Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer

Journal of Thoracic Oncology

Volumn 13, Issue 2, 2018, Pages 165-183

  Socinski, Mark A ^a   Obasaju, Coleman ^b   Gandara, David ^c   Hirsch, Fred R ^d   Bonomi, Philip ^e   Bunn, Paul A ^d   Kim, Edward S ^f   Langer, Corey J ^g   Natale, Ronald B ^h   Novello, Silvia ⁱ   Paz Ares, Luis ^j   Pérol, Maurice ^k   Reck, Martin ^l   Ramalingam, Suresh S ^m   Reynolds, Craig H ⁿ   Spigel, David R ^o   Wakelee, Heather ^p   Thatcher, Nick ^q  

^a FLORIDA HOSPITAL CANCER INSTITUTE   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^e RUSH UNIVERSITY MEDICAL CENTER   (United States)

^f LEVINE CANCER INSTITUTE   (United States)

^g UNIVERSITY OF PENNSYLVANIA   (United States)

^h Department of Hematology Oncology Cedars Sinai Comprehensive Cancer Center   (United States)

ⁱ UNIVERSITY OF TURIN   (Italy)

^j HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^k CENTRE LÉON BÉRARD   (France)

^l Member of the German Center for Lung Research   (Germany)

^m EMORY UNIVERSITY   (United States)

ⁿ Florida Cancer Specialists   (United States)

^o SARAH CANNON RESEARCH INSTITUTE   (United States)

^p STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^q CHRISTIE HOSPITAL   (United Kingdom)

more..

Author keywords

Non small cell lung cancer; Squamous cell lung cancer; Treatment algorithm; Treatment guidelines

Indexed keywords

AFATINIB; ATEZOLIZUMAB; CETUXIMAB; DOCETAXEL; ERLOTINIB; NECITUMUMAB; NIVOLUMAB; PEMBROLIZUMAB; RAMUCIRUMAB;

ADVANCED CANCER; CANCER IMMUNOTHERAPY; CANCER PROGNOSIS; CANCER SURVIVAL; CLINICAL PRACTICE; DRUG EFFICACY; DRUG TARGETING; EMERGENCY TREATMENT; EVIDENCE BASED MEDICINE; HUMAN; NON SMALL CELL LUNG CANCER; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; REVIEW; SQUAMOUS CELL LUNG CARCINOMA; LUNG TUMOR; PATHOLOGY; SQUAMOUS CELL CARCINOMA;

CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; HUMANS; LUNG NEOPLASMS;

EID: 85042408205     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1016/j.jtho.2017.11.111     Document Type: Review

References (131)

