前立腺全摘後に再発の危険性が高いので放射線治療をと勧める医師がいる。
海外から３つのランダム化比較試験が報告されているためだ(EORTC22911, 米国Thompson, ARO-96-02/AUOAP0905)
米国のランダム化比較試験では生命予後の改善が認められたが、他の２つの試験では再発は抑えられるものの生命予後の改善は認められなかった。
さらに全摘後の放射線治療は副作用が少なくないため、全摘後に再発していないのにも関わらず再発予防で放射線治療を行うことにとても抵抗を感じている。
過剰治療となる恐れがあるからである。
海外と違い日本では全摘後に詳細に高感度PSAをチェックして再発を見逃さないようにしているので、PSA再発してから放射線治療を行えばよいと考えている。
この考えを後押ししてくれるのが下記の論文
2012年のEuropean urologyにBrigantiらが報告している。
Early Salvage Radiation Therapy Does Not Compromise Cancer Control in Patients with pT3N0 Prostate Cancer After Radical Prostatectomy: Results of a Match-controlled Multi-institutional Analysis
2012年5月、MDV3100（開発コード、一般名*：enzalutamide）が再燃前立腺がんに対して米国FDAで認可されましたね
今後再燃前立腺がんの治療や予後が大きく改善されると思います。
MDV32100は前立腺がん治療の「game changer」となりそうです。
再燃前立腺がんに対する有効性を示すAFFIRM 試験↓
AFFIRM 試験
ドセタキセルによる化学療法施行歴のある進行性去勢抵抗性前立腺がん患者1,199名を対象に複数国で実施したプラセボ対照二重盲検比較試験（MDV3100 用量：160mg/日）である AFFIRM 試験において、全生存期間の中央値は、プラセボ群の13.6か月に対して、MDV3100群では18.4か月でした（p<0.0001、ハザード比=0.631）。
MDV3100 の忍容性は良好でした。プラセボ群と比較し MDV3100 群で頻度が高かった主な副作用は疲労、下痢、ほてりでした。MDV3100 群の発作の発生率は 1%未満でした。重篤な有害事象、投与中止に至った有害事象、死亡に至った有害事象のすべてについて、プラセボ群と比較してMDV3100 群で低い発現率を示しました。
今後再燃前立腺がんの治療や予後が大きく改善されると思います。
MDV32100は前立腺がん治療の「game changer」となりそうです。
再燃前立腺がんに対する有効性を示すAFFIRM 試験↓
AFFIRM 試験
ドセタキセルによる化学療法施行歴のある進行性去勢抵抗性前立腺がん患者1,199名を対象に複数国で実施したプラセボ対照二重盲検比較試験（MDV3100 用量：160mg/日）である AFFIRM 試験において、全生存期間の中央値は、プラセボ群の13.6か月に対して、MDV3100群では18.4か月でした（p<0.0001、ハザード比=0.631）。
MDV3100 の忍容性は良好でした。プラセボ群と比較し MDV3100 群で頻度が高かった主な副作用は疲労、下痢、ほてりでした。MDV3100 群の発作の発生率は 1%未満でした。重篤な有害事象、投与中止に至った有害事象、死亡に至った有害事象のすべてについて、プラセボ群と比較してMDV3100 群で低い発現率を示しました。
米Medivation社とアステラス製薬は経口アンドロゲン受容体拮抗薬MDV3100を開発治験中だった。
MDV3100は、3つの作用点に働きかけてアンドロゲン受容体拮抗作用を発揮するというユニークな作用機序を持つ。
ドセタキセル治療歴のある進行した前立腺癌患者に160mg/日を投与する多施設無作為化フェーズ3AFFIRM試験が進行中だったが、プラセボと比較して4.8か月の生存延長効果が認められたため、試験は中止となった。
これで再燃前立腺がんに対しMDV3100がFDAで認可されるのはは間違いなだろう。
再燃前立腺癌に対しては
docetaxel
provenge
abiraterone
cabazitaxel
と有効な薬剤が増えつつある。
日本で使えるものはdocetaxelのみでabirateroneとcabazitaxelは治験中と聞く。
一日でも早くこれらの薬剤の日本での承認が本当に待ち遠しい。
また、一日でも早い日本での承認のためには国際的な治験に日本が参加する必要がある。
多くの患者から「一日でも早くFDAで認可された薬を使いたい」との声が聞かれるが、
自分が積極的に治験に参加したいとの声は少数派である。
一日でも早く薬の効果を享受するためには治験に参加する積極的姿勢が必要で、「効果のある薬は早く使いたい。治験に参加はしたくない」では国際的にまかり通らないのではないだろうか？
From Medscape Medical News > Oncology
Prostate Cancer Trial Stopped as MDV3100 Improves Survival
Nick Mulcahy
November 3, 2011 — The experimental oral agent for metastatic castration-resistant prostate cancer, MDV3100 (Medivation), improved survival by 4.8 months, compared with placebo, in a phase 3 trial, the company announced.
