ASCO Annual Meeting
CHICAGO — Continuation maintenance therapy with
pemetrexed improved PFS in patients with advanced nonsquamous non-small cell
lung cancer who also received the chemotherapy drug during their initial
treatment regimen, according to study results presented here.
The PARAMOUNT trial is the first to demonstrate the
concept of continuation maintenance therapy in patients with nonsquamous NSCLC.
“Pemetrexed has shown to be an effective
maintenance treatment in patients who have not received induction
treatments,” said lead author Luis, Paz-Ares, MD, PhD, chair of
oncology at Seville University Hospital in Seville, Spain. “In this trial,
we explored maintenance treatment with pemexetred in patients already treated
with pemexetred in the induction phase.”
The double blind, placebo-controlled phase 3 trial
included 939 patients who received standard first-line induction therapy of
four cycles of 500 mg/m2 pemetrexed (Almita, Lilly) and 75
mg/m2 cisplatin on the first day of a 21-day cycle. Median patient
age was 61 years, and all patients received vitamin B12, folic acid
and dexamethasone. Of 539 patients who did not progress on the regimen, 359
received maintenance pemetrexed (500 mg/m2 on day 1 of a 21-day
cycle) and 180 received placebo and best supportive care. The primary endpoint
Continuation maintenance therapy resulted in a
significant 38% reduction in the risk of disease progression (HR=0.62;
“The hazard ratio of .62 means that patients
treated with pemetrexed had a decrease in the risk of progression of 38% in the
whole period of the study. The magnitude of the benefit is clinically
significant and may support its use in this clinical context.”
Median PFS was 4.1 months in the pemetrexed group and
2.8 months in the placebo group. The disease control rate was 71.8% in the
pemetrexed group compared with 59.6% for those receiving placebo.
The most severe grade 3/4 adverse events in the
pemetrexed group were fatigue (4.2%), anemia (4.5%) and neutropenia (3.6%).
– by Carey Cowles
For more information:
- Paz-Ares LG. #CRA7510. Presented at: 2011 ASCO Annual
Meeting; Chicago; June 3-7, 2011.
Disclosure: Dr. Paz-Ares has served in a consultant or advisory
role for Lilly.
This trial gives the medical oncologist a very important piece of
information. A couple of years ago, it was shown that giving pemetrexed with
cisplatin as initial therapy for stage IV NSCLC led to a survival improvement
over a comparator, gemcitabine, and that was the basis for its use a standard
therapy. Approximately 2 years ago another clinical trial was done, where
pemetrexed was given not as initial therapy, but as second therapy. There it
showed that patients improved their time free of cancer.
One missing piece of information is what do you do about those patients
who started pemetrexed, who are doing well on pemetrexed — should you
continue it? Would you get the same magnitude of benefit if you switched to
something else? Or should you switch to something else? This trial answer that.
It’s very important as an example of how you can achieve an incremental
benefit in our patients by the optimal use of drugs that are already available.
We can improve the lives of these patients in their time free of cancer by
extending the time that pemetrexed is given, while we continue to look for
- Mark G. Kris, MD,
Cancer Center, New York, NY
Disclosure: Dr. Kris has served in a consultant or advisory role
with GlaxoSmithKline, Merck, and Sanofi-Aventis.