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Poster display session

1341 - Predictive factors for poor progression-free survival in patients with non-small-cell lung cancer treated with nivolumab

Date

10 Sep 2017

Session

Poster display session

Topics

Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Thoracic Malignancies

Presenters

Yoshihiko Taniguchi

Citation

Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376

Authors

Y. Taniguchi1, A. Tamiya1, S. Isa2, K. Nakahama1, K. Okishio2, T. Shiroyama3, H. Suzuki3, T. Inoue4, M. Tamiya4, K. Nishino4, T. Kumagai4, T. Hirashima3, F. Imamura4, S. Atagi2

Author affiliations

  • 1 Internal Medicine, Kinki-chuo Chest Medical Center, 591-8555 - Sakai/JP
  • 2 Clinical Research Center, Kinki-chuo Chest Medical Center, 591-8555 - Sakai/JP
  • 3 Thoracic Malignancy, Osaka Prefectural Habikino Hospital, 583-8588 - Habikino/JP
  • 4 Thoracic Oncology, Osaka International Cancer Institute, 541-8567 - Osaka/JP
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Resources

Abstract 1341

Background

Nivolumab (Nivo) has shown promising effects in patients with non-small-cell lung cancer (NSCLC) as a second- or later-line treatment. However, owing to the inclusion of random patients, the observed progression-free survival (PFS) in a clinical setting may be shorter than that in a clinical trial. For treatment effectiveness, it is important to clarify which patients may not experience any benefit from Nivo treatment. Therefore, in this multicenter retrospective study, we aimed to identify which patients would not be eligible for Nivo treatment.

Methods

In this study, data for 201 patients treated with Nivo during 17 December 2015 to 31 July 2016 at three respiratory medical centers in Japan were retrospectively reviewed. We collected clinical data including age, sex, smoking history, performance status (PS) score, body mass index (BMI), histological types, epidermal growth factor receptor (EGFR) mutation status, number of previous treatment, steroid use and laboratory data (Lactate Dehydrogenase (LDH) and C-reactive protein) at the time of Nivo treatment commencement. We investigated relationship between PFS and patient characteristics. Patients were followed-up for disease status until September 2016.

Results

The median age at the time of administration Nivo was 68 years, 135 patients were male, 157 patients had smoking history, 153 patients had a PS score of 0–1, and 23 patients received steroids. For all participants, median PFS was 2.9 months, over all response rate was 15.9% and disease control rate was 51.7%. In the univariate analysis, PS score ≥2, steroid use at baseline, and LDH level >240 IU/L was significantly associated with poor PFS. Furthermore, in the multivariate analysis, PS score ≥2 (hazard ratio [HR]: 1.57; 95% confidence interval (CI): 1.06–2.29; p = 0.027), steroid use at baseline (HR: 2.37; 95% CI: 1.44–3.74; p = 0.001) and LDH level >240 IU/L (HR: 1.63; 95% CI: 1.15–2.31; p = 0.007) were significantly associated with poor PFS.

Conclusions

PS score ≥2, steroid use at baseline, and high LDH levels were predictive of poor PFS in patients with NSCLC treated with Nivo. Careful monitoring is recommended for treating such patients with Nivo.

Clinical trial identification

Legal entity responsible for the study

Fumio Imamura

Funding

Ono pharmaceutical Co., Ltd. Bristol-Myers Squibb Co., Ltd.

Disclosure

Y. Taniguchi: Ono Pharmaceutical, Bristol-Myers Squibb and Chugai Pharmaceutical. A. Tamiya: Ono Pharmaceutical, Bristol-Myers Squibb, Chugai Pharmaceutical, AstraZeneca, Eli Lilly and Boehringer Ingelheim. S-I. Isa, K. Nakahama: Ono Pharmaceutical and Bristol-Myers Squibb. K. Okishio: Ono Pharmaceutical. T. Shiroyama: Ono Pharmaceutical, Bristol-Myers Squibb, Taiho Pharmaceutical, Boehringer Ingelheim and AstraZeneca. H. Suzuki: Ono Pharmacetical, Bristol-Myers Squibb, Taiho Pharmacetical, Boehringer Ingelheim, Pfizer and Eli-Lilly. T. Inoue: Boehringer Ingelheim and Ono Pharmaceutical. M. Tamiya: Ono Pharmaceutical, Bristol-Myers Squibb, Chugai Pharmaceutical, Pfizer, AstraZeneca, Taiho Pharmaceutical, Eli Lilly, Asahi Kasei Pharmaceutical, Daichi Sankyo and Boehringer Ingelheim K. Nishino: Chyugai, Boehringer Ingelheim, Eli Lilly and AstraZeneca. T. Kumagai: Ono Pharmaceutical, AstraZeneca and Boehringer Ingelheim. T. Hirashima: Ono Pharmaceutical, Bristol-Myers Squibb, MSD Oncology, AstraZeneca, Eisai, Daiichi Sankyo, Merck Serono, Lilly Japan, Taiho Pharmaceutical, Chugai Pharma, Kyowa Hakko Kirin, Takeda, Boehringer Ingelheim and Bayer. F. Imamura: Ono Pharmaceutical company, Bristol-Myers Squibb, Pfizer Inc, AstraZeneca K. K., Novartis Pharma K. K., Kyowa Hakko Kirin Co. Ltd., Boehinger Ingelheim GmbH, Taiho Pharmaceutical Co. Ltd., Eli Lilly Japan K. K. and Chugai Pharceutical Co. Ltd. S. Atagi: Bristol-Myers Squibb, Ono Pharmaceutical, Pfizer, Chugai Pharmaceutical, AstraZeneca, MSD, Taiho Pharmaceutical, Yakult Pharmaceutical Industry, Eli Lilly and Boehringer Ingelheim.

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