title: Activity of topotecan given intravenously for 5 days every three weeks in patients with advanced non-small cell lung cancer pretreated with platinum and taxanes: a phase II study.
abstract: Topotecan, a semi-synthetic camptothecin analogue with topoisomerase I interaction, has shown to be an active agent in the treatment of advanced refractory lung cancer. This paper describes the authors' experience with this drug when used as a single agent in patients (pts) with advanced non-small cell lung cancer (NSCLC) refractory to platinum- and taxane-containing chemotherapy regimens. Thirty-five patients with NSCLC refractory to previous chemotherapy and KI ≥ 60% were included in the study. Their characteristics are as follows: median age of 52 years (range 43-69) and Karnofsky PS of 70 (60-80); 27 were male and 8 were female. Twenty-one (60%) patients had adenocarcinoma; eleven (31.4%), squamous cell, and three (8.5%), undifferentiated carcinoma. There was a median of two disease sites and two prior chemotherapy regimens. Topotecan was administered at a dose of 1.25 mg/m(2) I.V. daily for 5 days, repeated every 21 days until disease progression, maximal response, or intolerable toxicity. After 73 cycles, patients received a median of 2 treatment cycles (1-9). All patients except one were considered evaluable for toxicity; eight episodes (24%) of nausea/vomiting and two episodes (6%) of grade 1-2 asthenia, respectively, were reported. Four (12%) patients developed grade 1-2 anemia and two (6%) subjects suffered grade 3 anemia. Seven (21%) patients had grade 1-2 neutropenia and one (3%) presented grade 5 neutropenia. In 33 patients evaluable for activity of the 35 subjects included in the study; one (2.8%) presented a partial response; nine (25.7%) had stable disease, and 23 (65.7%) exhibited disease progression. Median time to progression and overall survival were 54 (12-210) and 70 (12-324) days, respectively. Intravenous topotecan at that dose and administration schedule displays scant activity in terms of response rate in individuals with advanced NSCLC previously treated with platinum and taxanes. The role and usefulness of chemotherapy in this setting warrants further investigation and confirmation through comparative studies.
authors.affiliation: Servicio de Oncología Médica, Medical Oncology Department, Hospital Universitario Central de Asturias, Julián Clavería, s/n, 33006, Oviedo, Asturias, Spain. eestebang@seom.org
authors.forename: Emilio Esteban
authors.initials: EE
authors.lastname: Gonzalez
authors.forename: Noemi
authors.initials: N
authors.lastname: Villanueva
authors.forename: Joaquin
authors.initials: J
authors.lastname: Fra
authors.forename: Jose Pablo
authors.initials: JP
authors.lastname: Berros
authors.forename: Paula
authors.initials: P
authors.lastname: Jimenez
authors.forename: María
authors.initials: M
authors.lastname: Luque
authors.forename: Isabel
authors.initials: I
authors.lastname: Muñiz
authors.forename: Pilar
authors.initials: P
authors.lastname: Blay
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Fernandez
authors.forename: José María
authors.initials: JM
authors.lastname: Vieitez
authors.forename: Carolina
authors.initials: C
authors.lastname: Muriel
authors.forename: Miguel
authors.initials: M
authors.lastname: Sanmamed
authors.forename: Pablo Pardo
authors.initials: PP
authors.lastname: Coto
authors.forename: Marta
authors.initials: M
authors.lastname: Izquierdo
authors.forename: Enrique
authors.initials: E
authors.lastname: Estrada
authors.forename: Angel J
authors.initials: AJ
authors.lastname: Lacave
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017671:Platinum Compounds / Q000008:administration & dosage; D011446:Prospective Studies; D013534:Survival; D043823:Taxoids / Q000008:administration & dosage; D059004:Topoisomerase I Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D019772:Topotecan / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D017671:Platinum Compounds; D043823:Taxoids; D059004:Topoisomerase I Inhibitors; D019772:Topotecan
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