Zefei Jiang

Beijing Medical University, Peping, Beijing, China

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Publications (43)148.71 Total impact

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    ABSTRACT: mTOR inhibition reverses trastuzumab resistance via the hyperactivated PIK/AKT/mTOR pathway due to PTEN loss, by sensitising PTEN-deficient tumours to trastuzumab. The BOLERO-1 study assessed the efficacy and safety of adding everolimus to trastuzumab and paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer. In this phase 3, randomised, double-blind trial, patients were enrolled across 141 sites in 28 countries. Eligible patients were aged 18 years or older, with locally assessed HER2-positive advanced breast cancer, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, who had not received previous trastuzumab or chemotherapy for advanced breast cancer within 12 months of randomisation, had measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) or bone lesions in the absence of measurable disease, without previous systemic treatment for advanced disease except endocrine therapy. Patients were randomly assigned (2:1) with an interactive voice and web response system to receive either 10 mg everolimus once a day orally or placebo plus weekly trastuzumab intravenously at 4 mg/kg loading dose on day 1 with subsequent weekly doses of 2 mg/kg of each 4 week cycle plus paclitaxel intravenously at a dose of 80 mg/m(2) on days 1, 8, and 15 of each 4 week cycle. Randomisation was stratified according to previous use of trastuzumab and visceral metastasis. Patients and investigators were masked to the assigned treatments. Identity of experimental treatments was concealed by use of everolimus and placebo that were identical in packaging, labelling, appearance, and administration schedule. The two primary objectives were investigator-assessed progression-free survival in the full study population and in the subset of patients with hormone receptor-negative breast cancer at baseline; the latter was added during the course of the study, before unmasking based on new clinical and biological findings from other studies. All efficacy analyses were based on the intention-to-treat population. Enrolment for this trial is closed and results of the final progression-free survival analyses are presented here. This trial is registered with ClinicalTrials.gov, number NCT00876395. Between Sept 10, 2009, and Dec 16, 2012, 719 patients were randomly assigned to receive everolimus (n=480) or placebo (n=239). Median follow-up was 41·3 months (IQR 35·4-46·6). In the full population, median progression-free survival was 14·95 months (95% CI 14·55-17·91) with everolimus versus 14·49 months (12·29-17·08) with placebo (hazard ratio 0·89, 95% CI 0·73-1·08; p=0·1166). In the HR-negative subpopulation (n=311), median progression-free survival with everolimus was 20·27 months (95% CI 14·95-24·08) versus 13·08 months (10·05-16·56) with placebo (hazard ratio 0·66, 95% CI 0·48-0·91; p=0·0049); however, the protocol-specified significance threshold (p=0·0044) was not crossed. The most common adverse events with everolimus were stomatitis (314 [67%] of 472 patients in the everolimus group vs 77 [32%] of 238 patients in the placebo group), diarrhoea (267 [57%] vs 111 [47%] patients), and alopecia (221 [47%] vs 125 [53%]). The most frequently reported grade 3 or 4 adverse events in the everolimus group versus the placebo group were neutropenia (117 [25%] vs 35 [15%]), stomatitis (59 [13%] vs three [1%]), anaemia (46 [10%] vs six [3%]) and diarrhoea (43 [9%] vs 10 [4%]) On-treatment adverse event-related deaths were reported in 17 (4%) patients in the everolimus group and none in the placebo group. Although progression-free survival was not significantly different between groups in the full analysis population, the 7·2 months prolongation we noted with the addition of everolimus in the HR-negative, HER2-positive population warrants further investigation, even if it did not meet prespecified criteria for significance. The safety profile was generally consistent with what was previously reported in BOLERO-3. Proactive monitoring and early management of adverse events in patients given everolimus and chemotherapy is crucial. Novartis Pharmaceuticals. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet Oncology 06/2015; 16(7). DOI:10.1016/S1470-2045(15)00051-0 · 24.69 Impact Factor
