Individual-patient-based data meta-analysis of randomized trials in gastric cancer

2018 Fiscal Year Annual Research Report

• Project/Area Number: 15H05661
• Research Institution: The University of Tokyo
• Principal Investigator: 大庭 幸治 東京大学, 大学院情報学環・学際情報学府, 准教授 (30422926)
• Project Period (FY): 2015-04-01 – 2019-03-31
• Keywords: 臨床疫学 / メタアナリシス / 生物統計学 / 臨床試験 / 代替エンドポイント / 悪性腫瘍

Outline of Annual Research Achievements

最終年度までに、GASTRIC（Global Advanced/Adjuvant Stomach Tumor Research through International Collaboration）2nd roundでは、過去に実施された17試験6843名の個人データを収集することができた。1st roundのデータと併せると、進行・再発胃がんを対象としたランダム化比較試験について、10,912名のデータを収集できたことになる。これは全世界の胃癌ランダム化比較試験に関するデータベースとして最大であり、ご協力いただいた研究者、被験者の方々に改めて感謝申し上げる。
更新された解析データを用いて、無増悪生存期間（Progression-free survival）の全生存期間（Overall survival）に対する代替エンドポイントとしての妥当性検証を行った。GASTRIC 2nd roundでは、2010年以後に報告されたRECIST(Response Evaluation Criteria in Solid Tumors)により客観的な腫瘍縮小の評価がなされた臨床試験のデータを利用し、メタアナリシスアプローチといわれる方法論に基づいて妥当性評価を行った。比例ハザード性の仮定が成り立たないことが明らかとなったため、log-logisticモデルを用いて、平均生存時間の比によって効果の関連性を評価した。その結果、これまでの全てのデータを用いた場合、試験レベルでの効果の相関が0.77（95%CI=0.32 to 1.00)、2nd Roundのみのデータに基づいた場合、その相関が0.93 (95%CI=0.70 to 1.00)に高まることが明らかとなった。以上より、PFSとOSには治療効果間の強い相関が確認され、代替エンドポイントとしての妥当性を確認することができた。

