Researchers Propose Standard of Care for Patients with Partially Platinum-Sensitive Ovarian Cancer

September 24, 2009
Christin Melton

Many clinicians continue to puzzle over the best way to treat patients with ovarian cancer who relapse 6 to 12 months after treatment with a platinum-based chemotherapy regimen. These women are typically categorized as “partially” platinum-sensitive.

Many clinicians continue to puzzle over the best way to treat patients with ovarian cancer who relapse 6 to 12 months after treatment with a platinum-based chemotherapy regimen. These women are typically categorized as “partially” platinum-sensitive. Some researchers in the United States were hopeful that trabectedin (Yondelis), which has demonstrated activity in this patient group, would help fill this gap in therapy options, but the FDA declined to approve the drug this month, requesting additional information.

In a Thursday session at ECCO 15- ESMO 34 Joint Congress, Dr Paul Vasey, consultant medical oncologist and associate professor of medicine, University of Queensland, Australia, discussed results from the CALYPSO trial. This phase III international study is the largest ever to focus on platinum-sensitive patients whose ovarian cancer has relapsed more than 6 months after initial treatment.

CALYPSO looked at the effectiveness and safety of carboplatin plus pegylated liposome doxorubicin (PLD) compared with standard therapy consisting of carboplatin and paclitaxel (Taxol). Earlier results showed the regimen was active and well tolerated by platinum-sensitive patients. Today’s analyses considered the subset of patients with partial platinum sensitivity. “Not only was the combination of carboplatin and PLD shown to be no inferior to carboplatin-paclitaxel in these patients, it was also shown to be significantly superior,” Dr Vasey said.

Median PFS associated with the PLD regimen was 1.4 months longer than median PFS in the paclitaxel group (9.4 months vs. 8.8 months, respectively; P = .004). The PLD regimen also had less toxicity, with women receiving this combination demonstrating significantly lower rates of peripheral neuropathy, hypersensitivity reactions, and alopecia compared with the paclitaxel-arm.

Adverse Effect, %

PLD + Carboplatin

Paclitaxel + Carboplatin

Peripheral neuropathy

4

29

Hypersensitivity reactions

6

22

Alopecia

9

86

“The lower incidences of peripheral neuropathy and hypersensitive reactions observed in the carboplatin and PLD study group are important because these side effects can be dose-limiting and often lead to treatment discontinuation,” according to Professor Eric Pujade-Lauraine, MD, PhD, professor, Universite de Paris Descartes in France. Prof Pujade-Lauraine heads Group d’Investigateurs Nationaux pour l’etude des Cancers Ovariens, which took part in the multinational study. He recommended the combination of PLD and carboplatin as the “preferred therapeutic option for patients with partially platinum-sensitive relapsed ovarian cancer.”

ECCO/ESMO Abstract 18LBA