1. Travis, W.D., Brambilla, E., Nicholson, A.G., et al. The 2015 World Health Organization Classification of Lung Tumors: impact of genetic, clinical and radiologic advances since the 2004 classification. J Thorac Oncol 10 (2015), 1243–1260.
2. American Cancer Society. What is non-small cell lung cancer? http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Accessed December 1, 2016.
3. Youlden, D.R., Cramb, S.M., Baade, P.D., The International Epidemiology of Lung Cancer: geographical distribution and secular trends. J Thorac Oncol 3 (2008), 819–831.
4. Hirsch, F.R., Spreafico, A., Novello, S., Wood, M.D., Simms, L., Papotti, M., The prognostic and predictive role of histology in advanced non-small cell lung cancer: a literature review. J Thorac Oncol 3 (2008), 1468–1481.
5. Janssen-Heijnen, M.L., Schipper, R.M., Razenberg, P.P., Crommelin, M.A., Coebergh, J.W., Prevalence of co-morbidity in lung cancer patients and its relationship with treatment: a population-based study. Lung Cancer 21 (1998), 105–113.
6. Papi, A., Casoni, G., Caramori, G., et al. COPD increases the risk of squamous histological subtype in smokers who develop non-small cell lung carcinoma. Thorax 59 (2004), 679–681.
7. Rosado-de-Christenson, M.L., Templeton, P.A., Moran, C.A., Bronchogenic carcinoma: radiologic-pathologic correlation. Radiographics 14 (1994), 429–446.
8. Siegel, R.L., Miller, K.D., Jemal, A., Cancer statistics, 2015. CA Cancer J Clin 65 (2015), 5–29.
9. Subramanian, J., Morgensztern, D., Goodgame, B., et al. Distinctive characteristics of non-small cell lung cancer (NSCLC) in the young: a surveillance, epidemiology, and end results (SEER) analysis. J Thorac Oncol 5 (2010), 23–28.
10. Socinski, M.A., Obasaju, C., Gandara, D., et al. Clinicopathologic features of advanced squamous NSCLC. J Thorac Oncol 11 (2016), 1411–1422.
11. Nichols, L., Saunders, R., Knollmann, F.D., Causes of death of patients with lung cancer. Arch Pathol Lab Med 136 (2012), 1552–1557.
12. Caliò A., Nottegar, A., Gilioli, E., et al. ALK/EML4 fusion gene may be found in pure squamous carcinoma of the lung. J Thorac Oncol 9 (2014), 729–732.
13. König, K., Peifer, M., Fassunke, J., et al. Implementation of amplicon parallel sequencing leads to improvement of diagnosis and therapy of lung cancer patients. J Thorac Oncol 10 (2015), 1049–1057.
14. Miyamae, Y., Shimizu, K., Hirato, J., et al. Significance of epidermal growth factor receptor gene mutations in squamous cell lung carcinoma. Oncol Rep 25 (2011), 921–928.
15. Paik, P.K., Hasanovic, A., Wang, L., Rekhtman, N., Ladanyi, M., Kris, M.G., Multiplex testing for driver mutations in squamous cell carcinomas of the lung. [abstract] J Clin Oncol, 30(suppl), 2012, 7505.
16. Pan, Y., Wang, R., Ye, T., et al. Comprehensive analysis of oncogenic mutations in lung squamous cell carcinoma with minor glandular component. Chest 145 (2014), 473–479.
17. Rekhtman, N., Paik, P.K., Arcila, M.E., et al. Clarifying the spectrum of driver oncogene mutations in biomarker-verified squamous carcinoma of lung: lack of EGFR/KRAS and presence of PIK3CA/AKT1 mutations. Clin Cancer Res 18 (2012), 1167–1176.
18. Cancer Genome Atlas Research Network, Hammerman, P.S., Lawrence, M.S., et al. Comprehensive genomic characterization of squamous cell lung cancers. Nature 489 (2012), 519–525.
19. Wang, J., Shen, Q., Shi, Q., et al. Detection of ALK protein expression in lung squamous cell carcinomas by immunohistochemistry. J Exp Clin Cancer Res, 33, 2014, 109.
20. Zhao, W., Choi, Y.L., Song, J.Y., et al. ALK, ROS1 and RET rearrangements in lung squamous cell carcinoma are very rare. Lung Cancer 94 (2016), 22–27.
21. Masters, G.A., Temin, S., Azzoli, C.G., et al. Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 33 (2015), 3488–3515.
22. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines). Non-small cell lung cancer. Version 8.2017. http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed August 4, 2017.
23. Novello, S., Barlesi, F., Califano, R., et al. Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 27 (2016), v1–v27.
