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Oxaliplatin, irinotecan, and 5-fluorouracil/leucovorin in advanced gastric adenocarcinoma: A phase II trial



Oxaliplatin, irinotecan, and 5-fluorouracil/leucovorin in advanced gastric adenocarcinoma: A phase II trial



Journal of Clinical Oncology 26(15_Suppl): 4542-4542



NlmCategory="UNASSIGNED">4542 Background: 5-fluorouracil (5FU)/leucovorin (LV) still remains the mainstay for the management of patients (pts) with metastatic gastric carcinoma, but long term results are still unsatisfactory. Oxaliplatin (OXA) and irinotecan (IRI) have shown interesting activity in combination with 5FU and LV in these pts. A triplet regimen incorporating all these active agents could be more effective than each doublets. Pts with locally advanced, unresectable or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma were eligible for this phase II study. Treatment consisted of OXA 85 mg/sqm (2-h i.v. infusion), and IRI 150 mg/sqm (30-90 min i.v. infusion) on day 1; 6S-LV 250 mg/sqm (2-h i.v. infusion) and 5FU 750 mg/sqm i.v. bolus on day 2. Cycles were repeated every 2 weeks for a maximum of 12 cycles. The Simon's two-stage design required more than 16 responses among the first 46 pts to enroll 19 more pts. The final sample size of 65 pts has an 80% power to demonstrate a 45% response rate (RR) with a 5% alpha error. From July 2005 to February 2007, 46 pts (males, 33; females, 13) were enrolled by 11 SICOG centers. Thirty-three pts had a gastric, and 13 pts a GEJ adenocarcinoma. Median age was 61 (range, 40-81) yrs. Twenty-one pts were in ECOG PS 0, 24 pts in PS 1, and 1 pt in PS 2. Disease was locally advanced in 2 pts, and metastatic in 44 pts. 6 pts had 1 site, 40 pts ≥ 2 sites of disease. Prior radical surgery had been performed in 18 pts, and 7 of them had also received adjuvant 5FU-based therapy. A total of 331 triplet cycles were administered, with a median of 8 (range, 4-12) cycles/pt. Most common WHO G ≥3 toxicity by pts were: neutropenia (39%), vomiting (24%), diarrhea (9%), and febrile neutropenia (7%). Two CRs and 15 PRs were registered, for an overall response rate of 37%; 20 pts achieved a SD. Since the activity required in the first stage has been achieved, a total of 65 pts have been acrrued. This preliminary analysis demonstrated the tolerability and promising activity of the triplet regimen in advanced/metastatic gastric or GEJ adenocarcinoma. Updated activity on the final sample size, as well as pts follow-up will be presented at the meeting. No significant financial relationships to disclose.

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Accession: 058488023

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PMID: 27949132


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