Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 326-335 |
| Number of pages | 10 |
| Journal | Hematol. Oncol. |
| Volume | 39 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2021 |
Keywords
- chronic lymphocytic leukemia
- idelalisib
- real-world evidence
- creatinine
- rituximab
- antineoplastic agent
- purine derivative
- quinazolinone derivative
- adult
- aged
- Article
- cancer patient
- cancer prognosis
- cancer recurrence
- cancer survival
- chronic lymphatic leukemia
- clinical outcome
- colitis
- comorbidity
- controlled study
- creatinine clearance
- diarrhea
- drug dose reduction
- drug efficacy
- drug safety
- drug withdrawal
- ECOG Performance Status
- female
- gastrointestinal disease
- human
- hypertransaminasemia
- immunoglobulin gene
- infection
- leukemia relapse
- leukoencephalopathy
- major clinical study
- male
- multicenter study
- neutropenia
- observational study
- outcome assessment
- overall response rate
- overall survival
- pneumonia
- progression free survival
- rash
- retrospective study
- risk factor
- treatment duration
- clinical trial
- disease free survival
- metabolism
- middle aged
- mortality
- recurrent disease
- survival rate
- very elderly
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
- Disease-Free Survival
- Female
- Humans
- Leukemia, Lymphocytic, Chronic, B-Cell
- Male
- Middle Aged
- Purines
- Quinazolinones
- Recurrence
- Rituximab
- Survival Rate
Fingerprint
Dive into the research topics of 'Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group: Hematological Oncology'. Together they form a unique fingerprint.Cite this
- APA
- Standard
- Harvard
- Vancouver
- Author
- BIBTEX
- RIS
Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group : Hematological Oncology. / Rigolin, G.M.; Cavazzini, F.; Piciocchi, A. et al.
In: Hematol. Oncol., Vol. 39, No. 3, 2021, p. 326-335.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group
T2 - Hematological Oncology
AU - Rigolin, G.M.
AU - Cavazzini, F.
AU - Piciocchi, A.
AU - Arena, V.
AU - Visentin, A.
AU - Reda, G.
AU - Zamprogna, G.
AU - Cibien, F.
AU - Vitagliano, O.
AU - Coscia, M.
AU - Farina, L.
AU - Gaidano, G.
AU - Murru, R.
AU - Varettoni, M.
AU - Paolini, R.
AU - Sportoletti, P.
AU - Pietrasanta, D.
AU - Molinari, A.L.
AU - Quaglia, F.M.
AU - Laurenti, L.
AU - Marasca, R.
AU - Marchetti, M.
AU - Mauro, F.R.
AU - Crea, E.
AU - Vignetti, M.
AU - Gentile, M.
AU - Montillo, M.
AU - Foà, R.
AU - Cuneo, A.
AU - Chiarenza, A.
AU - Perbellini, O.
AU - Mannina, D.
AU - Sancetta, R.
AU - Olivieri, A.
AU - Molica, S.
AU - Pane, F.
AU - Patti, C.
AU - Iliariucci, F.
AU - Gozzetti, A.
AU - Califano, C.
AU - Galieni, P.
AU - Augello, A.F.
AU - Vallisa, D.
AU - Cura, F.
AU - Frustaci, A.M.
AU - Fazi, P.
AU - Trentin, L.
AU - Ferrara, F.
AU - Group, GIMEMA
N1 - Cited By :2 Export Date: 12 February 2022 CODEN: HAOND Correspondence Address: Cuneo, A.; Department of Medical Sciences, Italy; email: cut@unife.it Chemicals/CAS: creatinine, 19230-81-0, 60-27-5; idelalisib, 1146702-54-6, 870281-82-6; rituximab, 174722-31-7; idelalisib; Purines; Quinazolinones; Rituximab Funding details: Roche Funding details: Gilead Sciences Funding details: AbbVie Funding details: Shire Funding text 1: This work was supported by BEAT Leukemia to AC and by AIL‐FE to AC and GMR. Funding text 2: This work was supported by BEAT Leukemia to AC and by AIL-FE to AC and GMR. Funding text 3: Gian Matteo Rigolin, lecturing for Abbvie, Gilead and research funding from Gilead. Francesco Cavazzini, advisory board for Novartis; travel expenses from Janssen. Andrea Visentin, speaker's bureau from Janssen, Abbvie, Italfarmaco, Gilead, Gianluigi Reda, honoraria from AbbVie, Gilead, Janssen. Marta Coscia, honoraria from Janssen, Gilead, Abbvie, Shire; research support from Janssen and Karyopharm Therapeutics, Lucia Farina, advisory board for Janssen; lecturing for Abbvie. Gianluca Gaidano, advisory board and speaker's bureau for Janssen and Abbvie; Advisory Board for AstraZeneca. Marzia Varettoni, advisory board for Janssen, Roche, AstraZeneca. Travel expenses from Abbvie. Francesca M. Quaglia, advisory board for AstraZeneca; speaker bureau for Janssen. Luca Laurenti, advisory board and lecturing for