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10.1245/s10434-007-9751-7
Annals of Surgical Oncology 15:1064-1069 (2008)
© 2008 Society of Surgical Oncology
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Original Article

PIK3CA Exon 20 Mutation is Independently Associated with a Poor Prognosis in Breast Cancer Patients

Yuen-Liang Lai, MD1,2,3, Bey-Liing Mau, MD PhD4, Wen-Hsuan Cheng, MS5, Han-Ming Chen, MD6, Hsi-Hsiung Chiu, MD7 and Chin-Yuan Tzen, MD PhD5,8,9

1 Hospice Palliative Care Center, Mackay Memorial Hospital, 45 Minsheng Road, Danshui, Taipei 251, Taiwan
2 Center for General Education, National Yang-Ming University, 155 Sec. 2, Linong Street, Beitou, Taipei 112, Taiwan
3 School of Medicine, Taipei Medical University, 250 Wuxin Street, Xinyi, Taipei 110, Taiwan
4 Division of General Internal Medicine, Sun Yat-Sen Cancer Center, 125 Lihder Road, Beitou, Taipei 112, Taiwan
5 Department of Pathology, Mackay Memorial Hospital, 45 Minsheng Road, Danshui, Taipei 251, Taiwan
6 Department of Surgery, Ten-Chan General Hospital, 155 Yanping Road, Chungli, Taoyuan 320, Taiwan
7 Department of Surgery, Cheng-Ching Hospital, 118 Sec. 3, Chungkang Road, Taichung 407, Taiwan
8 Mackay Medicine, Nursing and Management College, 92 Shengjing Road, Beitou, Taipei 112, Taiwan
9 National Taipei College of Nursing, 365 Minte Road, Beitou, Taipei 112, Taiwan

Correspondence: Address correspondence and reprint requests to: Chin-Yuan Tzen, MD PhD; E-mail: jeffrey{at}ms2.mmh.org.tw

Background: Prognostic factors that could select breast cancer patients with poor survival, and influence clinical trials of targeted therapy, are needed. However, the reported observations regarding the impact of PI3KCA mutation on breast cancers are controversial.

Methods: We analyzed exons 4, 7, 9, and 20 of PI3KCA on a series of 158 patients. Clinicopathological characteristics were correlated with the mutation data.

Results: Among 152 patients who were available for follow-up (median follow-up time, 6.57 years), 26% had PIK3CA mutations, more than half of which occurred in exon 20. The five-year survival rate of patients with exon 20 mutations (46%) was significantly lower than that of patients without (75%) (p = 0.0054). Multivariate analysis showed that PIK3CA exon 20 mutations and nodal involvement were independent risk factors for overall survival. The relative risk of death in patients with PIK3CA exon 20 mutations was 2.881 (95% CI, 1.406–5.900; p = 0.0038).

Conclusions: PIK3CA mutations are common in invasive ductal carcinomas of the breast. Our result suggests that PIK3CA exon 20 mutation is an independent risk factor for poor prognosis in breast cancer patients, indicating that differences in patient numbers with PIK3CA exon 20 mutations in study and control arms should be avoided in clinical trials of PI3K inhibitors.

Key Words: PI3K • PIK3CA mutation • Prognosis • Breast cancer






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