Publications by authors named "Yoshimasa Shiraishi"

Article Synopsis
  • The study investigates the impact of dual immunotherapy (nivolumab and ipilimumab) along with platinum-based chemotherapy on patients with untreated brain metastases from non-small cell lung cancer (NSCLC).
  • In total, 30 patients were enrolled, and the results showed a 50% intracranial response rate with a 20% rate of complete response, indicating effectiveness in targeting brain lesions.
  • The findings suggest that this treatment combination has promising potential for managing NSCLC patients with brain metastases, achieving a median intracranial progression-free survival of 8.1 months.
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Background: Adjuvant therapy with durvalumab, with or without tremelimumab, may have efficacy in patients with limited-stage small-cell lung cancer who do not have disease progression after standard concurrent platinum-based chemoradiotherapy.

Methods: In a phase 3, double-blind, randomized, placebo-controlled trial, we assigned patients to receive durvalumab at a dose of 1500 mg, durvalumab (1500 mg) plus tremelimumab at a dose of 75 mg (four doses only), or placebo every 4 weeks for up to 24 months. Randomization was stratified according to disease stage (I or II vs.

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  • A phase 3 trial evaluated the effectiveness of adding a CTLA-4 inhibitor to standard platinum-based chemotherapy and PD-1/PD-L1 inhibitors for patients with advanced non-small-cell lung cancer, as no prior studies had focused on this combination's survival benefits.
  • Conducted across 48 hospitals in Japan, the trial involved patients aged 20+ with untreated NSCLC, but had to stop recruitment early due to a concerning number of treatment-related deaths in the nivolumab-ipilimumab group.
  • The final results indicated no significant difference in overall survival between those receiving pembrolizumab and those receiving nivolumab-ipilimumab, with median survival rates of 23.7 months and 20.5
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Objective: Universal polymerase chain reaction (PCR) screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on hospital admission is an effective approach to preventing coronavirus disease 2019 (COVID-19) outbreaks in medical facilities. However, false-positive test results due to a recent infection are a concern. We investigated the usefulness and limitations of universal PCR screening for SARS-CoV-2 on hospital admission in a real-world setting.

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  • Tracheomediastinal fistula is a rare but serious complication that can occur in cancer patients, particularly those undergoing chemoradiotherapy for limited stage small cell lung cancer.
  • In this reported case, the fistula developed despite a positive treatment response, due to gradually increasing metastatic cancer in nearby lymph nodes, leading to mediastinitis.
  • The patient successfully recovered from the mediastinitis with antibiotics, although the fistula persisted, and the report also reviews previous studies on similar fistulas and their clinical characteristics.
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  • Immune-related adverse events (irAEs) can influence the effectiveness of PD-L1 inhibitors in treating metastatic non-small cell lung cancer (NSCLC), but their impact on nonmetastatic NSCLC outcomes was previously unclear.
  • This study evaluated the relationship between irAEs and progression-free survival (PFS) in Stage III NSCLC patients undergoing treatment with the PACIFIC regimen, analyzing both mild and nonmild irAEs through robust statistical methods.
  • Findings indicated that patients with nonmild irAEs experienced poorer PFS compared to those with mild irAEs or none at all, suggesting that mild irAEs could indicate better survival outcomes while more severe reactions treated with steroids are linked to worse outcomes.
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Background: Osimertinib shows pronounced efficacy for EGFR mutation-positive non-small cell lung cancer (NSCLC) including associated central nervous system (CNS) metastases. Tumors inevitably develop resistance to the drug, however. Osimertinib is sometimes readministered after completion of standard chemotherapy.

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Introduction: Pulmonary sarcomatoid carcinoma (PSC) is a rare subtype of lung cancer associated with poor prognosis and resistance to conventional chemotherapy. Immune checkpoint inhibitors (ICIs), alone or in combination with chemotherapy, were found to have clinical benefits in PSC in recent studies. Nevertheless, because these studies included a small number of patients owing to disease rarity, larger studies are needed to evaluate the effectiveness and safety of ICI-based therapy for PSC.

