6533b7d3fe1ef96bd1260be1
RESEARCH PRODUCT
Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STEP trial.
Gridelli C.Gallo C.Morabito A.Iaffaioli R. V.Favaretto A.Isa L.Barbera S.Gamucci T.Ceribelli A.Filipazzi V.Maione P.Rossi A.Barletta E.Signoriello S.De Maio E.Piccirillo M. C.Di Maio M.Rocco G.Vecchione A.Perrone F.Cesare GridelliPaolo MaioneAntonio RossiCiro GalloGiuseppe SignorielloPaolo ChiodiniSimona SignorielloFrancesco PerroneMassimo Di MaioMaria Carmela PiccirilloErmelinda De MaioJane BryceAlessandro MorabitoRaffaele CostanzoGaetano RoccoRosario Vincenzo IaffaioliEmiddio BarlettaRoberta FormatoAldo VecchioneAdolfo FavarettoGiulia PaselloCristina MagroLuciano IsaRaffaele VeneziaMario ComandèSanti BarberaFrancesco RendaAntonio VolpintestaTeresa GamucciMaria Anna GiampaoloGiovanni MansuetoAnna CeribelliIlaria CarboneDomenica PellegriniVirginio FilipazziElena PiazzaSabrina FerrarioVittorina ZagonelGiuditta Di IserniaMarco CiaparroneFrancovito PiantedosiFabiana VitielloNicolò BorsellinoMaria Elia VitaleLuigi BrancaccioSergio SpinaMaria Rosaria ValerioRaffaella FellettiSalvatore TafutoMarianna GiampagliaRita MigliorinoFrancesco RosettiFrancesco CarrozzaNestore RossiMario SpataforaManlio MencoboniErnest Marshallsubject
OncologyMaleLung NeoplasmsDeoxycytidineCarboplatinchemistry.chemical_compoundElderlyAntineoplastic Combined Chemotherapy Protocols80 and overCarcinoma Small CellMultivariate AnalysiEtoposideEtoposidePlatinum compoundsAged 80 and overArea under the curveSCLCVinorelbinePrognosisElderly; Etoposide; Gemcitabine; Platinum compounds; SCLC; Vinorelbine; Aged; Aged 80 and over; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma Small Cell; Cisplatin; Deoxycytidine; Disease-Free Survival; Etoposide; Female; Humans; Lung Neoplasms; Male; Multivariate Analysis; Prognosis; Proportional Hazards Models; Quality of Life; Treatment Outcome; Vinblastine; VinorelbineTreatment OutcomeOncologyPlatinum compoundToxicityFemalemedicine.drugHumanPulmonary and Respiratory Medicinemedicine.medical_specialtyPrognosiVinorelbineVinblastineDisease-Free SurvivalInternal medicinemedicineHumansAgedProportional Hazards ModelsCisplatinAntineoplastic Combined Chemotherapy ProtocolPerformance statusbusiness.industryCarcinomaSmall CellGemcitabineGemcitabineCarboplatinSurgeryLung NeoplasmchemistryMultivariate AnalysisProportional Hazards ModelQuality of LifeCisplatinbusinessdescription
Introduction: Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence. Methods: Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥60% and unacceptable toxicity ≤25% were required to define a combination worthy of further studies. Results: Median age of 78 eligible patients was 74 years. GemVin produced a 36.7% objective response rate. GemEto and GemCis arms were found not sufficiently active. GemCar produced 16 responses (14 with area under the curve [AUC] 3.5 and 2 with AUC 4.0) in 26 patients (61.5%) and 6 cases of unacceptable toxicity (3 at each Car dose). Conclusions: In elderly patients with extensive SCLC, GemVin, GemEto, and GemCis are not enough active and do not merit further studies. Gem plus Car might deserve further attention. © 2011 by the International Association for the Study of Lung Cancer.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2011-10-28 |