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Reducing the time interval between cycles using standard doses of docetaxel and lenogastrim support
Author(s) -
Culine Stéphane,
Romieu Gilles,
Fabbro Michel,
Becht Catherine,
Cupissol Didier,
Guillemare Catherine,
Bleuse JeanPierre,
Lotz Véronique,
Gourgou Sophie
Publication year - 2004
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.20351
Subject(s) - docetaxel , medicine , neutropenia , surgery , toxicity , chemotherapy
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 Only 3 patients were treated in the 10‐day interval arm and were withdrawn because of toxicity—1 patient had Grade 3 asthenia after the second cycle and 2 patients had Grade 3 dermatitis after 4 cycles.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. Cancer 2004. © 2004 American Cancer Society.