  • Cancer Research 05/2015; 75(9 Supplement):S6-01-S6-01. DOI:10.1158/1538-7445.SABCS14-S6-01 · 9.33 Impact Factor
  • Cancer Research 05/2015; 75(9 Supplement):P3-10-02-P3-10-02. DOI:10.1158/1538-7445.SABCS14-P3-10-02 · 9.33 Impact Factor
  • Zefei Jiang · Fan Qi · Shaohua Zhang · Li Bian · Tao Wang · Lei Li
    Cancer Research 05/2015; 75(9 Supplement):P3-13-10-P3-13-10. DOI:10.1158/1538-7445.SABCS14-P3-13-10 · 9.33 Impact Factor
  • Cancer Research 05/2015; 75(9 Supplement):P1-13-07-P1-13-07. DOI:10.1158/1538-7445.SABCS14-P1-13-07 · 9.33 Impact Factor
  • Cancer Research 05/2015; 75(9 Supplement):P4-01-19-P4-01-19. DOI:10.1158/1538-7445.SABCS14-P4-01-19 · 9.33 Impact Factor
  • Zefei Jiang
    Zhonghua yi xue za zhi 03/2015; 95(12):891-3.
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    Hang Jiang · Tao Wang · Zefei Jiang
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    ABSTRACT: Background Goserelin plus aromatase inhibitors (AI) have already been used in male advanced breast cancer, but the cases that fulvestrantin male breast cancer are rare. Case presentation Here we report a case of long-term (3 years) response to Goserelin plus continuing endocrine treatments given for a male advanced breast cancer. The patient prolongs his life with high life quality, and has more time with his family. Conclusion Goserelin plus endocrine treatments may benefit male breast cancer.
    World Journal of Surgical Oncology 12/2014; 12(1):393. DOI:10.1186/1477-7819-12-393 · 1.41 Impact Factor
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    ABSTRACT: In the present study, we investigated the incidence of cardiotoxicity within 5 years of trastuzumab treatment and evaluated potential risk factors in clinical practice. The study cohort included 415 patients diagnosed with early breast cancer (EBC). Cardiotoxicity incidence was evaluated in patients receiving trastuzumab and those who did not. Multivariate Cox proportional hazards regression models were used to estimate hazard ratios and 95% confidence intervals of potential risk factors for trastuzumab-related cardiotoxicity after appropriate adjustments. Incidence of cardiotoxicity in patients treated with trastuzumab was significantly higher than that in controls (23.7% vs. 10.8%, p<0.001). This result was adjusted for factors that might increase the risk of cardiotoxicity, such as history of coronary artery diseases or the use of anthracyclines for more than four cycles. Our findings indicated that treatment with trastuzumab was strongly associated with cardiotoxicity in EBC patients.
    Journal of Breast Cancer 12/2014; 17(4):363-9. DOI:10.4048/jbc.2014.17.4.363 · 1.58 Impact Factor
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    ABSTRACT: Apatinib is an oral, highly potent tyrosine-kinase inhibitor targeting VEGFR2. Phase I study showed the recommended dose of 750 mg/d with substantial antitumor activity. This phase II study aims to evaluate the optimum dose level for the efficacy and safety of apatinib monotherapy in heavily pretreated patients with metastatic triple negative breast cancer (mTNBC) in China. Phase IIa was first performed among 25 patients previously treated with anthracycline and/or taxane. All patients received apatinib 750 mg/d p.o. in a 4-week cycle. Subsequently, a phase IIb study of 59 patients was activated, with the endpoint progression-free survival (PFS). The dosage of drug for the Phase IIb was determined according to safety, tolerability and efficacy from the phase IIa study. As a result of toxicity associated with the 750 mg dose in phase IIa, the recommended initial dose of apatinib in the phase IIb was 500mg/d. In phase IIb, grade 3/4 hematologic toxicities were thrombocytopenia (13.6%), leukopenia (6.8%), neutropenia (3.4%) and anemia (1.7%). The most frequent grade 3/4 non-hematologic toxicities were hand-foot syndrome, proteinuria, hypertension, and increased ALT. In the 56 evaluable patients, overall response rate and clinical benefit rate (CBR) were 10.7% and 25.0%, respectively. Median PFS and overall survival were 3.3 (95 % CI, 1.7–5.0) and 10.6 (95 % CI, 5.6–15.7) months, respectively. Our results indicate that apatinib dose of 500 mg rather than 750 mg is the recommended starting dose for the heavily pretreated mTNBC patients with measurable rate of PR and PFS. © 2014 Wiley Periodicals, Inc.
