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Source text - English (ID:27920) – KOL
Dr. Hoffman: So when we think about pancreatic cancer it’s not so clear cut what we should test for. There are several cancer syndromes that can increase susceptibility to pancreatic cancer. The vast majority of genetic cases of pancreatic cancer, not majority, but the largest percent are from BRCA2 mutations, so that’s the one we think about first and so we would want to focus our history on breast and ovarian cancers. But then we have to think about p16 where we can see melanoma and pancreatic cancer; HNPCC or Lynch syndrome with colon and uterine cancer; Peutz Jeghers which is the one that you probably all saw pictures of in medical school and don’t get to see that many patients with where there’s freckling all over the lips and the inside of the mouth and these patients get a larger number of growths in the colon, cancers in the breast, and they can also have pancreatic tumors; Li Fraumeni, which is a very difficult cancer syndrome in that if affects many, many organs and that there isn’t necessarily screening available for all of those organs; hereditary pancreatitis, when people have pancreatitis for a long period of time, it seems that they become more predisposed to pancreatic cancer; and then a neurologic syndrome, Ataxia telangectasia, which we normally wouldn’t think about at all in terms of cancers, also has an increased risk of pancreatic cancer. So, this is, sort of, the differential that we think about when someone comes through the door with pancreatic cancer. And when that person says to us, “Well, what can you do for my kids if they’re at risk for pancreatic cancer?” we have to be honest and say that there’s no evidence based medicine right now that has the screening protocol that’s necessarily effective for pancreatic cancer. But there are, in fact, study groups, I think there’s one at MGH, there’s definitely at Hopkins, and we’ve had some clinicians here who have been amenable to going ahead with some screening options especially if there’s been multiple family members with pancreatic cancer.
So we went on to continue asking the history in this family. And thankfully this woman was the only person in her generation affected with cancer so far. But then we started to take more of a history and we found out that unfortunately her father had died quite young at age 50, I’m sorry that’s hard to see, of melanoma. And so now we hear pancreatic cancer and melanoma, we know that there’s a gene, p16, which can cause that. But melanoma is often somewhat common cancer, so we weren’t sure and went on and took more of a history, and then we saw that unfortunately two people that had melanoma, and a second person that had pancreatic cancer. And we took more history and saw that this was an extremely prevalent problem in the family that had not been discussed previously. And, you know, this woman, she just had no idea that she was at risk for pancreatic cancer. And, you know, taking the history she sort of did know all of this stuff but it just never came up that it might affect her life. So we went ahead and did testing on her and she was found to have a p16 mutation. And it’s always a little bit nerve-wracking for us as physicians to go in the room and give sort of heavy news that someone has the p16 mutation because you then know that you’re about to upset them tremendously in terms of the fact that they can be passing this on to their children. But this woman was actually quite educated and understood that by finding out that she had a p16 mutation we were enabling and empowering her family to figure out of those people in the family who had not yet been affected with cancers were they likely to be affected with cancers in the future or could they go back to the baseline population in terms of their risk factors, in terms of the risks of those cancers?
So, like I said, she came back positive. Then we had this woman come back and the sister, and the woman who was affected came back p16 positive, this woman thankfully came back negative, but there was really no way to predict ahead of time she was going to be negative. She had the same 50/50 risk that all of the rest siblings had. So now since she’s negative she can tell her children that they don’t have to worry so much, but now that she’s positive she has four daughters who all need to get tested. This woman came into us at 23 years of age and she said “I’m about to get married and I’m thinking about having children and I’m not sure that I want to pass onto my children knowingly what my mother passed…could have passed onto me.” And so she actually was very mature about this. We don’t have that many 23 year olds that come to us for cancer predisposition testing. But she had gone through a lot and I think really appreciated her mother and other family members had suffered with their cancers and said, “I’m not sure. Maybe I would adopt if I was a carrier of this mutation.” So she wanted to get tested, and thankfully she came back negative, so that was very happy. And she got married and had a baby and all is well.
