PMID- 10650806
OWN - NLM
STAT- MEDLINE
DCOM- 20000222
LR  - 20221207
IS  - 0250-7005 (Print)
IS  - 0250-7005 (Linking)
VI  - 19
IP  - 5C
DP  - 1999 Sep-Oct
TI  - Single-agent gemcitabine as second-line treatment in patients with advanced non 
      small cell lung cancer (NSCLC): a phase II trial.
PG  - 4535-8
AB  - BACKGROUND: Although the use of salvage chemotherapy in advanced non-small cell 
      lung cancer (NSCLC) is controversial, pretreated symptomatic patients often need 
      some kind of treatment to achieve symptoms relief. Gemcitabine is one of the most 
      active new drugs in advanced NSCLC and preliminary reports suggest that it is 
      active also in patients previously treated with platinum compounds. AIM: to 
      evaluate activity and toxicity and the effect on quality of life of gemcitabine 
      in platinum-pretreated patients with advanced NSCLC. METHODS: single-stage phase 
      2 trial with p0 = 5%, p1 = 20%, alfa = 5%, beta = 10%; 34 patients required and 4 
      objective responses expected to warrant further studies. Gemcitabine was 
      administered at dose of 1000 mg/m2, i.v., d 18-15, every 4 weeks, for a maximum 
      of 6 cycles. Quality of life was measured by EORTC C-30 and LC-13 questionnaires. 
      RESULTS: from September 1996 to July 1998, 30 patients have been enrolled. There 
      were 6 (20% exact 95% CI 8-39%) partial responses (2 responses were in pts with 
      brain metastases and 2 in patients progressed during first-line chemotherapy). 
      All patients (but one died because myocardial infarction, progressed; median time 
      to progression was 10 weeks (95% CI 7-12); 28 patients died; median survival was 
      22 weeks (95% CI 17-29). Quality of life analysis showed no significant change 
      but for the improvement of cough after 3 cycles of chemotherapy. There was no 
      severe toxicity. CONCLUSION: gemcitabine is active as second line for patients 
      with advanced NSCLC who received platinum-based first line treatment. In view of 
      such results randomized trials comparing gemcitabine versus best supportive care 
      are warranted.
FAU - Gridelli, C
AU  - Gridelli C
AD  - National Cancer Institute, Italy. cgridelli@sirio-oncology.it
FAU - Perrone, F
AU  - Perrone F
FAU - Gallo, C
AU  - Gallo C
FAU - Rossi, A
AU  - Rossi A
FAU - Barletta, E
AU  - Barletta E
FAU - Barzelloni, M L
AU  - Barzelloni ML
FAU - Creazzola, S
AU  - Creazzola S
FAU - Gatani, T
AU  - Gatani T
FAU - Fiore, F
AU  - Fiore F
FAU - Guida, C
AU  - Guida C
FAU - Scognamiglio, F
AU  - Scognamiglio F
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PL  - Greece
TA  - Anticancer Res
JT  - Anticancer research
JID - 8102988
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antimetabolites, Antineoplastic/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Deoxycytidine/*analogs & derivatives/therapeutic use
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Gemcitabine
EDAT- 2000/01/29 09:00
MHDA- 2000/02/26 09:00
CRDT- 2000/01/29 09:00
PHST- 2000/01/29 09:00 [pubmed]
PHST- 2000/02/26 09:00 [medline]
PHST- 2000/01/29 09:00 [entrez]
PST - ppublish
SO  - Anticancer Res. 1999 Sep-Oct;19(5C):4535-8.