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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

3178 - Open-label multicenter randomized phase II study of docetaxel plus bevacizumab or pemetrexed plus bevacizumab for elderly (_75 years old) patients (pts) with previously untreated advanced non-squamous non-small-cell lung cancer (NSCLC): TORG1323

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Immunotherapy

Tumour Site

Presenters

Takeshi Honda

Citation

Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292

Authors

T. Honda1, T. Kouzuki2, Y. Tsunezuka3, N. Seki1, T. Shibayama4, T. Okimoto5, H. Taniguchi6, Y. Takeda7, N. Hata8, K. Sugimoto9, N. Takahashi10, K. Sakai11, T. Nishimura12, S. Ikeda13, S. Watanabe14, K. Mori15, T. Shinkai16

Author affiliations

  • 1 Department Of Internal Medicine, Division Of Medical Oncology, Teikyo University, 173-8606 - Tokyo/JP
  • 2 Department Of Respiratory Medicine, Shikoku Cancer Center, Ehime/JP
  • 3 Department Of General Thoracic Surgery, Ishikawa Prefectural Central Hospital, Ishikawa/JP
  • 4 Department Of Respiratory Medicine, Okayama Medical Center, Okayama/JP
  • 5 Department Of Internal Medicine, Division Of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane/JP
  • 6 Department Of Respiratory Medicine, Toyama Prefectural Central Hospital, Toyama/JP
  • 7 Respiratory Medicine, Center Hospital of the National Center for Global Health and Medicine, Tokyo/JP
  • 8 Department Of Respiratory Medicine, Kawaguchi Municipal Medical Center, Saitama/JP
  • 9 Department Of Respiratory Medicine, Japanese Red Cross Kobe Hospital, Hyogo/JP
  • 10 Department Of Respiratory Medicine, Nihon University Itabashi Hospital, Tokyo/JP
  • 11 Department Of Pulmonary Medicine, Saitama Medical Center, Saitama/JP
  • 12 Department Of Respiratory Medicine, Kyoto Katsura Hospital, Kyoto/JP
  • 13 Department Of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa/JP
  • 14 Department Of Respiratory Medicine, Niigata University Medical&Dental Hospital, Niigata/JP
  • 15 Department Of Respiratory Medicine, Jizankai Medical Foundation Tsuboi Cancer Center Hospital, Fukushima/JP
  • 16 Department Of Respiratory Medicine, Shonan East General Hospital, Kanagawa/JP
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Resources

Abstract 3178

Background

The addition of bevacizumab (B) to platinum doublets prolongs the survival for non-squamous (NSQ) NSCLC. The role of monotherapy with B is unclear for elderly NSQ NSCLC patients (pts). We presented the comparable efficacy data in a previous meeting. Here, we present the survival and quality of life analyses of TORG1323.

Methods

Pts were pathologically diagnosed untreated elderly (≥75 years old) NSQ NSCLC, who were stage IIIB, IV, or recurrent disease, and PS 0-1. EGFR mutation or ALKrearranged pts were allowed after receiving each tyrosine kinase inhibitor. Pts were randomized 1:1 to receiving either docetaxel (D) or pemetrexed (P) with B. The primary endpoint was progression-free survival (PFS) assessed by independent review committee. B was administered 15 mg/kg, D was 50 mg/m2, or P was 500 mg/m2 every 3 weeks until disease progression or unacceptable toxicity based on our previous studies. Selection design was adopted for this study. The planned sample size was 120 pts to yield 80% power to select an optimal regimen correctly and PB is chosen for the further evaluation if the point estimate of hazard ratio (HR) for PFS was ≤1.20.

Results

Enrollment was terminated early at the end of March 2017 because of slow accrual. A total of 103 pts (DB/PB= 51/52 pts) were enrolled and 99 pts (49/50 pts) comprise the full analysis set. Patient characteristics were well balanced between the two arms. Median age was 78 (range: 75-88) in DB and 79 (75-94) in PB. EGFR mutation+/ALK translocation+/wild type/unknown= 13/0/34/2 in DB and 13/2/33/2 in PB. A total of 77 events occurred at data cut-off, which corresponded to 77.7% power. The median PFS of DB and PB were 6.1 months (mo) and 4.6 mo (HR 1.03, 95%C.I. 0.66-1.61: p = 0.901). The median OS of DB and PB were 18.7 mo and 26.6 mo (HR 0.69, 95% C.I. 0.36-1.30; p = 0.2465). The mean change from baseline of Functional Assessment of Cancer Therapy - Lung (FACT-L) total was -8.4 in DB and -2.7 in PB (p = 0.0096).

Conclusions

PB results in less deterioration of QoL. The efficacy is comparable between the two arms for elderly (≥75 years old) advanced NSQ NSCLC.

Clinical trial identification

UMIN000012786 01-Jan-2014.

Legal entity responsible for the study

Thoracic Oncology Research Group.

Funding

Chugai Pharmacutical Co., Ltd.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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