PARAMOUNT: phase III study of pemetrexed continuation maintenance therapy in advanced non-squamous NSCLC.

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PARAMOUNT phase III study of pemetrexed
continuation maintenance therapy in advanced
non-squamous NSCLC.
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Increase the duration of disease control
Objectives of maintenance therapy1
Improve overall survival
Maintaining tolerability
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Tolerance to maintenance drug is known from
induction treatment
Maximise the potential of the drug used in
1st-line
Potential advantages of continuation
maintenance approach24
Saves a drug for subsequent treatment lines
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PARAMOUNT pemetrexed/cisplatin followed by
pemetrexed for advanced non-squamous NSCLC1
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PARAMOUNT study objectives1
Overall survival (OS)
Objective tumour response rate (RR) (RECIST 1.0)
Patient-reported outcomes (EQ-5D)
Resource utilisation
Adverse events (AEs)
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PARAMOUNT patient characteristics (randomised
patients)1
Caucasian 339 (94) 171 (95)
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PARAMOUNT disease characteristics (randomised
patients)1
Disease stage IV 328 (91)
161 (89)
Adenocarcinoma/bronchoalveolar
310 (86) 160 (89)
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PARAMOUNT drug administration (randomised
patients)1
4.9 4.2
23 14
95 n.a.
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Pemetrexed continuation maintenance demonstrated
significant PFS benefit for patients1
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Pemetrexed continuation maintenance demonstrated
significant PFS benefit for patients1
HR 0.64
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Progression-free survival HRs in subgroups1
PFS results were internally consistent benefit
was seen across all subgroups
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PARAMOUNT median PFS according to responseto
induction treatment1
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PARAMOUNT post-discontinuation therapy
(PDT-eligible patients)1
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Maintenance therapy with pemetrexed generally
well tolerated1
Overall, toxicity was low in both arms
placebo n180
pemetrexed n359
Patients with 1 grade 3/4/5 laboratory toxicity
9 n33
lt1 n1
9 n32
4 n8
Patients with 1 grade 3/4/5 non-laboratory
toxicity
Difference between treatment groups was
significant (Fishers exact test p 0.05).
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PARAMOUNT CTCAEs grade 3/4/5 drug-related
toxicities (randomised patients)1
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PARAMOUNT health-related quality of life
assessment (EQ-5D)1

• Compliance at all time points during maintenance
  phase was gt80

• No statistical differences in EQ-5D index score
  or visual analog scale were observed between
  treatment arms

• EQ-5D results suggest that patients can tolerate
  long-term maintenance treatment with pemetrexed
  while maintaining their QoL

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PARAMOUNT conclusions1,10
PARAMOUNT demonstrates a positive risk/benefit
ratio for the administration of pemetrexed
continuation maintenance1,10

• Pemetrexed continuation maintenance therapy
  offers significantly
• improved PFS

• Pemetrexed continuation maintenance therapy is
  well tolerated

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Pemetrexed continuation maintenance
therapyapproach to maximise outcomes for
patients1,2
Acceptable toxicity ?
Conveniently administered ?
Keeps other treatments available ?
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Acknowledgements
We thank all of the patients and their caregivers
for participating in this trial.
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References

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