2008年からの転移性乳がんの治療ケアの進化 (ESME-MBC)
疫学戦略と医療経済 (ESME) 研究プログラム / 学術的実世界データ プラットフォーム: 2008 年からのフランスの総合がんセンターにおける転移性乳がんの治療ケアの進化
調査の概要
状態
条件
詳細な説明
このデータベースは、患者の電子医療記録 (EMR)、入院患者の入院記録、薬局記録からのデータを編集します。
患者データベース: 患者関連のデータは、患者の医療記録や複数分野のチーム ミーティングのレポートなど、構造化されていないソース (電子医療記録) からのデータを統合します。 患者の人口統計、原始腫瘍、再発、病理レポート、転移性疾患、治療ケア/設定、該当する場合は中止の理由、および臨床イベントに関する情報を提供できます。
治療データベース: 薬局記録関連データは、各フランス総合がんセンター (FCCC) 内の薬局によって処方および調剤される医薬品、特に化学療法と共同処方箋に関するすべてのデータを含む構造化データベースです。 センター外で処方されたり、配送されたりする製品に関する情報は含まれていません。 各センターの薬局データベースから、全身の治療パターン (日付、剤形、治療プロトコルなど) に関する情報を取得できます。
入院データベース: 入院関連データは、FCCC の入院に関連して報告されたすべての医療データを含む構造化された体系的なデータベースであり、フランス国民健康保険基金 (Assurance Maladie) への請求に使用されます。 患者の入院日と退院日、および放射線療法や手術を含む、実施された診断および治療手順に関する情報を提供します。
最終的なデータベースにインポートされたデータは、データ管理計画に従って、インポート前に管理、再コード化、および調整されます。 すべてのコーディング手順は、データ マネージャーによって事前に定義されています。 個人データの送信はありません。すべてのデータは、共有の匿名形式を使用して各センター内で一元化されます。 すべてのデータは遡及的にのみ取得されます。医療提供者または患者に連絡して、患者の医療記録から利用できないデータを回復しようとする試みは行われません。
ESME MBC データ プラットフォームは、FCCC で使用されるさまざまなソースからの既存のデータと利用可能なデータを一元化する臨床および治療データベースを目指しています。
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Mathieu Robain, MD, PhD
- メール:m-robain@unicancer.fr
研究連絡先のバックアップ
- 名前:Lise Bosquet, MsC
- メール:l-bosquet@unicancer.fr
研究場所
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Angers、フランス、49933
- 募集
- Institut de Cancérologie de l'Ouest - Paul Papin
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コンタクト:
- Geneviève PERROCHEAU
- 電話番号:+33 2 40 67 99 77
- メール:genevieve.perrocheau@ico.unicancer.fr
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コンタクト:
- Loïc CAMPION
- メール:loic.campion@ico.unicancer.fr
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Bordeaux、フランス、33076
- 募集
- Institut Bergonié
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コンタクト:
- Anne JAFFRE
- 電話番号:+33 5 56 33 78 48
- メール:a.jaffre@bordeaux.unicancer.fr
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Caen、フランス、14076
- 募集
- Centre François Baclesse
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コンタクト:
- Anne-Valérie GUIZARD
- 電話番号:+33 2 31 45 52 45
- メール:av.guizard@baclesse.unicancer.fr
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Clermont-Ferrand、フランス、63011
- 募集
- Centre Jean Perrin
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コンタクト:
- Marie-Ange MOURET-REYNIER
- 電話番号:+33 4 73 27 81 37
- メール:marie-ange.mouret-reynier@clermont.unicancer.fr
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Dijon、フランス、21079
- 募集
- Centre Georges-Francois Leclerc
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コンタクト:
- Sandrine DABAYUKO
- 電話番号:+33 45 34 80 67
- メール:SDabakuyo@cgfl.fr
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Lille、フランス、59020
- 募集
- Centre Oscar Lambret
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コンタクト:
- Marie-paule LEBITASY
- 電話番号:+33 3 20 29 55 60
- メール:m-lebitasy@o-lambret.fr
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Lyon、フランス、69373
- 募集
- Centre léon bérard
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コンタクト:
- Thomas BACHELOT
- 電話番号:+33 4 78 78 26 54
- メール:thomas.bachelot@lyon.unicancer.fr
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Marseille、フランス、13273
- 募集
- Institut Paoli-Calmettes
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コンタクト:
- Lilian LABORDE
- 電話番号:+33 4 91 22 35 10
- メール:LABORDEL@ipc.unicancer.fr
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Montpellier、フランス、34298
- 募集
- Institut régional du Cancer Montpellier / Val d'Aurelle
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コンタクト:
- Stéphanie DELAINE
- 電話番号:+33 4 67 61 47 39
- メール:Stephanie.delaine@icm.unicancer.fr
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Nancy、フランス
- 募集
- Institut de Cancerologie de Lorraine
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コンタクト:
- Carine LAURENT
- 電話番号:+33 3 83 59 83 32
- メール:c.laurent@nancy.unicancer.fr
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Nantes、フランス、44805
- 募集
- Institut de cancérologie de l'Ouest - René Gauducheau
