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1582 Very Elderly Patients with Chronic Phase-Chronic Myeloid Leukemia on Imatinib: No Impact of Concomitant Drugs on Complete Cytogenetic ResponseClinically Relevant Abstract

Chronic Myeloid Leukemia: Therapy
Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Therapy: Poster I
Saturday, December 5, 2015, 5:30 PM-7:30 PM
Hall A, Level 2 (Orange County Convention Center)

Alessandra Iurlo, MD, PhD1*, Roberto Latagliata, MD2*, Cristina Bucelli, MD3*, Dario Ferrero, MD4*, Fausto Castagnetti, MD/PhD5, Massimo Breccia, MD6*, Elisabetta Abruzzese, MD7, Daniele Cattaneo, MD8*, Carmen Fava, MD9*, Antonella Gozzini, MD10*, Mario Annunziata, MD11*, Mario Tiribelli, MD12*, Patrizia Pregno, MD13*, Fabio Stagno, MD/PhD14, Paolo Vigneri, MD/PhD15*, Francesco Cavazzini, MD16, Gianni Binotto17*, Giovanna Mansueto, MD18*, Sabina Russo, MD19*, Franca Falzetti, MD20, Enrico Montefusco, MD21*, Gabriele Gugliotta, PhD22*, Cristiana Gasbarrino, MD23*, Ada D'Addosio, MD24*, Laura Cortesi25*, Michele Cedrone, MD26*, Antonella Russo Rossi, MD27*, Paolo Avanzini, MD28*, Mauro Endri, MD29*, Antonio Spadea, MD30, Francesca Celesti, MD31*, Gianfranco Giglio, MD32*, Alessandro Isidori, M.D. PhD33, Monica Crugnola, MD34*, Elisabetta Calistri35*, Federica Sorą, MD, PhD36*, Giovanna Rege-Cambrin, MD37*, Simona Sica38*, Luigia Luciano, MD39, Ester Maria Orlandi, MD40*, Monica Bocchia, MD41*, Mauro Tettamanti42*, Giuliana Alimena, MD43, Giuseppe Saglio, MD PhD44*, Gianantonio Rosti, MD45*, Alessandro Nobili42*, Pier Mannuccio Mannucci, MD46 and Agostino Cortelezzi, MD47

1Division of Hematology, IRCCS Maggiore Policlinico Hospital Foundation, Milano, Italy
2Division of Hematology-Dept. of Cellular Biotechnologies and Hematology, University La Sapienza of Rome, Rome, Italy
3Oncohematology Division, IRCCS Ca' Granda - Maggiore Policlinico Hospital Foundation, University of Milan, Milano, Italy
4Chair of Hematology, Department of Medicine and Experimental Oncology, Torino, Italy
5Bologna University School of Medicine, Bologna, Italy
6Dipartimento di Ematologia e Biotecnologie, Universitą La Sapienza, Rome, Italy
7Hematology, S. Eugenio Hospital, Roma, Italy
8Department of Hematology, IRCCS Maggiore Policlinico Hospital Foundation, Milan, Italy
9Division of Internal Medicine - Hematology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Italy
10Hematology Unit, AOU Careggi, Firenze, Italy
11Hematology, OSPEDALE CARDARELLI, NAPOLI, Italy
12Division of Hematology and BMT, Department of Experimental and Clinical Medical Sciences, Azienda Ospedaliero-Universitaria di Udine, Udine, Italy
13Hematology Unit, AZ OSP. CITTA' DELLA SALUTE E SCIENZA TORINO, TORINO, Italy
14Section of Hematology, A.O.U. Policlinico, Catania, Italy
15Dep. Clinical and Experimental Medicine, University of Catania Medical School, Catania, Italy
16Haematology Dept., University of Ferrara, Ferrara, Italy
17Department of Medicine, Hematology and Clinical Immunology Section, University of Padova, Padova, Italy
18Department of Onco-Hematology, IRCCS-CROB, Rionero in Vulture, Italy
19Hematology Unit, University of Messina, Messina, Italy
20University of Perugia, Perugia, Italy
21Hematology Unity, Sant'Andrea Hospital, Rome, Italy
22"Serągnoli" Institute of Hematology, Bologna University School of Medicine, Bologna, Italy
23Onco-Hematology Unit, Universitą Cattolica Giovanni Paolo II, Campobasso, Italy
24Hematology, Villa San Pietro Hospital, Rome, Italy
25Department of Neuroscience, IRCCS - Istituto di Ricerche Farmacologiche, Milano, Italy
26UOC of Hematology, San Giovanni - Addolorata Hospital, Rome, Italy
27Hematology, University of Bari, Bari, Italy
28Hematology, S.Maria Nuova Hospital, Reggio Emilia, Italy
29Hematology Unit, Pordenone Hospital, Pordenone, Italy
30Clinical Oncology, Istituto Regina Elena, Rome, Italy
31Hematology, Belcolle Hospital, Viterbo, Italy
32Hematology, Cardarelli Hospital, Campobasso, Italy
33Hematology and Stem Cell Transplant Center, AORMN Hospital, Pesaro, Italy
34Clinical and Experimental Medicine, University of Parma, Parma, Italy
35Hematology Unit, Ospedale Ca' Foncello, Treviso, Treviso, Italy
36Universitą Cattolica del Sacro Cuore, Rome, Italy
37Division of Hematology and Internal Medicine, University of Turin, "San Luigi Gonzaga" University Hospital, Orbassano, Italy
38Institute of Hematology, Catholic University, Rome, Italy
39University of Naples Federico II, Napoli, Italy
40Dept of Oncology-Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
41Department of Hematology and Transplants, University of Siena, Siena, Italy
42Department of Neuroscience, IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy
43Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy
44Clinic of Internal Medicine and Hematology, Universitą di Torino - Ospedale San Luigi, 10043 Orbassano-Torino, Italy
45Department of Hematology and Oncological Sciences, Bologna, Italy
46Scientific Direction, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy
47Oncohematology Unit, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy

