ASCO 2009:早期治療並未改善復發卵巢癌的存活


  June 1, 2009 (佛州奧蘭多) — 在復發卵巢癌的婦女中,於沒有症狀下,根據升高的癌症抗原(CA)-125值進行早期治療並無存活利益。即使在將近5個月時立即開始化療,也和那些在有症狀時才開始治療者的結果沒有差異。
  
  研究結果發表於美國臨床腫瘤協會第45屆年會中的全體會議。
  
  達那-法柏癌症研究中心婦女癌症小組主任Eric P. Winer醫師表示,這是會影響所有卵巢癌婦女生命的一項研究。這類研究通常不易進行,但是相當重要。
  
  這些結果發表時主持簡報的Winer醫師指出,研究結果不只會影響治療與改善卵巢癌婦女的生命,也潛在降低了健康照護相關費用。
  
  每年有超過21,000名婦女發生卵巢癌,多數診斷為末期。主要作者、英國Mount Vernon癌症中心腫瘤科教授Gordon Rustin醫師表示,CA-125值增加是癌症復發的早期徵兆,但是其意義未知。
  
  Rustin醫師表示,約有80%的末期病患在第一線化療之後會復發,她們多數可以從後續治療獲益。連續測量腫瘤標記有助於早期發現,但是不清楚它是否有助於較好的結果。
  
  CA-125對於卵巢癌診斷和監控是一個有用的分析,緩解期的婦女也常進行定期的CA-125檢測。Rustin醫師解釋,在初步治療之後,可以用每3個月檢測一次的頻率進行多年的追蹤。
  
  【無存活利益與較差的生活品質】
  「OV05/EORTC 55955」試驗是探討根據CA-125 值為基準進行復發疾病的及早化療利益,對照組是症狀發生之後才開始治療。研究的初級結果是整體存活,次級結果包括距離第2線化療的時間、距離第3線治療或死亡的時間,以及生活品質。
  
  研究對象於1996至2005年間來自10個國家的59處地點。登記參與本試驗的1,442名病患中,529人被隨機指派根據升高的CA-125值及早進行立即治療、或者延遲治療(在症狀發生之後)。
  
  每3個月測量一次CA-125值,但是病患與研究團隊並不知道結果,僅由試驗單位監控。如果數值超過正常上限兩倍,病患即被隨機分派接受立即治療,或者繼續測量CA-125值,直到症狀復發才開始治療。
  
  Rustin醫師解釋,登記後的平均存活期間為70.8個月,通常在診斷後6個月登記。從登記到隨機分組的時間平均是9個月。
  
  早期治療組的病患比延遲治療組的病患早4.8個月開始第2線化療,Rustin醫師指出,兩組之間的此一差異相當顯著。早期治療組在之後4.6個月開始第3線治療。
  
  Rustin醫師表示,結果顯示,較早化療並未獲得較長的緩解期間。較早接受第2線化療的病患也較早開始第3線治療,這些病患也沒有較長的緩解期。
  
  追蹤期有56.9個月,這段期間有379名病患(72%) 死亡。 他表示,兩組之間的存活結果完全沒有差異。風險比為1.00 (P= .98)。
  
  較早的治療也和整體健康評分惡化有關。Rustin醫師表示,及早治療並未改善生活品質;實際上造成惡化。
  
  【改變照護標準?】
  這是首次確認婦女根據CA-125進行及早治療並無助益。
  
  婦女現在在追蹤照護時可以有兩種選擇:沒有例行的CA-125檢查或進行例行的CA-125檢測。Rustin醫師表示,即使CA-125值升高,也可以延遲化療。這是第一次,婦女可以再度確認根據CA-125進行及早治療並無助益,等到徵兆與症狀出現再開始化療也是安全的。
  
  洛杉磯Cedars-Sinai醫學中心婦女癌症研究中心主任Beth Karlan醫師認為,這些結果是重要的,許多改變了我們的照護實務。本研究讓我們質疑,如果未能改善存活或生活品質,何以要密集監測CA-125。Karlan醫師是本報告的商討對象。Karlan醫師表示,如果額外化療之及早介入未能改善存活且會影響生活品質,我們何須再這樣?
  
  本研究讓我們質疑,如果未能改善存活或生活品質,何以要密集監測CA-125 。
  
  雖然本研究強度有限且有限制,但整體而言,Karlan醫師認為這些結果會改變臨床實務。她表示,我們需要教育醫師和病患有第1級證據力的試驗,而建議進行較少次的監測。我們應該考慮延遲緩和化療,除非臨床症狀發生。
  
  在每日專題小組中,德州大學安德森癌症中心婦科腫瘤部的Robert L. Coleman醫師指出,病患可能希望繼續檢測CA-125。
  
  他表示,病患期待很高且希望有這個檢測。我們很難告訴病患它並不重要。
  
  MRC/NCRI以及EORTC Gynae Cancer Intergroups主導本研究。Rustin醫師宣告沒有相關財務關係。Karlan醫師接受Eli Lilly的獎助金,以及Amgen、AstraZeneca、Genentech、Gynecologic Oncology Group、Marshall Edwards和Unither Pharmaceuticals的研究資金。Coleman 醫師擔任Celgene、Genentech、GlaxoSmithKline、Merck、Morphotek等藥廠的諮商或顧問;接受GlaxoSmithKline、Lilly、Ortho Biotech, Sanofi-Aventis以及Novartis藥廠的研究資金/獎助金。
  
  美國臨床腫瘤協會(ASCO)第45屆年會:摘要 1。發表於2009年5月31日。
  

ASCO 2009: Early Treatment Does Not Improve Survival in Relapsed Ovarian Cancer

By Roxanne Nelson
Medscape Medical News

June 1, 2009 (Orlando, Florida) — There is no survival benefit from early treatment based on an elevated cancer antigen (CA)-125 level alone, in the absence of symptoms, among women with recurrent ovarian cancer. Even though chemotherapy was started nearly 5 months sooner, there was no difference in outcome from those who began treatment when they became symptomatic.

