EUROPEAN LUNG CANCER WORKING PARTY
Protocol 01992
A MASTER PROTOCOL FOR THE STUDY OF NEW BIOLOGICAL PROGNOSTIC
FACTORS IN PATIENTS WITH NON-SMALL CELL LUNG CANCER TREATED IN THE
PROTOCOLS OF THE EUROPEAN LUNG CANCER WORKING PARTY.
Protocol writing committee: J.P. SCULIER, P. VERMYLEN, T. BERGHMANS, M.
PAESMANS
Study coordinator : J.P. SCULIER
Statistician : M. PAESMANS
Data manager : P. MOMMEN
First draft : December 1998
Activation :
1.INTRODUCTION.
The ELCWP has conducted multiple investigations assessing in non-small cell
lung cancer the value of prognostic factors (1-4). Only “classical” variables were
evaluated, including demographic data, tumour characteristics, routine laboratory
tests and response to treatment. These studies were conducted in patients with
advanced disease, treated in seven consecutive prospective trials. A multivariate
statistical analysis for survival confirmed the role of some markers like disease
extent, Karnofsky performance status, white blood cells count, skin metastases, age
and sex, neutrophils count and calcemia. A RECPAM analysis allowed us to define 4
groups with distinct prognosis according to some of these factors. In another
multivariate analysis, we have shown that disease extent and response to
chemotherapy were the two single significant predictors of long-term survival.
Response to chemotherapy was related to age and platelet counts in a multivariate
logistic regression model. Finally the occurrence of an objective response to
chemotherapy was shown to be a predominant factor associated with improved
survival in advanced NSCLC.
The biology of lung cancer has been the recent object of multiple researches
resulting in a much better understanding of the mechanisms of occurrence and
development of the disease. A lot of studies have tried to identify the role and the
predictor effect of some of the identified biological abnormalities. Our Group has
started a systematic review of the literature on this topic to identify the biological
factors requiring clinical investigations.
2. STUDY OBJECTIVE.
To collect tissue samples to investigate by immunohistochemistry the role of the new
biological factors as prognostic factors.
3. STUDY POPULATION.
All the patients registered into the protocols of the ELCWP for the treatment of
NSCLC.
4. METHODS.
Tumour sample should be obtained for each patient included into the trial. The
specimens should be fixed in buffered formalin (10 %) for a maximum of 24 hours
(biopsies) or 48 hours (surgical samples) and paraffin embedded. Five consecutive
unmounted slides have to be cut per sample (on superfrost +/+ slides), the thickness
should be of approximately 6 microns. They have to be dried for 24 hours at 50°
Celsius and stored at 4°. The local pathological assessment has to be joined to the
pathological sample.
5. REGISTRATION.
For the centres that participate to the study, samples will be required, when a new
patient is registered into a therapeutic protocol. If not possible, the reason has to be
given: no material anymore available, patient’s refusal, cytological diagnosis,
pathological material not available at the investigator’s site, neglect.
The following information has to be given about the sample: site (primary, node,
metastasis), type (biopsy, surgical piece).
6. REFERENCES.
Paesmans M, Sculier JP, Libert P et al. Prognostic factors for survival in advanced
non-small-cell lung cancer: univariate and multivariate analyses including
recursive partitioning and amalgamation algorithms in 1,052 patients. J Clin Oncol
13: 1221-1230; 1995.
2. Sculier JP, Paesmans M, Libert P et al. Long-term survival after chemotherapy
containing platinum derivatives in patients with advanced unresectable non-small
cell lung cancer. Eur J Cancer 30A: 1342-1347; 1994.
3. Paesmans M, Sculier JP, Libert P et al. Response to chemotherapy has predictive
value for further survival of patients with advanced non-small cell lung cancer: 10
years experience of the European Lung Cancer Working Party. Eur J Cancer 33:
2326-2332; 1997.
4. Borges M, Sculier JP, Paesmans M et al. Prognostic factors for response to
chemotherapy containing platinum derivatives in patients with unresectable nonsmall cell lung cancer (NSCLC). Lung Cancer 16: 21-33; 1996.
1.
BANQUE DE TUMEURS : FEUILLE D’ENREGISTREMENT
Date :
Protocole :
Nom :
Investigateur :
Centre :
Echantillon :
oui
non
Si non : raison
 Centre non participant
 Plus de matériel disponible
 Refus du patient
 Diagnostic cytologique
 Matériel non disponible dans le centre de l’investigateur
 Oubli
 Autre, préciser :
Si oui :
Type prélèvement/Site
Biopsie
Pièce chirurgicale
Autre
Primaire
Ganglion
Métastase (spécifier
organe) :