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2. Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer

Author

Yoshioka, H., Shimokawa, M., Seto, T., Morita, S., Yatabe, Y., Okamoto, I., Tsurutani, J., Satouchi, M., Hirashima, T., Atagi, S., Shibata, K., Saito, H., Toyooka, S., Yamamoto, N., Nakagawa, K., and Mitsudomi, T.

Published
2019
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3. 1160P Survival impact of second-line immune checkpoint inhibitors in the elderly patients with advanced squamous non-small cell lung cancer: Post-hoc analysis from a CAPITAL study

Author

Kogure, Y., primary, Kada, A., additional, Hashimoto, H., additional, Atagi, S., additional, Takiguchi, Y., additional, Saka, H., additional, Ebi, N., additional, Inoue, A., additional, Kurata, T., additional, Fujita, Y., additional, Nishii, Y., additional, Shibayama, T., additional, Itani, H., additional, Endo, T., additional, Yamamoto, N., additional, and Gemma, A., additional

Published
2022
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4. 64P Clinical benefit of platinum doublet therapy for elderly patients with advanced non-small cell lung cancer: A prospective multicenter study of the national hospital organization in Japan

Author

Shimokawa, M., primary, Kanazu, M., additional, Saito, R., additional, Mori, M., additional, Tamura, A., additional, Okano, Y., additional, Fujita, Y., additional, Endo, T., additional, Motegi, M., additional, Takata, S., additional, Kita, T., additional, Sukoh, N., additional, Takenoyama, M., additional, and Atagi, S., additional

Published
2022
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6. 1332P A randomized phase II trial of standard versus low-dose nab-paclitaxel for previously treated advanced non-small cell lung cancer (JMTO LC14-01)

Author

Takeuchi, S., primary, Sugawara, S., additional, Teramukai, S., additional, Noro, R., additional, Fujikawa, K., additional, Hirose, T., additional, Atagi, S., additional, Minami, S., additional, Iida, S., additional, Kuraishi, H., additional, Aiba, T., additional, Kawahara, M., additional, Minegishi, Y., additional, Matsumoto, M., additional, Seike, M., additional, Gemma, A., additional, and Kubota, K., additional

Published
2021
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7. 1333P Dose and schedule modifications of carboplatin plus nab-paclitaxel for elderly patients with squamous non-small cell lung cancer from the CAPITAL study

Author

Saito, G., primary, Kogure, Y., additional, Kada, A., additional, Hashimoto, H., additional, Atagi, S., additional, Takiguchi, Y., additional, Saka, H., additional, Ebi, N., additional, Inoue, A., additional, Kurata, T., additional, Yamanaka, T., additional, Ando, M., additional, Shibayama, T., additional, Itani, H., additional, Nishii, Y., additional, Fujita, Y., additional, Yamamoto, N., additional, and Gemma, A., additional

Published
2021
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9. Efficacy and Safety of Carboplatin With Nab-Paclitaxel Versus Docetaxel in Elderly Patients with Squamous-Cell Lung Cancer (CAPITAL): A Randomized, Multicenter, Open-Label, Phase III Trial

Author

Takayasu Kurata, Takashi Seto, Harada T, Nobuyuki Yamamoto, Takeharu Yamanaka, Mitsuhiro Takenoyama, Akihiko Gemma, Atagi S, Isamu Okamoto, Masahiro Seike, Y. Kogure, Yasuo Takiguchi, Hamamoto Y, Saito Am, Ebi N, Kaoru Kubota, Hiroya Hashimoto, Hideo Saka, A. Kada, Shunichiro Iwasawa, M. Ando, Masafumi Yamaguchi, and Akihisa Inoue

Subjects
medicine.medical_specialty, Systemic chemotherapy, business.industry, Squamous cell lung cancer, Carboplatin, Clinical trial, chemistry.chemical_compound, chemistry, Docetaxel, Family medicine, medicine, Open label, business, Objective response, medicine.drug, Nab-paclitaxel
Abstract

