ABSTRACT
OBJECTIVES: To assess the efficacy and toxicity profile of single agent docetaxel at a higher dose than previously evaluated in patients with androgen-independent prostate cancer (AIPC). PATIENTS AND METHODS: Patients with metastatic and progressive AIPC were treated with docetaxel 100 mg/m on day 1 of a 3-week cycle. RESULTS: Twenty-five patients with overt and rapid symptomatic deterioration from AIPC were entered into this study. Nine men achieved a reduction in PSA of >50% and 4 >80% for an overall PSA response of 52% (95% confidence interval [CI], 31-73%). Sixty percent of men experienced pain relief. Of 16 subjects with measurable disease, 25% achieved partial response (95% CI, 0-48 months), 44% stable disease, and 31% progressed. Median time to progression was 4.5 months (95% CI, 2.9-6.1 month) and median survival was 9.3 months (95% CI, 5.7-12.9 months). Toxicity was significant and included grade 3 or greater neutropenia (76%), dehydration (16%), thrombosis (8%), confusion (4%), and death (4%). CONCLUSION: Docetaxel is an active agent against AIPC and should be used judiciously. The side effect profile of the 100 mg/m dose was significant and cannot be recommended for everyday clinical practice.
Subject(s)
Antineoplastic Agents/administration & dosage , Prostatic Neoplasms/drug therapy , Taxoids/administration & dosage , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/adverse effects , Docetaxel , Humans , Male , Middle Aged , Survival Analysis , Taxoids/adverse effectsABSTRACT
OBJECTIVES: The efficacy of a concomitant oxaliplatin/bolus 5-fluorouracil/leucovorin regimen in 123 heavily pretreated patients with advanced colorectal cancer was evaluated. Patients with an Eastern Cooperative Oncology Group performance status of 0 to 2 and radiographically progressive cancer which failed to respond to between two and five prior treatment modalities were consented and enrolled. METHODS: Patients received oxaliplatin on day 1 of weeks 1, 3, and 5 of an 8-week cycle. 5-fluorouracil/leucovorin was administered on day 1 of weeks 1 through 6. RESULTS: Grade 3 to 4 toxicities were as follows: diarrhea 30%; vomiting 11%; hematologic < 3%; peripheral neuropathy 2.5%. Of the 101 patients evaluable for response, 7% achieved a partial response (median duration 4.25 mo), 1 patient achieved a minor response (7 mo), and 31% had stable disease (median duration 6.08 mo). The median time to progression was 3.6 months. CONCLUSION: This regimen in heavily pretreated patients with disseminated colorectal cancer is of modest benefit, often at the expense of considerable gastrointestinal toxicity. It appears that the use of oxaliplatin/bolus 5-fluorouracil/leucovorin is more toxic than oxaliplatin/infusional 5-fluorouracil and possibly less effective.
