Phase II study of sequential cisplatin plus 5-fluorouracil/leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma

来自 EBSCO

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作者：

F Loupakis，G Masi，L Fornaro，E Vasile，G Allegrini，E Fontana，C Granetto，L Salvatore，L Mentuccia，M Andreuccetti

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摘要：

Purpose 5-Fluorouracil (5-FU) plus cisplatin (C) can be considered a standard option for advanced gastric cancer (AGC). Irinotecan (Ir) and docetaxel (D) are active agents with no complete cross-resistance with C and 5-FU. Concomitant combination of Ir or D with C and 5-FU is feasible, but with substantial toxicities. A different way to include all active agents in first-line treatment of AGC may be to use them sequentially. We aimed to evaluate the activity and the safety profile of sequential chemotherapy with 5-FU-based doublets with C, Ir and D in the first-line treatment of AGC. Methods We conducted a phase II study of first-line sequential chemotherapy in metastatic GC. Treatment consisted of 3 cycles of C+infused 5-FU and leucovorin (CFL) followed by 3 cycles of Ir+5-FU/LV (IrFL) followed by 3 cycles of D+5-FU/LV (DFL). Primary end-point was response rate. Results Forty-six patients were enrolled, median age 60years, sites of disease (single/multiple)=9/37, PS 0/1=27/19, gastric/gastro-oesophageal junction=39/7. Median number of cycles was 9. Main grade 3–4 toxicities were neutropenia (37%), febrile neutropenia (2%), diarrhoea (4%), stomatitis (9%). Response rate after the planned 9 cycles was 45% (15 partial and 5 complete responses among 43 evaluable patients). Median PFS and OS: 6.8 and 11.1months, respectively. Conclusion This sequential treatment is feasible with a favourable safety profile and produced encouraging results in terms of activity and efficacy.

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关键词：

Gastric cancer Cisplatin 5 Fluorouracil Irinotecan Docetaxel Sequential chemotherapy

DOI：

10.1007/s00280-009-1196-1

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年份：

2010