Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529)

Abstract Introduction Stage IV non-small cell lung carcinoma (NSCLC) with oligometastases is potentially curable by radical treatment. This study aimed to evaluate the efficacy and safety of chemoradiotherapy (CRT) for thoracic disease, including the primary lesion and lymph node metastases, combine...

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Main Authors: Takaaki Tokito, Kazuhiko Yamada, Hidenobu Ishii, Yuichi Takiguchi, Go Saito, Koichi Minato, Hisao Imai, Hiroshi Tanaka, Satoru Miura, Kageaki Watanabe, Yoshifusa Koreeda, Akira Ono, Naoki Furuya, Toshihiro Misumi, Kazushige Hayakawa, Etsuyo Ogo, Hiroaki Okamoto
Format: Article
Language:English
Published: BMC 2025-01-01
Series:Radiation Oncology
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Online Access:https://doi.org/10.1186/s13014-024-02577-5
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author Takaaki Tokito
Kazuhiko Yamada
Hidenobu Ishii
Yuichi Takiguchi
Go Saito
Koichi Minato
Hisao Imai
Hiroshi Tanaka
Satoru Miura
Kageaki Watanabe
Yoshifusa Koreeda
Akira Ono
Naoki Furuya
Toshihiro Misumi
Kazushige Hayakawa
Etsuyo Ogo
Hiroaki Okamoto
author_facet Takaaki Tokito
Kazuhiko Yamada
Hidenobu Ishii
Yuichi Takiguchi
Go Saito
Koichi Minato
Hisao Imai
Hiroshi Tanaka
Satoru Miura
Kageaki Watanabe
Yoshifusa Koreeda
Akira Ono
Naoki Furuya
Toshihiro Misumi
Kazushige Hayakawa
Etsuyo Ogo
Hiroaki Okamoto
author_sort Takaaki Tokito
collection DOAJ
description Abstract Introduction Stage IV non-small cell lung carcinoma (NSCLC) with oligometastases is potentially curable by radical treatment. This study aimed to evaluate the efficacy and safety of chemoradiotherapy (CRT) for thoracic disease, including the primary lesion and lymph node metastases, combined with local consolidative therapy (LCT) for oligometastases. Methods This was a multicenter Phase II trial for patients with Stage IV NSCLC with oligometastases for whom CRT for thoracic disease was feasible. The treatment procedures included CRT containing platinum-doublet for thoracic disease and LCT for oligometastases within 8 weeks of starting or completing CRT. The primary endpoint was the 2-year survival rate. Results We enrolled 19 patients between June 2016 and May 2020. The median age was 68 (range: 51–74) years. Twelve patients had adenocarcinoma, and 6 had squamous cell carcinoma. The metastasis sites included the brain, bone, adrenal gland, lung, and cervical lymph node (n = 9, 7, 2, 1, and 1, respectively). All patients completed CRT concurrently with LCT for all oligometastases. There were 11 partial responses, resulting in a response rate of 58% (95% confidence interval [CI] 33.5–79.7%). Median progression-free survival and overall survival were 8.6 (95% CI 7.0–10.2) and 42.1 (80% CI 13.6–not reached) months, respectively. The 2-year survival rate was 68.4% (80% CI 52.6%–79.9%). Fourteen patients (74%) showed progression with newly observed lesions. There were no severe adverse events, and toxicities were tolerable. Conclusion Chemotherapy in combination with aggressive LCT for NSCLC with oligometastases might extend survival and achieve local control. Clinical trial registration: University Hospital Medical Information Network, Japan (protocol identification number: UMIN000022431, first registration date: 01/JUN/2016).
