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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Oct 15, 2024
Date Accepted: Apr 17, 2025

The final, peer-reviewed published version of this preprint can be found here:

Assessing the Efficacy of Current Histopathological Tumor Reporting Systems for Evaluating the Response to Neoadjuvant Chemotherapy for Breast Carcinoma: Protocol for an Observational Study

Sajjanar A, Vagha S

Assessing the Efficacy of Current Histopathological Tumor Reporting Systems for Evaluating the Response to Neoadjuvant Chemotherapy for Breast Carcinoma: Protocol for an Observational Study

JMIR Res Protoc 2025;14:e56825

DOI: 10.2196/56825

PMID: 40523279

PMCID: 12209717

Assessing the Efficacy of Current Histopathological Tumor Reporting Systems in Evaluating Response to Neoadjuvant Chemotherapy in Breast Carcinoma: An observational protocol study

  • Anita Sajjanar; 
  • Sunita Vagha

ABSTRACT

Background:

Breast carcinomas are a global health challenge, being the most frequently diagnosed cancer in women and a leading cause of cancer-related death. The standard treatment for breast cancer remains surgical resection followed by adjuvant therapies, where indicated such as chemotherapy, endocrine therapy, biological therapies, and radiotherapy. Currently, neoadjuvant chemotherapy is used for locally advanced breast cancer, inflammatory breast cancer, and down-staging of large tumors to allow for breast conservation therapy. Since it can achieve reduction or even complete regression of primary tumors and their metastasis. It provides a rare chance to assess therapy response, with a complete pathologic response serving as a surrogate marker of survival. Furthermore, patients can avoid the burden of toxicity and side effects by changing to a different medication or reducing the dose if they become resistant to therapy. This evaluation of the behavior of the tumor in situ during neoadjuvant chemotherapy and its association with the clinical outcome provides a great model for figuring out how predictive are the tumor properties. Various histopathological tumor reporting systems exist, such as NSABP B-18, Chevallier, Sataloff, Miller-Payne, and Residual Cancer Burden (RCB). However, discrepancies among these systems create challenges in predicting treatment . This study aims to refine and potentially modify existing histopathological grading systems used for breast carcinoma patients undergoing neoadjuvant chemotherapy. The primary objectives include identifying principal parameters, segregating insignificant ones, and proposing modifications for a more precise and unified grading system.

Objective:

This study aims to refine and potentially modify existing histopathological grading systems used for breast carcinoma patients undergoing neoadjuvant chemotherapy. The primary objectives include identifying principal parameters, segregating insignificant ones, and proposing modifications for a more precise and unified tumor reporting system.

Methods:

The present study will be retrospective and prospective study that included 84 patients diagnosed with breast carcinomas and undergone neoadjuvant chemotherapy between January 2019 and December 2023.The Institutional ethics committee clearance was obtained prior to commencement of study.Patient's medical records,history and clinical examination, radiological tests, and prior biopsies will be documented. According to conventional procedure,the resection specimens acquired during MRM after NACT will be examined and diagnosed by histopathology reporting. Following chemotherapy, a thorough examination of the histopathological specimens will be conducted to assess any changes in histomorphology. All patients with breast carcinomas diagnosed on fnac, trucut biopsy who had previously received NACT followed by Modified Radical Mastectomy (MRM)are included in study.

Results:

The study findings may guide clinicians in selecting and using the most effective Tumor Reporting Systems for evaluating NACT response in Carcinoma Breast patients. This could lead to improvements in clinical decision-making and more accurate assessment of treatment outcomes

Conclusions:

Overall, the study towards unraveling the clinical implications of employing various histopathological assessment systems in breast carcinoma patients undergone neoadjuvant chemotherapy.It involve a critical analysis of the strengths and limitations of different tumor reporting systems. Clinical Trial: CTRI


 Citation

Please cite as:

Sajjanar A, Vagha S

Assessing the Efficacy of Current Histopathological Tumor Reporting Systems for Evaluating the Response to Neoadjuvant Chemotherapy for Breast Carcinoma: Protocol for an Observational Study

JMIR Res Protoc 2025;14:e56825

DOI: 10.2196/56825

PMID: 40523279

PMCID: 12209717

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