Related Experiment Video
Updated: Jun 21, 2025

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
Published on: November 22, 2021
Osimertinib in a patient with end-stage kidney disease not on hemodialysis
Marta Pirovano1, Andrea Luciani2, Giulia Vanessa Re Sartò3
1Onconephrology Outpatient Clinic, Division of Nephrology and Dialysis, UOC Nephrology and Dialysis, ASST Fatebenefratelli Sacco, Fatebenefratelli Hospital, Piazzale Principessa Clotilde, 3, 20121, Milan, Italy. marta.pirovano96@gmail.com.
Abstract:
Osimertinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) effective in non- small cell lung cancer (NSCLC) with EGFR mutations. Since the drug is primally eliminated by the fecal route no dose adjustment is needed in patient with chronic-kidney disease (CKD); despite this there is limited data about its safety in cancer patients with end-stage renal disease (ESRD). Herein, we reported a case report of a 77-year-old woman, diagnosed in 2018 with lung adenocarcinoma EGFR mutated with lymph nodal and cerebral metastasis, who started Osimertinib 80 mg/day. She under- went 41 cycles of therapy with no Osimertinib interruptions, no severe toxicities and obtaining complete radiological response. We conclude that Osimertinib has an acceptable safety profile also in cancer patients with ESRD not undergoing hemodialysis (HD).
Insights
Osimertinib is an effective treatment for EGFR-mutated non-small cell lung cancer. This case study shows it is safe for patients with end-stage renal disease not on dialysis, with no dose adjustments needed.
Area of Science:
- Oncology
- Pharmacology
- Nephrology
Background:
- Osimertinib is an effective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC) with EGFR mutations.
- Primary elimination of Osimertinib is via the fecal route, suggesting no dose adjustment is needed for patients with chronic kidney disease (CKD).
- Limited data exists on Osimertinib's safety in cancer patients with end-stage renal disease (ESRD).
Purpose of the Study:
- To report the safety and efficacy of Osimertinib in a patient with end-stage renal disease (ESRD) and EGFR-mutated lung adenocarcinoma.
- To assess the tolerability of Osimertinib in a patient with ESRD not undergoing hemodialysis (HD).
Main Methods:
- A case report of a 77-year-old woman with EGFR-mutated lung adenocarcinoma and metastatic disease.
- The patient received Osimertinib 80 mg/day for 41 cycles.
- Treatment outcomes, including toxicity and radiological response, were monitored.
Main Results:
- The patient completed 41 cycles of Osimertinib without interruptions.
- No severe toxicities were observed during treatment.
- Complete radiological response was achieved.
Conclusions:
- Osimertinib demonstrates an acceptable safety profile in cancer patients with end-stage renal disease (ESRD) who are not undergoing hemodialysis (HD).
- The fecal elimination route of Osimertinib supports its use without dose modification in ESRD patients.
- Further studies are warranted to confirm these findings in a larger cohort.
More Related Videos
Related Concept Videos
Renal Failure: Dose Adjustments
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
Treatment for Pulmonary Arterial Hypertension: Receptor Tyrosine Kinase Inhibitors and Calcium Channel Blockers
TKIs, such as imatinib (Gleevec), are particularly effective in tackling the growth and mitogenic factors that become upregulated in PAH patients. These factors contribute to the...
Treatment for Pulmonary Arterial Hypertension: Endothelin Receptor Antagonists
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme...
Dialysis
Acute kidney injury develops suddenly and can be caused by pre-renal causes (e.g., hypovolemia, shock), intrinsic renal causes (e.g., acute tubular necrosis), or post-renal causes (e.g., urinary obstruction). In contrast, chronic renal failure progresses gradually over time and is often...
Targeted Cancer Therapies
There are several types of targeted therapies against...
Heart Failure Drugs: Inhibitors of Renin-Angiotensin System

