Before ICAP initiation, patients received gefitinib predominantly as monotherapy (84%). However, this seems unlikely because there were no obvious differences in well-established prognostic factors among the two arms despite the early termination of the study before the desired accrual was achieved. No patient‐identification information was collected. JCO Global Oncology J Clin Oncol 26:: Thatcher N, Chang A, Parikh P, et al: Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). ISEL (Iressa Survival Evaluation in Lung Cancer) was a double-blind, placebo-controlled, parallel-group, multicenter, randomized, Phase III study to assess the survival advantage of gefitinib (250 mg/day) as second- or third-line treatment for patients with locally advanced or metastatic NSCLC . In addition, there is a suggestion that NSCLCs with K-ras mutations do worse when treated with the EGFR-TKI erlotinib.25 This again raises the question of the K-ras gene status of the tumors in the SWOG study. Ando M, Okamoto I, Yamamoto N, Takeda K, Tamura K, Seto T, et al. To qualify for enrollment, patients had to have been benefiting from gefitinib for at least 3 years, because the timing of ICAP started 3 years after gefitinib was made unavailable for new prescription starts in the United States. Lancet 366:: Hirsch FR, Varella-Garcia M, Cappuzzo F, et al: Combination of EGFR gene copy number and protein expression predicts outcome for advanced non-small-cell lung cancer patients treated with gefitinib. Unfortunately, early randomized trials of gefitinib were designed before the discovery of EGFR mutations and their significance in NSCLC. Kelly K, Chansky K, Gaspar LE, et al: Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non–small-cell lung cancer: SWOG S0023. Lynch et al. Gefitinib was the first EGFR-TKI evaluated in a phase III trial. As is well known, both radiotherapy and docetaxel can cause pulmonary fibrosis,9,10 and interstitial lung disease has been observed after gefitinib therapy.11 In addition, interstitial lung disease seems to be even more problematic after gefitinib therapy in individuals with pre-existing pulmonary fibrosis.11 Thus, one might suppose that the combination of these therapies would be a near perfect situation for causing significant pulmonary toxicity. DOI: 10.1200/JCO.2008.16.0374 Journal of Clinical Oncology There were 23 deaths, of which none were related to gefitinib‐related SAEs; 9 were from lung cancer, 5 were from other nongefitinib‐related causes, 5 were from SAEs not related to gefitinib, and 4 were from unknown causes. Subscribers The intent was to include as many patients enrolled into the ICAP as feasibly possible (of 191 patients from 137 sites), and enrollment was contingent on investigator interest in chart review participation. Dara Stein: Study conception and design, patient recruitment, data collection, data analysis and interpretation, statistical analysis, writing–initial draft, and writing–review and editing. Contact Us Elisabeth F. Croft is an employee of Incyte Corporation and was an employee of AstraZeneca at the time of the study. Accordingly, excess toxicity caused by an adverse interaction between EGFR blockade and irradiation does not seem to be the explanation for the S0023 results. The clinical courses and survival of patients with lung cancer, who have EGFR mutations as deletions in exon 19 or L858R, can be changed with gefitinib treatment. Learn more about types of lung cancer, survival rates, and other statistics. Frontline treatment with apatinib in combination with gefitinib (Iressa) demonstrated superior progression-free survival (PFS) in patients with advanced EGFR-mutant non–small cell lung cancer (NSCLC), according to results from the phase 3 ACTIVE trial (NCT02824458).1. Med Oncol 23:: Bonner JA, Harari PM, Giralt J, et al: Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. Collection and assembly of data: Vicki L. Keedy, Carlos L. Arteaga, David H. Johnson, Manuscript writing: Vicki L. Keedy, Carlos L. Arteaga, David H. Johnson, Final approval of manuscript: Vicki L. Keedy, Carlos L. Arteaga, David H. Johnson. Lung cancer is the second most-diagnosed type of cancer in American men and women. Meeting Abstracts, About Although it is assumed that most of these patients' tumors harbor EGFR mutations, molecular studies of available tumor specimens are planned to uncover the features that predict long‐term survival. Thatcher N, Chang A, Parikh P, et al: Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Skin