直肠癌的治疗【单病种循证医学讨论试点】
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发布日期: 2006-11-07 19:53 文章来源: 丁香园 - 肿瘤医学讨论版
关键词: 循证医学 单病种治疗 直肠癌 点击次数:

网友[cbchinese]:

2002 UICC 分期
T – Primary Tumour
TX. Primary tumour cannot be assessed
T0. No evidence of primary tumour
Tis. Carcinoma in situ: intraepithelial or invasion of lamina propria1
T1. Tumour invades submucosa
T2. Tumour invades muscularis propria
T3. Tumour invades through muscularis propria into subserosa or into non-peritonealized pericolic or perirectal tissues
T4. Tumour directly invades other organs or structures2,3 and/or perforates visceral peritoneum

【RCT】Chemotherapy with preoperative radiotherapy in rectal cancer.

文章出处:N Engl J Med. 2006 Sep 14;355(11):1114-23

英文或中文摘要(只需原文的摘要,不需翻译):BACKGROUND: Preoperative radiotherapy is recommended for selected patients with rectal cancer. We evaluated the addition of chemotherapy to preoperative radiotherapy and the use of postoperative chemotherapy in the treatment of rectal cancer. METHODS: We randomly assigned patients with clinical stage T3 or T4 resectable rectal cancer to receive preoperative radiotherapy, preoperative chemoradiotherapy, preoperative radiotherapy and postoperative chemotherapy, or preoperative chemoradiotherapy and postoperative chemotherapy. Radiotherapy consisted of 45 Gy delivered over a period of 5 weeks. One course of chemotherapy consisted of 350 mg of fluorouracil per square meter of body-surface area per day and 20 mg of leucovorin per square meter per day, both given for 5 days. Two courses were combined with preoperative radiotherapy in the group receiving preoperative chemoradiotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy; four courses were planned postoperatively in the group receiving preoperative radiotherapy and postoperative chemotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy. The primary end point was overall survival. RESULTS: We enrolled 1011 patients in the trial. There was no significant difference in overall survival between the groups that received chemotherapy preoperatively (P=0.84) and those that received it postoperatively (P=0.12). The combined 5-year overall survival rate for all four groups was 65.2%. The 5-year cumulative incidence rates for local recurrences were 8.7%, 9.6%, and 7.6% in the groups that received chemotherapy preoperatively, postoperatively, or both, respectively, and 17.1% in the group that did not receive chemotherapy (P=0.002). The rate of adherence to preoperative chemotherapy was 82.0%, and to postoperative chemotherapy was 42.9%. CONCLUSIONS: In patients with rectal cancer who receive preoperative radiotherapy, adding fluorouracil-based chemotherapy preoperatively or postoperatively has no significant effect on survival. Chemotherapy, regardless of whether it is administered before or after surgery, confers a significant benefit with respect to local control. (ClinicalTrials.gov number, NCT00002523 [ClinicalTrials.gov].).

简要说明:
研究对象:T3-4可切除直肠癌。
RCT:术前放疗,术前同步放化疗,术前放疗术后化疗,术前同步放化疗术后化疗。
化疗方案:5Fu+CF。
结果:五年总生存率65.2%,无差异。
   五年局部复发率:术前化疗组8.7%;
           术后化疗组 9.6%;
           术前与术后化放疗组7.6%;
           未接受化疗组17.1%。

ith preoperative radiotherapy in rectal cancer.pdf (240.43k)


N – Regional Lymph Nodes
NX. Regional lymph nodes cannot be assessed
N0. No regional lymph node metastasis
N1. Metastasis in 1 to 3 regional lymph nodes
N2. Metastasis in 4 or more regional lymph nodes

M – Distant Metastasis
MX. Distant metastasis cannot be assessed
M0. No distant metastasis
M1. Distant metastasis

Stage Grouping

Stage 0 Tis N0 M0

Stage I T1, T2 N0 M0

Stage IIA T3 N0 M0
   IIB T4 N0 M0

Stage IIIA T1, T2  N1 M0
   IIIB T3, T4 N1 M0
   IIIC Any T N2 M0

Stage IV Any T Any N M1

网友[小术]:

【RCT】Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial.

文章出处:Jpn J Clin Oncol. 2006 Apr;36(4):237-44

摘要:BACKGROUND: Although adjuvant radiotherapy was proved to be effective for local control of rectal cancer even after standardized mesorectal excision, the role of adjuvant chemotherapy after such standardized surgery remains to be clarified. We aimed to assess the efficacy of a combination of uracil and tegafur for pathological stage III rectal cancer treated by standardized mesorectal excision with selective lateral pelvic lymphadenectomy. METHODS: We randomly assigned patients with completely resected stage III rectal cancer, who underwent standardized mesorectal excision with selective lateral pelvic lymphadenectomy, to receive either oral uracil-tegafur (400 mg/m2 tegafur per day) for one year or no treatment. Standardization and quality control of the surgery and pathological techniques were ensured by use of the guidelines of the Japanese Society for Cancer of the Colon and Rectum. The primary endpoint was relapse-free survival. The secondary endpoint was overall survival. RESULTS: We enrolled and randomized 276 patients. Excluding two ineligible patients, 274 were included in the analysis. Planned interim analysis 2 years after accrual termination revealed significant prolongation of relapse-free survival (P = 0.001) and overall survival (P = 0.005) in the uracil-tegafur group. The 3-year relapse-free survival and overall survival rates were 78 and 91% in the chemotherapy group and 60 and 81% in the surgery-alone group, respectively. Local recurrence rates were low in both groups. Grade 3 events occurred in 17% of the chemotherapy patients, but no grade 4 or more events occurred. CONCLUSION: Adjuvant chemotherapy with uracil-tegafur improves survival of patients with stage III rectal cancer after standardized mesorectal excision with selective lateral pelvic lymphadenectomy.

简要说明:
研究对象:III期可切除直肠癌术后。
RCT:手术加化疗组,单纯手术组。
化疗方案:口服UFT。
结果:两年无复发生存率和总生存率:手术加化疗组均较单纯手术组显著延长。
三年无复发生存率:手术加化疗组78%,单纯手术组60%。
三年总生存率:手术加化疗组91%,单纯手术组81%。
两组局部复发率均低。
化疗组有17%三度不良反应,但无四度及以上的不良反应。

237.pdf (119.96k)


【RCT】Three-dimensional conformal radiotherapy combined with FOLFOX4 chemotherapy for unresectable recurrent rectal cancer.

文章出处:World J Gastroenterol. 2006 Apr 28;12(16):2610-4

摘要:AIM: To investigate the effect of three-dimensional conformal radiotherapy (3-DCRT) in combination with FOLFOX4 chemotherapy for unresectable recurrent rectal cancer. METHODS: Forty-eight patients with unresectable recurrent rectal cancer were randomized and treated by 3-DCRT or 3-DCRT combined with FOLFOX4 chemotherapy between September 2001 and October 2003. For the patients without prior radiation history, the initial radiation was given to the whole pelvis by traditional methods with tumor dose of 40 Gy, followed by 3-DCRT for the recurrent lesions to the median total cumulative tumor dose of 60 Gy (range 56-66 Gy); for the post-radiation recurrent patients, 3-DCRT was directly given for the recurrent lesions to the median tumor dose of 40 Gy (36-46 Gy). For patients in the study group, two cycles chemotherapy with FOLFOX4 regimen were given concurrently with radiotherapy, with the first cycle given simultaneously with the initiation of radiation and the second cycle given in the fifth week for patients receiving conventional pelvis radiation or given in the last week of 3-DCRT for patients receiving 3-DCRT directly. Another 2-4 cycles (average 3.6 cycles) sequential FOLFOX4 regimen chemotherapy were given to the patients in the study group, beginning at 2-3 wk after chemoradiation. The outcomes of symptoms relieve, tumor response, survival and toxicity were recorded and compared between the study group and the control group. RESULTS: For the study group and the control group, the pain-alleviation rates were 95.2% and 91.3% (P > 0.05); the overall response rates were 56.5% and 40.0% (P > 0.05); the 1-year and 2-year survival rates were 86.9%, 50.2% and 80.0%, 23.9%, with median survival time of 25 mo and 16 mo (P < 0.05); the 2-year distant metastasis rates were 39.1% and 56.0% (P = 0.054), respectively. The side effects, except peripheral neuropathy which was relatively severer in the study group, were similar in the the two groups and well tolerated. CONCLUSION: Three-dimensional conformal radio-therapy combined with FOLFOX4 chemotherapy for unresectable recurrent rectal cancer is a feasible and effective therapeutic approach, and can reduce distant metastasis rate and improve the survival rate.

简要说明:
研究对象:不可切除的复发直肠癌。
RCT:单纯三维适形放疗,放疗加化疗。
化疗方案:FOLFOX4。
结果:疼痛缓解率:无差别。
总反应率:无差别。
一年生存率:放化疗组86.9%;单纯放疗50.2%。
两年生存率:放化疗组80.0%;单纯放疗23.9%。
中位生存期:放化疗组25m;单纯放疗16m。
两年远处转移率:无差别。
副反应联合放疗组外周神经毒性相对较强,余两组无差别,均能很好耐受。


网友[xiaohei409]:

【meta-analysis】The use of preoperative radiotherapy in the management of patients with clinically resectable rectal cancer: a practice guideline.

文章出处:BMC Med. 2003 Nov 24;1:1.

摘要:BACKGROUND: This systematic review with meta-analysis was designed to evaluate the literature and to develop recommendations regarding the use of preoperative radiotherapy in the management of patients with resectable rectal cancer. METHODS: The MEDLINE, CANCERLIT and Cochrane Library databases, and abstracts published in the annual proceedings of the American Society of Clinical Oncology and the American Society for Therapeutic Radiology and Oncology were systematically searched for evidence. Relevant reports were reviewed by four members of the Gastrointestinal Cancer Disease Site Group and the references from these reports were searched for additional trials. External review by Ontario practitioners was obtained through a mailed survey. Final approval of the practice guideline report was obtained from the Practice Guidelines Coordinating Committee. RESULTS: Two meta-analyses of preoperative radiotherapy versus surgery alone, nineteen trials that compared preoperative radiotherapy plus surgery to surgery alone, and five trials that compared preoperative radiotherapy to alternative treatments were obtained. Randomized trials demonstrate that preoperative radiotherapy followed by surgery is significantly more effective than surgery alone in preventing local recurrence in patients with resectable rectal cancer and it may also improve survival. A single trial, using surgery with total mesorectal excision, has shown similar benefits in local recurrence. CONCLUSION: For adult patients with clinically resectable rectal cancer we conclude that: Preoperative radiotherapy is an acceptable alternative to the previous practice of postoperative radiotherapy for patients with stage II and III resectable rectal cancer. Both preoperative and postoperative radiotherapy decrease local recurrence but neither improves survival as much as postoperative radiotherapy combined with chemotherapy. Therefore, if preoperative radiotherapy is used, chemotherapy should be added postoperatively to at least patients with stage III disease.

简要说明:
研究对象:成人II、III期 可切除直肠癌。
RCT:术前放疗,单纯手术。
结果:1、对于以往采用术后放疗的II、III期 可切除直肠癌患者,术前放疗是可以接受的选择;
2、术前放疗与术后放疗均可降低局部复发率,但同术后辅助放化联合治疗相比均未提高生存率,因此,如选择术前放疗,至少在III期 的患者应辅以术后化疗。


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