Alimta® (Pemetrexed)

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Pemetrexed: Fatigue in Patients Treated for NSCLC

Fatigue is a very common AE associated with the use of pemetrexed as a single agent or in combination therapy.


Clinical Trial Experience

  • In the treatment of locally advanced or metastatic NSCLC, the incidence of fatigue with pemetrexed monotherapy (second line) or in combination with cisplatin (first line) was comparable with the standard chemotherapy used in the control arms of the two phase 3 trials (docetaxel in second line and gemcitabine plus cisplatin in first line).1,2
  • Pemetrexed administered as maintenance treatment following first-line treatment with a platinum doublet was associated with a statistically higher incidence of grade 3/4 fatigue when compared to placebo (5% vs 0.5%; p=.001).3
  • Continuation maintenance with pemetrexed was associated with a significantly higher incidence of grade 3/4 fatigue when compared to placebo (5.3% vs 1.1%; p<.05 for grade 3 only). The incidence of grade 1/2 fatigue ranged from 6.7% to 14.5% for pemetrexed and 0% to 12.5% for placebo in cycles 1 through 11.4
  • In the first-line treatment of metastatic NSCLC with pembrolizumab or placebo plus pemetrexed/platinum, fatigue was commonly observed and did not differ significantly for those patients in the pembrolizumab-combination arm vs those in the placebo-combination arm (40.7% vs 38.1%, respectively).5

Management of Fatigue

  • Lilly does not recommend a specific approach to treating cancer- and/or treatment-associated fatigue. Decision on patient treatment options should be individually-based in consultation with their physician.
  • Patients with fatigue may benefit from pharmacologic and nonpharmacologic interventions. Natural and alternative remedies, as well as complementary treatments (eg, physical exercise), should also be considered.6


1Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008;26(21):3543-3551.

2Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004;22(9):1589-1597.

3Ciuleanu T, Brodowicz T, Zielinski C, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009;374(9699):1432-1440.

4Pujol JL, Paz-Ares L, de Marinis F, et al. Long-term and low-grade safety results of a phase III study (PARAMOUNT): maintenance pemetrexed plus best supportive care versus placebo plus best supportive care immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2014;15(6):418-425.

5Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer. N Engl J Med. 2018;378(22):2078-2092.

6Carnio S, Di Stefano RF, Novello S. Fatigue in lung cancer patients: symptom burden and management of challenges. Lung Cancer (Auckl). 2016;7:73-82.


AE = adverse event

Lilly = Eli Lilly and Company

NSCLC = non-small cell lung cancer

Fecha de la última revisión: 2019 M09 09

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