PMID- 15777979
OWN - NLM
STAT- MEDLINE
DCOM- 20050712
LR  - 20221207
IS  - 0169-5002 (Print)
IS  - 0169-5002 (Linking)
VI  - 48
IP  - 1
DP  - 2005 Apr
TI  - Increased dose-intensity of gemcitabine in advanced non small cell lung cancer 
      (NSCLC): a multicenter phase II study in elderly patients from the "polmone 
      toscano group" (POLTO).
PG  - 121-7
AB  - Gemcitabine is usually administered at a planned dose-intensity (DI) from 750 to 
      800 mg/m2/week. Preclinical data have suggested a possible dose-response 
      relationship of gemcitabine. A multicenter phase II study was conducted to 
      evaluate the activity in terms of no progression rate (complete responses+partial 
      responses+stable diseases) of gemcitabine administered at an increased DI (1000 
      mg/m2/week) in elderly advanced non-small-cell lung cancer (NSCLC) patients. 
      Secondary endpoints were to evaluate tolerability, progression free survival and 
      overall survival. Elderly (age>or=70 years) chemo-naive advanced NSCLC patients, 
      ECOG PS 0-2, were treated with intravenous gemcitabine 1500 mg/m2 intravenous (30 
      min infusion) on days 1 and 8 every 21 days for four courses. One hundred and 
      twenty-two patients with a median age of 75 years (range 70-84) entered the 
      study. The following grade 3 (NCI-CTC) haematological toxicities were reported 
      (percent of patients): neutropenia 2.4%, thrombocytopenia 1.6%, anaemia 2.4%. No 
      grades 3-4 non-haematological toxicities were observed. Among 111 evaluable 
      patients 52 (46.8%) no progressions, 17 (15.3%) partial responses (WHO criteria), 
      35 (31.5%) stable diseases and 59 (53.2%) progressions were observed. Median time 
      to progression was 3.2 months and median duration of survival was 5.4 months. The 
      overall 1-year survival rate was 27%. Although increased dose-intensity of 
      gemcitabine in elderly NSCLC patients is feasible without severe toxicities, this 
      does not seem to be associated with an increased activity and efficacy in 
      comparison to standard gemcitabine regimens with lower dose-intensities.
FAU - Tibaldi, C
AU  - Tibaldi C
AD  - Division of Medical Oncology, Department of Oncology, Livorno, Italy. 
      tiby@katamail.com
FAU - Ricci, S
AU  - Ricci S
FAU - Russo, F
AU  - Russo F
FAU - Bernardini, I
AU  - Bernardini I
FAU - Galli, L
AU  - Galli L
FAU - Chioni, A
AU  - Chioni A
FAU - Orlandini, C
AU  - Orlandini C
FAU - Grosso, A M
AU  - Grosso AM
FAU - Pegna, A Lopes
AU  - Pegna AL
FAU - Fabbri, A
AU  - Fabbri A
FAU - Innocenti, F
AU  - Innocenti F
FAU - Ferrari, K
AU  - Ferrari K
FAU - Tognarini, L
AU  - Tognarini L
FAU - Conte, P F
AU  - Conte PF
FAU - Falcone, A
AU  - Falcone A
CN  - POLTO group
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20041210
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Antimetabolites, Antineoplastic/*administration & dosage/adverse 
      effects/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/*pathology
MH  - Deoxycytidine/*administration & dosage/adverse effects/*analogs & 
      derivatives/*therapeutic use
MH  - Disease Progression
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/*pathology
MH  - Male
MH  - Neutropenia/chemically induced
MH  - Survival Analysis
MH  - Thrombocytopenia/chemically induced
MH  - Gemcitabine
EDAT- 2005/03/22 09:00
MHDA- 2005/07/13 09:00
CRDT- 2005/03/22 09:00
PHST- 2004/06/08 00:00 [received]
PHST- 2004/10/11 00:00 [revised]
PHST- 2004/10/18 00:00 [accepted]
PHST- 2005/03/22 09:00 [pubmed]
PHST- 2005/07/13 09:00 [medline]
PHST- 2005/03/22 09:00 [entrez]
AID - S0169-5002(04)00534-3 [pii]
AID - 10.1016/j.lungcan.2004.10.008 [doi]
PST - ppublish
SO  - Lung Cancer. 2005 Apr;48(1):121-7. doi: 10.1016/j.lungcan.2004.10.008. Epub 2004 
      Dec 10.