Combination of docetaxel and irinotecan as a second-line treatment of metastatic gastric cancer: a phase II study
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Abstract
Introduction. Gastric cancer is one of the aggressive malignancies that negatively impact the performance status of patients and cause a high incidence of cachexia. Docetaxel and irinotecan have confirmed efficacy in the second-line treatment of metastatic patients. However, most patients are not fit enough for third-line options. So, we tested the combination of these two drugs in second-line treatment to give patients the maximum benefit as a “last resort” treatment option.
Material and methods. Prospective analysis of metastatic gastric cancer patients was done in the second-line treatment. Patients received a combination of docetaxel and irinotecan. To assess response, we used RECIST version 1.1; toxicity was assessed with CTCAE version 5.0, quality of life was assessed by the QLQ-C30 model, and survival analysis was done by the Kaplan-Meier curves.
Results. A total of 32 patients were eligible for statistical analysis. The mean age at diagnosis was 56 years. The clinical control rate was 21.8%, of which 12.5% of patients had a partial response and 9.3% had stationary disease. The most common toxicity was neutropenia (18.8%) despite the routine use of prophylactic filgrastim. The median overall survival was 14 months; of which, 9 months represented median progression-free survival 1 (PFS1) and 12.5 months for progression-free survival 2 (PFS2). Reduction in tumor markers CEA and CA19-9 were predictive factors of survival (p = 0.004 and 0.028 respectively). Quality of life was negatively impacted both in responders and non-responders.
Conclusions. The combination of docetaxel and irinotecan is a valid choice for second-line treatment of gastric cancer, especially when carefully selecting suitable patients. This regimen serves as a “last resort” for individuals whose subsequent treatment options primarily involve best supportive care. The study is especially important for countries that do not have access to the recently approved immunotherapy options in this setting.
Keywords: gastric cancersecond linechemotherapydocetaxelirinotecan
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