European journal of cancer (Oxford, England : 1990) · 2025
PIK3CA mutations and first-line outcomes in endocrine-resistant HR+/HER2- metastatic breast cancer: A multicentric real-world study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Dieci Maria Vittoria, Vernaci Grazia, Colangelo Chiara, Bria Emilio, Massa Davide, Di Liso Elisabetta, Giorgi Carlo Alberto, Giarratano Tommaso, Napetti Davide, Bonomi Giorgio, Zanghì Francesca, Bottosso Michele, Lazzarini Elisabetta, Santarelli Laura, Boscolo Bragadin Andrea, Indraccolo Stefano, Guarneri Valentina
Аннотация
BACKGROUND: Outcomes and characteristics of endocrine-resistant, PIK3CA-mutated HR+ /HER2- advanced breast cancer patients in real-world are poorly investigated. Here, we explored the role of circulating PIK3CA mutations in endocrine-resistant patients in the ongoing prospective, multicentric CHAMBER study.
METHODS: PIK3CA was analyzed by NGS panel covering the full exonic region of PIK3CA gene. Endocrine resistance was defined as: i) primary: relapse during the first 2 years of adjuvant ET, or ii) secondary: relapse after 2 years of starting or within 1 year of completing ET. Overall survival (OS) was calculated from the start of first-line to death from any cause. Progression free survival 1 (PFS1) was calculated from the start of first-line to progression or death.
RESULTS: Among the overall CHAMBER population, 22 % patients met the criteria for endocrine-resistance (74/337). The study population consisted in 95 % women and 5 % men; median age at diagnosis was 50 years (IQR 44-63); 75 % of the women was postmenopausal;86 % of the total population presented with a secondary endocrine-resistance, 64 % had visceral relapse, 74 % had less than 3 metastatic sites, 79 % had received first-line CDK4/6 inhibitor. PIK3CA status was available for 63/74 pts, with a 29 % prevalence of mutation. PIK3CAmut was a negative prognostic factor for OS (median 65 [wt] vs 36 months [mut], log-rank p 0.024 HR 2.61 [95 % CI 1.10-6.22]) and PFS1 (median 22 [wt] vs 10 months [mut], log-rank p 0.012, HR 2.24 [95 % CI 1.18-4.26]).
CONCLUSION: The co-occurrence of endocrine-resistance and PIK3CAmut identifies a population with unfavorable prognosis, reinforcing the rationale of escalated therapies.
METHODS: PIK3CA was analyzed by NGS panel covering the full exonic region of PIK3CA gene. Endocrine resistance was defined as: i) primary: relapse during the first 2 years of adjuvant ET, or ii) secondary: relapse after 2 years of starting or within 1 year of completing ET. Overall survival (OS) was calculated from the start of first-line to death from any cause. Progression free survival 1 (PFS1) was calculated from the start of first-line to progression or death.
RESULTS: Among the overall CHAMBER population, 22 % patients met the criteria for endocrine-resistance (74/337). The study population consisted in 95 % women and 5 % men; median age at diagnosis was 50 years (IQR 44-63); 75 % of the women was postmenopausal;86 % of the total population presented with a secondary endocrine-resistance, 64 % had visceral relapse, 74 % had less than 3 metastatic sites, 79 % had received first-line CDK4/6 inhibitor. PIK3CA status was available for 63/74 pts, with a 29 % prevalence of mutation. PIK3CAmut was a negative prognostic factor for OS (median 65 [wt] vs 36 months [mut], log-rank p 0.024 HR 2.61 [95 % CI 1.10-6.22]) and PFS1 (median 22 [wt] vs 10 months [mut], log-rank p 0.012, HR 2.24 [95 % CI 1.18-4.26]).
CONCLUSION: The co-occurrence of endocrine-resistance and PIK3CAmut identifies a population with unfavorable prognosis, reinforcing the rationale of escalated therapies.