Publications by authors named "Tomoko Kataoka"
The Japanese Society for Cancer of the Colon and Rectum guidelines recommend intensive surveillance for curatively resected pathological stage I-III colorectal cancer. However, there is still no global consensus on the optimal method, duration, or frequency of surveillance, and no clinical trials have demonstrated the usefulness of surveillance. We are conducting a clinical trial to confirm the efficacy of less-intensive surveillance after R0 resection with lymph node dissection for stage I or low-risk stage II colorectal cancer in patients without risk factors for recurrence.
View Article and Find Full Text PDFMethotrexate, Doxorubicin, and Cisplatin Versus Methotrexate, Doxorubicin, and Cisplatin + Ifosfamide in Poor Responders to Preoperative Chemotherapy for Newly Diagnosed High-Grade Osteosarcoma (JCOG0905): A Multicenter, Open-Label, Randomized Trial.
Hiroaki Hiraga
,
Ryunosuke Machida
,
Akira Kawai
,
Toshiyuki Kunisada
,
Tsukasa Yonemoto
,
Tomoko Kataoka
J Clin Oncol
June 2025
Purpose: Our previous NECO phase II studies on high-grade osteosarcoma suggested that administering ifosfamide (IF; 16 g/m [4g/m once on day 1, then 2g/m once on days 2-7] × six) to patients showing a poor response (PrRsp) to preoperative chemotherapy with methotrexate, doxorubicin, and cisplatin (MAP) improves their prognoses. In this Japan Clinical Oncology Group (JCOG) study, JCOG0905, we aimed to investigate the efficacy and safety of IF in patients with PrRsp.
Methods: JCOG0905 is a multicenter, open-label, multi-institutional, randomized trial.
Article Synopsis
- Poor patient accrual in clinical trials affects the timely development of new treatments, with only about 23.6% of trials finishing within their planned periods.
- Factors leading to trial extensions include having planned accrual periods longer than three years and using stratified trial designs, particularly in randomized trials.
- Estimating accrual pace based on previous clinical trial data effectively improves the chances of completing trials on schedule, while other estimation methods, such as surveys, do not show the same benefit.
Article Synopsis
- In Japan, the Act on Safety of Regenerative Medicine controls the use of unapproved regenerative medicine products, while other countries may sell these products without such regulations.
- Research indicated that platelet-rich plasma was a frequently used unapproved treatment, primarily targeting knee issues.
- The average cost for these unapproved orthopedic regenerative medicine treatments was around $2,490.
Article Synopsis
- The focus of postoperative monitoring for patients with non-small cell lung cancer is to identify any recurrence or new cancers while treatments are still effective.
- Although guidelines suggest regular CT scans, evidence shows they may not actually improve patient survival, particularly in advanced stages of the disease.
- A new phase III trial starting in October 2022 aims to test the effectiveness of less frequent CT scans compared to standard monitoring, involving 1100 patients across 45 institutions over four years, with overall survival as the main goal.
Article Synopsis
- Chemoradiotherapy is a standard treatment for T1bN0M0 esophageal squamous cell carcinoma, but about 20% of patients face locoregional recurrence after treatment, necessitating further interventions like salvage surgery.
- Elective nodal irradiation during chemoradiotherapy may lower recurrence rates, prompting a clinical trial to test its effectiveness compared to standard treatment without this method.
- The trial aims to enroll 280 patients over 4 years, focusing on major progression-free survival as the primary outcome, and is registered in the Japan Registry of Clinical Trials.
Article Synopsis
- * It is a randomized phase II trial (JCOG2006) involving 86 patients from 44 institutions over 2 years, evaluating the efficacy and safety of the treatments.
- * The primary goal is to track tumor regression, while secondary goals include overall survival rates, response rates, and the occurrence of adverse events.
Long-term outcome of patients with peripheral ground-glass opacity-dominant lung cancer after sublobar resections.
Ichiro Yoshino
,
Yasumitsu Moriya
,
Kenji Suzuki
,
Masashi Wakabayashi
,
Hisashi Saji
,
Tomoko Kataoka
J Thorac Cardiovasc Surg
October 2023
Article Synopsis
- The study evaluated the long-term outcomes of patients with peripheral small ground-glass opacity-dominant lung cancer after sublobar resection, specifically a 10-year follow-up of 333 patients.
- Of the 314 patients who underwent sublobar resections, the 10-year relapse-free survival rate was 98.6% and overall survival was 98.5%, with only one local recurrence noted.
- The findings suggest that sublobar resection effectively cures this type of lung cancer, and the occurrence of second cancers among patients is comparable to that of the general Japanese population.
