Citation: Cancer Research. 2019, 79(4)
Author: Bhojwani A.; Flint H.; Hall B.; Wong H.; Innes H.; Cliff J.; Ahmed E.; Malik Z.; O'Hagan J.; Tolan S.; Hall A.; Hyatt K.; Errington D.; Alam F.; Robson P.; Thorp N.; O'Reilly S.; Law A.; Cicconi S.; Jackson R.; Palmieri C.
Abstract: Background: Palbociclib plus endocrine therapy (ET) significantly increases progression free survival compared to ET alone. Within PALOMA2 neutropenia was the most common AE and reason for dose reductions. No real data exists regarding dose reductions (DRs), dose interruptions (DIs), toxicities and benefits of palbociclib.
Objective(s): To describe the early haematological dynamics, DRs/DIs with 1st line palbociclib in the context of a routine UK clinical practice. <br/>Method(s): A prospective record was maintained of all patients with ER-positive, HER2-negative metastatic BC registered on the Pfizer patient programme at the Clatterbridge Cancer Centre NHS Foundation Trust. The clinical records of all patients commenced on treatment between April and December 2017 were reviewed, and clinico-pathological information, haematological data & toxicity data recorded. Data lock was 31st March 2018.
Result(s): 48 patients received at least one cycle of treatment. The median age was 58, 29% (14/48) premenopausal & 71% (34/48) postmenopausal. 43% (21/48) had bone only disease with 42% (20/48) having visceral disease. The median number of cycles delivered 8 (range 2-11). DRs: 18/48 (38%) patients had a total of 21 DRs; 14/18 (78%) had 1 DR to 100mg; 1/18 (5%) 1 DR to 75mg; & 3/18 (17%) 2 DRs to 75mg. Reasons for DRs: 13 neutropenia, 2 leukopenia, 1 thrombocytopenia, 2 fatigue, 1 poor appetite, 1 sore mouth & 1 non-specially unwell. DIs: occurred in 24/48 patients (50%). Details of DRs/DIs by cycle will be presented. 85% (41 of 48) patients remain on treatment with 59% (24/41) on 125mg; 34% (14/41) on 100mg & 7% (3/41) on 75mg. FBC were available for 41/48 (85%) cases & dynamics considered over the first 6 cycles using FBC at the time of planned treatment delivery. Hb Baseline all patients (AP):129 (121 - 138), patients; patients with no dose reductions (NDR) 127 (123 - 139) & patient dose reduction (DR): 130 (118 - 136). Hb changes to cycles 2, 4 and 6 AP: 122 (115 - 131), 121 (116 - 127) and 125 (116 - 134); NDR:122 (110 - 135), 125 (117 - 127) and 131 (116 - 135); DR: 115 (112 - 120), 120 (115 - 124) and 122 (115 - 129). WCC Baseline AP: 6.8 (5.6 - 7.7); NDR: 7.2 (6.3 - 7.7); DR: 6.7 (5.2 - 7.7). WCC changes to cycles 2, 4 and 6 AP: 3.7 (2.9 -4.4), 3.7 (3.1 - 4.4) and 3.3 (3 - 3.9); NDR: 3.5 (2.9 - 4.1), 3.6 (3.2 - 4.3) and 3.6 (3.1 - 4.1); DR: 2.1 (1.7 - 2.5), 4.3 (3 - 4.6) and 3.3 (2.8 - 3.5). ANC Baseline AP: 4.0 (3.2 - 5.1); NDR: 4.4 (3.4 - 5.0); DR: 3.6 (2.9 - 5.2). ANC changes to cycles 2, 4 and 6 AP: 1.5 (1.2 - 2.1), 1.7 (1.3 - 2.0) and 1.4 (1.2 - 1.9) NDR: 1.5 (1.1 - 2.1), 1.7 (1.4 - 2.0) and 1.3 (1.2 - 2.0); DR: 0.8 (0.6 - 0.8), 1.7 (1.2 - 2.3) and 1.4 (1.3 - 1.6). Plts Baseline AP: 298 (226 - 339), NDR: 252 (211 - 336); DR: 299 (253 - 339). Plt changes to cycles 2, 4 and 6 AP: 252 (198 -310), 221 (186 - 259) and 200 (169 - 243). NDR: 249 (185 - 334), 229 (171 - 267) and 205 (177 - 263);DR: 208 (199 - 210), 216 (199 - 243) and 194 (162 -210).
Conclusion(s): These initial real world data are consistent with the PALOMA2 data. Baseline WCC & ANC show no significant difference between NDR and DR cases. Updated data will be presented as well as outcome data for first time.
