OBJECTIVES: To evaluate the efficacy and safety of multiple cycles of high-dose carboplatin and paclitaxel and one consolidation cycle of high-dose melphalan with all cycles supported by hematopoietic stem cells and cytokine, in previously untreated patients with optimally debulked stage III epithelial ovarian cancer. PATIENTS AND METHOD: Patients had histologically documented epithelial ovarian cancer and optimal initial cytoreductive surgery. No prior chemotherapy was permitted. Adequate performance status, bone marrow, hepatic, and renal function was required. After being mobilized with cyclophosphamide 3 g/m(2), paclitaxel 300 mg/m(2), and filgrastim 5 microg/kg/day, peripheral blood stem cells (PBSC) were collected by leukapheresis. Patients received three cycles of carboplatin AUC 15 mg. min/ml iv, paclitaxel 250 mg/m(2), and PBSC with filgrastim every 28 days, followed by one cycle of melphalan 140 mg/m(2) and hematopoietic support. RESULTS: Nine patients entered the trial and received all planned cycles of chemotherapy. Of the eight patients who consented to surgical reassessment upon completing therapy, four had residual small-volume macroscopic disease, three had microscopic residual disease, and one had pathologic complete response. The estimated probability of a pathologic complete response was 12.5% (95% confidence interval: 0.3-52.7%). Hematologic toxicity was severe but manageable. Eleven of 45 cycles (24.4%) resulted in hospital admission for neutropenic fever, dehydration +/- diarrhea, syncope, or shortness of breath and pain secondary to tense ascites. CONCLUSIONS: The low pathological complete response rate did not justify toxicity; thus, the study was closed. High-dose chemotherapy as first-line treatment for epithelial ovarian cancer remains experimental and should be restricted to clinical trials.
OBJECTIVES: To evaluate the efficacy and safety of multiple cycles of high-dose carboplatin and paclitaxel and one consolidation cycle of high-dose melphalan with all cycles supported by hematopoietic stem cells and cytokine, in previously untreated patients with optimally debulked stage III epithelial ovarian cancer. PATIENTS AND METHOD:Patients had histologically documented epithelial ovarian cancer and optimal initial cytoreductive surgery. No prior chemotherapy was permitted. Adequate performance status, bone marrow, hepatic, and renal function was required. After being mobilized with cyclophosphamide 3 g/m(2), paclitaxel 300 mg/m(2), and filgrastim 5 microg/kg/day, peripheral blood stem cells (PBSC) were collected by leukapheresis. Patients received three cycles of carboplatin AUC 15 mg. min/ml iv, paclitaxel 250 mg/m(2), and PBSC with filgrastim every 28 days, followed by one cycle of melphalan 140 mg/m(2) and hematopoietic support. RESULTS: Nine patients entered the trial and received all planned cycles of chemotherapy. Of the eight patients who consented to surgical reassessment upon completing therapy, four had residual small-volume macroscopic disease, three had microscopic residual disease, and one had pathologic complete response. The estimated probability of a pathologic complete response was 12.5% (95% confidence interval: 0.3-52.7%). Hematologic toxicity was severe but manageable. Eleven of 45 cycles (24.4%) resulted in hospital admission for neutropenic fever, dehydration +/- diarrhea, syncope, or shortness of breath and pain secondary to tense ascites. CONCLUSIONS: The low pathological complete response rate did not justify toxicity; thus, the study was closed. High-dose chemotherapy as first-line treatment for epithelial ovarian cancer remains experimental and should be restricted to clinical trials.
Authors: Paul Sabbatini; Philipp Harter; Giovanni Scambia; Jalid Sehouli; Werner Meier; Pauline Wimberger; Klaus H Baumann; Christian Kurzeder; Barbara Schmalfeldt; David Cibula; Mariusz Bidzinski; Antonio Casado; Andrea Martoni; Nicoletta Colombo; Robert W Holloway; Luigi Selvaggi; Andrew Li; Jose del Campo; Karel Cwiertka; Tamas Pinter; Jan B Vermorken; Eric Pujade-Lauraine; Simona Scartoni; Monica Bertolotti; Cecilia Simonelli; Angela Capriati; Carlo Alberto Maggi; Jonathan S Berek; Jacobus Pfisterer Journal: J Clin Oncol Date: 2013-03-11 Impact factor: 44.544
Authors: M R Litzow; P P Peethambaram; S L Safgren; G L Keeney; S M Ansell; A Dispenzieri; M A Elliott; D A Gastineau; M A Gertz; D J Inwards; M Q Lacy; I N M Micallef; L F Porrata; W L Lingle; L C Hartmann; M H Frost; B A Barrette; H J Long; V J Suman; J M Reid; M M Ames; S H Kaufmann Journal: Bone Marrow Transplant Date: 2009-08-03 Impact factor: 5.483