Reducing the time interval between cycles using standard doses of docetaxel and lenogastrim support: a feasibility study.
BACKGROUND
As a single agent, 100 mg/m(2) of docetaxel every 3 weeks remains the standard schedule in the first-line treatment for metastatic disease. At this dose level, the major limiting toxicity is neutropenia. The current study was conducted to assess the feasibility of reducing time intervals between cycles while delivering standard doses of docetaxel with granulocyte-colony-stimulating factor (G-CSF; lenograstim).


METHODS
In the first part of the study, 24 patients were randomized to receive 1 of 4 schedules: 100 mg/m(2) of docetaxel every 21 days without lenograstim; 100 mg/m(2) of docetaxel every 18 days with lenograstim; 100 mg/m(2) of docetaxel every 14 days with lenograstim; or 100 mg/m(2) of docetaxel every 10 days with lenograstim. In the second part of the study, 15 additional patients were included to confirm the feasibility of the recommended interval between cycles.


RESULTS
Of the 39 patients treated, 14 patients (36%) withdrew from therapy because of Grade 3 (according to standard World Health Organization criteria) nonhematologic limiting toxicities. Only 3 patients were treated in the 10-day interval arm and were withdrawn because of toxicity--1 patient had Grade 3 asthenia after the second cycle and 2 patients had Grade 3 dermatitis after 4 cycles. Of the 24 patients treated in the 14-day intervals, Grade 3 limiting toxicities occurred in 8 patients (33%), including dermatitis in 3 patients; diarrhea, myalgia/arthralgia, or asthenia in 4 patients; and ungual toxicity in 1 patient.


CONCLUSIONS
Introduction of G-CSF (lenograstim) as primary prophylaxis allowed the administration of docetaxel every 14 days with manageable toxicities. Further studies are now required to assess the impact in terms of response rates and survival in patients with cancer.
Culine
Stéphane
S
Department of Medical Oncology, CRLC Val d'Aurelle, Parc Euromédecine, 34298 Montpellier Cedex 5, France. stculine@valdorel.fnclcc.fr
Romieu
Gilles
G
Fabbro
Michel
M
Becht
Catherine
C
Cupissol
Didier
D
Guillemare
Catherine
C
Bleuse
Jean-Pierre
JP
Lotz
Véronique
V
Gourgou
Sophie
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel