PMID- 35343187
OWN - NLM
STAT- MEDLINE
DCOM- 20220331
LR  - 20220603
IS  - 1998-4774 (Electronic)
IS  - 0019-509X (Linking)
VI  - 59
IP  - Supplement
DP  - 2022 Mar
TI  - 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.
PG  - S1-S10
LID - 10.4103/ijc.ijc_1374_21 [doi]
AB  - 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.
FAU - Malik, Prabhat S
AU  - Malik PS
AD  - Department of Medical Oncology, All India Institute of Medical Sciences, Ansari 
      Nagar, New Delhi, India.
FAU - Noronha, Vanita
AU  - Noronha V
AD  - Department of Medical Oncology, Tata Memorial Hospital, Dr. Ernest Borges road, 
      Parel, Mumbai, Maharashtra, India.
FAU - Dabkara, Deepak
AU  - Dabkara D
AD  - Department of Medical Oncology, Tata Medical Center, New town, Rajarhat, Kolkata, 
      West Bengal, India.
FAU - Maddu, Vamshi K
AU  - Maddu VK
AD  - Department of Medical Oncology, Apollo Cancer Institute, Jubilee Hills, 
      Hyderabad, Telangana, India.
FAU - Rajappa, Senthil
AU  - Rajappa S
AD  - Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital, 
      Banjara Hills, Hyderabad, Telangana, India.
FAU - Limaye, Sewanti
AU  - Limaye S
AD  - Department of Medical Oncology, Kokilaben Dhirubhai Ambani Hospital and Medical 
      Research Institute, Andheri (W), Mumbai, Maharashtra, India.
FAU - Batra, Ullas
AU  - Batra U
AD  - Department of Medical Oncology, Rajiv Gandhi Cancer Institute Research Centre, 
      Rohini, New Delhi, India.
LA  - eng
SI  - ClinicalTrials.gov/NCT03853551
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PL  - India
TA  - Indian J Cancer
JT  - Indian journal of cancer
JID - 0112040
RN  - 0 (Acrylamides)
RN  - 0 (Aniline Compounds)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 3C06JJ0Z2O (osimertinib)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
MH  - Acrylamides/adverse effects
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Aniline Compounds/adverse effects
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics
MH  - ErbB Receptors/genetics
MH  - Female
MH  - Humans
MH  - *Lung Neoplasms/drug therapy/genetics
MH  - Male
MH  - Middle Aged
MH  - Mutation
MH  - Protein Kinase Inhibitors/adverse effects
OTO - NOTNLM
OT  - Epidermal Growth Factor Receptor
OT  - non-small cell lung cancer
OT  - osimertinib
OT  - stage IV NSCLC
OT  - tyrosine kinase inhibitor
COIS- None
EDAT- 2022/03/29 06:00
MHDA- 2022/04/01 06:00
CRDT- 2022/03/28 07:09
PHST- 2022/03/28 07:09 [entrez]
PHST- 2022/03/29 06:00 [pubmed]
PHST- 2022/04/01 06:00 [medline]
AID - IndianJournalofCancer_2022_59_5_1_340519 [pii]
AID - 10.4103/ijc.ijc_1374_21 [doi]
PST - ppublish
SO  - Indian J Cancer. 2022 Mar;59(Supplement):S1-S10. doi: 10.4103/ijc.ijc_1374_21.