Pemetrexed (Alimta ®) also helps to control the form of more frequent lung cancer in elderly patients
-Pemetrexed receives positive opinion from CHMP as maintenance of continuation treatment
-new PARAMOUNT survey data show benefits in a difficult to treat population
Indianapolis, 2011-September the Committee for medicinal products for human use (CHMP) has issued its positive opinion for the use of pemetrexed (Alimta ®) as a continued maintenance treatment in patients with lung cancer do not Advanced microcÃtico of non squamous cell. Currently, there is no maintenance therapy of continuation in which used chemotherapy agent is the same one used previously in the front line.
This the CHMP positive opinion was based on the results of the PARAMOUNT Studio. PARAMOUNT is the second study that evaluates the use of pemetrexed as maintenance therapy in patients with this type of lung cancer non–small (NSCL) advanced not scaly, and is the first study that examines the use of the maintenance of continuation with pemetrexed used the combination of pemetrexed and cisplatin in the front line.
The results of this multicenter study and double-blind showed that the median of the progression free survival measured from randomization (after the first line treatment) was 3.9 months in the Group of pemetrexed, versus 2.6 months in the placebo group, with a reason of risk of the 0.64. Put another way, this study showed that pemetrexed improves in 36% of disease progression-free survival, compared with the placebo group. The rate of disease control (percentage of patients who get a response or stabilization), evaluated 6 weeks after randomization for the first time, was 71.8 percent (2.8% / 69.0%) in the Group of pemetrexed and 59.6 percent (0.6% / 59.0%) in the placebo group
Recently, a new subgroup analysis of data from the pivotal phase III PARAMOUNT study has shown that continuation with pemetrexed (Alimta ®) maintenance treatment also reduces the risk of disease progression in patients of 70 years or more with lung cancer non–small (NSCL) advanced of non squamous cell.
The new analysis results are presented during the session of Posters of cancer of lung metastatic (Abstract # 9072) at the Congress of cancer multidisciplinary European (formerly known as ECCO-ESMO) held in Stockholm (Sweden) in the 2011 edition.
At the PARAMOUNT Studio, a total of 939 patients with advanced non-squamous NSCLC were included in the study; 539 whose tumors have not progressed during the induction phase entered the phase of maintenance of the study. Of these, 92 patients were elderly.
The new sub-analysis presented in Stockholm compared the use of pemetrexed with placebo in patients with age > 70 years (n = 92). In this group of elderly patients, pemetrexed reduced the risk of progression of the disease by 65 per cent (reason for risk: 0.35; 95% CI: 0, 20-0, 63), based on a median progression-free survival of 6.4 months on the arm of pemetrexed versus 3.0 months in the placebo group. In the Group of patients under the age of 70, pemetrexed reduced the risk of progression of the disease by 31 per cent (ratio of risk, 0.69, 95%); IC: 0, 54-0, 90), with a progression free survival of 4.0 months for pemetrexed versus 2.8 months for placebo.
Lung cancer can be difficult to treat in patients over 70 years, they often have co-morbidities and can tolerate therapies against cancer worse ”, stated Dr. César Gridelli, one of the researchers of the PARAMOUNT Studio and doctor of the Hospital S. Giuseppe Moscati of AvellinoItaly. Indeed, some patients over 70 years of age only can offer them support treatments. These results show that the regime in keeping with pemetrexed can provide a benefit to certain patients of age advanced. ”
the study included patients with NSCLC advanced non squamous cells which were a combination of pemetrexed (500 mg/m2 on day 1 of each 21-day cycle) with cisplatin (75 mg/m2) in induction therapy. Patients whose disease had not progressed during induction with pemetrexed and cisplatin and had a functional State of 0-1 were distributed randomly to receive maintenance therapy with pemetrexed (500 mg/m2 on day 1 of each 21-day cycle) more optimal treatment support, or placebo more optimal support treatment until disease progression.
In general, adverse events more serious (grade 3/4) related to the medication were more frequent in elderly patients included in maintenance therapy of continuation than in patients under the age of 70 (21% vs 7%). These adverse effects were mainly haematological (anaemia and neutropenia). The study elderly patients tended to have a poorer than younger patients functional State (0 EF: 20% vs 34%, respectively;) EF 1: 79% vs 66%, respectively), and the older age group received more treatment cycles with pemetrexed (5.5 to 4.8 in the younger group).
The overall results of PARAMOUNT, which achieved its primary objective of progression-free survival, were presented in June 2011 at the annual meeting of the American Society of Clinical Oncology (ASCO).
Lung cancer No MicrocÃtico
Globally, lung cancer is the most common form of cancer and the most lethal, causing 1.3 million deaths a year 2 from 85-90 percent of all lung cancers are not microcÃticos3. The liver, bones and the brain are potential targets if these cancer cells enter the bloodstream.
The NSCL encompasses a group of histologÃas or types of tumour are distinguished by their cellular structure. Non-squamous histology includes adenocarcinoma, and large cell carcinoma, adding more than half of all diagnoses of CPNM3, as well as the qualified histologÃas as other ”.
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