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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 59
| Issue : 5 | Page : 1-10 |
Safety of osimertinib in adult patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer: Results from a Phase IV study in India
Prabhat S Malik1, Vanita Noronha2, Deepak Dabkara3, Vamshi K Maddu4, Senthil Rajappa5, Sewanti Limaye6, Ullas Batra7
1 Department of Medical Oncology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
2 Department of Medical Oncology, Tata Memorial Hospital, Dr. Ernest Borges road, Parel, Mumbai, Maharashtra, India
3 Department of Medical Oncology, Tata Medical Center, New town, Rajarhat, Kolkata, West Bengal, India
4 Department of Medical Oncology, Apollo Cancer Institute, Jubilee Hills, Hyderabad, Telangana, India
5 Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital, Banjara Hills, Hyderabad, Telangana, India
6 Department of Medical Oncology, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (W), Mumbai, Maharashtra, India
7 Department of Medical Oncology, Rajiv Gandhi Cancer Institute Research Centre, Rohini, New Delhi, India
Correspondence Address:
Prabhat S Malik
Department of Medical Oncology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijc.ijc_1374_21
Background: A Phase IV, single-arm study was conducted to assess the safety of osimertinib in Indian patients with epidermal growth factor receptor (EGFR) T790M mutation-positive stage IV non-small cell lung cancer (NSCLC).
Methods: Enrolled patients received 80 mg osimertinib for six cycles or until disease progression or unacceptable toxicity or withdrawal. Primary safety variables included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation/interruption/change (D/I/C) of drug dose, and AEs of special interest (AESIs). AEs were summarized by the percentage of patients experiencing at least one occurrence of each event.
Results: Of the 60 enrolled patients (median age 58 [range: 34–81] years; 51.7% women) at eight sites, nine patients were discontinued prematurely due to disease progression (n = 7) and death (n = 2); median (range) duration of treatment was 126 (1–134) days. Median age of patients was 58 (34–81) years; 51.7% (n = 31) were women; 86.7% (n = 52) were nonsmokers; and most of them (98.3%) had adenocarcinoma. About 75% (n = 45) of patients experienced any of the TEAEs, with the most frequent being fatigue and creatine phosphokinase (CPK) increase (n = 6, 10% each). TEAEs in 11 (18.3%) patients were judged as study treatment related, with CPK increase being the most common (n = 4, 6.7%). TEAEs led to D/I/C of drug dose in eight (13.3%) patients, with one being study treatment related. Nine (15%) patients had AESIs of dyspnea (n = 6), chest pain (n = 2), and cardiorespiratory arrest (n = 1); two of them had a fatal outcome. One AESI (mild dyspnea) was considered study drug related. TEAEs of grade ≥3 were reported in seven (11.7%) patients, including dyspnea in two (3.3%), followed by diarrhea, mucosal inflammation, cardiorespiratory arrest, and others (n = 1, 1.7% each). None of the SAEs and fatal events were considered as study treatment related. Seven (11.7%) patients had abnormal electrocardiogram (ECG; not clinically significant) at the end of the study.
Conclusion: Our study confirms the favorable safety profile of osimertinib without any new safety concerns in Indian patients with EGFR T790M mutation-positive stage IV NSCLC.
ClinicalTrials.gov Identifier: NCT03853551
CTRI registration no. CTRI/2018/10/015941
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