Cisplatin, 5-fluorouracil and interferon alpha 2b for recurrent or metastatic head and neck cancer.

On the basis of preclinical data suggesting the possibility of maximising the efficacy of 5-fluorouracil and cisplatin by interferon, a pilot clinical trial was initiated in recurrent and/or metastatic head and neck cancer. Thirty-four patients were treated with cisplatin at 100 mg m-2, followed by 5-fluorouracil at 1,000 mg m-2 by continuous infusion for 5 days. Interferon alpha 2b was administered at the dose of 3 million U i.m. daily for 7 days, beginning the day before chemotherapy. Courses were repeated every 3 weeks. Two patients achieved a complete remission, six a partial response, 14 had stable disease and 12 progressed on therapy, for an overall response rate of 23% (95% confidence interval 10-36%). Median survival time was 5 months. Toxicity was severe. Stomatitis, diarrhoea and myelosuppression were the most common side-effects. Because of the poor response rate and the presence of severe toxicity, in our opinion further clinical trials in head and neck cancer should be attempted only after a better definition in preclinical studies of interactions among 5-fluorouracil, cisplatin and interferon

EFFICACY OF ZOLEDRONIC ACID IN PATIENTS WITH RENAL CANCER METASTATIC TO BONE

I in renal cancer patients probably related to survival increase. There are few data in literature about the role of BPs in the treat- ment of bone disease from colorectal cancer. We present the pre- liminary data of a large Italian multicenter retrospective analysis. Methods. 284 renal cancer patients with evidence of bone metastases have been included in the study at the moment of ab- stract submission. Patients characteristics, skeletal related events (SRE) data and median survival after bone metastases appear- ance have been collected in a master data base and statistically analyzed. The primary efficacy endpoint was time to first SRE; secondary endpoint was median survival. Results. A total of 284 patients have been included for zole- dronic efficacy analysis. A total of 130 patients received zole- dronic acid (4 mg) via a 15-minute infusion every 4 weeks until performance status worsening or death. 154 patients have been analysed as control group. The median time to first SRE in the whole population was 1 month (0-72). The median time to first SRE in the zoledronic treated patients was 3 months (0-101) compared with 1 month (0-22) in the control group (p <0.05). The median survival after skeletal progression was 12 (1-178). The median survival in the zoledronic treated group was 15 months (2-120) compared with 7 months (1-178). (p <0.05). On- ly 2 cases of ONJ have been diagnosed. Conclusions. Complete results of statistical analysis will be presented during the meeting. The present analysis represents a confirmation, in clinical practice scenario, of zoledronic acid ac- tivity in bone metastases in renal cancer patients

Sequential chemotherapy with cisplatin, leucovorin, and 5-fluorouracil followed by docetaxel in previously untreated patients with metastatic gastric cancer: a phase II study

BACKGROUND: The combination of docetaxel, cisplatin, and 5-fluorouracil (5-FU) has demonstrated a survival advantage over cisplatin and 5-FU, but with substantial hematological toxicity. We aimed to evaluate the efficacy and toxicity of a sequential regimen with cisplatin, leucovorin, and 5-FU (PLF) followed by docetaxel in metastatic gastric cancer patients.METHODS: Treatment consisted of 4 cycles of biweekly PLF (cisplatin 50 mg/m(2) as a 30-min infusion on day 1, leucovorin 200 mg/m(2) in a 2-h infusion, and 5-FU 2,800 mg/m(2) in a 48-h continuous infusion starting on day 1) followed, in cases of response or stable disease, by 3 cycles of docetaxel (75 mg/m(2), every 3 weeks).RESULTS: Thirty-four patients were enrolled, with an average age of 64 years (range 34-69). The main cumulative grade 3-4 toxicities were: neutropenia (38.2%), febrile neutropenia (11.8%), and fatigue (14.7%). After the planned 7 cycles of treatment, the overall response rate was 38.2% (95% confidence interval [CI] 21.9-54.6), with 3 complete and 10 partial responses. Median progression-free survival and overall survival were 4.8 and 10.6 months, respectively.CONCLUSIONS: For patients with metastatic gastric cancer, the sequential administration of cisplatin, leucovorin, 5-FU, and docetaxel may be an effective palliative option and offers a far more favorable toxicity profile than the simultaneous use of docetaxel, cisplatin, and 5-FU