Auayporn Nademanee, Mark S. Kaminski, Myron S. Czuczman, Michael M. Millenson, Andrew D. Zelenetz, Joyce Niland, Jonathan W. Friedberg and Jane N. Winter

Background: The impact of patient body habitus and sex on outcomes in diffuse large B-cell lymphoma (DLBCL) remains controversial. We investigated the impact of body mass index (BMI), body surface area (BSA), age, and sex on clinical outcomes in patients with DLBCL treated in the rituximab era. Patients and Methods: Patients with de novo DLBCL (n=1,386) diagnosed between June 2000 and December 2010 treated with rituximab-containing chemotherapy were identified from the NCCN Oncology Outcomes Database for Non-Hodgkin's Lymphoma. Progression-free survival (PFS) and overall survival (OS) at 3 years were analyzed based on sex, age, and baseline BMI/BSA. Results: High BMI was associated with a lower risk of disease progression or death than low or normal BMI, whereas male sex was associated with poor clinical outcomes, especially among elderly patients (age >60 years). Compared with elderly women, elderly men experienced worse PFS (3-year hazard ratio [HR], 1.5) and OS (3-year HR, 1.6), but these differences diminished with increases in BMI and BSA. In multivariable analysis, normal BMI compared with high BMI was independently associated with poor outcomes (3-year PFS HR, 1.5; OS HR, 1.6) after adjusting for sex. Notably, only 13% of elderly men had BMI less than 25 kg/m2 and only 26% had BSA less than 2 m2. Conclusions: Analysis of unselected patients with DLBCL treated with rituximab-containing chemotherapy confirmed an age-dependent disadvantage to male sex in treatment outcomes, but this effect is abrogated by higher levels of BMI and BSA in most North American men.