A planned interim analysis of the AFFIRM trial revealed that estimated median survival was 18.4 months for men treated with MDV3100, compared with 13.6 months for men treated with placebo (P < .0001). This translates into a 37% reduction in the risk for death with MDV3100 (hazard ratio, 0.631).
As a result, the trial's Independent Data Monitoring Committee recommended that AFFIRM be stopped early and that men who were receiving placebo be offered MDV3100.
The recommendation was based on the fact that the study's prespecified interim efficacy stopping criteria were successfully met. The committee also examined the safety profile to date and determined that MDV3100 demonstrated a risk/benefit ratio that was favorable enough to stop the study, according to a company press statement.
"MDV3100 was rationally designed to target androgen-receptor signaling, a key driver of prostate cancer growth," said Howard I. Scher, MD, coprincipal investigator of the AFFIRM study, in a press statement. He is chief of the genitourinary oncology service at the Memorial-Sloan Kettering Cancer Center in New York City. "If approved, MDV3100 will be a welcome option for men with prostate cancers who have progressed on hormones and after initial chemotherapy."
The full results from AFFIRM, including safety data, will be presented at an upcoming scientific congress, according to the company.
The study is a randomized, double-blind, multinational trial comparing MDV3100 (160 mg/day) with placebo in 1199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy. Enrollment was completed in November 2010, and the interim analysis was triggered at 520 events.
If approved by the US Food and Drug Administration, MDV3100 will move into an increasingly crowded marketplace of products for the treatment of castration-resistant prostate cancer.
In phase 3 clinical trials in this setting, the immunotherapy sipuleucel-T (Provenge, Dendreon) has demonstrated a 4.1-month median survival benefit, and abiraterone (Zytiga, Johnson & Johnson) has shown a 3.9-month benefit. In addition, the chemotherapy cabazitaxel (Jevtana, sanofi-aventis) demonstrated a 2.4-month overall survival advantage over standard therapy.
MDV3100 and Abiraterone
MDV3100 was codeveloped by Charles Sawyers, MD, chair of human oncology and pathogenesis at Memorial Sloan-Kettering, and Michael Jung, PhD, professor of chemistry at the University of California, Los Angeles.
They theorized that androgen-receptor signaling is a driver in prostate cancer and that blocking the signaling would stop its growth. MDV3100 was designed to do just that.
In an earlier report on MDV3100, Dr. Scher told Medscape Medical News that it is a very potent antagonist of androgen receptors, and binds to the receptor very tightly.
MDV3100 is more potent and more specific than the older antiandrogens, such as flutamide (Drogenil) and bicalutamide (Casodex), which have been and are still being used in prostate cancer, usually with gonadotropin-releasing hormone agonists/antagonists, such as leuprolide (Lupron) and goserelin (Zoladex), said Dr. Scher. These older antiandrogen compounds also have some agonist activity, and have been found to stimulate prostate cancer growth in some men, Dr. Scher explained. This has not been seen with MDV3100, he noted at the time.
The mechanism of action of MDV3100 is very different from that of abiraterone, which is an inhibitor of androgen synthesis but does not block androgen binding, Dr. Scher said.
Because they act in different ways, there might be benefits from using the drugs together, he added.
Dr. Scher reports receiving research funding from Medivation. Coauthor Dr. Sawyers is a codeveloper of MDV3100, and is entitled to royalties that could result from its commercial success.
MDV3100は、3つの作用点に働きかけてアンドロゲン受容体拮抗作用を発揮するというユニークな作用機序を持つ。
ドセタキセル治療歴のある進行した前立腺癌患者に160mg/日を投与する多施設無作為化フェーズ3AFFIRM試験が進行中だったが、プラセボと比較して4.8か月の生存延長効果が認められたため、試験は中止となった。
これで再燃前立腺がんに対しMDV3100がFDAで認可されるのはは間違いなだろう。
再燃前立腺癌に対しては
docetaxel
provenge
abiraterone
cabazitaxel
と有効な薬剤が増えつつある。
日本で使えるものはdocetaxelのみでabirateroneとcabazitaxelは治験中と聞く。
一日でも早くこれらの薬剤の日本での承認が本当に待ち遠しい。
また、一日でも早い日本での承認のためには国際的な治験に日本が参加する必要がある。
多くの患者から「一日でも早くFDAで認可された薬を使いたい」との声が聞かれるが、
自分が積極的に治験に参加したいとの声は少数派である。
一日でも早く薬の効果を享受するためには治験に参加する積極的姿勢が必要で、「効果のある薬は早く使いたい。治験に参加はしたくない」では国際的にまかり通らないのではないだろうか？
From Medscape Medical News > Oncology
Prostate Cancer Trial Stopped as MDV3100 Improves Survival
Nick Mulcahy
November 3, 2011 — The experimental oral agent for metastatic castration-resistant prostate cancer, MDV3100 (Medivation), improved survival by 4.8 months, compared with placebo, in a phase 3 trial, the company announced.
