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

被引:8
作者
Loupakis, Fotios [1 ,2 ]
Masi, Gianluca [1 ,2 ]
Fornaro, Lorenzo [1 ,2 ]
Vasile, Enrico [1 ,2 ]
Allegrini, Giacomo [3 ]
Fontana, Eloise [4 ]
Granetto, Cristina [5 ]
Salvatore, Lisa [1 ,2 ]
Mentuccia, Lucia [6 ]
Andreuccetti, Michele [1 ,2 ]
Cortesi, Enrico [6 ]
Merlano, Marco [5 ]
Cascinu, Stefano [7 ]
Falcone, Alfredo [1 ,2 ]
机构
[1] Azienda Ospedaliero Univ Pisana, Unit Med Oncol 2, Ist Toscano Tumori, I-56126 Pisa, Italy
[2] Univ Pisa, Dept Oncol Transplants & New Technol Med, I-56126 Pisa, Italy
[3] Azienda USL 5, Ist Toscano Tumori, Med Oncol Unit, Pontedera, Italy
[4] Azienda USL 6, Ist Toscano Tumori, Med Oncol Unit, Cecina, Italy
[5] Azienda Ospedaliera S Croce & Carle, Unit Oncol, Cuneo, Italy
[6] Univ Roma La Sapienza, Med Oncol Unit, Dept Expt Med & Pathol, Rome, Italy
[7] Univ Politecn Marche, Azienda Osped Osped Riuniti, Med Oncol Unit, Ancona, Italy
关键词
Gastric cancer; Cisplatin; 5-Fluorouracil; Irinotecan; Docetaxel; Sequential chemotherapy; 1ST-LINE THERAPY; CANCER; FLUOROURACIL; CHEMOTHERAPY; TRIAL; METAANALYSIS; LEUCOVORIN; MANAGEMENT; REGIMEN;
D O I
10.1007/s00280-009-1196-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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. 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. Forty-six patients were enrolled, median age 60 years, 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 11.1 months, respectively. This sequential treatment is feasible with a favourable safety profile and produced encouraging results in terms of activity and efficacy.
引用
收藏
页码:559 / 566
页数:8
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