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  • 1
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2022
    In:  Holistic Integrative Oncology Vol. 1, No. 1 ( 2022-12)
    In: Holistic Integrative Oncology, Springer Science and Business Media LLC, Vol. 1, No. 1 ( 2022-12)
    Abstract: Breast cancer is now the most common malignant tumor worldwide. About one-fourth of female cancer patients all over the world suffer from breast cancer. And about one in six female cancer deaths worldwide is caused by breast cancer. In terms of absolute numbers of cases and deaths, China ranks first in the world. The CACA Guidelines for Holistic Integrative Management of Breast Cancer were edited to help improve the diagnosis and comprehensive treatment in China. Methods The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to classify evidence and consensus. Results The CACA Guidelines for Holistic Integrative Management of Breast Cancer include the epidemiology of breast cancer, breast cancer screening, breast cancer diagnosis, early breast cancer treatment, advanced breast cancer treatment, follow-up, rehabilitation, and traditional Chinese medicine treatment of breast cancer patients. Conclusion We to standardize the diagnosis and treatment of breast cancer in China through the formulation of the CACA Guidelines.
    Type of Medium: Online Resource
    ISSN: 2731-4529
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 2
    In: The Oncologist, Oxford University Press (OUP), Vol. 22, No. 11 ( 2017-11-01), p. 1333-1338
    Abstract: Trastuzumab is a key component of therapy for human epidermal growth receptor 2 (HER2) positive breast cancer. Because real-world data are lacking, the present research was conducted to evaluate the actual use of and the effectiveness of trastuzumab in the real world in China. Methods Inpatients with HER2 positive invasive breast cancer from 13 hospitals in Eastern China (2010–2015, n = 1,139) were included in this study. We aimed to assess the actual use of trastuzumab and to evaluate potential efficacy from trastuzumab in real-world research. Results Of 1,017 patients with early stage breast cancer (EBC), 40.5% (412/1,017) received trastuzumab therapy. Patients with EBC in resource-abundant regions (gross domestic product per capita & gt;$15,000 and trastuzumab included in Medicare) are more likely to receive trastuzumab than those in resource-limited regions (37.3% vs. 13.0%, p  & lt; .05). After metastasis, 50.8% (366/720) patients received trastuzumab as their first-line therapy. More than 10% of patients with metastatic breast cancer (MBC) continued trastuzumab therapy after twice progression in resource-abundant regions, whereas more than 40% of patients never received any trastuzumab therapy during the whole course of therapy in resource-limited regions. Overall, the improvement in survival for trastuzumab versus non-trastuzumab was substantial in EBC (hazard ratio [HR] = 0.609, 95% confidence interval [CI] : 0.505–0.744) and in MBC (HR = 0.541, 95% CI: 0.418–0.606). This association was greater for patients with MBC who had never received trastuzumab (HR = 0.493, 95% CI: 0.372–0.576) than for those who had received adequate trastuzumab therapy in EBC stage (HR = 0.878, 95% CI: 0.506–1.431). Conclusion This study showed great disparities in trastuzumab use in different regions and different treatment stages. Both EBC and MBC patients can benefit from trastuzumab, as the survival data show; however, when trastuzumab is adequate in the early stage, a further trastuzumab-based therapy in first-line treatment of MBC will be ineffective, especially for those with short disease-free survival, and a second line of anti-HER2 therapy will be recommended. (Research number: CSCO-BC RWS 15001).
    Type of Medium: Online Resource
    ISSN: 1083-7159 , 1549-490X
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2017
    detail.hit.zdb_id: 2023829-0
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  • 3
    In: BMC Cancer, Springer Science and Business Media LLC, Vol. 20, No. 1 ( 2020-12)
    Abstract: The efficacy and safety of lapatinib plus capecitabine (LC or LX) versus trastuzumab plus chemotherapy in patients with HER-positive metastatic breast cancer who are resistant to trastuzumab is unknown. Methods We retrospectively analyzed data from breast cancer patients who began treatment with regimens of lapatinib plus capecitabine (LC or LX) or trastuzumab beyond progression (TBP) at eight hospitals between May 2010 and October 2017. Results Among 554 patients who had developed resistance to trastuzumab, the median PFS (progression free survival) was 6.77 months in the LX group compared with 5.6 months in the TBP group (hazard ratio 0.804; 95% CI, 0.67 to 0.96; P  = 0.019). The central nervous system progression rate during treatment was 5.9% in the LX group and 12.5% in the TBP group ( P  = 0.018). Conclusion The combination of lapatinib and capecitabine showed a prolonged PFS relative to TBP in patients who had progressed on trastuzumab.
