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Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population

Fabio Efficace, Michele Baccarani, Massimo Breccia, Giuliana Alimena, Gianantonio Rosti, Francesco Cottone, Giorgio Lambertenghi Deliliers, Claudia Baratè, Antonella Russo Rossi, Giuseppe Fioritoni, Luigia Luciano, Diamante Turri, Bruno Martino, Francesco Di Raimondo, Melissa Dabusti, Micaela Bergamaschi, Pietro Leoni, Maria Pina Simula, Luciano Levato, Stefano Ulisciani, Dino Veneri, Simona Sica, Alessandro Rambaldi, Marco Vignetti, Franco Mandelli and for GIMEMA

Data supplements

  • Supplemental materials for: Efficace et al

    The following members of the Gruppo Italiano Malattie Ematologiche dell’Adulto (GIMEMA) Working Party on CML actively participated in this study, enrolling the study patients and collecting clinical data:

    Baccarani M., Rosti G. (University of Bologna, Bologna, Italy) Alimena G., Breccia M. (University of Rome “Sapienza,” Department of Cellular Biotechnologies and Hematology. Rome, Italy) Lambertenghi Deliliers G., Radaelli (IRCCS Ospedale Maggiore Policlinico, Milan, Italy)
    Petrini M., Baratè C. (University of Pisa, Pisa, Italy)
    Specchia G., Russo Rossi A. (University of Bari, Bari, Italy)
    Fioritoni G., Di Lorenzo R. (Local Health Unit of Pescara,Hematology, Pescara, Italy)
    Rotoli B., Luciano L. (University of Naples “Federico II,” Naples, Italy)
    Mirto S., Turri D. (Hospital “Cervello,” Hematology, Palermo, Italy)
    Nobile F., Martino B. (“Ospedali Riuniti“, Hematology, Reggio Calabria, Italy)
    Di Raimondo F., Stagno F. (Hospital “Ferrarotto,” Hematology, Catania, Italy)
    Cuneo A., Dabusti M. (Arcispedale Sant'Anna,” Ferrara, Italy)
    Gobbi M., Pierri I. (University of Genova, clinica ematologica S. Martino hospital, Genova, Italy)
    Leoni P., Scortechini A. (Hospital “Torrette,” Ancona, Italy)
    Angelucci E., Simula M.P. (Struttura Complessa di Ematologia e Centro Trapianti. Ospedale Oncologico di Riferimento Regionale "Armando Busiinco" Cagliari, Italy)
    Peta A., Levato L. (Azienda Ospedaliera Pugliese Ciaccio,” Hematology, Catanzaro, Italy)
    Saglio G., Fava C. (University of Turin, Orbassano, Italy)
    Pizzolo G., Veneri D. (University of Verona, Verona, Italy)
    Leone G., Sica S. (University of Rome “Cattolica S. Cuore,” Department of Hematology. Rome, Italy)
    Rambaldi A., Ferrari M. (“Ospedali Riuniti di Bergamo,” Hematology, Bergamo, Italy)
    Longinotti M., Pardini S. (University of Sassari, Hematology, Sassari, Italy)
    Gherlinzoni F. (Local Health Unit 9 of Treviso, Hematology, Treviso, Italy)
    Zaccaria A. (Hospital “Santa Maria delle Croci,” Hematology, Ravenna, Italy)
    Fanin R., Tiribelli M., D’odorico C. (University Hospital, Hematology, Udine, Italy)
    Rossi G. (Spedali civili Brescia, Brescia, Italy)
    Ferrara F. (Hospital “Antonio Cardarelli,” Napoli, Italy)
    Lauria F. (A.O. Universitaria Senese Pol. S. Maria alle Scotte ‐ UOC di Ematologia e Trapianti, Siena, Italy)

    Article Figures & Data

    Figures

    • Figure 1

      Adjusted mean differences between CML patients and their respective control groups by age categories. (A) Physical health and (B) mental health. A score below 0 line means worse outcomes for CML patients. Note that connecting lines among SF-36 outcomes are plotted only for descriptive purposes. *Statistically significant after Bonferroni adjustment (adjusted α = 0.05/8 = 0.00625). Statistical significance refers to the group specific adjusted mean differences of SF-36 scores between CML patients and matched control subjects. †Mean difference between CML patients by age group and the respective matched control subjects adjusted for age, gender, education, geographical area, and marital status. A negative sign indicates worse outcomes for CML patients. ‡Exceeds minimally important difference (ie, 8 points for the SF-36 scales and 2 points for the PCS and MCS scores). §Statistically significant (α = 0.05).

    • Figure 2

      Adjusted mean differences between CML patients and their respective control groups by sex. (A) Physical health and (B) mental health. A score below 0 line means worse outcomes for CML patients. Note that connecting lines among SF-36 outcomes are plotted only for descriptive purposes. *Statistically significant after Bonferroni adjustment (adjusted α = 0.05/8= 0.00625). Statistical significance refers to the group specific adjusted mean differences of SF-36 scores between CML patients and matched control subjects. †Mean difference between CML patients by sex and the respective matched control subjects adjusted for age, education, geographical area, and marital status. A negative sign indicates worse outcomes for CML patients. ‡Exceeds minimally important difference (ie, 8 points for the SF-36 scales and 2 points for the PCS and MCS scores). §Statistically significant (α = 0.05).

    • Figure 3

      Percentage of CML patients reporting the symptom by level of severity (N = 422).

