In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 14554-14554
Abstract:
14554 Background: Chronomodulated (Chrono) irinotecan (I), 5-fluorouracil (F), leucovorin and oxaliplatin (O) offered sustained tumor control in CRC patients (pts) failing several chemo (Gholam et al. The Oncologist 2006). The relevance of Chrono IFO as hepatic artery infusion (HAI) for long term outcome was investigated in CRC pts with liver metastases. Methods: 32 heavily pretreated non hospitalized CRC pts received 5-day (d) q21 d courses (c) with d1 I (160 mg/m 2 from 2 to 8 am, peak at 5 am) and d2–5 F (600 mg/m 2 /d from 10 pm to 10 am, peak at 4 am) and O (20 mg/m 2 /d from 10 am to 10 pm, peak at 4 pm). Intravenous cetuximab was also given to 3 pts. 172 courses (c) were given (median, 5; 1–15) using a multichannel pump (Mélodie, Aguettant, F). Toxicity was assessed q21 d and response q3 c with CT scan. Results: Prior chemo lines 1/2/3/4+: 3/5/10/14 pts; WHO Performance Status 0/1/2/3: 14/11/6/1 pts; median age: 63 years (32–73); liver only: 25 pts; liver and lung: 7 pts. Treatment was withdrawn for thrombosis (7 pts, 21%) and/or Grade (G) 3 abdominal pain (4 pts ). G3–4 diarrhea occurred in 6 pts (12%). G3–4 leucopenia, anemia and thrombocytopenia were respectively found in 5, 2 and 1 pt. G3 sensory neuropathy occurred in 3 pts with similar G at baseline. 3 pts displayed alopecia. Of 29 pts with measurable lesions, disease progressed in 12 pts (exclusively outside the liver for 4 pts) and was controlled in 17 pts (58%), including 10 objective responses - 34% [95% C.L. 13.4 to 50.6]. Partial hepatectomy was performed in 4 pts with measurable disease (14%): R0 (3 PR) and R1 (1 SD). Median Progression free survival (months, m) is 5 m [1.9 to 8.0] and median survival is 18.4 m [9.9 to 26.9], with 6 pts alive at 2.9 to 63 m. Conclusions: Triplet chronoHAI is safe in heavily pretreated pts and achieves consistent activity against CRC liver metastases despite prior failure on the same 3 drugs. The combination of systemic cetuximab with triplet HAI is feasible and could prevent extra hepatic dissemination, a hypothesis to be soon tested in a prospective European trial. Supported by ARTBC, Hôpital P. Brousse, Villejuif, France. No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2007.25.18_suppl.14554
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2007
detail.hit.zdb_id:
2005181-5
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