Rhabdomyolysis in a patient with advanced lung cancer treated with osimertinib: a case report
Case Report

Rhabdomyolysis in a patient with advanced lung cancer treated with osimertinib: a case report

You Li1,3#, Yu Liu1,2#, Zichen Zhao1#, Yan Zhang1,2

1Lung Cancer Center, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China; 2Department of Thoracic Oncology, Cancer Center, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China; 3Department of Respiratory, Dazhou Southern Hospital, Dazhou, China

Contributions: (I) Conception and design: Y Liu, Y Li; (II) Administrative support: Z Zhao; (III) Provision of study materials or patients: Y Zhang; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: All authors; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

#These authors contributed equally to this work.

Correspondence to: Yan Zhang. Lung Cancer Center, West China Hospital, Chengdu, China. Email: zhang.yan@scu.edu.cn.

Background: As a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), osimertinib is the standard treatment for patients with EGFR mutations. Diarrhea and rash are the most common side effects, and some rare adverse reactions have started appearing owing to their increased clinical application. Osimertinib-associated myositis was reported to be more common compared with previous studies; however, osimertinib-associated rhabdomyolysis (RM) has not yet been reported. This is the first report of osimertinib-associated RM during the treatment of a lung adenocarcinoma patient with EGFR exon 19 deletion and T790M mutation. Compared to myositis, RM could lead to much more serious consequences, such as acute renal failure (ARF), disseminated intravascular coagulation (DIC) and electrolyte disturbances. Our case exemplifies the symptoms, diagnosis and treatment of osimertinib-associated RM, meanwhile, the potential mechanisms and related therapeutic choices have been fully discussed.

Case Description: Herein, we present a 70-year-old non-smoking woman diagnosed with metastatic lung adenocarcinoma harboring an EGFR exon 19 deletion, who had received afatinib plus bevacizumab as the first-line therapy and almonertinib plus bevacizumab as the second-line therapy. Then the patient underwent osimertinib and bevacizumab as the third-line therapy. After 5-month treatment, the patient developed myalgia, muscular weakness, and tea-colored urine. The muscle strength grade of both the upper and lower limbs was III, and no other abnormalities were found. Serum creatine kinase (CK) and myoglobin (Mb) levels increased to 1,470 IU/L and 616.5 ng/mL. The patient also developed acute renal insufficiency, hyperuricemia, metabolic acidosis, and electrolyte disturbances. All symptoms were improved following the withdrawal of osimertinib. As a result, the patient was diagnosed with osimertinib-associated rhabdomyolysis.

Conclusions: This is the first report of osimertinib-associated RM during the treatment of a lung adenocarcinoma patient. Although osimertinib-associated RM is rare, it is worthy of clinical attention in clinical practice, especially in patients receiving osimertinib plus bevacizumab. Once developed myalgia, muscular weakness and tea-colored urine, laboratory tests including serum creatine kinase (CK) and myoglobin (Mb) levels must be done, also osimertinib should be timely withdrawn to identify the cause.

Keywords: Osimertinib; rhabdomyolysis; side effect; lung cancer; case report

Submitted Dec 26, 2022. Accepted for publication Mar 22, 2023. Published online Mar 30, 2023.

doi: 10.21037/tlcr-22-916

Highlight box

Key findings

• This is the first report of osimertinib-associated rhabdomyolysis (RM) during the treatment of a lung adenocarcinoma patient with EGFR exon 19 deletion and T790M mutation

What is known and what is new?

• Osimertinib-associated myositis was reported to be more common compared with previous studies.

• Regular testing of serum creatine kinase (CK) and myoglobin (Mb) levels and monitoring of relevant symptoms are highly recommended in clinical practice.

What is the implication, and what should change now?

• The manifestations associated with muscle injury should be considered with caution during osimertinib treatment, particularly in patients receiving osimertinib plus bevacizumab. The co-administration of bevacizumab may also increase the risk of rhabdomyolysis.