    Type of Medium: Online Resource
    ISSN: 1471-2407
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2041352-X
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  • 4
    In: Frontiers in Oncology, Frontiers Media SA, Vol. 11 ( 2021-4-29)
    Abstract: Axillary node status after neoadjuvant chemotherapy (NCT) in early breast cancer patients influences the axillary surgical staging procedure. This study was conducted for the identification of the likelihood of patients being node pathological complete response (pCR) post NCT. We aimed to recognize patients most likely to benefit from sentinel lymph node biopsy (SLNB) following NCT and to reduce the risk of missed detection of positive lymph nodes through the construction and validation of a clinical preoperative scoring prediction model. Methods The existing data (from March 2010 to December 2018) of the Chinese Society of Clinical Oncology Breast Cancer Database (CSCO-BC) was used to evaluate the independent related factors of node pCR after NCT by Binary Logistic Regression analysis. A predictive model was established according to the score of considerable factors to identify ypN0. Model performance was confirmed in a cohort of NCT patients treated between January 2019 and December 2019 in Henan Cancer Hospital, and model discrimination was evaluated via assessing the area under the receiver operating characteristic (ROC) curve (AUC). Results Multivariate regression analysis showed that the node stage before chemotherapy, the expression level of Ki-67, biologic subtype, and breast pCR were all independent related factors of ypN0 after chemotherapy. According to the transformation and summation of odds ratio (OR) values of each variable, the scoring system model was constructed with a total score of 1–5. The AUC for the ROC curves was 0.715 and 0.770 for the training and the validation set accordingly. Conclusions A model was established and verified for predicting ypN0 after chemotherapy in newly diagnosed cN+ patients and the model had good accuracy and efficacy. The underlined effective model can suggest axillary surgical planning, and reduce the risk of missing positive lymph nodes by SLNB after NCT. It has great value for identifying initial cN+ patients who are more appropriate for SLNB post-chemotherapy.
    Type of Medium: Online Resource
    ISSN: 2234-943X
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2021
    detail.hit.zdb_id: 2649216-7
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 17_suppl ( 2023-06-10), p. LBA1013-LBA1013
    Abstract: LBA1013 Background: Checkpoint blockade combined with taxanes based chemotherapy had generated mixed results as first line treatment for metastatic TNBC. Toripalimab, a humanized IgG4K monoclonal antibody specific for PD-1, provided significant clinical efficacy with a favorable safety profile in various solid tumors. The purpose of this study is to compare the efficacy and safety of toripalimab versus placebo, in combination with nab-P for metastatic or recurrent TNBC (NCT04085276). Methods: Patients with initially diagnosed metastatic or recurrent inoperable TNBC were randomized 2:1 to receive toripalimab (240mg, D1, q3w) or placebo along with nab-P on days1, 8 in 3-week cycles. Stratifications included PD-L1 expression, paclitaxel therapy history and line of prior therapy at enrollment. Primary endpoint was progression-free survival (PFS) assessed by a blinded independent central review (BICR) per RECIST v1.1, first in the PD-L1-positive population and then in the ITT population. Secondary endpoints included overall survival (OS) and safety. Results: 531 patients were randomized to toripalimab (n = 353) or placebo (n = 178); 200 and 100 patients, respectively had PD-L1 positive TNBC. At interim analysis, with the median follow-up of 14 months, a statistically significant improvement in PFS by BICR was demonstrated for the toripalimab arm in the PD-L1 positive subgroup (mPFS 8.4 vs 5.6 months; HR = 0.653, 95% CI 0.470-0.906, P = 0.0102). The PFS in the ITT population showed a similar trend (mPFS 8.4 vs 6.9 months, HR = 0.773, 95%CI 0.602-0.994). Descriptive analysis of OS showed a trend towards improved OS in the PD-L1 positive (mOS 32.8 vs 19.5 months; HR = 0.615, 95%CI 0.414-0.914) and the ITT population (mOS 33.1 vs 23.5 months; HR = 0.691, 95% CI 0.513-0.932). No new safety signals were identified. Grade≥3 adverse events (AEs) (56.4% vs 54.3%) and fatal AEs (0.6% vs 3.4%) were similar between arms, while AEs leading to discontinuation of toripalimab/placebo (8.5% vs. 3.4%) and immune-related (irAEs) (40.8% vs. 24.0%) were more frequent in the toripalimab arm. Conclusions: The addition of toripalimab to nab-P provided a significant improvement in PFS for PD-L1 positive metastatic or recurrent TNBC patients receiving first-line treatment with an acceptable safety profile. Patients will be followed for the final PFS and OS analysis. Clinical trial information: NCT04085276 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 6
