Trattamento medico del carcinoma ovarico in pazienti pretrattate con platino- derivati. Studio clinico-biologico

 

Nel marzo 1993 é stato avviato uno studio sul tumore ovarico.

Lo studio (Protocollo 93/1) aveva l’obiettivo di valutare l’attività e la tollerabilità della vinorelbina in pazienti con carcinoma ovarico avanzato, con particolare attenzione nel sottogruppo di pazienti platino-resistenti.

Sono state arruolate 33 pazienti.

Lo studio ha dimostrato che la vinorelbina è in grado di indurre una risposta obiettiva del 15%, mentre si è osservata una risposta obiettiva del 21% nelle pazienti ampiamente pretrattate e platino-resistenti. Si è osservato un peggioramento della preesistente neuropatia periferica.

Centri partecipanti :                     Istituto Nazionale Tumori, MILANO

Ospedale S. Gennaro, NAPOLI

Ospedale Civile, BUSTO ARSIZIO (VA)

Ospedale S. Lorenzo, FIRENZE

Policlinico di PALERMO

Ospedale Cà Foncello, TREVISO

Riferimento Bibliografico:

  • Phase II study of vinorelbine in patients with pretreated advanced ovarian cancer: activity in platinum-resistant disease.
    (Bajetta E1, Di Leo A, Biganzoli L, Mariani L, Cappuzzo F, Di Bartolomeo M, Zilembo N, Artale S, Magnani E, Celio L, Buzzoni R, Carnaghi C)
    J Clin Oncol. 1996 Sep;14(9):2546-51.

    Abstract
    PURPOSE:
    The aim of the study was to evaluate the activity of vinorelbine (VNLB) in a population of advanced ovarian cancer patients, with particular attention to defining its role in platinum-resistant disease.PATIENTS AND METHODS:
    Thirty-three patients were recruited and treated with VNLB 25 mg/m2 intravenously (IV) weekly. the median age was 53 years, performance status 0 to 2, and number of previous chemotherapy regimens two (range, one to five). Twenty-four patients were platinum-resistant; the remaining nine either were platinum-sensitive (four cases) or had undetermined sensitivity (five cases).

    RESULTS:
    The mean delivered dose-intensity of VNLB was 67% of the planned level, because 60% of the cycles were delayed due to neutropenia or anemia. Four partial responses (PRs) and one complete response (CR) were observed, for an overall response rate of 15% (95% exact confidence interval, 5.1% to 31.9%). All the responses occurred in the subgroup of 24 platinum-resistant cases, in whom the response rate was 21% (95% exact confidence interval, 7.1% to 42.1%). Seven patients became stabilized on VNLB, and 27% of the cases showed a reduction in serum cancer antigen 125 (CA 125) levels. G3/G4 side effects consisted of neutropenia, anemia, and worsening of preexisting peripheral neuropathy. No treatment-related deaths occurred.

    CONCLUSION:
    VNLB led to a 21% response rate in the population of heavily pretreated and platinum-resistant ovarian cancer patients. Further studies of VNLB alone or in combination with taxanes are warranted in patients with less pretreatment.

    PMID: 8823334   [PubMed – indexed for MEDLINE]

    Download articolo: J. Clin. Oncol. 1996