はあまりにも低い 1) 40 歳代を対象とするマンモグラフィ検診は デンスブレストのため 50 歳以上の検診成績に比べて その成績が不良であることは 前述の欧米の成績からも明らか 1) 欧米の検診ガイドラインでは 多くの国が対象年齢を 50 歳 ~69 歳に限定しているが 本邦では 40 歳後半に乳

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1 乳癌検診 ( マンモグラフィー 視触診 自己触診 ) の効果 ( ) 参考文献 8 の記載を追加 乳癌検診について勉強 欧米では 1980 年代後半以降の約 20 年間に乳癌死亡率低下 (20~30%) がみられている 1) 本邦では 乳癌罹患率は増加し マンモグラフィ検診の普及の遅れ等から早期乳癌の頻度が低く 乳癌死亡率も増加している 1) 米国予防医療専門委員会 (US Preventive Services Task Force : USPSTF) の報告書では 14 年間の観察期間で乳癌死亡に関する相対危険度は 全年齢層 50 歳以上 40 歳代で各々では ( いずれも有意差あり ) であり 検診群では各々 16% 22% 15% の乳癌死亡減少を認めている 1) 厚生労働省の通達 ( 老健 65 号 ) により 視触診検診の導入から 13 年後の 2000 年 3 月に 50 歳以上の女性に対する視触診 マンモグラフィ併用検診が導入された さらに 通達 ( 老老発第 号 ) により 2004 年 4 月 40 歳代女性へのマンモグラフィ 視触診併用検診の導入がなされた 1) ( 参考文献 1 より引用 ) 地域保健 老人保健事業報告から 住民検診のマンモグラフィ検診受診率 (2006 年 ) は 12.9% 163 万人である 1) 欧米のマンモグラフィ検診受診率 70~80% と比較すると 本邦のマンモグラフィ検診受診率

2 はあまりにも低い 1) 40 歳代を対象とするマンモグラフィ検診は デンスブレストのため 50 歳以上の検診成績に比べて その成績が不良であることは 前述の欧米の成績からも明らか 1) 欧米の検診ガイドラインでは 多くの国が対象年齢を 50 歳 ~69 歳に限定しているが 本邦では 40 歳後半に乳癌罹患率が高いという理由から 40 歳代以上を検診対象としている この年代のデンスブレスト対策が問題になっており その対策として 超音波検診の導入が検討されている 1) USPSTF の新ガイドラインは 50 歳以下の女性への 2 年ごとのマンモグラフィー検診は個人の危険因子の有無で判断されるとしている そして 50 歳から 74 歳までの女性は 2 年ごとにマンモグラフィー検診をルーチン的に受ける必要があると提唱し 75 歳以上の女性に関してはガイドラインの提示はない また 新ガイドラインでは自己触診は奨励しないとしている 2) 超音波検査による乳癌検診については 乳癌死亡率減少効果を示す科学的根拠はなく 標準化された検診法でない 1) 本邦での MRI 検診については 比較試験的の結果をもとにさらなる検討が必要である 1) マンモグラフィーの効果を示す複数の RCT のメタ解析がある 参考文献 3 では 39 歳から 69 歳までの女性に対するマンモグラフィーの効果が示されている Mammography screening reduces breast cancer mortality by 15% for women aged 39 to 49 years (relative risk, 0.85 [95% credible interval, 0.75 to 0.96]; 8 trials). Data are lacking for women aged 70 years or older. Radiation exposure from mammography is low. Patient adverse experiences are common and transient and do not affect screening practices. Estimates of overdiagnosis vary from 1% to 10%. Younger women have more false-positive mammography results and additional imaging but fewer biopsies than older women. Trials of clinical breast examination are ongoing; trials for breast self-examination showed no reductions in mortality but increases in benign biopsy results.

3 ( 参考文献 3 より引用 ) (For women age 39 to 49 years)this corresponds to a number needed to invite for screening to prevent one breast cancer death of 1,904 (95% C ri 929 to 6,378) over multiple screening rounds that varied by trial (2 to 9 rounds), and 11 to 20 years of follow-up. For women age 50 to 59 years, 6 trials (CNBSS-2 (52), Stockholm (26), Malmo (26), Swedish Two-County [2 trials] (26), Gothenburg (30)) provided a pooled relative risk for breast cancer mortality for women invited to mammography screening of 0.86 (95% CrI 0.75 to 0.99); number needed to invite 1,339 (95% CrI 322 to 7,455). For women age 60 to 69 years, 2 trials (Malmo (26) and Swedish Two-County [Ostergotland] (26)) provided a pooled relative risk for breast cancer mortality for women invited to mammography screening of 0.68 (95% CrI 0.54 to 0.87); number needed to invite 377 (95% CrI 230 to 1,050). 参考文献 4 も RCT のメタ解析 ( システマティックレビュー ) である この論文でも乳癌による死亡 は減少させるものの 総死亡は減少させないことが示されている Three trials with adequate randomisation did not show a significant reduction in breast cancer mortality at 13 years (relative risk (RR) 0.90, 95% confidence interval (CI) 0.79 to 1.02); four trials with suboptimal randomisation showed a significant reduction in breast cancer mortality with an

