PMID- 34086514
OWN - NLM
STAT- MEDLINE
DCOM- 20210818
LR  - 20220424
IS  - 1651-226X (Electronic)
IS  - 0284-186X (Linking)
VI  - 60
IP  - 7
DP  - 2021 Jul
TI  - A randomized phase 2 trial of first-line docetaxel, carboplatin, capecitabine 
      (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric 
      adenocarcinoma.
PG  - 948-953
LID - 10.1080/0284186X.2021.1928281 [doi]
AB  - BACKGROUND: No preferred first-line chemotherapy regimen exists for advanced 
      esophagogastric adenocarcinoma. Addition of docetaxel to cisplatin and 
      5-fluorouracil (DCF) has been shown to improve survival but is associated with 
      increased toxicity. In this randomized, non-comparative phase 2 trial, we tested 
      carboplatin, docetaxel, and capecitabine (CTX), a potentially useful modification 
      of DCF (NCT02177552). PATIENTS AND METHODS: Patients with advanced HER2-negative 
      esophagogastric adenocarcinoma not previously treated in the first-line setting 
      were randomized to intravenous docetaxel 60 mg/m(2) and carboplatin AUC5 plus 
      oral capecitabine 1000 mg/m(2) bd days 1-14, q4w (CTX) or intravenous epirubicin 
      50 mg/m(2) and oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 
      625 mg/m(2) bd days 1-21, q3w (epirubicin, oxaliplatin and capecitabine [EOX]). 
      Treatment continued until progression, intolerance or for a maximum of nine 
      cycles. The primary endpoint was 1-year survival for patients treated with CTX. 
      RESULTS: Between June 2014 and January 2019, a total of 98 eligible patients were 
      randomized. The 1-year survival rate was 34.7% (95% CI 21.8 - 47.9) with CTX and 
      36.7% (95% CI 23.6 - 50.0) with EOX. Progression-free survival and overall 
      survival were 6.1 months (95% CI 5.5 - 7.1) and 9.8 months (95% CI 8.2 - 11.0) 
      with CTX and 5.1 months (95% CI 4.3 - 7.0) and 10.2 months (95% CI 8.0 - 11.9) 
      with EOX, respectively. Related grade 3 or 4 treatment-emergent adverse events 
      (AEs) occurred in 86% of patients on CTX and 69% on EOX. Febrile neutropenia 
      occurred in 31.4% of patients on CTX and 13.7% on EOX. CONCLUSIONS: First-line 
      CTX showed insufficient efficacy and caused a high rate of febrile neutropenia. 
      CTX could not, therefore, be recommended for further study. This trial adds to 
      current knowledge of docetaxel combined with platinum and 5-FU: that the 
      combination is associated with increased toxicity and its use should be limited 
      to fit patients in need of a response.
FAU - Petersen, Peter C
AU  - Petersen PC
AUID- ORCID: 0000-0002-2337-4377
AD  - Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
FAU - Petersen, Lone N
AU  - Petersen LN
AD  - Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
FAU - Vogelius, Ivan
AU  - Vogelius I
AUID- ORCID: 0000-0002-8877-1218
AD  - Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
AD  - Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, 
      Denmark.
FAU - Bjerregaard, Jon K
AU  - Bjerregaard JK
AUID- ORCID: 0000-0003-1088-7242
AD  - Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
FAU - Baeksgaard, Lene
AU  - Baeksgaard L
AUID- ORCID: 0000-0003-4662-5164
AD  - Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
LA  - eng
SI  - ClinicalTrials.gov/NCT02177552
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210604
PL  - Sweden
TA  - Acta Oncol
JT  - Acta oncologica (Stockholm, Sweden)
JID - 8709065
RN  - 04ZR38536J (Oxaliplatin)
RN  - 15H5577CQD (Docetaxel)
RN  - 3Z8479ZZ5X (Epirubicin)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - BG3F62OND5 (Carboplatin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - *Adenocarcinoma/drug therapy
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Capecitabine/therapeutic use
MH  - Carboplatin/therapeutic use
MH  - Docetaxel
MH  - Epirubicin
MH  - Fluorouracil/adverse effects
MH  - Humans
MH  - Oxaliplatin/therapeutic use
MH  - *Stomach Neoplasms/drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Gastric cancer
OT  - adenocarcinoma
OT  - antineoplastic agents
OT  - carboplatin
OT  - taxanes
EDAT- 2021/06/05 06:00
MHDA- 2021/08/19 06:00
CRDT- 2021/06/04 17:17
PHST- 2021/06/05 06:00 [pubmed]
PHST- 2021/08/19 06:00 [medline]
PHST- 2021/06/04 17:17 [entrez]
AID - 10.1080/0284186X.2021.1928281 [doi]
PST - ppublish
SO  - Acta Oncol. 2021 Jul;60(7):948-953. doi: 10.1080/0284186X.2021.1928281. Epub 2021 
      Jun 4.