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Randomized Controlled Trial
. 2015 Jul 2;126(1):42-9.
doi: 10.1182/blood-2015-01-617993. Epub 2015 Apr 27.

Impact of comorbidities on overall survival in patients with chronic myeloid leukemia: results of the randomized CML study IV

Susanne Saussele  1 , Marie-Paloma Krauss  1 , Rüdiger Hehlmann  1 , Michael Lauseker  2 , Ulrike Proetel  1 , Lida Kalmanti  1 , Benjamin Hanfstein  1 , Alice Fabarius  1 , Doris Kraemer  3 , Wolfgang E Berdel  4 , Martin Bentz  5 , Peter Staib  6 , Maike de Wit  7 , Martin Wernli  8 , Florian Zettl  9 , Holger F Hebart  10 , Markus Hahn  11 , Jochen Heymanns  12 , Ingo Schmidt-Wolf  13 , Norbert Schmitz  14 , Michael J Eckart  15 , Winfried Gassmann  16 , Andrea Bartholomäus  17 , Antonio Pezzutto  18 , Elisabeth Oppliger Leibundgut  19 , Dominik Heim  20 , Stefan W Krause  21 , Andreas Burchert  22 , Wolf-Karsten Hofmann  1 , Joerg Hasford  2 , Andreas Hochhaus  23 , Markus Pfirrmann  2 , Martin C Müller  1 ; Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung and the German CML Study Group
Affiliations
Randomized Controlled Trial

Impact of comorbidities on overall survival in patients with chronic myeloid leukemia: results of the randomized CML study IV

Susanne Saussele et al. Blood. .

Abstract

We studied the influence of comorbidities on remission rate and overall survival (OS) in patients with chronic myeloid leukemia (CML). Participants of the CML Study IV, a randomized 5-arm trial designed to optimize imatinib therapy, were analyzed for comorbidities at diagnosis using the Charlson Comorbidity Index (CCI); 511 indexed comorbidities were reported in 1519 CML patients. Age was an additional risk factor in 863 patients. Resulting CCI scores were as follows: CCI 2, n = 589; CCI 3 or 4, n = 599; CCI 5 or 6, n = 229; and CCI ≥ 7, n = 102. No differences in cumulative incidences of accelerated phase, blast crisis, or remission rates were observed between patients in the different CCI groups. Higher CCI was significantly associated with lower OS probabilities. The 8-year OS probabilities were 93.6%, 89.4%, 77.6%, and 46.4% for patients with CCI 2, 3 to 4, 5 to 6, and ≥7, respectively. In multivariate analysis, CCI was the most powerful predictor of OS, which was still valid after removal of its age-related components. Comorbidities have no impact on treatment success but do have a negative effect on OS, indicating that survival of patients with CML is determined more by comorbidities than by CML itself. OS may therefore be inappropriate as an outcome measure for specific CML treatments. The trial was registered at www.clinicaltrials.gov as #NCT00055874.

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Figures

Figure 1
Figure 1
Flowchart of patient disposition.
Figure 2
Figure 2
Cumulative incidence of response according to CCI. (A) Cumulative incidence of CCyR. (B) Cumulative incidence of MMR.
Figure 3
Figure 3
Cumulative incidence of AP and BC according to CCI.
Figure 4
Figure 4
OS according to CCI. (A) OS according to CCI considering age. (B) OS according to CCI without considering age.
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