Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 3618
© 2005 American Society of Clinical Oncology

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Abstract

Resectability of liver metastases (LM) in patients with advanced colorectal cancer (ACRA) after treatment with the combination of oxaliplatin (OXA), irinotecan (IRI) and 5FU. Final results of a phase II study

Hosp Germans Trias i Pujol, Badalona, Spain; Hosp Miguel Servet, Zaragoza, Spain; Hosp Gen, Alicante, Spain; Hosp Univ Marqués de Valdecilla, Santander, Spain; Hosp de la Santa Creu i Sant Pau, Barcelona, Spain; Inst Català d’Oncologia, L’Hospitalet de Llobregat, Spain; Hospitals Vall d’Hebron, Barcelona, Spain; Hosp Reina Sofía, Córdoba, Spain; Hosp Gen, Elche, Spain; Hosp Clínico San Carlos, Madrid, Spain

3618

Background: OXA, IRI and 5FU have shown its efficacy in ACRC. The synergism of these three drugs has been shown in vitro and in vivo models. The purpose of this trial was to determine the response rate of the triple combination of OXA+IRI+5FU and to assess prospectively its impact on secondary resectability of previously non-resectable LM. Methods: 47 patients were included in the trial after signature of IRB-approved informed consent. All patients received OXA (85 mg/sqm) + IRI (150 mg/sqm) + 5FU (2250 mg/sqm in 48 h CI - TTD scheme) on D1 every 15 days, according to the recommended dose obtained from the phase I part of the trial (Anti-Cancer Drugs 2004, 15;469–471). Results: Male/female: 28/19, Median age 61.6 years (31–75), ECOG 0/1/2: 26/20/1. Efficacy and safety have been analyzed from a total of 489 cycles, being the median number of cycles per patient 11 (1–18). Grade 3–4 toxicities per patient were: neutropenia (40%), febrile neutropenia (4%), diarrhea (18%), nausea/vomiting (11%/15%), fatigue (11%), anemia and alopecia (9% each). Neurosensory symptoms observed were grade 0: 34 (72%), grade 1: 11 (23%) and grade 3: 2 (4%). No grade 2 neurotoxicity was observed. Efficacy: Tumor response has been assessed in the 42 patients for whom at least one measure was available: CR 1 (2%), PR 28 (67%), SD 13 (31%) and PD 0. TTP was 10.9 months and OS was 19.9 months. Secondary liver surgery was possible in 12 patients with previously non-resectable LM, with a rescue rate of 26%, being as high as 40% in patients with liver-only metastases. In this cohort, median OS has not been reached at 22 months median follow-up, with only 2/12 patients having died. Conclusions: The results of this prospective study show that first-line combination of OXA+IRI+5FU is highly active with an ORR of 69%, and has allowed the resectability of previously non-resectable LM up to 40% of patients with liver-only metastases, offering them the possibility of long-term survival without significant impact over safety profile.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting