本帖最後由 lsc0019 於 2009-8-22 02:08 編輯
作者：Barbara Boughton
出處：WebMD醫學新聞
August 4, 2009（加州舊金山）－當研究團隊於2001年開始進行RTOG 0214研究時，他們的想法是想要決定性地證實預防性頭顱放射線治療（PCI）可以改善後期非小細胞肺癌（NSCLC）患者預後。研究者於第13屆世界肺癌會議上表示，這項會議由肺癌研究國際學會舉辦，雖然科學家們從未達到他們的確切目標，該項研究僅隨機分派340位病患接受PCI或是持續觀察，其研究結果仍然可能對於癌症執業有決定性的影響。
這項研究的初期成果，於今年的美國臨床癌症學會會議上發布，隨機分派接受PCI與隨機分派至觀察組病患之間的整體存活率並無顯著差異。然而，觀察組病患一年後發生腦轉移的機率高出兩倍（18%相較於7.7%；P=0.004）。在會議上，研究團隊發表與其研究中次級試驗終點相關的結果，包括免於疾病惡化存活率、神經認知功能、以及生活品質。
這項研究中的病患罹患IIIA或IIIB期肺癌，且接受手術局部治療以及/或是放射線治療，加上或未加上化學治療而沒有疾病惡化的病患。PCI進行方式為每天總劑量30葛雷，每部分2葛雷。
雖然在一年時，PCI組與觀察組的免於疾病惡化率並無差異，但接受PCI病患有免於疾病存活率改善的趨勢，儘管並未達到統計上顯著差異（56.4%相較於51.2%）。研究團隊也發現，使用多種評量方式評估生活品質，兩組之間仍然無顯著差異，且病患的迷你精神狀態檢驗分數也沒有差異。然而，當研究團隊以霍普金斯口語學習測試，他們發現，接受PCI病患在一年時，立即回憶（P=0.03）與延遲回憶（P=0.008）上顯著惡化。
主要研究者、安大略多倫多大學Princess Margaret醫院的放射腫瘤學家Alexander Sun醫師表示，當納入年齡或是比較病患是否有腦轉移時，PCI組與觀察組的生活品質沒有明顯差異。這項前瞻性研究確實證實有好處，而當醫師與他們的病患們討論這項治療時，應該要考慮這項研究數據。
Sun醫師表示，需要對RTOG 0214病患長期後續追蹤來真實地評估PCI的風險與好處。更多對於病患之神經認知功能的後續追蹤，將會在美國治療放射學與腫瘤學會議上發表。
臨床試驗發表座談會的引言人、法國Lyon Sud醫院中心的Francoise Mornex醫師表示，這項研究給了我們對未來一個相當令人激勵的情景。以這樣循序的治療方法，毒性仍然是合理的，且這個劑量是安全的。
她附帶表示，對晚期NSCLC病患，總是有中樞神經系統功能衰竭的恐懼。當你比較這些病患接受PCI與沒有接受PCI時，你就是得到比較好的結果。然而，Mornex醫師表示，當你在計劃治療時，應該記住與PCI有關的記憶喪失與神經功能改變。她指出，這項研究中你必須記住的是，PCI的好處是非常真實的，且這將會改變未來的執業方法。
Sun與Mornex醫師都表示沒有相關資金上的往來。
Prophylactic Cranial Irradiation in Lung Cancer Patients Shows Definitive Benefits
By Barbara Boughton
Medscape Medical News
August 4, 2009 (San Francisco, California) — When researchers began the RTOG?0214 study in 2001, their intent was to show conclusively whether prophylactic cranial irradiation (PCI) improves survival in patients with advanced nonsmall-cell lung cancer (NSCLC). Although the scientists never met their accrual goal — the trial randomized just 340 patients to PCI or observation — the results might still have a decided impact on oncology practice, according to researchers here at the 13th World Conference on Lung Cancer, organized by the International Association for the Study of Lung Cancer.
The trial's initial results — announced at this year's American Society of Clinical Oncology meeting — showed no significant difference in overall survival rate between patients randomized to PCI and those randomized to observation. However, patients in the observation group were twice as likely to develop brain metastases after 1 year (18% vs 7.7%; P?= .004). At the meeting, the researchers announced results related to the secondary end points of their study, including disease-free survival, neurocognitive function, and quality of life.
Patients in the study had stage?IIIA or IIIB lung cancer without disease progression after loco-regional treatment with surgery and/or radiation therapy with or without chemotherapy. PCI was delivered at a total once-daily dose of 30?Gy at 2?Gy/fraction.
Although there was no difference in disease-free survival between the PCI and observation groups at 1 year, there was a trend toward improved disease-free survival in PCI patients, although it did not reach statistical significance (56.4% vs 51.2%). The researchers also found no difference in quality of life between the 2 groups after using several measures, and there was no difference in the patients' Mini-Mental Status Examination scores. However, when the researchers tested patients with the Hopkins Verbal Learning Test, they found that there was a significantly greater deterioration in immediate recall (P?= .03) and delayed recall (P = .008) in PCI patients after 1 year.
There was also no clear difference in quality of life between the PCI and observation groups when age was taken into account or when patients with and without brain metastases were compared. "This prospective study does show the benefits of PCI, and the data should be considered when doctors discuss this treatment with their patients," said lead researcher Alexander Sun, MD, radiation oncologist at Princess Margaret Hospital at the University of Toronto in Ontario. Dr. Sun noted that longer follow-up is needed on RTOG?0214 patients to truly assess the risks and benefits of PCI. More follow-up data on patients' neurocognitive function will be presented at this year's American Society for Therapeutic Radiology and Oncology meeting, he said.
"This study gives us quite an encouraging picture for the future," said FrancoiseMornex, MD, PhD, from the Centre Hospitalier Lyon Sud in France, moderator of the session at which the clinical trial was presented. "With this kind of sequential approach, the toxicity is reasonable and the dose is safe."
"With advanced NCSLC patients, there is always the danger of [central nervous system] failure. When you compare PCI to no PCI for these patients, you just see better results," she added. However, Dr. Mornex noted that memory loss and neurological changes can be attributed to PCI and should be kept in mind when planning treatment. "You have to remember in this study that the benefit of PCI was very real, and it could change practice in the future," she said.
Dr. Sun and Dr. Mornex have disclosed no relevant financial relationships.
13th World Conference on Lung Cancer (WCLC): Abstract C6.6. Presented August 2, 2009. |
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