MedicalResearch: What take-home message would you like the general public to understand about this new analysis from the Cleopatra study?
Potential Key Message Options:
- Updated results from the CLEOPATRA study showed that people treated with the combination of pertuzumab, trastuzumb and chemotherapy lived 15.7 months longer than those who received trastuzumab and chemotherapy alone (median survival of 56.5 months versus 40.8 months).
- The survival improvement of nearly 16 months observed in CLEOPATRA is unprecedented among studies of metastatic breast cancer. This is the kind of survival improvement that those of us who treat breast cancer strive for, and this data will be incredibly meaningful to patients and their families.
- Furthermore, the median survival of nearly five years observed in CLEOPATRA patients treated with the pertuzumab regimen is the longest ever observed in a clinical study of people with HER2-positive metastatic breast cancer, once one of the most aggressive forms of breast cancer.
- Patients who responded with shrinkage of their tumor had a response that was 8 months longer with the pertuzumab regimen compared to the trastuzumab and chemotherapy regimen.
MedicalResearch: In simple terms could you explain why the Cleopatra study was undertaken?
- CLEOPATRA was the pivotal, Phase III study where we evaluated the safety and efficacy of the pertuzumab regimen in people with previously untreated HER2-positive metastatic breast cancer. HER2-positive metastatic breast cancer has historically been one of the most aggressive forms of the disease.
- In CLEOPATRA we evaluated whether dual HER2 blockade by combining the antibody pertuzumab with trastuzumab and chemotherapy, would help people live longer (overall survival, OS) or live longer without their disease worsening (progression-free survival, PFS).
MedicalResearch: For a non-specialist reader, how would you describe the significance of the new data presented at ESMO 2014? (We need to be clear about what is new compared to previously published or reported data.)
- We previously reported that the pertuzumab regimen significantly extended the time before patients’ disease got worse (PFS) and improved survival.
- We are now reporting results of the final analysis of survival in CLEOPATRA after long term follow-up of patients in the study (longest follow up was approximately 6 years).
- What’s new about these results is that we can now see that the magnitude of survival improvement in CLEOPATRA is nearly 16 months.
MedicalResearch: Are there any important caveats or limitations to the new analysis that I should mention in a press release?
- The survival benefit observed with the pertuzumab regimen in CLEOPATRA was consistent across patient subgroups.
- The previously observed benefit in progression free survival was maintained after long ter follow up.
- The long-term safety profile of the pertuzumab regimen was unchanged from previous analyses and the long-term cardiac safety profile was maintained
MedicalResearch: Are there any subtleties in the data that you particularly want to emphasise in the press release? (For example, should we elaborate on the patients who crossed over into the pertuzumab arm after the previous report of OS benefit?)
- Overall survival was analyzed using all randomized patients, with no adjustments for cross over.
- Patients who crossed over from the placebo arm to the pertuzumab arm were analyzed as part of the placebo arm.
- As such, this is a very conservative final analysis of survival.
MedicalResearch: If the data in your presentation will differ from the data in the abstract, please let me know.
- No changes from the abstract.
Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer
MedicalResearch.com Interview with: Sandra M Swain, MD, FACP, FASCO (2015). Improved Survival with Combination Therapy for HER2- Positive Metastatic Breast Cancer MedicalResearch.com