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Poster Display session 1

1874 - A prospective phase II trial of carboplatin (CBDCA) and nab-paclitaxel (nabPTX) for advanced non-small cell lung cancer (NSCLC) with interstitial lung disease (ILD)


28 Sep 2019


Poster Display session 1


Tumour Site

Non-Small Cell Lung Cancer


Toshiyuki Harada


Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260


T. Harada1, H. Asahina2, S. Oizumi3, K. Takamura4, M. Harada3, K. Kanazawa5, Y. Fujita6, T. Kojima7, F. Sugaya8, H. Tanaka9, H. Ryoichi10, T. Ogi4, T. Ikari11, H. Yokouchi3, E. Kikuchi2, H.D. Akita12, H. Isobe7, M. Nishimura2

Author affiliations

  • 1 Center For Respiratoru Diseases, JCHO Hokkaido Hospital, 062-8618 - Sapporo/JP
  • 2 First Department Of Medicine, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 3 Department Of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 003-0804 - Sapporo/JP
  • 4 Department Of Respiratory Medicine, Obihiro-Kosei General Hospital, 080-0024 - Obihiro/JP
  • 5 Department Of Pulmonary Medicine, Fukushima Medical University School of Medicine, 960-1295 - Fukushima/JP
  • 6 Department Of Respiratory Medicine, National Hospital Organization Asahikiwa Medical Center, 070-8644 - Asahikawa/JP
  • 7 Department Of Medical Oncology, KKR Sapporo Medical Center, 062-0931 - Sapporo/JP
  • 8 Department Of Respiratory Medicine, Teine Keijinkai Hospital, 006-0811 - Sapporo/JP
  • 9 Department Of Respiratory Medicine, Hirosaki University Graduate School of Medicine, 036-8562 - Hirosaki/JP
  • 10 Department Of Respiratory Medicine, Asahi Chuo Hospital, 289-2511 - Asahi/JP
  • 11 Center For Respiratory Diseases, JCHO Hokkaido Hospital, 062-8618 - Sapporo/JP
  • 12 Department Of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, 060-8648 - Sapporo/JP


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Abstract 1874


Because of the high risk of exacerbation of ILD, patients with concomitant advanced NSCLC and ILD have been excluded from most clinical trials of chemotherapy, despite around 10% of all NSCLC cases. This study prospectively evaluated the efficacy and safety of nab-paclitaxel in combination with CBDCA in advanced NSCLC patients with ILD.


Enrolled patients had treatment-naïve, advanced NSCLC with ILD. Patients received 100 mg/m2nabPTX weekly and CBDCA at area under the concentration-time curve (AUC) 6 once every 3 weeks for 4-6 cycles. The primary endpoint was overall response rate (ORR); secondary endpoints included toxicity, progression-free survival (PFS) and overall survival (OS).


Thirty-six patients were enrolled between April 2014 and September 2017. Sixteen patients (44.4%) had an adenocarcinoma, followed by 15 (41.7%) squamous cell carcinoma, and 5 (13.9%) non-small cell carcinoma. The median number of cycles administered were 4 (range: 1-6). The ORR was 55.6% (95% confidence interval [CI]: 39.6-70.5). The median PFS and OS were 5.3 months (95% CI: 3.9-8.2) and 15.4 months (95% CI: 9.4-18.7). There was no significant difference between two groups, however, numerically better treatment outcomes were observed in the Sq group: the ORR was 66.7% (95% CI: 41.7–84.8) in the Sq group compared with 47.6% (95% CI: 28.3–67.6) in the Non-Sq group (P = 0.254); median PFS was 8.2 months (95% CI: 4.0–10.2) in the Sq group vs. 4.1 months (95% CI: 3.3-5.4) in the Non-Sq group (HR, 0.60 [95% CI, 0.30–1.20]; p = 0.15); median OS was 16.8 months (95% CI: 9.8–not reached) in the Sq group vs. 11.9 months (95% CI: 7.3-17.4) in the Non-Sq group (HR, 0.56 [95% CI, 0.24–1.28]; p = 0.17). Two patients (5.6%) experienced grade ≥2 pneumonitis and one patient (2.8%) died. After the protocol treatment, 24 patients (66.7%) underwent second-line therapy. Most preferred regimen were S-1 (n = 12, 50%), followed by vinorelbine (n = 4, 16.7%) and docetaxel (n = 3, 12.5%).


This is the first prospective phase II trial of weekly nabPTX in combination with CBDCA in advanced NSCLC patients with ILD. This treatment showed favorable efficacy and was well tolerated.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

The authors.


Has not received any funding.


T. Harada: Honoraria (institution): GlaxoSmithKline K.K.; Honoraria (institution): Hisamitsu Pharmaceutical Co.,Inc; Honoraria (institution): Boehrnger INgelheim. S. Oizumi: Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Chugai Pharmaceutical Co.; Research grant / Funding (institution): Pfizer; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Eli Lilly. Y. Fujita: Honoraria (institution): Eli Lilly; Honoraria (institution): Chugai Pharma; Honoraria (institution): Taiho Pharmaceutical; Honoraria (institution): Pfizer; Honoraria (institution): Hisamitsu Pharmaceutical; Honoraria (institution): Novartis; Honoraria (institution): Ono Pharmaceutical. All other authors have declared no conflicts of interest.

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