    Tables

    • Table 1

      Sociodemographic and clinical characteristics of CML study population by compliance with the survey booklet (respondents vs nonrespondents)

      VariableCompliance with the survey booklet
      Nonrespondents (n = 26)Respondents (n = 422)Total (N = 448)
      Sex, n (%)
          Female8 (30.8)172 (40.8)180 (40.2)
          Male18 (69.2)250 (59.2)268 (59.8)
      Age at study entry, y
          18-392 (7.7)61 (14.4)63 (14.1)
          40-5913 (50.0)187 (44.3)200 (44.6)
          60-697 (26.9)91 (21.6)98 (21.9)
          ≥ 704 (15.4)83 (19.7)87 (19.4)
          Median545757
          Range22.0-85.819.4-86.819.4-86.8
      Education, n (%)*
          Eighth grade or lessN/A194 (46.0)194 (46.0)
          High schoolN/A155 (36.7)155 (36.7)
          University degree or higherN/A70 (16.6)70 (16.6)
          MissingN/A3 (0.7)3 (0.7)
      Marital status, n (%)*
          DivorcedN/A30 (7.1)30 (7.1)
          SingleN/A42 (10.0)42 (10.0)
          Married/living togetherN/A313 (74.2)313 (74.2)
          WidowN/A31 (7.3)31 (7.3)
          MissingN/A6 (1.4)6 (1.4)
      Time from diagnosis, y
          Mean (SD)5.28 (1.56)5.32 (1.72)5.31 (1.71)
          Median5.15.15.1
          Range3.0-9.03.0-12.23.0-12.2
      Duration of imatinib therapy, y
          Mean (SD)5.20 (1.52)5.13 (1.47)5.13 (1.48)
          Median5.155
          Range3.0-8.83.0-9.33.0-9.3
      ECOG performance status, n (%)
          024 (92.3)286 (67.8)310 (69.2)
           ≥ 12 (7.7)136 (32.2)138 (30.8)
      Sokal-risk at diagnosis, n (%)
          Low (< 0.8)12 (46.2)222 (52.6)234 (52.2)
          Intermediate (0.8-1.2)9 (34.6)140 (33.2)149 (33.3)
          High (> 1.2)4 (15.4)46 (10.9)50 (11.2)
          Missing1 (3.8)14 (3.3)15 (3.3)
      Comorbidity at diagnosis, n (%)
          017 (65.4)269 (63.7)286 (63.8)
          ≥ 19 (34.6)153 (36.3)162 (36.2)
      Initial imatinib dose, n (%)
          < 400 mg/d0 (0.0)16 (3.8)16 (3.6)
          400 mg/d25 (96.2)385 (91.2)410 (91.5)
          > 400 mg/d1 (3.8)21 (5.0)22 (4.9)
      Current imatinib dose, n (%)
          < 400 mg/d1 (3.8)61 (14.5)62 (13.8)
          400 mg/d22 (84.7)327 (77.4)349 (77.9)
          > 400 mg/d3 (11.5)34 (8.1)37 (8.3)
      Dose change during treatment, n (%)
          No16 (61.5)257 (60.9)273 (60.9)
          Yes (at least once)10 (38.5)165 (39.1)175 (39.1)
      Time to first CCyR, y
          Mean (SD)0.90 (0.99)0.65 (0.62)0.66 (0.65)
          Median0.60.50.5
          Range0.0-5.20.1-6.30.0-6.3
      • CML indicates chronic myeloid leukemia; CCyR, complete cytogenetic response; SD, standard deviation; and N/A, not applicable.

      • * This was judged as N/A as this data was reported in the survey booklet.

    • Table 2

      SF-36 scale scores and adjusted mean differences between the overall CML population and the matched control group

      SF-36 scalesCML patients, mean (SD)Matched control group, mean (SD)Mean difference* (95% CI)P
      Physical health
          Physical functioning76.8 (24.8)80.5 (25.4)−3.9 (−6.7; −1.1).006
          Role physical61.6 (42.2)73.0 (40.2)−11.5 (−16.8; −6.3)< .001
          Bodily pain70.4 (26.2)70.7 (28.7)−0.3 (−3.7; 3.2).882
          General health52.7 (22.6)61.2 (22.9)−8.9 (−11.7; −6.0)< .001
          PCS46.0 (9.6)48.2 (10.3)−2.4 (−3.6; −1.3)< .001§
      Mental health
          Vitality56.2 (21.2)60.7 (20.8)−4.6 (−7.4; −1.8).001
          Social functioning73.9 (22.7)76.7 (24.3)−2.9 (−6.0; 0.2).069
          Role emotional64.5 (40.7)73.9 (38.0)−9.6 (−14.9; −4.3)< .001
          Mental health67.1 (19.8)66.3 (21.7)0.6 (−2.1; 3.4).659
          MCS49.3 (9.8)50.2 (9.7)−0.9 (−2.3; 0.4).166
      • CML indicates chronic myeloid leukemia; PCS, physical component summary; MCS, mental component summary; SD, standard deviation; and CI, confidence interval.

      • * Mean differences adjusted for age, sex, education, geographical area, and marital status.

      • Exceeds minimally important difference (ie, 8 points for the SF-36 scales and 2 points for the PCS and MCS scores).

      • Statistically significant after Bonferroni adjustment (adjusted alpha = 0.05/8 = 0.006 25).

      • § Statistically significant (alpha = 0.05).