And so…and actually a bunch of these sisters, even they came up from Maryland, they become…it’s kind of nice you get to meet the entire family sometimes even though there are doctors in other places they sort of grow attached to the person who gave them their news, and we did see, I think, three of these four, and three came back negative so far, so that was really exciting. And one of these brothers is out in Oregon, and he actually was diagnosed with melanoma and then went ahead and got tested and he did come back positive in the last month or so. So, that’s an excellent question, so we don’t have children unless there’s an intervention we would do at an early age, and the only intervention that we would do for people with the p16 mutation is dermatologic screening starting at 10 years of age. So we thought it was more appropriate to just recommend that dermatologic screening from the child from the age of 10 up until the age of consent, and at that point in time the child can decide whether she is ready for that testing and wants to have that information. But if there was some sort of intervention that would be very invasive or problematic to the child or would cause pain to the child we might consider doing the testing, but for this specific cancer syndrome we don’t.
So p16 does account for approximately 20-40% of hereditary melanoma. And unfortunately hereditary melanoma has a lot of names, and the p16 gene has a lot of names, and so sometimes we have to sort out what people are talking about when they tell us something runs in the family because they might very well know what they’re talking about and we might not be familiar with that terminology. So we do a lot of literature searching.
So for the p16 gene the benefits of testing involve knowing the mutation status to allow for tailored management. So 50% of the people will go on to develop melanoma by 50, 76% by 80. The average age of onset melanoma is not until 35 years, and only about 17% of families, per se, see the pancreatic cancer. So, you know, it’s not necessarily that with a given syndrome that we’re going to see a certain percentage of pancreatic cancer, maybe that a certain mutation within the p16 gene gives on a higher predisposition to pancreatic cancer. So obviously this family had a very high likelihood of getting pancreatic cancer while other families may just see the melanomas.
We do find that by telling someone their genetic status they have increased compliance with getting their skin exams every 6-12 months starting at age 10, and increased use of sunscreen and protective clothing. So this does tend to sort of shake people into reality and recognize that they really do have to protect themselves. And they stop doing as much risky behavior in terms of sun exposure and tanning beds.
