Pegfilgrastim omission safe, feasible for some patients with breast cancer
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Omitting routine prophylactic pegfilgrastim during the paclitaxel portion of treatment appeared safe and feasible for certain patients with breast cancer, according to study results published in Journal of Clinical Oncology.
Most patients completed four cycles of paclitaxel without pegfilgrastim — omitted according to a prespecified algorithm — within 7 weeks.
“As clinicians, we have long noted that many patients have elevated neutrophil counts on day 1 of dose-dense paclitaxel cycles, and many of us have held growth factor if day 1 counts were high,” Nancy U. Lin, MD, medical oncologist in the department of medical oncology at Dana-Farber Cancer Institute, told Healio. “Our group performed a retrospective case review as to actual clinical practice at our institution and found significant variability in how providers prescribed growth factors with paclitaxel — with some patients not given growth factors at all — yet without apparent significant complications. We thus set out to prospectively study whether omitting routine use of growth factors during dose-dense paclitaxel was safe and feasible.”
Lin and colleagues assigned 125 patients (median age, 46 years; range, 21-65) who previously completed four cycles of a dose-dense doxorubicin-cyclophosphamide regimen for stage I to stage III breast cancer to receive 175 mg/m² paclitaxel once every 2 weeks without pegfilgrastim (Neulasta, Amgen).
Most patients were white (80%) and had an ECOG performance status of 0 (95%). The majority (67%) were premenopausal.
Researchers assigned pegfilgrastim to those who had febrile neutropenia in a prior cycle or at investigator discretion if patients experienced infections or treatment delays of more than 1 week.
The rate of paclitaxel completion within 7 weeks from cycle one/day 1 to cycle four/day 1 served as the primary endpoint. Researchers considered the regimen feasible if 100 or more patients completed four cycles of paclitaxel without dose delay.
According to study results, 112 patients (90%; 95% CI, 83-94) completed dose-dense paclitaxel within 7 weeks, whereas three patients completed four cycles within 7 weeks and 10 patients did not complete four cycles.
Researchers found no causal relationship between omission of pegfilgrastim and noncompletion of paclitaxel. Common reasons for dose-reduction or delays in treatment were nonhematologic. Febrile neutropenia occurred in one patient who was able to complete paclitaxel on time.
Among the 6.4% of patients (n = 8) who received pegfilgrastim during the trial, treatment was administered during only 4.3% of paclitaxel cycles.
“Our prespecified algorithm resulted in a 95.7% reduction in the use of pegfilgrastim, relative to current standard of care,” Lin told Healio. “Despite the omission of routine pegfilgrastim, most patients were able to complete treatment on time, and we did not identify concerning safety signals with this approach.
“Adoption of our algorithm in appropriate patients could result in substantial reductions in the cost of care and spare some patients toxicities associated with growth factor support,” Lin added. “We additionally studied the use of a simplified dexamethasone premedication schedule with paclitaxel in the same clinical trial, and we hope to submit results of this analysis for review within the next few months.”
For more information:
Nancy U. Lin, MD, can be reached at Dana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA 02215; email: nlin@partners.org.
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