Is there a positive effect of participation on a clinical trial for patients with advanced non-small cell lung cancer?
BACKGROUND
There is general belief that patients who enrolled on a clinical trial have better outcomes compared to those who are treated outside of a trial. We analyzed if there was a 'trial effect' for patients with advanced non-small cell lung cancer (NSCLC) treated with chemotherapy.


METHODS
A retrospective analysis of cohorts of patients with advanced NSCLC who received chemotherapy inside and outside of a clinical trial were analyzed for response rates (RR), progression free survival (PFS), overall survival (OS), 1 and 2 year survival.


RESULTS
There were 194 patients who received chemotherapy of which, 54 were on a clinical trial and 140 outside of it. For the whole group, the RR, median PFS, OS, one and two-year survivals were 35.4%, six months (range, 2-70), seven months (range, 2-72), 29.8% and 9.7% respectively. The differences in RR and PFS of patients who were treated inside and outside of a clinical trial were not significant (P=0.6164, 0.0881). The differences in median OS and one-year survivals between the groups were significant (P=0.0052, 0.022). For the whole group, patients who received II line chemotherapy had better OS (P< or = 0.0001). More patients in the trial group received II line chemotherapy (P=0.0004).The difference in the median OS between the groups continued to be significant even after patients who received II line chemotherapy were censored (P=0.0437).


CONCLUSIONS
Patients with advanced NSCLC who were treated inside of a clinical trial had better OS compared to those who were treated outside of it.
Rajappa
S
S
Department of Medical Oncology and Pathology, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad-500 016, India. siddharth142@sify.com
Gundeti
S
S
Uppalapati
S
S
Jiwatani
S
S
Abhyankar
A
A
Pal
C
C
Digumarti
R
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010358:Patient Participation; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
D009944:Organoplatinum Compounds