Background: In Japan, docetaxel, a cytotoxic monotherapy, is the standard drug administered to elderly patients with advanced non-small cell lung cancer (NSCLC). Carboplatin plus nab-paclitaxel (nab-PC) demonstrated a high objective response rate (ORR) in patients with squamous histology and was suggested to improve overall survival (OS) for these patients. The CAPITAL trial aimed to assess the safety and efficacy of nab-PC versus docetaxel as first-line therapy for elderly patients with advanced squamous NSCLC. Methods: This multicenter, open-label, phase III, randomized trial was performed at 92 institutions in Japan. Inclusion criteria: 1) advanced squamous NSCLC with no prior systemic chemotherapy, 2) age ≥70 years, and 3) Eastern Cooperative Oncology Group performance status 0 or 1. Patients were randomized 1:1 to nab-PC arm (carboplatin AUC, 6 mg/mL/min plus nab-paclitaxel 100 mg/m2 weekly) or D arm (docetaxel 60 mg/m2) for each 21-day cycle. Findings: The nab-PC arm showed higher OS (hazard ratio [HR]: 0·52; 90%CI: 0·38–0·70; median: 16·9 versus 10·9 months; p = 0·0003), progression-free survival (median: 5·8 versus 4·0 months; HR: 0·42; 95%CI: 0·30–0·58; p < 0·0001), and ORR (66·3 versus 28·0%; p < 0·0001) than the D arm. The most common grade 3 or 4 adverse events were leukopenia (46·3%), neutropenia (63·2%), and anemia (38·9%) in the nab-PC arm, and leukopenia (56·7%), neutropenia (77·3%), and febrile neutropenia (17·5%) in the D arm; ≥ grade 2 sensory peripheral neuropathy was observed in 15 (15·8%) and 1 (1·0%) patient(s) in the nab-PC and D arms, respectively. Serious treatment-related adverse events and deaths occurred in 13 (13·7%) and 11 (11·3%) patients and in 2 and 1 patient(s) in the nab-PC and D arms, respectively. Interpretation: Nab-PC improved OS more than docetaxel and can be used as standard first-line treatment for elderly patients with advanced squamous NSCLC. Clinical Trial Registration Details: This trial was registered with the UMIN Clinical Trials Registry (UMIN000019843) and the Japan Registry of Clinical Trials (jRCTs041180110) and its protocol has been published previously. Funding Information: This study was conducted by the National Hospital Organization Nagoya Medical Center under a funding contract with Taiho Pharmaceutical Co. Ltd., Tokyo, Japan. Declaration of Interests: Y.K. reports grants from Taiho Pharmaceutical, during the conduct of the study; grants and personal fees from MSD, personal fees from AstraZeneca, Chugai Pharmaceutical, Taiho Pharmaceutical, Eli Lilly, Boehringer Ingelheim, Ono pharmaceutical, outside the submitted work. S.I. reports grants and personal fees from ONO PHARMACEUTICAL CO., LTD., personal fees from Chugai Pharmaceutical Co., Ltd., AstraZeneca K.K., MSD K.K, Bristol-Myers Squibb K.K., Taiho Pharmaceutical Co., Ltd., DAIICHI SANKYO COMPANY, LIMITED., outside the submitted work. H.S. reports grants from Taiho Pharmaceutical, during the conduct of the study; grants and personal fees from AstraZeneca, MSD K.K, Ono Pharmaceutical, personal fees from Boehringer Ingelheim, Chugai Pharma, from Kyorin, outside the submitted work. A.K. reports grants from Taiho Pharmaceutical Co., Ltd., during the conduct of the study; personal fees from Bayer Yakuhin, Ltd., outside the submitted work. S.A. reports grants from The National Cancer Center Research and Development Fund (26-A-22, 29-A-15, 2020-A-13), Taiho Pharmaceutical Co Ltd, during the conduct of the study; grants and personal fees from AstraZeneca, Ono, Taiho, Boehringer Ingelheim, Pfizer, Bristol-Myers Squibb, MSD, Eli Lilly, Chugai, Merck, grants and non-financial support from F. Hoffmann-La Roche, personal fees from Hisamitsu, Kyowa Hakko Kirin, Novartis Pharma, Thermo Fisher Scientific, outside the submitted work.YT reports grants and personal fees from Taiho pharmaceutical Co, during