24. Goldstraw, P., Chansky, K., Crowley, J., et al. The IASLC Lung Cancer Staging Project: proposals for revision of the TNM Stage Groupings in the forthcoming (eighth) edition of the TNM classification for lung cancer. J Thorac Oncol 11 (2016), 39–51.
25. McMillan, D.C., The systemic inflammation-based Glasgow Prognostic Score: a decade of experience in patients with cancer. Cancer Treat Rev 39 (2013), 534–540.
26. Scagliotti, G.V., Parikh, P., von Pawel, J., et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26 (2008), 3543–3551.
27. Johnson, D.H., Fehrenbacher, L., Novotny, W.F., et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22 (2004), 2184–2191.
28. Highlights of prescribing information. AVASTIN (bevacizumab). http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s312lbl.pdf. Accessed September 21, 2016.
29. European Medicines Agency. Tarceva 25 mg film-coated tablets. Summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000618/WC500033994.pdf. Accessed September 21, 2016.
30. Highlights of prescribing information. ALIMTA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf. Accessed December 1, 2016.
31. Highlights of prescribing information. XALKORI (crizotinib) capsules, for oral use. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s014lbl.pdf. Accessed September 21, 2016.
32. European Medicines Agency. IRESSA 250 mg film-coated tablets. Summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001016/WC500036358.pdf. Accessed September 22, 2016.
33. Scagliotti, G., Novello, S., von Pawel, J., et al. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol 28 (2010), 1835–1842.
34. Ferrell, B.R., Temel, J.S., Temin, S., et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 35 (2017), 96–112.
35. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines). Palliative care. Version 2.2017. https://www.nccn.org/professionals/physician_gls/PDF/palliative.pdf. Accessed August 14, 2017.
36. Highlights of prescribing information. KEYTRUDA (pembrolizumab). http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s008s012lbl.pdf. Accessed December 9, 2016.
37. European Medicines Agency. Keytruda summary of opinion (post authorisation). http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/003820/WC500218016.pdf. Accessed December 23, 2016.
38. Reck, M., Rodriguez-Abreu, D., Robinson, A.G., et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med 375 (2016), 1823–1833.
39. Brahmer, J.R., Rodriguez-Abreu, D., Robinson, A.G., et al. Progression after the next line of therapy (PFS2) and updated OS among patients with advanced NSCLC and PD-L1 TPS >=50% enrolled in KEYNOTE-024. [abstract] J Clin Oncol, 35(suppl 15), 2017, 9000.
40. Brahmer, J.R., Rodriguez-Abreu, D., Robinson, A.G., et al. Health-related quality of life for pembrolizumab vs chemotherapy in advanced NSCLC with PD-L1 >50%: data from KEYNOTE-024. [abstract] J Thorac Oncol, 12(suppl 4), 2017 PL04A.01.
41. Thatcher, N., Hirsch, F.R., Luft, A.V., et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol 16 (2015), 763–774.
42. Paz-Ares, L., Socinski, M.A., Shahidi, J., et al. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine–cisplatin plus necitumumab versus gemcitabine–cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol 27 (2016), 1573–1579.
43. Brahmer, J., Reckamp, K.L., Baas, P., et al. Nivolumab versus docetaxel in advanced squamous-cell non–small-cell lung cancer. N Engl J Med 373 (2015), 123–135.
44. Garon, E.B., Rizvi, N.A., Hui, R., et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 372 (2015), 2018–2028.
45. Herbst, R.S., Baas, P., Kim, D.W., et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 387 (2016), 1540–1550.
46. Soria JC, Fløtten Ø Horn L, et al. Efficacy and safety of pembrolizumab (pembro; MK-3475) for patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC) enrolled in KEYNOTE-001. Abstract presented at the 18th European Cancer Congress, Vienna, Austria, September 25-29, 2015.
47. Baas, P., Garon, E.B., Herbst, R.S., et al. Relationship between level of PD-L1 expression and outcomes in the KEYNOTE-010 study of pembrolizumab vs docetaxel for previously treated, PD-L1–Positive NSCLC. [abstract] J Clin Oncol, 34 No 15(suppl), 2016, 9015.
48. Fehrenbacher, L., Spira, A., Ballinger, M., et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet 387 (2016), 1837–1846.
