The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index; none of the 34 sources its claims cite is checked for support yet.
Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer
Open accessAbstract
BACKGROUND: Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown. METHODS: In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line EGFR-TKI therapy. The primary end point was investigator-assessed progression-free survival. RESULTS: The median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months; hazard ratio; 0.30; 95% confidence interval [CI], 0.23 to 0.41; P<0.001). The objective response rate was significantly better with osimertinib (71%; 95% CI, 65 to 76) than with platinum therapy plus pemetrexed (31%; 95% CI, 24 to 40) (odds ratio for objective response, 5.39; 95% CI, 3.47 to 8.48; P<0.001). Among 144 patients with metastases to the central nervous system (CNS), the median duration of progression-free survival was longer among patients receiving osimertinib than among those receiving platinum therapy plus pemetrexed (8.5 months vs. 4.2 months; hazard ratio, 0.32; 95% CI, 0.21 to 0.49). The proportion of patients with adverse events of grade 3 or higher was lower with osimertinib (23%) than with platinum therapy plus pemetrexed (47%). CONCLUSIONS: Osimertinib had significantly greater efficacy than platinum therapy plus pemetrexed in patients with T790M-positive advanced non-small-cell lung cancer (including those with CNS metastases) in whom disease had progressed during first-line EGFR-TKI therapy. (Funded by AstraZeneca; AURA3 ClinicalTrials.gov number, NCT02151981 .).
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“On the basis of investigator assessment, the median response duration was 9.7 months (95% CI, 8.3 to 11.6) in the osimertinib group and 4.1 months (95% CI, 3.0 to 5.6) in the platinum–pemetrexed group.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > EFFICACY
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“The objective response rate was significantly better with osimertinib (71%; 95% CI, 65 to 76) than with platinum therapy plus pemetrexed (31%; 95% CI, 24 to 40) (odds ratio for objective response, 5.39; 95% CI, 3.47 to 8.48; P<0.001).”
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“The response rate was significantly better in the osimertinib group (71%; 95% CI, 65 to 76) than in the platinum–pemetrexed group (31%; 95% CI, 24 to 40) (odds ratio, 5.39; 95% CI, 3.47 to 8.48; P<0.001) (Table 2).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > RESULTS
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“Improvement in outcomes with osimertinib over platinum–pemetrexed in the tumor and plasma ctDNA T790M-positive subgroup was similar to that in the intention-to-treat population.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
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“The most commonly reported adverse events in the platinum–pemetrexed group were nausea (in 67 patients [49%]), decreased appetite (in 49 [36%]), constipation (in 47 [35%]), and anemia (in 41 [30%]).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > SAFETY AND ADVERSE EVENTS
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“The proportion of patients with adverse events of grade 3 or higher was lower with osimertinib (23%) than with platinum therapy plus pemetrexed (47%).”
- Also stated in: § SAFETY AND ADVERSE EVENTS · plain
“Fewer patients reported adverse events of grade 3 or more in the osimertinib group than in the platinum–pemetrexed group (63 [23%] vs. 64 [47%]).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > RESULTS
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“In a mixed model for repeated-measures analysis, patient-reported outcomes were better in the osimertinib group than in the platinum–pemetrexed group across five prespecified symptoms during the overall period from randomization until 6 months (Table S4 in the Supplementary Appendix).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > EFFICACY
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“A similar finding was observed in the subgroup of patients with T790M-positive status on both tumor and plasma analyses (89 of 116 patients [77%] vs. 22 of 56 patients [39%]; odds ratio, 4.96; 95% CI, 2.49 to 10.15; P<0.001).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > EFFICACY
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“Osimertinib was associated with a lower rate of adverse events leading to permanent discontinuation than was platinum–pemetrexed (in 19 patients [7%] and 14 patients [10%], respectively).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > SAFETY AND ADVERSE EVENTS
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“The median duration of progression-free survival among patients with tumor and plasma T790M-positive status was 8.2 months in the osimertinib group versus 4.2 months in the platinum–pemetrexed group (hazard ratio, 0.42; 95% CI, 0.29 to 0.61) (Fig. 1C).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > EFFICACY
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“Fatal adverse events were reported in 4 patients in the osimertinib group (respiratory failure in 2, pneumonitis in 1, and ischemic stroke in 1). One fatal adverse event of hypovolemic shock was reported in the platinum–pemetrexed group.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > SAFETY AND ADVERSE EVENTS
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“In the osimertinib group, the most commonly reported adverse events were diarrhea (in 113 patients [41%]), rash (in 94 [34%]), dry skin (in 65 [23%]), and paronychia (in 61 [22%]) (Table 3).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > SAFETY AND ADVERSE EVENTS
plainn = 113- Asserted: passes — The authors put it forward as true.