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spelling doaj-art-b405b6d186df4a00a0557c1ad75f68022025-08-20T01:48:08ZengBMCRadiation Oncology1748-717X2025-01-0120111010.1186/s13014-024-02577-5Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529)Takaaki Tokito0Kazuhiko Yamada1Hidenobu Ishii2Yuichi Takiguchi3Go Saito4Koichi Minato5Hisao Imai6Hiroshi Tanaka7Satoru Miura8Kageaki Watanabe9Yoshifusa Koreeda10Akira Ono11Naoki Furuya12Toshihiro Misumi13Kazushige Hayakawa14Etsuyo Ogo15Hiroaki Okamoto16Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of MedicineDivision of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of MedicineDivision of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of MedicineDepartment of Medical Oncology, Graduate School of Medicine, Chiba University HospitalDepartment of Respirology, Graduate School of Medicine, Chiba University HospitalDivision of Respiratory Medicine, Gunma Prefectural Cancer CenterDivision of Respiratory Medicine, Gunma Prefectural Cancer CenterDepartment of Internal Medicine, Niigata Cancer Center HospitalDepartment of Internal Medicine, Niigata Cancer Center HospitalDepartment of Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalDepartment of Respiratory Medicine, Minamikyusyu National HospitalDivision of Thoracic Oncology, Shizuoka Cancer CenterDivision of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of MedicineDepartment of Data Science, National Cancer Center Hospital EastDepartment of Radiation Oncology, National Hospital Organization Disaster Medical CenterRadiation Oncology Center, Kurume UniversityDepartment of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen’s HospitalAbstract Introduction Stage IV non-small cell lung carcinoma (NSCLC) with oligometastases is potentially curable by radical treatment. This study aimed to evaluate the efficacy and safety of chemoradiotherapy (CRT) for thoracic disease, including the primary lesion and lymph node metastases, combined with local consolidative therapy (LCT) for oligometastases. Methods This was a multicenter Phase II trial for patients with Stage IV NSCLC with oligometastases for whom CRT for thoracic disease was feasible. The treatment procedures included CRT containing platinum-doublet for thoracic disease and LCT for oligometastases within 8 weeks of starting or completing CRT. The primary endpoint was the 2-year survival rate. Results We enrolled 19 patients between June 2016 and May 2020. The median age was 68 (range: 51–74) years. Twelve patients had adenocarcinoma, and 6 had squamous cell carcinoma. The metastasis sites included the brain, bone, adrenal gland, lung, and cervical lymph node (n = 9, 7, 2, 1, and 1, respectively). All patients completed CRT concurrently with LCT for all oligometastases. There were 11 partial responses, resulting in a response rate of 58% (95% confidence interval [CI] 33.5–79.7%). Median progression-free survival and overall survival were 8.6 (95% CI 7.0–10.2) and 42.1 (80% CI 13.6–not reached) months, respectively. The 2-year survival rate was 68.4% (80% CI 52.6%–79.9%). Fourteen patients (74%) showed progression with newly observed lesions. There were no severe adverse events, and toxicities were tolerable. Conclusion Chemotherapy in combination with aggressive LCT for NSCLC with oligometastases might extend survival and achieve local control. Clinical trial registration: University Hospital Medical Information Network, Japan (protocol identification number: UMIN000022431, first registration date: 01/JUN/2016).https://doi.org/10.1186/s13014-024-02577-5OligometastasisLocal consolidative therapyNon-small cell lung cancer
spellingShingle Takaaki Tokito
Kazuhiko Yamada
Hidenobu Ishii
Yuichi Takiguchi
Go Saito
Koichi Minato
Hisao Imai
Hiroshi Tanaka
Satoru Miura
Kageaki Watanabe
Yoshifusa Koreeda
Akira Ono
Naoki Furuya
Toshihiro Misumi
Kazushige Hayakawa
Etsuyo Ogo
Hiroaki Okamoto
Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529)
Radiation Oncology
Oligometastasis
Local consolidative therapy
Non-small cell lung cancer
title Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529)
title_full Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529)
title_fullStr Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529)
title_full_unstemmed Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529)
title_short Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529)
title_sort single arm multicenter phase ii study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage iv non small cell lung carcinoma with oligometastases cure oligo torg1529
topic Oligometastasis
Local consolidative therapy
Non-small cell lung cancer
url https://doi.org/10.1186/s13014-024-02577-5
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