title: Phase II prospective study of paclitaxel and carboplatin in older patients with newly diagnosed Müllerian tumors.
abstract: OBJECTIVE
  The primary objective was to determine the completion rate of 6 cycles of paclitaxel and carboplatin chemotherapy with no dose reductions in patients > or =70 years of age.
  
  
  METHODS
  Phase II study of intravenous (IV) carboplatin Area Under the Curve (AUC) of 5 and paclitaxel 175 mg/m(2) given to patients > or =70 years of age, had any stage Müllerian cancer, and an ECOG performance status (PS) of 0-2.
  
  
  RESULTS
  Twelve patients were enrolled (median age of 82 years, range 75 to 86 years). Six of 12 completed 6 cycles of chemotherapy with no dose reductions. Three patients died on study precipitating study closure; one with refractory cancer following cycle 1, one of aspiration pneumonia after cycle 1, and one with sudden death on day 5 of cycle 6. Patients undergoing upfront debulking surgery tolerated chemotherapy better compared to patients receiving neoadjuvant chemotherapy. Grade 3 or higher hematologic toxicities included 2 patients with febile neutropenia (17%). > or =Grade 3 non-hematologic toxicities included fatigue (8%), nausea (8%), constipation (8%), obstipation (8%), vomiting (8%), and hypoxia (8%).
  
  
  CONCLUSIONS
  In this prospective trial of standard carboplatin and paclitaxel chemotherapy in a heterogeneous population of elderly patients, chemotherapy was well tolerated by patients who underwent upfront debulking surgery, had a PS of 0-1, and had few comorbidities. Patients not undergoing upfront debulking surgery because of either advanced cancer or poor surgical risk had excess morbidity/mortality. Prospective studies to identify risk factors for toxicity prediction are needed.
authors.affiliation: Department of Medical Oncology Dana-Farber Cancer Institute, Boston, MA 02115, USA. ursula_matulonis@dfci.harvard.edu
authors.forename: Ursula A
authors.initials: UA
authors.lastname: Matulonis
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Krag
authors.forename: Carolyn N
authors.initials: CN
authors.lastname: Krasner
authors.forename: Tina
authors.initials: T
authors.lastname: Atkinson
authors.forename: Neil S
authors.initials: NS
authors.lastname: Horowitz
authors.forename: Hang
authors.initials: H
authors.lastname: Lee
authors.forename: Richard T
authors.initials: RT
authors.lastname: Penson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000188:drug therapy / Q000601:surgery; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy / Q000601:surgery; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D018200:Mixed Tumor, Mullerian / Q000188:drug therapy* / Q000601:surgery; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000601:surgery; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D016190:Carboplatin; D017239:Paclitaxel