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Proffered paper session - Haematological malignancies

3282 - Final Overall Survival Results of Frontline Bortezomib plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) vs R-CHOP in Transplantation-ineligible Patients (Pts) with Newly Diagnosed Mantle-Cell Lymphoma (MCL): A Randomized, Open-Label, Phase 3 (LYM-3002) Study

Date

21 Oct 2018

Session

Proffered paper session - Haematological malignancies

Topics

Cytotoxic Therapy

Tumour Site

Lymphomas

Presenters

Michele Ghielmini

Citation

Annals of Oncology (2018) 29 (suppl_8): viii359-viii371. 10.1093/annonc/mdy286

Authors

F. Cavalli1, J. Jin2, H. Pylypenko3, G. Verhoef4, N. Siritanaratkul5, J. Drach6, M. Raderer7, J. Mayer8, J. Pereira9, G. Tumyan10, R. Okamoto11, S. Nakahara12, P. Hu13, C. Appiani14, S. Nemat15, T. Robak16

Author affiliations

  • 1 Oncology, IOSI - Ospedale Regionale Bellinzona e Valli, 6500 - Bellinzona/CH
  • 2 University College Of Medicine, The First Affiliated Hospital of Zhejiang, 310000 - Zhejiang/CN
  • 3 Department Of Hematology, Cherkassy Regional Oncology Dispensary, 18009 - Cherkassy/UA
  • 4 Hematology, University Hospital Leuven, 3000 - Leuven/BE
  • 5 Siriraj Hospital, Mahidol University, 10700 - Bangkok/TH
  • 6 Hematology, Allgemeines Krankenhaus der Stadt Wien, Vienna/AT
  • 7 Vienna General Hospital,, University of Vienna, 1090 - Vienna/AT
  • 8 Internal Haemato-oncology Department, Masaryk University Hospital, Brno/CZ
  • 9 De Medicina Da Usp, Hospital Das Clinicas Da Faculdade, São Paulo/BR
  • 10 Cancer Research Center, N.N. Blokhin Academy Of Medical Science, Moscow/RU
  • 11 Chibanishi General Hospital, Tokyo Metropolitan - Komagome Hospital, Chiba/JP
  • 12 Oncology, Janssen Pharmaceutical, K.K., Tokyo/JP
  • 13 Biostatistics, Janssen Research & Development, LLC,, Raritan/US
  • 14 Established Products, Janssen Research & Development, LLC, Titusville/US
  • 15 Established Products, Janssen Research & Development, LLC, High Wycombe/GB
  • 16 Copernicus Memorial Hospital, Medical University of Lodz, Lodz/PL
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Resources

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Abstract 3282

Background

The LYM-3002 study compared the efficacy and safety of frontline VR-CAP versus R-CHOP in transplant-ineligible pts with untreated mantle-cell lymphoma (MCL). We report the final overall survival and safety outcomes of pts in the long-term follow-up phase after the primary progression-free survival endpoint was achieved.

Methods

Between May 2008 and July 2017, adult pts with confirmed stage II–IV MCL diagnosis, ECOG score of ≤ 2, who were treatment-naïve and ineligible for bone marrow transplantation, were randomized (1:1) to 6 or 8 (21-day) cycles of VR-CAP (rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, prednisone 100 mg/m2 plus bortezomib 1.3 mg/m2) or R-CHOP (rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, prednisone 100 mg/m2 and vincristine 1.4 mg/m2 [2 mg max]).

Results

A total of 487 pts (VR-CAP: 244; R-CHOP: 243) were included in the ITT population. With a median follow-up of 82 months (241 events: VR-CAP, 42% versus R-CHOP, 57%), median overall survival improved significantly (Table) and was approximately 3 years longer in VR-CAP (90.7 months) vs R-CHOP group (55.7 months; HR 0.66 [0.51; 0.85]; P = 0.001). Fewer pts treated with VR-CAP (n = 104; 43%) required subsequent treatments versus R-CHOP (n = 151; 62%), twenty pts had second primary malignancies. A total of 268 pts (VR-CAP: 140; R-CHOP: 128) were included in the follow-up analysis. In addition to 3 adverse events (VR-CAP: grade 4 lung adenocarcinoma and grade 4 gastric cancer; R-CHOP: grade 2 pneumonia), three and five pts from the VR-CAP and R-CHOP groups, respectively, were reported to have a fatal outcome.

Conclusions

VR-CAP demonstrated a statistically significant and robust survival benefit for transplant-ineligible patients with untreated MCL, along with an expected and manageable safety profile in this patient population.

Clinical trial identification

NCT00722137.

Legal entity responsible for the study

Janssen Research & Development, LLC, USA.

Funding

Janssen Research & Development, LLC, USA.

Editorial Acknowledgement

Editorial assistance provided by Dr. Namit Ghildyal, Janssen R&D.

Disclosure

N. Siritanaratkul: Research grants: Roche, Janssen-Cilag, during the conduct of the study. M. Raderer: Research grant: Celgene; Personal fees: Ipsen, Novartis. J. Mayer: Research grant: Janssen; Research and Development: Novartis, Eisai. R. Okamoto: Honoraria: Chugai, Kissei. S. Nakahara: Employee: Janssen Pharmaceutical K.K., Japan; Stock: Johnson & Johnson. P. Hu, C. Appiani, S. Nemat: Employee: Janssen R&D; Stock: Johnson & Johnson. T. Robak: Grant funding: Janssen Research and Development. All other authors have declared no conflicts of interest.

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