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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 34-39 |
| Number of pages | 6 |
| Journal | British Journal of Haematology |
| Volume | 145 |
| Issue number | 1 |
| DOIs | |
| State | Published - Apr 1 2009 |
| Externally published | Yes |
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Keywords
- Bortezomib
- Mantle cell lymphoma
- Non-Hodgkin lymphoma
- Proteasome inhibition
ASJC Scopus subject areas
- Hematology
Cite this
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. / O'Connor, Owen A.; Moskowitz, Craig; Portlock, Carol; Hamlin, Paul; Straus, David; Dumitrescu, Otilia; Sarasohn, Debra; Gonen, Mithat; Butos, John; Neylon, Ellen; Hamelers, Rachel; Mac-Gregor Cortelli, Barbara; Blumel, Susan; Zelenetz, Andrew D.; Gordon, Leo; Wright, John J.; Vose, Julie; Cooper, Brenda; Winter, Jane.
In: British Journal of Haematology, Vol. 145, No. 1, 01.04.2009, p. 34-39.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - 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
T2 - Results of a multicentre phase 2 clinical trial
AU - O'Connor, Owen A.
AU - Moskowitz, Craig
AU - Portlock, Carol
AU - Hamlin, Paul
AU - Straus, David
AU - Dumitrescu, Otilia
AU - Sarasohn, Debra
AU - Gonen, Mithat
AU - Butos, John
AU - Neylon, Ellen
AU - Hamelers, Rachel
AU - Mac-Gregor Cortelli, Barbara
AU - Blumel, Susan
AU - Zelenetz, Andrew D.
AU - Gordon, Leo
AU - Wright, John J.
AU - Vose, Julie
AU - Cooper, Brenda
AU - Winter, Jane
PY - 2009/4/1
Y1 - 2009/4/1
N2 - 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.
AB - 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.
KW - Bortezomib
KW - Mantle cell lymphoma
KW - Non-Hodgkin lymphoma
KW - Proteasome inhibition
UR - http://www.scopus.com/inward/record.url?scp=61849128387&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=61849128387&partnerID=8YFLogxK
U2 - 10.1111/j.1365-2141.2008.07466.x
DO - 10.1111/j.1365-2141.2008.07466.x
M3 - Article
C2 - 19220284
AN - SCOPUS:61849128387
VL - 145
SP - 34
EP - 39
JO - British Journal of Haematology
JF - British Journal of Haematology
SN - 0007-1048
IS - 1
ER -