A planned interim analysis of the AFFIRM trial revealed that estimated median survival was 18.4 months for men treated with MDV3100, compared with 13.6 months for men treated with placebo (P < .0001). This translates into a 37% reduction in the risk for death with MDV3100 (hazard ratio, 0.631).
As a result, the trial's Independent Data Monitoring Committee recommended that AFFIRM be stopped early and that men who were receiving placebo be offered MDV3100.
The recommendation was based on the fact that the study's prespecified interim efficacy stopping criteria were successfully met. The committee also examined the safety profile to date and determined that MDV3100 demonstrated a risk/benefit ratio that was favorable enough to stop the study, according to a company press statement.
"MDV3100 was rationally designed to target androgen-receptor signaling, a key driver of prostate cancer growth," said Howard I. Scher, MD, coprincipal investigator of the AFFIRM study, in a press statement. He is chief of the genitourinary oncology service at the Memorial-Sloan Kettering Cancer Center in New York City. "If approved, MDV3100 will be a welcome option for men with prostate cancers who have progressed on hormones and after initial chemotherapy."
The full results from AFFIRM, including safety data, will be presented at an upcoming scientific congress, according to the company.
The study is a randomized, double-blind, multinational trial comparing MDV3100 (160 mg/day) with placebo in 1199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy. Enrollment was completed in November 2010, and the interim analysis was triggered at 520 events.
If approved by the US Food and Drug Administration, MDV3100 will move into an increasingly crowded marketplace of products for the treatment of castration-resistant prostate cancer.
In phase 3 clinical trials in this setting, the immunotherapy sipuleucel-T (Provenge, Dendreon) has demonstrated a 4.1-month median survival benefit, and abiraterone (Zytiga, Johnson & Johnson) has shown a 3.9-month benefit. In addition, the chemotherapy cabazitaxel (Jevtana, sanofi-aventis) demonstrated a 2.4-month overall survival advantage over standard therapy.
MDV3100 and Abiraterone
MDV3100 was codeveloped by Charles Sawyers, MD, chair of human oncology and pathogenesis at Memorial Sloan-Kettering, and Michael Jung, PhD, professor of chemistry at the University of California, Los Angeles.
They theorized that androgen-receptor signaling is a driver in prostate cancer and that blocking the signaling would stop its growth. MDV3100 was designed to do just that.
In an earlier report on MDV3100, Dr. Scher told Medscape Medical News that it is a very potent antagonist of androgen receptors, and binds to the receptor very tightly.
MDV3100 is more potent and more specific than the older antiandrogens, such as flutamide (Drogenil) and bicalutamide (Casodex), which have been and are still being used in prostate cancer, usually with gonadotropin-releasing hormone agonists/antagonists, such as leuprolide (Lupron) and goserelin (Zoladex), said Dr. Scher. These older antiandrogen compounds also have some agonist activity, and have been found to stimulate prostate cancer growth in some men, Dr. Scher explained. This has not been seen with MDV3100, he noted at the time.
The mechanism of action of MDV3100 is very different from that of abiraterone, which is an inhibitor of androgen synthesis but does not block androgen binding, Dr. Scher said.
Because they act in different ways, there might be benefits from using the drugs together, he added.
Dr. Scher reports receiving research funding from Medivation. Coauthor Dr. Sawyers is a codeveloper of MDV3100, and is entitled to royalties that could result from its commercial success.
