このスライドは会員限定コンテンツです。
今すぐアカウント登録（無料）して、続きを読みましょう！
1/14
関連するスライド
一問一答で学ぶER抗菌薬 〜困った時のMEPMからおさらば〜
ゆるふわ救急医
70750
328
抗真菌薬 - 総論と薬剤各論，侵襲性カンジダ症を中心としたメジャーな真菌症 -
高野哲史
75500
287
小児の血液培養 本数についての調べられる範囲で
坪井栄佑
3768
15
切除不能大腸癌に対するFTD/TPI+BEVの従来法と隔週法の実用的ランダム化第Ⅲ相試験における治療早期副作用の比較:PRABITAS試験初回報告
日本臨床腫瘍学会
654
0
投稿した先生からのメッセージ
消化器疾患の中でも、消化器がんは困っている患者さんが多く、未解決の課題も多い領域であり、大きなやりがいを感じたためです。
JSMOは最新の研究や臨床の知見を共有し議論を深められる貴重な場だと感じています。
概要
Early Safety Outcomes of Biweekly Versus Conventional FTD/TPI Plus Bevacizumab in Colorectal Cancer: PRABITAS Analysis
[Background]
PRABITAS is a pragmatic, randomized phase III trial comparing biweekly versus conventional trifluridine/tipiracil (FTD/TPI) + bevacizumab (BEV) in metastatic colorectal cancer. The pragmatic design minimizes eligibility restrictions and permits physician-directed initiation and dose modifications. This first report from PRABITAS focuses on early treatment-related adverse event (TRAE) profiles.
[Methods]
Baseline characteristics and TRAEs were assessed in patients treated with conventional FTD/TPI + BEV (Arm A: FTD/TPI on day 1-5 and 8-12 every 28 days) or biweekly FTD/TPI + BEV (Arm B: FTD/TPI on day 1-5 every 14 days). Eligibility was assessed based on typical explanatory trial criteria, and patients were categorized as eligible or ineligible. Safety analyses included Cycles 1-2 in Arm A and Cycles 1-4 in Arm B, with events graded by CTCAE v5.0.
[Results]
A total of 972 patients from 179 institutions were enrolled from December 2023 to May 2025. Baseline characteristics and initial FTD/TPI dose reductions were balanced. Overall, 15.3% were ineligible under the explanatory trial criteria, most commonly due to ECOG PS 2, organ dysfunction or comorbidities. Compared with Arm A, Arm B showed lower rates of grade ≥2 nausea (14.2% vs. 8.0%), diarrhea (7.0% vs. 1.7%), fatigue (19.7% vs. 10.9%), and grade ≥3 neutropenia (39.2% vs. 13.6%). Febrile neutro
本スライドの対象者
投稿された先生へ質問や勉強になったポイントをコメントしてみましょう！
0 件のコメント
日本臨床腫瘍学会さんの他の投稿スライド
CRAFITYスコア別にみた、肝細胞癌の一次治療としてのAtezo+Bev療法とレンバチニブ療法の比較:国際共同研究
日本臨床腫瘍学会
843
0
第23回日本臨床腫瘍学会学術集会 JSMO2026 注目プログラム紹介⑦
日本臨床腫瘍学会
879
3
腫瘍内科学、どこから学びますか？
日本臨床腫瘍学会
1,763
9
このスライドと同じ診療科のスライド
CRAFITYスコア別にみた、肝細胞癌の一次治療としてのAtezo+Bev療法とレンバチニブ療法の比較:国際共同研究
日本臨床腫瘍学会
843
0
POLE校正機能欠損大腸がんの臨床的・ゲノム学的特徴および予測モデル
日本臨床腫瘍学会
224
0
ここまで出来る！最新の制吐療法 in 2026 〈特別企画 WJOGが初学者に教える制吐療法 ②〉
松本光史
3,337
9
HER2DXを活用した高齢者HER2陽性早期乳癌における多遺伝子解析研究 (Trans-RESPECT)
日本臨床腫瘍学会
663
0
アクショナブルな遺伝子変異を有する非扁平上皮非小細胞肺癌に対するCGPの有用性の検討
日本臨床腫瘍学会
694
2
包括的ゲノム・空間解析による尿膜管がんの分子基盤と起源の解明
日本臨床腫瘍学会
261
0
テキスト全文
2026年度奨励賞受賞者の紹介とメッセージ
2026年度奨励賞受賞者 榊田 智喜 （愛知県がんセンター 薬物療法部） 受賞演題： Early Safety Outcomes of Biweekly Versus Conventional FTD/TPI Plus Bevacizumab in Colorectal Cancer: PRABITAS Analysis
受賞者からのメッセージ JSMOに入会した理由，腫瘍内科を選択した理由， JSMOや腫瘍内科の魅力 消化器疾患の中でも、消化器がんは困っている患者さんが多 く、未解決の課題も多い領域であり、大きなやりがいを感じ たためです。 JSMOは最新の研究や臨床の知見を共有し議論を深められる 貴重な場だと感じています。
