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• W2590969209 abstract "4570 Background: In the 2007 ASCO Annual Meeting we reported the high activity of TCF-DD in MGC. Previous phase II trials showed that regimens with O, I, FA, and 5-FU are very active in MGC. Based on these studies we tested a sequential CT in order to avoid the occurrence of drug resistance. Methods: Chemo-naïve patients (pts) with MGC, PS ≤1, received in 16 weeks: 4 cycles of TCF- DD (docetaxel [D] 70 mg/m2 day [d] 1, cisplatin 60 mg/m2 d 1, l-FA 100 mg/m2 d 1 and 2, 5-FU 400 mg/m2 bolus and then 600 mg/m2 as a 22 h c.i. d 1 and 2, every 14 days) followed by 4 cycles of COFFI (O 85 mg/m2 d 1, I 140 mg/m2 d 1, l-FA 200 mg/m2 d 1, 5-FU bolus 400 mg/m2 d 1 and then 2,400 mg/m2 as a 48 h c.i. every 14 days). In both regimens pegfilgrastim 6 mg on d 4 was included. End points were response rate (ORR) and TTP (RECIST criteria and ITT principle). Results: 40 consecutive pts were enrolled; in 8 pts CT is ongoing. Median age: 64, range 40–81; 63% male. 11/32 pts required a dose reduction of TCF-DD, mostly because of grade 3–4 haematologic, gastrointestinal toxicity and lethargy. 25/32 completed the 4 cycles of TCF-DD and 12/32 respected the schedule. 28 were evaluated for response (2 early suspension: 1 allergic reaction to D and 1 severe toxicity; 2 early deaths: 1 bowel perforation and 1 sepsis): 2 CR, 16 PR, 7 SD and 3 PD were observed, for an ORR of 56% (95% CI, 39–73). 21 pts proceeded to COFFI. 2 required a dose reduction because of diarrhoea; all 21 pts were evaluated for response. The 2 CR observed after TCF-DD were maintained after COFFI. Among the 16 pts with PR after TCF-DD, 2 achieved CR, 5 further improved the response, 5 mantained PR, 2 progressed and 2 did not start COFFI (1 early death and 1 protocol violation). Among the 7 pts with SD after TCF-DD, 2 achieved PR, 2 mantained SD, 1 progressed and 2 did not start COFFI (1 protocol violation and 1 for other reasons). The ORR in the 32 pts was 63% (95% CI, 46%-79%). At a median f-up of 19 months (95% CI, 16–23) median TTP was 9 months (95% CI, 6–9,7). 1- year survival was 31%. 2 pts with multiple liver metastases mantained CR after 33 and 16 months. Conclusions: A sequential dose- dense strategy using TCF-DD followed by COFFI is feasible, highly effective and deserves to be tested in randomized studies. No significant financial relationships to disclose." @default.
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• W2590969209 date "2008-05-20" @default.
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• W2590969209 title "High efficacy of sequential chemotherapy (CT) with dose-dense modified TCF regimen (TCF-DD) followed by CT with oxaliplatin, folinic acid (FA), 5-fluorouracil (5-FU) and irinotecan (COFFI) in metastatic gastric cancer (MGC)" @default.
• W2590969209 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.4570" @default.
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