PSA検診について自分なりの考えをまとめたことがある。
PSA検診の是非について色々議論されているが、自分なりの結論は以下の通りである。
PSA検診を受けなければ前立腺がんの早期発見は極めて困難になる。
以下のことを条件に、これからもPSA検診を進めていきたい。
１：PSA検診の普及活動と同時に、検診を受けることの利点、欠点のさらなる啓蒙活動
２：PSAが異常であった場合の検査（生検）方法のさらなる侵襲低減化
３：前立腺がんと診断された場合の各種治療オプションの利点、欠点の詳しい提示。
４：前立腺がん治療のさらなる低侵襲化
５：無治療経過観察が可能な群を同定する方法を開発する努力
ところが今秋、The US Preventive Services Task Force （USPSTF）が
PSA検診は推奨できないとの声明を発表した。
USPSTFは以前より75歳以上の男性でのPSA検診は勧められないとしていたが、
今回は全年齢でのPSA検診を勧めないとした。
米国では十分にPSA検診が普及しており、実際問題、前立腺癌の死亡率は低下してきている。
日本ではまだ十分にPSA検診が普及しておらず、前立腺癌の死亡率は年々増加している。
今回のUSPSTFの声明により我が国のPSA検診普及が遅れれば、
前立腺癌死の増加は今後も食い止められないのではないだろうか？
Study Highlights
Researchers used common medical databases to address the following 4 questions:
Does PSA-based screening decrease prostate cancer–specific or all-cause mortality risk?
What are the harms of PSA-based screening for prostate cancer?
What are the benefits of treatment of early-stage or screening-detected prostate cancer?
What are the harms of treatment of early-stage or screening-detected prostate cancer?
Specifically, researchers sought randomized trials of screening for prostate cancer among asymptomatic or minimally symptomatic men. They also included randomized trials and cohort studies that examined radical prostatectomy or radiation therapy for the treatment of prostate cancer.
They identified 2 fair-quality and 3 poor-quality randomized trials of PSA-based screening as well as 2 randomized controlled studies describing the benefits and harms of prostate cancer treatments. 9 cohort studies provided data regarding the benefits of prostate cancer treatment, and 14 cohort studies reported harms of treatment.
The most important studies contributing to the study conclusions regarding prostate cancer screening were the US Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial and the European Randomized Study of Screening for Prostate Cancer (ERSPC).
After 7 years of follow-up in the PLCO trial, screening was associated with an increased incidence of prostate cancer but no significant effect on prostate cancer–specific or overall mortality. The PLCO trial was limited by contamination of the study cohort, with up to 52% of the men assigned to usual care receiving a PSA test at some point.
The ERSPC also demonstrated a higher incidence of prostate cancer associated with screening and no significant overall effect of screening on the risk for prostate cancer–specific mortality. However, screening was effective in reducing the risk for prostate cancer–specific mortality in a prespecified analysis of men between the ages of 55 and 69 years.
3 poor-quality trials failed to find a difference between prostate cancer screening and control groups in the risk for prostate cancer–specific mortality.
The risk for a false-positive test for cancer based on the PSA result was between 12% and 13%.
Serious infections or urinary retention occurred after 0.5% to 1.0% of prostate biopsies. No studies addressed possible psychological harms associated with prostate cancer screening.
One good-quality trial with 13 years of follow-up demonstrated that prostatectomy for localized prostate cancer reduced the risk for prostate cancer–specific mortality compared with watchful waiting. However, this benefit appeared limited to men younger than 65 years.
Cohort studies demonstrated that both prostatectomy and radiation therapy reduced the risks for prostate cancer–specific mortality and overall mortality.
Treating 5 men with prostatectomy resulted in 1 additional case of urinary incontinence. The number needed to harm for erectile dysfunction associated with prostatectomy is 3.
Radiation therapy is less associated with urinary incontinence, but it still has a number needed to harm of 7 to cause erectile dysfunction. Radiation therapy also appears to increase the risk for bowel injury, particularly in the short term.
Prostatectomy was associated with rates of perioperative death of approximately 0.5% and perioperative cardiovascular events of 0.6% to 3.0%.
On the basis of these data, draft recommendations from the USPSTF counsel against PSA-based screening for prostate cancer. This is a grade D recommendation, meaning that there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.
From Medscape Education Clinical Briefs
Intern Med. Published online October 7, 2011.
PSA検診の是非について色々議論されているが、自分なりの結論は以下の通りである。
PSA検診を受けなければ前立腺がんの早期発見は極めて困難になる。
以下のことを条件に、これからもPSA検診を進めていきたい。
１：PSA検診の普及活動と同時に、検診を受けることの利点、欠点のさらなる啓蒙活動
２：PSAが異常であった場合の検査（生検）方法のさらなる侵襲低減化
３：前立腺がんと診断された場合の各種治療オプションの利点、欠点の詳しい提示。
４：前立腺がん治療のさらなる低侵襲化
５：無治療経過観察が可能な群を同定する方法を開発する努力
ところが今秋、The US Preventive Services Task Force （USPSTF）が
PSA検診は推奨できないとの声明を発表した。
USPSTFは以前より75歳以上の男性でのPSA検診は勧められないとしていたが、
今回は全年齢でのPSA検診を勧めないとした。
米国では十分にPSA検診が普及しており、実際問題、前立腺癌の死亡率は低下してきている。
日本ではまだ十分にPSA検診が普及しておらず、前立腺癌の死亡率は年々増加している。
今回のUSPSTFの声明により我が国のPSA検診普及が遅れれば、
前立腺癌死の増加は今後も食い止められないのではないだろうか？
Study Highlights
Researchers used common medical databases to address the following 4 questions:
Does PSA-based screening decrease prostate cancer–specific or all-cause mortality risk?