2026年度奨励賞 受賞演題紹介
PRABITAS試験の背景とデザイン
ランダム化試験と実用的試験の違い
PRABITAS試験のベースライン特性と早期副作用
説明的臨床試験における適格性の評価
PRABITAS試験の主要なまとめと結論
Background ➢ Based on the results of the phase 3 SUNLIGHT trial 1), trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) is the standard treatment for refractory metastatic colorectal cancer (CRC) in later lines. ➢ FTD/TPI + BEV increases neutropenia compared with FTD/TPI alone. - Any grade: 62.2% vs. 51.2%, grade 3 or higher: 43.1% vs. 32.1%. ➢ Bi-weekly FTD/TPI + BEV (FTD/TPI: days 1-5, 14-day cycle) may reduce hematologic toxicity compared to the conventional schedule (FTD/TPI: days 1-5 and 8-12, 28-day cycle) without compromising efficacy 2-4). ➢ No randomized trial has directly compared these regimens. 1) Prager GW, et al. N Engl J Med. 2023 2) Satake H, et al. Oncologist. 2020 3) Matsuoka H, et al. Int J Clin Oncol. 2022 4) Satake H, et al. ASCO-GI 2024
PRABITAS Study Design A pragmatic, randomized phase III trial of bi-weekly versus conventional schedule of FTD/TPI plus bevacizumab for metastatic colorectal cancer (jRCTs041230120) Patients with metastatic CRC • • • Histologically confirmed adenocarcinoma of the colon or rectum Prior regimens including fluoropyrimidine, irinotecan, oxaliplatin anti-VEGF agents anti-EGFR antibody (RAS WT only) ECOG PS 0-2 Planned N=890 R 1:1 Stratification factors ECOG PS (0 vs. 1 vs. 2) RAS status (wild-type vs. mutant) facility Conventional FTD/TPI+BEV （Standard of care arm) FTD/TPI 35mg/m2 BID, days 1-5 and 8-12 BEV 5mg/kg IV, day 1 and 15 28-day cycle Bi-weekly FTD/TPI+BEV (Experimental arm) FTD/TPI 35mg/m2 BID, days 1-5 BEV 5mg/kg IV, day 1 14-day cycle Primary endpoints: Overall survival (non-inferiority) Sakakida T et al, ESMO Gastrointestinal Oncology 2024
Differences between Randomized Clinical Trials (RCTs) and Pragmatic Clinical Trials (PCTs) Pragmatic Explanatory Explanatory RCTs PCTs To determine causes and effects of treatment Goals To improve practice and inform clinical decisions Selected Participants Diverse, representative Limited (High-volume centers) Study sites Broad (various facilities) Strictly defined Evaluation methods Streamlined Highly protocolized Adherence to the intervention Flexible Califf RM, et al. Clin Trials. 2015;12:436-41. , NIH Collaboratory, Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Objectives ➢ This first report from PRABITAS evaluates the baseline characteristics and early treatment-related adverse events (TRAEs) Methods ➢ Baseline characteristics - Evaluated in the ITT population - Eligibility assessed based on explanatory trial criteria ➢ Early TRAEs - Evaluated in the Safety Analysis Full (SAF) population - Cycles 1–2 for conventional FTD/TPI + BEV - Cycles 1–4 for bi-weekly FTD/TPI + BEV - Grading based on CTCAE v5.0.