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In the paper
“Among 144 patients with metastases to the central nervous system (CNS), the median duration of progression-free survival was longer among patients receiving osimertinib than among those receiving platinum therapy plus pemetrexed (8.5 months vs. 4.2 months; hazard ratio, 0.32; 95% CI, 0.21 to 0.49).”
- Also stated in: § EFFICACY · plain
“The hazard ratio for progression-free survival favored osimertinib across all predefined subgroups that were analyzed (hazard ratio, <0.50 for each subgroup) (Fig. 2), including patients with CNS metastases (median duration of progression-free survival, 8.5 months vs. 4.2 months; hazard ratio, 0.32; 95% CI, 0.21 to 0.49) (Fig. 1B).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > RESULTS
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In the paper
“The median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months; hazard ratio; 0.30; 95% confidence interval [CI], 0.23 to 0.41; P<0.001).”
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“The duration of progression-free survival was significantly longer in the osimertinib group than in the platinum–pemetrexed group (median, 10.1 months vs. 4.4 months; hazard ratio after adjustment for Asian or non-Asian race, 0.30; 95% confidence interval [CI], 0.23 to 0.41; P<0.001) (Fig. 1A).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > RESULTS
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“In the BLOOM study (), in which 20 patients with leptomeningeal metastases from EGFR mutation–positive non–small-cell lung cancer were treated with osimertinib (at a dose of 160 mg once daily), preliminary results showed radiologic improvement in 7 patients.21”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
What the sources say
- Not checked yetcites [21] Yang JC-H, Kim D-W, Kim S-W, Osimertinib activity in patients (pts) with leptomeningeal (LM) disease from non-small cell lung cancer (NSCLC): updated results from BLOOM, a phase I study. J Clin Oncol 2016; 34: Suppl: 9002 abstract. source
plaindirectn = 7- Asserted: passes — The authors put it forward as true.
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In the paper
“Patients were stratified according to Asian or non-Asian race and were randomly assigned in a 2:1 ratio to receive oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > METHODS > TRIAL DESIGN AND TREATMENT
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In the paper
“Among patients receiving osimertinib, the AURA3 outcomes (median progression-free survival duration of 10.1 months and response rate of 71%) were in line with results of the phase 1/2 AURA and AURA2 studies.22,23”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
What the sources say
- Not checked yetcites [22] Jänne PA, Yang JC-H, Kim D-W, AZD9291 in EGFR inhibitor–resistant non–small-cell lung cancer. N Engl J Med 2015; 372: 1689– 99. 25923549 source
- Not checked yetcites [23] Yang J, Ramalingam SS, Jänne PA, Cantarini M, Mitsudomi T. LBA2_PR: Osimertinib (AZD9291) in pre-treated pts with T790M-positive advanced NSCLC: updated Phase 1 (P1) and pooled Phase 2 (P2) results. J Thorac Oncol 2016; 11: Suppl: S152– S153. source
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In the paper
“However, because of the high false negative rates with plasma ctDNA T790M testing, the analysis of a biopsy sample is recommended for patients with a plasma T790M-negative result who have disease progression after receiving first-line EGFR-TKI.26”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
What the sources say
- Not checked yetcites [26] Oxnard GR, Thress KS, Alden RS, Association between plasma genotyping and outcomes of treatment with osimertinib (AZD9291) in advanced non-small-cell lung cancer. J Clin Oncol 2016; 34: 3375– 82. 27354477 PMC5035123
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In the paper
“The safety profile in the platinum–pemetrexed group was consistent with that observed in the cisplatin–pemetrexed group in the IMPRESS trial.28”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
What the sources say
- Not checked yetcites [28] Soria JC, Wu YL, Nakagawa K, Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol 2015; 16: 990– 8. 26159065
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In the paper
“At the time of progression, about 60% of patients (regardless of race or ethnic background) are found to have a p.Thr790Met point mutation (T790M) in the gene encoding EGFR.13–16”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
What the sources say
- Not checked yetcites [13] Kobayashi S, Boggon TJ, Dayaram T, EGFR mutation and resistance of non–small-cell lung cancer to gefitinib. N Engl J Med 2005; 352: 786– 92. 15728811 source
- Not checked yetcites [14] Yu HA, Arcila ME, Rekhtman N, Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers. Clin Cancer Res 2013; 19: 2240– 7. 23470965 PMC3630270 source
- Not checked yetcites [15] Sequist LV, Waltman BA, Dias-Santa-gata D, Genotypic and histological evolution of lung cancers acquiring resistance to EGFR inhibitors. Sci Transl Med 2011; 3: 75ra26. PMC3132801 21430269 source
- Not checked yetcites [16] Oxnard GR, Arcila ME, Sima CS, Acquired resistance to EGFR tyrosine kinase inhibitors in EGFR-mutant lung cancer: distinct natural history of patients with tumors harboring the T790M mutation. Clin Cancer Res 2011; 17: 1616– 22. 21135146 PMC3060283 source
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In the paper
“The demographic and clinical characteristics of the patients at baseline were balanced in the two groups (Table 1).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > PATIENTS
plainn = 419- Asserted: passes — The authors put it forward as true.