49. Highlights of prescribing information. TECENTRIQ (atezolizumab). http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761041s000lbl.pdf. Accessed December 9, 2016.
50. Besse, B., Johnson, M., Janne, P.A., et al. Phase II, single-arm trial (BIRCH) of atezolizumab as first-line or subsequent therapy for locally advanced or metastatic PD-L1-selected non-small cell lung cancer (NSCLC) [abstract]. Eur J Cancer, 51(suppl 3), 2015, S717.
51. Gadgeel, S., Ciardiello, F., Rittmeyer, A., et al. OAK, a randomized Ph III study of atezolizumab vs docetaxel in patients with advanced NSCLC: results from subgroup analyses [abstract]. J Thorac Oncol 12 (2017), S9–S10.
52. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet 389 (2017), 255–265.
53. Smith, D.A., Vansteenkiste, J.F., Fehrenbacher, L., et al. Updated survival and biomarker analyses of a randomized phase II study of atezolizumab vs docetaxel in 2L/3L NSCLC (POPLAR) [abstract]. J Clin Oncol, 34(suppl 15), 2016, 9028.
54. Peters, S., Gettinger, S., Johnson, M.L., et al. Phase II trial of atezolizumab as first-line or subsequent therapy for patients with programmed death-ligand 1-selected advanced non-small-cell lung cancer (BIRCH). J Clin Oncol 35 (2017), 2781–2789.
55. Garon, E.B., Ciuleanu, T.E., Arrieta, O., et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet 384 (2014), 665–673.
56. Reck, M., Paz-Ares, L.G., Bidoli, P., et al. Exploratory subgroup analysis of patients (Pts) refractory to first-line (1L) chemotherapy from REVEL, a randomized phase III study of docetaxel (DOC) with ramucirumab (RAM) or placebo (PBO) for second-line (2L) treatment of stage IV non-small-cell lung cancer (NSCLC). [abstract] J Clin Oncol, 34(suppl 15), 2016, 9079.
57. Park, K., Kim, J.H., Cho, E.K., et al. East Asian subgroup analysis of a randomized, double-blind, phase 3 study of docetaxel and ramucirumab versus docetaxel and placebo in the treatment of stage IV non-small cell lung cancer following disease progression after one prior platinum-based therapy (REVEL). Cancer Res Treat 48 (2016), 1177–1186.
58. Gettinger, S., Rizvi, N.A., Chow, L.Q., et al. Nivolumab monotherapy for first-line treatment of advanced non–small-cell lung cancer. J Clin Oncol 34 (2016), 2980–2987.
59. Carbone, D.P., Reck, M., Paz-Ares, L., et al. First-line nivolumab in stage IV or recurrent non-small-cell lung cancer. N Engl J Med 376 (2017), 2415–2426.
60. Sandler, A.B., Nemunaitis, J., Denham, C., et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 18 (2000), 122–130.
61. Wozniak, A.J., Crowley, J.J., Balcerzak, S.P., et al. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non-small-cell lung cancer: a Southwest Oncology Group study. J Clin Oncol 16 (1998), 2459–2465.
62. Lilenbaum, R.C., Herndon, J.E. II, List, M.A., et al. Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the Cancer and Leukemia Group B (study 9730). J Clin Oncol 23 (2005), 190–196.
63. Hoang, T., Dahlberg, S.E., Schiller, J.H., Johnson, D.H., Does histology predict survival of advanced non-small cell lung cancer patients treated with platin-based chemotherapy? An analysis of the Eastern Cooperative Oncology Group Study E1594. Lung Cancer 81 (2013), 47–52.
64. Tan, E.H., Rolski, J., Grodzki, T., et al. Global Lung Oncology Branch trial 3 (GLOB3): final results of a randomised multinational phase III study alternating oral and i.v. vinorelbine plus cisplatin versus docetaxel plus cisplatin as first-line treatment of advanced non-small-cell lung cancer. Ann Oncol 20 (2009), 1249–1256.
65. Kelly, K., Crowley, J., Bunn, P.A. Jr., et al. Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. J Clin Oncol 19 (2001), 3210–3218.
66. Kelly, K., Chansky, K., Mack, P.C., et al. Chemotherapy outcomes by histologic subtypes of non-small-cell lung cancer: analysis of the Southwest Oncology Group database for antimicrotubule-platinum therapy. Clin Lung Cancer 14 (2013), 627–635.
67. Schiller, J.H., Harrington, D., Belani, C.P., et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346 (2002), 92–98.
68. Socinski, M.A., Bondarenko, I., Karaseva, N.A., et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol 30 (2012), 2055–2062.
