Helpt u ons aan 500 donateurs?

10 december 2018: lees ook dit artikel: 

https://kanker-actueel.nl/NL/ibrutinib-geeft-veel-betere-resultaten-op-ziekteprogressievrije-overleving-87-vs-74-procent-dan-bendamustine-plus-rituximab-bij-onbehandelde-oudere-cll-patienten-rituximab-lijkt-zinloos-naast-ibrutinib.html

29 maart 2018: Lees ook dit artikel: 

https://kanker-actueel.nl/ibrutinib-aanvullend-op-bendamustine-en-rituximab-verbetert-progressievrije-ziekte-en-overall-overleving-met-tientallen-procenten-bij-chronische-lymfatische-leukemia-en-recidief-van-lymfklierkanker-met-kleine-tumoren-copy-1.html

29 maart 2018: Bron: Cancer Medicine: 13 March 2018

Ook uit een Aziatische studie blijkt dat Ibrutinib (Imbruvica) superieure resultaten geeft in vergelijking met Rituximab bij recidief van CLL - Chronische Lymfatische Leukemie en SLL, een vorm van lymfklierkanker. (Zie ook in gerelateerde artikelen bv deze studie)

Na een mediane studiefollow-up van 17,8 maanden blijkt de ziektevrije tijd (OOR) al een verschil te geven van plus 45 procent en ook de overall overleving (OS) was al significant beter. 

ORR was significantly higher (P < 0.0001) with ibrutinib (53.8%) than with rituximab (7.4%). At a median follow‐up of 17.8 months, ibrutinib improved OS compared with rituximab (HR = 0.446; 95% CI: 0.221–0.900; P = 0.0206).

Hier de grafiek uit het studierapport: Ibrutinib versus rituximab in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: a randomized, open‐label phase 3 study

en ik geef maar geen verdere vertaling van de details want deze zijn duidelijk lijkt mij. Ga naar het volledige studierapprot en bekjk alle grafieken enz. Onderaan de grafiek staat het abstract met referentielijst.

Efficacy

In the updated analysis, 64 PFS events were reported (26 [24.5%] in the ibrutinib arm and 38 [70.4%] in the rituximab arm). PFS was significantly improved for patients in the ibrutinib arm compared with the rituximab arm (HR = 0.180, 95% CI: 0.105–0.308; P < 0.0001). The median PFS was not reached in the ibrutinib arm; median PFS for the rituximab arm was 8.3 months (range, 0–22.6 months). At the 18‐month landmark, the estimated PFS rate in the ibrutinib arm was 74.0%, and in the rituximab arm, it was 11.9% (Fig. 1A).

(A) Kaplan–Meier Curves for Progression‐Free Survival (ITT Population). The median progression‐free survival (PFS) was not reached in the ibrutinib arm. The median PFS for the rituximab arm was 8.34 months (95% confidence interval: 8.21–9.03 months). (B) Kaplan–Meier Curves for Overall Survival (ITT Population). With a median follow‐up of 17.84 months, overall survival was significantly improved in the ibrutinib arm compared with the rituximab arm.
Hier het abstract plus referentielijst:

Ibrutinib significantly improved PFS, ORR, and OS compared with rituximab; the results were robust and internally consistent. Ibrutinib displayed a manageable safety profile with no new or unexpected events reported.

Original Research

Ibrutinib versus rituximab in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: a randomized, open‐label phase 3 study

First published: 13 March 2018

Abstract

In the Asia‐Pacific region, treatment options are limited for patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Rituximab is widely used in this setting when purine analog‐based therapies are not appropriate. We evaluated the efficacy and safety of ibrutinib compared with rituximab in a randomized, open‐label phase 3 study in predominantly Asian patients with relapsed/refractory CLL/SLL. Patients (N = 160) were randomly assigned 2:1 to receive 420 mg ibrutinib (n = 106) until disease progression (PD) or unacceptable toxicity or up to six cycles of rituximab (n = 54). The primary endpoint was investigator‐assessed progression‐free survival (PFS); key secondary endpoints were overall response rate (ORR), overall survival (OS), and safety. Rituximab‐treated patients could crossover to receive ibrutinib after confirmed PD. At data cutoff, median treatment duration was 16.4 months for ibrutinib and 4.6 months for rituximab. Ibrutinib significantly improved PFS (hazard ratio  = 0.180, 95% confidence interval : 0.105–0.308). ORR was significantly higher (< 0.0001) with ibrutinib (53.8%) than with rituximab (7.4%). At a median follow‐up of 17.8 months, ibrutinib improved OS compared with rituximab (HR = 0.446; 95% CI: 0.221–0.900; = 0.0206). Overall incidence of adverse events (AEs) was similar between treatments and was not exposure‐adjusted. With ibrutinib, most common AEs were diarrhea and platelet count decreased; with rituximab, most common AEs were neutrophil count decreased and platelet count decreased. Grade ≥3 AEs were reported in 82.7% of ibrutinib‐treated patients and 59.6% of rituximab‐treated patients. Ibrutinib improved PFS, ORR, and OS compared with rituximab and displayed a manageable safety profile in Asian patients with relapsed/refractory CLL/SLL.