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Article Synopsis
  • - The study examined the timing and effects of durvalumab therapy after concurrent chemoradiotherapy (CCRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC).
  • - Conducted as a phase II clinical trial, 47 out of 50 treated patients showed a 1-year progression-free survival (PFS) rate of 75.0%, with an objective response rate of 78.7% and a median PFS of 14.2 months.
  • - The findings suggest that starting durvalumab immediately after CCRT is both effective and safe, with similar rates of serious side effects like pneumonitis to previous studies.
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  • - The study investigates the effectiveness and safety of combining bevacizumab with chemotherapy and atezolizumab in advanced non-small cell lung cancer (NSCLC) patients, building on the existing standard treatment protocols.
  • - Conducted as a phase 3 randomized clinical trial at 37 hospitals in Japan, it enrolled patients with advanced nonsquamous NSCLC between January 2019 and August 2020, focusing on those without genetic driver alterations or who had prior treatment with tyrosine kinase inhibitors.
  • - The primary outcome measured was progression-free survival (PFS), assessed by independent reviewers, with a total of 412 patients enrolled in two treatment groups: one receiving the standard regimen and the other receiving the combination with bev
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We conducted a phase 3 clinical trial to compare the efficacy of platinum-based combination chemotherapy together with nivolumab plus ipilimumab relative to that of platinum-based combination chemotherapy together with pembrolizumab in previously untreated patients with advanced NSCLC. The trial was terminated prematurely after treatment of 295 patients because of a high proportion of treatment-related deaths, three of which were due to cytokine release syndrome (CRS), in the nivolumab plus ipilimumab treatment arm. In addition, we encountered two cases of CRS that were effectively managed, for a total of five cases (3.

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Article Synopsis
  • - The study evaluates the combination of durvalumab immunotherapy and concurrent radiotherapy as a treatment for unresectable, locally advanced non-small cell lung cancer (NSCLC) without using chemotherapy, aiming to improve safety and efficacy over standard concurrent chemoradiotherapy.
  • - Conducted in Japan from September 2019 to May 2022, the DOLPHIN trial involved 74 patients with positive PD-L1 status and assessed the 12-month progression-free survival (PFS) rate, which was found to be 72.1% with a median PFS of 25.6 months.
  • - Results revealed potential benefits of the treated regimen, with minimal AEs reported, highlighting the efficacy of combining immun
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Therapy related-acute myeloid leukemia (t-AML) and myelodysplastic syndrome (t-MDS) are complications of chemotherapy and/or radiation therapy for malignant diseases. In this report, we describe a patient with advanced lung adenocarcinoma who developed autoimmune hemolytic anemia and MDS associated with a combination of atezolizumab and platinum-based chemotherapy. The patient showed progression from t-MDS to t-AML 20 months after the treatment was initiated.

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Background: Damage-associated molecular pattern (DAMP)-related immunogenic cell death triggers secondary adaptive immune responses. The relationship between DAMP levels and prognosis in patients with non-small cell lung cancer (NSCLC) who undergo a combination therapy of immune checkpoint inhibitors (ICI) and chemotherapy remains unclear.

Methods: Serial plasma samples were prospectively collected from 45 patients treated with ICI combination therapy for advanced NSCLC.

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Background: Immunotherapy has become a standard-of-care for patients with non-small-cell lung cancer (NSCLC). Although several biomarkers, such as programmed cell death-1, have been shown to be useful in selecting patients likely to benefit from immune checkpoint inhibitors (ICIs), more useful and reliable ones should be investigated. The prognostic nutritional index (PNI) is a marker of the immune and nutritional status of the host, and is derived from serum albumin level and peripheral lymphocyte count.

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Article Synopsis
  • Limited studies exist on the characteristics of pneumonitis associated with chemo-immunotherapy, prompting an investigation of its imaging features, prognostic factors, and clinical management in patients with non-squamous non-small cell lung cancer.
  • A multicenter study involving 53 patients revealed that most had an organizing pneumonia pattern, with 23% experiencing worsening respiratory status during treatment, leading to a high mortality rate.
  • Significant predictors of poor outcomes included the severity of pneumonitis at diagnosis, presence of diffuse alveolar damage, and extensive lung involvement, highlighting the need for better management guidelines in pneumonitis treatment.*
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Background: Tyrosine kinase inhibitors (TKIs) are effective for the treatment of non-small cell lung cancer (NSCLC) patients with activating mutations of the epidermal growth factor receptor (EGFR), but responses are not durable as tumors develop resistance. DS-1205c is a novel, specific, orally bioavailable, small-molecule AXL receptor TKI. In preclinical studies, DS-1205c restored TKI antitumor activity in a TKI acquired-resistance EGFR-mutant NSCLC tumor xenograft model.

