Abstract
BackgroundThe role of second-line therapy in gastric cancer patients mostly stemmed from clinical trials with monochemotherapy carried out in Asian countries. Nevertheless, these results cannot be broadly generalized as molecular studies suggested the existence of different sets of deregulated gene networks correlated with ethnicity. In the present study, we investigated the activity and safety of FOLFIRI given as a second-line therapy in metastatic gastric or gastro-esophageal junction cancer patients who experienced disease progression on or after first-line docetaxel-containing chemotherapy.MethodsPatients with histologically confirmed metastatic gastric cancer who failed docetaxel-containing first-line therapy and who received FOLFIRI in second line were eligible for the study. Seventy patients treated at three Italian cancer centers between 2005 and 2012 entered the study. Patients received every 2 weeks irinotecan 180 mg/m2 as 1 h infusion on day 1, folinic acid 100 mg/m2 intravenously days 1–2, and fluorouracil as a 400 mg/m2 bolus and then 600 mg/m2 continuous infusion over 22 hours days 1–2.ResultsWe observed 1(1.4%) complete response, 15 (21.4%) partial response, for an overall response rate of 22.8% (95% confidence interval (CI): 13.4-32.3). Stable disease was recorded in 21 (30%) patients. Median progression-free survival and overall survival were 3.8 months (95% CI: 3.3-4.4) and 6.2 months (95% CI: 5.3-7.1), respectively. The treatment was well tolerated, as the most common G3-4 toxicities were neutropenia (28.5%) and diarrhea (14.5%).ConclusionsFOLFIRI appears an effective and safe treatment option for pretreated metastatic gastric cancer patients, and deserves further investigation in randomized clinical trials.
Highlights
The role of second-line therapy in gastric cancer patients mostly stemmed from clinical trials with monochemotherapy carried out in Asian countries
Several randomized clinical trials demonstrated the role of chemotherapy in the first-line setting, as different regimens determined an improvement in survival and in quality of life (QoL) compared with best supportive care (BSC) alone [3,4,5]
Patients with histologically confirmed, docetaxelpretreated metastatic gastric cancer who received FOLFIRI in second line were eligible for the study
Summary
The role of second-line therapy in gastric cancer patients mostly stemmed from clinical trials with monochemotherapy carried out in Asian countries. These results cannot be broadly generalized as molecular studies suggested the existence of different sets of deregulated gene networks correlated with ethnicity. Gastric cancer and cancer of the gastro-oesophageal junction (GEJ) are a significant global health problem, representing the fourth most common cancer diagnosed worldwide [1] The prognosis for these patients remain poor, as the majority of them are diagnosed with locally advanced or metastatic disease with a median survival of 7–10 months [2]. The rates of administration of subsequent chemotherapy significantly differed among phase III studies conducted in front-line, spanning from 14% in the UK REAL 2 study [9] to 75% in the Japanese SPIRITS trial [7]
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