Vinorelbine-Based Regimens as Salvage Treatment in Patients with Advanced Non-Small Cell Lung Cancer: Two Parallel Multicenter Phase II Trials
| العنوان: | Vinorelbine-Based Regimens as Salvage Treatment in Patients with Advanced Non-Small Cell Lung Cancer: Two Parallel Multicenter Phase II Trials |
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| المؤلفون: | E. Sarra, Sophia Agelaki, X. Tsiafaki, E. Papadakis, Nikos Androulakis, Kostas Kalbakis, Vassilis Georgoulias, Helen Bania, Charalambos Kouroussis, George Blazoyiannakis, Adriani Harpidou, John Souglakos, Ageliki Rapti |
| المصدر: | Oncology. 60:235-241 |
| بيانات النشر: | S. Karger AG, 2001. |
| سنة النشر: | 2001 |
| مصطلحات موضوعية: | Adult, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Adolescent, medicine.medical_treatment, Salvage therapy, Neutropenia, Vinblastine, Vinorelbine, Gastroenterology, chemistry.chemical_compound, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Aged, Salvage Therapy, Chemotherapy, Ifosfamide, Performance status, business.industry, General Medicine, Middle Aged, medicine.disease, Carboplatin, Surgery, Regimen, Oncology, chemistry, Patient Compliance, Female, business, medicine.drug |
| الوصف: | Two parallel phase II trials were conducted in order to evaluate the efficacy and toxicity of vinorelbine-ifosfamide (VNB-IFX) and vinorelbine-carboplatin (VNB-C) combinations as salvage treatment in patients with advanced non-small cell lung cancer (NSCLC). Patients and Methods: Patients failing platinum-based front-line chemotherapy were enrolled in the VNB-IFX trial while patients failing non-platinum-containing chemotherapy were treated with VNB-C. Twenty-nine patients were treated with VNB-IFX [median age: 59 years; performance status, PS (WHO) 0–1: 72% and disease stage IV: 79%] and 37 with VNB-C [median age: 61 years; PS (WHO) 0–1: 51% and stage IV: 84%]. Patients received vinorelbine 25 mg/m2 i.v. on days 1 and 8 and ifosfamide 1.6 g/m2 i.v. on days 8–10 with uroprotective mesna, in cycles of 28 days. G-CSF (5 µg/kg/day s.c.) was administered prophylactically on days 11–16 or until hematological recovery. The VNB-C regimen consisted of carboplatin 300 mg/m2 on day 1 and vinorelbine 30 mg/m2 on days 1 and 8 every 28 days. Results: Twenty-six patients were evaluable for response in the VNB-IFX trial and 29 in the VNB-C. Overall response rates (intent-to-treat analysis) were 3% (1 patient; duration of response: 3 months) for the VNB-IFX and 16% (median duration of response: 7.5 months) for the VNB-C combination. The median time to progression and survival for patients receiving VNB-IFX were 4.5 and 6 months (1-year survival: 19%), respectively; the corresponding values for VNB-C were 9.0 and 8.5 months (1-year survival: 38%). The median survival of patients achieving stable disease was 10 (VNB-IFX) and 14.5 (VNB-C) months. Grade 3–4 neutropenia occurred in 4 (13%) of the patients treated with VNB-IFX; all cases were complicated with fever. Grade 3–4 neutropenia was documented in 13 (35%) patients in the VNB-C trial; 6 (16%) developed neutropenic fever. There were no treatment-related deaths. Non-hematologic toxicity for the VNB-IFX and VNB-C regimens was mild with grade 2–3 peripheral neurotoxicity occurring in 3 (10%) and 7 (19%) patients, and grade 2–3 asthenia in 11 (38%) and 18 (48%) patients, respectively. Conclusion: Both combinations were associated with a tolerable toxicity profile. VNB-C demonstrated notable activity in patients previously treated with a taxane-based regimen, whilst VNB-IFX failed to produce a significant response rate in patients treated with platinum-containing chemotherapy. Stabilization of disease was associated with a favorable survival in both studies. |
| تدمد: | 1423-0232 0030-2414 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::72b1ed275212f01f5e1193edfcd9b3c8 https://doi.org/10.1159/000055324 |
| حقوق: | CLOSED |
| رقم الأكسشن: | edsair.doi.dedup.....72b1ed275212f01f5e1193edfcd9b3c8 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14230232 00302414 |
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