Details

Autor(en) / Beteiligte

• Lambertini, Matteo
• Martel, Samuel
• Campbell, Christine
• Guillaume, Sébastien
• Hilbers, Florentine S.
• Schuehly, Uwe
• Korde, Larissa
• Azim, Hatem A.
• Di Cosimo, Serena
• Tenglin, Richard C.
• Huober, Jens
• Baselga, José
• Moreno‐Aspitia, Alvaro
• Piccart‐Gebhart, Martine
• Gelber, Richard D.
• de Azambuja, Evandro
• Ignatiadis, Michail

Titel

Pregnancies during and after trastuzumab and/or lapatinib in patients with human epidermal growth factor receptor 2–positive early breast cancer: Analysis from the NeoALTTO (BIG 1‐06) and ALTTO (BIG 2‐06) trials

Ist Teil von

• Cancer, 2019-01, Vol.125 (2), p.307-316

Ort / Verlag

United States: Wiley Subscription Services, Inc

Erscheinungsjahr

2019

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Background Limited data exist on the safety of using anti–human epidermal growth factor receptor 2 (HER2) targeted agents during pregnancy. To date, only retrospective studies have assessed the prognosis of patients with a pregnancy after prior early breast cancer, with no data in HER2‐positive patients. Methods The Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization (NeoALTTO) trial and the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) trial were randomized phase 3 trials for patients with HER2‐positive early breast cancer. In both trials, pregnancy information was prospectively collected. Pregnancy outcomes were compared between patients unintentionally exposed to trastuzumab and/or lapatinib during gestation (the exposed group) and those who became pregnant after trastuzumab and/or lapatinib completion (the unexposed group). In the ALTTO trial, disease‐free survival (DFS) was compared between pregnant patients and those aged 40 years or younger without a subsequent pregnancy via an extended Cox model with time‐varying covariates to account for a guarantee‐time bias. Results Ninety‐two patients (12 in the exposed group and 80 in the unexposed group) had a pregnancy: 7 in the NeoALTTO trial and 85 in the ALTTO trial. Seven patients (58.3%) in the exposed group and 10 patients (12.5%) in the unexposed group opted for an induced abortion; in the unexposed group, 10 patients (12.5%) had a spontaneous abortion. No pregnancy/delivery complications were reported for the remaining cases, who successfully completed their pregnancy, with the exception of 1 fetus with trisomy 21 (Down syndrome). No significant difference in DFS (adjusted hazard ratio, 1.12; 95% confidence interval, 0.52‐2.42) was observed between young patients with a pregnancy (n = 85) and young patients without a pregnancy (n = 1307). Conclusions For patients with HER2‐positive early breast cancer, having a pregnancy after treatment completion appears to be safe without compromising fetal outcome or maternal prognosis. For patients with human epidermal growth factor receptor 2–positive early breast cancer, having a pregnancy after treatment completion appears to be safe without compromising fetal outcome or maternal prognosis. A short, unintentional exposure to trastuzumab and/or lapatinib during gestation does not seem to affect newborn outcomes upon treatment discontinuation, although few live births are described for these patients.