Janssen, Gilead, Abbvie, Roche, and AstraZeneca. Roberto Marasca, research grant personal fees and nonfinancial support from Janssen, personal fees, and nonfinancial support from Gilead and personal fee from Abvie, Roche, Shire, Pfizer. Marco Montillo, honoraria from Abbvie, Gilead, Janssen, Roche; advisory board for Abbvie, Acerta/AstraZeneca, Gilead, Janssen, Roche, and Verastem, Robin Foà, Editorial boards and/or speaker's bureau for Janssen, AbbVie, Amgen, Novartis, Roche, Pfizer, Antonio Cuneo, Advisory board, and speaker bureau for Abbvie, Gilead, Janssen, AstraZeneca. No conflict of interest for all other authors. References: Awan, F.T., Byrd, J.C., New strategies in chronic lymphocytic leukemia: shifting treatment paradigms (2014) Clin Cancer Res, 20, pp. 5869-5874; Arnason, J.E., Brown, J.R., Targeting B cell signaling in chronic lymphocytic leukemia (2017) Curr Oncol Rep, 19, p. 61; Fürstenau, M., Hallek, M., Eichhorst, B., Sequential and combination treatments with novel agents in chronic lymphocytic leukemia (2019) Haematologica, 104, pp. 2144-2154; Byrd, J.C., Furman, R.R., Coutre, S.E., Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia (2013) N Engl J Med, 369, pp. 32-42; Byrd, J.C., Furman, R.R., Coutre, S.E., Ibrutinib treatment for first-line and relapsed/refractory chronic lymphocytic leukemia: final analysis of the pivotal phase Ib/II PCYC-1102 study (2020) Clin Cancer Res, 26, pp. 3918-3927; Brown, J.R., Byrd, J.C., Coutre, S.E., Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110δ, for relapsed/refractory chronic lymphocytic leukemia (2014) Blood, 123, pp. 3390-3397; Furman, R.R., Sharman, J.P., Coutre, S.E., Idelalisib and rituximab in relapsed chronic lymphocytic leukemia (2014) N Engl J Med, 370, pp. 997-1007; Sharman, J.P., Coutre, S.E., Furman, R.R., Final results of a randomized, phase III study of rituximab with or without idelalisib followed by open-label idelalisib in patients with relapsed chronic lymphocytic leukemia (2019) J Clin Oncol, 37, pp. 1391-1402; Ghia, P., Pluta, A., Wach, M., ASCEND: phase III, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia (2020) J Clin Oncol, 38, pp. 2849-2861; Coutré, S.E., Barrientos, J.C., Brown, J.R., Management of adverse events associated with idelalisib treatment: expert panel opinion (2015) Leukemia Lymphoma, 56, pp. 2779-2786; Cuneo, A., Barosi, G., Danesi, R., Management of adverse events associated with idelalisib treatment in chronic lymphocytic leukemia and follicular lymphoma: a multidisciplinary position paper (2019) Hematol Oncol, 37, pp. 3-14; Ghia, P., Cuneo, A., Ibrutinib in the real world patient: many lights and some shades (2016) Haematologica, 101, pp. 1448-1450; Parikh, S.A., Achenbach, S.J., Call, T.G., The impact of dose modification and temporary interruption of ibrutinib on outcomes of chronic lymphocytic leukemia patients in routine clinical practice (2020) Cancer Med, 9, pp. 3390-3399; Hallek, M., Cheson, B.D., Catovsky, D., 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 (2008) Blood, 111, pp. 5446-5456; Karim, S., Booth, C.M., Effectiveness in the absence of efficacy: cautionary tales from real-world evidence (2019) J Clin Oncol, 37, pp. 1047-1050; Islam, P., Mato, A.R., Utilizing real-world evidence (RWE) to improve care in chronic lymphocytic leukemia: challenges and opportunities (2020) Curr Hematol Malig Rep, 15, pp. 254-260; Cuneo, A., Follows, G., Rigolin, G.M., Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA, ERIC and UK CLL FORUM study (2018) Haematologica, 103, pp. 1209-1217; Cuneo, A., Mato, A.R., Rigolin, G.M., Efficacy of bendamustine and rituximab in unfit patients with previously untreated chronic lymphocytic leukemia. Indirect comparison with ibrutinib in a real-world setting. A GIMEMA-ERIC and US study (2020) Cancer Med, 9, pp. 8468-8479; Jones, J.A., Robak, T., Brown, J.R., Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial (2017) Lancet Haematol, 4 (3), pp. e114-e126; Shanafelt, T.D., Kay, N.E., Rabe, K.G., Hematologist/oncologist disease-specific expertise and survival: lessons from chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (2012) Cancer, 118, pp. 1827-1837; Forum, U.K.C.L.L., Ibrutinib for relapsed/refractory