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In the paper
“Osimertinib had significantly greater efficacy than platinum therapy plus pemetrexed in patients with T790M-positive advanced non–small-cell lung cancer (including those with CNS metastases) in whom disease had progressed during first-line EGFR-TKI therapy.”
- Also stated in: § DISCUSSION · plain
“In conclusion, osimertinib was more effective than combination platinum-based chemotherapy in patients with T790M-positive non–small-cell lung cancer (including those with CNS metastases) after disease progression with first-line EGFR-TKI therapy.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
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In the paper
“Similarly, the treatment outcomes with platinum–pemetrexed (a median progression-free survival duration of 4.4 months and response rate of 31%) were broadly in line with cisplatin–pemetrexed treatment in a T790M-positive population (as defined according to the results on a plasma ctDNA test) in the IMPRESS trial.25”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
What the sources say
- Not checked yetcites [25] Soria J, Kim S, Wu Y, Gefitinib/chemotherapy vs chemotherapy in EGFR mutation-positive NSCLC resistant to first-line gefitinib: IMPRESS T790M subgroup analysis. J Thorac Oncol 2015; 10: Suppl: S207– S208.
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“The findings of AURA3 support the feasibility of detecting EGFR T790M from plasma ctDNA samples, in line with previous reports.26,27”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
What the sources say
- Not checked yetcites [26] Oxnard GR, Thress KS, Alden RS, Association between plasma genotyping and outcomes of treatment with osimertinib (AZD9291) in advanced non-small-cell lung cancer. J Clin Oncol 2016; 34: 3375– 82. 27354477 PMC5035123
- Not checked yetcites [27] Jenkins S, Yang J, Ramalingam S, 134O_PR: Plasma ctDNA analysis for detection of EGFR T790M mutation in patients (pts) with EGFR mutation-positive advanced non-small cell lung cancer (aNSCLC). J Thorac Oncol 2016; 11: 4 Suppl: S153– S154.
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“In our trial, the benefit of osimertinib in the subgroup of patients with CNS metastases was shown by a longer duration of progression-free survival than among those treated with platinum–pemetrexed.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
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“On the basis of these results, the Food and Drug Administration approved osimertinib under the Breakthrough Therapy Designation Program.24”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
What the sources say
- Not matchedcites [24] FDA approves new pill to treat certain patients with non-small cell lung cancer. Press release of the Food and Drug Administration, November 13, 2015 (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472525.htm).
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plaindirectn = 411- Asserted: passes — The authors put it forward as true.
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None of the sources cited for this claim have been checked yet.