    International Journal of Cancer 10/2014; 135(8). DOI:10.1002/ijc.28829 · 5.09 Impact Factor
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    ABSTRACT: To explore the prognostic value of applying a semi-automated detection system for detecting circulating tumor cells (CTC) for different stages and various subtypes of breast cancer. Immunomagnetic separation and immunofluorescent staining were employed to detect the expressions of CTC and CTC HER-2. Chi-square test, univariate and multivariate analyses were used to examine the correlations between CTC and clinical characteristics. CTC was detected in 57.5% (138/240) of metastatic breast cancer (MBC). CTC enumeration, HER-2 status, number of metastasis and bone metastasis were relevant (P < 0.05). CTC was detected in 23.1% (6/26) of early-stage breast cancer (EBC). CTC enumeration, pathological type, estrogen receptor (ER), progesterone receptor (PR), Ki-67, tumor size and lymph node metastasis were irrelevant (P > 0.05). HER-2-positive MBC detected less CTC than HER-2-negative (χ(2) = 12.296, P < 0.001) . CTC HER-2 expression was different between HER-2-positive and negative patients in 99 MBC cases (χ(2) = 8.082, P = 0.004). CTC enumeration is different for various stages and different subtypes of breast cancer. CTC enumeration and bone metastasis are relevant. CTC detection in EBC may predict tumor relapse. And CTC HER-2 expression is different between HER-2-positive and negative MBC patients.
    Zhonghua yi xue za zhi 09/2014; 94(36):2812-5.
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    ABSTRACT: IntroductionPhosphatidylinositol 3-kinase (PI3K) pathway deregulation (i.e. PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) has been shown to enhance breast cancer cell survival and confer resistance to chemotherapeutic agents. We studied the prognostic and predictive value of PIK3CA mutations and PTEN low in patients receiving paclitaxel alone or in combination with lapatinib.Methods Immunohistochemistry and mutation analyses were used to evaluate PTEN and PIK3CA, respectively. Kaplan-Meier analysis with log-rank tests, logistic regression and Cox models were used in analyses of these biomarkers with efficacy endpoints.ResultsIn the overall population, PIK3CA mutations were associated with poorer overall survival (OS) (hazard ratio [HR]¿=¿1.87; 95% confidence interval [CI]: 1.22, 2.88; P¿=¿0.001). PTEN expression was not associated with OS (P¿=¿0.474). In the PIK3CA wild-type subgroup, lapatinib plus paclitaxel reduced risk of progression compared with paclitaxel alone (HR¿=¿0.44; 95% CI: 0.28, 0.69; P¿<¿0.0001); progression-free survival (PFS) was not significantly improved within the PIK3CA mutation subgroup (P¿=¿0.179). In the PTEN low group, OS was improved with addition of lapatinib (P¿=¿0.039). In both PTEN subgroups, addition of lapatinib was associated with improvements in PFS (P¿<¿0.050). PIK3CA and PTEN were not predictive of treatment based on interaction tests (P¿>¿0.05).ConclusionPTEN was neither a significant prognostic nor predictive factor. PIK3CA mutations were an adverse prognostic factor for survival but not predictive for lapatinib benefit.Trial registrationClinicalTrials.gov NCT00281658 (registered 23 January 2006).