Introduction

At present, lung cancer is still the leading cause of cancer mortality, accounting for 18% of all cancer-related deaths (1). Activating mutations in epidermal growth factor receptor (EGFR) are observed in 15–50% of non-small cell lung cancer (NSCLC) patients (2). Osimertinib has been approved by the U.S. Food & Drug Administation (FDA) for the first-line treatment of patients with metastatic NSCLC and EGFR mutations and those with T790M-positive NSCLC who progressed on prior EGFR tyrosine kinase inhibitor (EGFR-TKI) treatment (3). Osimertinib was reported to have a better tolerability in patients with locally advanced and metastatic EGFR-positive NSCLC than the first and second generation EGFR-TKIs, the most common osimertinib-associated adverse events were rash, diarrhea, nausea, dry skin, paronychia and stomatitis (4-6). Previous clinical study has reported that the incidence of myositis associated with osimertinib is less than 1%, except for one retrospective study, which showed that symptomatic myositis or asymptomatic serum creatine kinase (CK) elevation occurred in over 10% (4/38) of patients treated with osimertinib (3).

Rhabdomyolysis (RM) involves acute destruction and dissolution of skeletal muscle, resulting in the release of large amounts of muscle cell components into the circulation. Apart from myalgia and weakness, its clinical manifestations, including dark-colored urine and systemic symptoms such as malaise, fever, abdominal pain, nausea, and vomiting, can also occur in RM. These may be accompanied by intravascular volume depletion, metabolic acidosis, and various electrolyte abnormalities, and patients with severe disease could also develop acute renal failure (ARF) and disseminated intravascular coagulation (DIC) (4,5).

To date, osimertinib-associated RM has not been reported. Herein, we report the case of a patient with an EGFR exon 19 deletion and T790M mutations who developed RM, a rare adverse event, after treatment with osimertinib. In this case, bevacizumab was co-administrated with osimertinib, which may increase the risk of osimertinib-associated RM. We present this case to exemplify the symptoms, diagnosis and treatment of osimertinib-associated RM, meanwhile, the related therapeutic choice of osimertinib plus oxycodone and bevacizumab have been fully discussed. We present the following article in accordance with the CARE reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-22-916/rc).

Case presentation

A 70-year-old Chinese woman presented with generalized pain with muscle weakness for 2 weeks and tea-colored urine. The patient was diagnosed with metastatic adenocarcinoma with EGFR exon 19 deletion and programmed cell death 1 ligand (PD-L1) expression of 5% 2 years previously (Figure 1). Imaging examinations showed primary cancer in the left lower lobe with metastasis to the bilateral hilar, mediastinal lymph nodes, right lung, and pleura. The patient subsequently underwent first-line combination treatment with afatinib and bevacizumab (7.5 mg/kg every three weeks) from September 2019. The best efficacy evaluation was a partial response (PR). However, progressive disease (PD) was detected in July 2020 due to the growth of the hilar, mediastinal lymph nodes, pleural lesions, and new brain metastases. Blood testing revealed a T790M mutation, and she received almonertinib (110 mg daily) plus bevacizumab in September 2020 as second-line treatment. The patient tolerated this treatment well and the best efficacy evaluation was PR. However, follow-up imaging showed disease progression after 5 months of treatment in June 2021. The patient declined chemotherapy, and osimertinib (80 mg daily) plus bevacizumab were administered as third-line treatment. The patient tolerated the treatment well initially, and imaging revealed stable disease of the primary and metastatic lesions.

Figure 1 Histopathology and immunohistochemistry of tumor tissues in our patient. (A) The hematoxylin-eosin staining (H&E staining) under microscopy (100×); (B,C) Immunohistochemical staining for TTF1 and NapsinA (100×). H&E, hematoxylin-eosin.

Nevertheless, after 5 months of treatment, she experienced generalized pain with muscle weakness, mainly in the extremities. Oxycodone was then administered, and there were no changes of combined drugs (Figure 2). Approximately 2 weeks later, tea-colored urine appeared. The muscle strength grade of both the upper and lower limbs was III, and no other abnormalities were found. Serum creatine kinase (CK) and myoglobin (Mb) levels increased to 1,470 IU/L and 616.5 ng/mL, respectively, together with acute renal insufficiency, hyperuricemia, metabolic acidosis, and electrolyte disturbances (such as hyperkalemia and hypocalcemia) (Table 1). Other possible causes of elevated CK levels, such as myocardial infarction, stroke, and combined medications, were excluded by auxiliary examinations.

Figure 2 Chest CT showing the changes in lung lesions and mediastinal lymph nodes. The disease became stable after 3 months of osimertinib administration at 80 mg/day, and then disease progressed after 5 months. (A1,B1) Before the administration of osimertinib; (A2,B2) 3 months after the administration of osimertinib; (A3,B3) 5 months after the administration of osimertinib. CT, computed tomography.