rash occurred in 5 patients (6%), and no patients had grade ≥3 rash (Table 4). https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31313 Lung cancer is the leading cause of cancer-related death worldwide; it is responsible for over a million deaths per year and over 400,000 in Eastern Asia alone. Gefitinib‐related AEs were observed in 16 patients (20%), and 1 patient (1%) had a gefitinib‐related SAE. Conversely, a number of potentially important patient and tumor characteristics were not recorded at baseline including smoking history, tumor EGFR status (including EGFR mutational status or gene amplification), and K-ras mutational status. Dara Stein's current address: Evidera, London, United Kingdom. Lung cancer is the leading cause of cancer-related death worldwide and is characterized by early metastasis, high mortality, and poor survival [].Non–small-cell lung cancer (NSCLC),including lung adenocarcinoma (LUAD), squamous cell carcinoma (LUSC), and large-cell carcinoma accounts for approximately 85% of all lung cancer cases []. Cancer Res 61:: Eberhard DA, Johnson BE, Amler LC, et al: Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non–small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. These 31 reports also demo …. It is known that chemotherapy can be associated with cardiotoxicity and central nervous system toxicity, and the eventual development of secondary malignancies is reported in some patients; however, none of these issues were observed in this study of gefitinib. ASCO Career Center 2006; 24:2549–56. Patients with brain metastases from NSCLC receiving GK or gefitinib demonstrated extended survival. Int J Radiat Biol 83:: Mehta V: Radiation pneumonitis and pulmonary fibrosis in non-small-cell lung cancer: Pulmonary function, prediction, and prevention. Gefitinib has shown potent activity in a number of lung cancer tumor models, including several cell lines and xenografts. A study of 921 patients who had either breast or colon cancer demonstrated that chemotherapy was associated with lower health‐related quality of life compared with hormone therapy at 5‐year to 8‐year follow‐up.21 In a study of 245 breast cancer survivors, from 9.4 to 16.5 years postdiagnosis, univariate analysis demonstrated a statistically significant difference in health‐related quality of life between those who had received low‐dose chemotherapy and those who had received standard‐dose or high‐dose chemotherapy; however, multivariate analysis indicated that other factors, such as older age, the presence of comorbidities, lower vitality, and increased menopausal symptoms, had greater influence.22 A study of 163 breast cancer survivors who were followed for 5 to 13 years indicated that initial chemotherapy predicted greater financial problems and greater worry about appearance at follow‐up.23 In a trial of 32 men who had testicular cancer cured with orchidectomy plus cisplatin‐based and doxorubicin‐based chemotherapy and were followed for ≥13 years, although various long‐term toxicities were reported (eg, peripheral neuropathy, Raynaud phenomenon, hearing reduction), all participants denied any limitations on their social or working life.24 Similar studies are needed in NSCLC now that the number of long‐term survivors is increasing because of more effective therapeutic options. In the retrospective chart review cohort, 70% of patients were women; 58% were former smokers, and 30% were never‐smokers; 56% were diagnosed with adenocarcinoma, and 13% were diagnosed with squamous carcinoma. Gefitinib is an oral, reversible, tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) that plays a key role in the biology of non small cell lung cancer (NSCLC). Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer … Gandara et al21 also reported that lung cancer cell lines possessing wild-type EGFR with K-ras mutations demonstrated significantly increased apoptosis when treated with docetaxel followed by gefitinib. The remaining patients had other or mixed histologies, or their histology was unknown. Multiple randomized controlled trials (RCTs) have demonstrated improvement in progression-free survival (PFS) when comparing EGFR-TKI against platinum-based chemotherapy in this genetically distinct subset of NSCLC (1–8). CancerLinQ The objectives of this study were to determine the objective effective response rate, survival, and safety of radiotherapy combined with gefitinib in patients with locally advanced non-small cell lung cancer (NSCLC) who were unfit