NCCN卵巢癌指引仍有爭議


  【24drs.com】根據NCCN第17屆年會中的發表,國家綜合癌症網絡(NCCN)的卵巢癌指引依舊持續有一些爭議。
  
  加州洛杉磯希望之城綜合癌症中心的Robert Morgan醫師表示,去年還沒有太多改變,但是指引有許多方面有爭議,其中一個爭議是有關使用生物標記CA-125監測手術和/或化療的病患,Morgan醫師形容CA-125是最具爭議性的病患追蹤方式。
  
  追蹤指引呼籲病患每2-4個月回診2年,之後每3-4個月回診3年,然後每年1次;根據指引,進行這些回診時,CA-125和其他腫瘤標記如果最初有升高,應予以檢查。在追蹤期間,指引提供了兩個不同的方式探討CA-125升高(生化復發),影像檢查之後,可以立即治療復發的疾病或者等到臨床復發後才治療。
  
  Morgan醫師指出,歐洲的隨機試驗比較了這兩種方式的結果(登載於Lancet期刊、2010;376:1155-1163),該試驗確認CA-125在偵測無症狀的復發卵巢癌方面是可信任的。不過,該試驗也顯示,復發卵巢癌婦女如果根據CA-125值升高而比較早開始化療,和等到症狀發生才治療者相比,並沒有活得比較久,他們也因為化療而生活品質降低。
  
  Morgan醫師解釋,歐洲試驗的第一作者Gordon Rustin醫師曾表示,不完全遵守CA-125也是有效;這在心態上否定了病患和醫師選擇使用該標記。Morgan醫師表示他的病患大部分希望他遵守CA-125。
  
  Morgan醫師指出,主要還是要相當及時,他向NCCN會議的聽眾表示,一篇有關CA-125的辯論,參與辯論的有Rustin醫師(來自英國Mount Vernon癌症中心)以及卵巢癌專家Beth Karlan醫師(來自加州洛杉磯Samuel Oschin綜合癌症研究中心)。
  
  Morgan醫師表示,NCCN和婦科腫瘤醫師協會建議討論病患使用CA-125的可用性。
  
  Morgan醫師為該指引辯護時表示,歐洲的試驗與關於存活的負面結果有許多限制。該試驗並未探討次級減瘤術對於復發案例的可能影響,研究對象並未根據減瘤術之後的殘餘病灶進行分類,影像檢查緩解情形並不一致,復發時的治療處方並未標準化。
  
  密西根大學綜合癌症中心Carolyn Johnston醫師表示,卵巢癌指引少數值得注意的改變之一,NCCN對某些病患的分類從2A類升為第1類,建議考慮新輔助化療。
  
  特別的是,根據該指引,新輔助的化療則是建議用於體積分期III/IV病灶、確認不適合手術者,該指引有一部分也建議使用初級的間歇性減瘤術。
  
  Johnston醫師反問,我們如何選擇適合新輔助化療的病患?最重要的,應是由婦科醫師決定。一般而言,這些病患因為病灶過大而無法手術,或者減積後的發病率而排除了預定的手術。
  
  Morgan醫師解釋,這類病患在術前給予化療的方式在美國和在歐洲並未被廣泛接受,因此,這個建議是NCCN卵巢癌指引的另一個爭議點。
  
  Johnston醫師指出,需有研究釐清和預測哪些病患會有不完整的減瘤結果,但是,所有案例中,應在化療前確認疾病之診斷;使用細針穿刺、液體細胞學檢查或切片來確認。
  
  新輔助化療的好處的最佳證據來自一篇第3期試驗(N Engl J Med期刊、2010;363:943-953)。
  
  第IIIC/IV期卵巢、腹膜和輸卵管癌的病患被隨機分組接受初級減積手術(之後進行6療程的白金製劑化療,主要是使用paclitaxel/carboplatin)或間歇性減積手術(術前和術後分別進行3療程的化療)。
  
  Johnston醫師表示,對於輔助和新輔助組,整體存活期間中位數相似(29 vs 30個月),不過,新輔助組的併發症比較小;輔助組和新輔助組的術後死亡率顯著降低(分別是6.0% vs 2.7%),其他降低的包括等級3/4的術後發燒(8.0% vs 2.0%)、等級3/4的出血(7.0% vs 1.0%)以及凝血(2.4% vs 0.3%)。
  
  資料來源:http://www.24drs.com/professional/list/content.asp?x_idno=6766&x_classno=0&x_chkdelpoint=Y
  

Controversies Continue in NCCN Ovarian Cancer Guidelines

By Nick Mulcahy
Medscape Medical News

March 20, 2012 (Hollywood, Florida) — The ovarian cancer guidelines from the National Comprehensive Cancer Network (NCCN) address a number of ongoing controversies, according to a presenter here at the NCCN 17th Annual Conference.