4 RR of 0.75 (95% CI 0.67 to 0.83). The RR for all seven trials combined was 0.81 (95% CI 0.74 to 0.87).

5

6 ( 参考文献 4 より引用 ) 文献 8 はアメリカにおける 30 年間のマンモグラフィーが乳癌の発生に及ぼした影響を示している 健診によって発見された早期乳癌の数は 10 万人年当たり 122 人増加し 進行乳癌の数は 10 万人年あたり 8 人減少した 健診で発見された早期癌の 122 人中 8 人だけが進行癌に進展すると予想されるため 健診自体は乳癌死亡率に対して影響が少なく 治療が死亡率減少と密接に関連していることが予想されている women 40 years of age or older. The introduction of screening mammography in the United States has been associated with a doubling in the number of cases of early-stage breast cancer that are detected each year, from 112 to 234 cases per 100,000 women--an absolute increase of 122 cases per 100,000 women.

7 Concomitantly, the rate at which women present with late-stage cancer has decreased by 8%, from 102 to 94 cases per 100,000 women--an absolute decrease of 8 cases per 100,000 women. With the assumption of a constant underlying disease burden, only 8 of the 122 additional early-stage cancers diagnosed were expected to progress to advanced disease. After excluding the transient excess incidence associated with hormone-replacement therapy and adjusting for trends in the incidence of breast cancer among women younger than 40 years of age, we estimated that breast cancer was overdiagnosed (i.e., tumors were detected on screening that would never have led to clinical symptoms) in 1.3 million U.S. women in the past 30 years. We estimated that in 2008, breast cancer was overdiagnosed in more than 70,000 women; this accounted for 31% of all breast cancers diagnosed. ( 参考文献 8 より引用 )

8 視触診の効果については 視触診 + マンモグラフィーと視触診単独を比較した RCT がある ( 参 考文献 6) スクリーニングの効果を直接検討したわけではないが 視触診単独でも マンモグラフ ィーを併用しても乳癌による死亡に差はなく 間接的に視触診の効果を示している可能性がある This trial randomly and individually assigned women aged years At 13-year follow-up, with 107 and 105 deaths from breast cancer in the respective groups, the cumulative rate ratio was 1.02 (95% confidence interval = ). ( 参考文献 6 より引用 ) 自己触診の効果を検討した RCT( 参考文献 5) がある その結果 自己触診を指導する介入を 行うと 良性の病変の発見は増えるものの 乳癌による死亡は減少していない むしろ 介入群で はバイオプシーなど侵襲的な検査が増加している There were 135 (0.10%) breast cancer deaths in the instruction group and 131 (0.10%) in the control group. The cumulative breast cancer mortality rates through 10 to 11 years of follow-up were similar (cumulative risk ratio for women in the instruction group relative to that in the control

9 group = 1.04, 95% confidence interval = 0.82 to 1.33; P =.72). However, more benign breast lesions were diagnosed in the instruction group than in the control group. ( 参考文献 5 より引用 ) コクランのシステマティックレビューでも同様の結果である There was no statistically significant difference in breast cancer mortality between the groups (relative risk 1.05, 95% confidence interval (CI) 0.90 to 1.24; 587 deaths in total). ( 参考文献 7 より引用 )

10 マンモグラフィーによる検診 (+ 視触診 ) の効果はありそう 今後 エコーや MRI をどう使うのかが 面白くなってくると思う 効果は高く 侵襲は少なく 偽陽性も少なく コストは安く そんな検診なら 文句は無いけれど 現実はそうなっていない 参考文献 1. 森本忠興, 長尾妙子, 岡崎憲二, 吉良美砂子, 森本雅美, 中川靖士, 丹黒章. 乳癌検診の現 状. 外科治療, 101(6) : , 北野敬子婦人科がん検診新ガイドライン. ナーシングビジネス, 4(3) : 232, Nelson HD, Tyne K, Naik A, Bougatsos C, Chan BK, Humphrey L; U.S. Preventive Services Task Force. Screening for breast cancer: an update for the U.S. Preventive Services Task Force. Ann Intern Med Nov 17;151(10):727-37, W Gøtzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD DOI: / CD pub4. 5. Thomas DB, Gao DL, Ray RM, Wang WW, Allison CJ, Chen FL, Porter P, Hu YW, Zhao GL, Pan LD, Li W, Wu C, Coriaty Z, Evans I, Lin MG, Stalsberg H, Self SG. Randomized trial of breast self-examination in Shanghai: final results. J Natl Cancer Inst Oct 2;94(19): Miller AB, To T, Baines CJ, Wall C. Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged years. J Natl Cancer Inst Sep 20;92(18): Kösters JP, Gøtzsche PC. Regular self-examination or clinical examination for early detection of breast cancer. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD DOI: / CD Bleyer A, Welch HG. Effect of three decades of screening mammography on breast-cancer incidence. N Engl J Med Nov 22;367(21): doi: /nejmoa PubMed PMID:

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