What are the harms of PSA-based screening for prostate cancer?
What are the benefits of treatment of early-stage or screening-detected prostate cancer?
What are the harms of treatment of early-stage or screening-detected prostate cancer?
Specifically, researchers sought randomized trials of screening for prostate cancer among asymptomatic or minimally symptomatic men. They also included randomized trials and cohort studies that examined radical prostatectomy or radiation therapy for the treatment of prostate cancer.
They identified 2 fair-quality and 3 poor-quality randomized trials of PSA-based screening as well as 2 randomized controlled studies describing the benefits and harms of prostate cancer treatments. 9 cohort studies provided data regarding the benefits of prostate cancer treatment, and 14 cohort studies reported harms of treatment.
The most important studies contributing to the study conclusions regarding prostate cancer screening were the US Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial and the European Randomized Study of Screening for Prostate Cancer (ERSPC).
After 7 years of follow-up in the PLCO trial, screening was associated with an increased incidence of prostate cancer but no significant effect on prostate cancer–specific or overall mortality. The PLCO trial was limited by contamination of the study cohort, with up to 52% of the men assigned to usual care receiving a PSA test at some point.
The ERSPC also demonstrated a higher incidence of prostate cancer associated with screening and no significant overall effect of screening on the risk for prostate cancer–specific mortality. However, screening was effective in reducing the risk for prostate cancer–specific mortality in a prespecified analysis of men between the ages of 55 and 69 years.
3 poor-quality trials failed to find a difference between prostate cancer screening and control groups in the risk for prostate cancer–specific mortality.
The risk for a false-positive test for cancer based on the PSA result was between 12% and 13%.
Serious infections or urinary retention occurred after 0.5% to 1.0% of prostate biopsies. No studies addressed possible psychological harms associated with prostate cancer screening.
One good-quality trial with 13 years of follow-up demonstrated that prostatectomy for localized prostate cancer reduced the risk for prostate cancer–specific mortality compared with watchful waiting. However, this benefit appeared limited to men younger than 65 years.
Cohort studies demonstrated that both prostatectomy and radiation therapy reduced the risks for prostate cancer–specific mortality and overall mortality.
Treating 5 men with prostatectomy resulted in 1 additional case of urinary incontinence. The number needed to harm for erectile dysfunction associated with prostatectomy is 3.
Radiation therapy is less associated with urinary incontinence, but it still has a number needed to harm of 7 to cause erectile dysfunction. Radiation therapy also appears to increase the risk for bowel injury, particularly in the short term.
Prostatectomy was associated with rates of perioperative death of approximately 0.5% and perioperative cardiovascular events of 0.6% to 3.0%.
On the basis of these data, draft recommendations from the USPSTF counsel against PSA-based screening for prostate cancer. This is a grade D recommendation, meaning that there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.
From Medscape Education Clinical Briefs
Intern Med. Published online October 7, 2011.
「ビタミンEは前立腺癌の発生を増加させるかもしれない」
という論文が掲載されました。JAMA. 2011;306:1549-1556
35,533人を対象に行われたSELECT試験の結果です。
ビタミンE単独摂取は1.17倍前立腺癌の発生リスクが統計学的有意に増加するとのこと。
ビタミンサプリメントを摂取している人は注意を。
Study Highlights
Men eligible for study participation were at least 50 years old (for black men) or 55 years old (for all other participants) and had a prostate-specific antigen (PSA) value of 4.0 ng/mL or less. They also had normal digital rectal examination for prostate cancer.
Participants were randomly assigned to 1 of 4 placebo-controlled treatment groups: selenium 200 µg/day, vitamin E 400 IU/day, both selenium and vitamin E, or double placebo.
Participants underwent a limited history and physical examination every 6 months during the study and were encouraged to receive prostate cancer screening according to the community standard.
The main study outcome was incident prostate cancer. Researchers also followed the incidence rates of other types of cancer, along with incident type 2 diabetes mellitus and cardiovascular disease.
Active study treatment was discontinued after approximately 5.5 years.
35,533 men underwent randomization between 2001 and 2004. The median age of men was 63 years, and nearly 80% of participants were white. The mean PSA level at baseline was 1.1 ng/mL.
The current report provides another 54,464 person-years of follow-up. There was no difference regarding the intensity of PSA testing during follow-up in comparing the study intervention groups.
