@article {LINK385, author = {K. LINK and K. HAPPICH and I. SCHIRNER and B. J{\"U}NGERT and V. BR{\"U}CKL and G. M{\"A}NNLEIN and M. BR{\"U}CKL and S. MERKEL and J. G{\"O}HL and W. HOHENBERGER and E.G. HAHN and A. WEIN}, title = {Palliative Second-line Treatment with Weekly High-dose 5-Fluorouracil as 24-hour Infusion and Folinic Acid (AIO) plus Oxaliplatin after Pre-treatment with the AIO-Regimen in Colorectal Cancer (CRC)}, volume = {24}, number = {1}, pages = {385--392}, year = {2004}, publisher = {International Institute of Anticancer Research}, abstract = {Background and Aims: The aim of this work was to evaluate the efficacy and safety of second-line treatment with weekly high-dose 5-Fluorouracil (5-FU) as a 24-hour infusion (24-h inf.) and folinic acid (FA) (AIO-regimen) plus Oxaliplatin (L-OHP) after pre-treatment with the AIO regimen, focusing in particular on the efficacy of palliative first- and second-line treatment in colorectal carcinoma (CRC). Patients and Methods: Patients with non-resectable distant CRC metastases were enrolled in a prospective phase II study for palliative second-line treatment after previous palliative first-line treatment in accordance with the AIO regimen. On an outpatient basis, the patients received a treatment regimen comprising biweekly 85 mg/m2 L-OHP in the form of a 2-hour intravenous (i.v.) infusion and 500 mg/m2 FA as a 1 to 2-hour i.v. infusion, followed by 2,600 mg/m2 5-FU administered as a 24-h inf. i.v. once weekly. A single treatment cycle comprised 6 weekly infusions followed by 2 weeks of rest. Results: During second-line treatment, a total of 26 patients received 340 chemotherapy applications. As the main symptom of toxicity, diarrhoea (NCI-CTC toxicity grade 3+4) presented in 5 patients (19\%; 95\% CI: 4-34), followed by nausea (CTC grade 3) in one patient (4\%; 95\% CI: 0-11). Twenty-three patients were evaluable for treatment response. The remission data can be summarised as follows: Complete remission (CR): n=1 (4\%; 95\% CI: 0-13); partial remission (PR): n=3 (13\%; 95\% CI: 0-27); stable disease (SD): n=11 (48\%; 95\% CI: 27-68) and progressive disease (PD): n=8 (35\%; 95\% CI: 15-54). The median progression-free survival (PFS) rate (n=26) was 3.3 months (range 0-11.5), the median survival time counted from the start of second-line treatment (n=26) 11.6 months (range 2.1-33.0) and the median survival time counted from the start of first-line treatment (n=26) 19.9 months (range 7.7-49.8). Conclusion: Palliative second-line treatment according to the AIO regimen plus L-OHP is feasible in an outpatient setting and well tolerated by the patients. Tumour control (CR + PR + SD) was achieved in 65\% of the patients, the median survival time being 11.6 months. The AIO regimen followed by the {\textquoteleft}AIO regimen plus L-OHP{\textquoteright} therapy sequence led to a promising median survival time of 19.9 months (range 7.7-49.8).}, issn = {0250-7005}, URL = {https://ar.iiarjournals.org/content/24/1/385}, eprint = {https://ar.iiarjournals.org/content/24/1/385.full.pdf}, journal = {Anticancer Research} }