    Breast cancer research: BCR 07/2014; 16(4):405. DOI:10.1186/s13058-014-0405-y · 5.49 Impact Factor
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    ABSTRACT: Objective: To explore the value of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in monitoring therapy responses and analyze the predictive value of tumor biomarkers in neoadjuvant chemotherapy for breast cancer. Methods: From August 2010 to August 2013, the patients diagnosed as primary invasive breast cancer were admitted into this multi-center study. All of them received 6 cycles of neoadjuvant chemotherapy and DCE-MRI during the procedure and underwent surgery. The associations between clinical therapy response and pathologic response as well as predictive factors were analyzed. Results: As for evaluating neoadjuvant treatment response, DCE-MRI had statistically significant correlations with histopathology. PR negativity, HER-2 over-expression and high Ki-67 index were statistically correlated with pathologic complete response (pCR) (P < 0.05). Conclusion: DCE-MRI is a reliable method of assessing the response of neoadjuvant therapy for breast cancer. And the immunohistochemistry status of PR, HER-2 and Ki-67 were related with pCR.
    Zhonghua yi xue za zhi 07/2014; 94(26):2018-21. DOI:10.3760/cma.j.issn.0376-2491.2014.26.005
  • Huiqiang Zhang · Zefei Jiang
    Zhonghua yi xue za zhi 07/2014; 94(26):2001-3. DOI:10.3760/cma.j.issn.0376-2491.2014.26.001
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    ABSTRACT: Background: This multicenter prospective study aimed to assess the utility of dynamic enhanced magnetic resonance imaging (MRI) prior to breast-conserving surgery for breast cancer. Methods: The research subjects were drawn from patients with primary early resectable breast cancer treated in the breast disease centers of six three-level hospitals in Beijing from 1 January 2010 to 31 December 2012. The participants were allocated to a breast-conserving surgery group (breast-conserving group) or a total mastectomy group (total mastectomy group). Enhanced MRI was used to measure breast volume, longest diameter of tumor and tumor volume. The correlations between these measurements and those derived from histopathologic findings were assessed. The relationships between the success rate of breast-conserving surgery and MRI- and pathology-based measurement results were statistically analyzed in the breast-conserving group. Results: The study included 461 cases in the total mastectomy group and 195 in the breast-conserving group. Allocation to these groups was based on clinical indications and patient preferences. The cut-off for concurrence between MRI- and pathology-based measurements of the longest diameter of tumor was set at 0.3 cm. In the total mastectomy group, the confidence interval for 95% concurrence of these measurements was 35.41%-44.63%. Correlation coefficients for MRI and histopathology-based measurements of breast volume, tumor volume and tumor volume/breast volume ratio were r = 0.861, 0.569, and 0.600, respectively (all P < 0.001). In the breast-conserving group, with 0.30 cm taken as the cut-off for concurrence, the 95% confidence interval for MRI and pathology-based measurements of the longest diameter of tumor was 29.98%-44.01%. The subjective and objective success rates for breast-conserving surgery were 100% and 88.54%, respectively. Conclusions: There were significant correlations between dynamic enhanced MRI- and histopathology-based measurements of the longest diameter of breast lesions, breast and tumor volumes, and breast volume/tumor volume ratios. Preoperative MRI examination improves the success rate of breast-conserving surgery.