Table 1

Routine blood and urine tests in the patient

Tests Reference value Baseline Peak value Follow-up value
Creatinine (μmol/L) 49–88 84 197 92
MCV (fL) 82–100 92 90.3 94
MCH (pg) 27–34 32 27.3 30.1
MCHC (g/L) 316–354 324 303 312
Leukocyte count (×109/L) 3.5–9.5 4.73 5.41 5.37
AKP (IU/L) 50–135 107 138 128
GGT (IU/L) <45 37 60 47
Albumin (g/L) 40.0–55.0 38 28.6 32.5
Glomerular filtration rate (mL/min/m2) 56–122 60.86 21.72 54.52
Uric acid (μmol/L) 160–380 225 558 233
Potassium (mmol/L) 3.5–5.5 4.03 2.93 3.59
Magnesium (mmol/L) 0.75–1.02 0.87 1.05 0.67
Calcium (mmol/L) 2.11–2.52 2.19 1.71 1.88
Color of urine Clear Clear Clear Clear
Urinary specific gravity 1.003–1.030 1.02 1.041 1.02
Protein in urine (g/L) Negative: 0 0.15(−/+) 0.3(+) (−)
Red blood cells in urine (/μL) 0–25 27 716 38
pH 7.35–7.45 – 7.296 7.409

The peak value was tested on 29th November 2021. The follow-up value was tested on 8th December 2021. MCV, mean corpuscular volume; MCH, mean corpuscular hemoglobin; MCHC, mean corpuscular hemoglobin concentration; AKP, alkaline phosphatase; GGT, γ-glutamyl transpeptidase.

Osimertinib was interrupted in November 2021. Due to her poor performance status score, the patient did not undergo further examinations, such as a muscle biopsy. Osimertinib-associated rhabdomyolysis was considered after a multidisciplinary discussion with nephrologists and pharmacologists. Osimertinib was discontinued thereafter, and after symptomatic treatments such as alkalinization of urine and rehydration, the patient’s myalgia was relieved, her serum CK and Mb levels decreased (Figure 3), myoglobinuria returned to normal, and her renal function also improved (Table 1, Figure 4).

Figure 3 Changes in serum CK and Mb levels throughout the osimertinib treatment. Osimertinib was started in June 2021. Myalgia and muscle weakness appeared in November 2021, while myoglobinuria occurred after 2 weeks. Osimertinib treatment was discontinued on November 30, 2021. A remarkable decrease in both serum CK and Mb levels was observed after the withdrawal of osimertinib. CK, creatine kinase; Mb, myoglobin.
Figure 4 Timeline figure describe the whole disease process of the case. EGFR, epidermal growth factor receptor; CK, creatine kinase; Mb, myoglobin.

All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Declaration of Helsinki (as revised in 2013). Written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

Discussion

It is commonly considered that the diagnosis of RM is established when patients present with myalgia or muscle weakness, combined with a serum CK level ≥1,000 U/L or ≥ five times the upper limit (4,5). Serum CK levels are slightly elevated in myositis and notably in RM; lower serum CK levels may more appropriately be defined as osimertinib-associated myositis, which is accompanied by myalgia or muscle weakness, and usually without myoglobinemia or myoglobinuria (3). Neither myositis nor RM has been officially reported as a side effect of osimertinib in major studies; nevertheless, manifestations of muscle damage including fatigue, weakness, and increased liver enzymes were observed in the AURA2, AURA3, and FLAURA studies (3,6-8). In this case, after receiving the treatment of osimertinib plus bevacizumab, the patient demonstrated a satisfying treatment response in the beginning. All laboratory tests showed normal results. However, five months later, the patient began to develop muscular pain. Oxycodone was then administrated and there was no change of other combined drugs. Moreover, the patient received the treatment of bevacizumab since the first-line therapy and did not show any RM-related symptoms. Therefore, these symptoms were considered to be mainly related to osimertinib rather than oxycodone. Osimertinib-associated myositis was reported to be more common compared with previous studies; however, osimertinib-associated RM has not yet been reported (3,9,10) (Table 2).