References:

  • 1Eichhorst, B., T. Robak, E. Montserrat, P. Ghia, P. Hillmen, M. Hallek, et al. 2015. Chronic lymphocytic leukaemia: ESMO clinical practice guidelines for diagnosis, treatment and follow‐up. Ann. Oncol. 26(Suppl. 5):v78–v84.
  • 2Chihara, D., H. Ito, T. Matsuda, A. Shibata, A. Katsumi, S. Nakamura, et al. 2014. Differences in incidence and trends of haematological malignancies in Japan and the United States. Br. J. Haematol. 164:536–545.
  • 3Redaelli, A., B. L. Laskin, J. M. Stephens, M. F. Botteman, and C. L. Pashos. 2004. The clinical and epidemiological burden of chronic lymphocytic leukaemia. Eur. J. Cancer Care (Engl.) 13:279–287.
  • 4Yang, S. M., J. Y. Li, R. P. Gale, and X. J. Huang. 2015. The mystery of chronic lymphocytic leukemia (CLL): why is it absent in Asians and what does this tell us about etiology, pathogenesis and biology? Blood Rev. 29:205–213.
  • 5Yoon, S. O., C. Suh, D. H. Lee, H. S. Chi, C. J. Park, S. S. Jang, et al. 2010. Distribution of lymphoid neoplasms in the Republic of Korea: analysis of 5318 cases according to the World Health Organization classification. Am. J. Hematol. 85:760–764.
  • 6Gale, R. P., W. Cozen, M. T. Goodman, F. F. Wang, and L. Bernstein. 2000. Decreased chronic lymphocytic leukemia incidence in Asians in Los Angeles County. Leuk. Res. 24:665–669.
  • 7Mak, V., D. Ip, O. Mang, C. Dalal, S. Huang, A. Gerrie, et al. 2014. Preservation of lower incidence of chronic lymphocytic leukemia in Chinese residents in British Columbia: a 26‐year survey from 1983 to 2008. Leuk. Lymphoma 55:824–827.
  • 8Chan, T. S., Y. S. Lee, I. Del Giudice, M. Marinelli, C. Ilari, L. Cafforio, et al. 2017. Clinicopathological features and outcome of chronic lymphocytic leukaemia in Chinese patients. Oncotarget 8:25455–25468.
  • 9Dong, H. J., L. T. Zhou, D. X. Zhu, D. M. Wang, C. Fang, H. Y. Zhu, et al. 2011. The prognostic significance of TP53 mutations in Chinese patients with chronic lymphocytic leukemia is independent of del(17p13). Ann. Hematol. 90:709–717.
  • 10Lai, Y. Y., and X. J. Huang. 2011. Cytogenetic characteristics of B cell chronic lymphocytic leukemia in 275 Chinese patients by fluorescence in situ hybridization: a multicenter study. Chin. Med. J. (Engl.) 124:2417–2422.
  • 11Qiu, H. X., W. Xu, X. S. Cao, M. Zhou, Y. F. Shen, Y. L. Xu, et al. 2008. Cytogenetic characterisation in Chinese patients with chronic lymphocytic leukemia: a prospective, multicenter study on 143 cases analysed with interphase fluorescence in situ hybridisation. Leuk. Lymphoma 49:1887–1892.
  • 12Marinelli, M., C. Ilari, Y. Xia, I. Del Giudice, L. Cafforio, I. Della Starza, et al. 2016. Immunoglobulin gene rearrangements in Chinese and Italian patients with chronic lymphocytic leukemia. Oncotarget 7:20520–20531.
  • 13Jang, M. A., E. H. Yoo, K. Kim, W. S. Kim, C. W. Jung, S. H. Kim, et al. 2013. Chronic lymphocytic leukemia in Korean patients: frequent atypical immunophenotype and relatively aggressive clinical behavior. Int. J. Hematol. 97:403–408.
  • 14Tomomatsu, J., Y. Isobe, K. Oshimi, Y. Tabe, K. Ishii, M. Noguchi, et al. 2010. Chronic lymphocytic leukemia in a Japanese population: varied immunophenotypic profile, distinctive usage of frequently mutated IGH gene, and indolent clinical behavior. Leuk. Lymphoma 51:2230–2239.
  • 15Li, Z., F. Li, S. Yi, Z. Gu, Z. Yu, Y. Xu, et al. 2015. Superior efficacy of rituximab‐based chemoimmunotherapy as an initial therapy in newly diagnosed patients with B cell indolent lymphomas: long‐term results from a single center in China. BMC Cancer 15:555.