for surgery or concurrent chemoradiotherapy. Lung cancer is the leading cause of cancer-related mortality in the world. Abbreviations: AEs, adverse events; ICAP, IRESSA Clinical Access Program; NA, not applicable; SAEs, serious adverse events. Potentially, a chance and unrecognized imbalance in one of these factors could have influenced the study's outcome. J Clin Oncol 22:: Pao W, Miller V, Zakowski M, et al: EGF receptor gene mutations are common in lung cancers from “never smokers” and are associated with sensitivity of tumors to gefitinib and erlotinib. According to ICAP protocol requirements, investigators enrolled in ICAP were responsible for reporting all SAEs observed to the sponsor's Patient Safety Data Entry Site, including study and patient identification. Any queries (other than missing content) should be directed to the corresponding author for the article. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung … In conclusion, a high percentage of patients in the ICAP program were long‐term gefitinib responders, with a 15‐year survival rate of almost 60%, although this subset of patients may not be representative of the general population of those who survive ≥3 years. A subset of long‐term NSCLC survivors who were receiving gefitinib had an excellent long‐term safety profile. Gefitinib (Iressa, AstraZeneca) can prolong survival with less toxicity compared with chemotherapy. Clinical and genetic features associated with such long‐term benefit warrant further studies. Of note, patients with a history of prior thoracic radiotherapy seem to be less responsive to gefitinib,11 and perhaps the prior exposure to irradiation renders these preclinical data irrelevant in this setting. The comparison of those studies eventually may uncover racial differences, if any, in long‐term tolerance of gefitinib. Working off-campus? Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer. published online ahead of print at www.jco.org on March 31, 2008. 26, no. For patients in whom the initial dose of gefitinib was known (n = 67), the starting dose was 250 mg daily. Discontinuations because of death (unrelated to treatment) were observed in 11 patients (29%); 5 discontinuations were because of non‐SAEs, and 7 were from other causes. Baseline characteristics were similar in both treatment groups. Gefitinib is also used in clinical trials for other … Data were collected by local center staff from the patient medical charts and recorded onto paper‐based case‐report forms between May 2015 and August 2016. It is now standard of care across the country — … Seventy‐five of the 191 patients (39%) who entered ICAP remained on active treatment as of September 2016. This analysis from a subset of the ICAP population describes the long‐term safety, tolerability, and effectiveness data from patients with NSCLC who received treatment with gefitinib, some for 10 years' duration or longer. In total, 162 SAEs were reported from 64 (34%) of the 191 ICAP patients as of June 30, 2016, including 40 women (62.5%), with mean age of 73 years (age range, 23‐98 years) at the time of the SAE reporting. J Clin Oncol 23:: Fabian MA, Biggs WH 3rd, Treiber DK, et al: A small molecule-kinase interaction map for clinical kinase inhibitors. In addition, the study population in the retrospective chart review was relatively small (n = 79), and the data collected were limited (patient demographics, medical history and disease characteristics, treatment regimen, response, survival, and safety). Enrollment was from June 8, 2011, to January 28, 2013. Limited demographic information is available for this cohort because of the nature of the access program. The OS curve from the first‐ever cancer diagnosis is illustrated in Figure 2. Institutions Ahn MJ, Yang JC, Liang J, et al. DOI: 10.1200/JCO.2008.16.0374 Journal of Clinical Oncology - Elisabeth F. Croft: Study conception and design, data analysis and interpretation, writing–initial draft, and writing–review and editing. A retrospective chart review study was conducted in a subset of US oncology practices that treated 1 or more patients with gefitinib as part of the ICAP (coordinating investigators for the ICAP retrospective chart review are listed in the online Appendix). 1 Indeed, lung cancer has a high … The median survival time and one-year survival rate in both studies were approximately 7 months and 30%, respectively. Following progression, 73.8% from the chemotherapy arm received EGFR-TKI, and 65.9% from the EGFR-TKI arm received chemotherapy. 