Dataset Information

Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy.

ABSTRACT:

Background

Postoperative radiotherapy (PORT) could be useful for pN1 breast cancer patients who have undergone breast-conserving surgery (BCS) or mastectomy. However, the value of regional nodal irradiation (RNI) for BCS patients, and the indications for post-mastectomy radiotherapy (PMRT) for pN1 breast cancer mastectomy patients, have recently been challenged due to the absence of relevant trials in the era of modern systemic therapy. "PORT de-escalation" should be assessed in patients with pN1 breast cancer.

Methods

The PORT-N1 trial is a multicenter, randomized, phase 3 clinical trial for patients with pN1 breast cancer that compares the outcomes of control [whole-breast irradiation (WBI) and RNI/PMRT] and experimental (WBI alone/no PMRT) groups. PORT-N1 aims to demonstrate non-inferiority of the experimental group by comparing 7-year disease-free survival rates with the control group. Female breast cancer patients with pT1-3 N1 status after BCS or mastectomy are eligible. Participants will be randomly assigned to the two groups in a 1:1 ratio. Randomization will be stratified by surgery type (BCS vs. mastectomy) and histologic subtype (triple-negative vs. non-triple-negative). In patients who receive mastectomy, dissection of ≥5 nodes is required when there is one positive node, and axillary lymph node dissection when there are two or three positive nodes. Patients receiving neoadjuvant chemotherapy are not eligible. RNI includes a "high-tangent" or wider irradiation field. This study will aim to recruit 1106 patients.

Discussion

The PORT-N1 trial aims to verify that PORT de-escalation after BCS or mastectomy is safe for pN1 breast cancer patients in terms of oncologic outcomes and capable of reducing toxicity rates. This trial will provide information crucial for designing PORT de-escalation strategies for patients with pN1 breast cancer.

Trial registration

This trial was registered at ClinicalTrials.gov (NCT05440149) on June 30, 2022.

SUBMITTER: Lee TH

PROVIDER: S-EPMC9670382 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy.

Lee Tae Hoon TH Chang Ji Hyun JH Jang Bum-Sup BS Kim Jae Sik JS Kim Tae Hyun TH Park Won W Kim Yong Bae YB Kim Su Ssan SS Han Wonshik W Lee Han-Byoel HB Shin Kyung Hwan KH

BMC cancer 20221116 1

<h4>Background</h4>Postoperative radiotherapy (PORT) could be useful for pN1 breast cancer patients who have undergone breast-conserving surgery (BCS) or mastectomy. However, the value of regional nodal irradiation (RNI) for BCS patients, and the indications for post-mastectomy radiotherapy (PMRT) for pN1 breast cancer mastectomy patients, have recently been challenged due to the absence of relevant trials in the era of modern systemic therapy. "PORT de-escalation" should be assessed in patients ...[more]

PMID: 36384573

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Project description:Introduction: The early randomized controlled trials revealed no differences in survival between breast-conserving surgery (BCS) and mastectomy. However, breast cancer treatment has undergone changes, and the results of recent population-based registry studies suggest superior long-term survival after BCS. To explore the current evidence, a systematic review and meta-ana lysis of population-based observational studies from 2010 and onward was conducted. Methods: A literature search was conducted in the PubMed, Embase, and Cochrane databases to identify relevant literature. Keywords included “mastectomy,” “breast conserving surgery,” and “survival.” The identified studies were narratively reviewed and effect sizes (hazard ratios [HRs]) for overall (OS) and breast cancer-specific survival (BCSS) were combined with random-effects models. Results: A total of 30 reports were included in the review, and results from 25 studies were included in the meta-analyses. Compared with mastectomy, BCS was associated with better OS (HR = 1.34 [1.20–1.51]; N = 1,311,600) and BCSS (HR = 1.38 [1.29–1.47]; N = 494,267). Selected subgroups of patients, based on lymph node status, age (<50 years/≥50 years), and radiation therapy after mastectomy (±), all showed better overall survival after BCS. The number (range 4–12) and type of prognostic variables adjusted for in the survival analyses of the studies did not statistically significantly moderate the differences in survival between BCS and mastectomy. Conclusions: The combined findings from large population-based studies indicate that BCS is associated with survival benefit compared with mastectomy, suggesting that BCS be the recommended treatment of early breast cancer (T1-2N0-1M0) if a radical lumpectomy can be performed. Mini-Abstract: A systematic review and meta-analysis of population-based observational studies comparing the survival after breast-conserving surgery and mastectomy in patients with breast cancer. The review comprises 30 papers from 2010 to 2021. More than 1.3 million patients are included in the meta-analyses.