521 additional prostate cancers were recorded since the initial report. Treatment with vitamin E was associated with a significant increase in the risk for prostate cancer (hazard ratio, 1.17; 99% confidence interval, 1.004 - 1.36).
However, treatment with selenium alone or selenium plus vitamin E was not associated with a significant change in the risk for prostate cancer.
Gleason 6 prostate cancer was the most common cancer grade overall. However, the association between vitamin E and the risk for prostate cancer appeared to span the spectrum of cancer grades.
The difference in the risk for prostate cancer between vitamin E and placebo became apparent by study year 3 and gradually increased thereafter, including after the discontinuation of active treatment.
Selenium was not associated with a significant change in the risk for incident type 2 diabetes during the longer follow-up period. There were no other significant associations between study treatments and the risks for types of cancer other than prostate cancer, or in the risks for cardiovascular events or overall mortality.
From Medscape Education Clinical Briefs
JAMA. 2011;306:1549-1556.
という論文が掲載されました。JAMA. 2011;306:1549-1556
35,533人を対象に行われたSELECT試験の結果です。
ビタミンE単独摂取は1.17倍前立腺癌の発生リスクが統計学的有意に増加するとのこと。
ビタミンサプリメントを摂取している人は注意を。
Study Highlights
Men eligible for study participation were at least 50 years old (for black men) or 55 years old (for all other participants) and had a prostate-specific antigen (PSA) value of 4.0 ng/mL or less. They also had normal digital rectal examination for prostate cancer.
Participants were randomly assigned to 1 of 4 placebo-controlled treatment groups: selenium 200 µg/day, vitamin E 400 IU/day, both selenium and vitamin E, or double placebo.
Participants underwent a limited history and physical examination every 6 months during the study and were encouraged to receive prostate cancer screening according to the community standard.
The main study outcome was incident prostate cancer. Researchers also followed the incidence rates of other types of cancer, along with incident type 2 diabetes mellitus and cardiovascular disease.
Active study treatment was discontinued after approximately 5.5 years.
35,533 men underwent randomization between 2001 and 2004. The median age of men was 63 years, and nearly 80% of participants were white. The mean PSA level at baseline was 1.1 ng/mL.
The current report provides another 54,464 person-years of follow-up. There was no difference regarding the intensity of PSA testing during follow-up in comparing the study intervention groups.
521 additional prostate cancers were recorded since the initial report. Treatment with vitamin E was associated with a significant increase in the risk for prostate cancer (hazard ratio, 1.17; 99% confidence interval, 1.004 - 1.36).
However, treatment with selenium alone or selenium plus vitamin E was not associated with a significant change in the risk for prostate cancer.
Gleason 6 prostate cancer was the most common cancer grade overall. However, the association between vitamin E and the risk for prostate cancer appeared to span the spectrum of cancer grades.
The difference in the risk for prostate cancer between vitamin E and placebo became apparent by study year 3 and gradually increased thereafter, including after the discontinuation of active treatment.
Selenium was not associated with a significant change in the risk for incident type 2 diabetes during the longer follow-up period. There were no other significant associations between study treatments and the risks for types of cancer other than prostate cancer, or in the risks for cardiovascular events or overall mortality.
From Medscape Education Clinical Briefs
JAMA. 2011;306:1549-1556.
