title: Epirubicin and gemcitabine as first-line treatment in malignant pleural mesothelioma.
abstract: Malignant pleural mesothelioma represents a rare disease, for which chemotherapy actually remains unsatisfactory. From August 1998 to November 2001, 28 chemo-radio-immunonaive patients were consecutively enrolled in the trial: 22/6 males/females; median age 63 years (range, 45-79); median ECOG PS 1 (range, 0-2). They were treated with epirubicin (100 mg/m2 iv on day 1) plus gemcitabine (1000 mg/m2 iv on days 1 and 8) every 4 weeks for 6 cycles. Patients who responded to chemotherapy (n = 6) were subsequently treated with interleukin-2 (4,500,000 IU) subcutaneously every other day, until progression. A total of 124 epirubicin-gemcitabine cycles were administered (median, 6/patient; range, 2-6). Twenty-six patients were evaluated for toxicity. According to WHO criteria, we observed grade III-IV hematological and gastrointestinal toxicity respectively in 3 patients (11%) and 1 patient (3%). No red cell transfusions were required and no toxic deaths occurred. Two patients (8%) could not be evaluated for response (no therapy performed). According to WHO criteria, the final responses were: partial in 4 patients (14%), stable disease in 19 patients (69%), and progression in 3 patients (10%). In 26 patients, the median survival was 55 weeks (range, 7-222) and median time to progression 30 weeks (range, 4-156). At the time of this writing, no patient is alive. The 1-year survival was 32%, 2-year survival 11%, and 4% at 3 and 4 years. All patients were at stage III, and time to progression was 58 weeks and survival 63.5 weeks, without any toxicity. This multi-center phase II clinical trial showed that epirubicin plus gemcitabine, as a first-line treatment in malignant pleural mesothelioma, has promising activity with a good tolerability profile and symptom palliation. The role of interleukin-2 in maintenance therapy for malignant pleural mesothelioma is encouraging and requires further study.
authors.affiliation: 16th Pneumo-Oncology Unit, C. Forlanini Hospital, Rome, Italy. lportalone@virgilio.it
authors.forename: Luigi
authors.initials: L
authors.lastname: Portalone
authors.forename: Antonio
authors.initials: A
authors.lastname: Antilli
authors.forename: Francesco
authors.initials: F
authors.lastname: Nunziati
authors.forename: Carlo
authors.initials: C
authors.lastname: Crispino
authors.forename: Filippo
authors.initials: F
authors.lastname: de Marinis
authors.forename: Luigi
authors.initials: L
authors.lastname: Friggeri
authors.forename: Alessandra
authors.initials: A
authors.lastname: Lombardi
authors.forename: Vito
authors.initials: V
authors.lastname: Lorusso
authors.forename: Paolo
authors.initials: P
authors.lastname: Pronzato
authors.forename: Domenico
authors.initials: D
authors.lastname: Sambiasi
authors.forename: Mauro
authors.initials: M
authors.lastname: Signora
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008654:Mesothelioma / Q000188:drug therapy*; D008875:Middle Aged; D010997:Pleural Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D015251:Epirubicin; D000093542:Gemcitabine