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Article ; Online: Survivorship Bias in Analyses of Immune Checkpoint Inhibitor Trials-In Reply.

Toi, Yukihiro / Sugawara, Shunichi

JAMA oncology

2019 Volume 5, Issue 8, Page(s) 1226–1227

Language	English
Publishing date	2019-06-04
Publishing country	United States
Document type	Journal Article
ISSN	2374-2445
ISSN (online)	2374-2445
DOI	10.1001/jamaoncol.2019.1190
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Article ; Online: Incidence, Clinical Characteristics, and Predictors of Cardiovascular Immune-Related Adverse Events Associated with Immune Checkpoint Inhibitors.

Isawa, Tsuyoshi / Toi, Yukihiro / Sugawara, Shunichi / Taguri, Masataka / Toyoda, Shigeru

The oncologist

2022 Volume 27, Issue 5, Page(s) e410–e419

Abstract: Background: Cardiovascular immune-related adverse events (CV-irAEs) associated with immune checkpoint inhibitors (ICIs) may have been underreported given that most previous reports were retrospective. We aimed to evaluate the incidence, clinical ... ...

Abstract	Background: Cardiovascular immune-related adverse events (CV-irAEs) associated with immune checkpoint inhibitors (ICIs) may have been underreported given that most previous reports were retrospective. We aimed to evaluate the incidence, clinical characteristics, and predictors of CV-irAEs and determine the feasibility of serial cardiac monitoring using a combination of B-type natriuretic peptide, cardiac troponin T, and electrocardiogram for the prediction of future symptomatic (grade ≥2) CV-irAEs. Materials and methods: This was a prospective observational study that included 129 consecutive patients with non-small-cell lung cancer who received ICI monotherapy at a single center. Serial cardiac monitoring was performed during ICI monotherapy. Results: A total of 35 (27%) patients developed any grade ≥1 CV-irAEs with a median time of onset of 72 (interquartile range 44-216) days after ICI treatment initiation. Multivariate Fine-Gray regression analysis showed that prior acute coronary syndrome (adjusted hazard ratio [HR] 3.15 (95% [CI], 2.03-4.91), prior heart failure hospitalization (adjusted HR 1.65 [95% CI, 1.17-2.33]), and achievement of disease control (adjusted HR 1.91, [95% CI, 1.16-3.14]) were significantly associated with grade ≥1 CV-irAEs. Serial cardiac monitoring revealed that patients with preceding grade 1 CV-irAEs were associated with a significantly higher risk of onset of grade ≥2 CV-irAEs compared with those without preceding grade 1 CV-irAEs (HR: 6.17 [95% CI, 2.97-12.83]). Conclusion: CV-irAEs were more common than previously recognized and have several predictors. Moreover, serial cardiac monitoring may be feasible for the prediction of future grade ≥2 CV-irAEs.
MeSH term(s)	Carcinoma, Non-Small-Cell Lung/drug therapy ; Humans ; Immune Checkpoint Inhibitors/adverse effects ; Incidence ; Lung Neoplasms/drug therapy ; Retrospective Studies
Chemical Substances	Immune Checkpoint Inhibitors
Language	English
Publishing date	2022-04-30
Publishing country	England
Document type	Journal Article ; Observational Study
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1093/oncolo/oyac056
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Article ; Online: Immune Checkpoint Inhibitor Can Reduce HCV-RNA without Liver Damage.

Fukuda, Ryo / Sugawara, Shunichi / Kondo, Yasuteru

Internal medicine (Tokyo, Japan)

2020 Volume 59, Issue 18, Page(s) 2245–2248

Abstract: Recently, immune checkpoint inhibitors (iCIs) have been used to treat cancers. Once some of the iCIs for the treatment of hepatocellular carcinoma (HCC) are certified in clinical trials, they are likely be administered to HCC patients with hepatitis C ... ...

