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Phase II study of carboplatin–paclitaxel alone or with bevacizumab in advanced sarcomatoid carcinoma of the lung: HOT1201/NEJ024

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International Journal of Clinical Oncology Aims and scope Submit manuscript

Abstract

Objectives

Only a few prospective studies have been conducted to examine the efficacy and safety of systemic chemotherapy for patients with pulmonary sarcomatoid carcinomas (PSCs). There is, thus, a crucial need to develop novel treatment strategies for this rare tumor.

Patients and methods

Chemotherapy-naïve patients with histologically confirmed PSCs were assigned to receive either carboplatin/paclitaxel alone (CP) or with bevacizumab (CPB) followed by bevacizumab maintenance. The primary endpoint was overall response rate (ORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety.

Results

This study was closed before accumulating the expected number of cases due to slow patient accrual. Eventually, 16 patients were enrolled. The ORR was 25.0% and disease control rate was 56.3%. CPB was administered in all four patients with an objective response [partial response (PR)]; among the four PR cases, two patients had pleomorphic carcinoma, and two had carcinosarcoma. Median PFS and median survival time (MST) in all the enrolled patients were 2.6 months and 8.8 months, respectively. Median PFS was 1.2 months in the CP group and 4.2 months in the CPB group. In addition, MST was 7.9 months in the CP group and 11.2 months in the CPB group. Hematological and non-hematological adverse events were common and reversible, although ileus (grade 4) and nasal bleeding (grade 3) occurred in one case each in the CPB group.

Conclusions

CPB might be effective as first-line treatment for PSCs. Further study is warranted to clarify the role of cytotoxic chemotherapy for this rare and aggressive tumor.

Clinical trials registration

University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN000008707).

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Acknowledgements

We thank all participating patients, their families, and the site investigators. Authors also thank Dr. Satoshi Morita for his technical support for statistical considerations.

Funding

This study was supported by a Grant-in-Aid for Scientific Research (JSPS KAKENHI Grant Number 15K09164).

Author information

Authors and Affiliations

  1. Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 3-54 Kikusui 4-2 Shiroishi-ku, Sapporo, 003-0804, Japan

    Satoshi Oizumi & Mamoru Kunisaki

  2. Hokkaido University Graduate School of Medicine, Sapporo, Japan

    Satoshi Oizumi, Eiki Kikuchi & Hirotoshi Dosaka-Akita

  3. Obihiro Kousei Hospital, Obihiro, Japan

    Kei Takamura

  4. JCHO Hokkaido Hospital, Sapporo, Japan

    Toshiyuki Harada

  5. Kobe University Graduate School of Medicine, Kobe, Japan

    Motoko Tachihara

  6. Iwate Medical University School of Medicine, Morioka, Japan

    Naoto Morikawa

  7. Sapporo Higashi Tokusyukai Hospital, Sapporo, Japan

    Ryoichi Honda

  8. Niigata University Medical and Dental Hospital, Niigata, Japan

    Satoshi Watanabe

  9. Juntendo University, Graduate School of Medicine, Tokyo, Japan

    Tetsuhiko Asao

  10. Miyagi Cancer Center, Natori, Japan

    Tatsuro Fukuhara

  11. Nippon Medical School, Graduate School of Medicine, Tokyo, Japan

    Rintaro Noro

  12. Hiroshima University, Hiroshima, Japan

    Yasuhiro Tsutani

  13. Asahikawa Medical University Hospital, Asahikawa, Japan

    Toshiyuki Tenma

  14. Saitama Medical University International Medical Center, Hidaka, Japan

    Kunihiko Kobayashi

Authors
  1. Satoshi Oizumi
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  2. Kei Takamura
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  3. Toshiyuki Harada
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  4. Motoko Tachihara
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  5. Naoto Morikawa
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  6. Ryoichi Honda
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  7. Satoshi Watanabe
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  8. Tetsuhiko Asao
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  9. Mamoru Kunisaki
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  10. Tatsuro Fukuhara
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  12. Eiki Kikuchi
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  13. Yasuhiro Tsutani
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  14. Toshiyuki Tenma
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  15. Kunihiko Kobayashi
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  16. Hirotoshi Dosaka-Akita
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Consortia

North East Japan Study Group, Hokkaido Lung Cancer Clinical Study Group

Contributions

SO was the primary investigator and contributed to study design. KT, TH, MT, NM, RH, SW, TA, MK, TF, RN, EK, YT, and TT were involved in patient accrual and data collection. KK and HDA chaired the study group and contributed to the administrative management of the study. SO performed data analysis and interpretation. The first draft of the manuscript was written by SO. All authors contributed to subsequent editing, critical review, and final approval to submit the report for publication.

Corresponding author

Correspondence to Satoshi Oizumi.

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Conflict of interest

SO received honoraria from AstraZeneca and Eli Lilly and research funding from Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Kissei Pharmaceutical, Ono Pharmaceutical, Pfizer, Merck Biopharma, Sanofi, Taiho Pharmaceutical, and Takeda Pharmaceutical; MT received honoraria from AstraZeneca, Chugai Pharmaceutical, Eli Lilly, MSD, and Ono Pharmaceutical and research funding from AstraZeneca; SW received honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, MSD, Novartis, Ono Pharmaceutical, Pfizer, and Taiho Pharmaceutical and research funding from AstraZeneca and Boehringer Ingelheim; TA received honoraria from AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Eli Lilly, MSD, Ono Pharmaceutical, Taiho Pharmaceutical, and Takeda Pharmaceutical; RN received honoraria from AstraZeneca and Novartis; YT received honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Ono Pharmaceutical, and Taiho Pharmaceutical; KK received honoraria from AstraZeneca; All other authors declare that they have no conflicts of interest.

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Oizumi, S., Takamura, K., Harada, T. et al. Phase II study of carboplatin–paclitaxel alone or with bevacizumab in advanced sarcomatoid carcinoma of the lung: HOT1201/NEJ024. Int J Clin Oncol 27, 676–683 (2022). https://doi.org/10.1007/s10147-021-02113-5

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  • DOI: https://doi.org/10.1007/s10147-021-02113-5

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