    Chinese medical journal 07/2014; 127(13):2401-6. DOI:10.3760/cma.j.issn.0366-6999.20132508 · 1.05 Impact Factor
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    ABSTRACT: Objective: To evaluate the serum HER2 ECD level and its significance in advanced breast cancer patients with different molecular subtypes. Methods: A total of 322 advanced breast cancer patients were enrolled. The serum HER2 ECD concentrations were quantitatively detected by enzyme-linked immunosorbent assay(ELISA). Its relationship with clinicopathological characteristics and clinical significance were analyzed. Results: It was found that 55.9% (19/34)Luminal A, 42.7% (44/103) Luminal B-HER2(-), 70.6% (60/85) Luminal B-HER2(+), 73.8% (45/61)HER2-enriched and 23.1% (9/39) triple-negative patients had serum concentrations of HER2 ECD at least 15 ng/ml respectively. The prevalence of elevated ECD level in patients of different molecular subtypes differed significantly (P < 0.001). Tissue HER2 status, number of metastatic sites, visceral metastasis, CA15-3 and carcinoembryonic antigen(CEA) levels exhibited statistically significant correlations with the prevalence of elevated serum HER2 ECD level. The serum concentrations of HER2 ECD decreased after effective targeted therapy in tissue HER2-positive patients. Conclusion: The prevalence of elevated serum levels of HER2 ECD differed significantly in advanced breast cancer patients with different molecular subtypes. The serum HER2 ECD level may reflect both histological HER2 status and tumor load. And the dynamic changes of ECD concentrations are somewhat correlated with the efficacies of targeted treatment.
    Zhonghua yi xue za zhi 05/2014; 94(18):1384-7.
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    ABSTRACT: To explore the clinical characteristics and prognosis of ductal carcinoma in situ (DCIS) and early stage ductal breast cancer with invasive depth ≤ 1 cm. Follow-up analyses were performed for the clinical data of 57 patients with DCIS, 46 with pT1mic and 74 with pT1a-b breast cancer treated or consulted at our hospital. Single factor analysis was used to examine their prognostic factors. Among them, estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2(HER-2) positive rate and visual tumor size (2.0(0.1-7.0) vs 2.0(0.5-10.0) vs 2.0(0.3-10.0) cm)had no statistical differences between 3 groups (all P > 0.05). After median follow-up periods of 63, 38, 59 months, 12 patients suffered recurrence and metastasis and the rate of each group had no statistical differences. For pT1a-b patients with positive hormone receptor, endocrine therapy markedly reduced the risk of recurrence and metastasis (P = 0.024) . pT1mic, pT1a-b patients on chemotherapy had higher or comparable recurrence rate versus those without. And DCIS patients on chemotherapy had a much higher recurrence rate (P = 0.016) . In pT1a-b group, HER-2 positive patients had higher recurrence and metastasis rates. Yet there was a decreasing tendency after Herceptin treatment. Chemotherapy without proper indications may not improve the prognosis of DCIS, pT1mic and pT1a-b patients. Endocrine therapy is the crucial prognostic factor of patients with positive hormone receptor. Use of Herceptin for HER-2-positive patients is probably significant.
    Zhonghua yi xue za zhi 01/2014; 94(4):269-72. DOI:10.3760/cma.j.issn.0376-2491.2014.04.008
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    ABSTRACT: To explore the prediction value for dynamic changes of circulating tumor cell (CTC) in therapeutic response and prognosis of Chinese metastatic breast cancer patients. A total of 300 metastatic breast cancer patients from six breast cancer centers in China were included from March 2010 to January 2011. The CTC levels of metastatic breast cancer patients were detected with a CellSearch system before starting a new systemic therapy (baseline) and after 3-4, 6-8 weeks. The progression-free survival (PFS) of different groups according to dynamic changes of CTC was estimated by the Kaplan-Meier method and compared with Log-Rank test. The median follow-up time was 36.86 weeks. The median PFS of patients with ≥ 5 CTCs/7.5 ml at baseline but with < 5 CTCs/7.5 ml after treatment of 3-4 weeks was significantly prolonged than that those with persistent ≥ 5 CTCs/7.5 ml at the same timepoint (30.4 vs 14.1 weeks, P = 0.010). Furthermore, the median PFS of former had no significant statistic difference with those with < 5 CTCs/7.5 ml at baseline (30.4 vs 42.0 weeks, P = 0.780). The analysis result of PFS for three groups according to CTC of 6-8 weeks treatment was consistent with that according to CTC of 3-4 weeks. The median PFS of patients with ≥ 5 CTCs/7.5 ml at baseline but with < 5 CTCs/7.5 ml after treatment of 6-8 weeks was significantly prolonged than that those with persistent ≥ 5 CTCs/7.5 ml at the same time point (33.4 vs 8.9 weeks, P = 0.000). The median PFS of former had no significant statistic difference with those with < 5 CTCs/7.5 ml at baseline(33.4 vs 42.0 weeks, P = 0.950). The dynamic changes of CTC levels during therapy may predict an improvement of progression disease risk and has significance in therapeutic efficacy monitoring.
