August 2, 2006 (亞特蘭大) — 根據一項新調查，醫師間常討論規範外的治療方式且常用在
癌症病患，但是腫瘤科醫師間對這些方法的態度大異其趣；最近的美國臨床腫瘤學會(ASCO)第42屆年會中，研究者建議專家們發展指導規範以幫助醫師在處方實驗式治療方式時有所依循。
主要作者、北卡羅萊納大學的Jeffrey Peppercorn醫師在年會中發表他的壁報時表示，我們從ASCO 中隨機調查了一些美國腫瘤科醫師，直接調查他們對規範外的治療方式的態度和實務面，我們評估了人口統計因子、態度、使用規範外的處方和對假定案例的反應之間的關聯。
研究者指出已經登載的資料中沒有臨床試驗以外的試探式治療方式的使用頻率，也沒有醫師對這些使用方式的態度的相關報告；研究者設定調查471位腫瘤科醫師，有146位回覆、回覆率為31%。
回覆者之中有 93%曾討論實驗式治療方式，有81%表示曾經如此開方；曾經如此開方者中有66%一年至少這樣開方一次，約12% 每個月開方一次或更多次這種規範外的治療方式。
但有68%表示反對要求一年至少這樣開方一次，有6%拒絕每個月開方一次或更多次。
【許多人認為病患接受實驗式治療方式會感到氣餒】
回覆者之中多達61%認為病患接受實驗式治療方式會感到氣餒，約 31%認為並不適用於所有人；超過半數表示如果有要提供病患實驗式治療方式時應對病患充分告知，但有34%不同意如此；回覆者之中有26% 病患有權考慮接受規範外的治療方式，56% 則不以為然。
Peppercorn醫師和他的團隊將這些受訪者依照實務層面分類，發現學院派的腫瘤醫師比社區醫師更常提供規範外的治療方式(89%相較於75%；以費雪精確檢定之 P = .06)；學院派的腫瘤醫師也比較常討論這些治療方式，每個月至少一次(45%相較於12%； P = .003) ，且否認要求於每月至少一次的依據(15%相較於2%; P = .02)。
研究者報告指出，非學院派的腫瘤醫師較少要求者也常提供規範外的治療方式給病患(P = .04)；此點在執業超過15年以上的醫師特別明顯 (P = .08)，相信試驗式和非試驗式照顧的是相當的 (P = .01) 且相信病患有權接受試驗式治療(P = .004) 的腫瘤醫師較可能提供這些治療方式。
但一般來說，研究者表示不論是實務面還是人口統計方面的因素都會影響開方態度，該團隊報告，在假定的案例中，對於是否開方規範外的治療方式則少有一致；舉例來說，最近的試驗得到的資料中有41%表示將在病患要求時開方含trastuzumab為佐藥的規範外之治療方式。
研究者表示，他們的研究指出試驗式治療方式倫理方面考量的附加研究的需求，以及後續實務規範之發展，以幫助腫瘤醫師和病患做決定。
ASCO 42屆年會：摘要 6047。發表於June 5, 2006。
Oncologists Divided Over Experimental Treatments
By Allison Gandey
Medscape Medical News
August 2, 2006 (Atlanta) — According to a new survey, off-protocol therapies are commonly discussed in physicians' offices and are often administered to cancer patients, but attitudes toward these approaches continue to vary widely in the oncology community. At the recent 42nd annual meeting of the American Society of Clinical Oncology (ASCO), researchers recommended that experts develop guidelines to help physicians navigate the murky waters of prescribing experimental therapies.
"We surveyed a random sample of American medical oncologists chosen from the ASCO directory regarding their attitudes and practices surrounding off-protocol prescribing," lead author Jeffrey Peppercorn, MD, from the University of North Carolina at Chapel Hill, stated during his presentation in a poster session at the meeting. "We evaluated the correlation between demographic factors, attitudes, use of off-protocol prescribing, and response to hypothetical cases."
The investigators point out that there are no published data on the frequency of investigational-therapy use outside of clinical trials, or of physician attitudes toward their use. The researchers sent surveys to 471 oncologists and received responses from 146 — a 31% response rate.
A total of 93% of respondents reported discussing experimental therapies with patients, and 81% said they had prescribed them. Of these, 66% reported prescribing investigational treatments at least once a year. About 12% said they prescribed an off-protocol therapy once a month or more.
But 68% reported denying requests for such treatments at least once a year and 6% refused to provide them once a month or more frequently.
Many Said Patients Should be Discouraged From Using Investigational Therapies
The majority of respondents — 61% — said that patients should be discouraged from using off-protocol treatments. A smaller number — 31% — said they should not be available at all. More than half the oncologists surveyed said that patients considering trial enrollment should be informed if an investigational therapy is available; 34% disagreed. A total of 26% of respondents thought that patients considering enrollment have a right to off-protocol treatment; 56% said this is not the case.
Dr. Peppercorn and his team stratified the cohort by practice setting and found that academic oncologists were more likely than community oncologists to have ever provided off-protocol therapy (89% vs 75%; P = .06 by Fisher's exact test). Academic oncologists were also more likely to discuss these therapies at least once a month (45% vs 12%; P = .003) and to deny requests on at least a monthly basis (15% vs 2%; P = .02).
The researchers report that, despite generally fewer requests, oncologists in nonacademic practice settings were more likely to provide an off-protocol prescription to patients (P = .04). This was especially true of physicians in practice for more than 15 years (P = .08). Oncologists who believe that trial and nontrial care are equivalent (P = .01) and those who believe that patients have a right to access investigational therapies (P = .004) were also more likely to make these treatments available.
But in general, the researchers say that neither practice setting nor other demographic factors predicted attitudes toward prescribing. "For hypothetical cases, there was little consensus regarding when to prescribe off-protocol therapies," the team reports. "For example, prior to the release of data from recent trials, 41% reported that they would prescribe adjuvant trastuzumab off-protocol at a patient's request."
The investigators say their study highlights the need for additional research into the ethical considerations of experimental therapies and the development of subsequent practice guidelines to help oncologists and patients make decisions.
ASCO 42nd Annual Meeting: Abstract 6047. Presented June 5, 2006.
作者：
Allison Gandey 2007-6-20