Article Synopsis
- The study aimed to evaluate how daily living activities (ADL) deteriorate in elderly patients (75+) after surgery for non-small cell lung cancer (NSCLC) and identify factors that predict this decline.
- Out of 986 screened patients, 876 were eligible, with 85.1% reporting no significant deterioration in ADL after 6 months, while 11.4% showed notable decline; social activities were particularly affected.
- Factors linked to ADL deterioration included poor health status, low geriatric screening scores, the type of surgical procedure, and surgery duration, with 22.1% of patients indicating a decrease in quality of life post-surgery.
Article Synopsis
- Chemotherapy paired with antiangiogenic agents like bevacizumab, ramucirumab, and aflibercept is the standard second-line treatment for metastatic colorectal cancer, but it's unclear which agent to choose due to limited prospective study evidence.
- Previous research indicates that ramucirumab may work better for patients with high VEGF-D levels, while aflibercept may be more effective for those with high VEGF-A.
- The JCOG2004 study is a randomized phase II trial enrolling 345 patients over two years to identify these predictive biomarkers and measure progression-free survival as the main goal.
Article Synopsis
- Recent studies indicate that early tumor shrinkage (ETS) and depth of response (DpR) can predict chemotherapy outcomes in cancer, particularly in advanced biliary tract cancer.
- In a study involving 354 patients from JCOG1113, participants were categorized based on their tumor reduction at 6 weeks and maximum shrinkage by 12 weeks, with survival outcomes analyzed using a Cox proportional hazard model.
- Results showed that patients achieving ETS and high DpR had better progression-free survival (PFS) and overall survival (OS), indicating that these measures are effective early indicators of treatment success.
Carboplatin and irinotecan (CI) vs. carboplatin and etoposide (CE) for the treatment of extended-stage small-cell lung cancer in an elderly population: A phase II/III randomized control trial.
Tsuneo Shimokawa
,
Hiroaki Okamoto
,
Ryunosuke Machida
,
Yuki Misumi
,
Yukio Hosomi
,
Tomoko Kataoka
Lung Cancer
July 2023
Article Synopsis
- A study was conducted to compare the effectiveness of carboplatin plus irinotecan (CI) against carboplatin plus etoposide (CE) in improving overall survival for elderly patients with extensive-disease small-cell lung cancer (ED-SCLC).
- A total of 258 elderly patients participated, with results showing a median overall survival of 13.2 months for the CI group and 12.0 months for the CE group, although this difference wasn't statistically significant.
- While CI demonstrated some efficacy and had different side effects compared to CE, the findings indicate that CE should continue to be the standard treatment for this patient population.
Article Synopsis
- A phase II/III study was conducted to compare the effectiveness of dose-dense weekly paclitaxel plus carboplatin against conventional treatment in patients with metastatic or recurrent cervical cancer, but it was halted early due to no significant improvement in response rates.
- The study included 122 patients and analyzed overall and progression-free survival, as well as adverse events, with no notable differences between the dose-dense and conventional treatment arms.
- Final results showed that dose-dense therapy did not provide better outcomes than conventional therapy, and certain factors like treatment without bevacizumab were linked to better survival rates.
Article Synopsis
- The study assessed the safety and effectiveness of segmentectomy for patients with non-small-cell lung cancer (NSCLC) tumors up to 3 cm, particularly those with ground-glass opacity (GGO).
- Conducted across 42 institutions in Japan, the trial involved 396 patients and focused on a primary endpoint of 5-year relapse-free survival (RFS), ultimately demonstrating a 98% RFS after a median follow-up of 5.4 years.
- The findings suggest that segmentectomy could be a viable standard treatment option for NSCLC patients with GGO tumors 3 cm or smaller, with low rates of serious complications.
Article Synopsis
- Soft tissue sarcomas (STS) are rare cancers treated mainly with doxorubicin-based chemotherapy as the first line, and various drugs like trabectedin, eribulin, and pazopanib are considered for second-line treatment, with no clear evidence supporting one over the others.
- The JCOG1802 study is a randomized phase II trial aimed at comparing the effectiveness of trabectedin, eribulin, and pazopanib in patients with advanced STS who have not responded to initial doxorubicin treatment.
- The study’s primary goal is to evaluate progression-free survival, while secondary goals assess overall survival and other relevant treatment outcomes in eligible participants aged 16 and older with specific STS diagnoses.
Article Synopsis
- A study evaluated the effectiveness of the drug S-1 as an adjuvant treatment for patients with resected biliary tract cancer, comparing it with observation alone.
- This phase 3 trial involved 440 patients across 38 Japanese hospitals and aimed to measure overall survival rates after treatment.
- Results indicated that after 3 years, patients receiving S-1 had a 77.1% survival rate, compared to 67.6% in the observation group, showing a significant survival benefit associated with S-1 treatment.