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コンタクト:
- Geneviève PERROCHEAU
- 電話番号:+33 2 40 67 99 77
- メール:genevieve.perrocheau@ico.unicancer.fr
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コンタクト:
- Loïc CAMPION
- メール:loic.campion@ico.unicancer.fr
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Nice、フランス、06189
- 募集
- Centre Antoine Lacassagne
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コンタクト:
- Emmanuel CHAMOREY
- 電話番号:+33 4 92 03 15 29
- メール:emmanuel.chamorey@nice.unicancer.fr
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Paris、フランス、75005
- 募集
- Institut Curie
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コンタクト:
- Etienne BRAIN
- メール:etienne.brain@curie.fr
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Reims、フランス、51056
- 募集
- Institut Jean Godinot
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コンタクト:
- Damien PARENT
- 電話番号:+33 3 26 50 42 76
- メール:damien.parent@reims.unicancer.fr
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Rennes、フランス、35042
- 募集
- Centre Eugène Marquis
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コンタクト:
- Mathias BRETON
- 電話番号:+33 2 99 25 32 67
- メール:m.breton@rennes.unicancer.fr
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Rouen、フランス、76038
- 募集
- Centre Henri Becquerel
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コンタクト:
- Agnès LOEB
- 電話番号:+33 2 32 08 22 80
- メール:agnes.loeb@chb.unicancer.fr
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Saint-Cloud、フランス、92210
- 募集
- Institut Curie - Hôpital René Huguenin
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コンタクト:
- Etienne BRAIN
- 電話番号:+33 1 47 11 15 15
- メール:etienne.brain@curie.fr
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Strasbourg、フランス、67065
- 募集
- Centre Paul Strauss
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コンタクト:
- Michel VELTEN
- 電話番号:+33 3 88 25 24 53
- メール:mvelten@strasbourg.unicancer.fr
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Toulouse、フランス、31059
- 募集
- Institut Claudius Regaud
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コンタクト:
- Delphine BERCHERY
- 電話番号:05 31 15 50 60
- メール:Berchery.Delphine@iuct-oncopole.fr
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Villejuif、フランス、94805
- 募集
- Institut Gustave Roussy
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コンタクト:
- Valérie DEJEAN
- 電話番号:+33 1 42 11 46 49
- メール:valerie.dejean@gustaveroussy.fr
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
包含基準 :
- 18歳の患者
- フランスの総合がんセンターで化学療法、標的療法、免疫療法、放射線療法、ホルモン療法を受けている患者。
除外基準:なし
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:回顧
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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治療ケアの進化について説明する
時間枠:ベースライン
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患者の特徴、腫瘍の特徴および治療パターン
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ベースライン
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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生存基準に対する治療戦略の影響について説明する
時間枠:診断または最初の治療の日から、何らかの原因で死亡した日まで。 2023年までフォローアップします。
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全生存
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診断または最初の治療の日から、何らかの原因で死亡した日まで。 2023年までフォローアップします。
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生存基準に対する治療戦略の影響について説明する
時間枠:診断または最初の治療の日から、最初に記録された進行の日または何らかの原因による死亡の日まで。 2023年までフォローアップします。
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無増悪生存期間
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診断または最初の治療の日から、最初に記録された進行の日または何らかの原因による死亡の日まで。 2023年までフォローアップします。
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協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター:Lise Bosquet, MsC、UNICANCER
出版物と役立つリンク
一般刊行物
- Gobbini E, Ezzalfani M, Dieras V, Bachelot T, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Cleaud AL, Robain M, Courtinard C, Cailliot C, Perol D, Delaloge S. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer. 2018 Jun;96:17-24. doi: 10.1016/j.ejca.2018.03.015. Epub 2018 Apr 13.
