- 66 years old
- Diagnosed with stage IV SqCC of the lung
- Experienced disease progression after first-line treatment on platinum-based chemotherapy and immunotherapy12
- Started GILOTRIF as second-line treatment1
*Not an actual patient
NSCLC=non-small cell lung cancer
The only FDA-approved oral option for patients like George.
No biomarker testing required.
Nearly 8 months Overall Survival in LUX-Lung 81,13
In advanced SqCC of the lung progressing after platinum-based chemotherapy*
51% disease control rate for GILOTRIF vs. erlotinib in LUX-Lung 813
Stay ahead of your metastatic SqCC NSCLC patients.
For patients like George, consider the only FDA-approved oral option, GILOTRIF, after progression on platinum-based chemotherapy1,13
Resources for You
Resources for Your Patients
References: 1. GILOTRIF [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2. Hochmair MJ, Morabito A, Hao D, et al. Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: an observational study [published online October 19, 2018]. Future Oncol. doi:10.2217/fon-2018-0711 3. Halmos B, Tan EH, Soo Ra, et al. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: results from a global real-world study (RealGido). Lung Cancer. 2019;127:103-11. 4. Yang JCH, Wu YL, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-151. 5. Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-3334. 6. Ke EE, Zhou Q, Zhang QY, et al. A higher proportion of the EGFR T790M mutation may contribute to the better survival of patients with exon 19 deletions compared with those with L858R. J Thorac Oncol. 2017;12(9):1368-1375. 7. Data on file. Boehringer Ingelheim. CTR. 8. Lee CK, Wu YL, Ding PN, et al. Impact of specific epidermal growth factor receptor (EGFR) mutations and clinical characteristics on outcomes after treatment with EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR-mutant lung cancer: a meta-analysis. J Clin Oncol. 2015;33(17):1958-1965. 9. Yang JC, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX- Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16(7):830-838. 10. Yang JCH, Wu JYS, Hsia TC, et al. Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial. Lancet Oncol. 2012;13:539-548. 11. Wu YL, Zhou C, Hu CP, et al. 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(2):213-222. 12. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: non-small cell lung cancer, version 5. 2018. 13. Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015;16(8):897 907. 14. Yang JCH, Sequist LV, Zhou C, et al. 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. Ann Oncol. 2016;27(11):2103-2110. 15. U.S. Food & Drug Administration (FDA). FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations (press release). https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm592558.htm. Accessed 3.13.2019.
Indications and usage
- GILOTRIF (afatinib) tablets is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have resistant EGFR mutations.
- GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
LUX-Lung 8: HEAD-TO-HEAD vs ERLOTINIB IN PATIENTS WITH METASTATIC SqCC1,13
- Randomized, multicenter, open-label phase III trial that assessed the safety and efficacy of GILOTRIF 40 mg orally once daily (n=398) vs erlotinib 150 mg once daily (n=397) in patients with metastatic squamous NSCLC with disease progression following ≥4 cycles of platinum based chemotherapy
- Primary endpoint was PFS; key secondary endpoint was OS
Similar occurance of serious ARs vs erlotinib1,13
In advanced SqCC of the lung (LUX-Lung 8)
- 44% of patients in each treatment arm experienced serious adverse reactions13
†Includes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration.
‡Includes acne, dermatitis, acneiform dermatitis, eczema, erythema, exfoliative rash, folliculitis, rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, rash pustular, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer.
§Includes paronychia, nail infection, nail bed infection.
Treatment-related discontinuation due to any adverse reactions was similar in both arms (20% VS 17% FOR GILOTRIF VS ERLOTINIB)13
- Discontinuation of therapy in GILOTRIF-treated patients for adverse reactions was 20%. The most frequent adverse reactions that led to discontinuation in GILOTRIF-treated patients were diarrhea (4.1%) and rash/acne (2.6%).1