PMID- 9207875
OWN - NLM
STAT- MEDLINE
DCOM- 19970722
LR  - 20221207
IS  - 0007-4551 (Print)
IS  - 0007-4551 (Linking)
VI  - 84
IP  - 3
DP  - 1997 Mar
TI  - [A phase II multicenter study of gemcitabine in non small cell lung cancers].
PG  - 282-8
AB  - Gemcitabine is a novel pyrimidine nucleoside whose activity has been demonstrated 
      on solid tumors. We report here the results of a multicentre phase II trial of 
      gemcitabine in chemonaive patients with inoperable non small cell lung cancer 
      (NSCLC). Gemcitabine was given weekly at a dose of 1,250 mg/m2 administered as a 
      30 min intravenous infusion, for 3 weeks followed by 1 week of rest (1 cycle). 
      All the 161 patients included were evaluable for toxicity and 151 of them were 
      evaluable for efficacy. The majority of patients had a stage IIIb (31.1%) or 
      stage IV (64.6%) disease; 10.6%, 83.2% and 6.2% of patients had a WHO performance 
      status (PS) 0, 1, and 2, respectively. Adenocarcinoma accounted for 52.2% of 
      cases and squamous cell carcinoma for 43.5% of cases. Three complete responses 
      and 30 partial responses gave an objective response (OR) rate of 21.8% (95% 
      confidence interval; 15.5-29.3%). All responses were validated by an independent 
      Oncology Review Board. Median duration of response was 7.6 months. Median time to 
      progression was 4.6 months (3.3 months in non responders and 7.6 months in 
      responders). Median survival was 7.3 months in non responders and 13.4 months in 
      responders (p < 0.001), which gave an overall median survival of 8.9 months (95% 
      CI: 0.1-21.9 months) in the entire study population. An improvement of symptoms 
      and personal state was also observed. Treatment was well tolerated. Neutropenia 
      was the only dose limiting toxicity. WHO grade 3 or 4 neutropenia occurred in 
      19.6% and 5.7% of patients, respectively. With a 21.8% OR rate, this multicentre 
      study confirms the activity of gemcitabine as a single agent in patients with 
      inoperable NSCLC. Its good tolerance and original mode of action make gemcitabine 
      a drug of choice in the therapeutic strategy of these tumors.
FAU - Le Chevalier, T
AU  - Le Chevalier T
AD  - Institut Gustave-Roussy, Villejuif, France.
FAU - Gottfried, M
AU  - Gottfried M
FAU - Gatzemeier, U
AU  - Gatzemeier U
FAU - Shepherd, F
AU  - Shepherd F
FAU - Weynants, P
AU  - Weynants P
FAU - Cottier, B
AU  - Cottier B
FAU - Groen, H J
AU  - Groen HJ
FAU - Rosso, R
AU  - Rosso R
FAU - Mattson, K
AU  - Mattson K
FAU - Cortes-Funes, H
AU  - Cortes-Funes H
FAU - Tonato, M
AU  - Tonato M
FAU - Burkes, R L
AU  - Burkes RL
FAU - Voi, M
AU  - Voi M
FAU - Ponzio, A
AU  - Ponzio A
LA  - fre
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - English Abstract
PT  - Journal Article
PT  - Multicenter Study
TT  - Etude multicentrique de phase II de la gemcitabine dans les cancers bronchiques 
      non a petites cellules (CBNPC).
PL  - France
TA  - Bull Cancer
JT  - Bulletin du cancer
JID - 0072416
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antimetabolites, Antineoplastic/adverse effects/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology
MH  - Deoxycytidine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Gemcitabine
EDAT- 1997/03/01 00:00
MHDA- 1997/03/01 00:01
CRDT- 1997/03/01 00:00
PHST- 1997/03/01 00:00 [pubmed]
PHST- 1997/03/01 00:01 [medline]
PHST- 1997/03/01 00:00 [entrez]
PST - ppublish
SO  - Bull Cancer. 1997 Mar;84(3):282-8.