摘要:

The combination of irinotecan (CPT-11), bolus 5-fluorouracil (5-FU) and folinic acid (FA) (Saltz regimen) has recently been questioned as first-line chemotherapy for metastatic colorectal cancer after high early death rates due to gastrointestinal and thromboembolic events were reported in two US trials. Therefore, we carefully evaluated the safety and efficacy of this regimen, with high value placed on the management of delayed diarrhea. Forty-six patients with metastatic colorectal cancer received this first-line treatment in nine German outpatient clinics. Dose reductions were mandatory from the first cycle in case of toxicity grade >2. Chemotherapy was administered only to diarrhea-free patients. During a total of 175 cycles administered treatments were delayed for 1 week in 11.6% and given at a reduced dose in 14.5%. All and 40 patients were evaluable for toxicity and response, respectively. Grade 3/4 toxicities included diarrhea (n=10), leukopenia (n=9), neutropenia (n=3) and anemia (n=4). One non-fatal pulmonary embolism occurred. Four complete responses (CR) and 10 partial responses were seen, for an overall response rate of 35%. In addition, 16 patients (40%) had stable disease. Resectability of liver metastases was achieved in three patients, including one pathologically confirmed CR. Median progression-free and overall survival were 5 and 13 months, respectively. We conclude that outpatient treatment with the Saltz regimen was well tolerated. Severe gastrointestinal toxicity and thromboembolic events were rarely observed and never fatal. As down-staging was possible, combinations of CPT-11 and FA/5-FU should be further investigated in neoadjuvant protocols.

ISSN:0959-4973    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

At present, systemic treatment is not generally recommended for advanced biliary tract and gall bladder carcinomas. In particular cases, however, it may be justified to consider systemic chemotherapy treatment. In four cases we investigated the efficacy of palliative systemic treatment in metastatic biliary tract and gall bladder adenocarcinomas. Similar to the proceedings in a phase II study for metastatic pancreas adenocarcinomas, four patients with advanced biliary tract and gall bladder adenocarcinomas received a combination treatment of gemcitabine (GEM) and weekly high-dose 5-fluorouracil (5-FU) as a 24-h infusion. Altogether, the four patients received 96 chemotherapy applications. The palliative chemotherapy was tolerated well. In one patient, leukocytopenia (toxicity grade III) and thrombocytopenia (toxicity grade III) occurred. In three patients, the palliative systemic treatment led to stable disease, partly with a significant decrease of the CA 19-9 tumor marker, and in one patient to partial remission (PR). The survival times in these four patients were 6, 10, 17 and 26 months. Even in the case of PR, a curative hemihepatectomy right could be achieved after ‘downsizing’. We conclude that in the four case studies, the applied palliative combination treatment based on GEM and 5-FU proved to be effective. However, future multicenter studies will be necessary to determine the significance of palliative chemotherapy in biliary tract and gall bladder carcinomas.

ISSN:0959-4973    

出版商:OVID    

年代:2003

数据来源: OVID