米Amgen社は、2011年5月17日、「XGEVA」（デノスマブ）をホルモン療法抵抗性の転移性前立腺癌患者に投与して骨転移抑制効果を調べたフェーズ3試験で、好結果が得られたと発表した。
臨床試験のデータは、米国泌尿器科学会年次総会で同日報告された。
多施設無作為化フェーズ3試験は、PSA値が上昇しているホルモン療法抵抗性前立腺癌患者で、骨転移は認められない男性1434人を登録、デノスマブまたは偽薬に無作為に割り付けた。主要エンドポイントは、骨転移なしの生存期間に設定されていた。 骨転移なしの生存期間の中央値は、偽薬群に比べデノスマブ群で4.2カ月長かった（25.2カ月と29.5カ月）。骨転移のハザード比は0.85（95％信頼区間0.73-0.98）だった。
さらに、初回骨転移までの期間はデノスマブ群で3.7カ月長く（ハザード比は0.84、0.71-0.98）、症候性の骨転移もデノスマブ群のほうが有意に少なかった（ハザード比は0.67、0.49-0.92）。
全生存期間には差は無く（ハザード比1.01、0.85-1.20）、無増悪生存期間にも有意差は見られなかった（0.89、0.78-1.02）。
デノスマブ群に最も多く見られた有害事象は腰痛で、偽薬群に比べ低カルシウム血症と顎骨壊死も多く報告されていた。
デノスマブは、破骨細胞の形成・活性化に必須のRANKリガンドを標的とする完全ヒト型モノクローナル抗体で、米国では2010年11月18日に、骨転移がある固形癌患者の骨関連事象の予防に用いることが許可されている。
http://medical.nikkeibp.co.jp/leaf/all/search/cancer/news/201105/519802.html
ASPIRE 1830Z-F52C/K
CPU: intel Pentium Dual core U5600 1.33GHz
メモリー：2GB
HDD: 3320GB
SDカード(8GB)を刺して、
ReadyBoostを使用して処理スピード向上を図ってます。
http://windows.microsoft.com/ja-JP/windows7/Using-memory-in-your-storage-device-to-speed-up-your-computer
出先で使うためにdellのネットＰＣを買って３年。
ついに壊れるサインが出てきました（グラフィックボードの問題？）。
dellのネットPCは軽いし安いし、
「そこそこの速さ」で動いてくれるし・・と満足していたのですが、
だんだん「そこそこの速さ」では我慢できなくなってきて・・
新機購入を決断
今回ＰＣ選びの決め手は
軽いこと
Atom以外のCPU搭載
vaio以外
mac以外
この４点
macは大好きだったのですが、
最後に購入したiBookが、買って１年以内に故障。
普通に持ち歩いていただけなのにHDDが壊
保証期間内だったので無償で修理してもらいましたが、
Macオフィスの遅さに辟易してたこともあり、だんだん使わなくなりました。
Vaioは買って１年以内に普通に持ち歩いていて液晶が割れました。
修理に１０万円！
もうほんとに「あほ」かと
液晶は保証範囲外とはいえ、
普通に持ち歩いてて液晶が割れるとは、想定外です。
sonyブランドに対する信頼性がガタガタと崩れて、
PCだけでなく、カメラもビデオカメラも買い替え時はsony以外のブランドにしました。
どちらも完全に個人的な、一方的な、偶発的な怒りであり、両社に一切の落ち度はございません
今回はacerの
ASPIRE 1830Z-F52C/K
を購入しました。
すごくいいです！！
この軽さでこのスピード
充電もすごく持ちがいいです！！
セカンドＰＣとしてならお勧めです！
CPU: intel Pentium Dual core U5600 1.33GHz
メモリー：2GB
HDD: 3320GB
SDカード(8GB)を刺して、
ReadyBoostを使用して処理スピード向上を図ってます。
http://windows.microsoft.com/ja-JP/windows7/Using-memory-in-your-storage-device-to-speed-up-your-computer
出先で使うためにdellのネットＰＣを買って３年。
ついに壊れるサインが出てきました（グラフィックボードの問題？）。
dellのネットPCは軽いし安いし、
「そこそこの速さ」で動いてくれるし・・と満足していたのですが、
だんだん「そこそこの速さ」では我慢できなくなってきて・・
新機購入を決断
今回ＰＣ選びの決め手は
軽いこと
Atom以外のCPU搭載
vaio以外
mac以外
この４点
macは大好きだったのですが、
最後に購入したiBookが、買って１年以内に故障。
普通に持ち歩いていただけなのにHDDが壊
保証期間内だったので無償で修理してもらいましたが、
Macオフィスの遅さに辟易してたこともあり、だんだん使わなくなりました。
Vaioは買って１年以内に普通に持ち歩いていて液晶が割れました。
修理に１０万円！
もうほんとに「あほ」かと
液晶は保証範囲外とはいえ、
普通に持ち歩いてて液晶が割れるとは、想定外です。
sonyブランドに対する信頼性がガタガタと崩れて、
PCだけでなく、カメラもビデオカメラも買い替え時はsony以外のブランドにしました。
どちらも完全に個人的な、一方的な、偶発的な怒りであり、両社に一切の落ち度はございません
今回はacerの
ASPIRE 1830Z-F52C/K
を購入しました。
すごくいいです！！
この軽さでこのスピード
充電もすごく持ちがいいです！！
セカンドＰＣとしてならお勧めです！
NEC VALUESTAR L
CPU: coe i7
メモリ：8G
HDD:1TB
OS: win7
動画編集をやりながらネット検索やパワーポイントで学会のスライド作り・・
同時進行的に色々やりたかったので、
2010年時点で一番性能が良さそうな
NEC VALUESTAR L を購入しました。
とてもいいです！！超おすすめ！！
サクサク動いてくれます！！
ただ、キーボードの配列がおかしい？
Ctrlキーが今まで使ってきたキーボードと違う場所なので、
ショートカットを使うためにCtrlキーを押そうとして
頻繁に他のキーを押しちゃってます・・・
