Patients with chemotherapy-refractory mantle cell lymphoma experience high response rates and identical progression-free survivals compared with patients with relapsed disease following treatment with single agent bortezomib: Results of a multicentre phase 2 clinical trial Journal Article

  

Authors:	O'Connor, O. A.; Moskowitz, C.; Portlock, C.; Hamlin, P.; Straus, D.; Dumitrescu, O.; Sarasohn, D.; Gonen, M.; Butos, J.; Neylon, E.; Hamelers, R.; Mac-Gregor Cortelli, B.; Blumel, S.; Zelenetz, A. D.; Gordon, L.; Wright, J. J.; Vose, J.; Cooper, B.; Winter, J.
Article Title:	Patients with chemotherapy-refractory mantle cell lymphoma experience high response rates and identical progression-free survivals compared with patients with relapsed disease following treatment with single agent bortezomib: Results of a multicentre phase 2 clinical trial
Abstract:	The recent approval of bortezomib for the treatment of mantle cell lymphoma (MCL) by the US Food and Drug Administration is based on the results of the multicentre PINNACLE study with supportive data from a number of single and multicentre Phase 2 studies. This multicentre Phase 2 study enroled 40 patients with heavily pretreated MCL. The overall response rate (ORR) was 47%, including 5 complete remissions and 14 partial remissions. Overall, these remissions are relatively durable. The ORR in relapsed and refractory patients was 50% and 43% respectively (P = 0·74), while both populations of patients exhibited essentially similar progression-free survival (PFS; 5·6 months vs. 3·9 months, P = 0·81). Responding patients experienced a PFS from bortezomib that was similar to their line of prior therapy (7·8 months vs. 8·4 months, respectively). The data showed similar responses in relapsed and refractory patients as well as remission durations similar to prior therapy, suggesting that there may be little cross-resistance with other conventional cytotoxic agents. Importantly, these data suggest that MCL patients with refractory or poorly responsive disease may still derive meaningful clinical benefit from treatment with bortezomib. © 2009 Blackwell Publishing Ltd.
Keywords:	adult; cancer chemotherapy; cancer survival; clinical article; controlled study; treatment response; aged; disease-free survival; unclassified drug; overall survival; fludarabine; prednisone; thalidomide; clinical trial; constipation; fatigue; doxorubicin; diarrhea; drug dose reduction; treatment duration; antineoplastic agents; united states; cancer radiotherapy; comparative study; cytarabine; ibritumomab tiuxetan; methotrexate; rituximab; anorexia; carboplatin; progression free survival; bortezomib; controlled clinical trial; mantle cell lymphoma; pain; phase 2 clinical trial; sensory neuropathy; boronic acids; neoplasm recurrence, local; protease inhibitors; pyrazines; anemia; etoposide; blood toxicity; nausea; randomized controlled trial; vomiting; drug administration schedule; combination chemotherapy; cyclophosphamide; dexamethasone; vincristine; food and drug administration; ifosfamide; monoclonal antibody; coughing; dizziness; dyspnea; fever; hyperglycemia; hypomagnesemia; lymphocytopenia; rash; hyperkalemia; hypoalbuminemia; hypokalemia; hyponatremia; insomnia; cancer regression; multicenter study; population; remission induction; single drug dose; hypoglycemia; cancer relapse; tositumomab i 131; pralatrexate; pentostatin; epothilone derivative; lymphoma, mantle-cell; hypernatremia; hypocalcemia; non-hodgkin lymphoma; proteasome inhibition; cladribine; mapatumumab; temsid; autologous peripheral blood stem cell transplantation; cross resistance; drug resistance, multiple
Journal Title:	British Journal of Haematology
Volume:	145
Issue:	1
ISSN:	0007-1048
Publisher:	John Wiley & Sons
Date Published:	2009-04-01
Start Page:	34
End Page:	39
Language:	English
DOI:	10.1111/j.1365-2141.2008.07466.x
PUBMED:	19220284
PROVIDER:	scopus
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-61849128387&partnerID=40&md5=16454ba5a1d19b2027d8096caf04557d
Notes:	--- - "Cited By (since 1996): 9" - "Export Date: 30 November 2010" - "CODEN: BJHEA" - "Source: Scopus"

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