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Translation - Japanese (ID:27920) – KOL
ホフマン博士：さて、膵臓癌について考えてみますと、そのための検査としては何があるかというと、あまりはっきりしていません。膵臓癌に対する感受性を増大させ得る幾つかの癌症候群があります。膵臓癌の遺伝的症例の圧倒的多数は、大多数ではありませんが最も割合の高いものは、BRCA2の変異によるものなので、まずそれについて考えます、従って、乳癌と卵巣癌の歴史について焦点をおきたいと思います。しかし、またメラノーマや膵臓癌にみられるp16についても考えなければなりませんし、大腸癌と子宮癌のあるHNPCCあるいはリンチ症候群；また、おそらく医学生の時に皆さん、写真を見たけれども、唇や口の内側全体に雀斑のある患者を実際に見ることは少ないのですが、大腸に多数の増殖や、また乳癌があり、また膵臓癌がある可能性もあるといったポイツ-ジェガーズ症候群；そして、多数の器官が罹患し、これら全ての器官についてのスクリーニングの方法が必ずしもあるわけではないリー-フラウメニ癌症候群；さらに、長期間にわたる膵臓炎のために、膵臓癌に罹患しやすくなると思われる遺伝的膵臓炎；あるいは、通常は癌との関連は考えられないのですが、膵臓癌の危険性を増加させる毛細管拡張性運動失調なども考える必要があります。したがって、これは、いってみれば、膵臓癌の患者が診察室のドアを開けて入って来た時に、われわれが考える鑑別法と言っていいでしょう。そしてその患者が“では、もし私の子供達に膵臓癌の危険性があるとしたら、何ができますか？”と聞いてくるなら、正直に、現在の医学では膵臓癌に必ず効果的であるというスクリーニングの方法はないことを告げなければなりません。しかいながら、実をいうと、そのための研究グループがあります。そのひとつはMGHにあると思いますし、ホプキンスには絶対にあります。そしてここには、特に、もし膵臓癌のある複数の家族メンバーがいれば、幾つかのスクリーニングの選択肢を進んで行おうとしている何人かの医師がいます。
そこで、われわれは、この患者の家族歴について質問を続けました。有難いことに、この女性はこれまでのところ、彼女の世代では唯一の癌患者であることがわかりました。しかし、さらに家族歴について尋ね始めると、不運なことに父親が50歳というかなり若い年齢で、とても残念なことに、メラノーマのために死亡したことがわかりました。さて、膵臓癌とメラノーマということですが、その原因となり得る遺伝子、p16があることがわかっています。しかし、メラノーマはしばしば一般的な癌なので、確信がなく、さらに家族歴をよく調べてみますと、不運なことに、メラノーマに罹った人が二人あり、そのうちの二人目の人には膵臓癌があったということがわかりました。そしてさらに家族歴を調べると、それはこの家族に非常にゆきわたった問題でありながら、それまでに論議されれいなかったことがわかりました。そして、この女性は、彼女が膵臓癌を罹患する危険性があることについて全く知りませんでした。つまり、家族歴から彼女はこれらのことを知っていたわけですが、それが彼女の人生に影響を与えようとは思ってもみなかったということです。そこで、さらに次の段階として、彼女を検査した結果、p16の変異があることがわかりました。診察室に入って行き、患者にp16の変異があるといった重苦しい知らせを告げるのは医師として、常に、かなり神経の疲れることです。何故なら、それが患者の子供達に引き継がれる可能性があるという事実によって、患者をとてつもなく動揺させるであろうことがわかっているからです。しかし、この女性は、実のところ、かなり教育があり、彼女にp16の変異があることを知ることによって、危険因子という意味で、またそれらの癌の危険性という意味で、家族の中でまだ癌の発症のないメンバーが将来、癌に罹患する可能性が高いのか、あるいは一般の人々と同じであるのかを知ることが可能となることを理解しました。
従って、お話しましたように、彼女は前向きで受け止めました。そこで、この女性は彼女の姉妹と再度来院をし、膵臓癌のある女性はp16陽性でしたが、その姉妹は有難いことに、陰性でした。しかし、彼女が将来にわたって常に陰性であるかどうかを予測する方法は全くありません。彼女については、残りの全ての兄弟と同じように危険性は半々です。さて、陰性である彼女は子供達にそれほど心配しなくても良いと言えますが、他方、陽性である彼女は四人の娘達の全員を検査させる必要があります。この女性は23歳で来院したのですが、“私は近く結婚するつもりで、子供をつくることを考えていますが、私の母親が亡くなったことを知りながら、私に引く継がれたかもしれない病気を子供達に引き継がせたいかどうかということがよくわかりません”と言いました。従って、彼女はこのことについて、非常に成熟した理解をもっていました。23歳で、われわれの所へ癌素因の検査のために来る人はまれです。しかし、彼女は多くを体験してきて、母親と他の家族のメンバーが癌で苦しんだことを本当によく理解して、“どうしていいのかわかりません。もしこの変異があるなら、おそらく、養子をもらうことになると思います“と言いました。そこで、彼女は検査を受け、有難いことに結果は陰性でした。とても嬉しかったことです。そして彼女は結婚し、子供が生まれ、皆さん、元気に暮らしています。
それからですね、これらの姉妹の一団がメリーランドからも来まして、時によっては家族全員に会うというのは嬉しいことです。他の病院にも医師はいるわけですが、患者は、知らせをもたらした医師に信頼をよせるようになり、われわれは四人のうち、三人を診ましたが、これまでのところ、三人は陰性でした。非常に喜ばしいことです。そして兄弟のうちの一人がオレゴンに住んでいて、ここ1ヶ月余りの間に、実は、彼はメラノーマと診断され、検査を受けたところ、陽性でした。そういうことで、それは非常に良い質問です、従って、早期に行える治療措置がない限り、子供は作りません、そしてp16の変異についてできることは、10歳時からの皮膚科的スクリーニングだけです。そこで、子供が10歳から同意書に署名できる年齢まで皮膚科のスクリーニングを受けることを勧めることが、より適切であろうと考えました。その時点になれば、その子は検査を受ける用意があるかどうか、そしてそれについての情報を得ることを希望するかについて決めることができるでしょう。しかし、子供にとって非常に侵襲性であったり、問題となるような、あるいは痛みをもたらすであろう、ある種の治療措置があれば、子供に検査を行うことを考えるかもしれませんが、この特定の癌症候群については、それはしません。
