Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin–paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002)

Inoue, Akira; Kobayashi, Kunihiko; Maemondo, Makoto; Sugawara, Shunichi; Oizumi, Satoshi; Isobe, Hiroshi; Gemma, Akihiko; Harada, Masao; Yoshizawa, Hirohisa; Kinoshita, Ichiro; Fujita, Yuka; Okinaga, Shoji; Hirano, Haruto; Yoshimori, Kozo; Harada, Toshiyuki; Saijo, Yasuo; Hagiwara, Koichi; Morita, Satoshi; Nukiwa, Toshihiro

doi:10.1093/annonc/mds214

Cited by 463 publications

(331 citation statements)

References 18 publications

Supporting

Mentioning

294

Contrasting

Unclassified

Order By: Relevance

“…We examined first-line gefitinib chemotherapy, as it is the standard first-line chemotherapy for advanced NSCLC with EGFR mutations. Patients with NSCLC harboring an EGFR mutation who were treated with gefitinib, platinum and pemetrexed or docetaxel exhibited a median survival of ~3 years (14). For advanced NSCLC patients with sensitive EGFR mutations, the OS time is longer and there are additional options for subsequent chemotherapy.…”

Section: Surrogate Endpoints For Overall Survival In Advancedmentioning

confidence: 99%

Surrogate endpoints for overall survival in advanced non-small-cell lung cancer patients with mutations of the epidermal growth factor receptor gene

Yoshino

Imai

Mori

et al. 2014

Molecular and Clinical Oncology

View full text Add to dashboard Cite

Abstract. Subsequent therapies confound the ability to discern the effect of first-line chemotherapy on overall survival (OS). We investigated whether progression-free survival (PFS), post-progression survival (PPS) and tumor response were valid surrogate endpoints for OS following first-line chemotherapy in individual patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epidermal growth factor receptor gene mutations. We retrospectively analyzed 35 patients with advanced NSCLC treated with first-line gefitinib. The associations of PFS, PPS and tumor response with OS were analyzed. PPS was found to be strongly correlated with OS, unlike PFS and tumor shrinkage. The factors significantly associated with PPS were performance status (PS) after first-line treatment, best response to second-line treatment and number of regimens used after disease progression. PPS may be a surrogate for OS in this patient population and further therapy after disease progression following first-line chemotherapy may significantly affect OS. However, a larger study is required to validate these results.

show abstract

Section: Surrogate Endpoints For Overall Survival In Advancedmentioning

confidence: 99%

Surrogate endpoints for overall survival in advanced non-small-cell lung cancer patients with mutations of the epidermal growth factor receptor gene

Yoshino

Imai

Mori

et al. 2014

Molecular and Clinical Oncology

View full text Add to dashboard Cite

show abstract

“…Эти мутации выявля-ются у 10-35% пациентов с НМРЛ, чаще у некурильщи-ков/незаядлых курильщиков, женщин, пациентов с аде-нокарциномой и пациентов восточноазиатского проис-хождения. Несколько рандомизированных исследова-ний III фазы последовательно показали, что гефитиниб, эрлотиниб и позже афатиниб более эффективны с точки зрения частоты ответа (ЧО) и выживаемости без про-грессирования (ВБП), менее токсичны и лучше перено-сятся, чем стандартная двухкомпонентная химиотерапия на основе препаратов платины, у пациентов с НМРЛ и частыми мутациями гена EGFR, ранее не получавших лечение [11][12][13][14][15][16][17][18][19][20].…”

Section: таргетная терапия опухолейunclassified

“…В исследованиях III фазы у 25-95% пациентов наблю-дались НЯ любой степени и 1-14% -НЯ ≥3 степени (табл. 9) [11][12][13][14][15][16][17][18][19][20][39][40][41][42][43][44][45][46][47][48].…”

Section: желудочнокишечные нежелательные явления диареяunclassified

Algorithms for Management of Patients With Adverse Events on Therapy With Tyrosine Kinase Inhibitors Egfr

Сакаева¹

2017

Med. sov.