Project description:IntroductionBreast cancer is the most prevalent cancer and the leading cause of cancer-related death in women. Conventional open mastectomy (C-OM) is one of the most common procedures for breast cancer, which involves the removal of the nipple-areola complex and a large proportion of the breast skin, leading to poor cosmetic effect and restriction of upper extremity function. Single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) could conceal the incision along the wrinkles in the axilla, preserve all the breast skin and nipple-areola complex and provide a better cosmetic outcome and quality of life. This trial aims to investigate the oncological safety between SIE-NSM and C-OM in early breast cancer patients.Methods and analysisThis is a single centre, non-blinded, randomised controlled trial (RCT) and will be conducted at Beijing Friendship Hospital. Patients will be enrolled in the inpatient ward. Breast surgeons will notify patients who meet the inclusion and exclusion criteria with the instruction of this RCT. Patients will be randomly assigned to C-OM or SIE-NSM with a 3:1 allocation as per a computer-generated randomisation schedule. Patients will be followed-up for 12 months for analysing surgical outcomes. The primary outcome is the local recurrence rate at a 12-month follow-up. The secondary outcome is the distant metastasis rate, cosmetic satisfaction score and psychosocial well-being score after a 12-month follow-up. To ensure the accuracy of the cosmetic satisfaction score and psychosocial well-being score, the standard scale, Breast-Q score, will be applied.Ethics and disseminationThis study will be conducted according to the medical ethics committee of the Beijing Friendship Hospital and according to the principles of the Declaration of Helsinki. All patients will receive clear instruction of their disease and treatment plan. Informed consent will be obtained from all patients when they agree to comply with our research plan. The results will be disseminated at academic presentations and publications in peer-reviewed journals. The raw data will be confidentially stored in our electronic data capture database. Data will not be shared unless an appropriate data request is submitted after the trial completion and peer-review journal publication.Trial registration numberNCT04461847.