Abstract	Recently, immune checkpoint inhibitors (iCIs) have been used to treat cancers. Once some of the iCIs for the treatment of hepatocellular carcinoma (HCC) are certified in clinical trials, they are likely be administered to HCC patients with hepatitis C virus (HCV). However, the immunopathogenesis of HCV after the administration of iCIs has not been clarified. We experienced a lung cancer patient with HCV infection treated by nivolumab, programmed cell death 1 (PD-1) antibody. HCV-RNA gradually decreased after the start of nivolumab treatment. However, no increase in transaminase was observed during the decline of HCV-RNA. It was thought that HCV-specific cytotoxic T lymphocytes (CTLs) were activated by iCIs.
MeSH term(s)	Aged ; Hepacivirus/drug effects ; Hepatitis C/complications ; Humans ; Immune Checkpoint Inhibitors/pharmacology ; Immune Checkpoint Inhibitors/therapeutic use ; Lung Neoplasms/complications ; Lung Neoplasms/drug therapy ; Male ; Nivolumab/pharmacology ; Nivolumab/therapeutic use ; RNA, Viral/drug effects ; Transaminases/blood
Chemical Substances	Immune Checkpoint Inhibitors ; RNA, Viral ; Nivolumab (31YO63LBSN) ; Transaminases (EC 2.6.1.-)
Language	English
Publishing date	2020-06-09
Publishing country	Japan
Document type	Case Reports ; Journal Article
ZDB-ID	32371-8
ISSN	1349-7235 ; 0021-5120 ; 0918-2918
ISSN (online)	1349-7235
ISSN	0021-5120 ; 0918-2918
DOI	10.2169/internalmedicine.3726-19
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Article ; Online: Phase II study of carboplatin/nab-paclitaxel/atezolizumab combination therapy for advanced nonsquamous non-small cell lung cancer patients with impaired renal function: RESTART trial.

Shiraishi, Yoshimasa / Kishimoto, Junji / Shimose, Takayuki / Toi, Yukihiro / Sugawara, Shunichi / Okamoto, Isamu

BMC cancer

2022 Volume 22, Issue 1, Page(s) 964

Abstract: Background: First-line treatment of nonsquamous non-small cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination therapy together with immune checkpoint inhibitors (ICIs). However, phase III studies of combinations of cytotoxic ...

Abstract	Background: First-line treatment of nonsquamous non-small cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination therapy together with immune checkpoint inhibitors (ICIs). However, phase III studies of combinations of cytotoxic chemotherapy and ICIs have included only patients with maintained organ function, not those with renal impairment. Methods: Cytotoxic chemotherapy-naïve advanced nonsquamous NSCLC patients aged 20 years or older with impaired renal function (creatinine clearance of 15 to 45 mL/min) are prospectively registered in this single-arm phase II study and receive combination therapy with carboplatin, nanoparticle albumin-bound (nab-) paclitaxel, and atezolizumab. Individuals with known genetic driver alterations including those affecting EGFR, ALK, ROS1, BRAF, MET, RET, and NTRK are excluded. We plan to enroll 40 patients over 2 years at 32 oncology facilities in Japan. The primary end point is confirmed objective response rate. Discussion: If the study demonstrates efficacy and safety of carboplatin/nab-paclitaxel/atezolizumab, then this combination regimen may become a treatment option even for nonsquamous NSCLC patients with impaired renal function. Trial registration: Registered with Japan Registry for Clinical Trials on 25 February 2021 (jRCTs071200102).
MeSH term(s)	Albumins ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Carboplatin ; Carcinoma, Non-Small-Cell Lung/complications ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Humans ; Kidney/physiology ; Lung Neoplasms/chemically induced ; Lung Neoplasms/complications ; Lung Neoplasms/drug therapy ; Paclitaxel ; Protein-Tyrosine Kinases ; Proto-Oncogene Proteins ; Renal Insufficiency/chemically induced
Chemical Substances	130-nm albumin-bound paclitaxel ; Albumins ; Antibodies, Monoclonal, Humanized ; Proto-Oncogene Proteins ; atezolizumab (52CMI0WC3Y) ; Carboplatin (BG3F62OND5) ; Protein-Tyrosine Kinases (EC 2.7.10.1) ; Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2022-09-08
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	2041352-X
ISSN	1471-2407 ; 1471-2407
ISSN (online)	1471-2407
ISSN	1471-2407
DOI	10.1186/s12885-022-10056-x
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Article ; Online: Phase II study of S-1 and irinotecan combination therapy in EGFR-mutated non-small cell lung cancer resistant to epidermal growth factor receptor tyrosine kinase inhibitor: North Japan Lung Cancer Study Group Trial 0804 (NJLCG0804).

Nakamura, Atsushi / Harada, Masao / Watanabe, Kana / Harada, Toshiyuki / Inoue, Akira / Sugawara, Shunichi

Medical oncology (Northwood, London, England)

2022 Volume 39, Issue 11, Page(s) 163

Abstract: We conducted a multicenter phase II trial to evaluate the efficacy and safety of S-1 and irinotecan combination therapy in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer treated with epidermal growth factor receptor ... ...

