Activity and toxicity of GI147211 in breast, colorectal and non-small-cell lung cancer patients: an EORTC-ECSG phase II clinical study

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Ημερομηνία

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peer-reviewed

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Ann Oncol

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Συμπληρωματικός/δευτερεύων τίτλος

Περιγραφή

BACKGROUND: GI147211 is a water-soluble synthetic analogue of camptothecin showing promising in vivo and in vitro antitumor activity and an acceptable toxicity profile. PATIENTS AND METHODS: Between April 1995 and November 1996, 67 eligible patients with pretreated breast cancer (25 patients) and chemo-naive colorectal (19 patients) and non-small-cell lung cancer (23 patients) were entered into three multicentric, non-randomized phase II trials. Treatment schedule consisted of intravenous GI1147211 administered at a dose of 1.2 mg/m2/day for five consecutive days every three weeks. RESULTS: Hematological toxicity was common with grade 3-4 neutropenia in 54% of patients and neutropenic fever together or not associated with infection in 14.5% of patients. Grade 3-4 thrombocytopenia and grade 2-4 anemia were observed in 20% and in 68% of patients, respectively. Non-hematological toxicity was generally mild to moderate and consisted mainly of gastrointestinal toxicity, asthenia and alopecia. A dose-escalation to 1.5 mg/m2/d was feasible in 17 (25%) patients. The antitumor activity of GI1147211 was moderate in breast cancer patients (3 partial responses (PRs), response rate (RR) 13%) and minimal in non-small cell lung cancer patients (2 PRs, RR 9%). No objective responses were obtained in colorectal patients. CONCLUSIONS: GI147211, at the dose and schedule employed in this study, showed an acceptable safety profile but a modest antitumor activity in the examined tumor types.

Περιγραφή

Λέξεις-κλειδιά

Adult, Aged, Antineoplastic Agents/adverse effects/*pharmacology/therapeutic use, Breast Neoplasms/*drug therapy/pathology, Camptothecin/adverse effects/analogs & derivatives/*pharmacology/therapeutic use, Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology, Colorectal Neoplasms/*drug therapy/pathology, Dose-Response Relationship, Drug, Female, Humans, Infusions, Intravenous, Lung Neoplasms/*drug therapy/pathology, Male, Middle Aged, Treatment Outcome

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http://www.ncbi.nlm.nih.gov/pubmed/10997805
http://annonc.oxfordjournals.org/content/11/7/793.full.pdf

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en

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Γενική Περιγραφή / Σχόλια

Ίδρυμα και Σχολή/Τμήμα του υποβάλλοντος

Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής

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