Showing papers by "Gong Tang published in 2012"
TL;DR: The addition of bevacizumab to neoadjuvant chemotherapy significantly increased the rate of pathological complete response, which was the primary end point of this study.
Abstract: A B S T R AC T BACKGROUND Bevacizumab and the antimetabolites capecitabine and gemcitabine have been shown to improve outcomes when added to taxanes in patients with metastatic breast cancer. The primary aims of this trial were to determine whether the addition of capecitabine or gemcitabine to neoadjuvant chemotherapy with docetaxel, followed by doxorubicin plus cyclophosphamide, would increase the rates of pathological complete response in the breast in women with operable, human epidermal growth factor receptor 2 (HER2)–negative breast cancer and whether adding bevacizumab to these chemotherapy regimens would increase the rates of pathological complete response. METHODS
406 citations
TL;DR: Relatively low-level exposure to benzene experienced by petroleum distribution workers was associated with an increased risk of MDS, but not AML, suggesting that MDS may be the more relevant health risk for lower exposures.
Abstract: Background Benzene at high concentrations is known to cause acute myeloid leukemia (AML), but its relationship with other lymphohematopoietic (LH) cancers remains uncertain, particularly at low concentrations. In this pooled analysis, we examined the risk of five LH cancers relative to lower levels of benzene exposure in petroleum workers. Methods We updated three nested case-control studies from Australia, Canada, and the United Kingdom with new incident LH cancers among petroleum distribution workers through December 31, 2006, and pooled 370 potential case subjects and 1587 matched LH cancer-free control subjects. Quantitative benzene exposure in parts per million (ppm) was blindly reconstructed using historical monitoring data, and exposure certainty was scored as high, medium, or low. Two hematopathologists assigned diagnoses and scored the certainty of diagnosis as high, medium, or low. Dose-response relationships were examined for five LH cancers, including the three most common leukemia cell-types (AML, chronic myeloid leukemia [CML], and chronic lymphoid leukemia [CLL]) and two myeloid tumors (myelodysplastic syndrome [MDS] and myeloproliferative disease [MPD]). Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using conditional logistic regression, controlling for age, sex, and time period. Results Cumulative benzene exposure showed a monotonic dose-response relationship with MDS (highest vs lowest tertile, >2.93 vs ≤0.348 ppm-years, OR = 4.33, 95% CI = 1.31 to 14.3). For peak benezene exposures (>3 ppm), the risk of MDS was increased in high and medium certainty diagnoses (peak exposure vs no peak exposure, OR = 6.32, 95% CI = 1.32 to 30.2) and in workers having the highest exposure certainty (peak exposure vs no peak exposure, OR = 5.74, 95% CI = 1.05 to 31.2). There was little evidence of dose-response relationships for AML, CLL, CML, or MPD. Conclusions Relatively low-level exposure to benzene experienced by petroleum distribution workers was associated with an increased risk of MDS, but not AML, suggesting that MDS may be the more relevant health risk for lower exposures.
156 citations
Université de Montréal1, University of Pittsburgh2, University of Texas Southwestern Medical Center3, Kaiser Permanente4, Virginia Commonwealth University5, McGill University6, Ohio State University7, McGill University Health Centre8, MedStar Washington Hospital Center9, Aultman Hospital10, Allegheny General Hospital11
TL;DR: The effect of substituting lapatinib for trastuzumab (T) in combination with weekly paclitaxel (WP) following AC as well as adding L to T with WP following AC on pathologic complete response (pCR) rates was determined.
Abstract: LBA506 Background: The purposes of this trial are to determine the effect of substituting lapatinib (L) for trastuzumab (T) in combination with weekly paclitaxel (WP) following AC as well as adding L to T with WP following AC on pathologic complete response (pCR) rates. Methods: Women with HER2-positive operable breast cancer received standard AC q3wks x 4 cycles followed by WP (80 mg/m2) on days 1, 8, and 15 q28 days x 4 cycles. Concurrently with WP, patients received either T (4 mg/kg load, then 2 mg/kg) weekly until surgery, L (1250 mg) daily until surgery, or weekly T plus L (750 mg) daily until surgery. Following surgery, patients received trastuzumab to complete 52 wks of HER2-targeted therapy. The primary endpoint is pCR breast. For each of the two primary comparisons, the Fisher’s exact test was used to test the equality of pCR rates. A Hochberg-type step-up procedure was applied to address multiple testings and to control the family-wise error rate at 0.05. Results: 51% were clinically node posit...
44 citations
TL;DR: The 21-gene RS maintains significant prognostic impact in ER+, node+ pts who have received anthracycline- or anthrACYcline/taxane-based adjuvant chemotherapy, and the need to target pts with high residual risk for recurrence with additional therapies to overcome unfavorable biology, potential endocrine and/or chemotherapy resistance is emphasized.
Abstract: 1 Background: RS predicts outcome in node- and node+, ER+ pts treated with adjuvant endocrine therapy as well as benefit from adjuvant chemotherapy, with high RS receiving most of the benefit. We studied the prognostic impact of RS in node+, ER+ pts treated with adjuvant chemotherapy plus endocrine therapy as part of the NSABP B-28 trial. Methods: B-28 compared doxorubicin/cyclophosphamide (ACX4) with ACX4 followed by paclitaxel X4. Pts >50 yrs and those<50 yrs with ER+ and/or PR+ tumors also received 5 yrs of tamoxifen concurrently with chemotherapy. Between 8/95 and 5/98 3060 pts were accrued. The present study includes 1,065 pts ER+ by central tissue microarray IHC assay, tamoxifen treated, assessed by RS. Median follow-up time was 11.2 yrs. Results: Of the 1,065 pts, 386 (36%) had low RS<18; 364 (34%) intermediate RS,18-30; and 315 (30%) high RS≥31. In univariate analyses RS was a significant predictor of DFS, distant recurrence-free interval (DRFI) and OS (Table). In multivariate analyses, RS provide...