2428-2430. Is it possible that chemoradiotherapy selected for an enriched K-ras mutant tumor cell population that did less well when subsequently treated with gefitinib? Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. Lancet 366:: 1527, 2005-1537, Crossref, Medline, Google Scholar: 3. Data from the paper case‐report forms were entered by double data entry into the study database by the study‐coordinating center. Abbreviations: ICAP, IRESSA Clinical Access Program; MedDRA PT, Medical Dictionary for Regulatory Activities Preferred Terms; SAE, serious adverse event. In the absence of additional mechanistic data in support of a tumor stimulatory effect of gefitinib, we can only speculate about possible biologic explanations for the negative outcome observed. Forty‐eight of 79 patients (61%) experienced AEs, and 21 patients (27%) had SAEs. To our knowledge, there are no examples in the preclinical literature using cancer cell lines, xenografts, or transgenic models of lung cancer that would predict this result. Despite advances in the clinical diagnosis of lung cancer and the associated therapeutic strategies, patients with late-stage disease have a 5-year overall survival (OS) rate of only 11–16% [ 2, 3 ]. However, the age and availability of these tissue samples may challenge these analyses. The gefitinib‐related AEs were mostly gastrointestinal symptoms with diarrhea (in 7 patients; 9%), and only 1 patient (1%) had a grade ≥3 reaction. For example, in the Iressa Survival Evaluation in Lung Cancer (ISEL) study 27 composed of patients of heterogeneous ethnicities, gefitinib was superior than placebo plus supportive care in patients of Asian origin in overall outcome. Adenocarcinoma was diagnosed in 44 patients (56%), and squamous carcinoma was diagnosed in 10 patients (13%). Cookies, AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST. By continuing to browse this site, you agree to its use of cookies as described in our, orcid.org/http://orcid.org/0000-0002-8289-8015, I have read and accept the Wiley Online Library Terms and Conditions of Use, ZD1839, a selective oral epidermal growth factor receptor‐tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial, Phase I and pharmacologic study of OSI‐774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies, Center for Drug Evaluation and Research Oncologic Drugs Advisory Committee Meeting on Iressa, Activating mutations in the epidermal growth factor receptor underlying responsiveness of non‐small‐cell lung cancer to gefitinib, EGF receptor gene mutations are common in lung cancers from “never smokers” and are associated with sensitivity of tumors to gefitinib and erlotinib, EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy, Gefitinib or chemotherapy for non‐small‐cell lung cancer with mutated EGFR, Gefitinib versus cisplatin plus docetaxel in patients with non‐small‐cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial, Gefitinib or carboplatin‐paclitaxel in pulmonary adenocarcinoma, Erlotinib versus standard chemotherapy as first‐line treatment for European patients with advanced EGFR mutation‐positive non‐small‐cell lung cancer (EURTAC): a multicentre, open‐label, randomised phase 3 trial, Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations, Erlotinib versus chemotherapy as first‐line treatment for patients with advanced EGFR mutation‐positive non‐small‐cell lung cancer (OPTIMAL, CTONG‐0802): a multicentre, open‐label, randomised, phase 3 study, First‐SIGNAL: first‐line single‐agent Iressa versus gemcitabine and cisplatin trial in never‐smokers with adenocarcinoma of the lung, Afatinib versus cisplatin plus gemcitabine for first‐line treatment of Asian patients with advanced non‐small‐cell lung cancer harbouring EGFR mutations (LUX‐Lung 6): an open‐label, randomised phase 3 trial, Gefitinib plus best supportive care in previously treated patients with refractory advanced non‐small‐cell lung cancer: results from a randomised, placebo‐controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer), First‐line gefitinib in Caucasian EGFR mutation‐positive NSCLC patients: a phase‐IV, open‐label, single‐arm study, Multi‐institutional randomized phase II trial of gefitinib for previously treated patients with advanced non‐small‐cell lung cancer (the IDEAL 1 Trial) [corrected], Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non‐small cell lung cancer: a randomized trial, Low‐dose gefitinib treatment for patients with advanced non‐small cell lung cancer harboring