放化疗 (CMT) 现已成为肛门鳞状细胞癌的标准治疗方法。采用放疗 + 双药化疗(氟尿嘧啶和丝裂霉素)。[30]James RD, Glynne-Jones R, Meadows HM, et al. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2 × 2 factorial trial. Lancet Oncol. 2013;14:516-524.http://www.ncbi.nlm.nih.gov/pubmed/23578724?tool=bestpractice.com无病生存率和无结肠造口的生存率:高质量的证据显示,与单独放疗+ 丝裂霉素相比,放疗 + 丝裂霉素 + 氟尿嘧啶可达到较高的无病生存率和无结肠造口术的生存率。[28]Flam M, John M, Pajak TF, et al. Role of mitomycin in combination with fluorouracil and radiotherapy, and salvage chemoradiation in the definitive nonsurgical treatment of epidermoid carcinoma of the anal canal: results of a phase III randomized intergroup study. J Clin Oncol. 1996;14:2527-2539.http://www.ncbi.nlm.nih.gov/pubmed/8823332?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。两项随机试验发现,与基于氟尿嘧啶/顺铂的放化疗相比,基于氟尿嘧啶/丝裂霉素的放化疗可显著改善患者的无病生存和总生存率。[29]Gunderson LL, Winter KA, Ajani JA, et al. Long-term update of US GI intergroup RTOG 98-11 phase III trial for anal carcinoma: survival, relapse, and colostomy failure with concurrent chemoradiation involving fluorouracil/mitomycin versus fluorouracil/cisplatin. J Clin Oncol. 2012;30:4344-4351.http://www.ncbi.nlm.nih.gov/pubmed/23150707?tool=bestpractice.com[30]James RD, Glynne-Jones R, Meadows HM, et al. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2 × 2 factorial trial. Lancet Oncol. 2013;14:516-524.http://www.ncbi.nlm.nih.gov/pubmed/23578724?tool=bestpractice.com与单独放疗相比,CMT 可改善局部控制疾病的局部控制和缓解率:高质量的证据显示,综合治疗 (CMT) 与单独放疗相比,可显著改善局部控制(3 年后为 61% vs 39%;[23]UKCCCR Anal Cancer Trial Working Party. Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. Lancet. 1996;348:1049-1054.http://www.ncbi.nlm.nih.gov/pubmed/8874455?tool=bestpractice.com[24]Northover J, Glynne-Jones R, Sebag-Montefiore D, et al. Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I). Br J Cancer. 2010;102:1123-1128.http://www.ncbi.nlm.nih.gov/pubmed/20354531?tool=bestpractice.com5 年后为 68% vs 50%[25]Bartelink H, Roelofsen F, Eschwege F, et al. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer radiotherapy and gastrointestinal cooperative groups. J Clin Oncol. 1997;15:2040-2049.http://www.ncbi.nlm.nih.gov/pubmed/9164216?tool=bestpractice.com)。该方法与单独放疗相比也可改善缓解率(80% vs 54%)。[25]Bartelink H, Roelofsen F, Eschwege F, et al. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer radiotherapy and gastrointestinal cooperative groups. J Clin Oncol. 1997;15:2040-2049.http://www.ncbi.nlm.nih.gov/pubmed/9164216?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。和无结肠造口生存率无结肠造口的生存率:高质量的证据显示,综合治疗 (CMT) 与单独放疗相比可显著改善无结肠造口术的生存率(72% vs 40%)。[25]Bartelink H, Roelofsen F, Eschwege F, et al. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer radiotherapy and gastrointestinal cooperative groups. J Clin Oncol. 1997;15:2040-2049.http://www.ncbi.nlm.nih.gov/pubmed/9164216?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。。[26]Glynne-Jones R, Lim F. Anal cancer: an examination of radiotherapy strategies. Int J Radiat Oncol Biol Phys. 2011;79:1290-1301.http://www.ncbi.nlm.nih.gov/pubmed/21414513?tool=bestpractice.com诱导化疗或放疗剂量强化并不能改善患者的无结肠造口生存率。控制糖尿病患者心血管风险行动 (ACCORD) 3 试验发现,诱导化疗或标准放化疗后用短距离放射治疗强化,并未显著改善患者无结肠造口术生存率。[27]Peiffert D, Tournier-Rangeard L, Gérard JP, et al. Induction chemotherapy and dose intensification of the radiation boost in locally advanced anal canal carcinoma: final analysis of the randomized UNICANCER ACCORD 03 trial. J Clin Oncol. 2012;30:1941-1948.http://www.ncbi.nlm.nih.gov/pubmed/22529257?tool=bestpractice.com
实施盆腔放疗,5 天/周,以 1.8 Gy/天的剂量作用于全部盆腔,随后应用锥形束作用于真骨盆,总剂量为 45 Gy(5 周)。
化疗应在放疗的第 1 和 5 周进行。氟尿嘧啶应 96 小时连续输注(第 1-4 天和第 29-33 天),丝裂霉素应在第 1 和 29 天单次静脉推注。
对于 T3 或 T4 和/或 N1 病变的患者,一些肿瘤医生添加了两个周期的诱导化疗,并增加总放疗剂量(从 45 Gy 增至 50.4 Gy),但尚不清楚是否可改善患者结局。
参见本地给药和治疗指南专家协议。