27 citations
TL;DR: Results support previous findings of lack of CT benefit in pts with a low RS result, and significantly predicts risk for LRR, DR, DFS event, and death in N+, ER+ pts treated with AC or AC→Pac adjuvant CT.
Abstract: Background: The RS result predicts outcome in N- and N+, ER+ pts treated with adjuvant endocrine therapy. RS also predicts benefit from adjuvant chemotherapy (CT) and pts with a high RS result receive most of the benefit. We evaluated the association between RS and paclitaxel (Pac) benefit in N+, ER+ pts from NSABP B-28. Methods: B-28 compared 4 cycles of doxorubicin/cyclophosphamide (AC) vs. AC followed by Pac × 4 (AC→Pac). Pts ≥50 yrs and those Results: Median follow-up time was 11.2 yrs. Of the 1065 pts, 386 (36%) had low RS ( Conclusions: RS significantly predicts risk for LRR, DR, DFS event, and death in N+, ER+ pts treated with AC or AC→Pac adjuvant CT. Pts with a low RS value have similar outcomes whether treated with AC or with AC→Pac and most of Pac benefit is evident in pts with intermediate/high RS. Although there was no significant interaction between RS and Pac benefit, these results support previous findings of lack of CT benefit in pts with a low RS result. Supported by: NCI grants U10-CA-12027, -69651, -37377, -69974, U24-CA-114732, and CA-75362; Susan G. Komen for the Cure® grants; and Bristol-Myers Squibb Pharmaceutical Research Institute Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr S1-10.
23 citations
TL;DR: A discrete-time Poisson process-based method to estimate the accrual rate at time of projection and subsequently the trial closure date is proposed and showed that application could help to save considerable amount of expenditure in patient management without compromising theAccrual goal in multi-center clinical trials.
Abstract: In a phase III multi-center cancer clinical trial or a large public health study, sample size is predetermined to achieve desired power, and study participants are enrolled from tens or hundreds of participating institutions. As the accrual is closing to the target size, the coordinating data center needs to project the accrual closure date on the basis of the observed accrual pattern and notify the participating sites several weeks in advance. In the past, projections were simply based on some crude assessment, and conservative measures were incorporated in order to achieve the target accrual size. This approach often resulted in excessive accrual size and subsequently unnecessary financial burden on the study sponsors. Here we proposed a discrete-time Poisson process-based method to estimate the accrual rate at time of projection and subsequently the trial closure date. To ensure that target size would be reached with high confidence, we also proposed a conservative method for the closure date projection. The proposed method was illustrated through the analysis of the accrual data of the National Surgical Adjuvant Breast and Bowel Project trial B-38. The results showed that application of the proposed method could help to save considerable amount of expenditure in patient management without compromising the accrual goal in multi-center clinical trials.
21 citations
TL;DR: It is concluded that second trimester high sFlt1 and sEng levels were possibly associated with an increased risk of preeclampsia after adjustment for maternal factors traditionally associated with the syndrome.
17 citations
MedStar Washington Hospital Center1, University of Pittsburgh2, University of Texas Southwestern Medical Center3, University Hospital Galway4, Kaiser Permanente5, Université de Montréal6, Christiana Care Health System7, Wake Forest University8, MedStar Franklin Square Medical Center9, Mayo Clinic10, Aultman Hospital11, Allegheny General Hospital12
TL;DR: Whether adjuvant DD AC→PG will be superior to DDAC→P as well as to TAC in DFS and to compare the relative DFS of TAC andDD AC→P is compared.
Abstract: LBA1000 Background: The primary aims were to determine whether adjuvant DD AC→PG will be superior to DD AC→P as well as to TAC in DFS and to compare the relative DFS of TAC and DD AC→P. Secondary endpoints include survival and toxicity. Methods: From Nov 3, 2004 to May 3, 2007, 4894 women were randomized; 1630 to TAC (docetaxel [T] 75 mg/m2, doxorubicin [A] 50 mg/m2, cyclophosphamide [C] 500 mg/m2 q3 wks x 6), 1634 to DD AC→P (A 60 mg/m2 and C 600 mg/m2 q2 wks x 4 followed by P 175 mg/m2 q2 wks x 4), and 1630 to DD AC→PG (A 60 mg/m2 and C 600 mg/m2 q2 wks x 4 → P 175 mg/m2 + G 2000 mg/m2q2 wks x 4). Primary G-CSF support was required and erythropoiesis-stimulating agents (ESA) were used at investigator discretion. 52% were postmenopausal, 65% had 1 - 3 positive nodes, and 80% had HR+ breast cancer. Log-rank tests were used for pair-wise comparisons of the primary (DFS) and secondary (OS) endpoints among the three treatment arms. Results: With 64 months median follow-up, 5-year DFS in DD AC→PG group was 80...
15 citations
TL;DR: Withdrawn by Author Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P6-07-01.
Abstract: Withdrawn by Author Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P6-07-01.
4 citations
TL;DR: It is very unlikely the Gamma– Poisson model could be implemented in many multi-center trials even if the necessary assumptions hold, and the approach may not be so sophisticated as the Gamma-Poisson model.
3 citations
TL;DR: Chuang et al. as discussed by the authors used generalized linear mixed models in time series studies of air pollution, and showed that the generalized linear mixedmodels can be used for air pollution analysis.