Be-TeaM: An Italian real-world observational study on second-line therapy for EGFR-mutated NSCLC patients

Reale, Maria Lucia; Chiari, Rita; Tiseo, Marcello; Vitiello, Fabiana; Barbieri, Fausto; Ceresoli, Giovanni Luca; Finocchiaro, Giovanna; Romano, Gianpiero; Piovano, Pier Luigi; Conte, Alessandro Del; Borra, Gloria; Verderame, Francesco; Scotti, Vieri; Nonnis, Daniela; Galetta, Domenico; Sergi, Concetta; Migliorino, Maria Rita; Tonini, Giuseppe; Cecere, Fabiana Letizia; Berardi, Rossana; Pino, Maria Simona; Martelli, Olga; Carta, Annamaria; Vattemi, Emanuela; Pagano, Maria; Zullo, Alessandro; Ferrari, Silvia; Rossi, Antonio; Novello, Silvia

doi:10.1016/j.lungcan.2019.12.006

Cited by 10 publications

(15 citation statements)

References 41 publications

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“…For patients who develop T790M resistance mutations following first-line afatinib, osimertinib, which has shown striking activity in patients with T790M-positive NSCLC after failure of firstline TKIs (45), would represent the optimal subsequent treatment option. Findings of a real-world observational study in NSCLC patients with EGFR mutations in Italy indicated that the vast majority of patients (114 of 120; 95.0%) who developed T790M mutations after first-line EGFR TKI treatment (erlotinib, gefitinib or afatinib) received targeted therapy with osimertinib (46). In the current study, the majority of patients went on to receive chemotherapy such as pemetrexed or gemcitabine, while only 15.2% received subsequent osimertinib.…”

Section: Discussionmentioning

confidence: 57%

Real-world experience of afatinib as first-line therapy for advanced EGFR mutation-positive non-small cell lung cancer in Korea

Lee¹,

Choi²,

Chang³

et al. 2021

Transl Lung Cancer Res

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Background: We investigated the clinical characteristics and treatment outcomes of Korean patients receiving first-line afatinib for advanced epidermal growth factor receptor mutation-positive (EGFRm + ) nonsmall cell lung cancer (NSCLC) in a real-world setting.Methods: Electronic case reports were retrospectively reviewed from patients across 15 sites in South Korea. Outcome measures included baseline characteristics, overall response rate (ORR), time-totreatment discontinuation (TTD), and overall survival (OS). Subgroups were: presence/absence of brain metastases at baseline, dose reductions, and baseline EGFR mutation category.Results: Among 422 patients, 39.8% had brain metastases and 59.0%/25.1%/10.0%/5.0% had Del19/ L858R/compound/uncommon EGFR mutations at baseline. ORR was 62.6% overall; responses were observed across all EGFR mutation categories, including against compound mutations. Median TTD was 17.8 months; median OS was not reached (NR). Median TTD and OS were longer in patients without versus with brain metastases (TTD: 22.9 vs. 14.8 months, P=0.001; OS: NR vs. 40.3 months, P=0.0009) and patients with versus without dose reductions (TTD: 22.2 vs. 14.2 months, P=0.0004; OS: NR vs. 40.3 months, P=0.0117). Median OS was 30.5/37.7 months in patients receiving chemotherapy/osimertinib as subsequent therapy. The most common treatment-related adverse events (TRAEs; any grade/grade ≥3)were diarrhea (31.3%/8.5%) and rash (23.0%/8.1%). Overall, 34 patients (8.1%) discontinued afatinib due to AEs.Conclusions: Afatinib was well tolerated with no new safety signals, and efficacy was encouraging in Korean patients with EGFRm + NSCLC, including those with baseline brain metastases and/or uncommon EGFR mutations. AE management with dose reductions facilitated a long TTD, prolonging the chemotherapy-free period for many patients.

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Section: Discussionmentioning

confidence: 57%

Real-world experience of afatinib as first-line therapy for advanced EGFR mutation-positive non-small cell lung cancer in Korea

Lee¹,

Choi²,

Chang³

et al. 2021

Transl Lung Cancer Res

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“…While afatinib was the most common 1 L EGFR-TKI received in our study, other real-world retrospective studies have identified gefitinib 26 , 28 , 29 or erlotinib 13 , 24 as the most commonly initiated 1 L EGFR-TKI. This may have been due to differences in geographic location, dates of data retrieval, reimbursement status, or other inclusion criteria between studies.…”

Section: Discussionmentioning

confidence: 65%

“…In these studies, the low percentages of patients receiving 2 L osimertinib is likely due to the low T790M testing rates; 19% (47/246 patients) and 39% (63/160 patients) were tested, respectively, and consequently low numbers of T790M-positive patients were identified. 24,32 While afatinib was the most common 1 L EGFR-TKI received in our study, other real-world retrospective studies have identified gefitinib 26,28,29 or erlotinib 13,24 as the most commonly initiated 1 L EGFR-TKI. This may have been due to differences in geographic location, dates of data retrieval, reimbursement status, or other inclusion criteria between studies.…”

Section: Discussionmentioning

confidence: 67%

“…21 Real-world studies (RWS) have confirmed the use of EGFR-TKIs as 1 L standard of care for patients with EGFRm advanced/metastatic NSCLC. [24][25][26][27][28] Post-progression testing, subsequent treatment patterns, 24,25,29 and survival outcomes 25,30,31 are, however, less well reported. Such data may impact clinical decision-making concerning the use of 1 L EGFR-TKIs, particularly in countries where osimertinib is not yet approved in this setting.…”

Section: Introductionmentioning

confidence: 99%

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Treatment patterns, testing practices, and outcomes in the pre-FLAURA era for patients with EGFR mutation-positive advanced NSCLC: a retrospective chart review (REFLECT)

Addeo

Hochmair²,

Janžič

et al. 2021

Ther Adv Med Oncol

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Introduction: For epidermal growth factor receptor mutation-positive (EGFRm) non-small-cell lung cancer (NSCLC), EGFR-tyrosine kinase inhibitors (EGFR-TKIs) are the preferred first-line (1 L) treatment in the advanced setting. Osimertinib, a third-generation EGFR-TKI, received full approval in 2017 for second-line (2 L) treatment of EGFR T790M-positive NSCLC. The REFLECT study characterizes real-world treatment/testing patterns, attrition rates, and outcomes in patients with EGFRm advanced NSCLC treated with 1 L first-/second-generation (1G/2G) EGFR-TKIs before 1 L osimertinib approval. Methods: Retrospective chart review (NCT04031898) of European/Israeli adults with EGFRm unresectable locally advanced/metastatic NSCLC, initiating 1 L 1G/2G EGFR-TKIs 01/01/15–30/06/18 (index date). Results: In 896 patients (median follow-up of 21.5 months), the most frequently initiated 1 L EGFR-TKI was afatinib (45%). Disease progression was reported in 81%, including 10% (86/896) who died at 1 L. By the end of study, most patients discontinued 1 L (85%), of whom 33% did not receive 2 L therapy. From index, median 1 L real-world progression-free survival was 13.0 (95% confidence interval (CI): 12.3–14.1) months; median overall survival (OS) was 26.2 (95% CI: 23.6–28.4) months. 71% of patients with 1 L progression were tested for T790M; 58% were positive. Of those with T790M, 95% received osimertinib in 2 L or later. Central nervous system (CNS) metastases were recorded in 22% at index, and 15% developed CNS metastases during treatment (median time from index 13.5 months). Median OS was 19.4 months (95% CI: 17.1–22.1) in patients with CNS metastases at index, 24.8 months (95% CIs not available) with CNS metastases diagnosed during treatment, and 30.3 months (95% CI: 27.1, 33.8) with no CNS metastases recorded. Conclusion: REFLECT is a large real-world study describing treatment patterns prior to 1 L osimertinib availability for EGFRm advanced NSCLC. Given the attrition rates highlighted in the study and the impact of CNS progression on outcomes, offering a 1 L EGFR-TKI with CNS penetration may improve patient outcomes in this treatment setting.

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“…However, because of reimbursement issues, several centers still continue to adopt a sequential strategy characterized by the upfront use of firstor secondgeneration TKIs followed by osimertinib at the time of systemic disease progression in the case of T790M positivity according to cell-free DNA or tumor tissue genotyping. 17 Although both crizotinib and alectinib are currently approved and reimbursed by the Italian Health System as potential first-line options in ALK-positive advanced NSCLC, most oncologists prescribe upfront alectinib, followed by platinum chemotherapy at the time of disease progression. For patients who received crizotinib as first-line therapy, subsequent treatment with ceritinib and alectinib is recommended, whereas new ALK -TKIs, such as brigatinib and lorlatinib, are currently available only in the context of compassionate use programs or clinical trials.…”

Section: Systemic Therapymentioning

confidence: 99%

Lung Cancer in Italy

Passiglia

Calandri

Guerrera

et al. 2019

Journal of Thoracic Oncology

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Be-TeaM: An Italian real-world observational study on second-line therapy for EGFR-mutated NSCLC patients

Cited by 10 publications

References 41 publications

Real-world experience of afatinib as first-line therapy for advanced EGFR mutation-positive non-small cell lung cancer in Korea

Real-world experience of afatinib as first-line therapy for advanced EGFR mutation-positive non-small cell lung cancer in Korea

Treatment patterns, testing practices, and outcomes in the pre-FLAURA era for patients with EGFR mutation-positive advanced NSCLC: a retrospective chart review (REFLECT)

Lung Cancer in Italy

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