Medical Care Unit, Department of Medicine, European Institute of Oncology, via Ripamonti 435, Milan 20141, Italy.
BMC Cancer. 2011 Feb 3;11:55. doi: 10.1186/1471-2407-11-55.
To evaluate efficacy and feasibility of chemo-radiotherapy in patients with non-metastatic anal squamous-cell-cancer.
TNM staged anal squamous-cell cancer patients were treated with pelvic radiotherapy concomitant to continuous infusion fluorouracil plus cisplatin for at least 2 cycles. In T3-T4 or any T - N+ tumours or in "slow-responder" cases, 1-2 chemotherapy courses were subsequently administered. Tumour assessment was performed at baseline and 6-8 weeks after radiotherapy to evaluate response.
29 patients were enrolled: 4 males, 25 females; median age 57 years; baseline T1/T2/T3/T4 2/12/7/8; N involvement 17. Median dose pelvic radiotherapy was 59.4 Gy (range: 54-74). In 5 patients 2 chemotherapy courses, in 12 patients three and in 12 patients four courses were performed. At first evaluation, 27 CR (93.1%; 95% CI: 78% - 98%) and 2 SD were observed. Main grade (G) 3 toxic events were neutropenia (8%), diarrhoea (8%) and dermatitis (62%). Most frequent late events G3-G4 occurred in 14 patients: proctitis (5), dermatitis (4), bladder dysfunctions (2), sexual dysfunctions (9), lower extremity venous thromboses (2), dysuria (1), stenosis (1) and tenesmus (1). Five patients reported G1 leucopoenia. The rate of colostomy was 14%. After a median follow up of 42 months (range: 4-81), 20 patients are still alive without relapse and 3 died due to PD. The estimated 7-year DFS was 83.4% (C.I.: 68.3%-98.5%) and the estimated 7-year OS was 85.7% (C.I.: 70% - 100%). The 1-year and the estimated 7-year colostomy-free survivals were 85.9% (C.I.: 73.1% - 98.7%).
Concurrent cisplatin plus fluorouracil and radiotherapy is associated with favourable local control rates and acute toxicity. Future investigations will be directed towards research into molecular biomarkers related to disease progression and resistance to chemo-radiotherapy and to the evaluation of new cytotoxic agents or targeted drugs, such as anti-epidermal growth factor receptor, concomitant to RT and to determining the role of intensity-modulated radiotherapy.
评估非转移性肛门鳞癌患者接受化疗放疗的疗效和可行性。
对分期为 TNM 的肛门鳞癌患者进行盆腔放疗，同时持续输注氟尿嘧啶和顺铂至少 2 个周期。对于 T3-T4 或任何 T-N+肿瘤，或在“慢反应者”病例中，随后给予 1-2 个化疗周期。在放疗后 6-8 周进行基线和肿瘤评估，以评估反应。
共纳入 29 例患者：4 例男性，25 例女性；中位年龄 57 岁；基线 T1/T2/T3/T4 分别为 2/12/7/8；N 累及 17 例。盆腔放疗中位剂量为 59.4Gy（范围：54-74）。5 例患者行 2 个周期化疗，12 例患者行 3 个周期化疗，12 例患者行 4 个周期化疗。首次评估时，27 例患者为完全缓解（93.1%；95%CI：78%-98%），2 例为部分缓解。主要为 3 级毒性事件为中性粒细胞减少（8%）、腹泻（8%）和皮炎（62%）。14 例患者发生最常见的迟发性 3-4 级事件：直肠炎（5 例）、皮炎（4 例）、膀胱功能障碍（2 例）、性功能障碍（9 例）、下肢静脉血栓形成（2 例）、尿痛（1 例）、狭窄（1 例）和里急后重（1 例）。5 例患者报告 1 级白细胞减少症。造口率为 14%。中位随访 42 个月（范围：4-81）后，20 例患者仍无复发且存活，3 例患者因 PD 死亡。估计 7 年无疾病生存率为 83.4%（C.I.：68.3%-98.5%），估计 7 年总生存率为 85.7%（C.I.：70%-100%）。1 年和估计 7 年无造口生存分别为 85.9%（C.I.：73.1%-98.7%）。
顺铂联合氟尿嘧啶和放疗具有良好的局部控制率和急性毒性。未来的研究将致力于研究与疾病进展和对放化疗耐药相关的分子生物标志物，并评估新的细胞毒性药物或靶向药物，如抗表皮生长因子受体，与放疗同时使用，并确定调强放疗的作用。
