Nonpegylated liposomal doxorubicin combination regimen in patients with diffuse large B‐cell lymphoma and cardiac comorbidity. Results of the HEART01 phase II trial conducted by the Fondazione Italiana Linfomi

Luminari, Stefano; Viel, Elda; Ferreri, Andrés J.M.; Zaja, Francesco; Chimienti, Emanuela; Musuraca, Gerardo; Tucci, Alessandra; Balzarotti, Monica; Tani, Monica; Salvi, Francesca; Pesce, Emanuela; Ferrari, Ângela; Liberati, Anna Marina; Spadea, Antonio; Marino, Dario; Bruno-Ventre, Maria; Volpetti, Stefano; Bottelli, Chiara; Ravaioli, Elena; Merli, Francesco; Spina, Michele

doi:10.1002/hon.2425

Cited by 35 publications

(20 citation statements)

References 37 publications

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“…In a series of 530 newly diagnosed DLBCL patients ≥80 years of age, OS was prolonged in those receiving b85%, compared with ≥85%, anthracycline dose intensity [51]. Other approaches with anthracycline utilization include reduced dose intensity and use of nonpegylated liposomal doxorubicin [52][53][54][55]. Unfortunately, anthracycline dose intensity data were not available in our data set.…”

Section: Discussionmentioning

confidence: 99%

Treatment approaches for older and oldest patients with diffuse large B-cell lymphoma – Use of non-R-CHOP alternative therapies and impact of comorbidities on treatment choices and outcome: A Humedica database retrospective cohort analysis, 2007–2015

Morrison

Hamilton²,

Ogbonnaya³

et al. 2020

Journal of Geriatric Oncology

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a b s t r a c tIntroduction: We characterized real-world treatment patterns in older (65-74 years) and oldest (75-85 years) patients with diffuse large B-cell lymphoma (DLBCL) receiving initial therapy (R-CHOP, non-R-CHOP regimens). Impact of comorbidities on treatment choice, and overall and progression-free survival (OS, PFS) were assessed by age. Patients and Methods: Using the Humedica database, we identified 1436 newly diagnosed patients with DLBCL who received frontline therapy from 1/07-9/15. The 885 patients ≥65 years of age were further evaluated for baseline demographics, comorbidities, initial therapy, and PFS/OS. Results: Of 885 patients, 406 (45.9%) were age 65-74, and 479 (54.1%) age 75-85, years. First line therapy was R-CHOP (61.8%) or non-R-CHOP (38.2%). Although Charlson Comorbidity Index (CCI) scores were similar at baseline, congestive heart failure and myocardial infarction were more common in those receiving non-R-CHOP regimens. Survival outcomes were superior for those receiving initial R-CHOP, versus non-R-CHOP, therapy (median PFS 53.9 versus 27.8 months; two-year PFS 71.2% versus 51.6%, p b .0001; median OS not reached versus 45 months; two-year OS 81.3% versus 62.9%, p b .0001, respectively). Only 10.4% (R-CHOP) and 12.1% (non-R-CHOP) of patients received second line therapies. Two-year OS by age (65-74, 75-85 years) was 66.4% and 39.1%, respectively with R-CHOP (p = .0045), and 74.3% and 54.5%, respectively with non-R-CHOP (p = .004), therapy. Age ≥ 75 years and CCI of 2+ were associated with shorter OS and PFS. Conclusions: This study identified real-world first line treatment patterns for older patients with DLBCL. Our findings support the feasibility of administering standard R-CHOP therapy, even to oldest patients with DLBCL.