  • 16Ogawa, Y., M. Ogura, T. Suzuki, K. Ando, T. Uchida, Y. Shirasugi, et al. 2013. A phase I/II study of ofatumumab (GSK1841157) in Japanese and Korean patients with relapsed or refractory B‐cell chronic lymphocytic leukemia. Int. J. Hematol. 98:164–170.
  • 17Tobinai, K., M. Ogura, K. Ishizawa, T. Suzuki, W. Munakata, T. Uchida, et al. 2016. Safety and tolerability of ibrutinib monotherapy in Japanese patients with relapsed/refractory B cell malignancies. Int. J. Hematol. 103:86–94.
  • 18Wierda, W. G., A. D. Zelenetz, L. I. Gordon, J. S. Abramson, R. H. Advani, C. B. Andreadis, et al. 2017. NCCN guidelines insights: chronic lymphocytic leukemia/small lymphocytic leukemia, version 1.2017. J. Natl. Compr. Canc. Netw. 15:293–311.
  • 19Lamanna, N. 2012. Treatment of older patients with chronic lymphocytic leukemia. Curr. Hematol. Malig. Rep. 7:21–25.
  • 20Fischer, K., P. Cramer, R. Busch, S. Bottcher, J. Bahlo, J. Schubert, et al. 2012. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J. Clin. Oncol. 30:3209–3216.
  • 21Hallek, M., K. Fischer, G. Fingerle‐Rowson, A. M. Fink, R. Busch, J. Mayer, et al. 2010. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open‐label, phase 3 trial. Lancet 376:1164–1174.
  • 22Buggy, J. J., and L. Elias. 2012. Bruton tyrosine kinase (BTK) and its role in B‐cell malignancy. Int. Rev. Immunol. 31:119–132.
  • 23Janssen‐Cilag International NV. 2016. Imbruvica [summary of product characteristics]. Janssen‐Cilag International NV, Beerse, Belgium.
  • 24Pharmacyclics LLC. 2017. Imbruvica [package insert]. Pharmacyclics LLC, Sunnyvale, CA.
  • 25Byrd, J. C., R. R. Furman, S. E. Coutre, I. W. Flinn, J. A. Burger, K. A. Blum, et al. 2013. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N. Engl. J. Med. 369:32–42.
  • 26Byrd, J. C., J. R. Brown, S. O'Brien, J. C. Barrientos, N. E. Kay, N. M. Reddy, et al. 2014. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N. Engl. J. Med. 371:213–223.
  • 27Weiner, G. J. 2010. Rituximab: mechanism of action. Semin. Hematol. 47:115–123.
  • 28Furman, R. R., J. P. Sharman, S. E. Coutre, B. D. Cheson, J. M. Pagel, P. Hillmen, et al. 2014. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N. Engl. J. Med. 370:997–1007.
  • 29Mato, A. R., J. Jahnke, P. Li, M. Mehra, V. P. Ladage, M. Mahler, et al. 2016. Characterization of real world survival outcomes among older adults with chronic lymphocytic leukemia receiving second line treatment in the pre novel‐agents era: an analysis of the 2007‐2013 SEER‐Medicare database. Blood 128:4790.
  • 30Ysebaert, L., B. P. Philip, and S. Stilgenbauer. 2014. Real‐world treatment patterns of rituximab usage as single‐agent therapy or part of combination regimens in chronic lymphocytic leukemia (CLL) in Eu5 countries (UK, France, Germany, Italy, and Spain). Value Health 17:A234.
  • 31Feinberg, B., B. Schenkel, A. McBride, L. Ellis, and J. Radtchenko. 2015. Real‐world treatment patterns in first line and relapsed chronic lymphocytic leukemia (CLL). Clin. Lymphoma Myeloma Leuk. 15:S204–S205.
  • 32Mato, A., C. Nabhan, N. E. Kay, M. A. Weiss, N. Lamanna, T. J. Kipps, et al. 2016. Real‐world clinical experience in the Connect® chronic lymphocytic leukaemia registry: a prospective cohort study of 1494 patients across 199 US centres. Br. J. Haematol. 175:892–903.
