Docetaxel plus gemcitabine versus gemcitabine in elderly patients with advanced non-small cell lung cancer and use of a geriatric assessment: Lessons from a prematurely closed Hellenic Oncology Research Group randomized phase III study.
To compare first-line treatment with docetaxel plus gemcitabine (DG) versus gemcitabine (G) in elderly patients with advanced/metastatic non-small-cell lung cancer (NSCLC).



Chemotherapy-naïve patients with inoperable stage IIIB/IV NSCLC, ≥70years, with an ECOG performance status (PS) of 0-2 were enrolled. Patients were stratified by PS and disease stage and randomized to either DG (docetaxel 30mg/m2plus gemcitabine 900mg/m2i.v.) or G (gemcitabine 1200mg/m2i.v.) on days 1 and 8, every 3weeks. The study's primary end-point was overall survival (OS).



In this prematurely closed study, 106 patients with a median age of 75years (range, 70-92) were enrolled (DG: n=54; G: n=52); 77 (73%) had stage IV disease and 18 (17%) a PS of 2. There was no difference in terms of median OS (14.6 vs 12.2months; p=0.121), progression-free survival (PFS) (3.4 vs 2.6months; p=0.757) and overall response rate (26.0% vs 15.4%; p=0.233) between DG and G arm, respectively. Patients with an Instrumental Activities of Daily Living (IADL) score<7 had significantly lower median OS (7.6 vs 15.4months; p=0.002) and median PFS (1.7 vs 4.4months; p=0.009) than patients with higher IADL score. The regimens were well tolerated with no significant difference in severe toxicity.



DG and G demonstrated comparable efficacy in elderly patients with NSCLC and high IADL score was correlated with superior clinical outcome.
401 Army General Hospital, Athens, Greece; Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Athanasios
A
Karampeazis
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Lambros
L
Vamvakas
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Athanasios
A
Kotsakis
401 Army General Hospital, Athens, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Charalambos
C
Christophyllakis
Medical Oncology Department, 251 General Air Force Hospital, Athens, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Nikolaos
N
Kentepozidis
1st Department of Pulmonary Disease, Sismanoglion Hospital, Athens, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Vassilios
V
Chandrinos
1st Department of Pulmonary Disease, "Sotiria" General Hospital, Athens, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Anna
A
Agelidou
1st Department of Medicine, University of Athens, Medical School, "Sotiria" General Hospital, Athens, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Aris
A
Polyzos
1st Department of Pulmonary Disease, Sismanoglion Hospital, Athens, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Xanthi
X
Tsiafaki
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Dora
D
Hatzidaki
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471. Electronic address: georgoul@med.uoc.gr.
Vassilis
V
Georgoulias
D000203:Activities of Daily Living; D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D057239:Early Termination of Clinical Trials; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine
Docetaxel; Elderly patients; Gemcitabine; NSCLC