TY - JOUR
T1 - PREDICT underestimates survival of patients with HER2-positive early-stage breast cancer
AU - Agostinetto, Elisa
AU - Ameye, Lieveke
AU - Martel, Samuel
AU - Aftimos, Philippe
AU - Pondé, Noam
AU - Maurer, Christian
AU - El-Abed, Sarra
AU - Wang, Yingbo
AU - Vicente, Malou
AU - Chumsri, Saranya
AU - Bliss, Judith
AU - Kroep, Judith
AU - Colleoni, Marco
AU - Petrelli, Fausto
AU - Del Mastro, Lucia
AU - Moreno-Aspitia, Alvaro
AU - Piccart, Martine
AU - Paesmans, Marianne
AU - de Azambuja, Evandro
AU - Lambertini, Matteo
N1 - Funding Information:
This work was supported by Les Amis de l’Institut Bordet (Grant No. 2018-09). The ALTTO trial received financial support from GlaxoSmithKline (until January 2015), Novartis Pharma AG (as of January 2015) and the National Cancer Institute of the National Institutes of Health (NCI-NIH; Grant No. U10CA180821 and U10CA180882 to the Alliance for Clinical Trials in Oncology and Grant No. CA025224 to the legacy North Central Cancer Treatment Group). Matteo Lambertini acknowledges the support from the Italian Association for Cancer Research (“Associazione Italiana per la Ricerca sul Cancro”, AIRC; MFAG 2020 ID 24698) and the Italian Ministry of Health (5 × 1000 funds 2017). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the present manuscript. All authors agreed and share the final responsibility for the provided interpretation of the study results and for the decision to submit for publication. The abstract of the present work was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2021 and was awarded an ASCO Merit Award.
Funding Information:
This work was supported by Les Amis de l’Institut Bordet (Grant No. 2018-09). The ALTTO trial received financial support from GlaxoSmithKline (until January 2015), Novartis Pharma AG (as of January 2015) and the National Cancer Institute of the National Institutes of Health (NCI-NIH; Grant No. U10CA180821 and U10CA180882 to the Alliance for Clinical Trials in Oncology and Grant No. CA025224 to the legacy North Central Cancer Treatment Group). Matteo Lambertini acknowledges the support from the Italian Association for Cancer Research (“Associazione Italiana per la Ricerca sul Cancro”, AIRC; MFAG 2020 ID 24698) and the Italian Ministry of Health (5 × 1000 funds 2017). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the present manuscript. All authors agreed and share the final responsibility for the provided interpretation of the study results and for the decision to submit for publication. The abstract of the present work was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2021 and was awarded an ASCO Merit Award.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - The prognostic performance of PREDICT in patients with HER2-positive early breast cancer (EBC) treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies is unclear. Therefore, we investigated its prognostic performance using data extracted from ALTTO, a phase III trial evaluating adjuvant lapatinib ± trastuzumab vs. trastuzumab alone in patients with HER2-positive EBC. Our analysis included 2794 patients. After a median follow-up of 6.0 years (IQR, 5.8–6.7), 182 deaths were observed. Overall, PREDICT underestimated 5-year OS by 6.7% (95% CI, 5.8–7.6): observed 5-year OS was 94.7% vs. predicted 88.0%. The underestimation was consistent across all subgroups, including those according to the type of anti HER2-therapy. The highest absolute differences were observed for patients with hormone receptor negative-disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively). AUC under the ROC curve was 73.7% (95% CI 69.7–77.8) in the overall population, ranging between 61.7% and 77.7% across the analyzed subgroups. In conclusion, our analysis showed that PREDICT highly underestimated OS in HER2-positive EBC. Hence, it should be used with caution to give prognostic estimation to HER2-positive EBC patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.
AB - The prognostic performance of PREDICT in patients with HER2-positive early breast cancer (EBC) treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies is unclear. Therefore, we investigated its prognostic performance using data extracted from ALTTO, a phase III trial evaluating adjuvant lapatinib ± trastuzumab vs. trastuzumab alone in patients with HER2-positive EBC. Our analysis included 2794 patients. After a median follow-up of 6.0 years (IQR, 5.8–6.7), 182 deaths were observed. Overall, PREDICT underestimated 5-year OS by 6.7% (95% CI, 5.8–7.6): observed 5-year OS was 94.7% vs. predicted 88.0%. The underestimation was consistent across all subgroups, including those according to the type of anti HER2-therapy. The highest absolute differences were observed for patients with hormone receptor negative-disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively). AUC under the ROC curve was 73.7% (95% CI 69.7–77.8) in the overall population, ranging between 61.7% and 77.7% across the analyzed subgroups. In conclusion, our analysis showed that PREDICT highly underestimated OS in HER2-positive EBC. Hence, it should be used with caution to give prognostic estimation to HER2-positive EBC patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.
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U2 - 10.1038/s41523-022-00452-8
DO - 10.1038/s41523-022-00452-8
M3 - Article
AN - SCOPUS:85134484041
SN - 2374-4677
VL - 8
JO - npj Breast Cancer
JF - npj Breast Cancer
IS - 1
M1 - 87
ER -