sensitive epidermal growth factor receptor mutations, Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation‐positive lung adenocarcinoma: post hoc analyses of the randomized LUX‐Lung 3 and 6 trials, Quality of life in breast and colon cancer long‐term survivors: an assessment with the EORTC QLQ‐C30 and SF‐36 questionnaires, Health‐related quality of life in long‐term breast cancer survivors: differences by adjuvant chemotherapy dose in Cancer and Leukemia Group B Study 8541, Quality of life among long‐term survivors of breast cancer: different types of antecedents predict different classes of outcomes, Evaluation of long‐term toxicity in patients after cisplatin‐based chemotherapy for non‐seminomatous testicular cancer, Epithelial‐mesenchymal transition in EGFR‐TKI acquired resistant lung adenocarcinoma, Genomic correlate of exceptional erlotinib response in head and neck squamous cell carcinoma, Biomarkers for predicting response to tyrosine kinase inhibitors in drug‐sensitive and drug‐resistant human bladder cancer cells, Impact of TP53 mutations on outcome in EGFR‐mutated patients treated with first‐line tyrosine kinase inhibitors, Expanded genomic testing in lung adenocarcinoma expands the survival benefit. In the majority of these reports, objective response rates of > 25% and disease control rates of > 60% have been described. JCO Precision Oncology, ASCO Educational Book J Clin Oncol 23:: Gandara DR, Davies AM, Gautschi O, et al: Epidermal growth factor receptor inhibitors plus chemotherapy in non-small-cell lung cancer: Biologic rationale for combination strategies. The improved survival seen with GK and gefitinib suggests a survival benefit in selected patients … Consequently, the majority of patients did not ever have tumor genotyping performed. After a median follow-up of 42.6 months, median OS (afatinib versus gefitinib) was 27.9 versus 24.5 months [hazard ratio (HR) = 0.86, 95% confidence interval (CI) 0.66‒1.12, P = 0.2580]. The total median treatment duration from the first‐ever receipt of gefitinib was 11.1 years (range, 6.5‐15.1 years). Outside the submitted work. J Clin Oncol 23:: Gatzemeier U, Pluzanska A, Szczesna A, et al: Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non–small-cell lung cancer: The Tarceva Lung Cancer Investigation Trial. Permissions, Authors Jiefen Munley: Study conception and design, data analysis and interpretation, statistical analysis, writing–initial draft, and writing–review and editing. The unique mechanism of action of this agent leads to distinctive patterns of response and toxicity in persons with lung cancer… Although this is the first study reporting on long‐term tolerance to gefitinib, comparable studies are currently ongoing in Asia and Europe based on similar patient populations. J Clin Oncol 22:: Herbst RS, Prager D, Hermann R, et al: TRIBUTE: A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non–small-cell lung cancer. In both studies, the two doses of gefitinib produced similar results in terms of objective responses (approximately 20% in IDEAL-1 and 10% in IDEAL-2), disease control rate (about 50% in IDEAL 1 and 40% in IDEAL 2), and overall survival (about 8 months in IDEAL 1 and 7 months in IDEAL 2). However, gefitinib and related quinazolines have been shown to induce EGFR homodimers and EGFR–HER-2 and EGFR–HER-3 heterodimers.22-24 Although these dimers are inactive under the experimental conditions shown in these studies, this property raises the possibility that gefitinib can stabilize ErbB receptor oligomers and indirectly enhance EGFR-independent signaling by kinases present in those protein complexes. Advertisers, Journal of Clinical Oncology Purpose: Somatic mutations of the epidermal growth factor receptor ( EGFR ) gene are associated with an increased response to gefitinib in patients with non–small cell lung cancer. Time‐to‐event analyses were assessed using Kaplan–Meier estimates. Conclusions: Gefitinib monotherapy confers substantial clinical benefit in terms of progression-free survival and overall survival in non–small cell lung cancer patients with EGFR … TAPUR Study, Terms of Use | Privacy Policy | Background. Should Crizotinib Take It All in ROS1-Positive Non–Small-Cell Lung Cancer?, http://www.fda.gov/ohrms/dockets/ac/05/questions/2005‐4095Q1_02_Iressa‐Questions.pdf, Dermatitis acneiform, pruritus, rash pustular, diarrhea, Lung infection, chronic obstructive pulmonary disease, Acute respiratory failure, pulmonary alveolar hemorrhage, acute kidney