"There have not been a lot of changes in the past year, but there are various areas of controversy in the guidelines," Robert Morgan, MD, from the City of Hope Comprehensive Cancer Center in Los Angeles, California, told Medscape Medical News at the conference.

One such controversy is about the usefulness of the biomarker CA-125 to monitor patients who have been treated with surgery and/or chemotherapy. Dr. Morgan called CA-125 the "most controversial" aspect of patient follow-up.

The follow-up guidance calls for patient visits every 2 to 4 months for 2 years, every 3 to 4 months for 3 years, and annually after that. At all of these visits, CA-125 and other tumor markers should be checked if "initially elevated," according to the guideline.

The guidelines offer clinicians 2 different routes to take in the event of rising CA-125 (biochemical recurrence) during follow-up — after imaging studies, one can either undertake immediate treatment for recurrent disease or delay treatment until clinical relapse.

Dr. Morgan noted that a European randomized trial compared outcomes with these 2 options (Lancet. 2010;376:1155-1163). That trial confirmed that CA-125 can reliably detect asymptomatic relapsing ovarian cancer.

However, it also showed that women with relapsed ovarian cancer did not live longer if chemotherapy was started earlier on the basis of a rising CA-125 level, as opposed to delaying treatment until symptoms developed. They also had a diminished quality of life because of chemotherapy.

The lead author of the European trial, Gordon Rustin, MD, has said, in effect, "don't follow CA-125 at all," Dr. Morgan explained. But that mentality denies patients and their clinicians the choice of using the marker, he said.

"Most of my patients...really want me to follow the CA-125," said Dr. Morgan.

The subject continues to be very timely, noted Dr. Morgan. He told the NCCN audience that just last week, Medscape Hematology-Oncology published a debate on CA-125 between Dr. Rustin, who is from the Mount Vernon Cancer Centre in Northwood, United Kingdom, and another ovarian cancer expert, Beth Karlan, MD, from the Samuel Oschin Comprehensive Cancer Institute in Los Angeles, California.

The NCCN and the Society of Gynecologic Oncologists suggest discussing the possible utility of CA-125 with patients, said Dr. Morgan.

In defense of that guidance, Dr. Morgan pointed out that the European trial — and its negative findings about survival — had multiple limitations. The trial did not address the possible role of secondary cytoreduction in recurrent cases, participants were not stratified for residual disease after cytoreduction, remission was not consistently confirmed by imaging, and treatment regimens at relapse were not standardized.

Neoadjuvant Chemotherapy for Some Patients

In one of the few notable changes in the ovarian cancer guidelines, the NCCN has upgraded to category 1 (from 2A) their recommendation to consider neoadjuvant chemotherapy in some patients, said Carolyn Johnston, MD, from the University of Michigan Comprehensive Cancer Center in Ann Arbor.

Specifically, neoadjuvant chemotherapy is recommended for patients with bulky stage III/IV disease who are determined "not to be surgical candidates," reads the guideline. Primary interval cytoreduction is also recommended as part of this guidance.

"How do we select patients who are candidates for neoadjuvant therapy?" Dr. Johnston asked rhetorically. First of all, the decision should be made by a gynecologic oncologist, she answered.

In general, these patients "have too much bulk for surgery" or the morbidity of debulking precludes the upfront surgery, she told the NCCN audience.

Dr. Morgan explained that the approach of giving chemotherapy before surgery to these types of patients is not as well accepted in the United States as it is in Europe. Therefore, this recommendation is another area of controversy in the NCCN ovarian cancer guidelines.

"Work needs to be done" to clarify and predict which patients will have incomplete cytoreduction, Dr. Johnston added. But in all cases, the diagnosis of the disease should be confirmed before chemotherapy; use fine-needle aspiration, cytology of fluid, or biopsy to confirm.

The best evidence of the advantages of neoadjuvant chemotherapy comes from a phase 3 trial (N Engl J Med. 2010;363:943-953).

Study participants with stage IIIC/IV ovarian, peritoneal, and fallopian tube carcinoma were randomized to receive either primary debulking surgery (followed by 6 cycles of platinum-based chemotherapy, which was mostly paclitaxel/carboplatin) or interval debulking surgery (which was preceded and followed by 3 cycles of the chemotherapy).

For the adjuvant and neoadjuvant groups, median overall survival was similar (29 vs 30 months), said Dr. Johnston. However, there were fewer complications in the neoadjuvant group, she said.

Those complications, as reported by Medscape Medical News when the study was first presented, included a statistically significant reduction in postoperative deaths in the adjuvant and neoadjuvant cohorts (6.0% vs 2.7%). The other reductions included grade 3/4 postoperative fever (8.0% vs 2.0%), grade 3/4 hemorrhage (7.0% vs 1.0%), and blood clots (2.4% vs 0.3%).

National Comprehensive Cancer Network (NCCN) 17th Annual Conference. Presented March 15, 2012.

    
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