PURPOSE: A standard chemotherapy regimen for neuroendocrine carcinoma of the gastrointestinal tract (GI-NEC) has not been established. Treatment usually consists of platinum doublets, consistent with the standard treatment for small-cell lung cancer (SCLC), with which it shares clinicopathological similarities. Here, we retrospectively examined responses of five GI-NEC patients treated with amrubicin chloride (AMR) which has shown activity against SCLC as salvage therapy. METHODS: Five patients with histologically proven unresectable GI-NEC in whom previous chemotherapy regimens had failed were treated with AMR, a synthetic anthracycline with potent topoisomerase II inhibition. RESULTS: Primary tumors were located in the esophagus in three patients, anus in one, and colon in one. AMR was administered intravenously at 35-40 mg/m(2) on days 1-3 every 3 weeks for a median of six treatment cycles (range, 2-8). Although all patients had received one to four previous chemotherapy regimens, including cisplatin doublets, three of five achieved objective responses to AMR. All three had esophageal NEC in relapse following combination treatment with irinotecan plus cisplatin. The most common adverse events of ≥ grade 3 were neutropenia (75%), anemia (60%), thrombocytopenia (20%), and febrile neutropenia (20%). CONCLUSIONS: Single-agent AMR achieved objective responses in three of five patients with GI-NEC. This compound may be a candidate for prospective evaluation in a larger series.
PURPOSE: A standard chemotherapy regimen for neuroendocrine carcinoma of the gastrointestinal tract (GI-NEC) has not been established. Treatment usually consists of platinum doublets, consistent with the standard treatment for small-cell lung cancer (SCLC), with which it shares clinicopathological similarities. Here, we retrospectively examined responses of five GI-NEC patients treated with amrubicin chloride (AMR) which has shown activity against SCLC as salvage therapy. METHODS: Five patients with histologically proven unresectable GI-NEC in whom previous chemotherapy regimens had failed were treated with AMR, a synthetic anthracycline with potent topoisomerase II inhibition. RESULTS:Primary tumors were located in the esophagus in three patients, anus in one, and colon in one. AMR was administered intravenously at 35-40 mg/m(2) on days 1-3 every 3 weeks for a median of six treatment cycles (range, 2-8). Although all patients had received one to four previous chemotherapy regimens, including cisplatin doublets, three of five achieved objective responses to AMR. All three had esophageal NEC in relapse following combination treatment with irinotecan plus cisplatin. The most common adverse events of ≥ grade 3 were neutropenia (75%), anemia (60%), thrombocytopenia (20%), and febrile neutropenia (20%). CONCLUSIONS: Single-agent AMR achieved objective responses in three of five patients with GI-NEC. This compound may be a candidate for prospective evaluation in a larger series.