Tyrosine-kinase inhibitors (TKIs) have completely changed the expected survival of chronic myeloid leukemia (CML) patients which is now approaching that of the general population: a relevant proportion of CML patients are currently elderly or very elderly. Very elderly patients represent generally a small proportion in published experiences. Older CML patients imatinib treated, as it happens in the general population, receive other drug treatments for associated chronic illnesses. Our aim is to assess if and which classes of concomitant drugs have an impact on cytogenetic response in chronic phase (CP)-CML very elderly (age >75 years) patients.

Two hundred and twelve very elderly CP-CML patients, imatinib treated at 33 italian hematological institutions have been retrospectively evaluated. Median age at diagnosis was 78.5 years (range 75.0-93.0); 111 (52.4%) were male. Sixty-two (29.2%) were Sokal high risk. Sixty-seven (31.8%) were treated with reduced dose imatinib (<400 mg/day), and the remaining patients with imatinib >400 mg/day. Concomitant drugs were 1-2 in 73 (34.4%) patients, 3-4 in 59 (27.8%), and >5 in 64 (30.2%); 16 (7.6%) did not assume any concomitant drug. Drugs more frequently used were antiplatelets, assumed by 104 (49.1%) patients, followed by diuretics in 91 (42.9%) patients, proton pump inhibitors (PPIs) in 86 (40.6%), ACE inhibitors in 55 (25.9%), beta blockers in 44 (20.7%), angiotensin II receptors blockers (ARB) in 41 (19.3%), calcium channel blockers in 34 (16%), statins in 25 (11.8%), and alpha blockers in 11 (5.2%).

Univariate logistic regression models were computed to assess the association between cytogenetic response after 6 or 12 months of imatinib treatment and number of concomitant drugs or selected drug classes. Statistical analyses were done using JMP 11.1 (SAS Institute Inc., Cary, NC, USA).

Complete cytogenetic response (CCyR) was obtained in 124 (58.8%) patients, of whom 70 (33%) within 6 months. Consequently, we focused our study on the impact of number and types of drugs on CCyR rate, which represents the primary therapeutic endpoint in the elderly. Cytogenetic response distribution according to concomitant drugs is reported in table 1.

We did not find any significant correlation between number of concomitant drugs, single classes of antihypertensive drugs, antiplatelets, PPIs or statins and CCyR rate at 6 or 12 months.

Even though few pharmacokinetic interactions are reported between imatinib and some of medications we considered, this does not seem to have an impact on cytogenetic response rate in our cohort. Indeed, our results confirm the well-known safety and efficacy of imatinib also in very elderly CML patients.

Table 1. Cytogenetic response according to concomitant drugs

Drug classes

Cytogenetic response

CCyR <6 months

CCyR 7-12 months

CCyR >12 months

No CCyR

Antiplatelets (n=104)

38 (36.5%)

31 (29.8%)

11 (10.6%)

24 (23.1%)

Diuretics (n=91)

32 (35.2%)

21 (23.1%)

13 (14.3%)

25 (27.4%)

Proton pump inhibitors (n=86)

30 (34.9%)

22 (25.6%)

13 (15.1%)

21 (24.4%)

ACE inhibitors (n=55)

19 (34.6%)

11 (20%)

12 (21.8%)

13 (23.6%)

Beta blockers (n=44)

18 (40.9%)

11 (25%)

3 (6.8%)

12 (27.3%)

Angiotensin II receptor blockers (n=41)

19 (46.3%)

11 (26.8%)

5 (12.3%)

6 (14.6%)

Calcium channel blockers (n=34)

10 (29.4%)

7 (20.6%)

6 (17.7%)

11 (32.3%)

Statins (n=25)

9 (36%)

7 (28%)

2 (8%)

7 (28%)

Alpha blockers (n=11)

4 (36.4%)

/

1 (9.1%)

6 (54.5%)

Disclosures: Castagnetti: Novartis: Consultancy , Honoraria ; BMS: Consultancy , Honoraria ; Pfizer: Consultancy , Honoraria ; ARIAD: Consultancy , Honoraria . Abruzzese: BMS, Novartis, Pfizer, Ariad: Consultancy . Tiribelli: Bristol Myers Squibb: Consultancy , Speakers Bureau ; Ariad Pharmaceuticals: Consultancy , Speakers Bureau ; Novartis Farma: Consultancy , Speakers Bureau . Rosti: Novartis: Honoraria , Research Funding , Speakers Bureau ; Bristol Myers Squibb: Honoraria , Research Funding , Speakers Bureau .

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