Phase II trial of bortezomib for patients with advanced renal cell carcinoma Journal Article


Authors: Kondagunta, G. V.; Drucker, B.; Schwartz, L.; Bacik, J.; Marion, S.; Russo, P.; Mazumdar, M.; Motzer, R. J.
Article Title: Phase II trial of bortezomib for patients with advanced renal cell carcinoma
Abstract: Purpose: To assess the efficacy and toxicity of bortezomib (Velcade; Milennium Pharmaceuticals Inc, Cambridge, MA; formerly PS-341) in patients with metastatic renal cell carcinoma (RCC). Patients and Methods: Thirty-seven patients with metastatic RCC were treated with bortezomib. The first 25 patients enrolled onto the trial were treated with a dose of 1.5 mg/m2. The dose was decreased to 1.3 mg/m2 for the subsequent 12 patients, because more than 50% of the patients treated at the higher dose required dose reductions. Bortezomib was given by intravenous administration on a twice-weekly schedule for 2 weeks followed by 1 week without treatment until progression or unacceptable toxicity occurred. Twenty-three patients (62%) previously had undergone nephrectomy, and 19 patients (51%) had previously been treated with cytokine therapy. Results: Of the 37 assessable patients, the best response was a partial response in four patients (11%; 95% CI, 3% to 25%) and stable disease in 14 patients (38%; 95% CI, 23% to 55%). The four patients with partial response experienced response durations of 8, 8+, 15+, and 20+ months. Grade 2 or 3 sensory neuropathy was present in 10 patients (53%) overall. One patient in the 1.5 mg/m2 group had grade 3 sensory neuropathy; no grade 3 sensory neuropathy was seen in the 1.3 mg/m2 group. Conclusion: The results of this trial suggest that bortezomib has an antitumor effect in individual patients with metastatic RCC. The small proportion of patients who achieved a partial response does not support routine use in metastatic RCC. Efforts to identify the molecular profile associated with clinical response or combination therapy with interferon alfa or other novel agents, may be considered. © 2004 by American Society of Clinical Oncology.
Keywords: adult; clinical article; treatment outcome; aged; middle aged; clinical trial; cancer growth; dose response; drug efficacy; antineoplastic agents; antineoplastic agent; metastasis; bortezomib; phase 2 clinical trial; sensory neuropathy; boronic acids; pyrazines; antineoplastic activity; drug effect; pathology; cancer therapy; kidney carcinoma; kidney neoplasms; nephrectomy; kidney tumor; carcinoma, renal cell; infusions, intravenous; boronic acid derivative; pyrazine derivative; intravenous drug administration; humans; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 22
Issue: 18
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2004-09-15
Start Page: 3720
End Page: 3725
Language: English
DOI: 10.1200/jco.2004.10.155
PROVIDER: scopus
PUBMED: 15365068
DOI/URL:
Notes: J. Clin. Oncol. -- Cited By (since 1996):115 -- Export Date: 16 June 2014 -- CODEN: JCOND -- Source: Scopus
Altmetric Score
MSK Authors
  1. Paul Russo
    446 Russo
  2. Robert Motzer
    745 Motzer
  3. Madhu Mazumdar
    120 Mazumdar
  4. Lawrence H Schwartz
    281 Schwartz
  5. Jennifer M Bacik
    46 Bacik
  6. Stephanie Marion
    8 Marion