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RESEARCH PRODUCT
Cisplatin-based first-line treatment of elderly patients with advanced non-small-cell lung cancer: Joint analysis of MILES-3 and MILES-4 phase III trials
Ferdinando RiccardiRoberto BordonaroMaria Carmela PiccirilloGaetano RoccoSimona SignorielloV. FilipazziCesare GridelliVittorio GebbiaFortunato CiardielloManlio MencoboniFrancesco RosettiPaolo MaioneFabrizio NelliFrancesco PerroneFabrizio ArtioliDomenico BilanciaAlessandro MorabitoRoberto BiancoSaverio CinieriCiro GalloLaura BonannoDiego CortinovisVittorio FregoniSilvana LeoRaffaele CostanzoMarco Angelo BurgioAndrea LucianiLuigi CavannaGiuditta Di IserniaGennaro Danielesubject
0301 basic medicineOncologyMaleCancer Researchmedicine.medical_specialtyPhases of clinical researchKaplan-Meier EstimatePemetrexedDeoxycytidine03 medical and health sciences0302 clinical medicineInternal medicineCarcinoma Non-Small-Cell Lungmedicineadvanced non small cell lung cancer (NSCLC) elderly patients cisplatin MILES 3 MILES 4Progression-free survivalLung cancerSurvival rateAgedAged 80 and overAntineoplastic Combined Chemotherapy ProtocolPerformance statusbusiness.industrymedicine.diseaseGemcitabineLung Neoplasm030104 developmental biologyPemetrexedTreatment OutcomeOncologyResponse Evaluation Criteria in Solid Tumors030220 oncology & carcinogenesisQuality of LifeFemaleCisplatinbusinessmedicine.drugHumandescription
Purpose To test the efficacy of adding cisplatin to first-line treatment for elderly patients with advanced non–small-cell lung cancer (NSCLC) within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4. Patients and Methods Patients with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin. In each trial, 382 events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed α of .05. Trials were closed prematurely because of slow accrual, but the joint database allowed us to analyze the efficacy of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center. Results From March 2011 to August 2016, 531 patients (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n = 268) or with cisplatin (n = 263). Median age was 75 years, 79% were male, and 70% had nonsquamous histology. At a median 2-year follow-up, 384 deaths and 448 progression-free survival events were recorded. Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P = .14) and global health status score of quality of life was not improved, whereas progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P = .005) and objective response rate (15.5% v 8.5%; P = .02) were significantly better. Significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin. Conclusion The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2018-09-01 |