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Effectiveness and safety of pemetrexed for non-small cell lung cancer… Farm Hosp. 2016;40(6):477-485 - 481 Table 2. Effectiveness results N (%) Events Median Overall Survival, m (IC95%) Lower limit Upper limit P value Logrank Total 172 95 9 4.08 13.92 Gender Male 133 (77.33) 78 9 7.32 10.68 0.309 Female 39 (22.67) 17 16.15* 12.26 20.03 Age
482 - Farm Hosp. 2016;40(6):477-485 María Antonia Pérez-Moreno et al. Table 3. Response to the treatment and ending reasons N (%) Response to the treatment with pemetrexed DP (disease progression) 57 (33.14) SD (stable disease) 40 (23.26) PR (partial response) 39 (22.67) CR (complete response) 1 (0.58) ND (not defined) or no response (exitus) 35 (20.35) Reason for the end of treatment with pemetrexed End of scheduled treatment 27 (15.70) Voluntary abandonment 0 (0) severe toxicity 5 (2.91) Disease progression 66 (38.37) Exitus 3 (1.74) Loss of follow up 17 (9.88) Deterioration of general condition 23 (13.37) Others 28 (16.28) Continuous treatment at the end of the study 3 (1.74) No patients discontinued treatment for serious toxicity associated with it. The measures taken to the toxicity associated with pemetrexed were: end of the treatment (in 5 patients, due to asthenia, anemia, neutropenia and renal toxicity), doses reduction 20% (in 7 patients), delay of the next cycle of chemotherapy (for 4 patients), two patients required hospitalization (because of severe thrombocytopenia and rash) and for 10 patients other measures. Discussion This study (that is part of an ambitious research project supported by Spanish Government) has evaluated the effectiveness and safety of the treatment with pemetrexed in non-small-cell lung cancer when it´s used on real clinical practice, specifically in a homogeneous region with more than 8 million inhabitants and it is the first study to target full medical histories instead of databases. The majority of patients treated with pemetrexed were male, which is consistent with the fact that LC continues to be more prevalent in this sex 1 . In addition, a high percentage of patients had been smokers at some point in their lives, proving that this habit represents a very important risk factor for the development of this disease 19 . There are published previous studies which assessed the use of pemetrexed in NSCLC, but with a population of less patients 20,21 . Also, unlike the previous ones, the present study evaluates effectiveness of pemetrexed in all lines prescribed for treatment pemetrexed. As for the effectiveness results in terms of response to treatment, disease progression was the most common response. However, the rate of treatment response (complete response or partial response) was quite high, significantly higher than previous studies published as Villanueva et al. 21 or Picaza et al. 20 , although the percentage of patients with stage IV was also very high. Further, compared with the pivotal clinical trials for the approval of three indications of pemetrexed in the present study we found a greater response to treatment with pemetrexed. In combination with platinum for first-line induction treatment, Scagliotti et al. 22 detected a response rate of 30.6%, Hanna et al. 23 in second line treatment found 9.1%, and Paz-Ares et al. 8 described 3% of response for first-line maintenance treatment. Overall survival data were similar or higher relative to the published literature, except for first-line treatment combined with platinum, in which survival rates were lower than the study Scagliotti et al. 22 Similarly to published clinical trials differences in survival was observed according tumour histology, being significantly higher in non-squamous histology (adenocarcinoma and large cell), which confirms the fact that there are subpopulations of patients who may derive more benefit from treatment with pemetrexed. This finding differs from those obtained from previous retrospective studies such as Villanueva et al. 21 , in which no differences were found in survival according to histology, but in this study the majority was squamous histology. Pemetrexed has been shown to be significantly safer than other therapies for lung cancer treatment in different lines. In our study, in 27 patients treated with pemetrexed grade 3-4 adverse reactions were detected, which seems a low percentage of the total patients (15,70%), with low rates of haematological and gastrointestinal toxicity, even lower than published data, especially in case of neutropenia. Although most frequent were when pemetrexed was associated with platinum, no statistically significant differences were found. Nor does the development of adverse reactions associated with age. This perhaps could be due to the low frequency of detected events. This study is not without limitations. It refers to the Andalusian population, so it is a local study. Results could not be representative of the rest of areas. It is also a retrospective study without control group, so there are a lot of censored data because some of the clinical histories did not have all the required information of the data collection notebook, so the results shown may be somewhat bias. However, it provides valuable information about the effectiveness and safety of the drug in healthcare daily practice. Conclusions Pemetrexed resulted quite effective when it was used on real clinical practice, with higher survival in non-squamous histology (adenocarcinoma and large cell) and patients with the best score of ECOG scale. The toxicity profile was well tolerated.
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