title: Second-line treatment of non small cell lung cancer by biweekly gemcitabine and docetaxel +/- granulocyte-macrophage colony stimulating factor and low dose aldesleukine.
abstract: Background. The antitumor activity of a novel biweekly gemcitabine (G) + docetaxel (D) regimen +/- granulocyte-macrophage colony stimulating factor (GM-CSF) and aldesleukine (IL-2) has been evaluated in a phase II trial in advanced pretreated non-small-cell lung cancer (NSCLC). Results. The treatment was well tolerated. The 42.3% response rate exceeded the predefined target activity, while time to progression (TTP) and overall survival (OS) were 7 and 11.2 months, respectively. A greater objective response rate (58.3% vs 28.6%) and an increased number of eosinophils, basophils and activated mononuclear blood cells were observed in those patients who also received cytokine administration. Methods. Twenty-six NSCLC patients received second line G (1000 mg/m2) and D (75 mg/m2) every 15 days. 12/26 patients also received s.c. GM-CSF (100µg, days 2-6) and s.c. IL-2 (0.5MIU/ twice daily, days 7-14 and 16-29) by random selection. Conclusion. The biweekly GD regimen is a safe and active second-line treatment in NSCLC. Addition of immune-adjuvant cytokines' may enhance the activity of this therapeutic combination.
authors.affiliation: Section of Medical Oncology, Department Giorgio Segre of Pharmacology, Siena University School of Medicine, Siena, Italy.
authors.forename: Pierpaolo
authors.initials: P
authors.lastname: Correale
authors.forename: Salvatora
authors.initials: S
authors.lastname: Tindara Miano
authors.forename: Cinzia
authors.initials: C
authors.lastname: Remondo
authors.forename: Cristina
authors.initials: C
authors.lastname: Migali
authors.forename: Maria Saveria
authors.initials: MS
authors.lastname: Rotundo
authors.forename: Paolo
authors.initials: P
authors.lastname: Macrì
authors.forename: Pierosandro
authors.initials: P
authors.lastname: Tagliaferri
authors.forename: Michele
authors.initials: M
authors.lastname: Caraglia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gotti
authors.forename: Guido
authors.initials: G
authors.lastname: Francini
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage / Q000031:analogs & derivatives; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016173:Macrophage Colony-Stimulating Factor / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D016173:Macrophage Colony-Stimulating Factor; C082598:aldesleukin; D000093542:Gemcitabine