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Background: The standard of care for extensive-stage small cell lung cancer (ES-SCLC) is an immune checkpoint inhibitor (ICI) combined with platinum-etoposide (PE) chemotherapy. At initial diagnosis, about 25% of ES-SCLC patients have brain metastases, which are associated with a poor prognosis. The decision as to whether to treat brain metastases with local therapies such as surgery or radiotherapy before initiation of systemic chemoimmunotherapy is based on symptoms due to the brain lesions and the general condition of the patient.

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Background: Thyroid transcription factor-1 (TTF-1) expression in advanced non-squamous non-small cell lung cancer (NSCLC) has been associated with the efficacy of pemetrexed plus platinum chemotherapy. However, the relation between TTF-1 expression and efficacy of the combination of programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors plus pemetrexed and platinum chemotherapy, a standard first-line treatment regimen for advanced non-squamous NSCLC, has remained unclear.

Methods: We retrospectively evaluated TTF-1 expression in tumor tissue of patients with advanced or recurrent non-squamous NSCLC treated with PD-1/PD-L1 inhibitors plus pemetrexed and platinum chemotherapy in the first-line setting.

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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.

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Purpose: The addition of cytotoxic chemotherapy to immune-checkpoint inhibitor (ICI) may enhance antitumor effects. We conducted an open-label randomized phase II/III study to evaluate nivolumab + docetaxel combination therapy in comparison with nivolumab monotherapy for previously treated ICI-naïve non-small cell lung cancer (NSCLC).

Patients And Methods: The primary endpoint of the phase III study was overall survival (OS), and the secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and toxicity.

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Purpose: To explore the efficacy of retreatment with immune checkpoint inhibitors (ICI) in patients with advanced non-small cell lung cancer (NSCLC) who responded to prior ICI and had adequate ICI-free interval.

Patients And Methods: Patients with advanced NSCLC who had achieved complete response (CR), partial response (PR), or stable disease for ≥6 months with prior ICI therapy preceding progression were prospectively enrolled. All patients should have had ICI-free interval ≥60 days before registration.

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Introduction: We describe the results of an exploratory analysis performed on the first head-to-head study (JapicCTI-194611) comparing two different intravenous (IV) neurokinin 1 (NK) receptor antagonists, fosnetupitant and fosaprepitant, in combination with palonosetron (PALO) and dexamethasone (DEX) for the prevention of highly emetogenic chemotherapy (HEC)-induced nausea and vomiting (CINV). This analysis was performed to validate the findings of the primary analysis (previously published) utilizing a last observation carried forward (LOCF) approach for missing values for the efficacy endpoint of complete response (no emetic event and no rescue medication), while also evaluating the time periods encompassing the 0-168-hour (h) "extended overall phase" interval.

Methods: Patients scheduled to receive cisplatin-based chemotherapy were randomized 1:1 to fosnetupitant 235 mg or fosaprepitant 150 mg in combination with PALO 0.

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Background: First-line treatment of non-small cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination chemotherapy together with an immune checkpoint inhibitor, regardless of the expression level of the programmed cell death-1 (PD-1) ligand PD-L1 on tumor cells. Moreover, such chemotherapy plus nivolumab (antibody to PD-1) and ipilimumab (antibody to cytotoxic T lymphocyte-associated protein-4) prolonged survival in advanced NSCLC patients compared with chemotherapy alone. We have now designed a randomized, controlled phase III trial (NIPPON, JCOG2007) to confirm that platinum combination chemotherapy plus nivolumab and ipilimumab is superior to such chemotherapy plus pembrolizumab (antibody to PD-1) for treatment-naive patients with advanced NSCLC.

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