# Randomized Phase II Trial of Anthracycline-free and Anthracycline-containing Neoadjuvant Carboplatin Chemotherapy Regimens in Stage I-III Triple-negative Breast Cancer (NeoSTOP)

**Autores:** Priyanka Sharma, Bruce F Kimler, Anne O'Dea et al.
**Revista:** Clin Cancer Res (2021)
**PMID:** 33208340 | **PMCID:** PMC7887017
**DOI:** [10.1158/1078-0432.CCR-20-3646](https://doi.org/10.1158/1078-0432.CCR-20-3646)
**Fuente:** PubMed Central (open access full-text)

## Relevancia
Ensayo NeoSTOP fase II (n=100) compara dos esquemas de QT neoadyuvante con carboplatino en TNBC estadio I-III. La pCR (mama + axila) fue 54% en ambos brazos, demostrando que el régimen sin antraciclinas (CbD) es no inferior con mejor perfil de toxicidad. Relevante para el escenario cN+ TNBC donde se busca alta pCR axilar.

## Abstract
Addition of carboplatin (Cb) to anthracycline chemotherapy improves pathologic complete response (pCR), and carboplatin plus taxane regimens also yield encouraging pCR rates in triple-negative breast cancer (TNBC). Aim of the NeoSTOP multisite randomized phase II trial was to assess efficacy of anthracycline-free and anthracycline-containing neoadjuvant carboplatin regimens.

Patients aged ≥18 years with stage I-III TNBC were randomized (1:1) to receive either paclitaxel (P) weekly × 12 plus carboplatin AUC6 every 21 days × 4 followed by doxorubicin/cyclophosphamide (AC) every 14 days × 4 (CbP → AC, arm A), or carboplatin AUC6 + docetaxel (D) every 21 days × 6 (CbD, arm B). Stromal tumor-infiltrating lymphocytes (sTIL) were assessed. Primary endpoint was pCR in breast and axilla. Other endpoints included residual cancer burden (RCB), toxicity, cost, and event-free (EFS) and overall survival (OS).

One hundred patients were randomized; arm A (n=48) or arm B (n=52). pCR was 54% [95% confidence interval (CI), 40%-69%] in arm A and 54% (95% CI, 40%-68%) in arm B. RCB 0+I rate was 67% in both arms. Median sTIL density was numerically higher in those with pCR compared with those with residual disease (20% vs. 5%; p=0.25). At median follow-up of 38 months, EFS and OS were similar in the two arms. Grade 3/4 adverse events were more common in arm A compared with arm B, with the most notable differences in neutropenia (60% vs. 8%; p<0.001) and febrile neutropenia (19% vs. 0%; p<0.001). There was one treatment-related death (arm A) due to acute leukemia. Mean treatment cost was lower for arm B compared with arm A (p=0.02).

The two-drug CbD regimen yielded pCR, RCB 0+I, and survival rates similar to the four-drug regimen of CbP → AC, but with a more favorable toxicity profile and lower treatment-associated cost.

## Texto completo
Texto completo disponible en PMC: [PMC7887017](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887017/). El artículo describe los resultados del ensayo NeoSTOP comparando CbP→AC vs CbD en TNBC. Ambos brazos lograron pCR del 54% (mama+axila), con menor toxicidad y costo en el régimen sin antraciclinas. Apoya la consideración de regímenes desescalados de QT para favorecer pCR axilar sin sacrificar eficacia.

---
*Datos de PubMed. Citar: doi 10.1158/1078-0432.CCR-20-3646*
