We are analyzing https://link.springer.com/article/10.1007/s10637-010-9408-4.

Title:
A phase II trial of sorafenib in first-line metastatic urothelial cancer: a study of the PMH Phase II Consortium | Investigational New Drugs
Description:
Background Sorafenib is an oral multikinase inhibitor that blocks cell proliferation via the ERK pathway and angiogenesis via the VEGF pathway. This phase II trial was conducted to determine the efficacy and tolerability of sorafenib for the treatment of patients with metastatic urothelial cancer (UC) who had not had prior chemotherapy for advanced disease. Patients and Methods Seventeen chemo-naïve UC patients with adequate performance status and organ function were treated with sorafenib 400 mg twice daily on a continuous basis until progression or unacceptable toxicity. The primary endpoint was objective tumor response rate as measured by RECIST criteria. Secondary endpoints included rate of prolonged stable disease (>3 months), time to progression, median and 1 yr survival and safety and tolerability. Results There were no objective responses. Only one patient had stable disease by RECIST criteria and remained on treatment more than 3 months. Three patients had stable disease by RECIST criteria but were on treatment less than 3 months due to progressive disease (PD) or adverse events (AE). Eight patients had PD by RECIST criteria as their best overall response. Two patients had symptomatic PD prior to cycle 2 evaluation, and three patients were inevaluable (1 death, 1 AE, 1 withdrew consent).The time to progression was 1.9 months (range 0.7–8.7 months) and median survival was 5.9 months. The most common grade 3+ toxicities were abdominal pain, back pain, hand-foot reaction and bladder infection. Conclusions Sorafenib does not show sufficient activity as a single agent in first-line metastatic urothelial cancer to warrant further investigation.
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Keywords {🔍}

cancer, article, pubmed, google, scholar, cas, phase, sorafenib, patients, urothelial, advanced, study, bladder, metastatic, carcinoma, clin, oncol, trial, treatment, progression, months, privacy, cookies, content, sridhar, disease, access, gemcitabine, information, journal, publish, search, firstline, eisen, moore, recist, criteria, res, schwartz, human, growth, canada, data, log, research, drugs, consortium, february, srikala, winquist,

Topics {✒️}

month download article/chapter metastatic transitional-cell carcinoma phase ii consortium phase ii trial n-ras proto-oncogenes national cancer institute human urothelial carcinoma phase ii study raf/mek/erk pathway metastatic urothelial cancer advanced urothelial cancer full article pdf human bladder tumors refractory urothelial carcinoma cisplatin-based chemotherapy advanced hepatocellular carcinoma privacy choices/manage cookies oral multikinase inhibitor metastatic bladder cancer blocks cell proliferation phase iii study targeted agents genitourinary cancers symposium vegf receptor expression urinary bladder cancer superficial bladder cancer phase 2 trial invasive bladder cancer show sufficient activity anti-angiogenic therapy prior chemotherapy european economic area adequate performance status hand-foot reaction hill-harmon mb ras superfamily proteins copy number alterations clinical oncology lara pn jr article investigational conditions privacy policy visseren-grul cm de oliveira ac continuous dosing schedule bladder cancer progression moore mj long-term survival accepting optional cookies cisplatin versus methotrexate stadler wm