In the paper
“Despite high tumor response rates with first-line EGFR-TKIs, disease progresses in a majority of patients after 9 to 13 months of treatment.5–12”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
What the sources say
- Not checked yetcites [5] Maemondo M, Inoue A, Kobayashi K, Gefitinib or chemotherapy for non–small-cell lung cancer with mutated EGFR. N Engl J Med 2010; 362: 2380– 8. 20573926 source
- Not checked yetcites [6] Mitsudomi T, Morita S, Yatabe Y, 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. Lancet Oncol 2010; 11: 121– 8. 20022809 source
- Not checked yetcites [7] Zhou C, Wu YL, Chen G, 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. Lancet Oncol 2011; 12: 735– 42. 21783417 source
- Not checked yetcites [8] Rosell R, Carcereny E, Gervais R, 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. Lancet Oncol 2012; 13: 239– 46. 22285168 source
- Not checked yetcites [9] Sequist LV, Yang JC, Yamamoto N, Phase III study of afatinib or cisplatin plus pemetrexed in patients with meta-static lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013; 31: 3327– 34. 23816960 source
- Not checked yetcites [10] Wu YL, Zhou C, Liam CK, First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol 2015; 26: 1883– 9. 26105600 source
- Not checked yetcites [11] Wu Y-L, Zhou C, Hu C-P, 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. Lancet Oncol 2014; 15: 213– 22. 24439929 source
- Not checked yetcites [12] Mok TS, Wu Y-L, Thongprasert S, Gefitinib or carboplatin–paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947– 57. 19692680 source
plain- Asserted: passes — The authors put it forward as true.
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- Probably not a substantial claim. 7
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In the paper
“A prolongation in the QT interval was recorded in 10 patients (4%) in the osimertinib group and 1 patient (1%) in the platinum–pemetrexed group, with all events of grade 1 or 2 in severity except for one grade 3 event in the osimertinib group.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > SAFETY AND ADVERSE EVENTS
plainn = 10- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The hazard ratio for progression-free survival favored osimertinib across all predefined subgroups that were analyzed (hazard ratio, <0.50 for each subgroup) (Fig. 2), including patients with CNS metastases (median duration of progression-free survival, 8.5 months vs. 4.2 months; hazard ratio, 0.32; 95% CI, 0.21 to 0.49) (Fig. 1B).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > EFFICACY
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The duration of progression-free survival according to blinded independent central review was consistent with the investigator-assessed durations, with a median of 11.0 months versus 4.2 months (adjusted hazard ratio, 0.28; 95% CI, 0.20 to 0.38; P<0.001).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > EFFICACY
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Interstitial lung disease–like adverse events were reported in 10 patients (4%) in the osimertinib group (nine events of grade 1 or 2 in severity and one death) and in 1 patient (1%) in the platinum–pemetrexed group (one grade 3 event).”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > RESULTS > SAFETY AND ADVERSE EVENTS
plainn = 10- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“All the patients who underwent randomization were included in the intention-to-treat population, which was used for all efficacy analyses.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > METHODS > STATISTICAL ANALYSIS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Overall, adverse events tended to be more severe in the platinum–pemetrexed group, despite the longer treatment duration with osimertinib.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The safety analysis included all the patients in the intention-to-treat population who had received at least one dose of a trial drug and for whom data were available after the administration of the drug.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > METHODS > STATISTICAL ANALYSIS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“The presence of the T790M variant reduces binding of first-generation or second-generation EGFR-TKIs to the ATP-binding pocket of EGFR, thereby reducing EGFR-TKI–mediated inhibition of downstream signaling and potentially leading to disease progression.17–19”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
What the sources say
- Not checked yetcites [17] Yun CH, Mengwasser KE, Toms AV, The T790M mutation in EGFR kinase causes drug resistance by increasing the affinity for ATP. Proc Natl Acad Sci U S A 2008; 105: 2070– 5. 18227510 PMC2538882 source
- Not checked yetcites [18] Sos ML, Rode HB, Heynck S, Chemogenomic profiling provides insights into the limited activity of irreversible EGFR inhibitors in tumor cells expressing the T790M EGFR resistance mutation. Cancer Res 2010; 70: 868– 74. 20103621 source
- Not checked yetcites [19] Cross DA, Ashton SE, Ghiorghiu S, AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov 2014; 4: 1046– 61. 24893891 PMC4315625 source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“These findings were confirmed in a pooled analysis of two subsequent phase 2 studies of osimertinib (at a dose of 80 mg once daily) in 411 patients with T790M-positive non–small-cell lung cancer, in which the response rate was 66% on blinded independent central review and the median duration of progression-free survival was 11.0 months.23”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
