Cisplatin-based three drugs combination (NIP) as induction and adjuvant treatment in locally advanced non-small cell lung cancer: final results
| Autor: | Guillermo López Vivanco, Alberto Fittipaldo, Dominique Grunenwald, Leona Koubková, Aleksandra Szczesna, Grzegorz Ziolo, Maciej Krzakowski, Reury-Perng Perng, Francesco Carpagnano, Swan-Swan Leong, Cecilia De Almeida, Jubrail Dahabreh, Henryk Olechnowicz, Maya Gottfried, Rodryg Ramlau, Delphine Aubert |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male medicine.medical_specialty Lung Neoplasms Drug-Related Side Effects and Adverse Reactions Nausea medicine.medical_treatment Neutropenia Vinorelbine Triplet combination Vinblastine Gastroenterology Non-small cell lung cancer Downstaging Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Humans Ifosfamide Lung cancer Infusions Intravenous Mesna Aged Chemotherapy business.industry Neo-adjuvant chemotherapy Middle Aged medicine.disease Survival Analysis Neoadjuvant Therapy Surgery Adjuvant chemotherapy Oncology Stage III Chemotherapy Adjuvant Vomiting Female medicine.symptom Cisplatin business medicine.drug |
| Zdroj: | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 3(2) |
| ISSN: | 1556-1380 |
| Popis: | Introduction This phase III trial was conducted in non-small cell lung cancer patients with locally advanced stage II B (only T3N0) III A and III B (only T4 N0). Primary endpoint was 2-year survival; secondary were toxicity, disease-free survival, and overall survival. Methods After three cycles of vinorelbine (N) 25 mg/m 2 on days 1 and 5, ifosfamide/mesna (I) 3 g/m 2 on day 1, cisplatin (P) (NIP), patients were treated by surgery and within 45 days were randomized to two additional cycles of NIP versus observation. Results Median tumor diameter was 5.5 cm (1.2–10.6). Overall, 155 of 156 patients received chemotherapy: 133 (85%) men, median age: 59 years (35–75). Sixty-five percentage of patients were stage III A, 28% II B, and 7% III B. The study has been closed prematurely because of the low inclusion rate. After three cycles of induction in 143 assessable patients, 82 reported an objective response (57.3%) (95% CI: 48.8–65.6), with 3.5% complete response and 53.8% partial response. Relative dose intensity during neoadjuvant NIP (%) was 97, 98, and 98.5 for vinorelbine, ifosfamide/mesna, and cisplatin, respectively. Tolerance: G3 to 4 neutropenia in 3% of patients and G3 to 4 anemia in 4%; nonhematological toxicities included G3 nausea/vomiting in 11%, G3 anorexia and G3 to 4 infection in 6.5%, G3 asthenia in 10% and G3 to 4 alopecia in 25.5%. After a median of 32 days after NIP, 107 patients (69%) underwent operation with complete resection (R0) in 74% (79 of 107 patients). Downstaging (N2 to N0) after surgery was 29%. Operative mortality rate was 2.8%. Twenty-one days (median) after surgery, 79 patients were randomized to adjuvant NIP (47%) or control (53%). Tolerance of adjuvant NIP: 12.5% G3 to 4 nausea/vomiting, 19% G3 alopecia, 6% G3 infection, and G3 asthenia. Overall median survival 32.3 versus 31.8 months in the observation and NIP arms, respectively. Conclusions NIP allows 74% of R0 with no surgery delay. The few number of randomized patients did not allow to conclude on the efficacy of adjuvant chemotherapy. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|