title: A phase II study of weekly carboplatin and paclitaxel as first-line treatment of elderly patients with advanced ovarian cancer. A Multicentre Italian Trial in Ovarian cancer (MITO-5) study.
abstract: BACKGROUND
  Carboplatin/paclitaxel every 3 weeks is the standard for patients with ovarian cancer, but elderly patients frequently receive modified schedules or single agent chemotherapy to avoid toxicity. A phase II study was conducted to describe tolerability of a weekly schedule of both drugs in elderly patients.
  
  
  METHODS
  Patients aged>or=70 years with stage IC-IV ovarian cancer, performance status<or=2, were eligible. Treatment was carboplatin (AUC 2)+paclitaxel (60 mg/m2) on days 1, 8, 15 every 4 weeks, up to six cycles. A two-stage design was applied with lack of unacceptable toxicity as primary endpoint; 26 patients were required at the final stage, with at least 23 of them without unacceptable toxicity to conclude for a positive result. Geriatric assessment was performed by activity daily living (ADL) and instrumental ADL (IADL) scales.
  
  
  RESULTS
  Twenty-six patients were analysed (median age 77 years, range 70-84). Performance status was 0 in 10 and 1 in 16 patients; 14 patients had two or more comorbidities; 8 and 18 patients had some dependency in ADL or IADL. Twenty-three patients (88.5%) were treated without suffering unacceptable toxicity. Unacceptable toxic events were grade 3 heart rhythm, grade 3 increase of liver transaminases and prolonged haematological toxicity. Grade 1 neuropathy was reported in four cases. Out of 13 patients evaluable by RECIST, 5 partial responses were observed (response rate 38.5%). Two complete responses were observed among six patients with non-target lesions. Eight patients eligible for CA-125 response assessment had a response after six cycles. Median estimated progression-free survival was 13.6 months, and median overall survival was 32.0 months.
  
  
  CONCLUSIONS
  In a series of elderly ovarian cancer patients, characterized by a high incidence of comorbidities and functional impairment, weekly carboplatin and paclitaxel demonstrated a favourable toxicity profile.
authors.affiliation: Divisione di Oncologia Medica B, Istituto Nazionale Tumori, Napoli, Italy. sandro.pignata@fondazionepascale.it
authors.forename: Sandro
authors.initials: S
authors.lastname: Pignata
authors.forename: Enrico
authors.initials: E
authors.lastname: Breda
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Carmela
authors.initials: C
authors.lastname: Pisano
authors.forename: Vittorina
authors.initials: V
authors.lastname: Zagonel
authors.forename: Domenica
authors.initials: D
authors.lastname: Lorusso
authors.forename: Stefano
authors.initials: S
authors.lastname: Greggi
authors.forename: Rocco
authors.initials: R
authors.lastname: De Vivo
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use / Q000633:toxicity; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015897:Comorbidity; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D016190:Carboplatin; D017239:Paclitaxel