Impact on time to surgery on survival after NACT in breast cancer
Research type
Research Study
Full title
Impact on time to surgery on survival outcomes after completion of neoadjuvant chemotherapy in breast cancer patients
IRAS ID
222885
Contact name
Srinivas Pedamallu
Contact email
Sponsor organisation
Medway NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
1. Introduction
Neoadjuvant chemotherapy in the treatment of breast cancer is well established as a therapeutic modality for locally advanced disease, inflammatory cancers, large tumours, for selected high-risk cases and patients who might otherwise need a mastectomy due to the small size of the breast or position of the tumour within it.
Timing of surgery after neoadjuvant chemotherapy is very important and severe delays were reported to have serious impact on survival outcomes of these high risk patients. Patients with neoadjuvant chemotherapy to surgery intervals of up to 8 weeks was reported to had equivalent overall survival, recurrence free survival, and locoregional recurrence-free survival).Another recently published Italian study suggested that significantly worse overall survival and recurrence free survival was associated with time to surgery longer than 21 days.
Our study will aid us to identify factors causing delays in time to surgery after neoadjuvant chemotherapy and resultant impact on survival outcomes of these high risk patients. This might also provide insight into optimum time to surgery interval. This information will help us to time the surgery appropriately without influencing the survival outcome in these high risk patients by proper planning and avoiding unnecessary delays.
2. Aim of Study
To investigate the interval from conclusion of neoadjuvant chemotherapy to surgery in breast cancer patients, causes of potential delays and its impact on survival outcomes of these high risk patients.
3. Investigational plan
a) General Schema of Design
This is a retrospective review.
b) Study Duration, Enrolment and Number of Sites
c) Date Range of Study
Cases between 01/01/2012 and 31/12/2016 will be included.
d) Total Number of Sites/Total Number of Subjects Projected
This review will be conducted at Medway maritime hospital, Gillingham, Kent, United
Kingdom. This is estimated that about 60 cases will be included in the study.
e) Study Population
I. Inclusion Criteria
• Female patients
• All cases that had neoadjuvant chemotherapy followed by breast conserving surgery or mastectomy for breast cancer between 01/01/2012 and 31/12/2016 are included.
II. Exclusion Criteria
• Recurrent breast cancer
• Patients with distant metastases
4. Study Procedures
The study procedures are limited to review of existing medical records, clinical letters and laboratory reports.
5. Data Sources
Data will be collected from non-research sources such as hospital systems and medical records. Information such as demographic information, admission dates, and surgical information is collected from trust oasis database. Clinical letters are reviewed on trust OPN database. MDM summaries are reviewed from medical notes.
6. Data Elements to Abstracted
List of all of the variables that will be abstracted:
• Patient’s age
• Tumour biology such as type, grade, hormone receptor status, Her2 status, lymphovascular invasion and evidence of lymph node involvement.
• Type of chemotherapy regimen.
• Time interval between completion of last cycle of neoadjuvant chemotherapy to surgery.
• Delays in surgery due to side effects of chemotherapy.
• Patient decision to delay surgery, if any.
• Type of Surgery (Breast conserving surgery or Mastectomy).
• Pathological response to neoadjuvant chemotherapy (complete response, no response, partial response).
• Any evidence of local or regional recurrence in the post-operative follow-up period.
• Evidence of distant metastasis in the post-operative follow-up period.
• Mortality in the post-operative follow-up period.REC name
North of Scotland Research Ethics Committee 1
REC reference
17/NS/0007
Date of REC Opinion
16 Feb 2017
REC opinion
Further Information Favourable Opinion