Research Progress Status

平成30年度が最終年度であるため、記入しない。

Strategy for Future Research Activity

平成30年度が最終年度であるため、記入しない。

Research Products

• [Int'l Joint Research] Institut Gustav Roussy/Institut Curie/CHU Robert Debre(フランス)
  • Country Name: FRANCE
  • Counterpart Institution: Institut Gustav Roussy/Institut Curie/CHU Robert Debre
• [Int'l Joint Research] Hasselt University/KU Leuven(ベルギー)
  • Country Name: BELGIUM
  • Counterpart Institution: Hasselt University/KU Leuven
• [Int'l Joint Research] Seoul National University(韓国)
  • Country Name: KOREA (REP. OF KOREA)
  • Counterpart Institution: Seoul National University
• [Int'l Joint Research] Johannes Gutenberg-University Clinic(ドイツ)
  • Country Name: GERMANY
  • Counterpart Institution: Johannes Gutenberg-University Clinic
• [Journal Article] Efficacy and Safety of Polaprezinc (Zinc Compound) on Zinc Deficiency: A Systematic Review and Dose-Response Meta-Analysis of Randomized Clinical Trials Using Individual Patient Data. (2020)
  • Author(s): Furihata K, Tsuchikawa M, Miwa T, Naito Y, Oba K, Sakagami M.
  • Journal Title: Nutrients Volume: 12 Pages: E1128
  • DOI: 10.3390/nu12041128
  • Peer Reviewed
• [Journal Article] Relationship Between the Waiting Times for Surgery and Survival in Patients with Gastric Cancer. (2020)
  • Author(s): Kumazu Y, Oba K, Hayashi T, Yamada T, Hara K, Osakabe H, Shimoda Y, Nakazono M, Nagasawa S, Rino Y, Masuda M, Ogata T, Yoshikawa T, Oshima T.
  • Journal Title: World J Surg Volume: 44 Pages: 1209-1215
  • DOI: 10.1007/s00268-020-05367-8
  • Peer Reviewed
• [Journal Article] Lymph node retrieval after colorectal cancer surgery: a comparative study of the efficacy between the conventional manual method and a new fat dissolution method. (2020)
  • Author(s): Fujieda Y, Maeda H, Oba K, Okamoto K, Fukudome I, Shiga M, Kawanishi Y, Akimori T, Kuroiwa H, Nishimoto H, Namikawa T, Murakami I, Kobayashi M, Hanazaki K.
  • Journal Title: Surg Today Volume: - Pages: -
  • DOI: 10.1007/s00595-019-01944-0
  • Peer Reviewed
• [Journal Article] Comprehensive Comparative Analysis of Prognostic Value of Systemic Inflammatory Biomarkers for Patients with Stage II/III Colon Cancer (2020)
  • Author(s): Suzuki S, Akiyoshi T, Oba K, Otsuka F, Tominaga T, Nagasaki T, Fukunaga Y, Ueno M
  • Journal Title: Ann Surg Oncol Volume: 27 Pages: 844-852
  • DOI: 10.1245/s10434-019-07904-9
  • Peer Reviewed
• [Journal Article] Association between polymorphisms in EGFR and tumor response during cetuximab and oxaliplatin-based combination therapy in metastatic colorectal cancer: Analysis of data from two clinical trials (2019)
  • Author(s): Maeda H, Hazama S, Iwamoto S, Oba K, Tsunedomi R, Okayama N, Suehiro Y, Yamasaki T, Nakagami Y, Suzuki N, Nagano H, Sakamoto J, Mishima H, Nagata N.
  • Journal Title: Oncol Lett Volume: 18 Pages: 4555-4562
  • DOI: 10.3892/ol.2019.10787
  • Peer Reviewed
• [Journal Article] JOIN trial: treatment outcome and recovery status of peripheral sensory neuropathy during a 3-year follow-up in patients receiving modified FOLFOX6 as adjuvant treatment for stage II/III colon cancer (2019)
  • Author(s): Yoshino T, Kotaka M, Shinozaki K, Touyama T, Manaka D, Matsui T, Ishigure K, Hasegawa J, Inoue K, Munemoto Y, Takagane A, Ishikawa H, Ishida H, Ogata Y, Oba K, Goto K, Sakamoto J, Maehara Y, Ohtsu A.
  • Journal Title: Cancer Chemother Pharmacol Volume: 84 Pages: 1269-1277
  • DOI: 10.1007/s00280-019-03957-5
  • Peer Reviewed
• [Journal Article] SAPPHIRE: a randomised phase II study of planned discontinuation or continuous treatment of oxaliplatin after six cycles of modified FOLFOX6 plus panitumumab in patients with colorectal cancer. (2019)
  • Author(s): Munemoto Y, Nakamura M, Takahashi M, Kotaka M, Kuroda H, Kato T, Minagawa N, Noura S, Fukunaga M, Kuramochi H, Touyama T, Takahashi T, Miwa K, Satake H, Kurosawa S, Miura T, Mishima H, Sakamoto J, Oba K, Nagata N.
  • Journal Title: Eur J Cancer Volume: 119 Pages: 158-167
  • DOI: 10.1016/j.ejca.2019.07.006
  • Peer Reviewed
• [Journal Article] Prognostic impact of residual lateral lymph node metastasis after neoadjuvant (chemo)radiotherapy in patients with advanced low rectal cancer (2019)