the conduct of the study; grants and personal fees from Eli Lilly, Ono pharmaceutical Co, Chugai pharmaceutical Co, MSD, Takeda, grants from Daiichi Sankyo, Kyowa-Hakko Kirin, personal fees from Novartis, Boehringer Ingelheim, AstraZeneca, outside the submitted work. A.I. reports personal fees from AstraZeneca, Eli Lilly, Boehringer Ingelheim, Pfizer, Chugai Pharmaceutical, MSD, Daiichi Sankyo, outside the submitted work. T.K. reports personal fees from AstraZeneca, MSD, Eli Lilly, Chugai, Ono, Bristol Myers, Boehringer Ingelheim, grants from AstraZeneca, MSD, Ono, Eli Lilly, Takeda, outside the submitted work. I.O. reports grants from Boehringer Ingelheim, during the conduct of the study; grants and personal fees from AstraZeneca, Taiho Pharmaceutical, Boehringer Ingelheim, Ono Pharmaceutical, MSD Oncology, Lilly, Bristol-Myers Squibb, Chugai Pharma, grants from Astellas Pharma, Novartis, AbbVie, personal fees from Pfizer, outside the submitted work. M.Y. reports grants and personal fees from Chugai Pharmaceutical, grants from Daiichi Sankyo, MSD, Pfizer Japan, outside the submitted work. M.S. reports grants and personal fees from Taiho Pharmaceutical Co., LTD, Chugai Pharmaceutical Co., LTD, MSD K.K, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly Japan K.K., personal fees from AstraZeneca Co., Ltd, outside the submitted work. T.Y. reports grants and personal fees from Takeda, Chugai, Taiho, Ono, Bayer, personal fees from Boehringer Ingelheim, Pfizer, Sysmex, Gilead Sciences, AstraZeneca, MSD, Sanofi, Otsuka, Kyowa Kirin, grants from Daiichi-Sankyo, Astellas, outside the submitted work. M.A. reports grants from Kyowa Kirin, Co. Ltd., outside the submitted work. K.K. reports grants and personal fees from Ono, Boehringer Ingelheim, personal fees from Chugai, MSD, AstraZeneca, Eli Lilly, Daiichi Sankyo, Bristol Myers Squibb, Kyowa Hakko KIRIN, Taiho, outside the submitted work. M.T. reports grants and personal fees from AstraZeneca, Chugai Pharmaceutical, Covidien Japan, Eli Lilly Japan, Kyowa Hakko Kirin, MSD, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical, personal fees from Bristol-Myers Squibb, Johnson & Johnson, Nippon Kayaku, and grants from KM Biologics, outside the submitted work. TS reports grants and personal fees from Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, MSD, Novartis Pharma, Pfizer Japan, Takeda Pharmaceutical, grants from AbbVie, Kissei Pharmaceutical, LOXO Oncology, Merck Biopharma, personal fees from AstraZeneca, Bristol-Myers Squibb, Covidien Japan, Kyowa Hakko Kirin, Mochida Pharmaceutical, Nippon Boehringer Ingelheim, Ono Pharmaceutical, Taiho Pharmaceutical, Thermo Fisher Scientific, Precision Medicine Asia, outside the submitted work. N.Y. reports grants and personal fees from MSD K.K., Chugai Pharmaceutical CO., LTD., ONO PHARMACEUTICAL CO., LTD., DAIICHI SANKYO CO., LTD., TAIHO PHARMACEUTICAL CO., LTD., Takeda Pharmaceutical CO., LTD., Eli Lilly Japan K.K., Boehringer-Ingelheim, Novartis, Pfizer Inc., AstraZeneca, personal fees from Thermo Fisher Scientific, Bristol-Myers Squibb, Life Technologies Japan Ltd., NIPPON KAYAKU, Merk Biopharma, grants from Astellas Pharma Inc., TSUMURA & CO., SHIONOGI Co., Ltd., AbbVie GK., Amgen Inc., KYORIN Pharmaceutical Co., Ltd., Eisai Co., Ltd., TERUMO CORPORATION, Toppan Printing Co., Ltd., TOSOH, outside the submitted work. A.G. reports personal fees from Taiho, Nihon Kayaku, AstraZeneca, Chugai, Ono, Behringer-Ingelheim, outside the submitted work. All other authors declare no competing interests. Ethics Approval Statement: The study was approved by the Clinical Research Ethics Committee of each participating institution and written informed consent was obtained from each patient prior to participation in the study. It was conducted in accordance with the principles of the Declaration of Helsinki, 2013.

