Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Am J Clin Oncol. 2011 Apr;34(2):115-9. doi: 10.1097/COC.0b013e3181c4c7a8.
Through a phase I study with a fixed radiation dose of 54 Gy and escalating doses of weekly gemcitabine, we established a recommended dose of gemcitabine at 250 mg/m in combination with radiation therapy for patients with unresectable pancreatic cancer.
The purpose of this phase-II study was to evaluate the safety and efficacy of the regimen which was established in the phase I study.
In all patients with unresectable stage III and limited stage IV pancreatic cancer with no distant metastasis except for para-aortic lymph node involvement at a level as low as the left renal vein, a total dose of 54 Gy was delivered in 30 fractions of 1.8 Gy/d. Gemcitabine was given weekly at a dose of 250 mg/m.
Between December 2002 and March 2006, 22 patients were enrolled in this study and one withdrew after enrollment. Twenty of 21 patients (95%) completed the protocol therapy. Radiologic partial response was observed in 6 and stable disease was noted in 15. Normalization of the tumor marker (CA19-9) occurred in 61% of patients. The 1-year survival rate was 74% and the median survival time was 16.6 months. The major toxicity was leucopenia; grade 3 in 14 (67%), anorexia grade 3 in 2 (9.5%), and grade 3 gastric ulcer in 2 (10%) in National Cancer Institute's Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Neither grade 4 nor 5 was recognized.
Treatment with gemcitabine combined with radiation therapy according to the present schedule is well tolerated and can provide prolonged survival in patients with localized, unresectable pancreatic cancer.
通过一项固定剂量为 54Gy 和递增剂量每周吉西他滨的 I 期研究，我们确定了吉西他滨联合放疗治疗不可切除胰腺癌患者的推荐剂量为 250mg/m2。
本 II 期研究的目的是评估该方案在 I 期研究中确立的安全性和有效性。
所有局部不可切除的 III 期和局限于 IV 期的胰腺癌患者，且无远处转移，除主动脉旁淋巴结受累低于左肾静脉水平外，采用 30 次分割，每次 1.8Gy，总剂量为 54Gy。吉西他滨每周剂量为 250mg/m2。
2002 年 12 月至 2006 年 3 月，共有 22 例患者入组本研究，其中 1 例在入组后退出。21 例患者中的 20 例（95%）完成了方案治疗。影像学部分缓解 6 例，稳定疾病 15 例。肿瘤标志物（CA19-9）正常化率为 61%。1 年生存率为 74%，中位生存时间为 16.6 个月。主要毒性为白细胞减少症；3 级 14 例（67%），厌食症 3 级 2 例（9.5%），3 级胃溃疡 2 例（10%），均符合美国国立癌症研究所不良事件通用术语标准 3.0 版（NCI-CTCAE v3.0）。未发现 4 级或 5 级。
根据本方案，吉西他滨联合放疗治疗局部不可切除胰腺癌患者耐受性良好，可延长生存期。
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