Cetuximab and irinotecan as third-line therapy in advanced colorectal cancer patients: a single centre phase II trial.
Cetuximab and irinotecan as third-line therapy in advanced colorectal cancer patients: a single centre phase II trial.
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DOI：
10.1038/sj.bjc.6603018
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发表时间：
2006-03-27
影响因子：
8.8
通讯作者：
Tonini, G
中科院分区：
文献类型：
--
作者：
Vincenzi, B;Santini, D;Rabitti, C;Coppola, R;Zobel, BB;Trodella, L;Tonini, G
表皮生长因子受体（EGFR）参与癌细胞中失调的信号传导途径，在结直肠癌细胞中经常发生突变。西妥昔单抗是一种特异性阻断EGFR的单克隆抗体。我们评估了西妥昔单抗每周联合伊立替康治疗既往奥沙利铂或伊立替康治疗难治的转移性结直肠癌患者的疗效。我们纳入了55例重度预治疗患者（结肠/直肠：34/11，男性/女性：16/29，中位年龄63岁，范围：27-79），这些患者在基于奥沙利铂的一线化疗和基于伊立替康的二线方案期间或之内发生疾病进展。对患者进行肿瘤缓解随访，并评价肿瘤进展时间和治疗安全性。西妥昔单抗的初始剂量为400 mg m−2，随后每周输注250 mg m−2。伊立替康每周给药一次，剂量为90 mg m−2。所有患者均可评估治疗疗效，安全性缓解率为25.4%（95%CI：21.7-39.6%）; 38.2%（95%CI：18.6-39.8%）的患者显示疾病稳定为最佳缓解。因此，总体肿瘤控制率为63.6%（95% CI：46.4-70.6%）。中位至进展时间为4.7个月（95% CI：2.5-7.1个月），中位生存时间为9.8个月（95% CI：3.9-10.1个月）。最常见的G3-4非皮肤副作用是：腹泻（16.4%）、疲劳（12.7%）和口腔炎（7.3%）。89.1%的患者发生皮肤毒性，32.6%的病例为3-4级。在任何患者的任何疗程中均未发现过敏反应。27.3%的患者记录到发热，最常见于首次给药后。西妥昔单抗即使在奥沙利铂和伊立替康为基础的化疗方案后进展的重度预治疗结直肠癌患者中也具有临床显著活性。
The epidermal growth factor receptor (EGFR), which participates in signalling pathways that are deregulated in cancer cells, is frequently mutated in colorectal-cancer cells. Cetuximab is a monoclonal antibody that specifically blocks the EGFR. We evaluated the efficacy of cetuximab in weekly combination with irinotecan in metastatic colorectal cancer patients refractory to previous treatments based on oxaliplatin or irinotecan. We included 55 heavily pretreated patients (colon/rectum: 34/11, M/F: 16/29, median age 63 years, range: 27–79) whose disease had progressed during or within an oxaliplatin-based first-line chemotherapy and a irinotecan-based second-line regimen. Patients were followed for tumour response and were also evaluated for the time to tumour progression, and safety of treatment. Cetuximab was given at an initial dose of 400 mg m−2, followed by weekly infusions of 250 mg m−2. Irinotecan was administered weekly at the dose of 90 mg m−2. All patients were assessable for treatment efficacy and safety response rate was 25.4% (95% CI: 21.7–39.6%); 38.2% (95 CI: 18.6–39.8%) of patients showed a disease stability as the best response. As a consequence, the overall tumour control rate was 63.6% (95% CI: 46.4–70.6%). The median time to progression was 4.7 months (95% CI: 2.5–7.1 months) and the median survival time was 9.8 months (95% CI: 3.9–10.1 months). The most common G3-4 noncutaneous side toxicities were: diarrhoea (16.4%), fatigue (12.7%) and stomatitis (7.3%). 89.1% of patients developed skin toxicity and 32.6% of cases was of grade 3–4. No allergic reactions were identified at any courses in any patients. Fever was documented in 27.3% of patients and was most commonly recorded after the first administration. Cetuximab has clinically significant activity even in heavily pretreated colorectal cancer patients progressed after both oxaliplatin and irinotecan-based chemotherapy regimens.
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影响因子：
8.4
作者：
André, T;Louvet, C;de Gramont, A
通讯作者：
de Gramont, A
影响因子：
45.3
作者：
Peréz-Soler, R;Saltz, L
通讯作者：
Saltz, L
影响因子：
8.8
作者：
Peto R;Pike MC;Armitage P;Breslow NE;Cox DR;Howard SV;Mantel N;McPherson K;Peto J;Smith PG
通讯作者：
Smith PG
DOI：
10.1016/s0889-8588(02)00055-2
发表时间：
2002-10-01
影响因子：
2.4
作者：
Baselga, J;Albanell, J
通讯作者：
Albanell, J
影响因子：
5.8
作者：
Venook, A
通讯作者：
Venook, A