Abstract
The aim of the study was to compare efficacy and safety of first-line palliative chemotherapy with (EOX) epirubicin/oxaliplatin/capecitabine and (mDCF) docetaxel/cisplatin/5FU/leucovorin regimens for untreated advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. Fifty-six patients were randomly assigned to mDCF (docetaxel 40 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1, 5FU 1000 mg/m2/d days 1 and 2, cisplatin 40 mg/m2 day 3) or EOX (epirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, capecitabine 1250 mg/m2/d days 1–21). The primary endpoint was overall survival. The median overall survival was 9.5 months with EOX and 11.9 months with mDCF (p = 0.135), while median progression-free survival was 6.4 and 6.8 months, respectively (p = 0.440). Two-year survival rate was 22.2 % with mDCF compared to 5.2 % with EOX. Patients in the EOX arm had more frequent reductions in chemotherapy doses (34.5 vs. 3.7 %; p = 0.010) and delays in subsequent chemotherapy cycles (82.8 vs. 63.0 %; p = 0.171). There was no statistically significant difference in the rates of grade 3–4 adverse events (EOX 79.3 vs. mDCF 61.5 %; p = 0.234). As compared with the mDCF, the EOX regimen was associated with more frequent nausea (34.5 vs. 15.4 %), thromboembolic events (13.8 vs. 7.7 %), abdominal pain (13.8 vs. 7.7 %) and grades 3–4 neutropenia (72.4 vs. 50.0 %), but lower incidences of anemia (44.8 vs. 61.5 %), mucositis (6.9 vs. 15.4 %) and peripheral neuropathy (6.9 vs. 15.4 %). In conclusion, the mDCF regimen was associated with a statistically nonsignificant 2.4-month longer median overall survival without an increase in toxicity. This trial is registered at ClinicalTrials.gov, number NCT02445209.
Highlights
Worldwide, gastric cancer is the fourth most common malignancy and the second leading cause of cancer death [1]
Patients older than 18 years of age were eligible for inclusion if they had histologically confirmed inoperable locally advanced, recurrent or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction; (ECOG) Eastern Cooperative Oncology Group performance status 0–2; adequate renal, hepatic and hematologic function; and measurable or non-measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
0–1 2 Mean body mass index (BMI) at study entry, (SD) BMI groups at study entry 17–18.99 19–24.99 C25.0 Lymphocytes at study entry \1500 C1500 Previous curative treatment of gastric/GEJ adenocarcinoma Gastrectomy Extent of disease at study entry Locally advanced Metastatic Location of metastases Distant lymph nodes Liver Lungs Peritoneum Ovaries Pleura Other Number of metastatic sites involved 0 or 1 2 C3 Lauren classification Intestinal Diffuse Mixed Unknown. This randomized trial comparing two three-drug combination palliative chemotherapy regimens in advanced gastric and gastroesophageal junction HER2-negative adenocarcinoma showed that modified DCF (mDCF) chemotherapy compared to EOX is associated with a 2.4-month longer overall survival with no increase in toxicity
Summary
Gastric cancer is the fourth most common malignancy and the second leading cause of cancer death [1]. The meta-analysis showed an improvement in weighted average survival of approximately 2 months with addition of antracycline to cisplatin and 5FU regimen [5], and ECF combination (epirubicin/cisplatin/5FU) became a standard in many countries for treating this disease. The addition of docetaxel to cisplatin and 5FU (DCF regimen) improved survival of patients compared to cisplatin and 5FU alone in a phase 3 trial [7]; this three-drug combination was associated with a significant toxicity. The aim of the study was to compare the efficacy and toxicity of the first-line palliative three-drug chemotherapy with EOX and mDCF regimens, respectively, in patients with (HER2) human epidermal growth factor receptor 2 negative, locally advanced inoperable or metastatic gastric or gastroesophageal junction adenocarcinoma
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