Short hydration regimen and nephrotoxicity of intermediate to high-dose cisplatin-based chemotherapy for outpatient treatment in lung cancer and mesothelioma.

AIMS AND BACKGROUND: Cisplatin, a standard component of combination chemotherapy for several tumors, presents important anti-tumor properties but also several toxic effects. In particular, the major dose-limiting effect appears to be renal toxicity. In several countries, to reduce nephrotoxicity after cisplatin administration, a 24-h hydration is recommended following a chemotherapy treatment in a hospital regimen. In our Institutions, cisplatin chemotherapy is an outpatient treatment that provides adequate hydration with an NaCl solution plus furosemide and diuresis monitoring during treatment. METHODS AND STUDY DESIGN: To assess incidence of cisplatin nephrotoxicity using a short hydration regimen, which included 2000 ml of fluids with control of diuresis, individual outpatient data was pooled retrospectively from patients enrolled in large randomized studies regarding cisplatin-based chemotherapy in lung cancer and mesothelioma. From February 1999 to November 2002, 107 patients treated with cisplatin (> or = 75 mg/m2/cycle) were examined, monitoring serum creatinine and creatinine clearance levels. RESULTS: Five patients out of 107 (4.6%) were withdrawn from chemotherapy because of renal toxicity. For the other 102 patients, serum creatinine and creatinine clearance measurements were stable around the normal values during treatment. No time trends relating to serum creatinine levels or creatinine clearance and cycle numbers or cisplatin-cumulative doses were detected (P = 0.36 and P = 0.64, for the relationship with cycle number, and P = 0.39 and P = 0.65 for the relationship with cumulative dose, respectively, random effect model) after adjusting for the total number of cycles administered. CONCLUSIONS: These observations indicate that intermediate to high-dose cisplatin administration is feasible in outpatient management with a short hydration regimen without high risk of nephrotoxicity.

Docetaxel administered every two weeks as second-line chemotherapy for advanced non-small cell lung cancer: a phase II study.

BACKGROUND: The aim of this phase II study was to evaluate efficacy and toxicity of single-agent docetaxel, administered every two weeks as second-line treatment for patients with recurrent non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Forty-eight patients with confirmed NSCLC were enrolled in this trial The median age was 56.5 years (range 43-76), median PS was 1, and the main histology type was adenocarcinoma (54%). Only 8% of patients had previously received paclitaxel. Patients received docetaxel i.v., 50 mg/m2 over 1 hour, on day 1 every 2 weeks. RESULTS: The overall response rate was 8.3% (95% Confidence Interval 0.5-161%). The median time to disease progression, median survival time and 1-year survival rate were 3 months, 6 months and 21%, respectively. Grade 3-4 neutropenia was registered in 47% of patients, with only 1 patient (2%) experiencing febrile neutropenia. Nonhematological toxicity was mild (grade 1-2) and consisted mainly of asthenia (19%o) and diarrhea (10%). CONCLUSION: The bi-weekly schedule of docetaxel showed an activity comparable to the standard tri-weekly 75 mg/m2 schedule as second-line treatment for recurrent NSCLC. Though non-hematological toxicity is significantly reduced, myelosuppression is still a matter of concern.