What the sources say
- Not checked yetcites [23] Yang J, Ramalingam SS, Jänne PA, Cantarini M, Mitsudomi T. LBA2_PR: Osimertinib (AZD9291) in pre-treated pts with T790M-positive advanced NSCLC: updated Phase 1 (P1) and pooled Phase 2 (P2) results. J Thorac Oncol 2016; 11: Suppl: S152– S153. source
plainn = 411- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The trial was conducted in accordance with the provisions of the Declaration of Helsinki, Good Clinical Practice guidelines (as defined by the International Conference on Harmonisation), applicable regulatory requirements, and the policy on bioethics and human biologic samples of the trial sponsor, AstraZeneca.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > METHODS > TRIAL OVERSIGHT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“We determined that 221 events of progression or death would provide a power of 80% to reject the null hypothesis of no significant difference in the duration of progression-free survival between the two treatment groups, assuming a treatment effect hazard ratio of 0.67 with a P value of 0.05 indicating two-sided statistical significance.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > METHODS > STATISTICAL ANALYSIS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Osimertinib is an oral, irreversible EGFR-TKI that is selective for both EGFR and T790M resistance mutations with activity in the central nervous system (CNS).19–21”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
What the sources say
- Not checked yetcites [19] Cross DA, Ashton SE, Ghiorghiu S, AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov 2014; 4: 1046– 61. 24893891 PMC4315625 source
- Not checked yetcites [20] Ballard P, Yates JW, Yang Z, Pre-clinical comparison of osimertinib with other EGFR-TKIs in EGFR-mutant NSCLC brain metastases models, and early evidence of clinical brain metastases activity. Clin Cancer Res 2016; 22: 5130– 40. 27435396 source
- Not checked yetcites [21] Yang JC-H, Kim D-W, Kim S-W, Osimertinib activity in patients (pts) with leptomeningeal (LM) disease from non-small cell lung cancer (NSCLC): updated results from BLOOM, a phase I study. J Clin Oncol 2016; 34: Suppl: 9002 abstract. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Among patients with advanced non–small-cell lung cancer with a mutant epidermal growth factor receptor (EGFR), EGFR tyrosine kinase inhibitors (TKIs) are the standard first-line therapy.1–4”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
What the sources say
- Not checked yetcites [1] Masters GA, Temin S, Azzoli CG, Systemic therapy for Stage IV non-small-cell lung cancer: American Society of Clinical Oncology Clinical Practice Guideline update. J Clin Oncol 2015; 33: 3488– 515. 26324367 PMC5019421 source
- Not checked yetcites [2] Novello S, Barlesi F, Califano R, Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2016; 27: Suppl 5: v1– v27. 27664245 source
- Not checked yetcites [3] Tan DS, Yom SS, Tsao MS, The International Association for the Study of Lung Cancer consensus statement on optimizing management of EGFR mutation-positive non-small cell lung cancer: status in 2016. J Thorac Oncol 2016; 11: 946– 63. 27229180 source
- Not checked yetcites [4] National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: NSCLC (version 3.2017). 2016 (http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf). 28188192 source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“A sensitivity analysis of progression-free survival by blinded independent central review was conducted.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > METHODS > TRIAL END POINTS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Patients were stratified according to Asian or non-Asian race and were randomly assigned in a 2:1 ratio to receive oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles.”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > METHODS > TRIAL DESIGN AND TREATMENT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In AURA3, the safety profile for osimertinib was consistent with that reported previously and differed from that in the platinum–pemetrexed group.23”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > DISCUSSION
What the sources say
- Not checked yetcites [23] Yang J, Ramalingam SS, Jänne PA, Cantarini M, Mitsudomi T. LBA2_PR: Osimertinib (AZD9291) in pre-treated pts with T790M-positive advanced NSCLC: updated Phase 1 (P1) and pooled Phase 2 (P2) results. J Thorac Oncol 2016; 11: Suppl: S152– S153. source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“In the phase 1 component of AURA, a phase 1/2 trial (ClinicalTrials.gov number, ), the objective response rate for osimertinib in patients with T790M-positive non–small-cell lung cancer was 61%; the median duration of progression-free survival was 9.6 months.22”
§ Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer > Abstract > CONCLUSIONS
What the sources say
- Not checked yetcites [22] Jänne PA, Yang JC-H, Kim D-W, AZD9291 in EGFR inhibitor–resistant non–small-cell lung cancer. N Engl J Med 2015; 372: 1689– 99. 25923549
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper relies on this without support.
Platinum-pemetrexed was the standard of care for patients with T790M-positive advanced NSCLC after first-line EGFR-TKI at the time of trial initiation.
