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The prognostic relevance of HER2-positivity gain in metastatic breast cancer in the ChangeHER trial.

ABSTRACT: In metastatic breast cancer (mBC), the change of human epidermal growth factor receptor 2 (HER2) status between primary and metastatic lesions is widely recognized, however clinical implications are unknown. Our study address the question if relevant differences exist between subjects who preserve the HER2 status and those who gain the HER2 positivity when relapsed. Data of patients affected by HER2-positive mBC, treated with pertuzumab and/or trastuzumab-emtansine (T-DM1) in a real-world setting at 45 Italian cancer centers were retrospectively collected and analyzed. From 2003 to 2017, 491 HER2-positive mBC patients were included. Of these, 102 (20.7%) had been initially diagnosed as HER2-negative early BC. Estrogen and/or progesterone receptor were more expressed in patients with HER2-discordance compared to patients with HER2-concordant status (p < 0.0001 and p = 0.006, respectively). HER2-discordant tumors were characterized also by a lower rate of brain metastases (p = 0.01) and a longer disease free interval (p < 0.0001). Median overall survival was longer, although not statistically significant, in the subgroup of patients with HER2-discordant cancer with respect to patients with HER2-concordant status (140 vs 78 months, p = 0.07). Our findings suggest that patients with HER2-positive mBC with discordant HER2 status in early BC may have different clinical, biological and prognostic behavior compared to HER2-concordant patients.

SUBMITTER: Pizzuti L

PROVIDER: S-EPMC8253801 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background:Although 1% has been used as cut-off for estrogen receptor (ER) positivity, several studies have reported that tumors with ER?<?1% have characteristics similar to those with 1%???ER?<?10%. We hypothesized that in patients with human epidermal growth factor 2 (HER2)-negative breast cancer, a cut-off of 10% is more useful than one of 1% in discriminating for both a better pathological complete response (pCR) rate to neoadjuvant chemotherapy and a better long-term outcome with adjuvant hormonal therapy. Our objectives were to identify a percentage of ER expression below which pCR was likely and to determine whether this cut-off value can identify patients who would benefit from adjuvant hormonal therapy. Patients and methods:Patients with stage II or III HER2-negative primary breast cancer who received neoadjuvant chemotherapy followed by definitive surgery between June 1982 and June 2013 were included. Logistic regression models were used to assess the association between each variable and pCR. Cox models were used to analyze time to recurrence and overall survival. The recursive partitioning and regression trees method was used to calculate the cut-off value of ER expression. Results:A total of 3055 patients were analyzed. Low percentage of ER was significantly associated with high pCR rate (OR?=?0.99, 95% CI?=?0.986-0.994, P?<?0.001). The recommended cut-off of ER expression below which pCR was likely was 9.5%. Among patients with ER???10% tumors, but not those with 1%?ER?<?10% tumors, adjuvant hormonal therapy was significantly associated with long time to recurrence (HR?=?0.24, 95% CI?=?0.16-0.36, P?<?0.001) and overall survival (HR?=?0.32, 95% CI?=?0.2-0.5, P?<?0.001). Conclusion:Stage II or III HER2-negative primary breast cancer with ER?<?10% behaves clinically like triple-negative breast cancer in terms of pCR and survival outcomes and patients with such tumors may have a limited benefit from adjuvant hormonal therapy. It may be more clinically relevant to define triple-negative breast cancer as HER2-negative breast cancer with?<10%, rather than?<1%, of ER and/or progesterone receptor expression.

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The prognostic relevance of HER2-positivity gain in metastatic breast cancer in the ChangeHER trial.

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