Adverse events of the second-line treatment for patients with locally advanced or metastatic urothelial carcinoma of the bladder: network meta-analysis

Immunotherapy ◽  
2021 ◽  
Author(s):  
Ekaterina Laukhtina ◽  
Keiichiro Mori ◽  
Hadi Mostafaei ◽  
Axel S Merseburger ◽  
Peter Nyirady ◽  
...  
Keyword(s):  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Meta Analysis ◽  
Locally Advanced ◽  
Combination Regimen ◽  
Line Treatment ◽  
Second Line ◽  
Eligibility Criteria ◽  
Metastatic Urothelial Carcinoma ◽  
Carcinoma Of The Bladder

Aim: We aimed to compare the mortality rates related to adverse events (AEs) and discontinuation of treatment due to toxicity as well as all AEs of currently used regimens of second-line treatment strategies for advanced or metastatic urothelial carcinoma of the bladder. Methods: The MEDLINE and EMBASE databases were searched for articles according to the PRISMA extension statement for network meta-analysis. Results: Five trials comprising 2205 patients met our eligibility criteria. It is highly likely that immunotherapy, as single regimen, has the lowest rates of motor and sensory neuropathies, constipation, abdominal pain, alopecia, decreased appetite, vomiting and febrile neutropenia. Immunotherapy, in combination regimen, has the lowest rates of anemia and fatigue. Conclusion: Immunotherapy, especially as single regimen, demonstrated the highest favorable tolerability to most AEs.

Docetaxel As Monotherapy or Combined With Ramucirumab or Icrucumab in Second-Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma: An Open-Label, Three-Arm, Randomized Controlled Phase II Trial

2016 ◽  
Vol 34 (13) ◽  
pp. 1500-1509 ◽  
Author(s):  
Daniel P. Petrylak ◽  
Scott T. Tagawa ◽  
Manish Kohli ◽  
Andrea Eisen ◽  
Christina Canil ◽  
...  
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Urothelial Carcinoma ◽  
Locally Advanced ◽  
Growth Factor Receptor ◽  
Vascular Endothelial ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Urothelial Carcinoma ◽  
Endothelial Growth Factor

Purpose This trial assessed the efficacy and safety of docetaxel monotherapy or docetaxel in combination with ramucirumab (vascular endothelial growth factor receptor 2 antibody) or icrucumab (vascular endothelial growth factor receptor 1 antibody) after progression during or within 12 months of platinum-based regimens for patients with locally advanced or metastatic urothelial carcinoma. Patients and Methods Patients were randomly assigned (1:1:1) to receive docetaxel 75 mg/m2 intravenously (IV) on day 1 of a 3-week cycle (arm A), docetaxel 75 mg/m2 IV plus ramucirumab 10 mg/kg IV on day 1 of a 3-week cycle (arm B), or docetaxel 75 mg/m2 IV on day 1 plus icrucumab 12 mg/kg IV on days 1 and 8 of a 3-week cycle (arm C). Treatment continued until disease progression or unacceptable toxicity. The primary end point was investigator-assessed progression-free survival (PFS). Results A total of 140 patients were randomly assigned and treated in arms A (n = 45), B (n = 46), or C (n = 49). PFS was significantly longer in arm B compared with arm A (median, 5.4 months; 95% CI, 3.1 to 6.9 months v 2.8 months; 95% CI, 1.9 to 3.6 months; stratified hazard ratio, 0.389; 95% CI, 0.235 to 0.643; P = .0002). Arm C did not experience improved PFS compared with arm A (1.6 months; 95% CI, 1.4 to 2.9; stratified hazard ratio, 0.863; 95% CI, 0.550 to 1.357; P = .5053). The most common grade 3 or worse adverse events (arms A, B, and C) were neutropenia (36%, 33%, and 39%), fatigue (13%, 30%, and 20%), febrile neutropenia (13%, 17%, and 6.1%), and anemia (6.7%, 13%, and 14%, respectively). Conclusion The addition of ramucirumab to docetaxel met the prespecified efficacy end point for prolonging PFS in patients with locally advanced or metastatic urothelial carcinoma receiving second-line treatment and warrants further investigation in the phase III setting.

Paclitaxel, ifosfamide, and nedaplatin as second-line treatment for patients with metastatic urothelial carcinoma: A phase II study of the SUOC group

2011 ◽  
Vol 102 (6) ◽  
pp. 1171-1175 ◽  
Author(s):  
Hiroshi Kitamura ◽  
Keisuke Taguchi ◽  
Yasuharu Kunishima ◽  
Masahiro Yanase ◽  
Atsushi Takahashi ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Urothelial Carcinoma

Gemcitabine and ifosfamide as a second-line treatment for cisplatin-refractory metastatic urothelial carcinoma: a phase II study

2007 ◽  
Vol 18 (4) ◽  
pp. 487-491 ◽  
Author(s):  
Chia-Chi Lin ◽  
Chih-Hung Hsu ◽  
Chao-Yuan Huang ◽  
Hsiao-Yi Keng ◽  
Yu-Chieh Tsai ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Urothelial Carcinoma

Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer: ERIGE trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1095-1095
Author(s):  
Antonino Musolino ◽  
Rosa Porzio ◽  
Daniela Rubino ◽  
Antonio Frassoldati ◽  
Alessia Caldara ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Objective Response ◽  
Locally Advanced ◽  
Combination Regimen ◽  
Line Treatment ◽  
Second Line ◽  
Tumor Cell Death ◽  
Study Population

1095 Background: There are no well-established chemotherapy regimens for metastatic triple negative breast cancer. The combination of a microtubule inhibitor (eribulin) with a nucleoside analog (gemcitabine) may synergistically induce tumor cell death, especially in tumors like triple negative breast cancers (TNBC) characterized by high cell proliferation, aggressive tumor behavior, and chemo-resistance. Methods: We performed an open-label, national multicenter phase 2 study evaluating the combination of eribulin (0.88 mg/m2) plus gemcitabine (1000 mg/m2) on day 1 and 8, q21 as either first- or second-line treatment of locally advanced or metastatic TNBC. The Simon's optimal two-stage design was used for estimating objective response rate (ORR) as study primary endpoint. A prospective, molecular correlative study was carried out on germinal DNA of study population to assess the role of germinal DNA polymorphisms and BRCA mutations in predicting efficacy and toxicity of the combination regimen. Results: From July 2013 to September 2016 , 83 (37 in the first stage, 46 in the second one) assessable patients were enrolled. Median age at baseline was 56 years. Sixty-six and 17 patients were in first or second-line treatment, respectively. All patients were previously treated with an anthracycline and/or a taxane. With regard to the first stage of study enrolment, patients received a median number of 6 cycles of treatment. The ORR (CR+PR) was 43.24% (90% CI 29.3-58.0) and the clinical benefit rate (CR+PR+SD) was 64.9% (90% CI: 50.1%-77.8%). The most common grade 3/4 AEs ( > 10% of patients) were neutropenia without febrile neutropenia and liver toxicity. Grade 1/2 AEs were fatigue, anemia, thrombocytopenia, diarrhea, alopecia, peripheral neuropathy, and oral mucositis. Conclusions: The combination of eribulin and gemcitabine shows promising activity and a moderate toxicity profile in metastatic TNBC. More mature toxicity and outcome data of the final study population and correlation with genome analysis will be presented at the meeting. Clinical trial information: 2012-003505-10.

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