Published
2021

12. 368P Real-world characteristics, treatment, and outcomes of stage III non-small cell lung cancer in Japan: SOLUTION study

Author

Murakami, H., primary, Tsuboi, M., additional, Harada, H., additional, Sobue, T., additional, Kato, T., additional, Atagi, S., additional, Tokito, T., additional, Mio, T., additional, Oizumi, S., additional, Kozuki, T., additional, Sone, T., additional, Seike, M., additional, Ohashi, K., additional, Jinushi, M., additional, and Horinouchi, H., additional

Published
2020
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13. 1375P Predicting chemotherapy toxicity in elderly patients with advanced non-small cell lung cancer: A prospective multicenter study of the national hospital organization in Japan

Author

Shimokawa, M., primary, Kanazu, M., additional, Saito, R., additional, Mori, M., additional, Tamura, A., additional, Okano, Y., additional, Fujita, Y., additional, Endo, T., additional, Motegi, M., additional, Takata, S., additional, Kita, T., additional, Sukoh, N., additional, Takenoyama, M., additional, and Atagi, S., additional

Published
2020
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19. Patient-focused outcomes in RELAY, a phase III trial of ramucirumab plus erlotinib (RamErl) versus placebo plus ERL (PboErl) in untreated EGFR-mutated metastatic NSCLC (EGFR+ mNSCLC)

Author

Yoh, K., primary, Atagi, S., additional, Reck, M., additional, Garon, E.B., additional, Aix, S. Ponce, additional, Moro-Sibilot, D., additional, Winfree, K.B., additional, Frimodt-Moller, B., additional, Zimmermann, A.H., additional, Visseren-Grul, C.M., additional, and Nakagawa, K., additional

Published
2019
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21. Clinical outcomes in elderly patients with advanced non-small cell lung cancer: A prospective multicenter study of the National Hospital Organization in Japan

Author

Shimada, M., primary, Kanazu, M., additional, Shimokawa, M., additional, Saito, R., additional, Mori, M., additional, Tamura, A., additional, Okano, Y., additional, Fujita, Y., additional, Endo, T., additional, Motegi, M., additional, Takata, S., additional, Kita, T., additional, Sukoh, N., additional, Takenoyama, M., additional, and Atagi, S., additional

Published
2019
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22. HER3 ligand heregulin expression and clinical implication in patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer treated with EGFR-tyrosine kinase inhibitors

Author

Yonesaka, K., primary, Iwama, E., additional, Hayashi, H., additional, Suzuki, S., additional, Kato, R., additional, Watanabe, S., additional, Takahama, T., additional, Tanizaki, J., additional, Tanaka, K., additional, Takeda, M., additional, Sakai, K., additional, Azuma, K., additional, Chiba, Y., additional, Atagi, S., additional, Nishio, K., additional, Okamoto, I., additional, and Nakagawa, K., additional

Published
2019
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24. P1.04-62 Nomogram Based on Multivariable Regression Model Estimates the Overall Survival of Nivolumab for Previously Treated Advanced NSCLC

Author

Tamiya, M., primary, Tamiya, A., additional, Go, H., additional, Inoue, T., additional, Kimura, M., additional, Kunimasa, K., additional, Nakahama, K., additional, Taniguchi, Y., additional, Shiroyama, T., additional, Isa, S., additional, Nishino, K., additional, Kumagai, T., additional, Suzuki, H., additional, Atagi, S., additional, Hirashima, T., additional, Shintani, A., additional, and Imamura, F., additional

Published
2019
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25. Predicting chemotherapy toxicity in elderly patients with advanced non-small cell lung cancer: A prospective multicenter study of the National Hospital Organization in Japan