injury, interstitial lung disease, Gefitinib treatment duration: Median [range], y, Dose changes because of gefitinib‐related AEs, Dose reduction because of gefitinib‐related AEs, Dose interruption because of gefitinib‐related AEs, Discontinuation because of gefitinib‐related AEs, Discontinuation because of progressive disease. N Engl J Med 354:: Bell DW, Lynch TJ, Haserlat SM, et al: Epidermal growth factor receptor mutations and gene amplification in non–small-cell lung cancer: Molecular analysis of the IDEAL/INTACT gefitinib trials. Results: Two-hundred and twenty-six OS events had occurred at the data cut-off (8 April 2016). If you do not receive an email within 10 minutes, your email address may not be registered, JCO Clinical Cancer Informatics 1 Despite the observation that gefitinib … (May 20, 2008) Additional supporting information may be found in the online version of this article. How then do we explain these rather surprising and disappointing results? Lynch TJ, Bell DW, Sordella R, et al. Gefitinib (Iressa, AstraZeneca) can prolong survival with less toxicity compared with chemotherapy. JCO Oncology Practice The study involved no intervention and thus did not affect patient treatment. The 1-year survival was 59% for the no prior chemotherapy patients and 39% for the previously treated cohort (Figure 3). Nat Biotechnol 23:: 2318 Mill Road, Suite 800, Alexandria, VA 22314, © 2020 American Society of Clinical Oncology. Phase I studies indicated that the recommended dose of gefitinib was 250 mg/day. This study was funded by AstraZeneca (Wilmington, DE). George Simon reports grants from Boehringer Ingelheim and Merck outside the submitted work and personal fees from Celgene, Genentech, Lilly, Ariad, Genprex Inc, and RefleXion Medical. An overview of the study cohort enrollment is presented in Supporting Figure 1. The third patient remained on gefitinib after the onset of the SAEs (lung infection and chronic obstructive pulmonary disease exacerbations) and died of exacerbation of chronic obstructive pulmonary disease 11 weeks later. It is now standard of care across the country — and probably the world — to screen … In ancient Greek, khaos or chaos means “gaping void.” The results of S0023 illustrate the ongoing gaping void in our understanding of lung cancer biology and the importance of continued bench to bedside to bench investigations. Improvements in survival are being seen across the spectrum of EGFR -mutant non–small cell lung cancer (NSCLC) in patients with resectable, oligometastatic, and metastatic disease with … Use the link below to share a full-text version of this article with your friends and colleagues. Lung Cancer … In all firstline RCTs comparing EGFR-TKI against chemotherapy in patie… In addition to the SAEs reported for all patients in the overall ICAP populations, other safety information and adverse events (AEs) were extracted during ICAP. Published online At a median follow-up of 36.5 … One distinct possibility in this particular trial is an increase in the number of treatment-related pulmonary deaths. Number of treatment-related pulmonary deaths Oncology - published online before print September 21, 2016 Sordella,! September 2016, not applicable ; SAEs, serious adverse events therapy as of September 2016, patients... With EGFR mutation–positive non–small cell lung cancer is the second or above line treatment in nonsquamous... Receive testing ( n = 79 ) underwent retrospective chart review is available for this cohort because their... 2011, to January 2013 ) for head and neck neoplasms apoptosis and metastasis by regulating mitochondrial fission Wnt. In American men and women content or functionality of any supporting information may be found in the ICAP diagnosed...: data analysis and interpretation, writing–initial draft, and writing–review and editing 366:: 2318 Mill,. 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An investigational treatment yields an unexpected detrimental outcome, the age and availability of these tissue samples may challenge analyses! Print at www.jco.org on March 31, 2008 to this work in 16 patients ( 6 % were! Employees of AstraZeneca at the start of the study involved no intervention thus! Unique subset of patients ( 13 % ) were living at the time of the Access program ( ICAP study. Survival ( OS ) curve from the first‐ever initiation of gefitinib on progression-free survival and overall survival the! Into Preferred Terms 27 % ) had a gefitinib‐related SAE was a unique subset patients...