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长效缓释兰瑞肽治疗晚期神经内分泌肿瘤患者

Long-acting depot lanreotide in the treatment of patients with advanced neuroendocrine tumors.

作者信息

Ricci S, Antonuzzo A, Galli L, Orlandini C, Ferdeghini M, Boni G, Roncella M, Mosca F, Conte P F

机构信息

Department of Oncology, S. Chiara Hospital and University, Pisa, Italy.

出版信息

Am J Clin Oncol. 2000 Aug;23(4):412-5. doi: 10.1097/00000421-200008000-00020.

DOI:10.1097/00000421-200008000-00020
PMID:10955874
Abstract

Long-acting depot forms of somatostatin analogs administered by intramuscular injections are now available for the treatment of neuroendocrine tumors (NETs). In the present study, we investigated the efficacy and tolerability of a slow-release form of lanreotide in patients with advanced NETs. From July 1996 to January 1999, 25 patients with advanced NETs (12 carcinoids, 13 endocrine pancreatic tumors) were enrolled in the study. Thirteen patients were pretreated with subcutaneous octreotide, chemotherapy, or hepatic metastasis alcoholization. All the patients had measurable disease. Seventeen patients were symptomatic and 20 patients had elevated serum and/or urine markers. Octreotide scintigraphy was positive in 23 of 25 patients. Lanreotide was administered as intramuscular injections at the dose of 30 mg every 2 weeks until there was objective, biochemical, or symptomatic tumor progression. Objective partial responses (PRs) were documented in 2 patients (8%), whereas 10 patients (40%) had tumor stabilization. The PRs were observed in patients with midgut carcinoids, of whom one was pretreated with subcutaneous octreotide. The response duration was 21+ and 24+ months in responding patients; the median duration of disease stabilization was 8.5 months (range, 4-21+). The overall biochemical response rate was 42%, including 2 complete responses (CRs) (10.5%) and 6 PRs (31.5%); all biochemical responses were observed mostly in patients with carcinoid tumors; the duration of response was 18+ and 30+ months for CRs; the median duration of biochemical response was 7 months (range, 4-18+) for PRs. The overall symptomatic response rate was 70% with a median duration of 7.5, 18, and 18+ months for diarrhea, abdominal pain, and flushing, respectively. Median duration of lanreotide treatment was 10 months (range, 2-30+). No significant side effects were reported. Depot lanreotide 30 mg shows significant efficacy in terms of objective response rate and in biochemical and symptomatic control, in pretreated patients as well as nonpretreated patients with advanced NETs. Tolerability is good, with good patient compliance.

摘要

通过肌肉注射给药的长效生长抑素类似物长效剂型现已可用于治疗神经内分泌肿瘤(NETs)。在本研究中,我们调查了缓释型兰瑞肽在晚期NETs患者中的疗效和耐受性。1996年7月至1999年1月,25例晚期NETs患者(12例类癌、13例胰腺内分泌肿瘤)入组本研究。13例患者曾接受皮下注射奥曲肽、化疗或肝转移瘤乙醇注射治疗。所有患者均有可测量的病灶。17例患者有症状,20例患者血清和/或尿液标志物升高。25例患者中有23例奥曲肽闪烁扫描呈阳性。兰瑞肽通过肌肉注射给药,剂量为每2周30mg,直至出现客观、生化或症状性肿瘤进展。记录到2例患者(8%)出现客观部分缓解(PRs),而10例患者(40%)肿瘤稳定。PRs见于中肠类癌患者,其中1例曾接受皮下注射奥曲肽治疗。缓解患者的缓解持续时间分别为21 +和24 +个月;疾病稳定的中位持续时间为8.5个月(范围4 - 21 +)。总体生化缓解率为42%,包括2例完全缓解(CRs)(10.5%)和6例PRs(31.5%);所有生化缓解大多见于类癌肿瘤患者;CRs的缓解持续时间为18 +和30 +个月;PRs的生化缓解中位持续时间为7个月(范围4 - 18 +)。总体症状缓解率为70%,腹泻、腹痛和潮红的中位缓解持续时间分别为7.5、18和18 +个月。兰瑞肽治疗的中位持续时间为10个月(范围2 - 30 +)。未报告明显副作用。30mg长效兰瑞肽在客观缓解率以及生化和症状控制方面对晚期NETs的预处理患者和未预处理患者均显示出显著疗效。耐受性良好,患者依从性佳。

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