Association Between Proton Pump Inhibitors and Hematologic Toxicity of Pemetrexed (IPPEM)

pemetrexed is a multi-folate inhibitor approved in the treatment of non-small cell lung cancer (NSCLC) and pleural mesothelioma. Its toxicity profile is mainly hematologic (anemia, neutropenia and thrombopenia) and can be limiting when > grade 2 according to NCI-CTCAE criteria. First clinical trials highlighted hematologic toxicity, especially anemia, which was reduced by decreasing pemetrexed dosage from 600 to 500 mg/m² Q3W and by adding systematic vitamin supplementation (B9/B12). Despite this, incidence of hematological toxicity remains frequent with anemia occurring in more than 20% of patients treated by pemetrexed in combination. The investigators aim to investigate the potential association between PPIs and pemetrexed combination and the incidence of hematological toxicity in a multicenter and prospective study.

Primary Outcome Measures

  • Association between PPI consumption and pemetrexed-related hematological toxicity (grade ≥ 3) [ Time Frame: Day 0 ]
    The hematological toxicity will be found on biologic data the day or the day before chemotherapy. Classification will based on NCI-CTCAE criteria

Eligibility Criteria

Inclusion Criteria
Patients who receive a pemetrexed-based chemotherapy regimen for the treatment of non-small cell lung cancer (NSCLC) or mesothelioma,

Patients who consent to participate,

Patients for whom it is possible to characterize the consumption of proton pump inhibitors with name of the PPI
Exclusion Criteria
Patients who receive pemetrexed out of intravenous of for another condition than NSCLC or mesothelioma

Patients under 18 or who refused the participation in the data collection,

Patient previously treated by a pemetrexed-based chemotherapy,

Patients who first receive a pemetrexed-based regimen with an initial dose adjustment (<500 mg/m²) and dosage.

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: June 20th, 2018.

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Last update: February 19, 2019. 04:08:16 pm.