液晶とPCが一体になってるNEC VALUESTAR Wシリーズのほうがスタイリッシュなのですが、
液晶とPCが一緒だと壊れやすそうな気がします（完全に憶測です）。
今まで
Macのデスクトップ数台、mac cube1台、iMac数台、iBook2台、 Vaio(note)2台、 Dell(net PC)１台など使ってきましたが、
今はこれと ASPIRE 1830Zを使っています。
一番頼りになるＰＣ2台です（新しいので、当たり前ですねｗ）。
CPU: coe i7
メモリ：8G
HDD:1TB
OS: win7
動画編集をやりながらネット検索やパワーポイントで学会のスライド作り・・
同時進行的に色々やりたかったので、
2010年時点で一番性能が良さそうな
NEC VALUESTAR L を購入しました。
とてもいいです！！超おすすめ！！
サクサク動いてくれます！！
ただ、キーボードの配列がおかしい？
Ctrlキーが今まで使ってきたキーボードと違う場所なので、
ショートカットを使うためにCtrlキーを押そうとして
頻繁に他のキーを押しちゃってます・・・
液晶とPCが一体になってるNEC VALUESTAR Wシリーズのほうがスタイリッシュなのですが、
液晶とPCが一緒だと壊れやすそうな気がします（完全に憶測です）。
今まで
Macのデスクトップ数台、mac cube1台、iMac数台、iBook2台、 Vaio(note)2台、 Dell(net PC)１台など使ってきましたが、
今はこれと ASPIRE 1830Zを使っています。
一番頼りになるＰＣ2台です（新しいので、当たり前ですねｗ）。
古い論文だが、タバコやアルコールと前立腺がんリスクとは関係がないようだ。
Prostate cancer is common among men, and Hsing and colleagues examined how diet, tobacco use, and alcohol consumption affected the risk for fatal prostate cancer in the November 1, 1990, issue of Cancer Research. They examined 17,633 white men and found that fatal prostate cancer was more common among smokers as well as among individuals who used smokeless tobacco. Diet failed to have a significant effect on the risk for fatal prostate cancer, and consumption of alcohol and coffee also had no effect on prostate cancer risk.
ただし、前立腺がんになると手術にしても放射線治療にしても、内分泌治療にしても色々な薬を使用することになる。
アルコールによる肝障害
タバコによる肺障害
によって、必要な治療ができなくなる恐れがあるために禁煙と過度なアルコールは絶対に控えないといけない。
Prostate cancer is common among men, and Hsing and colleagues examined how diet, tobacco use, and alcohol consumption affected the risk for fatal prostate cancer in the November 1, 1990, issue of Cancer Research. They examined 17,633 white men and found that fatal prostate cancer was more common among smokers as well as among individuals who used smokeless tobacco. Diet failed to have a significant effect on the risk for fatal prostate cancer, and consumption of alcohol and coffee also had no effect on prostate cancer risk.
ただし、前立腺がんになると手術にしても放射線治療にしても、内分泌治療にしても色々な薬を使用することになる。
アルコールによる肝障害
タバコによる肺障害
によって、必要な治療ができなくなる恐れがあるために禁煙と過度なアルコールは絶対に控えないといけない。
コーヒーで前立腺がん予防！！
米国ハーバード大学から2011年4月に報告された論文だ。
1日6杯以上コーヒーを飲むと、致死的な前立腺がんになる可能性がなんと６０％（！）も低下するらしい。
コーヒーを飲んで前立腺がん予防！！
ただし、早期前立腺がんになる可能性はコーヒーを飲んでも変わらない。
また、コーヒーを飲むことで他の弊害が出る可能性も否定できない。
なので、1日6杯以上コーヒーを飲むことを勧めている論文ではない。
著者らはコーヒーに含まれる何らかの抗酸化物質が致死的な前立腺がんのリスクを軽減している可能性があると推測している。
http://jnci.oxfordjournals.org/content/early/2011/05/17/jnci.djr151.abstract
米国ハーバード大学から2011年4月に報告された論文だ。
1日6杯以上コーヒーを飲むと、致死的な前立腺がんになる可能性がなんと６０％（！）も低下するらしい。
コーヒーを飲んで前立腺がん予防！！
ただし、早期前立腺がんになる可能性はコーヒーを飲んでも変わらない。
また、コーヒーを飲むことで他の弊害が出る可能性も否定できない。
なので、1日6杯以上コーヒーを飲むことを勧めている論文ではない。
著者らはコーヒーに含まれる何らかの抗酸化物質が致死的な前立腺がんのリスクを軽減している可能性があると推測している。
http://jnci.oxfordjournals.org/content/early/2011/05/17/jnci.djr151.abstract