ビスフォスフォネートと食道がんリスク

 ビスフォスフォネートと食道癌のリスクについては否定的、との報告。

 データベースUK General Practice Research Databaseより、1996年から2006年までの間で、食道がんと胃がんの発生頻度をビスフォスフォネートの服用患者と服用していない患者で比較したコホート調査。

・平均フォロー4.5年(6ヶ月未満は除外)

・41,826人、81%が女性で、平均年齢70歳。

・服用群は、116名が胃がんか食道がん(うち79名が食道がん)

・非服用群は、115名が胃がんか食道がん(うち72名が食道がん)

・発生頻度は、1000人年で0.7。

・胃がん、もしくは食道がん発症のハザード比0.96 [95% confidence interval, 0.74-1.25]

・食道がん発症のハザード比1.07 [95% confidence interval, 0.77-1.49]

気づき)

 ・FDAは、2004年に顎骨壊死(のちに経口のビスフォスフォネート剤も)、2008年に重度筋骨格痛について注意を発し、2008,2009年に発がん性について調査を指示していた。

 ・食道がんのリスクは、 New Engl J Med 2009;360:89-90で、FDAは,アレンドロネートが発売された1995年10月から2008年5月までに,米国で,アレンドロネート投与した23例に食道がんが発生したとの報告を受け,8例が死亡していると報告されているようです。23例のうち18例(78%)が女性で,年齢中央値74歳であり,アレンドロネート投与開始から食道がんと診断されるまでの期間の中央値は2.1年(範囲0.5-10.0年)であったと記載されています。食道がんの主な発生部位は,食道下部(6例)で,何例かは胃にも発生が認められ,組織型は腺がん7例,扁平上皮がん1例であったようです。

 ・咽喉頭,食道等の粘膜以上を起こさないように服用方法を患者に指導はひきつづき

JAMA. 2010 Aug 11;304(6):657-63.

Exposure to oral bisphosphonates and risk of esophageal cancer.

CONTEXT: Use of oral bisphosphonates has increased dramatically in the United States and elsewhere. Esophagitis is a known adverse effect of bisphosphonate use, and recent reports suggest a link between bisphosphonate use and esophageal cancer, but this has not been robustly investigated.

OBJECTIVE: To investigate the association between bisphosphonate use and esophageal cancer.

DESIGN, SETTING, AND PARTICIPANTS: Data were extracted from the UK General Practice Research Database to compare the incidence of esophageal and gastric cancer in a cohort of patients treated with oral bisphosphonates between January 1996 and December 2006 with incidence in a control cohort. Cancers were identified from relevant Read/Oxford Medical Information System codes in the patient’s clinical files. Cox proportional hazards modeling was used to calculate hazard ratios and 95% confidence intervals for risk of esophageal and gastric cancer in bisphosphonate users compared with nonusers, with adjustment for potential confounders.

MAIN OUTCOME MEASURE: Hazard ratio for the risk of esophageal and gastric cancer in the bisphosphonate users compared with the bisphosphonate nonusers.

RESULTS: Mean follow-up time was 4.5 and 4.4 years in the bisphosphonate and control cohorts, respectively. Excluding patients with less than 6 months’ follow-up, there were 41 826 members in each cohort (81% women; mean age, 70.0 (SD, 11.4) years). One hundred sixteen esophageal or gastric cancers (79 esophageal) occurred in the bisphosphonate cohort and 115 (72 esophageal) in the control cohort. The incidence of esophageal and gastric cancer combined was 0.7 per 1000 person-years of risk in both the bisphosphonate and control cohorts; the incidence of esophageal cancer alone in the bisphosphonate and control cohorts was 0.48 and 0.44 per 1000 person-years of risk, respectively. There was no difference in risk of esophageal and gastric cancer combined between the cohorts for any bisphosphonate use (adjusted hazard ratio, 0.96 [95% confidence interval, 0.74-1.25]) or risk of esophageal cancer only (adjusted hazard ratio, 1.07 [95% confidence interval, 0.77-1.49]). There also was no difference in risk of esophageal or gastric cancer by duration of bisphosphonate intake.

CONCLUSION: Among patients in the UK General Practice Research Database, the use of oral bisphosphonates was not significantly associated with incident esophageal or gastric cancer.

これから)星薬科大学3年生1名の早期実習、看護学校で薬理、職場会議は来週に延期、専門・認定薬剤師制度の法人規定作成のための資料作り、職員面接1名、麻薬の帳簿整理、ちょっと忙しそう。ゆっくりストレッチ。

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