Methods - Assessment of Eligibility in Explanatory Clinical Trials ➢ Eligibility was assessed based on typical criteria from explanatory clinical trials - Patients categorized as eligible or ineligible. ➢ Early TRAEs analyzed between explanatory trial-eligible and -ineligible groups. Does the patient meet the following criteria? ECOG Performance Status = 2 Explanatory trial eligible group Neutrophil count < 1,200 /mm³ Hemoglobin < 8 g/dL Platelet count < 75,000 /µL AST or ALT ≥ 100 U/L (≥ 200 U/L with liver metastasis) Serum creatinine > 1.5 mg/dL Proteinuria (dipstick test ≤ 1+ or UPC ≤ 2) Presence of the Following Conditions Typically Considered Ineligible: • • • • • Active synchronous malignancy Psychiatric disorders or chronic steroids / immunosuppressants use Serious pulmonary or cardiac disease Brain or leptomeningeal metastasis Pleural effusion or ascites requiring drainage within 1 month No Yes Explanatory trial ineligible group
Baseline Characteristics Age, median (range) ≥ 75 years (%) Sex, (%) Male ECOG PS, (%) 0/1/2 Side of tumor, (%) Right / Left / Rectum Presence of primary lesion, (%) Sites of metastases, (%) Liver Lung Peritoneum Number of metastatic sites, (%) ≥3 RAS status, (%) Mutant BRAF status, (%) Mutant Conventional FTD/TPI+BEV Bi-weekly FTD/TPI+BEV N=486 68 (30-90) 25.1 N=484 68 (29-87) 24.8 60.1 54.5 55.3 / 41.6 /3.1 55.8 / 41.3 / 2.9 24.9 / 40.5 / 34.6 26.5 26.2 / 39.9 / 33.9 26.9 65.4 60.9 34.6 64.5 58.9 31.4 33.7 29.1 59.7 58.9 4.5 3.7
Early TRAEs Analysis was conducted on cases with available data. Conventional FTD/TPI+BEV N=473 Bi-weekly FTD/TPI+BEV N=476 All Grade (%) Grade ≥2 (%) Grade 3–4 (%) All Grade (%) Grade ≥2 (%) Grade 3–4 (%) Nausea 44.6 14.2 1.7 38.4 8.0 0.6 Vomiting 12.3 2.3 0.6 10.5 2.3 0.4 Diarrhea 24.9 7.0 1.7 19.3 1.7 0.2 Oral mucositis 14.2 3.4 0.2 17.9 3.8 0.4 Anorexia 53.5 19.7 3.6 46.6 10.9 1.9 Fatigue 44.4 11.0 1.9 46.8 10.7 1.7 Febrile Neutropenia 2.7 — 2.7 0.8 ー 0.8 Infection 6.8 5.5 1.3 6.3 5.3 1.7 Leukopenia 69.1 58.1 18.4 52.5 41.8 7.4 Neutropenia 79.1 63.6 39.1 66.0 42.9 13.7 Lower rates of grade ≥2 nausea (14.2% vs. 8.0%), diarrhea (7.0% vs. 1.7%), fatigue (19.7% vs. 10.9%), and grade ≥3 neutropenia (39.1% vs. 13.7%) in bi-weekly arm
Eligibility in Explanatory Clinical Trials Total N=970 ECOG Performance Status = 2 29 (3.0%) Neutrophil count < 1,200 /mm³ 33 (3.4%) Hemoglobin < 8 g/dL 9 (0.9%) Platelet count < 75,000 /µL 14 (1.4%) AST or ALT ≥ 100 U/L (≥ 200 U/L with liver metastasis) 6 (0.6%) Serum creatinine > 1.5 mg/dL 15 (1.5%) Proteinuria: Urine dipstick ≥2+ with UPC >2 12 (1.2%) Presence of the conditions typically considered ineligible 44 (4.5%) Meets any of the above criteria (Explanatory trial Ineligible) 149 (15.3%) Patients in this trial Ineligible 15.3% Eligible in explanatory trials 84.7%
Early TRAEs by Explanatory trial eligibility Analysis was conducted on cases with available data. Explanatory trial Eligible (N=806) Conventional FTD/TPI+BEV N=406 Bi-weekly FTD/TPI+BEV N=400 Absolute Difference Grade ≥2 (%) Grade 3–4 (%) Grade ≥2 (%) Grade 3–4 (%) Nausea 12.8 1.2 7.8 0.5 －5.0% Diarrhea 5.9 1.5 1.8 0.3 －4.1% Anorexia 18.7 3.2 11.0 1.8 －7.7% Neutropenia 62.8 38.2 42.3 13.0 －25.2% Explanatory trial Ineligible (N=143) Conventional FTD/TPI+BEV N=67 Bi-weekly FTD/TPI+BEV N=76 Absolute Difference Grade ≥2 (%) Grade 3–4 (%) Grade ≥2 (%) Grade 3–4 (%) Nausea 22.4 4.5 9.2 1.3 －13.2% Diarrhea 13.4 3.0 1.3 0 －12.1% Anorexia 25.4 6.0 10.5 2.6 －14.9% Neutropenia 68.7 44.8 46.1 17.1 －27.7%
Key Summary and Conclusions ➢ PRABITAS is a novel pragmatic phase 3 trial ➢ enrolled 972 patients from 179 sites in 17 months. ➢ 15.3% would have been ineligible for explanatory trials. ➢ In a direct randomized comparison, early safety outcomes showed: ➢ Bi-weekly FTD/TPI + BEV reduced neutropenia (≥G3) ➢ Reduced GI toxicities (≥G2), newly demonstrated in a head-to-head setting ➢ Greater benefit in patients who were not eligible for explanatory trials. ➢ The primary non-inferiority analysis of overall survival will be reported in 2026.
会員登録・ログインで「スライド内のテキスト」を参照いただけます。