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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons Australia, Ltd 2021
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.
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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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