“Chemotherapy was the standard control at the time of trial initiation.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In T790M-positive tumors, following progression after first- or second-generation EGFR TKIs, second-line osimertinib has demonstrated significant efficacy compared with chemotherapy (median PFS: 10.1 vs 4.4 months; HR, 0.30 (95% CI, 0.23‒0.40), P < 0.001).”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [48]
Experimental — accuracy not yet measuredIn the citing paper
“In addition to being used alone, osimertinib is also being studied in combination with other targeted therapies for NSCLC, such as inhibitors of the Met, Bcl-2, and MAPK pathways.138–140”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [140]
In the citing paper
“Even more variable are duration of response to targeted therapy, progression-free survival and overall survival16–26, 28–32, 35.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [21]
In the citing paper
“Across clinical trials of first-line targeted therapy for oncogene-addicted subgroups of NSCLC, rates of objective response [G] typically range between 50% and 83% and complete responses [G] are rare; in addition, some patients exhibit de novo resistance16–26, 28–32, 35.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [21]
In the citing paper
“In a randomized phase III trial[3], osimertinib significantly improved both progression-free survival (PFS) and objective response rate (ORR) when compared to platinum-pemetrexed chemotherapy for T790M-positive non-small cell lung cancer (NSCLC) after progression on 1st or 2nd generation EGFR-TKIs.”
From Landscape of EGFR-Dependent and -Independent Resistance Mechanisms to Osimertinib and Continuation Therapy Beyond Progression in EGFR -Mutant NSCLC (2018) · cites this paper as [3]
In the citing paper
“In the AURA3 phase III trial, osimertinib demonstrated signi fi cantly higher ef fi cacy than platinum-based chemotherapy in patients with T790M-positive NSCLC. 14”
From Osimertinib for Patients With Non–Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09) (2020) · cites this paper as [14]
In the citing paper
“Osimertinib was granted accelerated approval by the FDA in 2015 as a second-line treatment for NSCLC, and was approved as a first-line treatment for metastatic NSCLC in 2018 (ref.49).”
From Advances in covalent drug discovery (2022) · cites this paper as [49]
Citations
Cites
Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
Mok, T. S., Wu, Y.-L., Thongprasert, S., Yang, C.-H., Chu, D.-T., Saijo, N., Sunpaweravong, P., Han, B., Margono, B., Ichinose, Y., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0810699 · Cited by 8,261
Self-citationGefitinib or Chemotherapy for Non–Small-Cell Lung Cancer with Mutated EGFR
Maemondo, M., Inoue, A., Kobayashi, K., Sugawara, S., Oizumi, S., Isobe, H., Gemma, A., Harada, M., Yoshizawa, H., Kinoshita, I., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0909530 · Cited by 5,525
Rosell, R., Carcereny, E., Gervais, R., Vergnenegre, A., Massuti, B., Felip, E., Palmero, R., Garcia-Gomez, R., Pallares, C., Sanchez, J. M., et al. (2012) · The Lancet Oncology · doi:10.1016/s1470-2045(11)70393-x · Cited by 5,489
Mitsudomi, T., Morita, S., Yatabe, Y., Negoro, S., Okamoto, I., Tsurutani, J., Seto, T., Satouchi, M., Tada, H., Hirashima, T., et al. (2010) · The Lancet Oncology · doi:10.1016/s1470-2045(09)70364-x · Cited by 4,090
Zhou, C., Wu, Y.-L., Chen, G., Feng, J., Liu, X.-Q., Wang, C., Zhang, S., Wang, J., Zhou, S., Ren, S., et al. (2011) · The Lancet Oncology · doi:10.1016/s1470-2045(11)70184-x · Cited by 4,081
Self-citationEGFR Mutation and Resistance of Non–Small-Cell Lung Cancer to Gefitinib
Kobayashi, S., Boggon, T. J., Dayaram, T., Jänne, P. A., Kocher, O., Meyerson, M., Johnson, B. E., Eck, M. J., Tenen, D. G., & Halmos, B. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa044238 · Cited by 3,964
Genotypic and Histological Evolution of Lung Cancers Acquiring Resistance to EGFR Inhibitors