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 10, No. 1 ( 2020-10-22)
    Abstract: Stage IV breast cancer is metastatic breast cancer (MBC). Because real-world data are lacking in China, our research attempts to explore the effect of locoregional surgery on the prognosis of patients with MBC. A total of 987 patients from 10 hospitals and 2 databases in East China (2004–2018) were included in this study. Overall, 47% of patients underwent locoregional surgery, and 53% did not. Surgeons tended to perform surgery on patients with small tumours (T1/T2), positive hormone receptor (HR) markers, and metastatic sites confined to a single organ and non-visceral sites (bone only/others) (each p  〈  0.05). Kaplan–Meier survival curves and the log-rank test showed that median survival was longer for patients who had locoregional surgery than for those who did not (45.00 vs. 28.00 months; p   〈  0.001). Patients who underwent surgery after systemic treatment had better survival than those who underwent surgery immediately ( p   〈  0.001). In most subgroups, overall survival (OS) was significantly longer in the surgery group than in the no-surgery group (each p   〈  0.05), except for brain metastases and triple negative breast cancer. Therefore, we concluded that locoregional surgery for the primary tumour in MBC patients was associated with a marked reduction in risk of dying except for patients with brain metastases or triple-negative subtype.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2615211-3
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  • 7
    In: JAMA Network Open, American Medical Association (AMA), Vol. 6, No. 6 ( 2023-06-30), p. e2321388-
    Abstract: Breast cancer treatment has profoundly improved in China recently. However, trends in disparities and transitions of treatment in early-stage cancer between China and the US are not well known. Objective To identify changes for patients with early breast cancer by using large databases from China and the US. Design, Setting, and Participants This multicenter cross-sectional study used the Chinese Society of Clinical Oncology Breast Cancer (CSCO BC) database from hospitals in 13 provinces in China and the Flatiron Health (hereinafter referred to as Flatiron) database from more than 280 community oncology clinics in the US. Patients with stage I to III breast cancer diagnosed from January 1, 2011, to December 31, 2021, were included. Data were analyzed from June 10 to December 1, 2022. Main Outcomes and Measures The distribution of age, clinical stage, and cancer subtypes at diagnosis were examined overall and by year. The mean annual percent change (MAPC) from 2011 to 2021 in systemic therapy and surgery was also analyzed. Results A total of 57 720 patients with early breast cancer were screened from the CSCO BC (n = 45 970) and Flatiron (n = 11 750) databases. The median age at diagnosis in China among the 41 449 patients included in the age analysis was 47 (IQR, 40-56) years; in the US, the median age was 64 (IQR, 54-73) years. Among patients with clinical stage data in the CSCO BC (n = 22 794) and Flatiron (n = 4413) databases, the proportion of stage I cancer was 7250 (31.8%) vs 2409 (54.6%); stage II cancer, 10 043 (44.1%) vs 1481 (33.6%); and stage III cancer, 5501 (24.1%) vs 523 (11.9%). The proportion of hormone receptor–positive cancer in China was 69.8%, lower than that in the US (87.5%). For patients with ERBB2 (formerly HER2 or HER2/neu )-positive cancer, the proportion in China (30.2%) was higher than that in the US (15.6%). For neoadjuvant therapy, the annual rate increased from 247 of 1553 (15.9%) to 200 of 790 (25.3%) in China, with an MAPC of −4.4% (95% CI, −50.6% to 85.0%; P  = .89). For patients with ERBB2 -positive cancer, the proportion treated with trastuzumab in early-stage cancer in China increased significantly, with an MAPC of 22.1% (95% CI, 17.4%-26.9%; P   & amp;lt; .001), and overtook that in the Flatiron database since 2017 (1684 [68.5%] vs 550 [62.5%] ; P   & amp;lt; .001). Conclusions and Relevance The findings of this cross-sectional study suggest that disparities in treatment of early breast cancer narrowed between China and the US during the study period. The rapid growth of trastuzumab treatment in China was suggestive of differential access to targeted ERBB2 therapy.
