2026年7月11日 星期六

「好得令人難以置信」:一項關於癌症治療時機的中國研究被撤稿 (2/2)

Recently The New York Times reported the following:

‘Too Good to Be True’: A Chinese Study on Timing Cancer Therapy Is Retracted (2/2)

In a notice flagging a series of problems with a clinical trial, the journal Nature Medicine said its editors “no longer have confidence in the integrity of the results.”

By Rebecca Robbins - Rebecca Robbins is a Times reporter covering the pharmaceutical industry. She has been reporting on health and medicine since 2015.

June 25, 2026

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Dr. Yongchang Zhang, the study’s senior author, said in a statement that an internal review had “confirmed that part of the study execution and manuscript preparation might not reach the standards for publication in a high-impact journal.”

Dr. Zhang, a researcher at the Chinese hospital where the study was conducted, added: “We acknowledge these shortcomings and sincerely apologize for any inconvenience caused to the journal and its readers.” He did not provide an explanation for the problems cited by the journal.

The study had enrolled 210 patients with advanced lung cancer at Hunan Cancer Hospital in Changsha, a city in south-central China. Patients were randomly assigned to receive infusions of an immunotherapy — Merck’s blockbuster drug Keytruda or Tyvyt, which is not approved in the United States — either before or after 3 p.m.

The study reported that tumors did not progress for 11 months in patients who received the earlier infusions, compared with six months for those given the later infusions. Patients receiving the earlier infusions lived for 28 months, compared with 17 months for those infused later in the day.

Those “were numbers we usually associate with new blockbuster drugs, not scheduling decisions,” wrote Dr. Gilberto Lopes, an oncologist at the University of Miami. And rescheduling a patient “costs nothing,” he noted.

Dr. Anil Makam, an epidemiologist and health services researcher at the University of California, San Francisco, said such a drastic benefit, if real, would have prompted infusion clinics to overhaul staffing and scheduling to shift appointments to earlier in the day.

“If we believed the effects, it would be malpractice not to,” he said.

But within days after the study’s publication in Nature Medicine, online sleuths and physicians like Dr. Makam began raising concerns on social media and in blog posts. Less than three weeks after the study was published, the journal published an editor’s note saying it was investigating the issues.

In a statement on Thursday, Dr. João Monteiro, chief editor of Nature Medicine, which is published by Springer Nature, said, “We are grateful to the research community for bringing these concerns to our attention.”

Some scientists have long been intrigued by the idea of harnessing the body’s circadian rhythms to try to make drugs more effective or less toxic. For example, enzymes that the body uses to break down certain medicines are more abundant at certain times of day.

But critics of the Chinese study argued that immunotherapy works very differently from fast-acting drugs like Tylenol. The drug Keytruda lingers in the body and takes effect over several weeks. The study did not identify a biological reason for a difference in treatment timing that would produce such a significant benefit.

“There wasn’t any sound scientific rationale behind it,” said Dr. Roy Herbst, the incoming director of the Dartmouth Cancer Center in New Hampshire and Vermont.

In March, a team led by European researchers reported the findings of an analysis that looked at whether more than 3,000 cancer patients across eight studies had received immunotherapy in the morning or the afternoon. Their study, funded by the drugmaker Roche, which sells a number of cancer drugs, concluded that timing was “unlikely to be a critical determinant” of how well patients did.

Other studies looking back at outcomes have found an association between the time of day that patients receive a cancer immunotherapy and how well they fare. But the why remains unclear.

Doctors said it was possible that more energetic, healthier patients might opt for morning slots. Poorer or rural patients who live far from an infusion center — and tend to fare worse — might ask for afternoon slots because they need to spend the morning traveling to their appointment.

Translation

「好得令人難以置信」:一項關於癌症治療時機的中國研究被撤稿 (2/2)

《自然醫學》雜誌在聲明中指出一項臨床試驗存在一系列問題,並表示其編輯「不再對研究結果的可靠性有信心」

 (繼續)

該研究的資深作者Yongchang Zhang博士在聲明中表示,內部審查「證實部分研究執行和稿件準備工作可能不符合高影響力期刊的發表標準」。

Zhang博士是該研究開展所在中國醫院的研究員,他補充說:「我們承認這些不足,並對給期刊及其讀者帶來的任何不便深表歉意」。他沒有解釋期刊所指出的問題。

這項研究在湖南省長沙市湖南省腫瘤醫院 招募了210名晚期肺癌患者。患者被隨機分配接受免疫療法輸注-默克公司的重磅藥物KeytrudaTyvyt(該藥尚未在美國被批準)-分別在下午3點前或下午3點後進行。

研究報告顯示,接受較早輸注的患者腫瘤持續11個月沒有增大或惡化,而接受較晚輸注的患者腫瘤沒增大或惡化持續時間為6個月。接受較早輸注的患者平均存活期為28個月,而接受較晚輸注的患者平均存活期為17個月。

University of Miami腫瘤學家Gilberto Lopes博士寫道:「這些數據通常與重磅新藥相關,而不是與輸注時間安排相關的」。他還指出,重新安排患者的輸注時間「無需任何成本」。

加州大學舊金山分校 的流行病學家和衛生服務研究員Anil Makam博士表示,如果這種顯著的益處真的存在,那麼輸液診所應該會徹底改革人員配備與排班制度,調整時間,將輸液提前到一天中的早些時候。

他說:「如果我們相信這些效果,那麼不去調整就是瀆職」。

然而,這項研究發表在《自然醫學》雜誌幾天後,像Makam博士這樣的網路偵探和醫生就開始在社群媒體和部落格文章中表達擔憂。研究發表不到三週後,雜誌發表了編輯說明,表示正在調查這些問題。

《自然醫學》雜誌主編João Monteiro博士週四在一份聲明中表示:「我們感謝研究界讓我們注意到這些問題」。該雜誌由Springer Nature出版。

一些科學家長期以來一直對利用人體晝夜節律來提高藥物療效或降低藥物毒性的想法很感興趣。例如,人體用於分解某些藥物的酵素在一天中的某些時段含量更高。

但批評這項中國研究的人士認為,免疫療法的作用機制與Tylenol等速效藥物截然不同。藥物Keytruda會在體內停留數週,逐漸起效。研究並未找到治療時間差異有產生如此顯著療效的生物學原因。

即將上任的新罕布什爾州和佛蒙特州Dartmouth癌症中心主任Roy Herbst博士說:「這項研究背後沒有任何合理的科學依據」。

今年3月,一個由歐洲研究人員領導的團隊發表了一項分析結果,該分析考察了八項研究中3,000多名癌症患者接受免疫療法的時間(上午或下午)。這項由Roche製藥公司資助的研究得出結論,治療時間「不太可能是決定」患者療效的關鍵因素。Roche製藥公司銷售多種抗癌藥物。

其他回顧性研究發現,患者接受癌症免疫療法的時間與治療效果之間存在關聯。但原因尚不明確。

有醫生表示,精力更充沛、身體更健康的患者可能更傾向於選擇上午的治療時段。而居住地偏遠、遠離輸液中心的貧困患者(療效對他們往往較差)則可能要求下午的治療時段,因為他們需要花費上午的時間前往治療地點。

So, recently a medical journal article has caught the attention of cancer patients and doctors worldwide because of its extraordinary conclusion. Simply changing the time of day that immunotherapy was administered appeared to produce a stunning benefit for lung cancer patients, and eventually the study was retracted. Apparently, it is possible that healthier patients may have opted for morning slots while poorer patients, usually live in the rural area and tend to fare worse, may ask for afternoon slots because they need to spend the morning traveling to receive the immunotherapy in the afternoon.

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