Phase II study of amrubicin combined with carboplatin for thymic carcinoma and invasive thymoma north Japan lung cancer group study 0803

Akira Inoue, Shunichi Sugawara, Masao Harada, Kunihiko Kobayashi, Toshiyuki Kozuki, Shoichi Kuyama, Makoto Maemondo, Hajime Asahina, Akiko Hisamoto, Taku Nakagawa, Katsuyuki Hotta, Toshihiro Nukiwa

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: There has been no standard chemotherapy for advanced or recurrent thymic malignancies including thymic carcinoma (TC) and invasive thymoma (IT), though platinum and anthracycline have been reported as effective agents for the treatment of these diseases. The objective of this study was to evaluate the efficacy and safety of the combination of amrubicin (AMR), a new anthracycline agent, and carboplatin (CBDCA) in patients with advanced thymic malignancies. Methods: Patients with histologically confirmed thymic malignancies received AMR (35 mg/m2, days 1-3) and CBDCA (area under the curve 4.0, day 1) every 3 weeks. Patients who had received previous chemotherapy were treated with a reduced dose of AMR (30 mg/m2). The primary end point was objective response rate (ORR), and secondary endpoints were progression-free survival, overall survival, and toxicity profile. Results: From December 2008 to October 2012, 51 patients (33 TC and 18 IT) were enrolled. The median number of treatment cycles was four in each group. The ORR and progression-free survival were 30% (95% confidence interval, 14-46) and 7.6 months in the TC group, and 17% (95% confidence interval, 0-34) and 7.6 months in the IT group, respectively. The ORR of TC patients without previous chemotherapy (n = 19) was 42%. Although grade 3 or 4 hematological toxicities were common including neutropenia (82%) and febrile neutropenia (22%), these were transient and manageable. Nonhematological toxicities were moderate and no treatment-related death was observed. Conclusions: The combination of AMR with CBDCA was active for TC with acceptable toxicity, although it was not effective for IT. Further investigation of this regimen for advanced TC is warranted.

Original languageEnglish
Pages (from-to)1805-1809
Number of pages5
JournalJournal of Thoracic Oncology
Volume9
Issue number12
DOIs
Publication statusPublished - 2014

Fingerprint

Thymoma
Carboplatin
Lung Neoplasms
Japan
Anthracyclines
Drug Therapy
Disease-Free Survival
amrubicin
Confidence Intervals
Febrile Neutropenia
Neoplasms
Neutropenia
Platinum
Area Under Curve
Therapeutics
Safety

Keywords

  • Amrubicin
  • Chemotherapy
  • Invasive thymoma
  • Phase II
  • Thymic carcinoma

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Phase II study of amrubicin combined with carboplatin for thymic carcinoma and invasive thymoma north Japan lung cancer group study 0803. / Inoue, Akira; Sugawara, Shunichi; Harada, Masao; Kobayashi, Kunihiko; Kozuki, Toshiyuki; Kuyama, Shoichi; Maemondo, Makoto; Asahina, Hajime; Hisamoto, Akiko; Nakagawa, Taku; Hotta, Katsuyuki; Nukiwa, Toshihiro.

In: Journal of Thoracic Oncology, Vol. 9, No. 12, 2014, p. 1805-1809.

Research output: Contribution to journalArticle

Inoue, A, Sugawara, S, Harada, M, Kobayashi, K, Kozuki, T, Kuyama, S, Maemondo, M, Asahina, H, Hisamoto, A, Nakagawa, T, Hotta, K & Nukiwa, T 2014, 'Phase II study of amrubicin combined with carboplatin for thymic carcinoma and invasive thymoma north Japan lung cancer group study 0803', Journal of Thoracic Oncology, vol. 9, no. 12, pp. 1805-1809. https://doi.org/10.1097/JTO.0000000000000362
Inoue, Akira ; Sugawara, Shunichi ; Harada, Masao ; Kobayashi, Kunihiko ; Kozuki, Toshiyuki ; Kuyama, Shoichi ; Maemondo, Makoto ; Asahina, Hajime ; Hisamoto, Akiko ; Nakagawa, Taku ; Hotta, Katsuyuki ; Nukiwa, Toshihiro. / Phase II study of amrubicin combined with carboplatin for thymic carcinoma and invasive thymoma north Japan lung cancer group study 0803. In: Journal of Thoracic Oncology. 2014 ; Vol. 9, No. 12. pp. 1805-1809.
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title = "Phase II study of amrubicin combined with carboplatin for thymic carcinoma and invasive thymoma north Japan lung cancer group study 0803",
abstract = "Background: There has been no standard chemotherapy for advanced or recurrent thymic malignancies including thymic carcinoma (TC) and invasive thymoma (IT), though platinum and anthracycline have been reported as effective agents for the treatment of these diseases. The objective of this study was to evaluate the efficacy and safety of the combination of amrubicin (AMR), a new anthracycline agent, and carboplatin (CBDCA) in patients with advanced thymic malignancies. Methods: Patients with histologically confirmed thymic malignancies received AMR (35 mg/m2, days 1-3) and CBDCA (area under the curve 4.0, day 1) every 3 weeks. Patients who had received previous chemotherapy were treated with a reduced dose of AMR (30 mg/m2). The primary end point was objective response rate (ORR), and secondary endpoints were progression-free survival, overall survival, and toxicity profile. Results: From December 2008 to October 2012, 51 patients (33 TC and 18 IT) were enrolled. The median number of treatment cycles was four in each group. The ORR and progression-free survival were 30{\%} (95{\%} confidence interval, 14-46) and 7.6 months in the TC group, and 17{\%} (95{\%} confidence interval, 0-34) and 7.6 months in the IT group, respectively. The ORR of TC patients without previous chemotherapy (n = 19) was 42{\%}. Although grade 3 or 4 hematological toxicities were common including neutropenia (82{\%}) and febrile neutropenia (22{\%}), these were transient and manageable. Nonhematological toxicities were moderate and no treatment-related death was observed. Conclusions: The combination of AMR with CBDCA was active for TC with acceptable toxicity, although it was not effective for IT. Further investigation of this regimen for advanced TC is warranted.",
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author = "Akira Inoue and Shunichi Sugawara and Masao Harada and Kunihiko Kobayashi and Toshiyuki Kozuki and Shoichi Kuyama and Makoto Maemondo and Hajime Asahina and Akiko Hisamoto and Taku Nakagawa and Katsuyuki Hotta and Toshihiro Nukiwa",
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T1 - Phase II study of amrubicin combined with carboplatin for thymic carcinoma and invasive thymoma north Japan lung cancer group study 0803

