Phase II study of epirubicin, oxaliplatin and docetaxel combination in metastatic gastric or gastroesophageal junction adenocarcinoma.
BACKGROUND
This phase II study was designed to evaluate the activity and safety of a combination of epirubicin, oxaliplatin and docetaxel in metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


METHODS
Forty patients with measurable distant metastases received epirubicin 50 mg/m2, docetaxel 60 mg/m2 followed by oxaliplatin 100 mg/m2 on day 1 of each 21-day cycle. Primary end point was response rates (RR).


RESULTS
All patients were evaluable. The overall RR was 47.5% (95% confidence interval (CI) 32-63). The disease control was 80%. Median time for response was 6 weeks. Median time to progression was 6.3 months (95% CI 5.4-7.2) and the median overall survival time was 12.1 months (95% CI 10.7-13.5). Grade 3/4 neutropenia occurred in 50% of patients with two episodes of febrile neutropenia (5%). Other non-hematological grade 3 toxicities included sensory neuropathy in two patiens (5%), vomiting and mucositis in two patients (5%) and diarrhea in one patient (2.5%).


CONCLUSIONS
The combination of epirubicin, oxaliplatin and docetaxel was found to be effective and well tolerated in patiens with metastatic gastric or GEJ adenocarcinoma and maybe an appropriate regimen to be used in the neoadjuvant setting and with molecularly targeted agents.
Di Lauro
Luigi
L
Division of Medical Oncology B, Institute for Cancer Research, Rome, Italy. dilauro@ifo.it
Giacinti
Laura
L
Arena
Maria Grazia
MG
Sergi
Domenico
D
Fattoruso
Silvia Ileana
SI
Giannarelli
Diana
D
Lopez
Massimo
M
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D004943:Esophagogastric Junction / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D002945:Cisplatin