BACKGROUND: Single-agent platinum and single-agent pegylated liposomal doxorubicin (PLD) are both effective in the treatment of gynecologic malignancies. Based on evidence that combination platinum-containing regimens offer superior efficacy versus single-agent regimens, we conducted this study to determine the maximum tolerated dose (MTD) of PLD in combination with carboplatin. PATIENTS AND METHODS: In this phase I/II dose-finding study, six courses of PLD (20, 30, 40 or 50 mg/m2) and carboplatin (AUC 6) were administered every 28 days to women with advanced gynecologic malignancies. Three to six patients were treated at each dose level; an additional 12 patients were treated at the MTD. RESULTS: PLD 40 mg/m2 was identified as the MTD when administered with carboplatin. Five of 18 patients experienced a dose-limiting toxicity at the MTD; two patients had grade 3/4 neutropenia, and one each had grade 3 emesis and grade 3 thrombocytopenia and thrombosis. No patient developed cardiotoxicity. In 11 patients evaluable for response, there were two complete responses, two partial responses and four patients with stable disease. CONCLUSIONS: The MTD for PLD when administered in combination with carboplatin is 40 mg/m2. This regimen is well tolerated and offers promising activity in women with advanced gynecologic malignancies.
BACKGROUND: Single-agent platinum and single-agent pegylated liposomal doxorubicin (PLD) are both effective in the treatment of gynecologic malignancies. Based on evidence that combination platinum-containing regimens offer superior efficacy versus single-agent regimens, we conducted this study to determine the maximum tolerated dose (MTD) of PLD in combination with carboplatin. PATIENTS AND METHODS: In this phase I/II dose-finding study, six courses of PLD (20, 30, 40 or 50 mg/m2) and carboplatin (AUC 6) were administered every 28 days to women with advanced gynecologic malignancies. Three to six patients were treated at each dose level; an additional 12 patients were treated at the MTD. RESULTS: PLD 40 mg/m2 was identified as the MTD when administered with carboplatin. Five of 18 patients experienced a dose-limiting toxicity at the MTD; two patients had grade 3/4 neutropenia, and one each had grade 3 emesis and grade 3 thrombocytopenia and thrombosis. No patient developed cardiotoxicity. In 11 patients evaluable for response, there were two complete responses, two partial responses and four patients with stable disease. CONCLUSIONS: The MTD for PLD when administered in combination with carboplatin is 40 mg/m2. This regimen is well tolerated and offers promising activity in women with advanced gynecologic malignancies.
Authors: D Denschlag; F C Thiel; S Ackermann; P Harter; I Juhasz-Boess; P Mallmann; H-G Strauss; U Ulrich; L-C Horn; D Schmidt; D Vordermark; T Vogl; P Reichardt; P Gaß; M Gebhardt; M W Beckmann Journal: Geburtshilfe Frauenheilkd Date: 2015-10 Impact factor: 2.915
Authors: Sandro Pignata; Giovanni Scambia; Antonella Savarese; Enrico Breda; Paolo Scollo; Rocco De Vivo; Emanuela Rossi; Vittorio Gebbia; Donato Natale; Filomena Del Gaizo; Emanuele Naglieri; Antonella Ferro; Pietro Musso; Alfonso Maria D'Arco; Roberto Sorio; Carmela Pisano; Massimo Di Maio; Giuseppe Signoriello; Annalisa Annunziata; Francesco Perrone Journal: BMC Cancer Date: 2006-08-01 Impact factor: 4.430
Authors: S Pignata; G Scambia; C Pisano; E Breda; M Di Maio; S Greggi; G Ferrandina; D Lorusso; V Zagonel; A Febbraro; N Riva; V De Rosa; C Gallo; F Perrone Journal: Br J Cancer Date: 2007-05-08 Impact factor: 7.640