Association between quality of response and outcomes in patients with newly diagnosed mantle cell lymphoma receiving VR-CAPversusR-CHOP in the phase 3 LYM-3002 study.
In the phase 3 LYM-3002 study comparing intravenous VR-CAP with R-CHOP in patients with newly-diagnosed, measurable stage II-IV mantle cell lymphoma, not considered or ineligible for transplant, the median progression-free survival was significantly improved with VR-CAP (24.7versus14.4 months with R-CHOP;P<0.001). Thispost-hocanalysis evaluated the association between the improved outcomes and quality of responses achieved with VR-CAPversusR-CHOP in LYM-3002. Patients were randomized to six to eight 21-day cycles of VR-CAP or R-CHOP. Outcomes included progression-free survival, duration of response (both assessed by an independent review committee), and time to next anti-lymphoma treatment, evaluated by response (complete response/unconfirmed complete response and partial response), MIPI risk status, and maximum reduction of lymph-node measurements expressed as the sum of the product of the diameters. Within each response category, the median progression-free survival was longer for patients given VR-CAP than for those given R-CHOP (complete response/unconfirmed complete response: 40.9versus19.8 months; partial response: 17.1versus11.7 months, respectively); similarly, the median time to next anti-lymphoma treatment was longer among the patients given VR-CAP than among those treated with R-CHOP (complete response/unconfirmed complete response: not evaluableversus26.6 months; partial response: 35.3versus24.3 months). Within the complete/unconfirmed complete and partial response categories, improvements in progression-free survival, duration of response and time to next anti-lymphoma treatment were more pronounced in patients with low-and intermediate-risk MIPI treated with VR-CAP than with R-CHOP. In each response category, more VR-CAP than R-CHOP patients had a sum of the product of the diameters nadir of 0 during serial radiological assessments. Results of thispost-hocanalysis suggest a greater duration and quality of response in patients treated with VR-CAP in comparison with those treated with R-CHOP, with the improvements being more evident in patients with low- and intermediate-risk MIPI.LYM-3002 ClinicalTrials.gov: NCT00722137.
University Hospital Leuven, Belgium gregor.verhoef@uzleuven.be.
Gregor
G
Verhoef
Medical University of Lodz, Copernicus Memorial Hospital, Poland.
Tadeusz
T
Robak
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
Huiqiang
H
Huang
Cherkassy Regional Oncology Center, Ukraine.
Halyna
H
Pylypenko
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Noppadol
N
Siritanaratkul
Hospital das Clinicas da Faculdade de Medicina da USP, São Paolo, Brazil.
Juliana
J
Pereira
University of Vienna, Vienna General Hospital, Austria.
Johannes
J
Drach
Masaryk University Hospital Brno, Czech Republic.
Jiri
J
Mayer
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Japan.
Rumiko
R
Okamoto
Janssen Research & Development, LLC, Raritan, NJ, USA.
Lixia
L
Pei
Janssen Research & Development, High Wycombe, Buckinghamshire, UK.
Brendan
B
Rooney
Janssen Research & Development, High Wycombe, Buckinghamshire, UK.
Andrew
A
Cakana
Millennium Pharmaceuticals, Inc., Boston, MA, USA.
Helgi
H
van de Velde
Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, Ticino, Switzerland.
Franco
F
Cavalli
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage; D014750:Vincristine / Q000008:administration & dosage
D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone