The combination of carboplatin and pegylated liposomal doxorubicin hydrochloride therapy (PLDH) (Caelyx) shows significant benefits in treating patients who have relapsed within 6-12 months of a first-line platinum-based therapy (partially platinum-sensitive relapsed ovarian cancer) compared to the current standard therapy combination, carboplatin and paclitaxel.
Results from this subset population of the CALYPSO study were presented at the joint European Cancer Organisation (ECCO) 15 and 34th European Society for Medical Oncology (ESMO) congress and provide valuable insights to help shape future treatment practice.
Median progression-free survival in partially platinum-sensitive patients was extended from 8.8 months in the carboplatin and paclitaxel control group to 9.4 months in the carboplatin and PLDH study group. In addition, the study group had lower incidences of peripheral neuropathy (4%), hypersensitivity reactions (6%) and alopecia (9%) than those in the control group (29%, 22% and 86% respectively).
Dr Nicholas Reed, Consultant in Oncology, Beatson Oncology Centre Gartnavel General Hospital, Glasgow said “Not only has the carboplatin and PLDH combination demonstrated superior efficacy, but the findings in terms of improved tolerability have significant bearing given peripheral neuropathy and hypersensitivity reactions can be dose-limiting and often lead to treatment discontinuation. We now hope that the combination of carboplatin and PLDH becomes the preferred treatment option for patients in this setting, giving them the best possible chance to control their disease.”
CALYPSO is the largest international, multi-centre phase III study in recurrent ovarian cancer (N=974) designed to confirm the efficacy and safety profile of treatment with the combination of carboplatin and PLDH compared to the current standard therapy combination, carboplatin and paclitaxel, in patients with platinum-sensitive relapsed ovarian cancer.
Earlier analyses of the whole CALYPSO study population have shown that the combination of carboplatin and pegylated liposomal doxorubicin was non-inferior and was also significantly superior in terms of progression-free survival compared to standard treatment and with an improved tolerability profile leading to less treatment discontinuations.
Dr Reed continued “There is uncertainty regarding the best course of treatment for patients with partially platinum-sensitive relapsed ovarian cancer, who relapse within 6-12 months. Echoing earlier analyses from the CALYPSO study, these results show the real benefits that the carboplatin and PLDH combination can offer to these patients.”
Pegylated liposomal doxorubicin hydrochloride is a long-circulating, widely used cytotoxic agent. PLDH is indicated for the treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen; as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk; and in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
The licensed dose for CAELYX in advanced ovarian cancer is single administration of 50mg/m2 once every 4 weeks. Patients in the CALYPSO study were dosed with a combination of carboplatin (AUC5 every 28 days) and pegylated liposomal doxorubicin (30mg/m2 every 28 days). This treatment combination together with the lower dose of pegylated liposomal doxorubicin is currently unlicensed in the UK.