69. Ardizzoni, A., Boni, L., Tiseo, M., et al. Cisplatin- versus carboplatin-based chemotherapy in first-line treatment of advanced non–small-cell lung cancer: an individual patient data meta-analysis. J Natl Cancer Inst 99 (2007), 847–857.
70. Davis, K.L., Goyal, R.K., Able, S.L., Brown, J., Li, L., Kaye, J.A., Real-world treatment patterns and costs in a US Medicare population with metastatic squamous non-small cell lung cancer. Lung Cancer 87 (2015), 176–185.
71. Highlights of prescribing information. GEMZAR. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf. Accessed September 21, 2016.
72. Highlights of prescribing information.ABRAXANE. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021660s041lbl.pdf. Accessed September 21, 2016.
73. Luo, L., Hu, Q., Jiang, J.-X., et al. Comparing single-agent with doublet chemotherapy in first-line treatment of advanced non-small cell lung cancer with performance status 2: a meta-analysis. Asia Pac J Clin Oncol 11 (2015), 253–261.
74. Mörth, C., Valachis, A., Single-agent versus combination chemotherapy as first-line treatment for patients with advanced non-small cell lung cancer and performance status 2: a literature-based meta-analysis of randomized studies. Lung Cancer 84 (2014), 209–214.
75. Lilenbaum, R., Villaflor, V.M., Langer, C., et al. Single-agent versus combination chemotherapy in patients with advanced non-small cell lung cancer and a performance status of 2. Prognostic factors and treatment selection based on two large randomized clinical trials. J Thorac Oncol 4 (2009), 869–874.
76. Quoix, E., Zalcman, G., Oster, J.-P., et al. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet 378 (2011), 1079–1088.
77. Corre, R., Greillier, L., Le Caër, H., et al. Use of a comprehensive geriatric assessment for the management of elderly patients with advanced non-small-cell lung cancer: the phase III randomized ESOGIA-GFPC-GECP 08-02 study. J Clin Oncol 34 (2016), 1476–1483.
78. Gridelli, C., Perrone, F., Gallo, C., et al. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst 95 (2003), 362–372.
79. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. The Elderly Lung Cancer Vinorelbine Italian Study Group. J Natl Cancer Inst 91 (1999), 66–72.
80. Temel, J.S., Greer, J.A., Muzikansky, A., et al. Early palliative care for patients with metastatic non–small-cell lung cancer. N Engl J Med 363 (2010), 733–742.
81. Ritzwoller, D.P., Carroll, N.M., Delate, T., et al. Patterns and predictors of first-line chemotherapy use among adults with advanced non-small cell lung cancer in the Cancer Research Network. Lung Cancer 78 (2012), 245–252.
82. Søgaard, M., Thomsen, R.W., Bossen, K.S., Sørensen, H.T., Nørgaard, M., The impact of comorbidity on cancer survival: a review. Clin Epidemiol 5:suppl 1 (2013), 3–29.
83. Tabchi, S., Kassouf, E., Florescu, M., Tehfe, M., Blais, N., Factors influencing treatment selection and survival in advanced lung cancer. Curr Oncol 24 (2017), e115–e122.
84. Hirsch, F.R., Varella-Garcia, M., Bunn, P.A. Jr., et al. Epidermal growth factor receptor in non-small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. J Clin Oncol 21 (2003), 3798–3807.
85. Pirker, R., Pereira, J.R., Szczesna, A., et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 373 (2009), 1525–1531.
86. Pirker, R., Pereira, J.R., von Pawel, J., et al. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol 13 (2012), 33–42.
87. Highlights of prescribing information. PORTRAZZA (necitumumab) injection, for intravenous use. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf. Accessed September 21, 2016.
88. European Medicines Agency. Portrazza 800 mg concentrate for solution for infusion. Summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003886/WC500202694.pdf. Accessed September 21, 2016.
89. Pujol, J.L., Pirker, R., Lynch, T.J., et al. Meta-analysis of individual patient data from randomized trials of chemotherapy plus cetuximab as first-line treatment for advanced non-small cell lung cancer. Lung Cance 83 (2014), 211–218.
90. Hirsch, F.R., Herbst, R.S., Olsen, C., et al. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol 26 (2008), 3351–3357.