View full text Add to dashboard Cite

С емейство рецепторов ErbB является одной из наиболее широко изученных систем передачи сигналов [1]. Семейство ErbB включает четыре мембранно-связанных структурно родственных рецепто-ра тирозинкиназы: рецептор EGF (EGFR; также известен как ErbB1), HER2 (ErbB2), ErbB3 и ErbB4 [2]. Путь ErbB является одной из наиболее широко изученных систем передачи сигналов, вовлеченных в функционирование нормальных клеток, и при некоторых типах рака [1]. Нарушение регуляции активности рецепторов семейства ErbB и нисходящих сигнальных путей связано с развити-ем некоторых опухолей у человека.Механизм активации передачи сигналов ErbB зависит от лиганд-индуцированной стабильности гомо-или гете-родимеров, образованных различными тирозинкиназами рецепторов семейства ErbB [3]. Рецепторы семейства ErbB являются клинически доказанными мишенями для новых противоопухолевых препаратов [4][5][6][7].Ингибиторы EGFR показаны для лечения колорек-тального рака (панитумумаб, цетуксимаб), немелкокле-точного рака легкого (гефитиниб, эрлотиниб, афатиниб), плоскоклеточного рака головы и шеи (цетуксимаб), рака поджелудочной железы (эрлотиниб).В отличие от цитотоксической химиотерапии, лечение ингибиторами EGFR сопровождается минимальными неспеци фическими и гематологическими побочными эффектами.Активирующие мутации гена рецептора EGFR явля-ются наиболее значимыми предикторами ответа на ингибиторы тирозинкиназы EGFR (ИТК-EGFR) гефити- Ключевые слова: местнораспространенный и метастатический немелкоклеточный рак легкого, ингибиторы тирозин-киназы EGFR, терапия, нежелательные явления. D.D. SAKAEVA, MD, Prof., Republican Oncologic Dispensary of the Ministry of Health of the Republic of Bashkortostan, Ufa ALGORITHMS FOR MANAGEMENT OF PATIENTS WITH ADVERSE EVENTS ON THERAPY WITH TYROSINE KINASE INHIBITORS EGFRThe tyrosine kinase inhibitors (TKIs) of the epidermal receptor growth factor (EGFR) such as gefitinib, erlotinib and afatinib, are the standard first-line therapy in locally advanced and metastatic non-small cell lung cancer (NSCLC) with frequent mutations of the EGFR gene. These drugs are more effective from the point of view of frequency response (FR) and survival without progression (SWP), less toxic and better tolerated than the standard two-component chemotherapy based on platinum drugs. The most frequent adverse events (AE) are gastrointestinal (GI) (diarrhea and stomatitis/mucositis) and dermatological (rash, dry skin and paronychia). They are usually mild, but in some cases symptoms can be moderate and more severity and have a negative impact on quality of life (QOL) of the patient and can require dose adjustment or discontinuation of treatment. Management of AEs, including preventive measures, supportive therapy, temporary cancellation and a reduction in the dose of the drug is important. Recommendations for the prevention and treatment of dermatological toxicity (rash, dry skin and paronychia) and toxicity for the gastrointestinal tract (diarrhoea, stomatitis and mucositis) related to therapy TKI-EGFR are developed. These guidelines descri...

show abstract

“…Patients with NSCLC with IIIB and IV have particularly poor prognoses. In the last decade, the me-dian overall survival of the patients with metastatic NSCLC treated systemically within clinical studies, have grown from a few months to more than 20 months as reported in some studies results [4][5][6][7]. This improvement was obtained thanks not only to the modification of the previous treatment regimens [8][9][10][11], but first of all thanks to the application of new drugs, such as epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) and ALK inhibitors [12][13][14][15][16][17][18][19][20].…”

Section: Introductionmentioning

confidence: 99%

The results of first line systemic therapy of NSCLC in clinical practice

Adamowicz¹

2017

Nowotwory. Journal of Oncology

View full text Add to dashboard Cite

Introduction. Lung cancer is the most common cancer in the world. Every year, there are over 1.4 million new cases and about 1.3 million deaths due to lung cancer. Data on the results of palliative treatment of patients with non-small cell lung cancer in Poland are scarce. Methods. The results of first-line palliative chemotherapy in 204 lung cancer patients treated in the period 2011-2014 in two cancer centres were analysed. Results. The mean age of the study group was 63.4 ± 8.3 years; 155 patients received chemotherapy with cisplatin, 33 -schemes containing carboplatin, 8 -inhibitors of EGFR tyrosine kinase, 8 -vinorelbine or gemcitabine monotherapy. Complete regression was observed in 2 patients, partial response -in 52 patients (25%), stable disease in 92 (45%) and 58 (28%) patients had progression. Median survival for the entire group of patients was 12 months. Multidrug chemotherapy with cisplatin compared with chemotherapy involving carboplatin monotherapy was associated with increased toxicity in total (p = 0.04). An increased toxicity concerned only to haematological complications and renal insufficiency expressed by the level of creatinine in blood serum. There was no apparent effect of chemotherapy on the overall quality of life. Conclusions. The results of palliative treatment of non-small cell lung cancer in daily practice are comparable to those obtained in prospective clinical trials despite having a different population of treated patients. The use of palliative chemotherapy had no significant effect on quality of life. NOWOTWORY J Oncol 2017; 67, 1: 24-33

show abstract

Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin–paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002)

Cited by 463 publications

References 18 publications

Surrogate endpoints for overall survival in advanced non-small-cell lung cancer patients with mutations of the epidermal growth factor receptor gene

Surrogate endpoints for overall survival in advanced non-small-cell lung cancer patients with mutations of the epidermal growth factor receptor gene

Algorithms for Management of Patients With Adverse Events on Therapy With Tyrosine Kinase Inhibitors Egfr

The results of first line systemic therapy of NSCLC in clinical practice

Contact Info

Product

Resources

About