Table 2

Reported cases of elevated serum creatine kinase levels during osimertinib treatment for lung cancer

Case number Age (years) Sex Type of EGFR mutation Peak serum CK (U/L) Muscular symptoms Biopsy
1 (9) 68 Male T790M 1,238 Myalgia Present
2 (3) 72 Female L858R 790 Cramps None
3 (3) 66 Male T790M 2,511 Cramps None
4 (3) 68 Female Exon 19 and T790 596 None None
5 (3) 42 Male Exon 19 deletion 298 None None
6 (10) 56 Female Exon 19 deletion 989 Cramps None

EGFR, epidermal growth factor receptor; CK, creatine kinase.

As a rare side effect, the incidence of myositis associated with osimertinib was reported to be less than 1%, and serum CK elevation was reported in only one case in the AURA2 study (7). However, symptomatic myositis or asymptomatic CK elevation has a significantly higher incidence in real-world practice (3,10). Although RM did not occur in patients receiving combined treatment with EGFR-TKI and bevacizumab, the combination therapy yielded increased adverse effects compared with monotherapy, including CK elevation, myalgia, muscle weakness, and proteinuria, which may indicate that combination therapy is more likely to trigger potential muscle injury (11-19) (Table 3). Thus, the manifestations associated with muscle injury should be considered with caution during osimertinib treatment, particularly in patients receiving osimertinib plus bevacizumab.

Table 3

Reported adverse events associated with muscle injury during combined therapy of EGFR-TKIs and anti-angiogenic drugs

Study Treatment Phase AE
CPK increased Myoglobinemia or myoglobinuria Myalgia Muscle weakness Proteinuria Myositis
RELAY (13) Erlotinib+ Ramucirumab III – – – – 34% (75/221) –
SWOG S0635 and S0636 Trials (14) Erlotinib+ Bevacizumab II – – – 17% (28/161) 16% (26/161) –
SAKK 19/05) (15) Erlotinib+ Bevacizumab II – – – – 42% (42/101) –
OLCSG140 (16) Afatinib+ Bevacizumab I – – – – 58% (11/19) –
WJOG8715L (17) Osimertinib+ Bevacizumab II – – – – 58% (47/81 –
NCT02803203 (18) Osimertinib+ Bevacizumab I/II 4% (2/49) – 20% (10/49) 4% (2/49) 43% (21/49) 4% (2/49)
NEJ026 (19) Erlotinib+ Bevacizumab III – – – – 32% (36/112) –

EGFR-TKI, epidermal growth factor receptor-tyrosine kinase inhibitor; AE, adverse event; CPK, creatinine phosphokinase.

The mechanism of osimertinib-induced myopathy remains unclear. One in vitro study reported that EGFR has a key role in the differentiation process of myoblast. Thus, osimertinib may affect myoblast differentiation and cause skeletal muscle injury through blocking EGFR pathway (20). Considering that osimertinib is almost not influenced by strong CYP3A4 inhibitor, it is not considered that the concentration of osimertinib changes by oxycodone (21,22). Furthermore, bevacizumab is both a recombinant humanized monoclonal antibody and an anti-angiogenesis drug. Only muscle weakness has been reported as one of the adverse effects of bevacizumab, and there is no reference to CK increase or RM (23). There is only one report of an 82-year-old man with RM due to bevacizumab, and RM was reported after treatment with monoclonal antibodies and anti-angiogenic drugs; the mechanism may be associated with complement activation and elevated tumor necrosis factor-α (24-27). Thus, the co-administration of bevacizumab may also increase the risk of RM.

Conclusions

To our knowledge, this is the first report of osimertinib-associated RM during the treatment of a lung adenocarcinoma patient with an EGFR exon 19 deletion and T790M mutation. Regular testing of serum CK and Mb levels and monitoring for relevant symptoms are highly recommended in clinical practice, especially in patients receiving osimertinib plus bevacizumab.

Acknowledgments

We would like to offer our sincere thanks to the patient and his family for giving their consent to the publication of this case.

Funding: None.

Footnote

Reporting Checklist: The authors have completed the CARE reporting checklist. Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-22-916/rc

Peer Review File: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-22-916/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-22-916/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Declaration of Helsinki (as revised in 2013). Written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this article as: Li Y, Liu Y, Zhao Z, Zhang Y. Rhabdomyolysis in a patient with advanced lung cancer treated with osimertinib: a case report. Transl Lung Cancer Res 2023;12(3):629-636. doi: 10.21037/tlcr-22-916

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