Abstract 529
Aim/Background
Recent studies suggest that some clinical factors are associated with shorter progression-free survival (PFS) of EGFR-TKI alone. In patients (pts) with these factors, more effective strategies with EGFR-TKI are awaited. JO25567 demonstrated clinical benefit of EB in NSCLC pts with activating EGFR mt. To explore pts for whom EB could be applied as more beneficial strategy, we conducted exploratory subgroup analysis.
PFS by subgroups (months)
| Characteristics | EB | E | |||
|---|---|---|---|---|---|
| n | Median | n | Median | ||
| All | 75 | 16.0 | 77 | 9.7 | |
| Age (years) | 75 > | 63 | 15.4 | 62 | 9.7 |
| ≥75 | 12 | - | 15 | 9.7 | |
| Sex | Male | 30 | 18.0 | 26 | 9.7 |
| Female | 45 | 15.4 | 51 | 9.7 | |
| Smoking status | Non smoker | 42 | 12.8 | 45 | 8.4 |
| Other | 33 | 18.0 | 32 | 9.8 | |
| ECOG PS | 0 | 43 | 16.5 | 41 | 9.7 |
| 1 | 32 | 13.9 | 36 | 8.4 | |
| Clinical stage | IIIB or IV | 61 | 14.0 | 62 | 9.7 |
| Recurrent | 14 | 20.6 | 15 | 13.8 | |
| EGFR mt type | Exon 19 deletion | 40 | 18.0 | 40 | 10.3 |
| L858R | 35 | 13.9 | 37 | 7.1 | |
| The SLD of target lesions (mm) | Median: 37.5 > | 36 | 16.4 | 40 | 9.3 |
| ≥Median: 37.5 | 39 | 14.0 | 37 | 9.7 | |
| The number of affected organs | Median: 3 > | 34 | 18.0 | 32 | 15.2 |
| ≥Median: 3 | 41 | 14.1 | 45 | 8.4 | |
| PCE | Yes | 30 | 15.4 | 36 | 5.7 |
| No | 45 | 16.4 | 41 | 11.1 | |
Methods
JO25567 was open-label randomized trial. Pts with stage IIIB, IV or recurrent, non-squamous NSCLC, activating EGFR mt, ECOG performance status (PS) 0 or 1, and no previous chemotherapy were randomized either EB or E. We conducted subgroup analysis by baseline age, sex, smoking status, ECOG PS, clinical stage, EGFR mt type, the sum of longest diameter (SLD) of target lesions, the number of affected organs and pleural and/or cardiac effusion (PCE). Median PFS was estimated by Kaplan-Meier methods.
Results
PFS were shown in table. Especially in pts with PCE, in which PFS with E was shorter than the other subgroups, PFS exceeded 15 months in EB group. PCE progression were seen in 11 (30.6%) pts in E group and 5 (16.7%) pts in EB group with PCE at baseline. No new safety signals of EB and E were observed even in pts with PCE.
Conclusions
EB showed consistent clinical benefit regardless patient characteristics. EB could be beneficial strategy to the pts with baseline PCE. Further investigation in this population is warranted.
Clinical trial identification
JapicCTI-111390.
Disclosure
Y. Hosomi: honoraria: AstraZeneca, Taiho, Chugai, Boehringer Ingelheim, Eli Lilly, Ono. T. Seto: research fund: Chugai. Honoraria: Chugai. K. Goto: grants/research support: MSD, Astra Zeneka, Chugai, Boehringer Ingelheim, Bayer, Quintiles, GSK, OxOnc.; consultant fee: Chugai, GSK, Taiho; honoraria: Astra Zeneka, Phizer, Kyowa Hakko Kirin, Taiho, Chugai, Eli Lilly, Boehringer Ingelheim. N. Yamamoto: research fund: Taiho, Eisai, Chugai, Eli Lilly, Quintiles, BMS, Pfizer, Takeda, Novartis, Daiichi-Sankyo, Astellas. K. Tajima, N. Inagaki: full-time Employee: Chugai. N. Yamamoto: grants/Research support: Chugai, Boehringer-ingelheim; consultant fee: Boehringer-ingelheim; honoraria: Chugai, Astrazeneca, Boehringer-ingelheim. All other authors have declared no conflicts of interest.