さて、p16は、遺伝性メラノーマの20-40％の原因とされています。そしてあいにく、遺伝性メラノーマは多くの名称があり、p16遺伝子もいろいろな名称をもっています。そこで、時には、家族性のものについて誰かが話していると、何について話しているのか整理してみる必要があります。何故なら、その人は何について話しているのか良くわかっているかもしれませんが、われわれがその専門用語を知らないかもしれないからです。われわれは、多くの文献の検索を行います。
p16遺伝子について、検査を行うことで得られる利益には、変異状態を知ることで、用意された管理が可能になることが含まれます。それらの人々の50％は50歳までにメラノーマを発症し、76％が80歳までに発症します。メラノーマの発症の平均年齢は、35歳以上で、家族の約17％のみが、それ自体で、膵臓癌に罹患します。従って、ある割合の膵臓癌が起こるのは、必ずしも一定の症候群によるのではなく、p16遺伝子内のある特定の変異が膵臓癌に罹りやすくしているのかもしれません。従って、他の家族はメラノーマだけがみられる一方、明らかにこの家族は膵臓癌に非常にかかりやすいようです。
患者に遺伝子状態を伝えることによって、10歳から、6-12ヶ月毎に皮膚検査を受けるというスケジュールに従う患者が多くなり、サンスクリーンや防護用に衣服を着用する患者が多くなるということに気付いています。従って、このことは、人々を現実に目覚めさせ、どうしても自分自身を護らなければならないことを認識させます。そして、彼らは太陽光線への暴露や日焼け用ベッドについて、危険性のある行動をやめるようになります。
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English to Japanese: First-ever Progeria Clinical Drug Trial Information General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English 4. Risks
This is the first trial of its kind. Why FTI’s? Cells from patients with Progeria became more normal appearing when treated with FTIs. In addition, mice with the abnormal Progeria gene, when fed FTIs, also seems to get better. The next step in this process is to see if FTIs will have similar effects in humans. It is important to understand that the lab studies are not a guarantee that the drug will help humans. This is an experiment. You are helping us to understand if there is a benefit from this drug after 2 years.
The consent form, translated into your language, is 23 pages long, designed to include almost everything that could go wrong with taking this drug. In addition, because this drug has only just began testing in humans, it is still possible that there are severe problems caused by the drug that we do not yet know will occur. Since this drug has only been tested in a few patients, all of whom had cancer), it is also possible that this drug will have new, and potentially worse side effects when given to patients with Progeria.
Every drug has a risk of toxicity* (physical side effects) – aspirin, vitamins, etc. so there’s a chance the children will be worse off than when they started. In addition to the risk of toxicities, the drug might not work to stop the disease. You will therefore need to balance the risks of the drug with the unknown benefits of the treatment.
Common side effects of FTIs based on cancer trials (affecting 21-100 patients out of 100 patients):
Diarrhea is the most common, and can usually be prevented before it starts by using an anti-diarrhea medicine. So your child must start on anti-diarrhea medicine before the drug is given (Imodium) and then will go off of the Imodium if stools are normal.
