Abstract 1230P
Background
Despite the high prevalence of lung cancer among older adults, these are often under-represented in clinical trials, leading to uncertainties in the treatment of these patients in the clinical routine. With 43%, the German prospective non-interventional study (NIS) GIDEON enrolled a high proportion of patients aged ≥70 years, providing an opportunity to study the efficacy and safety of afatinib in this subcohort in routine clinical practice.
Methods
161 EGFR-mutated NSCLC patients were enrolled from 41 sites in Germany. 152 received at least one dose of afatinib, 146 patients were treated according to label. Efficacy (12-months progression-free survival (PFS) rate; objective response rate, ORR; disease control rate, DCR; progression-free survival, PFS and overall survival, OS) was prospectively assessed by investigators. Data about tolerability were collected during routine treatment. Exploratory post hoc analyses according to age group (<70 years, ≥70 years) were undertaken. All analyses were descriptive. Therefore, testing for statistical significance between patient groups was not performed.
Results
The most important results are summarized in the table. Table: 1230P
| <70 years (n=86) | ≥70 years (n=66) | |
| Del19 / L858R / others ex 18-21 | 65% / 26% / 9% | 64% / 18% / 18% |
| ECOG PS 0 / 1 / 2 / higher / | 53% / 41% / 0 / 1% | 41% / 45% / 6% / 3% |
| missing | 5% | 5% |
| Comorbidity index | ||
| 0 | 74% | 38% |
| ≥ 1 | 26% | 62% |
| Starting dose | ||
| 40mg | 84% | 62% |
| < 40mg | 16% | 38% |
| efficacy | ||
| mPFS | 10.6 mo | 17.2 mo |
| 12-mo PFS rate | 44% | 59% |
| mOS | 27.4 mo | 30.4 mo |
| 12-mo OS rate / 24-mo OS rate | 79% / 62% | 79% / 52% |
| ORR / DCR | 76% / 88% | 72% / 96% |
| safety | ||
| ADRs (all grades) | 97% | 95% |
| ADRs (≥ grade 3)* | 41% | 35% |
| Dose reduction | 62% | 58% |
Conclusions
Elderly patients (≥70 years) were well represented in GIDEON. Although these patients tended to have a worse ECOG PS and a higher proportion had a comorbidity index of ≥1, this seemed not to compromise efficacy. Furthermore, the safety profile of afatinib in elderly patients was similar to that seen in the younger subgroup with no new safety signals.
Clinical trial identification
NCT02047903.
Editorial acknowledgement
Legal entity responsible for the study
Boehringer Ingelheim Pharma GmbH & Co. KG.
Funding
Boehringer Ingelheim GmbH & Co. KG.
Disclosure
W.M. Brueckl: Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Chugai; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Roche Pharmaceuticals; Financial Interests, Personal, Advisory Role: Takeda. M. Reck: Financial Interests, Personal, Advisory Role: AbbVie; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche. J. Rawluk: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Takeda. K. Neben: Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Takeda; Financial Interests, Personal, Other: Amgen; Financial Interests, Personal, Other: Janssen; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Bayer; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: BMS; Financial Interests, Personal, Other: Chugai. M. Moeller: Financial Interests, Personal, Other: Boehringer Ingelheim; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Roche. S. Krueger: Financial Interests, Personal, Other: Boehringer Ingelheim; Financial Interests, Institutional, Funding: Boehringer Ingelheim. J.H. Ficker: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: GSK; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Norvartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Sanofi-Aventis. A. Schueler: Other, Personal, Full or part-time Employment: Boehringer Ingelheim GmbH Co KG. All other authors have declared no conflicts of interest.