Abstract	We conducted a multicenter phase II trial to evaluate the efficacy and safety of S-1 and irinotecan combination therapy in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer treated with epidermal growth factor receptor tyrosine kinase inhibitors. Epidermal growth factor receptor-mutated non-small-cell lung cancer patients treated with epidermal growth factor receptor tyrosine kinase inhibitors and platinum-based chemotherapy received 80 mg/m
MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/metabolism ; Disease-Free Survival ; ErbB Receptors ; Humans ; Irinotecan/therapeutic use ; Japan ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Lung Neoplasms/metabolism ; Mutation ; Protein Kinase Inhibitors/therapeutic use
Chemical Substances	Protein Kinase Inhibitors ; Irinotecan (7673326042) ; EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2022-08-16
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study
ZDB-ID	1201189-7
ISSN	1559-131X ; 0736-0118 ; 1357-0560
ISSN (online)	1559-131X
ISSN	0736-0118 ; 1357-0560
DOI	10.1007/s12032-022-01755-3
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Article ; Online: Efficacy of paclitaxel-carboplatin with bevacizumab as a late-line therapy for patients with advanced nonsquamous non-small cell lung cancer: A platinum rechallenge.

Sugisaka, Jun / Toi, Yukihiro / Kawashima, Yosuke / Domeki, Yutaka / Aiba, Tomoiki / Kawana, Sachiko / Nakamura, Atsushi / Yamanda, Shinsuke / Kimura, Yuichiro / Sugawara, Shunichi

Thoracic cancer

2023 Volume 14, Issue 31, Page(s) 3140–3146

Abstract: Background: There is no well-established late-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC). Therefore, we retrospectively determined the efficacy and safety of platinum rechallenge with paclitaxel-carboplatin and ... ...

Abstract	Background: There is no well-established late-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC). Therefore, we retrospectively determined the efficacy and safety of platinum rechallenge with paclitaxel-carboplatin and bevacizumab in patients with nonsquamous NSCLC as a late-line therapy in a clinical setting. Methods: Thirty patients with nonsquamous NSCLC who received paclitaxel-carboplatin with bevacizumab therapy as a late-line treatment at Sendai Kousei Hospital (Miyagi, Japan) between December 2011 and December 2021 were enrolled into the study. The efficacy and safety of this treatment were evaluated. The patients were further categorized into responders and nonresponders, and predictive factors of treatment response were estimated. Results: The median progression-free survival (PFS) was 6.3 (range, 4.9-6.8) months, and the median overall survival (OS) was 11.8 (range, 7.2-17.2) months. There were no significant differences in PFS and OS between patients with and those without epidermal growth factor receptor mutations. In the univariate analyses of this study, responders were younger than nonresponders (p = 0.012). No fatal adverse events were reported. Conclusions: With the increase in the number of treatment options in recent years, the sequence of treatments and overall therapeutic strategy are becoming increasingly important. Thus, platinum rechallenge with paclitaxel-carboplatin and bevacizumab, a late-line treatment for patients with nonsquamous NSCLC, may be an effective therapeutic option.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung ; Bevacizumab ; Carboplatin ; Platinum/therapeutic use ; Lung Neoplasms ; Retrospective Studies ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Paclitaxel
Chemical Substances	Bevacizumab (2S9ZZM9Q9V) ; Carboplatin (BG3F62OND5) ; Platinum (49DFR088MY) ; Antibodies, Monoclonal, Humanized ; Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2023-09-12
Publishing country	Singapore
Document type	Journal Article
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.15107
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Article: Monitoring of Plasma EGFR Mutations during Osimertinib Treatment for NSCLC Patients with Acquired T790M Mutation.

Watanabe, Kana / Saito, Ryota / Miyauchi, Eisaku / Nagashima, Hiromi / Nakamura, Atsushi / Sugawara, Shunichi / Tanaka, Nobuyuki / Terasaki, Hiroshi / Fukuhara, Tatsuro / Maemondo, Makoto

Cancers

2023 Volume 15, Issue 17

Abstract: Background: Osimertinib was first approved for the treatment of non-small cell lung cancer (NSCLC) in patients who have developed the epidermal growth factor receptor (EGFR) T790M mutation after treatment with EGFR tyrosine kinase inhibitors (TKIs). We ... ...