Article Synopsis
- A study was conducted to compare the effectiveness of two cancer treatments—mFOLFIRINOX and GnP—specifically for patients with locally advanced pancreatic cancer (LAPC).
- The trial included 126 patients, assessing outcomes like overall survival and how well the cancer responded to treatment, with GnP showing superior response rates and lower toxicity.
- The study concluded that GnP should be tested in further research due to its better overall performance compared to mFOLFIRINOX, marking progress over traditional gemcitabine treatments.
Effectiveness of Etoposide and Cisplatin vs Irinotecan and Cisplatin Therapy for Patients With Advanced Neuroendocrine Carcinoma of the Digestive System: The TOPIC-NEC Phase 3 Randomized Clinical Trial.
Chigusa Morizane
,
Nozomu Machida
,
Yoshitaka Honma
,
Takuji Okusaka
,
Narikazu Boku
,
Tomoko Kataoka
JAMA Oncol
October 2022
Article Synopsis
- Etoposide plus cisplatin (EP) and irinotecan plus cisplatin (IP) are two standard treatment regimens for advanced neuroendocrine carcinoma (NEC) of the digestive system, and this study aims to determine which is more effective for improving overall survival (OS).
- This phase 3 randomized clinical trial included 170 chemotherapy-naive patients aged 20 to 75 with recurrent or unresectable NEC from Japan, comparing the efficacy of the EP and IP regimens.
- Results showed that while median OS was 12.5 months for the EP group and 10.9 months for the IP group, the difference was not statistically significant, although EP was found to be more effective
Article Synopsis
- This study analyzed the effectiveness of two chemotherapy regimens in high-risk soft tissue sarcoma patients: gemcitabine plus docetaxel (GD) versus the standard Adriamycin plus ifosfamide (AI).
- Results showed that after treatment, the estimated 3-year overall survival was 91.4% for AI compared to 79.2% for GD, indicating that GD was not as effective as AI.
- Despite GD having milder side effects, it should not be adopted as a standard treatment for this type of cancer, as per the findings from the trial.
A randomized phase III trial of denosumab before curettage for giant cell tumor of bone. JCOG1610.
Jpn J Clin Oncol
September 2022
Article Synopsis
- The JCOG1610 trial aimed to compare preoperative denosumab treatment to curettage with local therapy for patients with giant cell tumor of bone, focusing on relapse-free survival as the main outcome.
- Patient enrollment started in October 2017 but was halted in December 2020 due to low participant numbers, with only 18 patients registered across 13 institutions at that time.
- Results indicated that preoperative denosumab did not show superiority over the traditional method in preventing tumor relapse, with similar relapse-free survival rates observed in both treatment groups after one and two years.
Article Synopsis
- Management of elderly patients with early gastric cancer is crucial in aging societies like Japan, where endoscopic resection is preferred for cancers with minimal lymph node metastasis risk (<1%).
- Endoscopic submucosal dissection is the recommended procedure due to its effective 'en bloc' resection and favorable short-term outcomes, while considerations for patients' physical and nutritional states are increasingly important.
- Data shows lower 5-year survival and significant post-operative mortality in older patients, prompting the need for less invasive treatment options and the development of tools to better assess lymph node metastasis risk.
In the FUGA-BT trial (JCOG1113), gemcitabine plus S-1 (GS) showed non-inferiority to gemcitabine plus cisplatin (GC) in overall survival (OS) with good tolerance for patients with advanced biliary tract cancer (BTC). We performed a subgroup analysis focused on the elderly cohort of this trial. All 354 enrolled patients in JCOG1113 were classify into two groups; < 75 (non-elderly) and ≥ 75 years (elderly) group.
View Article and Find Full Text PDFStudy protocol for JCOG1807C (DEEP OCEAN): a interventional prospective trial to evaluate the efficacy and safety of durvalumab before and after operation or durvalumab as maintenance therapy after chemoradiotherapy against superior sulcus non-small cell lung cancer.
Keiju Aokage
,
Masahiro Tsuboi
,
Yoshitaka Zenke
,
Hidehito Horinouchi
,
Naoki Nakamura
,
Tomoko Kataoka
Jpn J Clin Oncol
April 2022
Article Synopsis
- Superior sulcus tumors (SSTs) are challenging lung cancers, prompting a trial to assess a new treatment involving an immune-checkpoint inhibitor, durvalumab, after chemoradiotherapy (CRT) in patients with resectable SSTs.
- The trial focuses on measuring 3-year overall survival, with patients undergoing CRT followed by surgery and multiple courses of durvalumab.
- Initial safety assessments showed no significant issues, and patient enrollment is ongoing to further explore the treatment's efficacy and potential as a new standard care for SST.
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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