A randomized and open-label phase II trial reports the efficacy of neoadjuvant lobaplatin in breast cancer

Nat Commun. 2018 Feb 26;9(1):832. doi: 10.1038/s41467-018-03210-2.

Abstract

Currently, one sixth of triple-negative breast cancer (TNBC) patients who receive docetaxel (T) and epirubicin (E) as neoadjuvant chemotherapy achieve a pathologic complete response (pCR). This study evaluates the impact of adding lobaplatin (L) to the TE regimen. Here, we show data from 125 patients (63 TE and 62 TEL patients). Four patients did not complete all the cycles. Two-sided P values show that the addition of L (38.7% vs. 12.7%, P = 0.001) significantly increases the rate of pCR in the breast and the axilla (TpCR) and the overall response rate (ORR; 93.5% vs. 73.0%, P = 0.003). The occurrence of grade 3-4 anemia and thrombocytopenia is higher in the TEL group (52.5% vs. 10.0% and 34.4% vs. 1.7% respectively). These results demonstrate that the addition of L to the TE regimen as neoadjuvant chemotherapy improves the TpCR and the ORR rates of TNBC but with increased side effects.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anemia / diagnosis
  • Anemia / etiology
  • Anemia / pathology
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Axilla / pathology
  • Cyclobutanes / administration & dosage*
  • Cyclobutanes / adverse effects
  • Docetaxel
  • Epirubicin / administration & dosage*
  • Epirubicin / adverse effects
  • Female
  • Follow-Up Studies
  • Humans
  • Mammary Glands, Human / drug effects
  • Mammary Glands, Human / pathology
  • Middle Aged
  • Neoadjuvant Therapy / methods*
  • Odds Ratio
  • Organoplatinum Compounds / administration & dosage*
  • Organoplatinum Compounds / adverse effects
  • Remission Induction
  • Taxoids / administration & dosage*
  • Taxoids / adverse effects
  • Thrombocytopenia / diagnosis
  • Thrombocytopenia / etiology
  • Thrombocytopenia / pathology
  • Treatment Outcome
  • Triple Negative Breast Neoplasms / drug therapy*
  • Triple Negative Breast Neoplasms / pathology

Substances

  • Cyclobutanes
  • Organoplatinum Compounds
  • Taxoids
  • Docetaxel
  • Epirubicin
  • lobaplatin