Abstract	Background: Osimertinib was first approved for the treatment of non-small cell lung cancer (NSCLC) in patients who have developed the epidermal growth factor receptor (EGFR) T790M mutation after treatment with EGFR tyrosine kinase inhibitors (TKIs). We routinely evaluated the plasma of NSCLC patients with the T790M mutation to more rapidly detect an increase in disease activity and resistance to treatment. Methods: Eligible patients received osimertinib after resistance to the first- or second-generation of EGFR-TKIs in NSCLC harboring T790M mutation detectable in tumor tissue or plasma. Plasma samples were collected every 8 weeks during osimertinib treatment. The plasma analysis was performed using an improved PNA-LNA PCR clamp method. We tested samples for a resistance mechanism, including EGFR-activating, T790M, and C797S mutations, and assessed the association between the mutations and osimertinib treatment. Results: Of the 60 patients enrolled in the study, 58 were eligible for this analysis. In plasma collected before osimertinib treatment, activating mutations were detected in 47 of 58 patients (81.0%) and T790M was detected in 44 patients (75.9%). Activating mutations were cleared in 60.9% (28/46) and T790M was cleared in 93.0% (40/43). Of these, 71.4% (20/28) of activating mutations and 87.5% (35/40) of T790M mutation were cleared within 8 weeks of treatment. The total response rate (RR) was 53.4% (31/58). The median duration of treatment was 259 days, with a trend toward longer treatment duration in patients who experienced the clearance of activating mutations with osimertinib. At the time of disease progression during osimertinib treatment, C797S was detected in 3 of 37 patients (8.1%). Conclusion: Plasma EGFR mutation analysis was effective in predicting the effect of osimertinib treatment.
Language	English
Publishing date	2023-08-24
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15174231
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Article ; Online: Phase II trial of daily S-1 combined with weekly irinotecan in previously treated patients with advanced or recurrent squamous cell lung cancer: North Japan lung cancer group 1101.

Kawashima, Yosuke / Ishimoto, Osamu / Miyauchi, Eisaku / Sakakibara, Tomohiro / Harada, Toshiyuki / Usui, Kazuhiro / Inoue, Akira / Sugawara, Shunichi

Thoracic cancer

2023 Volume 14, Issue 27, Page(s) 2804–2810

Abstract: Background: This phase II trial was designed to evaluate the efficacy and safety of S-1 combined with weekly irinotecan as a second- or third-line treatment for patients with advanced or recurrent squamous cell lung cancer.: Methods: Patients with a ... ...

Abstract	Background: This phase II trial was designed to evaluate the efficacy and safety of S-1 combined with weekly irinotecan as a second- or third-line treatment for patients with advanced or recurrent squamous cell lung cancer. Methods: Patients with a body surface area <1.25, 1.25-1.50, and >1.50 m Results: Between September 2011 and December 2014, 30 patients were enrolled in this study. The overall response rate was 6.7% (95% confidence interval [CI]: 0.8%-22.1%), and the disease control rate was 73.3%. The median progression-free survival was 3.0 months (95% CI: 2.5-3.4 months), and the median overall survival was 10.5 months (95% CI: 5.6-13.7 months). Grade 3/4 treatment-related adverse events were reported in ≥10% of the patients, including leukopenia (21%), neutropenia (21%), anemia (17%), anorexia (10%), and hypokalemia (10%). Conclusions: Although the treatment-related adverse events were manageable, the combination of weekly irinotecan and S-1 did not have the expected effect.
MeSH term(s)	Humans ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Squamous Cell/drug therapy ; Carcinoma, Squamous Cell/etiology ; Epithelial Cells ; Irinotecan ; Japan ; Lung Neoplasms/etiology ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/etiology
Chemical Substances	Irinotecan (7673326042)
Language	English
Publishing date	2023-08-17
Publishing country	Singapore
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.15076
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Article ; Online: Long-Term Efficacy and Safety of Lorlatinib in Japanese Patients With

Teraoka, Shunsuke / Hayashi, Hidetoshi / Goto, Yasushi / Nishio, Makoto / Sugawara, Shunichi / Inoue, Takao / Oizumi, Satoshi / Toyoizumi, Shigeyuki / Matsumura, Masakazu / Messina, Rossella / Kato, Terufumi

JTO clinical and research reports

2024 Volume 5, Issue 3, Page(s) 100632

Abstract: Introduction: Lorlatinib was found to have improved efficacy versus crizotinib in the global phase 3 CROWN study (NCT03052608). Similar results were revealed for the Japanese population as for the overall population. We present results from the ... ...

