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Pegylated lyposomal doxorubicin (PLD) and oxaliplatin (LOH) as salvage chemotherapy in patients with previously treated metastatic gastric cancer (MGC).
J Clin Oncol 28, 2010 (suppl; abstr e13051)
Background: Aim of this study was to evaluate the activity and safety of a combination of pegylated liposomal doxorubicin (PLD) and oxaliplatin (LOHP) as salvage chemotherapy in patients with metastatic gastric cancer (MGC) who had been previously treated with docetaxel, capecitabine, 5-fluorouracil, and leucovorin. Methods: Thirty-six patients, with pretreated MGC, were recruited for the study. The treatment consisted of 40 mg/m2 PLD and 120 mg/m2 LOHP, administered over 2 days, every 3 weeks. Primary endpoint was response rate, secondary endpoints were toxicity, progression-free survival, and overall survival. Response to therapy was assessed using the RECIST criteria, toxicity was evaluated by NCI-CTC (version 2.0). Results: Characteristics of patients: median age 68 years, performance status was good in 30 patients. Visceral metastasis was present in 26 instances. All patients were previously treated with at least one line of chemotherapy. After a median follow-up of 11 months and 202 courses of chemotherapy administered (median 5 courses per patient), the overall response rate in the 36 evaluable patients was estimated to be 28%. Grade 3 and 4 hematological toxicities were neutropenia in 44% of patients, grade 2-3 diarrhea in 16% of patients, and grade 2 neuropathy in 12 patients. Median progression-free survival and overall survival were 5.8 months and 9.2 months, respectively. Median survival time from the diagnosis of metastatic disease was 31.5 months. Seventy-five percent of patients (95% c.i. 58-88%) obtained a clinical benefit from this chemotherapy regimen. Conclusions: PLD and LOHP is an active regimen, with a low toxicity rate, able to give palliation in a substantial number of patients with MGC pretreated with taxanes.
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