BACKGROUND: Both gemcitabine and pegylated liposomal doxorubicin (PLD) are antineoplastic drugs with clinical activity in patients with platinum-resistant ovarian cancer. The present study was designed to assess the efficacy and safety of biweekly scheduled gemcitabine and PLD combination therapy in such patients. METHODS: Eighteen women with ovarian cancer that had recurred within 6 months after standard carboplatin and paclitaxel therapy were eligible for enrollment. Gemcitabine 2000 mg/m(2) and PLD 20 mg/m(2) were administered intravenously on days 1 and 15 of a 28-day cycle. RESULTS: Hematological toxicity was mild. No severe (grade III/IV) leucopenia/neutropenia or thrombocytopenia was observed. Severe anemia was seen in only 3 (17%) patients. Several other severe nonhematological adverse effects were well tolerated and easily managed. The overall response rate was 28% (5 of 18; 95% confidence interval [CI], 10%-54%) with 2 (11%) complete and 3 (17%) partial responses. The median overall survival time was 17 months (range, 1 to 25 months). The median survival for patients with clinical benefit including disease response or stabilization was 17 months (range, 3 to 26 months) compared to that of patients with progressive disease, which was 2 months (range, 1 to 11 months; P = 0.04). CONCLUSION: A biweekly schedule of gemcitabine combined with PLD is an active and safe chemotherapy regimen with acceptable and easily manageable toxicities in women with recurrent platinum-resistant ovarian cancer.
BACKGROUND: Both gemcitabine and pegylated liposomal doxorubicin (PLD) are antineoplastic drugs with clinical activity in patients with platinum-resistant ovarian cancer. The present study was designed to assess the efficacy and safety of biweekly scheduled gemcitabine and PLD combination therapy in such patients. METHODS: Eighteen women with ovarian cancer that had recurred within 6 months after standard carboplatin and paclitaxel therapy were eligible for enrollment. Gemcitabine 2000 mg/m(2) and PLD 20 mg/m(2) were administered intravenously on days 1 and 15 of a 28-day cycle. RESULTS: Hematological toxicity was mild. No severe (grade III/IV) leucopenia/neutropenia or thrombocytopenia was observed. Severe anemia was seen in only 3 (17%) patients. Several other severe nonhematological adverse effects were well tolerated and easily managed. The overall response rate was 28% (5 of 18; 95% confidence interval [CI], 10%-54%) with 2 (11%) complete and 3 (17%) partial responses. The median overall survival time was 17 months (range, 1 to 25 months). The median survival for patients with clinical benefit including disease response or stabilization was 17 months (range, 3 to 26 months) compared to that of patients with progressive disease, which was 2 months (range, 1 to 11 months; P = 0.04). CONCLUSION: A biweekly schedule of gemcitabine combined with PLD is an active and safe chemotherapy regimen with acceptable and easily manageable toxicities in women with recurrent platinum-resistant ovarian cancer.
Authors: Paula M Fracasso; Kristie A Blum; Benjamin R Tan; Carole L Fears; Nancy L Bartlett; Matthew A Arquette; Romnee S Clark Journal: Cancer Date: 2002-11-15 Impact factor: 6.860
Authors: Dimosthenis V Skarlos; Haralabos P Kalofonos; George Fountzilas; Meletios A Dimopoulos; Nicholas Pavlidis; Evangelia Razis; Theofanis Economopoulos; Dimitrios Pectasides; Helen Gogas; Paris Kosmidis; Dimitrios Bafaloukos; George Klouvas; George Kyratzis; Gerasimos Aravantinos Journal: Anticancer Res Date: 2005 Jul-Aug Impact factor: 2.480
Authors: F M Muggia; J D Hainsworth; S Jeffers; P Miller; S Groshen; M Tan; L Roman; B Uziely; L Muderspach; A Garcia; A Burnett; F A Greco; C P Morrow; L J Paradiso; L J Liang Journal: J Clin Oncol Date: 1997-03 Impact factor: 44.544
Authors: A N Gordon; C O Granai; P G Rose; J Hainsworth; A Lopez; C Weissman; R Rosales; T Sharpington Journal: J Clin Oncol Date: 2000-09 Impact factor: 44.544
Authors: G D'Agostino; G Ferrandina; M Ludovisi; A Testa; D Lorusso; N Gbaguidi; E Breda; S Mancuso; G Scambia Journal: Br J Cancer Date: 2003-10-06 Impact factor: 7.640