- Delaloge S, Perol D, Courtinard C, Brain E, Asselain B, Bachelot T, Debled M, Dieras V, Campone M, Levy C, Jacot W, Lorgis V, Veyret C, Dalenc F, Ferrero JM, Uwer L, Kerbrat P, Goncalves A, Mouret-Reynier MA, Petit T, Jouannaud C, Vanlemmens L, Chenuc G, Guesmia T, Robain M, Cailliot C. Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study. Ann Oncol. 2016 Sep;27(9):1725-32. doi: 10.1093/annonc/mdw260. Epub 2016 Jul 19.
- Jacquet E, Lardy-Cleaud A, Pistilli B, Franck S, Cottu P, Delaloge S, Debled M, Vanlemmens L, Leheurteur M, Guizard AV, Laborde L, Uwer L, Jacot W, Berchery D, Desmoulins I, Ferrero JM, Perrocheau G, Courtinard C, Brain E, Chabaud S, Robain M, Bachelot T. Endocrine therapy or chemotherapy as first-line therapy in hormone receptor-positive HER2-negative metastatic breast cancer patients. Eur J Cancer. 2018 May;95:93-101. doi: 10.1016/j.ejca.2018.03.013. Epub 2018 Apr 11.
- Cabel L, Carton M, Cheaib B, Pierga JY, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Desmoulins I, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Perrocheau G, Piot I, Perol D, Simon G, Lerebours F. Oral etoposide in heavily pre-treated metastatic breast cancer: results from the ESME cohort and comparison with other chemotherapy regimens. Breast Cancer Res Treat. 2019 Jan;173(2):397-406. doi: 10.1007/s10549-018-5017-2. Epub 2018 Oct 24.
- Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Mazouni C, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, de La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Robain M, Filleron T, Cailliot C, Dalenc F. Survival Impact of Locoregional Treatment of the Primary Tumor in De Novo Metastatic Breast Cancers in a Large Multicentric Cohort Study: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2019 Feb;26(2):356-365. doi: 10.1245/s10434-018-6831-9. Epub 2018 Dec 11.
- Delaloge S, Perol D, Robain M, Cailliot C. Reply to 'The potential and perils of observational studies' by M. Buyse et al. Ann Oncol. 2017 Feb 1;28(2):436-437. doi: 10.1093/annonc/mdw572. No abstract available.
- Perol D, Robain M, Delaloge S, Cailliot C. Routinely collected data may usefully supplement randomised controlled data on treatment effects for mortality. BMJ. 2016 Dec 16;355:i6745. doi: 10.1136/bmj.i6745. No abstract available.
- Petitjean A, Smith-Palmer J, Valentine W, Tehard B, Roze S. Cost-effectiveness of bevacizumab plus paclitaxel versus paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in specialist oncology centers in France. BMC Cancer. 2019 Feb 11;19(1):140. doi: 10.1186/s12885-019-5335-8.
- Perol D, Robain M, Arveux P, Mathoulin-Pelissier S, Chamorey E, Asselain B, Berchery D, Gourgou S, Breton M, Delaine-Clisant S, Mons M, Dieras V, Carton M, Guizard AV, Laborde L, Laurent C, Loeb A, Mouret-Reynier MA, Parent D, Perrocheau G, Campion L, Velten M, Cailliot C, Ezzalfani M, Simon G. The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME). BMJ Open. 2019 Feb 21;9(2):e023568. doi: 10.1136/bmjopen-2018-023568.
- Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20.
- Le Saux O, Lardy-Cleaud A, Frank S, Debled M, Cottu PH, Pistilli B, Vanlemmens L, Leheurteur M, Levy C, Laborde L, Uwer L, D'hondt V, Berchery D, Lorgis V, Ferrero JM, Perrocheau G, Courtinard C, Mouret-Reynier MA, Velten M, Breton M, Parent D, Chabaud S, Robain M, Bachelot T. Assessment of the efficacy of successive endocrine therapies in hormone receptor-positive and HER2-negative metastatic breast cancer: a real-life multicentre national study. Eur J Cancer. 2019 Sep;118:131-141. doi: 10.1016/j.ejca.2019.06.014. Epub 2019 Jul 19.
- Gougis P, Carton M, Tchokothe C, Campone M, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Bachelot T, Hennequin A, Perrin C, Goncalves A, Uwer L, Eymard JC, Petit T, Mouret-Reynier MA, Chamorey E, Simon G, Saghatchian M, Cailliot C, Le Tourneau C. CineBreast-factors influencing the time to first metastatic recurrence in breast cancer: Analysis of real-life data from the French ESME MBC database. Breast. 2020 Feb;49:17-24. doi: 10.1016/j.breast.2019.10.004. Epub 2019 Oct 19.
- Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Delaloge S, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Chevrot M, Pasquier D, Bachelot T. Impact of breast cancer molecular subtypes on the incidence, kinetics and prognosis of central nervous system metastases in a large multicentre real-life cohort. Br J Cancer. 2019 Dec;121(12):991-1000. doi: 10.1038/s41416-019-0619-y. Epub 2019 Nov 13.
- Pasquier D, Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Petit A, Mouret-Reynier MA, Goncalves A, Dalenc F, Deluche E, Fresnel JS, Augereau P, Ferrero JM, Geffrelot J, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Mouttet-Audouard R, Bachelot T, Courtinard C. Treatment and outcomes in patients with central nervous system metastases from breast cancer in the real-life ESME MBC cohort. Eur J Cancer. 2020 Jan;125:22-30. doi: 10.1016/j.ejca.2019.11.001. Epub 2019 Dec 10.
- Deluche E, Antoine A, Bachelot T, Lardy-Cleaud A, Dieras V, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Courtinard C, Perol D, Robain M, Delaloge S. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008-2016. Eur J Cancer. 2020 Apr;129:60-70. doi: 10.1016/j.ejca.2020.01.016. Epub 2020 Mar 2.
- Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Rivera S, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, De La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Courtinard C, Filleron T, Robain M, Dalenc F. Radiation therapy to the primary tumor for de novo metastatic breast cancer and overall survival in a retrospective multicenter cohort analysis. Radiother Oncol. 2020 Apr;145:109-116. doi: 10.1016/j.radonc.2019.12.019. Epub 2020 Jan 10.
- Heudel P, Delaloge S, Parent D, Madranges N, Levy C, Dalenc F, Brain E, Uwer L, D'Hondt V, Augereau P, Mailliez A, Perrin C, Frenel JS, Sablin MP, Mouret-Reynier MA, Vermeulin T, Eymard JC, Petit T, Ferrero JM, Ilie S, Goncalves A, Chenuc G, Robain M, Simon G, Perol D. Real-world Evaluation of Oral Vinorelbine in the Treatment of Metastatic Breast Cancer: An ESME-MBC Study. Anticancer Res. 2020 Jul;40(7):3905-3913. doi: 10.21873/anticanres.14381.
- Frasca M, Sabathe C, Delaloge S, Galvin A, Patsouris A, Levy C, Mouret-Reynier MA, Desmoulins I, Vanlemmens L, Bachelot T, Goncalves A, Perotin V, Uwer L, Frenel JS, Ferrero JM, Bouleuc C, Eymard JC, Dieras V, Leheurteur M, Petit T, Dalenc F, Jaffre A, Chevrot M, Courtinard C, Mathoulin-Pelissier S. Palliative care delivery according to age in 12,000 women with metastatic breast cancer: Analysis in the multicentre ESME-MBC cohort 2008-2016. Eur J Cancer. 2020 Sep;137:240-249. doi: 10.1016/j.ejca.2020.07.007. Epub 2020 Aug 14.
- Frank S, Carton M, Dubot C, Campone M, Pistilli B, Dalenc F, Mailliez A, Levy C, D'Hondt V, Debled M, Vermeulin T, Coudert B, Perrin C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Patsouris A, Guesmia T, Bachelot T, Robain M, Cottu P. Impact of age at diagnosis of metastatic breast cancer on overall survival in the real-life ESME metastatic breast cancer cohort. Breast. 2020 Aug;52:50-57. doi: 10.1016/j.breast.2020.04.009. Epub 2020 Apr 23.
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- Sirieix J, Fraisse J, Mathoulin-Pelissier S, Leheurteur M, Vanlemmens L, Jouannaud C, Dieras V, Levy C, Ung M, Mouret-Reynier MA, Petit T, Coudert B, Brain E, Pistilli B, Ferrero JM, Goncalves A, Uwer L, Patsouris A, Tredan O, Courtinard C, Gourgou S, Frenel JS. Management and outcome of male metastatic breast cancer in the national multicenter observational research program Epidemiological Strategy and Medical Economics (ESME). Ther Adv Med Oncol. 2020 Dec 23;12:1758835920980548. doi: 10.1177/1758835920980548. eCollection 2020.
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転移性乳がんの臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
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