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         headline:A phase II trial of sorafenib in first-line metastatic urothelial cancer: a study of the PMH Phase II Consortium
         description:Background Sorafenib is an oral multikinase inhibitor that blocks cell proliferation via the ERK pathway and angiogenesis via the VEGF pathway. This phase II trial was conducted to determine the efficacy and tolerability of sorafenib for the treatment of patients with metastatic urothelial cancer (UC) who had not had prior chemotherapy for advanced disease. Patients and Methods Seventeen chemo-naïve UC patients with adequate performance status and organ function were treated with sorafenib 400 mg twice daily on a continuous basis until progression or unacceptable toxicity. The primary endpoint was objective tumor response rate as measured by RECIST criteria. Secondary endpoints included rate of prolonged stable disease (>3 months), time to progression, median and 1 yr survival and safety and tolerability. Results There were no objective responses. Only one patient had stable disease by RECIST criteria and remained on treatment more than 3 months. Three patients had stable disease by RECIST criteria but were on treatment less than 3 months due to progressive disease (PD) or adverse events (AE). Eight patients had PD by RECIST criteria as their best overall response. Two patients had symptomatic PD prior to cycle 2 evaluation, and three patients were inevaluable (1 death, 1 AE, 1 withdrew consent).The time to progression was 1.9 months (range 0.7–8.7 months) and median survival was 5.9 months. The most common grade 3+ toxicities were abdominal pain, back pain, hand-foot reaction and bladder infection. Conclusions Sorafenib does not show sufficient activity as a single agent in first-line metastatic urothelial cancer to warrant further investigation.
         datePublished:2010-02-27T00:00:00Z
         dateModified:2010-02-27T00:00:00Z
         pageStart:1045
         pageEnd:1049
         sameAs:https://doi.org/10.1007/s10637-010-9408-4
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            Sorafenib
            Metastatic urothelial cancer
            Phase II
            First-line
            Oncology
            Pharmacology/Toxicology
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      headline:A phase II trial of sorafenib in first-line metastatic urothelial cancer: a study of the PMH Phase II Consortium
      description:Background Sorafenib is an oral multikinase inhibitor that blocks cell proliferation via the ERK pathway and angiogenesis via the VEGF pathway. This phase II trial was conducted to determine the efficacy and tolerability of sorafenib for the treatment of patients with metastatic urothelial cancer (UC) who had not had prior chemotherapy for advanced disease. Patients and Methods Seventeen chemo-naïve UC patients with adequate performance status and organ function were treated with sorafenib 400 mg twice daily on a continuous basis until progression or unacceptable toxicity. The primary endpoint was objective tumor response rate as measured by RECIST criteria. Secondary endpoints included rate of prolonged stable disease (>3 months), time to progression, median and 1 yr survival and safety and tolerability. Results There were no objective responses. Only one patient had stable disease by RECIST criteria and remained on treatment more than 3 months. Three patients had stable disease by RECIST criteria but were on treatment less than 3 months due to progressive disease (PD) or adverse events (AE). Eight patients had PD by RECIST criteria as their best overall response. Two patients had symptomatic PD prior to cycle 2 evaluation, and three patients were inevaluable (1 death, 1 AE, 1 withdrew consent).The time to progression was 1.9 months (range 0.7–8.7 months) and median survival was 5.9 months. The most common grade 3+ toxicities were abdominal pain, back pain, hand-foot reaction and bladder infection. Conclusions Sorafenib does not show sufficient activity as a single agent in first-line metastatic urothelial cancer to warrant further investigation.
      datePublished:2010-02-27T00:00:00Z
      dateModified:2010-02-27T00:00:00Z
      pageStart:1045
      pageEnd:1049
      sameAs:https://doi.org/10.1007/s10637-010-9408-4
      keywords:
         Sorafenib
         Metastatic urothelial cancer
         Phase II
         First-line
         Oncology
         Pharmacology/Toxicology
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            affiliation:
                  name:London Regional Cancer Center
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                     name:London Regional Cancer Center, London, Canada
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            type:Person
            name:Andrea Eisen
            affiliation:
                  name:Odette Cancer Center
                  address:
                     name:Odette Cancer Center, Toronto, Canada
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            type:Person
            name:Sebastien J. Hotte
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                  name:Juravinski Cancer Center
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                  name:Juravinski Cancer Center
                  address:
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                  name:Princess Margaret Hospital, Phase II Consortium
                  address:
                     name:Princess Margaret Hospital, Phase II Consortium, Toronto, Canada
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                  type:Organization
            type:Person
            name:Chantale Blattler
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                  name:Princess Margaret Hospital, Phase II Consortium
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                     name:Princess Margaret Hospital, Phase II Consortium, Toronto, Canada
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                  name:Cancer Therapy Evaluation Program, National Cancer Institute
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         name:Princess Margaret Hospital, Phase II Consortium, Toronto, Canada
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               name:Odette Cancer Center, Toronto, Canada
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      name:Sebastien J. Hotte
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      name:Lisa Wang
      affiliation:
            name:Princess Margaret Hospital, Phase II Consortium
            address:
               name:Princess Margaret Hospital, Phase II Consortium, Toronto, Canada
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      affiliation:
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               name:Princess Margaret Hospital, Phase II Consortium, Toronto, Canada
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