Phase III randomized trial comparing cisplatin and carboplatin with or without ifosfamide in patients with advanced non-small-cell lung cancer. European Lung Cancer Working Party
| Autor: | Anna Efremidis, Jacques Thiriaux, Jean Klastersky, Constantinos Zacharias, Paul Mommen, Jean-Jacques Lafitte, Marianne Paesmans, M.C. Berchier, Jean-Paul Sculier, Vincent Ninane, V. Giner, Constantinos Alexopoulos, Jean-Sébastien Lecomte, Gérard Bureau |
|---|---|
| Rok vydání: | 1998 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Lung Neoplasms medicine.medical_treatment Urology Carboplatin law.invention chemistry.chemical_compound Randomized controlled trial law Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Humans Ifosfamide Lung cancer Aged Cisplatin Chemotherapy business.industry Middle Aged Prognosis medicine.disease Nitrogen mustard Surgery Survival Rate Regimen Oncology chemistry Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 16:1388-1396 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.1998.16.4.1388 |
| Popis: | PURPOSE A phase III randomized trial in patients with advanced non-small-cell lung cancer (NSCLC) was performed to determine if the addition of ifosfamide to moderate-dose cisplatin and carboplatin improved response rate (primary end point) and survival. PATIENTS AND METHODS A total of 529 patients were randomized to receive a combination of moderate-dose carboplatin (200 mg/m2 intravenously [i.v.] on day 1) and cisplatin (30 mg/m2 i.v. on days 2 and 3) with (CCI arm) or without (CC arm) ifosfamide (1.5 g/m2 i.v. on days 1 to 3). There were 248 eligible patients on the CC arm and 257 on the CCI arm, with 220 and 238 patients assessable for response, respectively. All but 23 had stage IV disease with pleural effusion. RESULTS There was a 16% objective response (OR) rate to CC and a 31% OR rate to CCI. That observed difference was highly statistically significant (P < 0.001). Duration of response and survival were not statistically different between arms. The CCI regimen was associated with significantly more acute toxicities: emesis, alopecia, leukopenia, and thrombocytopenia. The frequency of chronic renal, auditive, and peripheral neurologic toxicity was low in both arms (4.6% and 6.6%, respectively, after six courses of chemotherapy). The relative dose-intensity (RDI) of the CCI arm was significantly lower than that of the CC arm. CONCLUSION The addition of ifosfamide to moderate-dose cisplatin and carboplatin significantly improves the antitumoral response rate, but has no apparent effect an survival in advanced NSCLC. |
| Databáze: | OpenAIRE |
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