Erlotinib plus bevacizumab (EB) versus erlotinib alone (E) as first-line treatment for advanced non-squamous non–small-cell lung cancer (NSCLC) with activating EGFR mutation (mt): JO25567 exploratory subgroup analysis

Date

19 Dec 2015

Session

Thoracic cancers

Presenters

Yukio Hosomi

Citation

Annals of Oncology (2015) 26 (suppl_9): 125-147. 10.1093/annonc/mdv532

Authors

Y. Hosomi1, T. Seto2, M. Nishio3, K. Goto4, N. Yamamoto5, I. Okamoto6, K. Tajima7, N. Inagaki8, N. Yamamoto9

Author affiliations

  • 1 Department Of Thoracic Oncology And Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 113-8677 - Tokyo/JP
  • 2 Department Of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka/JP
  • 3 Department Of Thoracic Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo/JP
  • 4 Division Of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa/JP
  • 5 Department Of Experimental Therapeutics, Department Of Thoracic Oncology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center Hospital, Tokyo/JP
  • 6 Research Institute For Disease Of The Chest, Graduate School Of Medical Sciences, Kyushu University, Fukuoka/JP
  • 7 Clinical Science And Strategy Depatment, Chugai Pharmaceutical Co. Ltd, Tokyo/JP
  • 8 Medical Science Department, Chugai Pharmaceutical Co. Ltd, Tokyo/JP
  • 9 Third Department Of Internal Medicine, Wakayama Medical University, Wakayama/JP
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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.

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