Abstract 1834P
Background
Neutropenia is a major cause of infection-related morbidity and mortality in patients (pts) treated with chemotherapy (CT). This study investigated the febrile neutropenia (FN) and neutropenia incidence in intermediate-risk pts (FN risk of 10-20%) in real-world settings.
Methods
This MASCC real-world prospective, observational, multinational study aimed at establishing the rate of neutropenia and FN induced by CT regimens with an expected risk of FN of 10% to 20% (according to published guidelines). Eligible pts (> 18 years of age) included pts with solid tumor or lymphoma. Pts were observed for the duration of the CT (first cycle administered without FN prophylaxis) up to a maximum of 6 cycles. Primary endpoint was incidence of FN after the first CT cycle. Other endpoints included incidence of FN in subsequent cycles, incidence of neutropenia following cycle 1 and subsequent cycles.
Results
The current preliminary analysis included 340 intermediate-risk pts (out of 371 eligible pts registered) with solid tumor or lymphoma. In total 1502 cycles of CT were administered and analyzed. The median age was 58 years (18-83), including 225 females and 115 males. Metastatic disease was documented in 100 (29%) pts. Weight loss of less than 5% was documented in 265 (78%) pts. Dose reductions occurred in 75 (22%) pts and delayed in CT administration 146 (43%) pts. The overall incidence of FN was 13% and grade 4 neutropenia of 23%. The overall incidence of neutropenia episodes in cycle 1 were 77 (23%) with a 95% confidence interval (CI) 18-28% and grade 4 neutropenia in 38 (11%) pts with a 95% CI 8-15%. Additional results are shown in the table. Table: 1834P
Neutropenia and febrile neutropenia incidence
| Neutropenia for all cycles | Totals and % | 95% Confidence Intervals |
| Grade 1 | 76 (22%) | |
| Grade 2 | 64 (19%) | |
| Grade 3 | 59 (17%) | |
| Grade 4 | 73 (21%) | |
| Grade 4 in at least 1 cycle | 56 (16%) | 13%-21% |
| Febrile Neutropenia | ||
| Cycle 1 | 19 (6%) | 3%-9% |
| Total episodes for all cycles | 42 (13%) | |
| Pts with FN in at least 1 cycle | 32 (9%) | 7%-13% |
Conclusions
FN remains a significant problem in cancer intermediate-risk pts undergoing CT. An analysis of the risk factors for FN and neutropenia will be presented at the time of the meeting.
Clinical trial identification
MASCC Neutropenia, Infection & Myelosuppression Study Group - FN01.
Editorial acknowledgement
Legal entity responsible for the study
The autors.
Funding
Sandoz.
Disclosure
R. Popescu: Non-remunerated activity/ies, core faculty member Scientific coordinator: European School of Oncology (ESO) ESO-ESMO; Non-remunerated activity/ies, International Affairs Committee member ASCO, Educational Committee member, Educational Committee member, Masterclass in Clinical Oncology American Society of Clinical Oncology (ASCO) ; Non-remunerated activity/ies, Co-President palliative aargau: Track Chair ASCO Global Health Educational Programme 2019-2020. N. Mathieson: Full/Part-time employment: SANDOZ c/o Hexal. A. Krendyukov: Full/Part-time employment, Former Employee: SANDOZ c/o Hexal. B.L. Rapoport: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Sandoz ; Advisory/Consultancy: Amgen South Africa. All other authors have declared no conflicts of interest.