A pilot study of adjuvant chemotherapy with carboplatin and oral S‐1 for patients with completely resected stage II to IIIA non‐small cell lung cancer

Abstract Background Adjuvant chemotherapy with platinum‐based regimens for completely resected early‐stage non‐small cell lung cancer (NSCLC) provides overall survival benefit in several clinical trials. Objectives We conducted this prospective study to evaluate the efficacy and safety of adjuvant c...

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Main Authors: Hisashi Tanaka, Chiori Tabe, Fumihiko Okumura, Toshihiro Shiratori, Yoshiko Ishioka, Masamichi Itoga, Kageaki Taima, Takeshi Morimoto, Daisuke Kimura, Takao Tsushima, Sadatomo Tasaka
Format: Article
Language:English
Published: Wiley 2020-06-01
Series:Thoracic Cancer
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Online Access:https://doi.org/10.1111/1759-7714.13444
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author Hisashi Tanaka
Chiori Tabe
Fumihiko Okumura
Toshihiro Shiratori
Yoshiko Ishioka
Masamichi Itoga
Kageaki Taima
Takeshi Morimoto
Daisuke Kimura
Takao Tsushima
Sadatomo Tasaka
author_facet Hisashi Tanaka
Chiori Tabe
Fumihiko Okumura
Toshihiro Shiratori
Yoshiko Ishioka
Masamichi Itoga
Kageaki Taima
Takeshi Morimoto
Daisuke Kimura
Takao Tsushima
Sadatomo Tasaka
author_sort Hisashi Tanaka
collection DOAJ
description Abstract Background Adjuvant chemotherapy with platinum‐based regimens for completely resected early‐stage non‐small cell lung cancer (NSCLC) provides overall survival benefit in several clinical trials. Objectives We conducted this prospective study to evaluate the efficacy and safety of adjuvant chemotherapy with carboplatin and S‐1 for patients with completely resected stage II to IIIA NSCLC. Methods Patients with completely resected stage IIA to IIIA NSCLC were treated with four cycles of carboplatin with area under the concentration time curve of 5 mg/mL/min on day 1 plus S‐1 at 80–120 mg/bodyweight per day for two weeks, followed by one‐week rest as adjuvant chemotherapy. The primary endpoint was the completion rate of three cycles of the treatment. The secondary endpoints were safety and two‐year survival rate. Results A total of 19 patients were enrolled, until the study was terminated prematurely because of fatal pulmonary embolism in two patients. The median number of treatment cycles was three (range: 1–4). The completion rate of three cycles was 78.9% (95% confidence interval [CI]: 56.6–91.4%). Two‐year disease‐free survival rate was 57.8%. Grade 3 or 4 hematological toxicities included neutropenia (26.2%), anemia (5.2%), and thrombocytopenia (15.7%). Grade 3 or 4 nonhematological toxicities were anorexia (10.5%) and nausea (10.5%). Febrile neutropenia developed in 5.2%. In two patients (10.5%), grade five pulmonary embolism was observed, and the causal relationship with treatment could not be denied. Conclusions Carboplatin and oral S‐1 had modest survival benefit, but this regimen was not tolerable in an adjuvant setting because fatal pulmonary embolism occurred in two patients. Key points Carboplatin and oral S‐1 had modest survival benefit but this regimen was not tolerable. Fatal pulmonary embolism occurred in this regimen.
