Efficacy of avelumab in the treatment of oncourological malignances. Results of registration studies and own experience

I. Shevchuk, K. Nyushko, B. Alekseev
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Combined therapy with avelumab + axitinib in patients with previously untreated metastatic renal cell carcinoma showed higher progression-free survival and objective response rate compared to sunitinib in all IMDC (International Metastatic Renal Cancer Database Consortium) groups. Avelumab + axitinib is one of the immuno-oncology combinations with proven effectiveness for progression-free survival and objective response rate.Aim. To evaluate the effectiveness of avelumab in treatment of oncological urological diseases in routine clinical practice. Materials and methods. At the N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology - branch of the National Medical Research Radiology Center, 12 patients with locally advanced inoperable and metastatic urothelial cancer without progression after 1st line platinum-based chemotherapy in combination with gemcitabine received maintenance avelumab therapy. Median follow-up was 10 months. Primary endpoints were overall survival from the start of avelumab maintenance therapy and safety.Combined therapy with avelumab + axitinib was administered in 18 patients with metastatic renal cell carcinoma. Median follow-up was 9 (3-16) months. Overall survival, progression-free survival, response rate and safety in the overall population and according to IMDC groups were evaluated.Results. At data cut-off (March 2023) with median follow-up of 10 months, overall survival was 100 %, progression-free survival was 66.7 % (among patients who received more than 3 infusions - 100 %). Progression-free survival was higher in patients with tumors of the lower urinary tract compared to upper (72.5 % versus 60 %), complete response to induction platinum-based chemotherapy compared to partial response and stable disease (100 % versus 66.7 %) and presence of metastases in the lymph nodes only compared to visceral and bone metastases (100 % versus 66.7 %). Adverse events were observed in 4 (66.7 %) patients.Among 18 patients who received avelumab + axitinib, complete response was observed in 2 (11.1 %) patients, partial response in 6 (33.3 %) patients, stable disease in 9 (50 %) patients, disease progression in 1 (5.6 %) patient. Response to therapy was observed in patients of all prognosis groups; for large (>5 cm) metastases in the lungs, soft tissues, lymph nodes and bones response was observed 3 months after treatment start. Overall survival for this follow-up duration was 100 %, progression-free survival was 96.4 ± 11.2 %. Adverse events were observed in 8 (44.4 %) patients, and in 6 (75 %) of them they were grade I—II and did not require infusion regimen correction or axitinib dose reduction.Conclusion. Avelumab maintenance therapy in the 1st line is the standard of care for patients with locally advanced and metastatic urothelial cancer without disease progression during 1st line platinum-based chemotherapy. Maintenance therapy allows to achieve better overall survival and progression-free survival irrespective of the choice of platinum regimen (cisplatin or carboplatin), response to platinum-based chemotherapy, number of chemotherapy cycles, tumor localization and advancement.Experience of the N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology confirms results of the JAVELIN Bladder 100 trial on the effectiveness of avelumab maintenance therapy in routine clinical practice. Combination drug therapy with avelumab and axitinib in patients with metastatic renal cell carcinoma is an effective and safe treatment method which allows to achieve fast objective response and has good tolerability in patients irrespective of IMDC group or metastasis location. Effectiveness and favorable safety profile of avelumab + axitinib combination were proven in the context of routine clinical practice.","PeriodicalId":216890,"journal":{"name":"Cancer Urology","volume":"8 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Urology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17650/1726-9776-2023-19-1-169-177","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Background. In the JAVELIN Bladder 100 trial, 1st line maintenance with avelumab in combination with best supportive care significantly increased (9.2 months) overall survival compared to best supportive care in patients with locally advanced or metastatic urothelial cancer without progression after 1st line platinum-based chemotherapy: 29.7 months versus 20.5 months, respectively. Trial results led to inclusion of avelumab into the international guidelines as a standard of care with the highest level of evidence. Combined therapy with avelumab + axitinib in patients with previously untreated metastatic renal cell carcinoma showed higher progression-free survival and