Background: Although the ACOSOG Z0011 study showed axillary lymph node dissection (ALND) could be avoided in a specific population of sentinel lymph node positive patients, it’s not widely accepted by Chinese surgeons. We conducted a prospective single-arm study to confirm whether or not the results of Z0011 are applicable to Chinese patients. Methods: Patients conforming to the Z0011 criteria were prospectively enrolled at the Peking University People’s Hospital Breast Center from November 2014 to June 2019. Clinicopathological features of the study group were compared with the Z0011 study. Lymphedema after surgery, incidence of local-regional recurrence, and survival were analyzed. Results: One hundred forty-two patients who met Z0011 eligibility criteria were enrolled in this study; 115 had sentinel lymph node biopsy (SLNB) alone. When comparing with the Z0011 trial, younger patients were included (median age, 52 [26- 82] years vs 54 [25-90] years; P = 0.03). Among clinical T stage, tumor histology, hormone status, lymphovascular invasion, and the number of positive sentinel lymph nodes (SLNs), no statistically significant differences were observed. More patients received adjuvant chemotherapy and endocrine therapy (90.85% vs 58.0% and 80.99% vs 46.6% respectively, P < .001). A similar percentage of patients received radiotherapy, but more nodal radiotherapy procedures were carried out in our study (54.5% vs 16.9%). After median follow-up of 29 months, only 1 patient (0.9%) had ipsilateral breast tumor recurrence and no regional recurrence occurred. Conclusion: Our study showed that it is achievable to avoid ALND in patients eligible for Z0011 in China. Trial registration: ClinicalTrials Registered Number: NCT03606616. Registered 31 July 2018-Retrospectiverly registered, https://www.clinicaltrials.gov/ct2/show/NCT03606616?term=Wang+shu&draw=4&ra nk=21.
Purpose This study aimed to assess the value of the combination of indocyanine green (ICG) and methylene blue (MB) dye in early breast cancer patients undergoing sentinel lymph node biopsy (SLNB).Methods Between January 2011 and December 2015, 1061 early breast cancer patients underwent SLNB were included. SLNB was performed for enrolled patients by injection of both ICG and MB. Detection rate, positivity, and number of sentinel lymph nodes (SLNs) by ICG and MB were analysed. Axillary recurrence and arm lymphedema at 5.6 years follow-up were reported.Results The combination of ICG and MB resulted in a very high detection rate of 99.6%, the median number of sentinel lymph nodes was 3. A total of 374 histologically confirmed positive SLNs were detected in 237 patients, 96.6% of the positive patients and 94.1% of the positive nodes could be identified by the combination of ICG and MB. After a median follow-up of 5.6 (2 to 9.3) years, 0.64% of patients with negative SLNs had ipsilateral axillary recurrence, and the incidence of arm lymphedema was 2.1%. Conclusions Although the missing isotope control weakens the interpretation of the findings, the dual tracing modality of ICG and MB, without involvement of radioactive isotopes, was an effective method for SLNB in patients with early breast cancer.
PurposeThe Combination of taxanes and anthracyclines is still the mainstay of chemotherapy for early breast cancer. Capecitabine is an active drug with a favorable toxicity profile, showing strong anti-tumor activity against metastatic breast cancer. This trial assessed the efficacy and safety of the TX regimen (docetaxel and capecitabine) and compared it with the TE (docetaxel and epirubicin) regimen in locally advanced or high risk early HER2-negative breast cancer.Patients and MethodsThis randomized clinical trial was conducted at five academic centers in China. Eligible female patients were randomly assigned (1:1) to the TX (docetaxel 75mg/m2 d1 plus capecitabine 1000mg/m2 twice d1–14, q3w) or TE (docetaxel 75mg/m2 d1 plus epirubicin 75mg/m2 d1, q3w) groups for four cycles. The primary endpoint was a pathological complete response in the breast (pCR). Secondary endpoints included pCR in the breast and axilla, invasive disease-free survival (iDFS), overall survival (OS), and safety.ResultsBetween September 1, 2012, and December 31, 2018, 113 HER2-negative patients were randomly assigned to the study groups (TX: n = 54; TE: n = 59). In the primary endpoint analysis, 14 patients in the TX group achieved a pCR, and nine patients in the TE group achieved a pCR (25.9% vs. 15.3%), with a not significant difference of 10.6% (95% CI -6.0–27.3%; p = 0.241). In a subgroup with high Ki-67 score, TX increased the pCR rate by 24.2% (95% CI 2.2–46.1%; p = 0.029). At the end of the 69-month median follow-up period, both groups had equivalent invasive disease-free survival and overall survival rates. TX was associated with a higher incidence of hand-foot syndrome and less alopecia, with a manageable toxicity profile.ConclusionThe anthracycline-free TX regimen yielded comparable pCR and long-term survival rates to the TE regimen. Thus, this anthracycline-free regimen could be considered in selected patients.Trial RegistrationACTRN12613000206729 on 16/02/2013, retrospectively registered.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.