Clinical assessment of patients with advanced non-small-cell lung cancer eligible for second-line chemotherapy: a prognostic score from individual data of nine randomised trials.
OBJECTIVE
Knowledge of prognostic factors for advanced non-small-cell lung cancer (NSCLC) patients eligible for second-line treatment is scarce. The aim of this study was to assess the prognostic role of a number of routinely collected clinical variables and to provide a summary index to discriminate patients according to probability of survival.


METHODS
Individual data from nine randomised trials of second-line treatment in advanced NSCLC were analysed. Primary end-point was overall survival (OS). Cox model, stratified by trial, was used for multivariate analyses, and a prognostic index was provided and validated according to an internal/external procedure.


RESULTS
Out of 1239 patients, 1197 patients (97%) had complete information. Median OS was 7.4months. At multivariate analysis, prognosis was significantly influenced by gender (worse in males), performance status (PS), tumour histology (worse in squamous and other histology versus adenocarcinoma), stage (worse in IV versus IIIB), type of previous treatment (worse for patients pretreated with platinum) and response to first-line (worse for patients not obtaining objective response). Prognostic score values range from 0 to 14. When three categories were derived, median overall survival values were equal to 11.6, 7.5 and 3.0months for best (<5), intermediate (5-9) and worst (>9) categories, respectively.


CONCLUSIONS
Prognosis of patients eligible for second-line treatment of advanced NSCLC is significantly conditioned by gender, PS, histology, stage, previous use of platinum and response to first-line. A prognostic score was derived that discriminates well subjects with a relatively more favourable prognosis and those with very short life expectancy.
Di Maio
Massimo
M
Clinical Trials Unit, National Cancer Institute, Napoli, Italy.
Lama
Nicola
N
Morabito
Alessandro
A
Smit
Egbert F
EF
Georgoulias
Vassilis
V
Takeda
Koji
K
Quoix
Elisabeth
E
Hatzidaki
Dora
D
Wachters
Floris M
FM
Gebbia
Vittorio
V
Tsai
Chun-Ming
CM
Camps
Carlos
C
Schuette
Wolfgang
W
Chiodini
Paolo
P
Piccirillo
Maria Carmela
MC
Perrone
Francesco
F
Gallo
Ciro
C
Gridelli
Cesare
C
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D000970:Antineoplastic Agents