716 Oxaliplatin with high-dose folinic acid and 5-fluorouracil 48 H infusion in pretreated metastatic colorectal cancer (CRC)

• Published in: European journal of cancer (1990) 1995-11, Vol.31, p.S149-S150
• Main Authors: de Gramont, A., Vignoud, J., Tournigand, C., Louvet, C., Varette, C., Raymond, E., Krulik, M.
• Format: Article
• Language: English
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/0959-8049(95)95966-A

We report a phase II study in pretreated CRC. Regimen (FOLFOX2) was administered every two weeks. It consisted of oxaliplatin 100 mg/m 2 iv day 1; FA 500 mg/m 2 over 2 h, followed by 5FU 1.5–2 g/m 2 24 h CI days 1&2. Initial 5FU dose was 1.5 g/m 2 for two cycles and increased to 2 g/m 2 in case of no toxicity > grade 2. 40 pts have been evaluated: 25 M/15 F, mean age 60 yrs, liver metastasis 33 pts, lung 11, peritoneal 4, other 11, multiple 13, performance status (WHO) 0: 20, 1–2: 20. Previous chemotherapy consisted in different optimal FA-5FU modulations ± hydroxyurea. 16 previously received the same high-dose FA and 5FU CI regimen alone or with interferon-α. All pts had disease progression on first-line therapy for metastatic disease or < 6 months after adjuvant therapy. One CR, 18 PR (response rate 49%), 17 stable (44%), and 3 prog. (8%) were observed (1 non-evaluable pt). Nine pts who progressed on the same high-dose FA and 5FU CI regimen responded (56%). From start of FOLFOX, median PFS was 9.6 mths, 12-mth median survival 65%. WHO toxicity ≥ grade 2 was: acro-syndrome or neuropathy 28% pts (g 3: 8%), nausea 28% (g 3: 3%), diarrhea 36% (g 3: 8%), mucositis 31% (g 3: 11%), neutropenia 42% (g 3–4: 28), thrombopenia 17% (g 3–4: 8%), alopecia 28% (g 3: 8%), allergy 3%. 17 pts (42%) experienced grade 3–4 toxicity. This high-dose intensity schedule achieves a high response rate in pretreated metastatic CRC even in pts who had received the same high-dose FA and 5FU CI regimen. Limiting toxicities are neutropenia and neuropathy.