The results of the study were presented during the Plenary Session here at the American Society of Clinical Oncology 45th Annual Meeting.

"This is a study that can affect the lives of all women with ovarian cancer," said Eric P. Winer, MD, chief of the Division of Women's Cancers at the Dana–Farber Cancer Institute in Boston, Massachusetts. "This is the kind of research that is often very difficult to do, but it is very important."

The results of this study can not only influence treatment and improve the lives of women with ovarian cancer, it also has the potential to substantially reduce healthcare-related costs, added Dr. Winer, who moderated a press briefing during which these results were presented.

More than 21,000 women develop ovarian cancer each year, and most will be diagnosed with advanced disease. "A rise in the level of CA-125 is an early signal of cancer recurrence, but its meaning is not known," said lead author Gordon Rustin, MD, professor of oncology at Mount Vernon Cancer Center in Hertfordshire, United Kingdom.

"About 80% of patients with advanced disease will relapse after first-line chemotherapy, and most of them benefit from further therapy," said Dr. Rustin. "Serial measurement of circulating tumor markers has the potential for earlier detection, but it is unknown if it will lead to better outcomes."

CA-125 is a valuable assay for the diagnosis and monitoring of ovarian cancer, and it is common for women to undergo periodic CA-125 testing while they are in remission. Testing can occur as frequently as every 3 months for several years following their initial treatment, explained Dr. Rustin.

No Survival Advantage and Poorer Quality of Life

The OV05/EORTC?55955 trial was designed to investigate the benefit of early chemotherapy for relapsed disease on the basis of CA-125 levels alone, as opposed to treatment after symptom onset. The primary outcome of the study was overall survival, and secondary outcomes included time to second-line chemotherapy, time to third-line treatment or death, and quality of life.

The study participants were drawn from 59 sites in 10 countries between 1996 and 2005. Of the 1442 patients registered for the trial, 529 were randomized to either immediate treatment on the basis of rising CA-125 levels or delayed treatment (after the onset of symptoms).

CA-125 levels were measured every 3 months, but patients and the research team were blinded to the results, which were only monitored by the trials units. If the levels exceeded twice the upper limit of normal, the patients were randomized to immediate treatment or to continue with the blinded CA-125 measurements with treatment delayed until symptom recurrence.

Median survival from registration was 70.8 months, which occurred about 6 months after diagnosis, explained Dr. Rustin. "The time from registration to randomization was a median of 9 months."

Patients in the early-treatment group started second-line chemotherapy 4.8 months earlier than the delayed-treatment group, and Dr. Rustin pointed out that this difference between the 2 groups was highly significant. Third-line chemotherapy was begun 4.6 months sooner in the early-treatment group.

"The results showed that earlier chemotherapy did not induce a longer time to remission," said Dr. Rustin. Patients who received second-line chemotherapy earlier also received third-line treatment earlier, and these patients also did not benefit from a longer remission.

Follow-up was 56.9 months and, during that time, 379 (72%) patients died. "There was absolutely no difference in survival outcomes in the 2 groups," he said. The hazard ratio was 1.00 (P?= .98).

Earlier treatment was also associated with a deterioration in global health scores. "Early treatment did not improve quality of life; it actually made it worse," Dr. Rustin said.

Change Standard of Care?

For the first time, women can be reassured that there is no benefit from early treatment based on CA-125.

Women can now be offered a choice in follow-up care: no routine CA-125 or regular CA-125 surveillance. "Even if the CA-125 rises, chemotherapy can be delayed," said Dr. Rustin. "For the first time, women can be reassured that there is no benefit from early treatment based on CA-125, and that chemotherapy can be safely delayed until signs and symptoms appear."

These results are important and may change our standards of care, commented Beth Karlan, MD, director of the Women's Cancer Research Institute at Cedars-Sinai Medical Center in Los Angeles, California. "This study makes us question why we perform intensive CA-125 surveillance if it doesn't improve survival or quality of life," said Dr. Karlan, who served as a discussant of the paper. "If early intervention with additional chemotherapy does not improve survival and may in fact impair quality of life, then why are we doing it?"

This study makes us question why we perform intensive CA-125 surveillance if it doesn't improve survival or quality of life.

Although the study had strengths and limitations, overall, Dr. Karlan feels that these results can change clinical practice. "We need to educate clinicians and patients about the level?I evidence provided by the trial and recommend less frequent monitoring," she said. "We should consider delaying palliative chemotherapy until clinical recurrence."

During the daily Highlights Session, Robert L. Coleman, MD, from the Department of Gynecologic Oncology at the University of Texas MD Anderson Cancer Center in Houston, pointed out that patients might want to continue having CA-125 testing.

"Patient expectation is high and patients demand this test," he said. "We have a very hard time telling patients that it is not important."

The study was conducted by the MRC/NCRI and EORTC Gynae Cancer Intergroups. Dr. Rustin has disclosed no relevant financial relationships. Dr. Karlan has received honoraria from Eli Lilly and research funding from Amgen, AstraZeneca, Genentech, the Gynecologic Oncology Group, Marshall Edwards, and Unither Pharmaceuticals. Dr. Coleman has consulted and/or served in an advisory role for Celgene, Genentech, GlaxoSmithKline, Merck, Morphotek; and has received research funding/honoraria from GlaxoSmithKline, Lilly, Ortho Biotech, Sanofi-Aventis, and Novartis.

American Society of Clinical Oncology (ASCO) 45th Annual Meeting: Abstract 1. Presented May 31, 2009.

    
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