Abstract	Introduction: Lorlatinib was found to have improved efficacy versus crizotinib in the global phase 3 CROWN study (NCT03052608). Similar results were revealed for the Japanese population as for the overall population. We present results from the unplanned 3-year follow-up from the CROWN study in Japanese patients. Methods: Patients were randomized to either lorlatinib 100 mg once daily (n = 25) or crizotinib 250 mg twice daily (n = 23). The primary end point was progression-free survival assessed by blinded independent central review. Secondary end points included objective and intracranial responses assessed by blinded independent central review and safety. Results: At the data cutoff of September 20, 2021, median progression-free survival was not reached with lorlatinib and 11.1 months with crizotinib (hazard ratio = 0.36). Objective response rate was 72.0% with lorlatinib and 52.2% with crizotinib. For patients with baseline brain metastases, intracranial response rate was 100.0% versus 28.6% with lorlatinib versus crizotinib. Nine patients in the lorlatinib group received more than or equal to 1 subsequent anticancer systemic therapy, with ALK tyrosine kinase inhibitor as the most common first subsequent therapy. The safety profile was consistent with that reported previously, with no new safety signals. Conclusions: This updated analysis in the Japanese population revealed prolonged benefits of lorlatinib over crizotinib in patients with treatment-naive advanced
Language	English
Publishing date	2024-01-06
Publishing country	United States
Document type	Journal Article
ISSN	2666-3643
ISSN (online)	2666-3643
DOI	10.1016/j.jtocrr.2024.100632
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Article ; Online: Successful application of lorlatinib in a 23-year-old patient with anaplastic lymphoma kinase (ALK)-positive lung cancer and multiple brain metastases.

Murakami, Yosuke / Kawashima, Yosuke / Chiba, Shinji / Hara, Shuichiro / Yamazaki, Yusuke / Doman, Tsuyoshi / Saito, Shin / Odaka, Tetsuo / Ogasawara, Takahiro / Shimizu, Hisashi / Sugisaka, Jun / Aiba, Tomoiki / Toi, Yukihiro / Yamanda, Shinsuke / Kimura, Yuichiro / Sugawara, Shunichi

Cancer reports (Hoboken, N.J.)

2024 Volume 7, Issue 2, Page(s) e1981

Abstract: Background: Anaplastic lymphoma kinase (ALK)-positive lung cancer has a better long-term prognosis with ALK-inhibitor than other lung cancers. However, resistance to ALK-inhibitors and the control of metastases in the central nervous system (CNS) remain ...

Abstract	Background: Anaplastic lymphoma kinase (ALK)-positive lung cancer has a better long-term prognosis with ALK-inhibitor than other lung cancers. However, resistance to ALK-inhibitors and the control of metastases in the central nervous system (CNS) remain to be a challenge in the management of ALK-positive lung cancer. Case: We present the case of a 23-year-old man who developed multiple brain metastases while receiving alectinib treatment for ALK-positive lung cancer. After 3 months of lorlatinib initiation, brain metastases disappeared, and complete response (CR) was maintained. Conclusion: While lorlatinib can be used as first line therapy, this drug may be considered as second line or later option for patients with multiple brain metastases if the patient has already been treated with other ALK-inhibitors since lorlatinib is thought to have good CNS penetration. This treatment option should be verified by further research.
MeSH term(s)	Humans ; Male ; Young Adult ; Aminopyridines ; Anaplastic Lymphoma Kinase ; Brain Neoplasms/drug therapy ; Brain Neoplasms/secondary ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Lactams ; Lactams, Macrocyclic/therapeutic use ; Lung Neoplasms/drug therapy ; Lung Neoplasms/pathology ; Protein Kinase Inhibitors/therapeutic use ; Pyrazoles
Chemical Substances	Aminopyridines ; Anaplastic Lymphoma Kinase (EC 2.7.10.1) ; Lactams ; Lactams, Macrocyclic ; lorlatinib (OSP71S83EU) ; Protein Kinase Inhibitors ; Pyrazoles
Language	English
Publishing date	2024-01-11
Publishing country	United States
Document type	Case Reports
ISSN	2573-8348
ISSN (online)	2573-8348
DOI	10.1002/cnr2.1981
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