title: Carboplatin and nonpegylated liposomal doxorubicin in primary advanced or recurrent endometrial cancer: a phase 2 trial conducted by AGO Austria.
abstract: OBJECTIVE
  Recurrent/advanced endometrial carcinoma carries a poor prognosis. Chemotherapy usually consists of cisplatin/doxorubicin and paclitaxel or the doublet of carboplatin and paclitaxel.We report on final results of the Austrian phase 2 AGO trial of nonpegylated doxorubicin citrate and carboplatin in 39 patients with primary advanced or relapsed endometrial cancer. The main primary end point is response rate, and the main secondary end point is feasibility.
  
  
  METHODS
  Thirty-nine patients received 60 mg/m nonpegylated doxorubicin citrate and carboplatin (area under the curve, 5) every 3 weeks for 6 to 9 cycles or until progression. Best response during therapy, progression-free survival, and the toxicity profile were recorded.
  
  
  RESULTS
  Thirteen patients (33%) had primary advanced disease, and 26 patients (67%) had recurrent disease. Seventy-five percent of the tumors were adenocarcinomas, 15% were serous carcinomas, and 5% were clear cell and mixed müllerian carcinomas. We observed 1 complete response (3%) and 16 partial responses (41%) in the intention-to-treat population. The median progression-free survival was 7.2 months, and the median overall survival was 14.7 months. Overall, 177 cycles were administered; the mean number of cycles per patient was 4.5. Ten percent of patients received 9 cycles of chemotherapy, and 44% of patients received 6 cycles of chemotherapy. Grade 3/4 neutropenia occurred in 17%, grade 3/4 anemia in 5%, and grade 3/4 thrombopenia in 12% of the cycles. In 6% of the cycles, febrile neutropenia was noticed. Grade 3/4 nausea was seen in 5% of cycles. One patient (3%) experienced cardiac toxicity and had a reduction in the left ventricular ejection fraction to below 50%.
  
  
  CONCLUSIONS
  The reported combination demonstrates considerable activity and should be evaluated further.
authors.affiliation: *Department of Obstetrics and Gynecology, and †Study Center of AGO (Arbeitsgemeinschaft für Gynäkologisch Onkologie) Austria, Innsbruck Medical University, Innsbruck; ‡Department of Gynecology and Gynecologic Oncology, Medical University of Vienna, Vienna; §Department of Obstetrics and Gynecology, Medical University of Graz; ∥Department of Gynecology, Krankenhaus der Barmherzigen Brüder Graz, Graz; ¶Department of Obstetrics and Gynecology, Krankenhaus Oberpullendorf, Oberpullendorf; #Department of Obstetrics and Gynecology, Wilhelminenspital Wien, Vienna; **Department of Obstetrics and Gynecology, KH der Kreuzschwestern Wels, Wels; and ††Department of Obstetrics and Gynecology, KH Ried i.I. Schloßberg 1, Ried im Innkreis, Austria.
authors.forename: Birgit
authors.initials: B
authors.lastname: Volgger
authors.forename: Alain G
authors.initials: AG
authors.lastname: Zeimet
authors.forename: Alexander
authors.initials: A
authors.lastname: Reinthaller
authors.forename: Edgar
authors.initials: E
authors.lastname: Petru
authors.forename: Christian
authors.initials: C
authors.lastname: Schauer
authors.forename: Michaela
authors.initials: M
authors.lastname: Klein
authors.forename: Ursula
authors.initials: U
authors.lastname: Sevelda-Schwarzgruber
authors.forename: Gerhard
authors.initials: G
authors.lastname: Bogner
authors.forename: Gerhard
authors.initials: G
authors.lastname: Wolfram
authors.forename: Christian
authors.initials: C
authors.lastname: Marth
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001317:Austria; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin