Osimertinib in Indian patients with T790M-positive advanced nonsmall cell lung cancer

Noronha, Vanita; Majumdar, Swaratika; Joshi, Amit; Patil, Vijay; Trivedi, Vaishakhi; Chougule, Anuradha; Prabhash, Kumar

doi:10.4103/sajc.sajc_202_17

Cited by 8 publications

(5 citation statements)

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“…[6] The first Indian report of 13 patients showed good symptom control as well as an overall response rate of 55% (6/11 evaluable patients). [8] This was comparable to the objective response rate to osimertinib of 71% in AURA3. [6] This issue of IJMPO presents prospective observational data on 90 patients who had progressive disease while on EGFR TKI.…”

supporting

confidence: 52%

Editorial - T790M mutation and clinical outcomes with genuine osimertinib

Parikh

2019

Indian Journal of Medical and Paediatric Oncology

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supporting

confidence: 52%

Editorial - T790M mutation and clinical outcomes with genuine osimertinib

Parikh

2019

Indian Journal of Medical and Paediatric Oncology

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“…A recent retrospective European study in 135 patients reported that chemotherapy after progression on rst line TKI resulted in a median PFS of 5.4 months (95% CI, 4.7-6.1), and median OS of 15.3 months (95% CI, 116 − 18.9) [40]. In an earlier real world study report, we found that osimertinib at 80 mg a day in the second line and beyond setting for 17 patients with EGFR T790M mutation led to an ORR of 55% and DCR of 90.9%; survival data were immature at the time of this report [41]. In our present study, reduced frequency osimertinib was used in 82.4% patients with EGFR T790M mutations in the second line and beyond setting, and resulted in an ORR of 29.4%, DCR of 70.5%, median PFS of 5.9 months, and median OS of 17.6 months.…”

Section: Discussionmentioning

confidence: 56%

Reduced frequency dosing of osimertinib in EGFR-mutant non-small cell lung carcinoma: Real world data

Noronha,

Sahu,

Kapoor

et al. 2023

Preprint

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Introduction Osimertinib has better efficacy than first generation EGFR-directed TKIs with similar safety profile. However, osimertinib is not affordable for most in developing nations. Moreover, minimum biologically effective dose of osimertinib may be less than approved, given uncertainty surrounding dose determination strategy for targeted agents Materials and Methods This was retrospective observational multicentric study aimed to describe the objective response rate(ORR), disease control rate(DCR), progression free survival(PFS), overall survival(OS), and toxicity of osimertinib 80 mg orally administered less frequently than daily (ranging from alternate day to once weekly) in patients with EGFR-mutated non-small cell lung cancer. Results Between January 2021 and August 2023, we enrolled 22patients. Six received osimertinib 80mg once weekly, nine received 80mg every three days, and seven received 80mg alternate days. Responses included 0 complete responses, 7(31.8%) partial responses, 9(40.9%) stable diseases, and 5(22.7%) progressive disease. ORR was 31.8%, and DCR was 72.7%. Median PFS was 9.2months (95% confidence interval[CI] 2.9–15.7), and median OS was 17.8months (95%CI, 3.2–32.6). In patients who received reduced frequency osimertinib in the second line and beyond, the ORR was 29.4%, DCR was 70.5%, median PFS was 5.9months (95%CI, 1.1–10.6) and median OS was 17.6months (95%CI, 2.9–32.2). Grade- 3 and higher toxicities were noted in 8(36.3%) patients. Conclusion Less frequent dosing of osimertinib may be valid treatment option especially in second line and beyond in patients who cannot afford full dose osimertinib. This may provide additional treatment option with similar toxicity profile as standard dose osimertinib.

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“…A recent retrospective European study in 135 patients reported that chemotherapy after progression on first-line TKI resulted in a median PFS of 5.4 months (95% CI, 4.7–6.1), and median OS of 15.3 months (95% CI, 116–18.9) [ 26 ]. In an earlier real world study report, we found that osimertinib at 80 mg a day in the second line and beyond setting for 17 patients with EGFR T790M mutation led to an ORR of 55% and DCR of 90.9%; survival data were immature at the time of this report [ 27 ]. In our present study, 82.4% of the patients who received reduced frequency osimertinib had EGFR T790M mutation in the second line and beyond setting; therapy resulted in an ORR of 29.4%, DCR of 70.5%, median PFS of 5.9 months and median OS of 17.6 months.…”

Section: Discussionmentioning

confidence: 92%

Reduced frequency dosing of osimertinib in EGFR-mutant non-small cell lung carcinoma: real world data

Noronha,

Sahu,

Kapoor

et al. 2024

ecancer Journal

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Introduction Osimertinib is more efficacious and as safe as first-generation epidermal growth factor receptor (EGFR)-directed tyrosine kinase inhibitors. However, osimertinib is not affordable for most patients in developing nations. Moreover, the minimum biologically effective dose of osimertinib may be less than the approved dose. Materials and methods This was a retrospective observational multicentric study aimed to describe the efficacy (objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), overall survival (OS)) and toxicity of osimertinib 80 mg orally administered less frequently than daily (ranging from every other day to once-a-week) in patients with EGFR-mutated non-small cell lung cancer. Results Between January 2021 and August 2023, we enrolled 22 patients. Six received osimertinib 80 mg once-a-week, nine received 80 mg once-in-3-days and seven received 80 mg on alternate days. Responses included 0 complete responses, 7 (31.8%) partial responses, 9 (40.9%) stable disease and 5 (22.7%) progressive disease. ORR was 31.8%, and DCR was 72.7%. Median PFS was 9.2 months (95% confidence interval (CI) 2.9–15.7), and median OS was 17.8 months (95% CI, 3.2–32.6). In patients who received reduced frequency osimertinib in the second line and beyond, the ORR was 29.4%, DCR was 70.5%, median PFS was 5.9 months (95% CI, 1.1–10.6) and median OS was 17.6 months (95% CI, 2.9–32.2). Grade 3 and higher toxicities were noted in 8 (36.3%) patients. Conclusion Less frequent dosing of osimertinib may be a valid treatment option, especially in the second line and beyond setting in patients who cannot afford full dose daily osimertinib. This may provide an additional treatment option with a similar toxicity profile as that of standard dose osimertinib.

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Osimertinib in Indian patients with T790M-positive advanced nonsmall cell lung cancer

Cited by 8 publications

References 1 publication

Editorial - T790M mutation and clinical outcomes with genuine osimertinib

Editorial - T790M mutation and clinical outcomes with genuine osimertinib

Reduced frequency dosing of osimertinib in EGFR-mutant non-small cell lung carcinoma: Real world data

Reduced frequency dosing of osimertinib in EGFR-mutant non-small cell lung carcinoma: real world data

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