Sequist, L. V., Waltman, B. A., Dias-Santagata, D., Digumarthy, S., Turke, A. B., Fidias, P., Bergethon, K., Shaw, A. T., Gettinger, S., Cosper, A. K., et al. (2011) · Science Translational Medicine · doi:10.1126/scitranslmed.3002003 · Cited by 3,499
Sequist, L. V., Yang, J. C.-H., Yamamoto, N., O'Byrne, K., Hirsh, V., Mok, T., Geater, S. L., Orlov, S., Tsai, C.-M., Boyer, M., et al. (2013) · Journal of Clinical Oncology · doi:10.1200/jco.2012.44.2806 · Cited by 3,228
Self-citationNovello, S., Barlesi, F., Califano, R., Cufer, T., Ekman, S., Levra, M. G., Kerr, K., Popat, S., Reck, M., Senan, S., et al. (2016) · Annals of Oncology · doi:10.1093/annonc/mdw326 · Cited by 2,631
Yu, H. A., Arcila, M. E., Rekhtman, N., Sima, C. S., Zakowski, M. F., Pao, W., Kris, M. G., Miller, V. A., Ladanyi, M., & Riely, G. J. (2013) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-12-2246 · Cited by 2,454
Research works printed but not linked: 1
- Soria J, 2015, J Thorac Oncol, 10, S207
Cited by
Sorted by citations
Osimertinib in Untreated EGFR -Mutated Advanced Non–Small-Cell Lung Cancer
Soria, J.-C., Ohe, Y., Vansteenkiste, J., Reungwetwattana, T., Chewaskulyong, B., Lee, K. H., Dechaphunkul, A., Imamura, F., Nogami, N., Kurata, T., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1713137 · Cited by 5,508
Self-citationThe biology and management of non-small cell lung cancer
Herbst, R. S., Morgensztern, D., & Boshoff, C. (2018) · Nature · doi:10.1038/nature25183 · Cited by 4,891
Overall Survival with Osimertinib in Untreated, EGFR -Mutated Advanced NSCLC
Ramalingam, S. S., Vansteenkiste, J., Planchard, D., Cho, B. C., Gray, J. E., Ohe, Y., Zhou, C., Reungwetwattana, T., Cheng, Y., Chewaskulyong, B., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1913662 · Cited by 2,914
Self-citationLiquid biopsies come of age: Towards implementation of circulating tumour DNA
Wan, J. C. M., Massie, C., Garcia-Corbacho, J., Mouliere, F., Brenton, J. D., Caldas, C., Pacey, S., Baird, R., & Rosenfeld, N. (2017) · Nature Reviews Cancer · doi:10.1038/nrc.2017.7 · Cited by 2,809
A view on drug resistance in cancer
Vasan, N., Baselga, J., & Hyman, D. M. (2019) · Nature · doi:10.1038/s41586-019-1730-1 · Cited by 2,770
Metadata
- Authors
- Mok, T. S., Wu, Y.-L., Ahn, M.-J., Garassino, M. C., Kim, H. R., Ramalingam, S. S., Shepherd, F. A., He, Y., Akamatsu, H., Theelen, W. S. M. E., Lee, C. K., Sebastian, M., Templeton, A., Mann, H., Marotti, M., Ghiorghiu, S., & Papadimitrakopoulou, V. A.
- Affiliations
- Army Medical University (CN)
- Emory University (US)
- Goethe University Frankfurt (DE)
- AstraZeneca (United Kingdom) (GB)
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-02-16
- Volume
- 376
- Issue
- 7
- Pages
- 629-640
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC6762027
- OpenAlex
- W2560717039
- Semantic Scholar
- bd8840946a65bec6d407a96092eda55497e49a58
- Cited by
- 3,379
- References
- 25
- Citations by year
- 2026: 198 · 2025: 280 · 2024: 301 · 2023: 318 · 2022: 410 · 2021: 438 · 2020: 404 · 2019: 365 · 2018: 389 · 2017: 268
- FWCI
- 305.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- Research Explorer (The University of Manchester) (submittedVersion, other-oa)
- Funders
- Cancer Research UK (20465)
- National Cancer Institute (P30CA016672)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- osimertinib, T790M mutation, non-small cell lung cancer, EGFR tyrosine kinase inhibitor resistance, pemetrexed, carboplatin, cisplatin, second-line therapy, progression-free survival, central nervous system metastasis, brain metastases, objective response rate, adverse events
- MeSH terms
- Pemetrexed, Acrylamides, Adult, Aged, Aged, 80 and over, Aniline Compounds, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Indoles, Lung Neoplasms, Male, Middle Aged, Mutation, Piperazines, Platinum, Pyrimidines, Disease-Free Survival, Young Adult, ErbB Receptors
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-06, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-06 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
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