Granulocyte colony stimulating factor (G-CSF) prophylaxis and febrile neutropenia (FN) incidence in patients with solid tumours receiving myelotoxic chemotherapy who are assessed as high risk for FN: impact solid study

Konference: 2010 35th Congress ESMO – účast ČR

Kategorie: Podpůrná onkologická léčba, výživa nemocných a ošetřovatelská péče

Téma: Supportive Care

Číslo abstraktu: 1238PD

Autoři: J. Maenpaa; P. Sevelda; MUDr. Martin Šmakal; A. Trojan; J. Puertas; M. Schwenkglenks; F.L.G. Erdkamp; Zsolt Szabo; K. Bendall; K. Krzemieniecki

Purpose: G-CSF primary prophylaxis is recommended for patients undergoing chemotherapy (CT) who are at overall větší-rovno20% risk of FN. Overall risk combines CT myelotoxicity with patient-related risk factors (eg. age). We evaluated real-world G-CSF prophylaxis and neutropenia-related outcomes in patients receiving CT for solid tumours who were assessed as high větší-rovno20%) risk for FN.
Methods: This prospective observational study was conducted in Europe, Australia and Canada. Adults with breast, ovarian, small-cell or non-small cell lung cancers (SCLC and NSCLC) initiating any CT regimen were eligible, if physicians assessed them to be at větší-rovno20% risk of FN (per EORTC guidelines). G-CSF use was recorded. The primary outcome measure was the incidence of FN in cycles 1-8.
Results: Of the 1370 patients enrolled between 12/2007 and 10/2009, 1347 were analyzed. Most patients had breast cancer (Table). The most common CT agents were taxanes in breast cancer (70%), platinum in NSCLC (79%), platinum+etoposide in SCLC (74%) and platinum+paclitaxel in ovarian cancer (55%). Breast cancer patients were relatively young with early stage disease; they received more G-CSF primary prophylaxis than those with other tumours. FN incidence was highest in the SCLC group. Relative dose intensity was lower in lung and ovarian cancers. Neutropenia was a frequent reason for dose delays in all tumours.
Conclusions: Patient factors seemed to be a key determinant of high FN risk assessment in NSCLC and ovarian cancer, whereas breast cancer patients were undergoing curative CT. Despite patients being deemed high risk for FN, G-CSF primary prophylaxis was relatively infrequent and varied by tumour. Physicians appeared more willing to accept CT dose modifications in lung and ovarian cancers than in breast cancer. Sponsor: Amgen Europe (Clinicaltrials.gov NCT00883181)


n (%) [95% CI] Breast cancer (N=829) NSCLC (N=224) SCLC (N=137) Ovarian (N=157)
Median age (range), years 52 (18-82) 62 (28-83) 62 (42-81) 62 (25-84)
Age ≥65 years 136 (16%) 96 (43%) 51 (37%) 71 (45%)
Advanced stage* 90 (11%) 126 (56%) 98 (72%) 122 (78%)
Prior CT/RT 41 (5%) 59 (26%) 35 (26%) 34 (22%)
Any G-CSF PP 457 (55%) 45 (20%) 44 (32%) 31 (20%)
Pegfilgrastim PP 393 (47%) 22 (10%) 33 (24%) 24 (15%)
Any reactive G-CSF 197 (24%) 59 (26%) 37 (27%) 44 (28%)
Reactive pegfilgrastim 101 (12%) 16 (7%) 16 (12%) 16 (10%)
No G-CSF 175 (21%) 120 (54%) 56 (41%) 82 (52%)
FN (cycles 1-8) 77 (9%) [7, 11] 18 (8%) [5, 12] 0 (15%) [10, 21] 12 (8%) [4, 13]
RDI ≥85% 714 (86%) [84, 88] 133 (59%) [53, 66] 91 (66%) [58, 74] 109 (69%) [62, 76]

*Breast cancer and NSCLC: stage IV; SCLC: extensive; ovarian: stage III-IV. PP, primary prophylaxis: G-CSF initiated in cycle 1 between days 1-7, or by day 12 if chemotherapy extended beyond day 7. Reactive G-CSF: use of G-CSF other than PP (ie. secondary prophylaxis, treatment). RDI, Relative dose intensity (vs planned). RT, radiotherapy


Disclosure: J. Maenpaa: Member of IMPACT SOLID steering committee. Member of MSD-Schering Plough advisory board on ovarian cancer (Finland); P. Sevelda, M. Smakal, A. Trojan, J. Puertas, F.L.G. Erdkamp and K. Krzemieniecki: Member of IMPACT SOLID steering committee; M. Schwenkglenks: Research funding from Amgen (Europe) GmbH. Member of Amgen advisory boards and IMPACT SOLID steering committee; Z. Szabo: Amgen employee and stock holder; K. Bendall: Amgen employee.

Datum přednesení příspěvku: 9. 9. 2010