RESUMO
Pegylated liposomal doxorubicin (PLD) has the advantage of delivering active anthracycline directly to the tumor site, while exposing the patient to a lesser degree of doxorubicin-associated toxicities. Recently, a regimen in which paclitaxel is infused weekly over 1 h produced substantial antitumor activity with little myelosuppression. We designed a phase II trial to study the efficacy and toxicity of 10 mg/m(2) PLD on Days 1, 8 and 15, plus 70 mg/m(2) paclitaxel weekly in patients with untreated metastatic breast cancer and a high risk of cardiotoxicity. The study included 35 patients, with 31 (88.5%) evaluable for efficacy and 35 (100%) for toxicity. A total of 28 patients (80%) had two or more sites of disease. Overall, 4 complete and 16 partial responses were noted with an overall response rate of 64.5%, with 6 cases of stable and 5 cases of progressive disease. Toxicity was found to be manageable in that the only grade 3-4 side effects recorded were palmar-plantar erythrodysesthesia, 8.5%; mucositis, 2.8%; leucopenia, 12.5%; anemia, 2.8% and AST/ALT, 2.8%. No cardiotoxicity was observed. In conclusion, weekly PLD plus paclitaxel appears to be a well-tolerated and effective approach for metastatic breast cancer patients with a high risk of cardiotoxicity.
RESUMO
BACKGROUND: This study evaluated the antitumor efficacy and safety of a novel oxaliplatin/raltitrexed combination in pretreated advanced colorectal cancer patients. PATIENTS AND METHODS: Forty-five patients with 5-fluorouracil-refractory metastatic colorectal cancer received raltitrexed 3.0 mg/m2 as a 15-minute intravenous (i.v.) infusion, followed 45 min later by l-OHP 130 mg/m2 i.v. as 2-h venous infusion on 1 day every 3 weeks. All patients had histologically proven metastatic colorectal cancer, age 18-75, measurable disease and normal baseline biological values. Most patients (60%) had >2 disease sites. All patients were assessed for safety and also for response according to an intent-to-treat fashion. RESULTS: The overall response rate was 29% (95% CL 16%-44%) including one CR (2%) and 12 PR (27%). Six patients (16%) showed a stabilization of disease for a tumor growth control rate of 45%. The median time to progression was 4 months (range 1-12+) and median overall survival was 9 months (range 1-29+). CONCLUSION: These data confirm that this oxaliplatin/raltitrexed combination is effective against metastatic colorectal carcinoma, well tolerated with low grade toxicity and easy to administer. Further evaluation of this regimen seems warranted as an alternative to fluoropyrimidine-based combinations.