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Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401)
BACKGROUND: A cisplatin plus irinotecan (CPT‐11) regimen is used for patients with extensive disease small cell lung cancer (ED‐SCLC). Amrubicin (AMR) is primarily used for relapsed SCLC. The HOT1401/NJLCG1401 trial, an open‐label randomized phase II trial, was designed to assess the benefit of main...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons Australia, Ltd
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287008/ https://www.ncbi.nlm.nih.gov/pubmed/34076966 http://dx.doi.org/10.1111/1759-7714.14048 |
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author | Tanaka, Hisashi Hasegawa, Yukihiro Fujita, Yuka Nakamura, Atsushi Kikuchi, Eiki Kawai, Yasutaka Harada, Toshiyuki Watanabe, Naomi Yokouchi, Hiroshi Usui, Kazuhiro Saito, Ryota Watanabe, Hiroshi Masuda, Tomomi Fukuhara, Tatsuro Kudo, Keita Honda, Ryoichi Oizimi, Satoshi Maemondo, Makoto Inoue, Akira Morikawa, Naoto |
author_facet | Tanaka, Hisashi Hasegawa, Yukihiro Fujita, Yuka Nakamura, Atsushi Kikuchi, Eiki Kawai, Yasutaka Harada, Toshiyuki Watanabe, Naomi Yokouchi, Hiroshi Usui, Kazuhiro Saito, Ryota Watanabe, Hiroshi Masuda, Tomomi Fukuhara, Tatsuro Kudo, Keita Honda, Ryoichi Oizimi, Satoshi Maemondo, Makoto Inoue, Akira Morikawa, Naoto |
author_sort | Tanaka, Hisashi |
collection | PubMed |
description | BACKGROUND: A cisplatin plus irinotecan (CPT‐11) regimen is used for patients with extensive disease small cell lung cancer (ED‐SCLC). Amrubicin (AMR) is primarily used for relapsed SCLC. The HOT1401/NJLCG1401 trial, an open‐label randomized phase II trial, was designed to assess the benefit of maintenance therapy in patients with ED‐SCLC who responded to induction therapy. METHODS: Patients with histologically‐ or cytologically‐confirmed ED‐SCLC were included and were treated with an induction therapy of four cycles of cisplatin (60 mg/m(2) on day 1) plus CPT‐11 (60 mg/m(2) on days 1, 8, and 15) every four weeks. After induction therapy, patients who had nonprogressive disease were randomized to receive either maintenance CPT‐11 (60 mg/m(2) on days 1 and 8) every three weeks, or AMR (35 mg/m(2) on days 1–3) every three weeks. RESULTS: A total of 34 patients were enrolled; 20 patients had progressive disease or received incomplete induction chemotherapy. Finally, 14 patients were randomly assigned to receive CPT‐11 (n = 7) or AMR (n = 7). This study was terminated prematurely because of low patient accrual. The overall objective response rate was 73%, the median PFS was 5.7 months (95% confidence interval [CI]: 3.6–11.8), and the median overall survival was 20.1 months (95% CI: 13.7–not reached). No statistically significant difference in progression‐free survival (PFS) were noted between patients treated with CPT‐11 and those treated with AMR. There were no treatment‐related deaths in this study. CONCLUSIONS: Maintenance therapy with CPT‐11 or AMR after induction therapy might be effective in some patients. |
format | Online Article Text |
id | pubmed-8287008 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley & Sons Australia, Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-82870082021-07-21 Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401) Tanaka, Hisashi Hasegawa, Yukihiro Fujita, Yuka Nakamura, Atsushi Kikuchi, Eiki Kawai, Yasutaka Harada, Toshiyuki Watanabe, Naomi Yokouchi, Hiroshi Usui, Kazuhiro Saito, Ryota Watanabe, Hiroshi Masuda, Tomomi Fukuhara, Tatsuro Kudo, Keita Honda, Ryoichi Oizimi, Satoshi Maemondo, Makoto Inoue, Akira Morikawa, Naoto Thorac Cancer Original Articles BACKGROUND: A cisplatin plus irinotecan (CPT‐11) regimen is used for patients with extensive disease small cell lung cancer (ED‐SCLC). Amrubicin (AMR) is primarily used for relapsed SCLC. The HOT1401/NJLCG1401 trial, an open‐label randomized phase II trial, was designed to assess the benefit of maintenance therapy in patients with ED‐SCLC who responded to induction therapy. METHODS: Patients with histologically‐ or cytologically‐confirmed ED‐SCLC were included and were treated with an induction therapy of four cycles of cisplatin (60 mg/m(2) on day 1) plus CPT‐11 (60 mg/m(2) on days 1, 8, and 15) every four weeks. After induction therapy, patients who had nonprogressive disease were randomized to receive either maintenance CPT‐11 (60 mg/m(2) on days 1 and 8) every three weeks, or AMR (35 mg/m(2) on days 1–3) every three weeks. RESULTS: A total of 34 patients were enrolled; 20 patients had progressive disease or received incomplete induction chemotherapy. Finally, 14 patients were randomly assigned to receive CPT‐11 (n = 7) or AMR (n = 7). This study was terminated prematurely because of low patient accrual. The overall objective response rate was 73%, the median PFS was 5.7 months (95% confidence interval [CI]: 3.6–11.8), and the median overall survival was 20.1 months (95% CI: 13.7–not reached). No statistically significant difference in progression‐free survival (PFS) were noted between patients treated with CPT‐11 and those treated with AMR. There were no treatment‐related deaths in this study. CONCLUSIONS: Maintenance therapy with CPT‐11 or AMR after induction therapy might be effective in some patients. John Wiley & Sons Australia, Ltd 2021-06-02 2021-07 /pmc/articles/PMC8287008/ /pubmed/34076966 http://dx.doi.org/10.1111/1759-7714.14048 Text en © 2021 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Tanaka, Hisashi Hasegawa, Yukihiro Fujita, Yuka Nakamura, Atsushi Kikuchi, Eiki Kawai, Yasutaka Harada, Toshiyuki Watanabe, Naomi Yokouchi, Hiroshi Usui, Kazuhiro Saito, Ryota Watanabe, Hiroshi Masuda, Tomomi Fukuhara, Tatsuro Kudo, Keita Honda, Ryoichi Oizimi, Satoshi Maemondo, Makoto Inoue, Akira Morikawa, Naoto Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401) |
title | Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401) |
title_full | Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401) |
title_fullStr | Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401) |
title_full_unstemmed | Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401) |
title_short | Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401) |
title_sort | randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first‐line induction therapy for extensive disease small cell lung cancer (hot1401/njlcg1401) |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287008/ https://www.ncbi.nlm.nih.gov/pubmed/34076966 http://dx.doi.org/10.1111/1759-7714.14048 |
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