  • 33Satram‐Hoang, S., C. Reyes, K. Q. Hoang, F. Momin, and S. Skettino. 2014. Treatment practice in the elderly patient with chronic lymphocytic leukemia‐analysis of the combined SEER and Medicare database. Ann. Hematol. 93:1335–1344.
  • 34Hallek, M., B. D. Cheson, D. Catovsky, F. Caligaris‐Cappio, G. Dighiero, H. Dohner, et al. 2008. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute‐Working Group 1996 guidelines. Blood 111:5446–5456.
  • 35Hallek, M., B. D. Cheson, D. Catovsky, F. Caligaris‐Cappio, G. Dighiero, H. Dohner, et al. 2012. Response assessment in chronic lymphocytic leukemia treated with novel agents causing an increase of peripheral blood lymphocytes. Blood http://www.bloodjournal.org/content/111/12/5446/tab-e-letters.
  • 36Marostica, E., J. Sukbuntherng, D. Loury, J. de Jong, X. W. de Trixhe, A. Vermeulen, et al. 2015. Population pharmacokinetic model of ibrutinib, a Bruton tyrosine kinase inhibitor, in patients with B cell malignancies. Cancer Chemother. Pharmacol. 75:111–121.
  • 37Brown, J., P. Hillmen, S. O'Brien, J. Barrientos, N. Reddy, S. Coutre, et al. 2017. Extended follow‐up and impact of high‐risk prognostic factors from the phase 3 RESONATE study in patients with previously treated CLL/SLL. Leukemia. https://doi.org/10.1038/leu.2017.175.
  • 38Byrd, J. C., R. R. Furman, S. E. Coutre, J. A. Burger, K. A. Blum, M. Coleman, et al. 2015. Three‐year follow‐up of treatment‐naive and previously treated patients with CLL and SLL receiving single‐agent ibrutinib. Blood 125:2497–2506.
  • 39Huhn, D., C. von Schilling, M. Wilhelm, A. D. Ho, M. Hallek, R. Kuse, et al. 2001. Rituximab therapy of patients with B‐cell chronic lymphocytic leukemia. Blood 98:1326–1331.
  • 40Itala, M., C. H. Geisler, E. Kimby, E. Juvonen, G. Tjonnfjord, K. Karlsson, et al. 2002. Standard‐dose anti‐CD20 antibody rituximab has efficacy in chronic lymphocytic leukaemia: results from a Nordic multicentre study. Eur. J. Haematol. 69:129–134.
  • 41Nguyen, D. T., J. A. Amess, H. Doughty, L. Hendry, and L. W. Diamond. 1999. IDEC‐C2B8 anti‐CD20 (rituximab) immunotherapy in patients with low‐grade non‐Hodgkin's lymphoma and lymphoproliferative disorders: evaluation of response on 48 patients. Eur. J. Haematol. 62:76–82.
  • 42Winkler, U., M. Jensen, O. Manzke, H. Schulz, V. Diehl, and A. Engert. 1999. Cytokine‐release syndrome in patients with B‐cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti‐CD20 monoclonal antibody (rituximab, IDEC‐C2B8). Blood 94:2217–2224.
  • 43Burger, J. A., A. Tedeschi, P. M. Barr, T. Robak, C. Owen, P. Ghia, et al. 2015. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N. Engl. J. Med. 373:2425–2437.
  • 44Shanafelt, T. D., S. A. Parikh, P. A. Noseworthy, V. Goede, K. G. Chaffee, J. Bahlo, et al. 2017. Atrial fibrillation in patients with chronic lymphocytic leukemia (CLL). Leuk. Lymphoma 58:1630–1639.

Plaats een reactie ...

Reageer op "Ibrutinib geeft veel betere ziektevrije tijd (plus 45 procent) in vergelijking met rituximab bij recidief van chronische lymfatische leukemie en SLL - lymfklierkanker"


Gerelateerde artikelen
 

Gerelateerde artikelen

Pirtobrutinib, een niet-covalente >> Reviewstudie beschrijft hoe >> Venetoclax plus rituximab >> acalabrutinib als monotherapie >> Ibrutinib geeft veel betere >> Man - 48 jaar - met al 20 >> BCL-2 remmer - ABT-199/GDC-0199 >> Ibrutinib geeft veel betere >> Ibrutinib aanvullend op Bendamustine >> Ibrutinib - Tyrosine kinase >>