PMID- 27919979 OWN - NLM STAT- MEDLINE DCOM- 20170130 LR - 20181202 IS - 1791-7530 (Electronic) IS - 0250-7005 (Linking) VI - 36 IP - 12 DP - 2016 Dec TI - Second-line Erlotinib or Intermittent Erlotinib plus Docetaxel in Male Ex-smokers with Squamous NSCLC: The TALISMAN Randomized Trial. PG - 6535-6540 AB - BACKGROUND/AIM: The TArceva and docetaxeL In former-Smokers MAle patients with recurrent non-small cell lung cancer (TALISMAN) phase II, open-label randomized trial evaluates the combination of erlotinib with docetaxel in the second-line therapy of ex-smoker males with advanced squamous non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients received erlotinib 150 mg/day (arm A; n=36) or docetaxel 75 mg/m(2) on day 1 of each 3-week cycle and erlotinib 150 mg/day on days 2-16 of each cycle (arm B; n=38). The primary end-point was progression-free rate (PFR) at 6 months. RESULTS: The study was prematurely interrupted due to slow enrolment. Three (8.3%) patients in arm A and 3 (8.1%) in arm B remained progression-free at 6 months. Median progression-free survival (PFS) was 2.3 months in arm A and 2.8 months in arm B. Median overall survival (OS) was 5.6 and 8.9 months, respectively. Overall, 77.8% of patients in arm A and 89.2% in arm B experienced treatment-related adverse events (AEs). CONCLUSION: Results do not support further investigation of the combination of erlotinib and docetaxel in this setting. CI - Copyright(c) 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved. FAU - Gridelli, Cesare AU - Gridelli C AD - Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy cgridelli@libero.it. FAU - Chella, Antonio AU - Chella A AD - University Hospital, Pisa, Italy. FAU - Valmadre, Giuseppe AU - Valmadre G AD - ASST Valtellina e Alto Lario, Sondrio, Italy. FAU - Allegrini, Giacomo AU - Allegrini G AD - Az-USL 5 Pisa, Pisa, Italy. FAU - Brighenti, Matteo AU - Brighenti M AD - Cremona Hospital, Cremona, Italy. FAU - Bidoli, Paolo AU - Bidoli P AD - San Gerardo Hospital, Monza, Italy. FAU - Rossi, Antonio AU - Rossi A AD - Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy. FAU - Maione, Paolo AU - Maione P AD - Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy. FAU - Migliorino, Maria Rita AU - Migliorino MR AD - San Camillo Hospital, Roma, Italy. FAU - Ricciardi, Serena AU - Ricciardi S AD - San Camillo Hospital, Roma, Italy. FAU - DE Marinis, Filippo AU - DE Marinis F AD - Thoracic Oncology Division, European Institute of Oncology (IEO), Milan, Italy. LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - Greece TA - Anticancer Res JT - Anticancer research JID - 8102988 RN - 0 (Taxoids) RN - 15H5577CQD (Docetaxel) RN - DA87705X9K (Erlotinib Hydrochloride) SB - IM MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy MH - Disease-Free Survival MH - Docetaxel MH - Erlotinib Hydrochloride/*administration & dosage MH - Humans MH - Lung Neoplasms/*drug therapy MH - Male MH - Middle Aged MH - *Smoking MH - Taxoids/*administration & dosage OTO - NOTNLM OT - Combination therapy OT - NSCLC OT - docetaxel OT - erlotinib OT - males OT - second-line treatment OT - smokers EDAT- 2016/12/07 06:00 MHDA- 2017/01/31 06:00 CRDT- 2016/12/07 06:00 PHST- 2016/08/10 00:00 [received] PHST- 2016/09/27 00:00 [revised] PHST- 2016/10/01 00:00 [accepted] PHST- 2016/12/07 06:00 [entrez] PHST- 2016/12/07 06:00 [pubmed] PHST- 2017/01/31 06:00 [medline] AID - 36/12/6535 [pii] AID - 10.21873/anticanres.11255 [doi] PST - ppublish SO - Anticancer Res. 2016 Dec;36(12):6535-6540. doi: 10.21873/anticanres.11255.