Other common side effects, many associated with the diarrhea: Stomach pain, loss of appetite, vomiting – all are not permanent.
Occasional (5-20 patients out of 100 patients) and Rare (less than 5 patients out of 100 patients) side effects:
There are many occasional and rare side effects listed, and they are compiled from every person, young and old, with terminal cancer that has taken FTI. There is no way to know for sure whether the drug or the cancer or other problems like underlying diseases of old age were the cause of these medical problems, so the FDA has listed every one of them in the consent form. That way you are fully informed with the information that we know about.
English to Japanese: Diagnostic and prognostic methods for lung disorders using gene expression profiles from nose epithelial cells General field: Medical Detailed field: Law: Patents, Trademarks, Copyright
Source text - English Abstract: The present invention provides methods for diagnosis and prognosis of lung cancer using expression analysis of one or more groups of genes, and a combination of expression analysis from a nasal epithelial cell sample. The methods of the invention provide far less invasive method with a superior detection accuracy for lung cancer when compared to any other currently available method for lung cancer diagnostic or prognosis. The invention also provides methods of diagnosis and prognosis of other lung diseases, such as lung cancer.
Translation - Japanese 要約：本発明は、一つ以上の遺伝子グループの発現パターンの解析、および鼻腔上皮細胞サンプルの発現パターンの解析との組み合わせを用いた肺癌の診断方法と予後診断方法を提供する。本発明の方法は、現行するどの肺癌の診断あるいは予後診断方法に比べても、検出精度に卓越し、はるかに侵襲性が少ない方法である。本発明はまた、肺癌のようなその他の肺疾患の診断方法および予後診断方法を提供する。
Japanese to English: Product information of AVN (anti-neoplastic therapeutic drug) General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Japanese 3.創傷治癒遅延による合併症(創し開、術後出血等)があらわれることがある。
（1）手術後の患者に本剤を投与する場合は、術創22の状態を確認し、投与の可否を検討すること。大きな手術の術創が治癒していない場合は、治療上の有益性が危険性を上回ると判断される場合を除き、本剤を投与しないこと(「慎重投与」の項参照）。
（2）本剤の投与中に創傷治癒遅延による合併症があらわれた場合は、創傷が治癒するまで本剤の投与を中止し、適切な処置を行うこと(「重大な副作用」の項参照)。
（3）本剤の投与終了後に手術を行う場合は、本剤の投与終了からその後の手術まで十分な期間をおくこと(「重要な基本的注意25」、「重大な副作用」の項参照)。
Translation - English 3. AVN administration can result in wound healing complications (wound dehiscence, post-operative hemorrhage etc.).
(1) AVN administration should be carefully considered in post-operative patients by examining their extent of wound healing, and AVN should not be administered unless it is deemed that the therapeutic benefits exceed the risks of AVN administration (see “Careful administration”).
(2) If wound healing complications are developed during administration of AVN, patients should receive proper medical treatment and AVN administration should be suspended until wound healing is complete (see "Clinically significant adverse reactions").
(3) Take an appropriate interval between termination of AVN treatment and subsequent elective surgery (see “Important precautions”, “Clinically significant adverse reactions”).
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Years of experience: 19. Registered at ProZ.com: Dec 2009. Became a member: Dec 2009.
BS in pharmaceutical science and PhD in medical science.
Having worked in the pharmaceutical industry in US as a PhD scientist for more than 20 years, I took an early retirement from the industry and became a full time freelance translator in 2004. During my career at the pharmaceutical industry, I constantly provided translation between JPN and ENG for colleagues. My fields of expertise are medical/pharmaceutical science, chemistry, and life science.
I provide translation between English and Japanese for pharmaceutical regulatory documents (CSRs, IBs, trial protocols, ICFs, etc.), clinical case reports, and biomedical research articles. My regular end clients are major pharmaceutical companies and academic research scientists in US and Japan.
Member since Dec '09