objective response rate compared to sunitinib in all IMDC (International Metastatic Renal Cancer Database Consortium) groups. Avelumab + axitinib is one of the immuno-oncology combinations with proven effectiveness for progression-free survival and objective response rate.Aim. To evaluate the effectiveness of avelumab in treatment of oncological urological diseases in routine clinical practice. Materials and methods. At the N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology - branch of the National Medical Research Radiology Center, 12 patients with locally advanced inoperable and metastatic urothelial cancer without progression after 1st line platinum-based chemotherapy in combination with gemcitabine received maintenance avelumab therapy. Median follow-up was 10 months. Primary endpoints were overall survival from the start of avelumab maintenance therapy and safety.Combined therapy with avelumab + axitinib was administered in 18 patients with metastatic renal cell carcinoma. Median follow-up was 9 (3-16) months. Overall survival, progression-free survival, response rate and safety in the overall population and according to IMDC groups were evaluated.Results. At data cut-off (March 2023) with median follow-up of 10 months, overall survival was 100 %, progression-free survival was 66.7 % (among patients who received more than 3 infusions - 100 %). Progression-free survival was higher in patients with tumors of the lower urinary tract compared to upper (72.5 % versus 60 %), complete response to induction platinum-based chemotherapy compared to partial response and stable disease (100 % versus 66.7 %) and presence of metastases in the lymph nodes only compared to visceral and bone metastases (100 % versus 66.7 %). Adverse events were observed in 4 (66.7 %) patients.Among 18 patients who received avelumab + axitinib, complete response was observed in 2 (11.1 %) patients, partial response in 6 (33.3 %) patients, stable disease in 9 (50 %) patients, disease progression in 1 (5.6 %) patient. Response to therapy was observed in patients of all prognosis groups; for large (>5 cm) metastases in the lungs, soft tissues, lymph nodes and bones response was observed 3 months after treatment start. Overall survival for this follow-up duration was 100 %, progression-free survival was 96.4 ± 11.2 %. Adverse events were observed in 8 (44.4 %) patients, and in 6 (75 %) of them they were grade I—II and did not require infusion regimen correction or axitinib dose reduction.Conclusion. Avelumab maintenance therapy in the 1st line is the standard of care for patients with locally advanced and metastatic urothelial cancer without disease progression during 1st line platinum-based chemotherapy. Maintenance therapy allows to achieve better overall survival and progression-free survival irrespective of the choice of platinum regimen (cisplatin or carboplatin), response to platinum-based chemotherapy, number of chemotherapy cycles, tumor localization and advancement.Experience of the N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology confirms results of the JAVELIN Bladder 100 trial on the effectiveness of avelumab maintenance therapy in routine clinical practice. Combination drug therapy with avelumab and axitinib in patients with metastatic renal cell carcinoma is an effective and safe treatment method which allows to achieve fast objective response and has good tolerability in patients irrespective of IMDC group or metastasis location. Effectiveness and favorable safety profile of avelumab + axitinib combination were proven in the context of routine clinical practice.
avelumab治疗肿瘤恶性肿瘤的疗效。注册研究的结果和自己的经验
背景。在JAVELIN膀胱100试验中,与一线铂基化疗后无进展的局部晚期或转移性尿路上皮癌患者的最佳支持治疗相比,阿韦单抗一线维持联合最佳支持治疗显着增加了总生存期(9.2个月):分别为29.7个月和20.5个月。试验结果使avelumab作为一种标准治疗纳入国际指南,证据水平最高。在所有IMDC(国际转移性肾癌数据库联盟)组中,与舒尼替尼相比,阿维单抗+阿西替尼联合治疗先前未经治疗的转移性肾癌患者显示出更高的无进展生存期和客观缓解率。Avelumab + axitinib是一种免疫肿瘤学组合,在无进展生存和客观缓解率方面已被证明有效。目的:评价阿维单抗治疗泌尿外科肿瘤的临床疗效。材料和方法。在N.A.洛帕特金科学研究所泌尿科和介入放射学-国家医学研究放射学中心分支,12例局部晚期不能手术和转移性尿路上皮癌患者在一线铂基化疗联合吉西他滨后没有进展,接受了维持性阿维单抗治疗。中位随访时间为10个月。主要终点是开始avelumab维持治疗后的总生存期和安全性。对18例转移性肾细胞癌患者进行了avelumab + axitinib联合治疗。中位随访时间为9(3-16)个月。评估总体人群和IMDC组的总生存期、无进展生存期、有效率和安全性。截止数据(2023年3月),中位随访10个月,总生存率为100%,无进展生存率为66.7%(接受3次以上输注的患者为100%)。下尿路肿瘤患者的无进展生存率高于上尿路肿瘤患者(72.5%比60%),对诱导铂类化疗的完全缓解高于部分缓解和疾病稳定(100%比66.7%),仅存在淋巴结转移与内脏和骨转移相比(100%比66.7%)。不良事件4例(66.7%)。在接受avelumab + axitinib治疗的18例患者中,2例(11.1%)患者完全缓解,6例(33.3%)患者部分缓解,9例(50%)患者病情稳定,1例(5.6%)患者病情进展。观察各预后组患者对治疗的反应;对于肺、软组织、淋巴结和骨骼的大(> 5cm)转移瘤,在治疗开始3个月后观察疗效。随访期间的总生存率为100%,无进展生存率为96.4±11.2%。8例(44.4%)患者出现不良事件,其中6例(75%)为I-II级,不需要调整输注方案或减少阿西替尼剂量。一线的Avelumab维持治疗是一线铂基化疗期间无疾病进展的局部晚期和转移性尿路上皮癌患者的标准护理。无论选择铂类方案(顺铂或卡铂)、对铂类化疗的反应、化疗周期数、肿瘤定位和进展如何,维持治疗都能获得更好的总生存期和无进展生存期。na Lopatkin泌尿外科与介入放射科学研究所的经验证实了JAVELIN膀胱100试验在常规临床实践中关于avelumab维持治疗有效性的结果。阿维单抗和阿西替尼联合治疗转移性肾细胞癌是一种有效、安全的治疗方法,无论IMDC组或转移部位如何,均可快速获得客观反应,且耐受性良好。阿维单抗+阿西替尼联合治疗的有效性和良好的安全性已在常规临床实践中得到证实。
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