Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma
Monday, April 11th, 2005.
Annals of Oncology 2005 16(6):923-927. [Link]
C. Manegold1,*, J. Symanowski2, U. Gatzemeier3, M. Reck3, J. von Pawel4, C. Kortsik5, K. Nackaerts6, P. Lianes7 and N. J. Vogelzang8
1 Heidelberg University Medical Center, Mannheim, Germany; 2 Eli Lilly and Company, Indianapolis, IN, USA; 3 Hospital Grosshansdorf, Grosshansdorf, Germany; 4 Asklepios-Fachklinik, Munchen-Gauting, Germany; 5 St Hildegardis-Krankenhaus, Mainz, Germany; 6 University Hospital Gasthuisberg, Leuven, Belgium; 7 Hospital de Mataro, Barcelona, Spain; 8 Nevada Cancer Institute, Las Vegas, NV, USA
Abstract
Background: A phase III trial in patients with malignant pleural mesothelioma demonstrated a survival advantage for pemetrexed plus cisplatin compared with single-agent cisplatin. Because post-study chemotherapy (PSC) may have influenced the outcome of the trial, we examined its use and association with survival.
Patients and methods: Eighty-four patients from the pemetrexed plus cisplatin arm and 105 patients from the single-agent cisplatin arm received PSC. Kaplan–Meier survival estimates were compared by treatment groups, and by PSC and non-PSC subgroups.
Results: The percentage of patients receiving PSC was imbalanced between the treatment arms. Fewer pemetrexed plus cisplatin treated patients received PSC (37.2% versus 47.3%). A multiple regression analysis performed in this trial showed that PSC had a statistically significant correlation with prolonged survival (P <0.01), adjusting for baseline prognostic factors and treatment intervention. The adjusted hazard ratio for PSC over non-PSC subgroups was 0.56 (confidence interval 0.44–0.72).
Conclusions: PSC in malignant pleural mesothelioma was significantly associated with prolonged survival. It is not known whether the reduced risk of death was associated with PSC or whether patients who had prolonged survival tended to receive more PSC. The pemetrexed plus cisplatin treatment group had a statistically significant survival advantage even though fewer patients from that arm of the trial received PSC. The potentially beneficial role of PSC should be assessed in prospective trials.
Glossary
- oncology
- (on-call-o-jee) the branch of medicine concerned with the diagnosis and treatment of cancer.
- chemotherapy
- (key-mo-THER-uh-pee) treatment with drugs to destroy cancer cells. Chemotherapy is often used with surgery or radiation to treat cancer when the cancer has spread, when it has come back (recurred), or when there is a strong chance that it could recur.
- cancer
- malignancy; a group of diseases typified by abnormal, generally out-of-control, cell growth.
- mesothelioma
- a tumor derived from mesothelial tissue, such as the peritoneum (lining the abdomen) or pleura (lining the lungs). More on mesothelioma.
- pemetrexed
- chemotheraputic agent that interferes with a crucial process that allows cancer cells to reproduce and spread. Specifically, pemetrexed stops the production of three enzymes that are required to feed the cancer cell. Often used in combination with cisplatin. Marketed under the name ALIMTA. See: Alimta.
