Pregnancies during and following trastuzumab (T) and/or lapatinib (L) in patients (pts) with HER2-positive (HER2+) early breast cancer (EBC): Analysis from the NeoALTTO (BIG 1-06) and ALTTO (BIG 2-06) trials.
Bibliographic record
Abstract
10065 Background: Limited data exist on the safety of using targeted agents in pregnant cancer pts. So far, only retrospective studies assessed the prognosis of pts having a pregnancy after prior EBC with no data in HER2+ pts. We aimed to evaluate the outcome of pregnancies occuring during or following T and/or L and the prognostic effect of having a pregnancy in HER2+ EBC pts. Methods: NeoALTTO and ALTTO were randomized phase 3 trials in HER2+ EBC pts. In both trials, pregnancy information was prospectively collected. Pregnancy outcomes were compared between pts unintentionally exposed to T and/or L during gestation (exposed group) and those who got pregnant following T and/or L completion (not-exposed group). In the ALTTO trial, disease-free (DFS) and overall survival (OS) of pregnant pts were compared to those of pts ≤40 years without subsequent pregnancy with the Extended Cox Model With Time-Varying Covariates to account for guarantee-time bias. Results: Out of 455 and 8,381 pts included in NeoALTTO and ALTTO, 92 pts (7 in NeoALTTO and 85 in ALTTO) had a pregnancy at a median age of 33 years (range 23-40). Pregnancy outcomes are reported in the table No difference in DFS (HR 1.24; 95% CI 0.58-2.6) or OS (HR 0.53; 95% CI 0.13-2.17) was observed between young pts with (n = 85 pts) or without (n = 1,392 pts) a pregnancy. Conclusions: Despite fewer live births were described in the exposed group, unintentional exposure to T and/or L during gestation does not seem to affect newborns’ outcomes upon treatment discontinuation. Having a pregnancy after HER2+ EBC does not appear to impact on DFS or OS. These data are of high relevance to counsel young EBC pts facing pregnancy-related issues. Clinical trial information: NCT00490139. Exposed Group n = 17 pts Not-exposed Group n = 75 pts Completed pregnancy 7 (41%) 52 (69%) Induced abortion 10 (59%) 7 (9%) Spontaneous abortion 0 10 (13%) Ongoing/unknown 0 6 (8%) Live births 7 (41%) 54 (72%) Congenital anomalies 0 1 (2%) Oligohydramnios 0 0 Gestational week at delivery (range) 38.5 (34-39) 39 (38-40) Apgar score (range) 9 (9-9) 9 (9-10) Newborn weight, g (range) 3,145 (2,880-3,776) 3,440 (3,016-3,710) Newborn length, cm (range) 50 (49-52.5) 51 (49-52.5)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".