Abstract 587P
Background
Despite the rising number of elderly (E) cancer pt, they are underrepresented in clinical trials, due in part to the lack of data on INDs clinical effects on this fragile population. We reviewed our series to compare tolerance and efficacy of ph1 drugs in E vs. younger (Y) pt.
Methods
We analyzed our pt treated in Ph1 trials, except ClinPharm studies, from Nov08 to Dec16. 31 baseline clinical (age, sex, ECOG, BMI, hypothyroid, HBP, DM, clots, cardiopathy, COPD, #prior lines, liver mets, #sites, therapy type) and analytical (hemogram, alb, AlkPhos, ALT, AST, TBil, Creat, GGT, LDH, ANC/lymph, PLT/lymph, Ca, Mag) values were collected; also toxicity and objective response (OR). Variables distribution according to age groups (≥ 65y vs. <65y) and their association to OR or severe (G3-5) toxicity were assessed (Pearson’s chi square). Kaplan-Meier survival curves were compared with log-rank test.
Results
773 consecutive pt treated in 85 ph1 trials in START Madrid-CIOCC were included. Mean age was 58.7y (18-87) and 33.6% were ≥ 65y (E group). 48,1% were male. ECOG 0, 55.8%; 1, 42.2%. 29% pt had GI tumors, 20% lung, 14% breast, and 12% GYN. 131 pt (17.3%) received IO, 303 (39.9%) targeted and 325 (42.8%) chemo drugs. No statistically significant disbalance in the baseline variables was seen between the 2 groups, except for the E that had higher percents of male gender, HBP, DM, hypothyroid, prior clots, COPD, high ALT or Creat, and lower #mets, alb, LDH or calcium. In total: 20.1% and 31.8% of 773 pt had severe hemo and non-hemo toxicity, respectively. 103 of 730 evaluable pt achieved an OR (14.1%) and 271 pt (48.8%) stable disease; their mOS was 10.8 m (95%CI: 9.8-10.8). Per groups: 18.8% of E and 20.7% of Y pt had severe hemo toxicity (p=.5), and 30.2% and 32.7%, respectively, severe non-hemo toxicity (p=.4); regarding activity, 12.4% and 15% of pt had OR, respectively, in the E and Y groups (p=.3). No statistically significant differences between E and Y groups regarding OS (9.7m and 11.5 m, p=.1) or PFS (2.3m and 2.2m, p=.7) were seen.
Conclusions
Similar good antitumor activity (OR, PFS, OS) and acceptable tolerance profiles were found in our PhI elderly cancer pt compared to those that were <65 years old. This justifies our best efforts in increasing participation of older patients in phI trials.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.