Background Ovarian cancer is the next most lethal gynaecological malignancy after cervical cancer, with about 125,000 deaths each year worldwide. Treatment options are still limited and even though 80% of women respond to first-line treatment many undergo recurrence and death. In Italy trabectedin in combination with pegylated liposomal doxorubicin has been approved for the treatment of patients with relapsed platinum-sensitive ovarian cancer since March 2011, but NHS refunds are limited to only partially platinum-sensitive patients, who have relapsed between 6 and 12 months after treatment with platinum-based treatment. This ruling stems from the results obtained from the open-label randomised phase III OVA-301 clinical trial for this group of patients, which included only patients treated in second line.
Purpose To analyse the responses in terms of progression-free survival (PFS) of 2 groups of patients who relapsed after treatment with platinum-based treatment: partially platinum-sensitive patients, who relapse between 6 and 12 months and platinum-sensitive patients, who relapse after 12 months.
Materials and methods Clinical cards and protocol sequences with trabectedin were analysed contained in the database of the compounding centre of 2 cancer centres in Sicily. Patients were enrolled from 2010 to 2012, including multi-treated patients. Progression-free survival after the first platinum-based treatment and PFI (platinum free interval) were calculated and the relative PFS was calculated. Records of platinum-resistant patients who relapsed between 0 and 6 months after treatment were also analysed with permission of the Italian law no. 648/96.
Results The patients who received trabectedin have mostly been heavily pre-treated (III and IV line), only 10% are receiving second-line treatment. The median PFS with PFI≥ 6 months is 6.96, and the platinum-resistant group (27%) shows a median PFS of 2.5 months.
The partially platinum-sensitive group had a PFS of 6.96 months, and the platinum- sensitive group 5.6 months.
Conclusions To confirm the relationship found in the trials, the PFI greatly influences the response even in multi-treated patients: the response in terms of PFS is greater in the partially platinum-sensitive. The limitation of the treatment only to the setting of partially platinum-sensitive patients imposed by the Italian regulatory agency allows for greater access to care for patients who can benefit most at the expense of those for which, however, there is no therapeutic alternative with comparable effectiveness.
At the moment there are no studies on the use of trabectedin in association with III or IV line of treatment for a comparison of the responses in clinical practice.
No conflict of interest.
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