    Zhonghua yi xue za zhi 01/2014; 94(4):265-8.
  • Li Bian · Tao Wang · Shaohua Zhang · Zefei Jiang
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    ABSTRACT: The purpose of this prospective, nonrandomized, controlled study was to compare the regimen of continuously administering trastuzumab and capecitabine (HX) with the regimen of lapatinib plus capecitabine (LX) for metastatic breast cancer (MBC) patients who are resistant to trastuzumab and have previously received taxane treatment. The patients in the HX group received trastuzumab (6 mg/kg every 21 days following a loading dose of 8 mg/kg on cycle 1) and capecitabine (2,000 mg/m(2)/day, days 1 to 14 every 21 days). The patients in the LX group received lapatinib (1,250 mg/day) and capecitabine (2,000 mg/m(2)/day, days 1 to 14 every 21 days). The median progression-free survival (PFS) of the patients in the HX and LX groups was 4.5 vs. 6.0 months, respectively (p = 0.006). The proportion of patients having a PFS ≥6 months in the HX and LX groups was 30 vs. 55 %, respectively (p = 0.005). The incidence rate of new brain metastases during treatment was 12 and 3 % in the HX and LX groups, respectively, which was not significantly different (p = 0.16). In conclusion, application of the lapatinib plus capecitabine regimen in MBC patients with a trastuzumab-resistant tumor can more effectively control the disease compared with continuous administration of trastuzumab plus capecitabine.
    Tumor Biology 06/2013; 34(5). DOI:10.1007/s13277-013-0884-y · 3.61 Impact Factor
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    ABSTRACT: Objective: To construct eukaryotic expression vector of myc-tagged human HER2 and investigate its role in breast cancer cell proliferation and drug resistance. Methods: Human HER2 gene was amplified by PCR and cloned into the pXJ-40-myc vector. The recombinant myc-HER2 was identified by enzyme digestion and sequencing, transfected into breast cancer cell line ZR75-1, and then was detected by Western blotting. Next, CCK8 assay was performed to investigate myc-Her2 transfected cell proliferation. Trastuzumab, anti-Her2 antibody, was added to determine the sensitivity of cells transfected with myc-Her2. Results: Enzyme digestion and sequencing confirmed the myc-HER2 vector was constructed successfully. Western blotting showed the expression of myc-HER2 in the ZR75-1 cells. The result of cell growth curve showed that cells transfected with myc-her2 grew significantly faster than the control cells. Moreover, trastuzumab obviously suppressed the growth of ZR75-1 cells transfected with myc-HER2. Conclusion: The myc-HER2 vector was successfully constructed which lays an experimental foundation for the study of HER2 drug resistance to trastuzumab.
    Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology 06/2013; 29(6):606-8.

Publication Stats

139 Citations
148.71 Total Impact Points

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  • 2014
    • Beijing Medical University
      Peping, Beijing, China
    • 307 Hospital of the Chinese People's Liberation Army
      Peping, Beijing, China
  • 1998–2014
    • Academy of Military Medical Sciences
      T’ien-ching-shih, Tianjin Shi, China
  • 2013
    • The 251st Hospital of Chinese PLA
      Chzhantseyakou, Hebei, China
  • 2011
    • Beijing Cancer Hospital
      Peping, Beijing, China