Efficacy and toxicity of weekly Docetaxel as second/third line chemotherapy for advanced Non Small Cell lung cancer (NSCLC)

Aim: The purpose of this study was to evaluate the efficacy and toxicity of weekly Docetaxel in patients with locally advanced or metastatic NSCLC previously treated with platinum compounds. Patients and Methods: Twenty patients with locally advanced or metastatic platinum compounds pretreated NSCLC were included in this phase II trial. Docetaxel was administered at a dose of 30 mg/m2, repeated once a week for 3 consecutive weeks followed by a 1-week rest period (1 cycle). Patients were evaluated for tumor response every 8 weeks (after every other cycle). Therapy was continued for a maximum of six courses in patients showing tumor response or stable disease. Results: Patients’ baseline characteristics included : median age 64 years ( range 44– 73); male female 14/6; ECOG- PS grade 0 in 10, 1 in 6 and 2 in 4; stage III / IV 5/15. 15 patients had received one previous chemotherapy regimen and 5 two. The median number of weekly infusions of docetaxel administered was 10 (range 1–18). All twenty patients were assessable for response. Three patients (15%) achieved a partial response and six patients showed either stable disease or a minor response. No response or stabilization have been obtained in patients treated with two previous chemotherapy regimens. Median survival time was 39 weeks and median time to progression 12 weeks. Grade 3/4 leukopenia occurred in two patients. No other grade 3 or 4 hematologic toxicities were observed. The following grade 3/4 non-hematologic toxicities were seen: nausea/vomiting (one patient), mucositis (two patients) and diarrhea (one patient). Three patients withdrew from the study due to dose-limiting toxicities (two due to severe neutropenia and one due to mucositis). Conclusion: 30 mg/m2 weekly docetaxel administration is effective and well tolerated even in heavily pretreated patients with advanced or metastatic NSCLC. Four months after treatment, PS was > 80 in 17 pts (55%) and improved but still <80 in the remaining pts. However, no long lasting toxicities or late sequelae were observed except for various grades on xerostomia. Conclusions: In our experience, this post-operative radiochemotherapy treatment appears feasible and tolerable with manageable toxicity.