91. Hirsch, F.R., Redman, M.W., Herbst, R.S., et al. Biomarker-enriched efficacy of cetuximab-based therapy: Squamous subset analysis from S0819, a phase III trial of chemotherapy with or without cetuximab in advanced NSCLC. [abstract] J Clin Oncol, 34(suppl 15), 2016, 9090.
92. Redman, M.W., Crowley, J.J., Herbst, R.S., Hirsch, F.R., Dr, Gandara, Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819. Clin Cancer Res 18 (2012), 4004–4012.
93. Cappuzzo, F., Ciuleanu, T., Stelmakh, L., et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 11 (2010), 521–529.
94. Pérol, M., Chouaid, C., Pérol, D., et al. Randomized, phase III study of gemcitabine or erlotinib maintenance therapy versus observation, with predefined second-line treatment, after cisplatin-gemcitabine induction chemotherapy in advanced non–small-cell lung cancer. J Clin Oncol 30 (2012), 3516–3524.
95. Zhang, L., Ma, S., Song, X., et al. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial. Lancet Oncol 13 (2012), 466–475.
96. Brodowicz, T., Krzakowski, M., Zwitter, M., et al. Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: a phase III trial. Lung Cancer 52 (2006), 155–163.
97. Fidias, P.M., Dakhil, S.R., Lyss, A.P., et al. Phase III study of immediate compared with delayed docetaxel after front-line therapy with gemcitabine plus carboplatin in advanced non–small-cell lung cancer. J Clin Oncol 27 (2009), 591–598.
98. Cicenas, S., Geater, S.L., Petrov, P., et al. Maintenance erlotinib versus erlotinib at disease progression in patients with advanced non-small-cell lung cancer who have not progressed following platinum-based chemotherapy (IUNO study). Lung Cancer 102 (2016), 30–37.
99. Ciuleanu, T., Socinski, M., Obasaju, C., et al. Efficacy and safety of necitumumab continuation monotherapy in patients with EGFR-expressing tumors in SQUIRE, a phase 3 study. [abstract] J Thorac Oncol, 12, 2017, S334.
100. Ciuleanu, T.E., Socinski, M.A., Obasaju, C.K., et al. Safety and efficacy of necitumumab continuation therapy: subgroup analysis of phase 3 SQUIRE study. [abstract] J Clin Oncol, 33(suppl 15), 2015, e19024.
101. Highlights of prescribing information. TARCEVA (erlotinib). http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf. Accessed October 9, 2017.
102. Hanna, N., Shepherd, F.A., Fossella, F.V., et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22 (2004), 1589–1597.
103. Scagliotti, G., Hanna, N., Fossella, F., et al. The differential efficacy of pemetrexed according to NSCLC histology: a review of two phase III studies. Oncologist 14 (2009), 253–263.
104. Di Maio, M., Chiodini, P., Georgoulias, V., et al. Meta-analysis of single-agent chemotherapy compared with combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 27 (2009), 1836–1843.
105. European Medicines Agency. Tecentriq. Summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004143/WC500235778.pdf. Accessed October 16, 2017.
106. Hui, R., Gandhi, L., Carcereny Costa, E., et al. Long-term OS for patients with advanced NSCLC enrolled in the KEYNOTE-001 study of pembrolizumab (pembro). [abstract] J Clin Oncol, 34(suppl 15), 2016, 9026.
107. Ameratunga, M., Pavlakis, N., Gebski, V., Broad, A., Khasraw, M., Epidermal growth factor receptor-tyrosine kinase inhibitors in advanced squamous cell carcinoma of the lung: a meta-analysis. Asia Pac J Clin Oncol 10 (2014), 273–278.
108. Shepherd, F.A., Dancey, J., Ramlau, R., et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18 (2000), 2095–2103.
109. Shepherd, F.A., Rodrigues Pereira, J., Ciuleanu, T., et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353 (2005), 123–132.
110. Ciuleanu, T., Stelmakh, L., Cicenas, S., et al. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol 13 (2012), 300–308.
111. Garassino, M.C., Martelli, O., Broggini, M., et al. Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): a randomised controlled trial. Lancet Oncol 14 (2013), 981–988.
112. Okano, Y., Ando, M., Asami, K., et al. Randomized phase III trial of erlotinib (E) versus docetaxel (D) as second- or third-line therapy in patients with advanced non-small cell lung cancer (NSCLC) who have wild-type or mutant epidermal growth factor receptor (EGFR): docetaxel and Erlotinib Lung Cancer Trial (DELTA) [abstract]. J Clin Oncol, 31(suppl 15), 2013, 8006.