Author

Kanazu, M., primary, Shimokawa, M., additional, Saito, R., additional, Mori, M., additional, Tamura, A., additional, Okano, Y., additional, Fujita, Y., additional, Endo, T., additional, Motegi, M., additional, Takata, S., additional, Kita, T., additional, Sukoh, N., additional, Takenoyama, M., additional, and Atagi, S., additional

Published
2019
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26. EP1.01-14 The Scour Using Pretreatment NLR, Liver Metastasis, PD-L1 Status and PS as a Marker of Outcomes in Nivolumab-Treated Patients with Advanced NSCLC

Author

Tamiya, A., primary, Tamiya, M., additional, Taniguchi, Y., additional, Nakahama, K., additional, Isa, S., additional, Shiroyama, T., additional, Inoue, T., additional, Suzuki, H., additional, Okishio, K., additional, Hirashima, T., additional, Imamura, F., additional, and Atagi, S., additional

Published
2019
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30. Nivolumab treatment beyond progressive disease in advanced non-small cell lung cancer.

Author

Enomoto, T., Tamiya, A., Matsumoto, K., Adachi, Y., Azuma, K., Inagaki, Y., Kouno, S., Taniguchi, Y., Saijo, N., Okishio, K., and Atagi, S.

Abstract

Purpose: This study evaluated the efficacy and safety of nivolumab treatment beyond progressive disease (PD) in non-small cell lung cancer (NSCLC). Patients/methods: Medical records of consecutive patients with advanced NSCLC who received nivolumab between December 2015 and December 2018 were reviewed. Clinical outcomes of three groups of eligible patients who received nivolumab as a second-line treatment after PD were compared based on Response Evaluation Criteria in Solid Tumors v1.1. We conducted subgroup analyses in patients with and without new lesions at first PD. Results: Twenty-eight patients continued nivolumab treatment beyond PD (TBP). Post PD, 46 patients switched to other anti-cancer treatment (OAT), and 21 received no further anti-cancer treatment (NAT). There were no significant differences in overall survival (OS) or survival post progression (SPP) between TBP and OAT groups (OS: 15.6 vs. 13.4 months, P =.40, SPP: 12.2 vs. 9.3 months, P =.42). Subgroup analyses indicated that among patients without new lesions at first PD, SPP was longer in the TBP than in the OAT groups (12.6 vs. 9.3 months, P =.22, HR: 0.64; 95% CI 0.31‒1.31). The frequency of immune-related adverse events leading to discontinuation during nivolumab beyond PD was equivalent to that for pre-PD (10.7 vs. 12.6%). Conclusions: No significant benefits were associated with continuation of nivolumab for advanced NSCLC patients. Continuation of nivolumab beyond PD could be a more useful option in patients without new lesions at first PD. Treatment-related toxicities require attention during nivolumab treatment not only before PD but also beyond PD. [ABSTRACT FROM AUTHOR]

Published
2021
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35. P1.01-33 Randomized Phase 2 Study Comparing CBDCA+PTX+BEV and CDDP+PEM+BEV in Treatment-Naïve Advanced Non-Sq NSCLC (CLEAR study)

Author

Harada, T., primary, Udagawa, H., additional, Sugiyama, E., additional, Atagi, S., additional, Koyama, R., additional, Watanabe, S., additional, Nakamura, Y., additional, Harada, D., additional, Hataji, O., additional, Tanaka, F., additional, Niimi, A., additional, Kida, H., additional, Satouchi, M., additional, Inoue, A., additional, Urata, Y., additional, Yamane, Y., additional, Yoh, K., additional, Yoshioka, H., additional, Yamanaka, T., additional, and Goto, K., additional

Published
2018
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37. P1.01-32 A Multicenter, Open-Label, Phase II Trial of S-1 Plus Carboplatin in Advanced Non-Small Cell Lung Cancer Patients with Interstitial Lung Disease

Author

Hanibuchi, M., primary, Kakiuchi, S., additional, Atagi, S., additional, Ogushi, F., additional, Shimizu, E., additional, Haku, T., additional, Toyoda, Y., additional, Azuma, M., additional, Kondo, M., additional, Kawano, H., additional, Otsuka, K., additional, Sakaguchi, S., additional, Nokihara, H., additional, Goto, H., additional, and Nishioka, Y., additional

