第二次的減積手術並不會延長卵巢癌患者的存活期


  Dec. 9, 2004 - 一項刊載於12月9日新英格蘭醫學期刊上的隨機性研究結果顯示,第二次的減積手術並不會延長末期卵巢癌患者的存活期。
  
  克里夫蘭Case Western Reserve University的Peter G. Rose醫師指出,在延長末期卵巢癌患者存活期上所作的努力,並沒有太大的成效;這類病症的標準療法包含主要癌細胞及轉移性癌細胞的全面切除、切除手術完成後再進行化療,而化療後所接續的減積手術則用來降低腫瘤負擔。
  
  這項試驗一共有550位末期卵巢癌婦女患者參與,這些婦女都在第一次手術後殘留了直徑1公分以上的腫瘤;在以paclitaxel及cisplatin合併治療3次以後,如果患者沒有症狀惡化的現象,就會被以隨機的方式分為兩組,第1組進行第二次減積手術,再接續3個另外增加的化學療程,第2組則只進行另外的3個化學療程。
  
  在424位合乎試驗條件的患者中,216位被以隨機性的方式編為第1組,第2組則有208位;第1組中有15位患者(7%)沒有接受第二次的減積手術,其中有一部分是患者本身不願意,另一部分則因為其他醫療方面的限制而無法接受。
  
  在2003年3月份時,296位患者死亡,82位病況惡化;第1組的無惡化存活期為第2組的1.07倍,第1組的死亡相關風險因素則為第2組的0.99倍;由此可知,兩組的數值都類似。
  
  兩組的手術侵犯程度可能有一些無法量化的差異,腫瘤大小的測量並不一致等,都是本研究的限制因素。
  
  Rose醫師表示,對於末期卵巢癌患者,第一次的減積手術已經是最大極限了,第二次的減積手術,及手術後的化療(paclitaxel及cisplatin)並不會延長無惡化存活期,甚至不會延長總存活期;雖然對於明顯為末期的患者而言,手術是標準的初期治療法,但是手術前使用新輔助化療法(neoadjuvant)的可行性也正在評估當中;目前在歐洲有一項隨機性的臨床試驗正在進行,目的在作一些不同療法的比較,一為第1次手術及手術後化療的合併療法,另一則是新輔助性化療加上手術的合併療法。
  
  本研究由美國國家癌症研究機構所贊助。
  
  密西西比醫學院的Tate Thigpen醫師為新英格蘭醫學期刊的總編輯,他指出,在選擇卵巢癌的治療法時,應該將可以預測治療結果的因素列為最重要的考量,這包括腫瘤的殘留量、腫瘤生物學及外科切除手術的極限等。
  
  Thigpen醫師表示,外科切除所必須考慮的5點理由支持了一項論點,那就是這類手術必須要在化療之前進行;在美國,對於末期卵巢癌的處理,這個論點和現行的醫療標準程序相符,標準的醫療程序為,先進行減積手術,再以paclitaxel及carboplatin作化療,而第二次的減積手術應該保留給第1次手術不完全的患者。

Secondary Cytoreduction for Ov

By Laurie Barclay, MD
Medscape Medical News

Dec. 9, 2004 — Secondary cytoreduction for advanced ovarian cancer does not improve survival, according to the results of a randomized study published in the Dec. 9 issue of the New England Journal of Medicine.

"Efforts to improve survival among women with advanced ovarian cancer have had only limited success," write Peter G. Rose, MD, from Case Western Reserve University in Cleveland, Ohio, and colleagues. "Standard treatment of such cases is a combination of maximal resection of primary and metastatic carcinoma and postoperative chemotherapy.... Secondary surgical cytoreduction after chemotherapy is a strategy for reducing tumor burden."

Within six weeks after primary surgery, 550 women with advanced ovarian cancer and residual tumor exceeding 1 cm in diameter after primary surgery were enrolled. If a patient had no evidence of progressive disease after three cycles of postoperative paclitaxel plus cisplatin, she was randomized to undergo secondary cytoreductive surgery followed by three more cycles of chemotherapy or three more cycles of chemotherapy alone.

Of 424 eligible patients, 216 patients were randomized to receive secondary surgical cytoreduction followed by chemotherapy and 208 patients were randomized to receive chemotherapy alone. Of the patients randomized to secondary surgery, 15 patients (7%) did not undergo surgery because they declined it or because it was medically contraindicated.

As of March 2003, 296 patients had died and 82 had progressive disease. Compared with the chemotherapy-alone group, the secondary surgery group had a likelihood of progression-free survival of 1.07 (95% confidence interval [CI], 0.87 - 1.31; P = .54) and a relative risk of death of 0.99 (95% CI, 0.79 - 1.24; P = .92).

Study limitations include possible differences in surgical aggressiveness that are difficult to quantify and interobserver variability in tumor measurements,

"For patients with advanced ovarian carcinoma in whom primary cytoreductive surgery was considered to be maximal, the addition of secondary cytoreductive surgery to postoperative chemotherapy with paclitaxel plus cisplatin does not improve progression-free survival or overall survival," the authors write. "Although surgery is currently considered the initial standard treatment for patients with a good performance status who have apparent, advanced disease, the value of neoadjuvant (preoperative) chemotherapy is being investigated.... A randomized European trial comparing primary surgery plus postoperative chemotherapy with neoadjuvant chemotherapy plus surgery is ongoing."

The National Cancer Institute supported this study. One of the authors reports having received consulting fees from Eli Lilly and Aventis.

In an accompanying editorial, Tate Thigpen, MD, from the University of Mississippi School of Medicine in Jackson, discusses the history of treatment options for ovarian cancer. Important predictors of outcome include the volume of residual disease, biology of the tumor, and extent of surgical debulking.

"The five points cited as the rationale for surgical debulking support the contention that such surgery should be performed before the initiation of chemotherapy," Dr. Thigpen writes. "This approach is consistent with the current standard of care for advanced ovarian carcinoma in the United States: initial surgical cytoreduction is followed by chemotherapy with paclitaxel plus carboplatin. Secondary surgical cytoreduction should be reserved for patients in whom the initial surgical effort at cytoreduction was not considered to be maximal."

N Engl J Med. 2004;351:2489-2497, 2544-2546

Reviewed by Gary D. Vogin, MD

    
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