Abstract
When patients with advanced breast cancer (ABC) are treated with neoadjuvant chemotherapy (NACT), efficacy is monitored by the extent of tumor shrinkage. Since their publication in 1981, World Health Organization (WHO) guidelines have been widely practiced in clinical trials and oncologic practice, for standardized tumor response evaluation. With advances in cancer treatment and tumor imaging, a simpler criterion based on one-dimensional rather than bi-dimensional (WHO) tumor measurement, named Response Evaluation Criteria in Solid Tumors (RECIST) was introduced in 2000. Both approaches have four response categories: complete response, partial response, stable disease and progressive disease (PD). Bi-dimensional measurement data of 151 patients with ABC were analysed with WHO and RECIST criteria to compare their response categories and inter criteria reproducibility by Kappa statistics. There was 94% concordance and 9/151 patients were re-categorized with RECIST including 6/12 PD cases. RECIST therefore under-estimates and delays diagnosis of PD. This is undesirable because it may delay or negate switch over to alternate therapy. Analysis was repeated with a new criteria named RECIST-Breast (RECIST-B), with a lower threshold for PD (≥10% rather than ≥20% increase of RECIST). This showed higher concordance of 97% with WHO criteria and re-categorization of only 4/151 patients (1/12 PD cases). RECIST-B criteria therefore have advantages of both ease of measurement and calculations combined with excellent concordance with WHO criteria, providing a practical clinical tool for response evaluation and offering good comparison with past and current clinical trials of NACT using WHO guidelines.
Highlights
A vast majority of breast cancer patients present with advanced disease in the developing countries (Chopra et al, 2001; Yip et al, 2006; Agarwal et al, 2007; Eniu et al, 2008; Khokher et al, 2012)
Clinical response to neoadjuvant chemotherapy (NACT) was evaluated by the World Health Organization (WHO) criteria. clinical complete response (cCR) was defined as complete disappearance of tumor mass, clinical Partial Response when there was ≥50% reduction in the product of two perpendicular dimensions of the tumor mass, clinical Progressive Disease when there was ≥25% increase in the product of two perpendicular dimensions of tumor and clinical Stable Disease when the change did not meet the criteria for other categories. cCR and cPR were grouped as responders and cSD and cPD as non-responders
Among the 94 patients categorized as cPR according to WHO criteria, one was categorized as cSD and among the 35 patients categorized as cSD according to WHO criteria, two were categorized as cPR, by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Summary
A vast majority of breast cancer patients present with advanced disease in the developing countries (Chopra et al, 2001; Yip et al, 2006; Agarwal et al, 2007; Eniu et al, 2008; Khokher et al, 2012). With advances in cancer treatment and tumor imaging, a simpler criterion based on onedimensional rather than bi-dimensional (WHO) tumor measurement, named Response Evaluation Criteria in Solid Tumors (RECIST) was introduced in 2000.
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