Postoperative surveillance protocol for patients with localized and locally advanced renal cell carcinoma based on validated prognotic nomogram and risk group stratification system
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1 弘前大学医学部泌尿器科学教室 腎癌術後フォローアップ プロトコール Since 参考文献 Postoperative surveillance protocol for patients with localized and locally advanced renal cell carcinoma based on validated prognotic nomogram and risk group stratification system Lam JS, Shvarts O, Leppert JT, Pantuck AJ, Figlin RA, Belldegrun AS. J Urol , 2005 Division of Urologic Oncology, the Department of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California 90095, USA. 1
2 Hirosaki Risk Group Assignment pn stage pn0 O or 1 pt stage pt1 pt2-4 pn1 Grade : G1-2 G3 G1-3 N+ Group Low Risk High Risk 2
3 術後フォローアップ スケジュール 3M 6M 1y 1.5y 2y 2.5y 3y 3.5y 4y 4.5y 5y 7y 9y Low High N+ 項目 : 末梢血 血沈 生化学 ( 肝胆道系 腎機能 電解質 CRP) 定期検査ごとに問診と身体所見を確認する 3
4 Hirosaki Risk Group Assignment について なるべくカンタンに 誰でもわかるように を目標に術後フォローアップのプロトコールを作成した 以下に示すように 519 例の検討による Evidence を元に作成している 原著では Low Intermediate High に分けているが Intermediate と High は予後不良群と考えられるため カテゴリーの単純化も含め High にまとめた PS も議論となるが 簡便化のため今回のプロトコールからは外した ただ のちの解析に必要となる場合もあるため 退院サマリーには記載する 4
5 Appendix : Original Literature Postoperative surveillance protocol for patients with localized and locally advanced renal cell carcinoma based on validated prognotic nomogram and risk group stratification system Lam JS, Shvarts O, Leppert JT, Pantuck AJ, Figlin RA, Belldegrun AS. J Urol , 2005 Division of Urologic Oncology, the Department of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California 90095, USA. PURPOSE: We created an evidence based postoperative surveillance protocol for patients with localized and locally advanced renal cell carcinoma (RCC) based on a risk group stratification system. MATERIALS AND METHODS: 559 patients undergoing surgery for localized and ocally advanced RCC were stratified into low risk (LR), intermediate risk (IR) and high risk (HR) groups based on the University of California-Los Angeles Integrated Staging System (UISS). Tumor recurrences were identified and categorized according to time and location. RESULTS: Patients with localized disease had a lower 5-year recurrence rate than patients with locally advanced (nodal) disease (27.6% vs 64%, p <0.0001). Patients in the LR, IR, and HR groups following nephrectomy demonstrated 5-year recurrence-free rates of 90.4%, 61.8%, and 41.9%, respectively (p <0.0001), and median times to recurrence of 28.9, 17.8 and 9.5 months, respectively (p <0.0001). Chest and abdomen recurrences comprised of 75% and 37.5%, 77.4% and 58.1%, and 45.2% and 67.7% of recurrences in the LR, IR and HR groups, respectively. In patients with node positive disease, chest and abdomen comprised of 58.8% and 76.5% of recurrences, respectively. Patients undergoing partial nephrectomy did not demonstrate a greater rate of local or distant recurrence compared with patients undergoing radical nephrectomy. CONCLUSIONS: Significant differences in incidence and time to recurrence following surgical resection for RCC mandates unique surveillance protocols for patients in each of the UISS risk groups. LR group patients should be followed for at least 5 years, whereas IR and HR group patients require longer surveillance. HR group patients require more stringent abdominal surveillance, whereas LR group patients should emphasize the chest. Patients with nodal disease also require stringent followup. Patients undergoing partial nephrectomy for 5 localized disease can be followed according to the same UISS risk group based protocol.
6 UISS Risk Group Assignment N1 N stage O or 1 Nodule Disease N0 T stage T1 T2 T3 T4 Grade : G1-2 G3-4 G1-4 G1 G>1 G1-4 ECOG:PS : PS0 PS>0 PS0-3 PS0 PS>0 PS0-3 Lam JS., et al. J Urol 174. Low Risk Intermediate Risk High Risk 6
7 ECOG: Performance Status Grade 一般状態 0 無症状で社会活動ができ 制限を受けることなく 発病前と同等にふるまえる 1 軽度の症状があり 肉体労働は制限を受けるが 歩行 軽労働や坐業はできる ( 軽い家事 事務など ) 2 歩行や身の回りのことはできるが 時に少し介助がいることもある 軽労働はできないが 日中の 50% は起居している 3 身の回りのある程度のことはできるが しばしば介助がいり 日中の 5 0% は就床している 4 身の回りのこともできず 常に介助がいり 終日就床を必要としている 7
8 患者背景 年齢中央値 : 61 歳 (23-93 歳 ) Follow up 中央値 :26M N0: 519 例 N1 :40 例 限局癌 365/519 例 (70%) 局所進行性癌が 154 /519 例 (30%) 5 年遠隔再発率 限局癌 27.6% 局所進行性癌 64% 有意差あり (p<0.0001) グループ別人数構成 LR 196 例 (37.8%) IR251 例 (48.4%) HR72 例 (13.9%) 8 Lam JS., et al. J Urol 174.
9 Recurrence Free Survival Lam JS., et al. J Urol
10 Result Row Risk 群 5 年非再発率 90.4% 術後 1~2 年以内に肺転移をきたしやすい (3.3%) が 5 年以降では転移なし 腹部転移もまれ Intermediate Risk 群 5 年非再発率 61.8% 再発部位 : 肺転移が最多の64.5% 骨 27.4% 腹部転移 24.1% 腎摘出部 14.5% 肺転移 : 術後 1 年以内に41.7% 腹部転移 : 術後 1 年以内に58% high Risk 群 5 年非再発率 41.9% 再発部位 : 肺転移が最多の38.7% 腎摘出部 25.8% 腹部転移 25.8% 肝臓 16.1% 肺転移 : 術後 1 年以内に50% 5 年後以降の肺転移 7% 腹部転移 : 術後 1 年以内に 62% 5 年後以降の腹部転移 5% N+ 群 5 年非再発率 36% 再発部位 : 胸部 58.8% 腹部 76.5% 1 年以内に62.5% が再発 2 年以内に全例再発 Lam JS., et al. J Urol
11 UISS risk group based Surveillance Protocol リスクに合わせたフォローアップスケジュール Lam JS., et al. J Urol
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