  • Author(s): Akiyoshi T, Toda S, Tominaga T, Oba K, Tomizawa K, Hanaoka Y, Nagasaki T, Konishi T, Matoba S, Fukunaga Y, Ueno M, Kuroyanagi H.
  • Journal Title: BJS Open Volume: 3 Pages: 822-829
  • DOI: 10.1002/bjs5.50194
  • Peer Reviewed / Open Access
• [Journal Article] Detection of atypical data in multicenter clinical trials using unsupervised statistical monitoring. (2019)
  • Author(s): Trotta L, Kabeya Y, Buyse M, Doffagne E, Venet D, Desmet L, Burzykowski T, Tsuburaya A, Yoshida K, Miyashita Y, Morita S, Sakamoto J, Praveen P, Oba K.
  • Journal Title: Clin Trials Volume: 16 Pages: 512-522
  • DOI: 10.1177/1740774519862564
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Development and Validation of a Prediction Model for Organ-Specific Recurrences After Curative Resection of Colon Cancer (2019)
  • Author(s): Nagata H, Ishihara S, Oba K, Tanaka T, Hata K, Kawai K, Nozawa H
  • Journal Title: Dis Colon Rectum. Volume: 62 Pages: 1043-1054
  • DOI: 10.1097/DCR.0000000000001430
  • Peer Reviewed
• [Journal Article] One-Day Versus Three-Day Dexamethasone in Combination with Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Individual Patient Data-Based Meta-Analysis. (2019)
  • Author(s): Okada Y, Oba K, Furukawa N, Kosaka Y, Okita K, Yuki S, Komatsu Y, Celio L, Aapro M.
  • Journal Title: Oncologist Volume: 24 Pages: 1593-1600
  • DOI: 10.1634/theoncologist.2019-0133
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Immunogenomic profiles associated with response to neoadjuvant chemoradiotherapy in patients with rectal cancer (2019)
  • Author(s): Akiyoshi T, Tanaka N, Kiyotani K, Gotoh O, Yamamoto N, Oba K, Fukunaga Y, Ueno M, Mori S.
  • Journal Title: Br J Surg Volume: 106 Pages: 1381-1392
  • DOI: 10.1002/bjs.11179
  • Peer Reviewed
• [Journal Article] Biweekly S-1 plus oxaliplatin (SOX) reintroduction in previously treated metastatic colorectal cancer patients (ORION 2 study): a phase II study to evaluate the efficacy and safety (2019)
  • Author(s): Tanioka H, Honda M, Tanaka C, Morita Y, Ishibashi K, Kato T, Matsuda C, Kataoka M, Satake H, Munemoto Y, Kobayashi K, Takahashi M, Nakata K, Sakamoto J, Oba K, Mishima H
  • Journal Title: Int J Clin Oncol Volume: 24 Pages: 836-841
  • DOI: 10.1007/s10147-019-01414-0
  • Peer Reviewed
• [Journal Article] A multicenter single-arm Phase II clinical trial of second-line FOLFIRI plus panitumumab after first-line treatment with FOLFOX plus panitumumab for initial RAS wild-type colorectal cancer with evaluation of circulating tumor DNA: A protocol study (2019)
  • Author(s): Maeda H, Nagata N, Nagasaka T, Oba K, Mishima H, Kato T, Yoshida K, Muro K, Sakamoto J
  • Journal Title: Oncol Lett Volume: 17 Pages: 1980-1985
  • DOI: 10.3892/ol.2018.9763
  • Peer Reviewed
• [Journal Article] Efficacy of CapeOX plus Cetuximab Treatment as a First-Line Therapy for Patients with Extended RAS/BRAF/PIK3CA Wild-Type Advanced or Metastatic Colorectal Cancer. (2018)
  • Author(s): Iwamoto S, Maeda H, Hazama S, Oba K, Okayama N, Suehiro Y, Yamasaki T, Suzuki N, Nagano H, Sakamoto J, Mishima H, Nagata N
  • Journal Title: J Cancer Volume: 18 Pages: 4092-4098
  • DOI: 10.7150/jca.26840
  • Peer Reviewed
• [Journal Article] A randomized phase III study of hepatic arterial infusion chemotherapy with 5-fluorouracil and subsequent systemic chemotherapy versus systemic chemotherapy alone for colorectal cancer patients with curatively resected liver metastases (Japanese Foundation for Multidisciplinary Treatment of Cancer 32) (2018)
  • Author(s): Kusano M, Aoyama T, Okabayashi K, Hirata K, Tsuji Y, Nakamori S, Asahara T, Ohashi Y, Yoshikawa T, Sakamoto J, Oba K, Saji S
  • Journal Title: J Cancer Res Ther Volume: 14 Pages: S761-S766
  • DOI: 10.4103/0973-1482.179188
  • Peer Reviewed
• [Journal Article] A phase II study of bevacizumab and irinotecan plus alternate-day S-1 as a second-line therapy in patients with metastatic colorectal cancer: the AIRS study. (2018)
  • Author(s): Matsuda C, Honda M, Tanaka C, Kondo K, Takahashi T, Kosugi C, Tokunaga Y, Takemoto H, Kim HM, Sakamoto J, Oba K, Mishima H