Project description:BackgroundRecent evidence suggests a survival advantage after breast-conserving surgery compared with mastectomy. Previous studies have compared survival outcomes after standard breast-conserving surgery, but no studies have compared survival outcomes after oncoplastic breast-conserving surgery. The aim of this study was to compare survival outcomes after breast-conserving surgery + radiotherapy (and an oncoplastic breast-conserving surgery + radiotherapy subgroup) with those after mastectomy ± radiotherapy.MethodsPatients diagnosed with primary invasive breast cancer between 1 January 2010 and 31 December 2019 were identified from a prospectively maintained National Cancer Registry. Overall survival and breast cancer-specific survival outcomes were analysed using Kaplan-Meier analysis and Cox regression analysis adjusting for patient demographics, tumour characteristics, and treatment adjuncts.ResultsA total of 14 182 patients were eligible (8537 patients underwent standard breast-conserving surgery + radiotherapy, 360 patients underwent oncoplastic breast-conserving surgery + radiotherapy, 2953 patients underwent mastectomy + radiotherapy, and 2332 patients underwent mastectomy - radiotherapy). The median follow-up was 7.27 (range 0.2-13.6) years. Superior 10-year survival was observed after breast-conserving surgery + radiotherapy (overall survival: 81.2%; breast cancer-specific survival: 93.3%) compared with mastectomy + radiotherapy (overall survival: 63.4%; breast cancer-specific survival: 75.9%) and mastectomy - radiotherapy (overall survival: 63.1%; breast cancer-specific survival: 87.5%). Ten-year overall survival and breast cancer-specific survival after oncoplastic breast-conserving surgery + radiotherapy were 86.1% and 90.2% respectively. After adjusted analysis, breast-conserving surgery + radiotherapy was associated with superior survival outcomes compared with mastectomy + radiotherapy (overall survival: HR 1.34 (95% c.i. 1.20 to 1.51); breast cancer-specific survival: HR 1.62 (95% c.i. 1.38 to 1.90)) and mastectomy - radiotherapy (overall survival: HR 1.57 (95% c.i. 1.41 to 1.75); breast cancer-specific survival: HR 1.70 (95% c.i. 1.41 to 2.05)). Similar survival outcomes were observed amongst patients treated with oncoplastic breast-conserving surgery + radiotherapy compared with mastectomy + radiotherapy (overall survival: HR 1.72 (95% c.i. 1.62 to 2.55); breast cancer-specific survival: HR 1.74 (95% c.i. 1.06 to 2.86)) and mastectomy - radiotherapy (overall survival: HR 2.21 (95% c.i. 1.49 to 3.27); breast cancer-specific survival: HR 1.89 (95% c.i. 1.13 to 3.14)).ConclusionBreast-conserving surgery + radiotherapy and oncoplastic breast-conserving surgery + radiotherapy are associated with superior overall survival and breast cancer-specific survival compared with mastectomy ± radiotherapy. The findings should inform discussion of surgical treatment options for patients with breast cancer.

Project description:IntroductionThis study compares the perioperative results, aesthetic outcome and oncologic safety of single-port insufflation endoscopic nipple-sparing subcutaneous mastectomy combined with immediate reconstruction using prosthesis implantation (SIE-NSM-IRPI) with those of conventional open-nipple and areola-sparing subcutaneous mastectomy combined with immediate reconstruction using prosthesis implantation (C-NSM-IRPI).MethodsIn this retrospective cohort study, 64 early-stage breast cancer patients were divided into SIE-NSM-IRPI (n = 38) and C-NSM-IRPI (n = 26) groups. Perioperative results (operation time, intraoperative blood loss, incision length, drainage duration, and recent complications) were then compared between the two groups. Differences in satisfaction with the breasts, psychosocial well-being, physical well-being (chest) and sexual well-being were analyzed according to the BREAST-Q scale, and survival outcomes were also compared.ResultsThe median follow-up time was 51.5 months. The incision length of SIE-NSM-IRPI was shorter than that of C-NSM-IRPI (P < 0.001). SIE-NSM-IRPI achieved the same detection rate and median number of sentinel lymph nodes as C-NSM-IRPI (3.00vs. 4.00, P = 0.780). The incidence of prosthesis removal due to infection or prosthesis exposure in the SIE-NSM-IRPI group was lower than that in the C-NSM-IRPI group (P = 0.015). Satisfaction with breasts (82.00vs.59.00, P < 0.001), psychosocial well-being (93.00vs.77.00, P = 0.001) and physical well-being (chest) (89.00vs.82.00, P < 0.001) scores were higher in the SIE-NSM-IRPI group. There were no significant differences between the two groups in disease-free survival (hazard ratio = 0.829, 95% confidence interval = 0.182-3.779) and overall survival (hazard ratio = 1.919, 95% confidence interval = 0.169-21.842).ConclusionIn this selected cohort of patients with early breast cancer, SIE-NSM-IRPI was comparable to C-NSM-IRPI, considering oncologic safety and detection of sentinel lymph nodes. It had a lower incidence of prosthesis removal, shorter incision length, and was associated with better patient satisfaction with the breasts. More random clinical trials of this novel approach in a larger cohort of Chinese patients with an extended follow-up period are needed in the future.

Dataset Information

Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy.

Background

Methods

Discussion

Trial registration

Publications

Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy.

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