PMID- 37789989
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231030
IS  - 1758-8340 (Print)
IS  - 1758-8359 (Electronic)
IS  - 1758-8340 (Linking)
VI  - 15
DP  - 2023
TI  - Safety and effectiveness of sacituzumab govitecan in patients with metastatic 
      triple-negative breast cancer in real-world settings: first observations from an 
      interdisciplinary breast cancer centre in Germany.
PG  - 17588359231200454
LID - 10.1177/17588359231200454 [doi]
LID - 17588359231200454
AB  - BACKGROUND: Sacituzumab govitecan has been recently approved by the USFDA and EMA 
      for the treatment of patients with metastatic triple-negative breast cancer 
      (mTNBC). We report real-world safety and effectiveness in patients with mTNBC 
      receiving sacituzumab govitecan treatment at a breast cancer centre in Germany. 
      METHODS: Data from patients who had received sacituzumab govitecan as treatment 
      for mTNBC, in both de novo and relapsed disease, at the Kliniken Essen-Mitte, 
      Essen, Germany, were collected through institutional records. Data were analysed 
      for safety parameters and survival outcomes and reported using descriptive 
      statistics. RESULTS: Patients (N = 43) received a median (range) of 5 (1-28) 
      cycles of sacituzumab govitecan and were followed up for a median of 12.9 months. 
      The most reported adverse events (AEs) of any grade were alopecia (n = 39; 
      90.7%), diarrhoea (n = 16; 37.2%), fatigue (n = 15, 34.9%), anaemia (n = 15, 
      34.9%) and neutropenia (n = 14, 32.6%). AEs ⩾ Grade 3 with the highest incidence 
      were neutropenia (n = 12; 27.9%) and diarrhoea (n = 8; 18.6%). In eight (18.6%) 
      patients, dose of sacituzumab govitecan dose was reduced due to patients' 
      clinical condition prior to commencing treatment; in further 17 (39.5%) patients, 
      sacituzumab govitecan dose had to be reduced or treatment interrupted on account 
      of AEs associated with the drug after treatment had commenced. Median 
      progression-free survival and median overall survival were calculated to be 
      5.0and 13.1 months, respectively. CONCLUSION: The real-world safety and 
      effectiveness profile of sacituzumab govitecan in patients with mTNBC are in line 
      with clinical trial data. Further studies are required to guide optimal use of 
      sacituzumab govitecan against mTNBC, especially in context of management of 
      accompanying AEs.
CI  - (c) The Author(s), 2023.
FAU - Reinisch, Mattea
AU  - Reinisch M
AD  - Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Henricistrasse 92, Essen 
      45136, Germany.
FAU - Bruzas, Simona
AU  - Bruzas S
AD  - Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
FAU - Spoenlein, Jennifer
AU  - Spoenlein J
AD  - Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
FAU - Shenoy, Satyendra
AU  - Shenoy S
AD  - Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
FAU - Traut, Alexander
AU  - Traut A
AD  - Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen, 
      Germany.
FAU - Harrach, Hakima
AU  - Harrach H
AD  - Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
FAU - Chiari, Ouafaa
AU  - Chiari O
AD  - Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
FAU - Cremer, Efsthatia
AU  - Cremer E
AD  - Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
FAU - Ataseven, Beyhan
AU  - Ataseven B
AD  - Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen, 
      Germany.
AD  - Department of Obstetrics and Gynecology, University Hospital, 
      Ludwig-Maximilians-Universitat, Munich, Germany.
FAU - Gubelt, Lars
AU  - Gubelt L
AD  - Zentralapotheke, Kliniken Essen-Mitte, Essen, Germany.
FAU - Kuemmel, Sherko
AU  - Kuemmel S
AD  - Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
AD  - Department of Gynecology with Breast Center, Charite - Universitatsmedizin 
      Berlin, Berlin, Germany.
LA  - eng
PT  - Journal Article
DEP - 20230928
PL  - England
TA  - Ther Adv Med Oncol
JT  - Therapeutic advances in medical oncology
JID - 101510808
PMC - PMC10542232
OTO - NOTNLM
OT  - effectiveness
OT  - metastatic
OT  - real-world evidence
OT  - sacituzumab govitecan
OT  - safety
OT  - triple-negative breast cancer
EDAT- 2023/10/04 06:44
MHDA- 2023/10/04 06:45
PMCR- 2023/09/28
CRDT- 2023/10/04 03:57
PHST- 2023/02/24 00:00 [received]
PHST- 2023/08/25 00:00 [accepted]
PHST- 2023/10/04 06:45 [medline]
PHST- 2023/10/04 06:44 [pubmed]
PHST- 2023/10/04 03:57 [entrez]
PHST- 2023/09/28 00:00 [pmc-release]
AID - 10.1177_17588359231200454 [pii]
AID - 10.1177/17588359231200454 [doi]
PST - epublish
SO  - Ther Adv Med Oncol. 2023 Sep 28;15:17588359231200454. doi: 
      10.1177/17588359231200454. eCollection 2023.