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Section: Discussionmentioning

confidence: 99%

Treatment approaches for older and oldest patients with diffuse large B-cell lymphoma – Use of non-R-CHOP alternative therapies and impact of comorbidities on treatment choices and outcome: A Humedica database retrospective cohort analysis, 2007–2015

Morrison

Hamilton²,

Ogbonnaya³

et al. 2020

Journal of Geriatric Oncology

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“…Patients with cardiac failure may require concepts free from or with lower doses of doxorubicin. For example, the HEART 01 phase II trial reported that a non-PEGylated liposomal doxorubicin combination regimen in patients with DLBCL and cardiac comorbidity was feasible and resulted in a 72% overall response rate, and was similar to the results seen in healthy patients receiving non-PEGylated doxorubicin (Luminari et al, 2018). For patients with dementia, and severe psychiatric comorbidities, treatments may not always be possible to deliver due to poor compliance, and treating the malignant disease may be of lower priority.…”

Section: Comorbidities and Novel Targeted Treatments And Other Treatmmentioning

confidence: 92%

Comorbidities and sex differences in causes of death among mantle cell lymphoma patients – A nationwide population‐based cohort study

et al. 2019

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Summary The prognosis for mantle cell lymphoma (MCL) remains poor. Our aim was to assess the impact of comorbidities on survival and causes of death. For 1,385 MCL patients (1,009 males, 376 females) diagnosed in 2000–2014 (median age 71 years, range 22–96) comorbidities ≤ 10 years of diagnosis were classified according to the Charlson comorbidity index (CCI; 0, 1, 2+). Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated to compare lymphoma‐specific and all‐cause mortality rates. Model‐based predictions were used to obtain probabilities of death. Overall, 44% had any comorbidity (CCI 1+) and 28% severe comorbidity (CCI 2+). Over a median follow‐up of 3·7 years (range 0–16), 633 (46%) died, the majority (76%) from lymphoma. Severe comorbidity was independently associated with higher all‐cause [hazard ratio (HR) = 1·52; 95% CI: 1·24–1·85) and lymphoma‐specific mortality (HR = 1·31; 95% CI: 1·04–1·65). Particularly among patients with connective tissue, renal and psychiatric diseases, and dementia. Among females with any comorbidity, non‐lymphoma deaths represented a larger proportion of all deaths, compared to males with any comorbidity. In general, more efficient lymphoma treatments need to be considered also for patients with severe comorbidity. However, among females with any comorbidity, the likelihood of non‐lymphoma death was still considerable, perhaps favouring a more liberal use of a “wait and watch” approach.

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“…grade 3-4 cardiac adverse events were observed in 6 patients. no significant deterioration of lVeF was identified in any of the subjects [10].…”

Section: Review Of Relevant Literaturementioning

confidence: 70%

Non-pegylated liposomal doxorubicin based on treatment of diffuse large B cell lymphoma in old patient with increased cardiovascular risk – case report and review of literature

Joks

Urbaniak

2019

OncoReview

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The use of anthracyclines in the treatment of patients with diffuse large B-cell lymphoma is crucial, however may be sometimes difficult or even contraindicated due to coexisting cardiovascular diseases. An alternative to conventional anthracyclines seems to be liposomal forms that have been registered in the first line of treatment for women with metastatic breast cancer. Data on their use in patients with non-Hodgkin's lymphomas indicate high efficacy and acceptable toxicity. We present case report of treatment with immunochemotherapy using non-pegylated liposomal doxorubicin in elderly woman with diffuse large B-cell lymphoma coexisting with ischemic heart disease, hypertension, type 2 diabetes. In addition, we present review of literature and the aspects of the use of drugs off-label.

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Nonpegylated liposomal doxorubicin combination regimen in patients with diffuse large B‐cell lymphoma and cardiac comorbidity. Results of the HEART01 phase II trial conducted by the Fondazione Italiana Linfomi

Cited by 35 publications

References 37 publications

Treatment approaches for older and oldest patients with diffuse large B-cell lymphoma – Use of non-R-CHOP alternative therapies and impact of comorbidities on treatment choices and outcome: A Humedica database retrospective cohort analysis, 2007–2015

Treatment approaches for older and oldest patients with diffuse large B-cell lymphoma – Use of non-R-CHOP alternative therapies and impact of comorbidities on treatment choices and outcome: A Humedica database retrospective cohort analysis, 2007–2015

Comorbidities and sex differences in causes of death among mantle cell lymphoma patients – A nationwide population‐based cohort study

Non-pegylated liposomal doxorubicin based on treatment of diffuse large B cell lymphoma in old patient with increased cardiovascular risk – case report and review of literature

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