    Type of Medium: Online Resource
    ISSN: 2574-3805
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
    detail.hit.zdb_id: 2931249-8
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  • 8
    In: Translational Breast Cancer Research, AME Publishing Company, Vol. 2 ( 2021-1), p. 2-2
    Type of Medium: Online Resource
    ISSN: 2218-6778
    Language: Unknown
    Publisher: AME Publishing Company
    Publication Date: 2021
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. e18566-e18566
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 10
    In: BMC Medicine, Springer Science and Business Media LLC, Vol. 20, No. 1 ( 2022-12-27)
    Abstract: Pyrotinib (an irreversible pan-ErbB inhibitor) plus capecitabine has survival benefits and acceptable tolerability in patients with HER2-positive metastatic breast cancer. We further assessed addition of pyrotinib to trastuzumab and docetaxel in the neoadjuvant setting. Methods In this multicenter, double-blind, phase 3 study (PHEDRA), treatment-naive women with HER2-positive early or locally advanced breast cancer were randomly assigned (1:1) to receive four neoadjuvant cycles of oral pyrotinib or placebo (400 mg) once daily, plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg) and docetaxel (100 mg/m 2 ) every 3 weeks. The primary endpoint was the total pathological complete response (tpCR; ypT0/is and ypN0) rate per independent central review. Results Between Jul 23, 2018, and Jan 8, 2021, 355 patients were randomly assigned, 178 to the pyrotinib group and 177 to the placebo group. The majority of patients completed four cycles of neoadjuvant treatment as planned (92.7% and 97.7% in the pyrotinib and placebo groups, respectively). The tpCR rate was 41.0% (95% CI 34.0 to 48.4) in the pyrotinib group compared with 22.0% (95% CI 16.6 to 28.7) in the placebo group (difference, 19.0% [95% CI 9.5 to 28.4] ; one-sided P 〈 0.0001). The objective response rate per investigator was 91.6% (95% CI 86.6 to 94.8) in the pyrotinib group and 81.9% (95% CI 75.6 to 86.9) in the placebo group after the neoadjuvant treatment, resulting in an increase of 9.7% (95% CI 2.7 to 16.6). The most common grade 3 or worse adverse events were diarrhea (79 [44.4%] in the pyrotinib group and nine [5.1%] in the placebo group), neutropenia (33 [18.5%] and 36 [20.3%] ), and decreased white blood cell count (29 [16.3%] and 24 [13.6%] ). No deaths were reported during neoadjuvant treatment. Conclusions The primary endpoint of the study was met. Neoadjuvant pyrotinib, trastuzumab, and docetaxel significantly improved the tpCR rate compared with placebo, trastuzumab, and docetaxel, with manageable toxicity, providing a new option for HER2-positive early or locally advanced breast cancer. Trial registration ClinicalTrials.gov, NCT03588091
    Type of Medium: Online Resource
    ISSN: 1741-7015
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2131669-7
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