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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

1042 - A multicenter single-arm phase II study of nab-paclitaxel/carboplatin for non-small cell lung cancer patients with interstitial lung disease

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

Presenters

Yuko Usui

Citation

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

Authors

Y. Usui1, H. Kenmotsu2, K. Mori3, A. Ono2, K. Yoh1, T. Baba4, Y. Fujiwara5, O. Yamaguchi6, R. Ko7, H. Okamoto8, N. Yamamoto9, T. Ninomiya10, T. Ogura4, T. Kato11

Author affiliations

  • 1 Department Of Thoracic Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2 Division Of Thoracic Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 3 Clinical Trial Coordination Office Biostatistician, Shizuoka Cancer Center Hospital, 4118777 - Nagaizumi/JP
  • 4 Department Of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama/JP
  • 5 Developmental Therapeutics, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 6 Department Of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama/JP
  • 7 Department Of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo/JP
  • 8 Department Of Respiratory Medicine And Medical Oncology, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 9 Third Department Of Internal Medicine, Wakayama Medical University, Wakayama/JP
  • 10 Department Of Respiratory Medicine And Allergy, Okayama University, Okayama/JP
  • 11 Division Of Thoracic Oncology, Kanagawa Cancer Center, Yokohama/JP
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Resources

Abstract 1042

Background

The prognosis of non-small cell lung cancer (NSCLC) patients with interstitial lung disease (ILD) has been reported to be poor, and 10-20% of those receiving chemotherapy experienced exacerbation of ILD induced by chemotherapy. To evaluate the safety and efficacy of nab-paclitaxel (nab-P)/ carboplatin (C) for NSCLC patients with ILD, this multicenter phase II study was conducted.

Methods

Chemotherapy-naive patients with pathologically confirmed advanced NSCLC and ILD received 4 cycles of nab-P (100 mg/m2, d1, 8, 15) + C (AUC=6 d1) every 3 weeks. ILDs were diagnosed based on the fibrosing ILD criteria and categorized to three patterns by investigators; usual interstitial pneumonia (UIP), possible UIP, inconsistent UIP. Primary endpoint was exacerbation-free rate (EFR) of ILD at 28 days after protocol treatment. Secondary endpoints were response rate, progression-free survival (PFS), overall survival (OS), EFR of ILD, toxicities.

Results

From 06/2014 to 12/2016, 94 patients were enrolled in this study, and 92 patients received protocol treatment. Median age was 70 years, 89% were male, 45/55% were PS 0/1, and 58% had non-squamous histology. In the primary analysis, EFR of ILD at 28 days after protocol treatment was 95.7% (88/92, 90%CI; 90.3-98.6). In the subgroup of patients with UIP pattern, EFR of ILD at 28 days was 94% (47/50). Response rate was 51% (90%CI; 40-62). At the time of data cutoff, median PFS was 6.1 months, and median OS was 15.1 months. The most common grade 3 or 4 adverse events were neutropenia (75%), leukopenia (53%), anemia (48%), thrombocytopenia (20%), hyponatremia (17%), febrile neutropenia (9%) and infection (7%). Two treatment-related deaths (one each of pulmonary infection and ILD exacerbation) were observed.

Conclusions

This study demonstrated that nab-P/C was well tolerated in NSCLC patients with ILD in terms of safety including risk of exacerbation of ILD, even if of UIP pattern. Although this study was a single arm, nab-P/C might be more effective compared with other regimens of previous reports.

Clinical trial identification

Legal entity responsible for the study

Kanagawa Cardiovascular and Respiratory Center.

Funding

Japanese Ministry of Health, Labor and Welfare.

Editorial Acknowledgement

Disclosure

H. Kenmotsu: Grants and Honoraria: AstraZeneca K.K., Chugai Pharmaceutical Co, Ltd., Boeringer Ingelheim, Ono Pharmaceutical Co, Ltd., Bristol-Myers K.K, Eli Lilly K.K, Kyowa Hakko Kirin Co., Ltd., MSD K.K., Novartis Pharma K.K. K. Yoh: Research funding and honoraria: Taiho Pharmaceutical. T. Baba: Honoraria: Ono Pharmaceutical Co, Ltd, Bristol Myers Squibb K.K., AstraZeneca K.K., Toray Industries, INC, Daiichi Sankyo, Inc.; Speakers’ bureau: AstraZeneca K.K., Boston Scientific Japan Co.,Ltd., Nippon Boehringer Ingelheim Co., Shionogi & Co., Ltd., Astellas Pharma Inc, Amco Inc., Asahi Kasei Pharma Corporation; Research funding: Taiho Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Savara Inc., Hisamitsu Pharmaceutical Co., Inc., AstraZeneca K.K. Y. Fujiwara: Grants: AbbVie, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Incyte, Merck Serono, Novartis grants; Personal fees: AstraZeneca, MSD, BMS, personal fees from Taiho, Ono, outside the submitted work. O. Yamaguchi: Honoraria: Bristol-Myers Squibb, Ono Pharmaceutical, AstraZeneca. H. Okamoto: Takeda, MSD, Ono, AstraZeneca, Merck, Chugai, Taiho, Bristol, Eli Lilly, Daiichi Sankyo. N. Yamamoto: Membership of advisory board: AstraZeneca, Boehringer-Ingelheim, Chugai, Eli Lilly, MSD, Takeda; Corporate-sponsored research: MSD, Eli Lilly, Chugai; Honoraria: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eli Lilly, MSD, Novartis, Ono Pharmaceutcial Ltd., Pfizer, Takeda. T. Ninomiya: Honoraria: Chugai Pharmaceutical Co., Nippon Boehringer Ingerheim Co. T. Ogura: Advisory board: Nippon Boehringer Ingelheim Co., Shionogi & Co., Ltd; Speakers’ bureau: Nippon Boehringer Ingelheim Co., Shionogi & Co., Ltd., Astellas Pharma Inc.; Research funding: Taiho Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co, Savara Inc, Hisamitsu Pharmaceutical Co., Inc., AstraZeneca K.K. T. Kato: Honoraria and Research grant: Bristol Myers Squibb and Taiho. All other authors have declared no conflicts of interest.

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