chronic lymphocytic leukemia: a UK and Ireland analysis of outcomes in 315 patients (2016) Haematologica, 101, pp. 1563-1572; Fernando, F., Griffin, J., Taylor, J., Multicentre retrospective analysis of chronic lymphocytic leukemia patients treated with idelalisib, “real world” data from the UK and Republic of Ireland - a cohort of 68 patients (2017) Blood, 130, p. 1733; Gordon, M.J., Huang, J., Chan, R.J., Bhargava, P., Danilov, A.V., Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials (2020) Br J Haematol, 192, p. 720. , https://doi.org/10.1111/bjh.16879; Hanlon, A., Brander, D.M., Managing toxicities of phosphatidylinositol-3-kinase (PI3K) inhibitors (2020) Hematology Am Soc Hematol Educ Program, 2020, pp. 346-356
PY - 2021
Y1 - 2021
N2 - Because the efficacy of new drugs reported in trials may not translate into similar results when used in the real-life, we analyzed the efficacy of idelalisib and rituximab (IR) in 149 patients with relapsed/refractory chronic lymphocytic leukemia treated at 34 GIMEMA centers. Median progression-free survival (PFS) and overall survival were 22.9 and 44.5 months, respectively; performance status (PS) ≥2 and ≥3 previous lines of therapy were associated with shorter PFS and overall survival (OS). 48% of patients were on treatment at 12 months; the experience of the centers (≥5 treated patients) and PS 0–1 were associated with a significantly longer treatment duration (p = 0.015 and p = 0.002, respectively). TP53 disruption had no prognostic significance. The overall response rate to subsequent treatment was 49.2%, with median OS of 15.5 months and not reached in patients who discontinued, respectively, for progression and for toxicity (p
AB - Because the efficacy of new drugs reported in trials may not translate into similar results when used in the real-life, we analyzed the efficacy of idelalisib and rituximab (IR) in 149 patients with relapsed/refractory chronic lymphocytic leukemia treated at 34 GIMEMA centers. Median progression-free survival (PFS) and overall survival were 22.9 and 44.5 months, respectively; performance status (PS) ≥2 and ≥3 previous lines of therapy were associated with shorter PFS and overall survival (OS). 48% of patients were on treatment at 12 months; the experience of the centers (≥5 treated patients) and PS 0–1 were associated with a significantly longer treatment duration (p = 0.015 and p = 0.002, respectively). TP53 disruption had no prognostic significance. The overall response rate to subsequent treatment was 49.2%, with median OS of 15.5 months and not reached in patients who discontinued, respectively, for progression and for toxicity (p
KW - chronic lymphocytic leukemia
KW - idelalisib
KW - real-world evidence
KW - creatinine
KW - rituximab
KW - antineoplastic agent
KW - purine derivative
KW - quinazolinone derivative
KW - adult
KW - aged
KW - Article
KW - cancer patient
KW - cancer prognosis
KW - cancer recurrence
KW - cancer survival
KW - chronic lymphatic leukemia
KW - clinical outcome
KW - colitis
KW - comorbidity
KW - controlled study
KW - creatinine clearance
KW - diarrhea
KW - drug dose reduction
KW - drug efficacy
KW - drug safety
KW - drug withdrawal
KW - ECOG Performance Status
KW - female
KW - gastrointestinal disease
KW - human
KW - hypertransaminasemia
KW - immunoglobulin gene
KW - infection
KW - leukemia relapse
KW - leukoencephalopathy
KW - major clinical study
KW - male
KW - multicenter study
KW - neutropenia
KW - observational study
KW - outcome assessment
KW - overall response rate
KW - overall survival
KW - pneumonia
KW - progression free survival
KW - rash
KW - retrospective study
KW - risk factor
KW - treatment duration
KW - clinical trial
KW - disease free survival
KW - metabolism
KW - middle aged
KW - mortality
KW - recurrent disease
KW - survival rate
KW - very elderly
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Disease-Free Survival
KW - Female
KW - Humans
KW - Leukemia, Lymphocytic, Chronic, B-Cell
KW - Male
KW - Middle Aged
KW - Purines
KW - Quinazolinones
KW - Recurrence
KW - Rituximab
KW - Survival Rate
U2 - 10.1002/hon.2861
DO - 10.1002/hon.2861
M3 - Article
SN - 0278-0232
VL - 39
SP - 326
EP - 335
JO - Hematol. Oncol.
JF - Hematol. Oncol.
IS - 3
ER -