PALOMAGE, a French real-world cohort of elderly women beyond age 70 with advanced breast cancer receiving palbociclib: Baseline characteristics and safety evaluation.

Abstract

1012 Background: Advanced breast cancer (ABC) is common in older patients, resulting from the high incidence of breast cancer beyond age 70. This population is often limited in clinical trials. Endocrine therapy (ET) combined with a CDK4/6 inhibitor is the standard of care in ABC overexpressing hormonal receptors (HR+). Data specific to older patients are scarce in the literature, deserving further research. Methods: PALOMAGE is an ongoing French prospective study evaluating palbociclib (PAL) + ET in real life setting in women aged ≥70 with HR+ HER2- ABC, split in 2 cohorts: ET sensitive patients with no prior systemic treatment for ABC (cohort A), and ET resistant patients and/or with prior systemic treatment for ABC (cohort B). Data collected include clinical characteristics, quality of life (EORTC QLQ-C30 and ELD14) and geriatric description [G8 and Geriatric-COre DatasEt (G-CODE)]. This analysis reports on baseline characteristics and safety data for the whole population. Results: From 10/2018 to 10/2020, 400 and 407 patients were included in cohort A and B, respectively. The median age was 79 years (69-98), 15.1% with an age > 85. ECOG performance status (PS) was ≥2 in 17.9% patients, 68.3% had a G8 score ≤14 suggesting frailty, 32.1% had bone only metastasis, and 44% had visceral disease. 35.8% of patients in cohort B had no prior treatment for ABC. Safety data were available for 787 patients. The median follow-up was 6.7 months (IC95% = 6.1-7.6). At start of treatment, full dose of PAL (125 mg) was used in 76% of the patients: 62.6%, 68.7% and 71.6% of patients aged ≥ 80, those with ECOG PS ≥2 and those with a G8 score ≤14, respectively. In the safety population, 70% had ≥1 adverse event (AE), including 43.1% grade 3/4 AE, and 22.9% ≥ 1 serious AE. Most frequent AE reported were neutropenia (43.2%), anemia (17.5%), asthenia (16.3%) and thrombocytopenia (13.6%). Grade 3/4 neutropenia was observed in 32.3% of patients, with febrile neutropenia in 1.1%. Grade 3/4 AE PAL-related were reported in 40.1%, 31.4% of patients aged < 80, ≥80, respectively. Regarding PAL, 23.4% of patients had a dose reduction and 41.8% had a temporary or permanent discontinuation due to AE. Safety data were similar in both cohorts. Geriatric data and impact on safety will be presented. Conclusions: PALOMAGE is a unique large real-world cohort focusing on older patients treated with PAL in France. These preliminary data do not suggest any new safety signal, matching data derived from PALOMA trials. The occurrence of less grade3/4 AE related to PAL in patients aged 80 and beyond might reflect the 30% decrease of PAL dose upfront. Effectiveness analyses are eagerly awaited. Clinical trial information: EUPAS23012 .

Palbociclib in combination with aromatase inhibitors in patients ≥ 75 years with oestrogen receptor-positive, human epidermal growth factor receptor 2 negative advanced breast cancer: A real-world multicentre UK study

“…A more recent US study of the rates of hospitalisation for complications of systemic therapy reported 11.1% of patients with breast cancer required hospital admission but this was not age-or stage-specific [18]. The results of our real-world study reflect good overall tolerability in the older population and are in keeping with the safety analysis from the PALOMAGE French study which showed palbociclib to be well-tolerated in this population with no new safety signals identified [9].…”

“…Real-world studies have looked at the efficacy and safety of palbociclib, some of which focussed on the older patient group. A French real-world study of palbociclib in patients aged over 70 years (PALOMAGE) reported a lower incidence of grade 3/4 adverse events in those aged !80 years [9]. A US retrospective analysis included 92 patients aged !70 years treated with palbociclib and reported significantly higher rates of dose reductions and delays in patients !70, but with no detriment to survival outcomes [10].…”

Real-world comparative effectiveness of palbociclib plus letrozole versus letrozole in older patients with metastatic breast cancer

“…Recent real-world data analyses have shown that palbociclib is effective in patients with HR+/HER2– MBC in routine US clinical practice, but detailed information about the use of CDK4/6 inhibitors specifically in older patients is limited [ [8] , [9] , [10] , [11] , [12] ]. The available real-world studies including older European patients (≥70 or ≥75 years) support the effectiveness or tolerability of palbociclib in these age groups [ 13 , 14 ]. A better understanding of treatment benefits and risks in older women in the real-world setting in the United States is needed.…”

The safety and efficacy of palbociclib in older patients with advanced breast cancer in a real-world setting

“…Another meta-analysis of phase II and III studies also showed that palbociclib was associated with significantly increased rates of neutropenia in an older subgroup compared to their younger counterparts, with an ORR of 2.57. Leukopenia, anemia, back pain, asthenia, and infections were also more frequent in the older group [25] . Recently, results were reported from the French prospective study PALOMAGE and its safety analysis of palbociclib + ET in a real-life setting in women aged ≥ 70 years with HR+/HER2-ABC, where 807 patients were included with a median age of 79 years old.…”