Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study.

Q2 Medicine Sarcoma Pub Date : 2019-11-15 eCollection Date: 2019-01-01 DOI:10.1155/2019/3158590

Prasad Narayanan, Palanki Satya Dattatreya, Rammohan Prasanna, Sundaram Subramanian, Kunal Jain, Nirni Sharanabasappa Somanath, Nisarg Joshi, Deepak Bunger, Mujtaba Ali Khan, Alok Chaturvedi, Imran Ahmad

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引用次数: 2

Abstract

Objective: To evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip) based chemotherapy in patients with sarcoma.

Methods: In this retrospective, multicenter (6 centers), observational study, we analyzed the medical charts of adult patients of either sex, who were treated with NDLS (75 mg/m² in 3-weekly cycles) based chemotherapy for the treatment of sarcoma. The efficacy outcomes were overall response rate (ORR: complete response (CR) + partial response (PR)) and disease control rate (DCR: CR + PR + stable disease (SD)) in patients who received NDLS-based chemotherapy in neoadjuvant and metastatic settings. Overall survival (OS) and safety were evaluated for all settings.

Results: Of 11 patients (neoadjuvant: 1, adjuvant: 3, and metastatic: 7) in this study, majority had leiomyosarcoma (63.6%, 7/11) followed by extraskeletal myxoid chondrosarcoma (EMC), high grade pleomorphic sarcoma of mandible, malignant fibrous histiocytoma of right thigh, and osteosarcoma of femur (9.1% each, 1/11 each). NDLS plus gemcitabine combination was used in 10 patients (90.9%), and NDLS plus cyclophosphamide was used in one patient with EMC (9.1%). Efficacy evaluation was performed for 7 patients (neoadjuvant: 1/1; metastatic: 6/7). Complete response was reported in one patient (soft tissue sarcoma of mandible) treated in neoadjuvant setting. In metastatic setting, ORR was 50% and DCR was 66.7% (CR: 16.7% (1/6), PR: 33.3% (2/6), SD: 16.7% (1/6)). At a median follow-up of 6.5 months (range: 0.06-20.2 months), median OS was not reached in neoadjuvant and adjuvant settings, but it was 15.8 months in metastatic setting. At least 1 AE was reported in 7 (63.6%) patients. Neutropenia, thrombocytopenia, lymphopenia, and anemia were the hematological AEs, whereas nausea, vomiting, and diarrhea were the most common nonhematological AEs. NDLS treatment was well tolerated without any new safety concerns.

Conclusion: Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of sarcoma. Further prospective trials are needed to confirm the data.

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多西紫杉醇脂质悬浮液纳米体化疗在肉瘤中的疗效和安全性:一项多中心回顾性研究。

目的:评价纳米体多西紫杉醇脂质悬浮液(NDLS, DoceAqualip)化疗治疗肉瘤的疗效和安全性。方法:在这项回顾性、多中心(6个中心)观察性研究中，我们分析了接受NDLS (75 mg/m2, 3周周期)化疗治疗肉瘤的成年患者的病历。疗效结果是在新辅助和转移情况下接受基于ndls化疗的患者的总缓解率(ORR:完全缓解(CR) +部分缓解(PR))和疾病控制率(DCR: CR + PR +稳定疾病(SD))。评估所有情况下的总生存期(OS)和安全性。结果:本组11例患者(新辅助1例，辅助3例，转移7例)中，以平滑肌肉瘤居多(63.6%，7/11)，其次为骨外黏液样软骨肉瘤(EMC)、下颌骨高度多形性肉瘤、右大腿恶性纤维组织细胞瘤、股骨骨肉瘤(9.1%，1/11)。NDLS联合吉西他滨治疗10例(90.9%)，NDLS联合环磷酰胺治疗1例(9.1%)。7例患者进行疗效评价(新辅助:1/1;转移性:6/7)。据报道，在新辅助治疗中，有1例患者(下颌骨软组织肉瘤)完全缓解。在转移灶中，ORR为50%，DCR为66.7% (CR: 16.7% (1/6)， PR: 33.3% (2/6)， SD: 16.7%(1/6))。在中位随访6.5个月(范围:0.06-20.2个月)时，新辅助和辅助组的中位OS未达到，但转移组的中位OS为15.8个月。7例(63.6%)患者报告至少1例AE。中性粒细胞减少、血小板减少、淋巴细胞减少和贫血是血液学不良反应，而恶心、呕吐和腹泻是最常见的非血液学不良反应。NDLS治疗耐受性良好，没有任何新的安全问题。结论:以纳米体多西紫杉醇脂质悬浮液为基础的化疗治疗肉瘤疗效好，耐受性好。需要进一步的前瞻性试验来证实这些数据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Sarcoma Medicine-Radiology, Nuclear Medicine and Imaging

CiteScore

5.00

自引率

0.00%

发文量

审稿时长

14 weeks

期刊介绍： Sarcoma is dedicated to publishing papers covering all aspects of connective tissue oncology research. It brings together work from scientists and clinicians carrying out a broad range of research in this field, including the basic sciences, molecular biology and pathology and the clinical sciences of epidemiology, surgery, radiotherapy and chemotherapy. High-quality papers concerning the entire range of bone and soft tissue sarcomas in both adults and children, including Kaposi"s sarcoma, are published as well as preclinical and animal studies. This journal provides a central forum for the description of advances in diagnosis, assessment and treatment of this rarely seen, but often mismanaged, group of patients.