Makiyama A, et al. – The clinicians conducted this study to elucidate the survival benefit of irinotecan monotherapy in advanced gastric cancer (AGC). In Japanese clinical practice, irinotecan monotherapy was relatively safely performed as a salvage–line treatment for AGC. Careful patient selection and intensive modification of the dose of irinotecan could possibly be correlated with favorable survival.

• From 2007 to 2014, the clinicians evaluated medical records of AGC patients who were treated with irinotecan monotherapy as salvage-line treatment in 6 institutions.

• The clinicians enrolled 146 patients who had prior fluoropyrimidine and taxane therapies.
• Out of them, 75.3% had prior platinum therapy.
• In this study, the median age was 66 (range 27–81) years, and 102 males (69.9%) were included.
• In 53/70/19/4 patients, performance status (PS) was 0/1/2/3.
• 89 patients (61.0%) had two or more metastatic sites.
• They performed irinotecan monotherapy as 3rd-/4th-line therapy in 135/11 (92.5%/7.5%).
• 4 (range 1-62) was the median number of administrations.
• At the physician’s discretion, 46 patients (31.5%) required initial dose reduction.
• The overall response rate was 6.8%, and the disease control rate was 43.1%.
• The median PFS was 3.19 months [95% confidence interval (CI) 2.30–4.08 months], and the median OS was 6.61 months (95% CI 5.94–7.28 months).
• Hematological toxicity (46 patients, 31.5%) and non-hematological toxicity (50 patients, 34.2%) were grade 3/4 adverse events.
• Because of adverse events, hospitalization was required in 31 patients (21.2%).
• Compared to those with relative dose intensity (RDI) 80% or higher patients with RDI less than 80% demonstrated similar survival.