title: Efficacy and safety of rechallenge treatment with gefitinib in patients with advanced non-small cell lung cancer.
abstract: Although patients with advanced non-small cell lung cancer (NSCLC) and an activating epidermal growth factor receptor (EGFR) mutation benefit from the use of EGFR-tyrosine kinase inhibitors (TKI), most of them progress within 12 months from treatment start due to acquired resistance. In clinical practice, many physicians frequently offer these patients retreatment with EGFR-TKIs after a chemotherapy break, based on small or retrospective studies.
  
  
  
  A phase II trial was conducted in patients with stage III/IV NSCLC, to assess the efficacy, safety and impact on quality of life (QoL) and disease-related symptoms of gefitinib rechallenge. Eligible patients had initially responded to first-line gefitinib and progressed after second-line chemotherapy.
  
  
  
  Of 61 enrolled patients, 73.8% were female, 100% had EGFR-mutated adenocarcinoma and 67.2% were never-smokers. Thirty-two (52.5%) patients obtained a clinical benefit, with 3 (4.9%) achieving a partial response and 29 (47.5%) having stable disease. Median progression-free survival was 2.8 months, overall survival 10.2 months and duration of gefitinib treatment 3.6 months. The most common all grade-adverse events were diarrhea (27.6%), nausea and/or vomiting (20.3%), rash (14.7%) and dyspnea (10.3%); no new toxicities were apparent.
  
  
  
  Findings from this study indicate that gefitinib rechallenge offers modest benefit and may be taken into consideration only for patients for whom no other treatment option exists.
authors: Medical Oncology Department, Istituto Toscano Tumori, Ospedale Civile, Viale Alfieri 36, 57100 Livorno, Italy. Electronic address: f.cappuzzo@googlemail.com.
authors: Federico
authors: F
authors: Cappuzzo
authors: Thoracic Medical Oncology, Istituto Nazionale Tumori "Fondazione G Pascale"-IRCCS, Via Semmola, 80131 Naples, Italy. Electronic address: a.morabito@istitutotumori.na.it.
authors: Alessandro
authors: A
authors: Morabito
authors: Cell Biology & Biotherapy Unit, Istituto Nazionale Tumori "Fondazione G Pascale"-IRCCS, Via Semmola, 80131 Naples, Italy. Electronic address: n.normanno@istitutotumori.na.it.
authors: Nicola
authors: N
authors: Normanno
authors: Department of Oncology, San Gerardo Hospital, Monza, Via Pergolesi 33, 20900 Monza, Italy. Electronic address: p.bidoli@hsgerardo.org.
authors: Paolo
authors: P
authors: Bidoli
authors: Medical Oncology, Azienda per l'Assistenza Sanitaria No. 5 (AAS5) - Friuli Occidentale - Presidio Ospedaliero di Pordenone, Via Montereale 24, 33170 Pordenone, Italy. Electronic address: alessandro.delconte@aas5.sanita.fvg.it.
authors: Alessandro
authors: A
authors: Del Conte
authors: Oncologia Falck, Division of Medical Oncology, Niguarda Ca' Granda Hospital, Piazza Ospedale Maggiore 3, 20162 Milan, Italy. Electronic address: laura.giannetta@ospedaleniguarda.it.
authors: Laura
authors: L
authors: Giannetta
authors: Thoracic Medical Oncology, Istituto Nazionale Tumori "Fondazione G Pascale"-IRCCS, Via Semmola, 80131 Naples, Italy. Electronic address: a.montanino@istitutotumori.na.it.
authors: Agnese
authors: A
authors: Montanino
authors: Medical Oncology, University Hospital Careggi, L. go Brambilla 3, 50134 Florence, Italy. Electronic address: francescamazzoni@hotmail.com.
authors: Francesca
authors: F
authors: Mazzoni
authors: Division of Oncology, Department of Translational Medicine, University of Eastern Piedmont "Amedeo Avogadro", 28100 Novara, Italy. Electronic address: r.buosi@maggioreosp.novara.it.
authors: Roberta
authors: R
authors: Buosi
authors: Department of Medical Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, Italy. Electronic address: marco.burgio@irst.emr.it.
authors: Marco Angelo
authors: MA
authors: Burgio
authors: Oncologia Falck, Division of Medical Oncology, Niguarda Ca' Granda Hospital, Piazza Ospedale Maggiore 3, 20162 Milan, Italy. Electronic address: giulio.cerea@ospedaleniguarda.it.
authors: Giulio
authors: G
authors: Cerea
authors: Department of Medical Oncology, "Santa Maria della Misericordia" Hospital, Azienda Ospedaliera di Perugia, 06132 Perugia, Italy. Electronic address: rita.chiari@ospedale.perugia.it.
authors: Rita
authors: R
authors: Chiari
authors: Department of Oncology, San Gerardo Hospital, Monza, Via Pergolesi 33, 20900 Monza, Italy. Electronic address: d.cortinovis@hsgerardo.org.
authors: Diego
authors: D
authors: Cortinovis
authors: Department of Medical Oncology, Istituto Clinico Humanitas IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy. Electronic address: giovanna.finocchiaro@cancercenter.humanitas.it.
authors: Giovanna
authors: G
authors: Finocchiaro
authors: Medical Oncology, Azienda per l'Assistenza Sanitaria No. 5 (AAS5) - Friuli Occidentale - Presidio Ospedaliero di Pordenone, Via Montereale 24, 33170 Pordenone, Italy. Electronic address: luisa.foltran@aas5.sanita.fvg.it.
authors: Luisa
authors: L
authors: Foltran
authors: Department of Thoracic Oncology, 1st Pulmonary Oncological Unit, Azienda Ospedaliera San Camillo-Forlanini, Rome, Italy. Electronic address: ritamigliorino@tiscali.it.
authors: Maria Rita
authors: MR
authors: Migliorino
authors: Division of Medical Oncology, University Hospital of Parma, Via Gramsci, 14, 43126 Parma, Italy. Electronic address: mtiseo@ao.pr.it.
authors: Marcello
authors: M
authors: Tiseo
authors: AstraZeneca, Palazzo Ferraris, Via Ludovico il Moro 6/C, 20080 Basiglio, Milan, Italy. Electronic address: silvia.ferrari@astrazeneca.com.
authors: Silvia
authors: S
authors: Ferrari
authors: Thoracic Oncology Division, Istituto Europeo di Oncologia (IEO), Via Ripamonti 435, 20141 Milan, Italy, Italy; Formerly Department of Thoracic Oncology, 1st Pulmonary Oncological Unit, Azienda Ospedaliera San Camillo-Forlanini, Rome, Italy. Electronic address: filippo.demarinis@ieo.it.
authors: Filippo
authors: F
authors: De Marinis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D018450:Disease Progression; D066246:ErbB Receptors / Q000235:genetics; D005260:Female; D000077156:Gefitinib; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009367:Neoplasm Staging; D047428:Protein Kinase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D011788:Quality of Life; D011799:Quinazolines / Q000494:pharmacology / Q000627:therapeutic use*; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib
keywords: Advanced stage NSCLC; EGFR mutation; Gefitinib; Rechallenge