AU - Inoue, Akira

AU - Sugawara, Shunichi

AU - Harada, Masao

AU - Kobayashi, Kunihiko

AU - Kozuki, Toshiyuki

AU - Kuyama, Shoichi

AU - Maemondo, Makoto

AU - Asahina, Hajime

AU - Hisamoto, Akiko

AU - Nakagawa, Taku

AU - Hotta, Katsuyuki

AU - Nukiwa, Toshihiro

PY - 2014

Y1 - 2014

N2 - Background: There has been no standard chemotherapy for advanced or recurrent thymic malignancies including thymic carcinoma (TC) and invasive thymoma (IT), though platinum and anthracycline have been reported as effective agents for the treatment of these diseases. The objective of this study was to evaluate the efficacy and safety of the combination of amrubicin (AMR), a new anthracycline agent, and carboplatin (CBDCA) in patients with advanced thymic malignancies. Methods: Patients with histologically confirmed thymic malignancies received AMR (35 mg/m2, days 1-3) and CBDCA (area under the curve 4.0, day 1) every 3 weeks. Patients who had received previous chemotherapy were treated with a reduced dose of AMR (30 mg/m2). The primary end point was objective response rate (ORR), and secondary endpoints were progression-free survival, overall survival, and toxicity profile. Results: From December 2008 to October 2012, 51 patients (33 TC and 18 IT) were enrolled. The median number of treatment cycles was four in each group. The ORR and progression-free survival were 30% (95% confidence interval, 14-46) and 7.6 months in the TC group, and 17% (95% confidence interval, 0-34) and 7.6 months in the IT group, respectively. The ORR of TC patients without previous chemotherapy (n = 19) was 42%. Although grade 3 or 4 hematological toxicities were common including neutropenia (82%) and febrile neutropenia (22%), these were transient and manageable. Nonhematological toxicities were moderate and no treatment-related death was observed. Conclusions: The combination of AMR with CBDCA was active for TC with acceptable toxicity, although it was not effective for IT. Further investigation of this regimen for advanced TC is warranted.

AB - Background: There has been no standard chemotherapy for advanced or recurrent thymic malignancies including thymic carcinoma (TC) and invasive thymoma (IT), though platinum and anthracycline have been reported as effective agents for the treatment of these diseases. The objective of this study was to evaluate the efficacy and safety of the combination of amrubicin (AMR), a new anthracycline agent, and carboplatin (CBDCA) in patients with advanced thymic malignancies. Methods: Patients with histologically confirmed thymic malignancies received AMR (35 mg/m2, days 1-3) and CBDCA (area under the curve 4.0, day 1) every 3 weeks. Patients who had received previous chemotherapy were treated with a reduced dose of AMR (30 mg/m2). The primary end point was objective response rate (ORR), and secondary endpoints were progression-free survival, overall survival, and toxicity profile. Results: From December 2008 to October 2012, 51 patients (33 TC and 18 IT) were enrolled. The median number of treatment cycles was four in each group. The ORR and progression-free survival were 30% (95% confidence interval, 14-46) and 7.6 months in the TC group, and 17% (95% confidence interval, 0-34) and 7.6 months in the IT group, respectively. The ORR of TC patients without previous chemotherapy (n = 19) was 42%. Although grade 3 or 4 hematological toxicities were common including neutropenia (82%) and febrile neutropenia (22%), these were transient and manageable. Nonhematological toxicities were moderate and no treatment-related death was observed. Conclusions: The combination of AMR with CBDCA was active for TC with acceptable toxicity, although it was not effective for IT. Further investigation of this regimen for advanced TC is warranted.

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KW - Chemotherapy

KW - Invasive thymoma

KW - Phase II

KW - Thymic carcinoma

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