  • Journal Title: Cancer Chemother Pharmacol Volume: 81 Pages: 1035-1041
  • DOI: 10.1007/s00280-018-3568-x
  • Peer Reviewed
• [Journal Article] Development and Validation of a Prediction Model for Postoperative Peritoneal Metastasis After Curative Resection of Colon Cancer. (2018)
  • Author(s): Nagata H, Ishihara S, Oba K, Tanaka T, Hata K, Kawai K, Nozawa H.
  • Journal Title: Ann Surg Oncol Volume: 25 Pages: 1366-1373
  • DOI: 10.1245/s10434-018-6403-z
  • Peer Reviewed
• [Journal Article] A phase II trial to evaluate the efficacy of panitumumab combined with fluorouracil-based chemotherapy for metastatic colorectal cancer: the PF trial (2018)
  • Author(s): Munemoto Y, Kanda M, Oba K, Kim HM, Takemoto H, Denda T, Nagata N, Takano N, Fukunaga M, Kataoka M, Tokunaga Y, Sakamoto J, Mishima H
  • Journal Title: Cancer Chemother Pharmacol Volume: 81 Pages: 829-838
  • DOI: 10.1007/s00280-018-3556-1
  • Peer Reviewed
• [Journal Article] Treatment using oxaliplatin and S-1 adjuvant chemotherapy for pathological stage III gastric cancer: a multicenter phase II study (TOSA trial) protocol (2018)
  • Author(s): Namikawa T, Maeda H, Kitagawa H, Oba K, Tsuji A, Yoshikawa T, Kobayashi M, Hanazaki K
  • Journal Title: BMC Cancer Volume: 18 Pages: 186
  • DOI: 10.1186/s12885-018-4109-z
  • Peer Reviewed / Open Access
• [Journal Article] Lymph node retrieval after dissolution of surrounding adipose tissue for pathological examination of colorectal cancer. (2018)
  • Author(s): Maeda H, Okamoto K, Oba K, Shiga M, Fujieda Y, Namikawa T, Hiroi M, Murakami I, Hanazaki K, Kobayashi M
  • Journal Title: Oncol Lett Volume: 15 Pages: 2495-2500
  • DOI: 10.3892/ol.2017.7629
  • Peer Reviewed
• [Journal Article] Meta-analysis of randomized clinical trials in the era of individual patient data sharing. (2018)
  • Author(s): Kawahara T, Fukuda M, Oba K, Sakamoto J, Buyse M.
  • Journal Title: Int J Clin Oncol Volume: 23 Pages: 403-409
  • DOI: 10.1007/s10147-018-1237-z
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Pattern of programmed cell death-ligand 1 expression and CD8-positive T-cell infiltration before and after chemoradiotherapy in rectal cancer. (2018)
  • Author(s): Ogura A, Akiyoshi T, Yamamoto N, Kawachi H, Ishikawa Y, Mori S, Oba K, Nagino M, Fukunaga Y, Ueno M
  • Journal Title: Eur J Cancer Volume: 91 Pages: 11-20
  • DOI: 10.1016/j.ejca.2017.12.005
  • Peer Reviewed
• [Journal Article] Risk factors for peritoneal recurrence in stage II-III colon cancer (2018)
  • Author(s): Mayanagi S, Kashiwabara K, Honda M, Oba K, Aoyama T, Kanda M, Maeda H, Hamada C, Sadahiro S, Sakamoto J, Saji S, Yoshikawa T
  • Journal Title: Dis Colon Rectum Volume: 61 Pages: 803-808
  • DOI: 10.1097/DCR.0000000000001002
  • Peer Reviewed
• [Journal Article] Clinical Signatures of Mucinous and Poorly Differentiated Subtypes of Colorectal Adenocarcinomas by a Propensity Score Analysis of an Independent Patient Database from Three Phase III Trials. (2018)
  • Author(s): Kanda M, Oba K, Aoyama T, Kashiwabara K, Mayanagi S, Maeda H, Honda M, Hamada C, Sadahiro S, Sakamoto J, Saji S, Yoshikawa T.
  • Journal Title: Dis Colon Rectum Volume: 61 Pages: 461-471
  • DOI: 10.1097/DCR.0000000000001022
  • Peer Reviewed
• [Presentation] Progression-free survival (PFS) as a surrogate endpoint for overall survival (OS) in advanced/recurrent gastric cancer (AGC) treatment: Individual-patient-data (IPD) based meta-analysis of randomized trials. (2020)
  • Author(s): Oba K, Paoletti X, Bang YJ, Michiels S, Moehler M, Morita S, Ohashi Y, Bouche; O, Sakamoto J, Sasako M, Shitara K, VanCutsem E, Buyse M, Burzykowski T, and the GASTRIC
  • Organizer: 2020 ASCO Annual Meeting
  • Int'l Joint Research
• [Book] Sample Size Calculations for Phase III Trials in Oncology. In: Halabi S, Michiels S (Eds.) Textbook of Clinical Trials in Oncology: A Statistical Perspective (2019)
  • Author(s): Oba K, Kuchiba A
  • Total Pages: 626
  • Publisher: CRC Press
  • ISBN: 9781138083776
• [Remarks] The GASTRIC
  • URL: https://gastricproject.org/