Background: Epirubicin, cisplatin, and
5-FU (ECF) is one of the most commonly used
first-line chemotherapy regimens in metastatic
gastric cancer. However, due to protracted
infusion schedule, need for special infusion
pumps, and catheter-related complications, the
practical utility and acceptability of standard
ECF regimen are limited, particularly in
resource-constrained settings including India.
Materials and Methods: In the present study, we
have used a more convenient modification of the
standard ECF protocol (using 5 days intravenous
infusion of 5-FU at a dose of 750 mg/m2/day, given
over 6 h through a peripheral venous line), in
Indian patients with metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma.
The primary endpoint was overall survival (OS).
The secondary endpoints were overall response rate
(ORR), progression-free survival (PFS), and
toxicity profile. Results: Between January 2014
and December 2017, 107 patients were assigned and
treated with this modified ECF regimen. The median
age was 52 years (range, 34–62); 66.3% were males
and 36.5% of the patients had ≥ 3 metastatic
disease site involvement at baseline. Dose
reductions due to toxicity were required in 14.9%
of the patients. The ORR was 32.7%; median PFS and
OS were 5.9 months (95% confidence interval [CI]:
4.7–6.9) and 10.4 months (95% CI: 8.4–11.8),
respectively. Both the hematological and
nonhematological toxicities were manageable, and
there was no toxicity-related death. The most
frequent Grade 3–4 adverse events were neutropenia
(18.7%), febrile neutropenia (13.1%), mucositis
(5.6%), and diarrhea (5.6%). Conclusions: In the
present study, the modified ECF regimen
demonstrated significant efficacy with an
acceptable toxicity profile in Indian patients
with metastatic gastric and GEJ adenocarcinoma.
The survival outcomes of this modified schedule
were comparable with those of the standard ECF
regimen, as reported earlier. Clearly, this
modified and more convenient ECF protocol should
be explored and validated through large
prospective randomized trials.