Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2015 Sep 18;5(9):e347.
doi: 10.1038/bcj.2015.75.

Managing chronic myeloid leukaemia in the elderly with intermittent imatinib treatment

D Russo  1 , M Malagola  1 , C Skert  1 , V Cancelli  1 , D Turri  2 , P Pregno  3 , M Bergamaschi  4 , M Fogli  5 , N Testoni  5 , A De Vivo  5 , F Castagnetti  5 , E Pungolino  6 , F Stagno  7 , M Breccia  8 , B Martino  9 , T Intermesoli  10 , G R Cambrin  11 , G Nicolini  12 , E Abruzzese  13 , M Tiribelli  14 , C Bigazzi  15 , E Usala  16 , S Russo  17 , A Russo-Rossi  18 , M Lunghi  19 , M Bocchia  20 , A D'Emilio  21 , V Santini  22 , M Girasoli  23 , R Di Lorenzo  24 , S Bernardi  1 , A Di Palma  1 , B M Cesana  25 , S Soverini  5 , G Martinelli  5 , G Rosti  5 , M Baccarani  26
Affiliations
Clinical Trial

Managing chronic myeloid leukaemia in the elderly with intermittent imatinib treatment

D Russo et al. Blood Cancer J. .

Abstract

The aim of this study was to investigate the effects of a non-standard, intermittent imatinib treatment in elderly patients with Philadelphia-positive chronic myeloid leukaemia and to answer the question on which dose should be used once a stable optimal response has been achieved. Seventy-six patients aged ⩾65 years in optimal and stable response with ⩾2 years of standard imatinib treatment were enrolled in a study testing a regimen of intermittent imatinib (INTERIM; 1-month on and 1-month off). With a minimum follow-up of 6 years, 16/76 patients (21%) have lost complete cytogenetic response (CCyR) and major molecular response (MMR), and 16 patients (21%) have lost MMR only. All these patients were given imatinib again, the same dose, on the standard schedule and achieved again CCyR and MMR or an even deeper molecular response. The probability of remaining on INTERIM at 6 years was 48% (95% confidence interval 35-59%). Nine patients died in remission. No progressions were recorded. Side effects of continuous treatment were reduced by 50%. In optimal and stable responders, a policy of intermittent imatinib treatment is feasible, is successful in about 50% of patients and is safe, as all the patients who relapsed could be brought back to optimal response.

PubMed Disclaimer

Conflict of interest statement

Domenico Russo, Patrizia Pregno and Simona Soverini receives compensation as a consultant for Novartis, Bristol-Myers Squibb and Ariad. Elisabetta Abruzzese receives compensation as a consultant for Ariad, Bristol-Myers Squibb, Novartis, Takeda and Pfizer. Giovanni Martinelli receives compensation as a consultant for Novartis, Bristol-Myers Squibb and Pfizer. Gianantonio Rosti, Fausto Castagnetti and Michele Baccarani receives compensation as a consultant for Novartis, Ariad, Bristol-Myers Squibb and Pfizer. Mario Tiribelli receives compensation as a consultant for Novartis, BMS and Ariad. The remaining authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram of INTERIM study—update at 72 months.
Figure 2
Figure 2
(a) Probability of maintaining the CCyR. In all, 16/76 patients (21%) lost CCyR, of whom 11 during the first 2 years and 5 later on. The probability of remaining in CCyR was 84% (95% CI 73–90) at 2 years, 81% (95% CI 69–88) at 4 years and 76% (95% CI 64–84) at 6 years. All 16 patients but 1 who was lost to follow-up were back to continuous imatinib treatment, same daily dose, and recovered the CCyR. (b) Probability of maintaining the MMR. In all, 32/76 patients (42%) lost MMR, including the 16 patients who had lost also the CCyR (Figure 1). The probability of remaining in MMR was 67% (95% CI 54–76) at 2 years and 60% (95% CI 47–70) at 4 and 6 years. All 32 patients but 1 who was lost to follow-up were back to continuous imatinib treatment, same daily dose, and recovered the MMR.
Figure 3
Figure 3
(a) Probability of remaining in the intermittent imatinib schedule (INTERIM). In all, 46/76 patients (61%) discontinued the intermittent schedule, of whom 24 during the first 2 years and 22 later on. The probability of maintaining the intermittent treatment schedule was 74% (95% CI 62–82) at 2 years, 59% (95% CI 46–69) at 4 years and 48% (95% CI 35–59) at 6 years. (b) Overall survival. No patients progressed and died of leukaemia. Nine patients (median age at death, 75 years) died in MMR for an overall survival of 87% (95% CI 78–95%) at 6 years.
See this image and copyright information in PMC

References

    1. 1Hehlmann R, Hochhaus A, Baccarani M. Chronic myeloid leukaemia. Lancet 2005; 370: 342–350. - PubMed
    1. 2Kantarjian HM, O'Brien S, Jabbour E, Garcia-Manero G, Quintas-Cardama A, Shan J et al. Improved survival in chronic myeloid leukemia since the introduction of imatinib therapy: a single-institution historical experience. Blood 2012; 119: 1981–1987. - PMC - PubMed
    1. 3Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 2013; 122: 872–884. - PMC - PubMed
    1. 4Hoglund M, Sandin F, Hellstrom K, Björeman M, Björkholm M, Brune M et al. Tyrosine kinase inhibitor usage, treatment outcome, and prognostic scores in CML: report from the population-based swedish CML registry. Blood 2013; 122: 1284–1292. - PMC - PubMed
    1. 5National Comprehensive Cancer Network: NCCN. Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia, version 1, 2015. www.nccn.org/professionals/physician_gls/pdf/cml.pdf. - PubMed

Publication types

MeSH terms