Published
2018
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40. The efficacy of dose reduced crizotinib for advanced ALK-positive non-small cell lung cancer

Author

Naito, M., primary, Naoki, Y., additional, Takata, S., additional, Ishii, S., additional, Taniguchi, Y., additional, Saijo, N., additional, Tamiya, A., additional, Omachi, N., additional, Okishio, K., additional, Morita, S., additional, Tanaka, A., additional, Shiroyama, T., additional, Morishita, N., additional, Suzuki, H., additional, Okamoto, N., additional, Hirashima, T., additional, and Atagi, S., additional

Published
2017
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41. Nab-paclitaxel in combination with carboplatin versus docetaxel in chemotherapy-naïve with advanced non-small-cell lung cancer aged 75 years old or more: Retrospective cohort study

Author

Katayama, K., primary, Tamiya, A., additional, Tanaka, Y., additional, Nakahama, K., additional, Taniguchi, Y., additional, Saijo, N., additional, Naoki, Y., additional, Omachi, N., additional, Okishio, K., additional, Kasai, T., additional, and Atagi, S., additional

Published
2017
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44. P3.04-002 A Randomized Phase II Study of Carboplatin plus Nab-Paclitaxel with or Without Nintedanib for NSCLC with IPF (J-SONIC): Trial in Progress

Author

Otsubo, K., primary, Kishimoto, J., additional, Kenmotsu, H., additional, Minegishi, Y., additional, Ichihara, E., additional, Shiraki, A., additional, Kato, T., additional, Atagi, S., additional, Horinouchi, H., additional, Ando, M., additional, Kondoh, Y., additional, Kusumoto, M., additional, Ichikado, K., additional, Yamamoto, N., additional, Nakanishi, Y., additional, and Okamoto, I., additional

Published
2017
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45. The efficacy and onset risk of interstitial lung disease of nivolumab in elderly (75 years old or older) patients with non-small cell lung cancer

Author

Tamiya, A., primary, Tamiya, M., additional, Nakahama, K., additional, Taniguchi, Y., additional, Shiroyama, T., additional, Isa, S-I, additional, Inoue, T., additional, Okishio, K., additional, Nishino, K., additional, Kumagai, T., additional, Suzuki, H., additional, Hirashima, T., additional, Imamura, F., additional, and Atagi, S., additional

Published
2017
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46. Final analysis of phase II trial of carboplatin, S-1, and gefitinib as first-line triplet chemotherapy for advanced non-small cell lung cancer patients with activating epidermal growth factor receptor mutations

Author

Tanaka, A., primary, Tamiya, A., additional, Tamiya, M., additional, Morita, S., additional, Shiroyama, T., additional, Saijo, N., additional, Minomo, S., additional, Tsuji, T., additional, Takeuchi, N., additional, Omachi, N., additional, Morishita, N., additional, Suzuki, H., additional, Okamoto, N., additional, Okishio, K., additional, Hirashima, T., additional, and Atagi, S., additional

Published
2017
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48. Correlation of radiation pneumonitis history before nivolumab and onset risk of interstitial lung disease or progression free survival of nivolumab in patients with non-small cell lung cancer

Author

Tamiya, A., primary, Tamiya, M., additional, Nakahama, K., additional, Taniguchi, Y., additional, Shiroyama, T., additional, Isa, S.-I., additional, Inoue, T., additional, Nishino, K., additional, Kumagai, T., additional, Suzuki, H., additional, Hirashima, T., additional, Imamura, F., additional, and Atagi, S., additional

Published
2017
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49. Predictive factors for poor progression-free survival in patients with non-small-cell lung cancer treated with nivolumab

Author

Taniguchi, Y., primary, Tamiya, A., additional, Isa, S-I., additional, Nakahama, K., additional, Okishio, K., additional, Shiroyama, T., additional, Suzuki, H., additional, Inoue, T., additional, Tamiya, M., additional, Nishino, K., additional, Kumagai, T., additional, Hirashima, T., additional, Imamura, F., additional, and Atagi, S., additional

Published
2017
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