Ricci S, Antonuzzo A, Galli L, Ferdeghini M, Bodei L, Orlandini C, Conte P F
Department of Ontology, S. Chiara Hospital and University, Pisa, Italy.
Ann Oncol. 2000 Sep;11(9):1127-30. doi: 10.1023/a:1008383132024.
In the present study we investigated the efficacy and tolerability of i.m. octreotide acetate (octreotide LAR) in patients with metastatic neuroendocrine tumors (NETs) previously treated and failed on i.m. lanreotide.
Fifteen patients (8 females, 7 males, median age 67 years, range 28-81 years) with metastatic NETs (8 endocrine pancreatic tumors, 7 midgut carcinoids) were enrolled in the study. All patients were in progressive disease (objective: 11 patients, symptomatic: 10 patients, biochemical: 11 patients) after treatment with slow release lanreotide, 30 mg every 14 days for a median time of 8 months (range 3-19 months). All patients had measurable disease; 12 patients had elevated serum and/or urine markers and 11 were symptomatic. Octreotide scintigraphy was positive in 13 of 15 patients. Octreotide LAR was administered as i.m. injection at the dose of 20 mg every four weeks until disease progression.
An objective partial response (PR) was documented in one patient (7%), no change (NC) in six (40%), and progressive disease (PD) in eight patients (53%). The PR was observed in one patient with non-functioning endocrine pancreatic tumor with progressive liver and lymph node metastases after 16 months of i.m. lanreotide therapy. The median duration of disease stabilization was 7.5 months (range 6-12+ months). The overall biochemical response rate was 41%, including CRs (33%) and PRs (8%); biochemical responses were observed in carcinoids as well as in endocrine pancreatic tumors; the median duration of response was 5 months for CRs and 7.5 months for PRs. The overall symptomatic response rate was 82%. The median duration of response for diarrhoea, abdominal pain, or both was 6.5 months (range 3-12+ months). Improvement in performance status (PS) was obtained in 5 of 11 patients with PS of 1 at study entry. Median duration of octreotide LAR treatment was seven months (range 3-12+ months). No serious adverse events were reported; mild side effects were reported in 26% of patients.
Octreotide LAR 20 mg shows significant efficacy in terms of objective response rate (PR + SD), biochemical and symptomatic control in patients with metastatic NETs of the GEP system pretreated and progressing on slow release lanreotide.
在本研究中，我们调查了醋酸奥曲肽（奥曲肽长效注射剂）对先前接受过醋酸亮丙瑞林治疗且治疗失败的转移性神经内分泌肿瘤（NETs）患者的疗效和耐受性。
15例转移性NETs患者（8例女性，7例男性，中位年龄67岁，范围28 - 81岁）（8例为内分泌胰腺肿瘤，7例为中肠类癌）纳入本研究。所有患者在接受每14天30mg缓释亮丙瑞林治疗中位时间8个月（范围3 - 19个月）后均处于疾病进展期（客观进展：11例患者，有症状：10例患者，生化指标进展：11例患者）。所有患者均有可测量的疾病；12例患者血清和/或尿液标志物升高，11例有症状。15例患者中有13例奥曲肽闪烁扫描呈阳性。奥曲肽长效注射剂每四周皮下注射20mg，直至疾病进展。
1例患者（7%）出现客观部分缓解（PR），6例（40%）病情无变化（NC），8例患者（53%）疾病进展（PD）。PR出现在1例非功能性内分泌胰腺肿瘤患者中，该患者在接受皮下注射亮丙瑞林治疗16个月后出现肝脏和淋巴结转移进展。疾病稳定的中位持续时间为7.5个月（范围6 - 12 +个月）。总体生化缓解率为41%，包括完全缓解（CRs，33%）和部分缓解（PRs，8%）；类癌和内分泌胰腺肿瘤均观察到生化缓解；CRs的中位缓解持续时间为5个月，PRs为7.5个月。总体症状缓解率为82%。腹泻、腹痛或两者的中位缓解持续时间为6.5个月（范围3 - 12 +个月）。11例研究入组时体能状态（PS）为1的患者中有5例体能状态得到改善。奥曲肽长效注射剂治疗的中位持续时间为7个月（范围3 - 12 +个月）。未报告严重不良事件；26%的患者报告有轻度副作用。
20mg奥曲肽长效注射剂在客观缓解率（PR + SD）、生化指标和症状控制方面对先前接受缓释亮丙瑞林治疗且病情进展的GEP系统转移性NETs患者显示出显著疗效。