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spelling doaj.art-a8a0dc620a0448d4914551e50fca6df82022-12-22T00:52:04ZengWileyThoracic Cancer1759-77061759-77142020-06-011161633163810.1111/1759-7714.13444A pilot study of adjuvant chemotherapy with carboplatin and oral S‐1 for patients with completely resected stage II to IIIA non‐small cell lung cancerHisashi Tanaka0Chiori Tabe1Fumihiko Okumura2Toshihiro Shiratori3Yoshiko Ishioka4Masamichi Itoga5Kageaki Taima6Takeshi Morimoto7Daisuke Kimura8Takao Tsushima9Sadatomo Tasaka10Department of Respiratory Medicine Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Respiratory Medicine Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Respiratory Medicine Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Respiratory Medicine Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Respiratory Medicine Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Respiratory Medicine Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Respiratory Medicine Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Respiratory Medicine Aomori Prefectural Central Hospital Aomori JapanDepartment of Thoracic and Cardiovascular Surgery Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Thoracic and Cardiovascular Surgery Hirosaki University Graduate School of Medicine Hirosaki JapanDepartment of Respiratory Medicine Hirosaki University Graduate School of Medicine Hirosaki JapanAbstract Background Adjuvant chemotherapy with platinum‐based regimens for completely resected early‐stage non‐small cell lung cancer (NSCLC) provides overall survival benefit in several clinical trials. Objectives We conducted this prospective study to evaluate the efficacy and safety of adjuvant chemotherapy with carboplatin and S‐1 for patients with completely resected stage II to IIIA NSCLC. Methods Patients with completely resected stage IIA to IIIA NSCLC were treated with four cycles of carboplatin with area under the concentration time curve of 5 mg/mL/min on day 1 plus S‐1 at 80–120 mg/bodyweight per day for two weeks, followed by one‐week rest as adjuvant chemotherapy. The primary endpoint was the completion rate of three cycles of the treatment. The secondary endpoints were safety and two‐year survival rate. Results A total of 19 patients were enrolled, until the study was terminated prematurely because of fatal pulmonary embolism in two patients. The median number of treatment cycles was three (range: 1–4). The completion rate of three cycles was 78.9% (95% confidence interval [CI]: 56.6–91.4%). Two‐year disease‐free survival rate was 57.8%. Grade 3 or 4 hematological toxicities included neutropenia (26.2%), anemia (5.2%), and thrombocytopenia (15.7%). Grade 3 or 4 nonhematological toxicities were anorexia (10.5%) and nausea (10.5%). Febrile neutropenia developed in 5.2%. In two patients (10.5%), grade five pulmonary embolism was observed, and the causal relationship with treatment could not be denied. Conclusions Carboplatin and oral S‐1 had modest survival benefit, but this regimen was not tolerable in an adjuvant setting because fatal pulmonary embolism occurred in two patients. Key points Carboplatin and oral S‐1 had modest survival benefit but this regimen was not tolerable. Fatal pulmonary embolism occurred in this regimen.https://doi.org/10.1111/1759-7714.13444Adjuvant chemotherapycarboplatinlung cancerpulmonary embolismS‐1
spellingShingle Hisashi Tanaka
Chiori Tabe
Fumihiko Okumura
Toshihiro Shiratori
Yoshiko Ishioka
Masamichi Itoga
Kageaki Taima
Takeshi Morimoto
Daisuke Kimura
Takao Tsushima
Sadatomo Tasaka
A pilot study of adjuvant chemotherapy with carboplatin and oral S‐1 for patients with completely resected stage II to IIIA non‐small cell lung cancer
Thoracic Cancer
Adjuvant chemotherapy
carboplatin
lung cancer
pulmonary embolism
S‐1
title A pilot study of adjuvant chemotherapy with carboplatin and oral S‐1 for patients with completely resected stage II to IIIA non‐small cell lung cancer
title_full A pilot study of adjuvant chemotherapy with carboplatin and oral S‐1 for patients with completely resected stage II to IIIA non‐small cell lung cancer
title_fullStr A pilot study of adjuvant chemotherapy with carboplatin and oral S‐1 for patients with completely resected stage II to IIIA non‐small cell lung cancer
title_full_unstemmed A pilot study of adjuvant chemotherapy with carboplatin and oral S‐1 for patients with completely resected stage II to IIIA non‐small cell lung cancer
title_short A pilot study of adjuvant chemotherapy with carboplatin and oral S‐1 for patients with completely resected stage II to IIIA non‐small cell lung cancer
title_sort pilot study of adjuvant chemotherapy with carboplatin and oral s 1 for patients with completely resected stage ii to iiia non small cell lung cancer
topic Adjuvant chemotherapy
carboplatin
lung cancer
pulmonary embolism
S‐1
url https://doi.org/10.1111/1759-7714.13444
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