113. Vale, C.L., Burdett, S., Fisher, D.J., et al. Should tyrosine kinase inhibitors be considered for advanced non-small-cell lung cancer patients with wild type EGFR? Two systematic reviews and meta-analyses of randomized trials. Clin Lung Cancer 16 (2015), 173–182.
114. Zhao, N., Zhang, X.C., Yan, H.H., Yang, J.J., Wu, Y.L., Efficacy of epidermal growth factor receptor inhibitors versus chemotherapy as second-line treatment in advanced non-small-cell lung cancer with wild-type EGFR: a meta-analysis of randomized controlled clinical trials. Lung Cancer 85 (2014), 66–73.
115. Soria, J.C., 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 16 (2015), 897–907.
116. ClinicalTrials.gov. NCT02154490. S1400 Lung-MAP: biomarker-targeted second-line therapy in treating patients with recurrent stage IV squamous cell lung cancer. https://clinicaltrials.gov/ct2/show/NCT02154490. Accessed March 28, 2017.
117. Lung-MAP. Lung-MAP clinical trials. Lung-MAP. http://lung-map.org/. Accessed March 28, 2017.
118. Living with squamous cell lung cancer—a guide for patients. https://www.iaslc.org/sites/default/files/wysiwyg-assets/lil73939f_nsclc_patient_booklet_interactive.pdf. Accessed March 16, 2017.
119. Rizvi, N.A., Hellmann, M.D., Brahmer, J.R., et al. Nivolumab in combination with platinum-based doublet chemotherapy for first-line treatment of advanced non–small-cell lung cancer. J Clin Oncol 34 (2016), 2969–2979.
120. Antonia, S.J., Brahmer, J.R., Khleif, S., et al. Phase 1/2 study of the safety and clinical activity of durvalumab in patients with non-small cell lung cancer (NSCLC). [abstract] Ann Oncol, 27(suppl 6), 2016, 1216PD.
121. Garassino, M.C., Vansteenkiste, J.F., Kim, J., et al. Durvalumab in ≥3rd-line locally advanced or metastatic, EGFR/ALK wild-type NSCLC: results from the phase 2 ATLANTIC study. [abstract] J Thorac Oncol, 12(suppl), 2017 PL04A.03.
122. Gulley, J.L., Rajan, A., Spigel, D.R., et al. Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with metastatic or recurrent non-small-cell lung cancer progressing after platinum-based chemotherapy: a phase Ib trial. [abstract] Eur J Cancer, 51(suppl 3), 2015, 3090.
123. Verschraegen, C.F., Chen, F., Spigel, D.R., et al. Avelumab (MSB0010718C; anti-PD-L1) as a first-line treatment for patients with advanced NSCLC from the JAVELIN Solid Tumor phase 1b trial: Safety, clinical activity, and PD-L1 expression. [abstract] J Clin Oncol, 34(suppl 15), 2016, 9036.
124. Antonia, S.J., Brahmer, J.R., Balmanoukian, A.S., et al. Safety and clinical activity of first-line durvalumab in advanced NSCLC: updated results from a phase 1/2 study. [abstract] J Clin Oncol, 35(suppl 15), 2017, e20504.
125. Balmanoukian, A.S., Antonia, S.J., Hwu, W.J., et al. Updated safety and clinical activity of durvalumab monotherapy in previously treated patients with stage IIIB/IV NSCLC. [abstract] J Clin Oncol, 35(suppl 15), 2017, 9085.
126. Gulley, J.L., Rajan, A., Spigel, D.R., et al. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN solid tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol 18 (2017), 599–610.
127. Jerusalem, G.H.M., Chen, F.L., Spigel, D.R., et al. JAVELIN solid tumor: safety and clinical activity of avelumab (anti-PD-L1) as first-line treatment in patients with advanced NSCLC. [abstract] J Thorac Oncol, 12(suppl), 2017, S130.
128. AstraZeneca. AstraZeneca reports initial results from the ongoing MYSTIC trial in stage IV lung cancer. https://www.astrazeneca.com/media-centre/press-releases/2017/astrazeneca-reports-initial-results-from-the-ongoing-mystic-trial-in-stage-iv-lung-cancer-27072017.html. Accessed August 14, 2017.
129. Garassino, M., Rizvi, N., Besse, B., et al. Atezolizumab as 1L therapy for advanced NSCLC in PD-L1-selected patients: updated ORR, PFS and OS data from the BIRCH study. [abstract] J Thorac Oncol 12:suppl (2017), S251–S252.
130. ClinicalTrials.gov. NCT01285609. Phase 3 trial in squamous non small cell lung cancer subjects comparing ipilimumab versus placebo in addition to paclitaxel and carboplatin. https://clinicaltrials.gov/ct2/show/NCT01285609?term=NCT01285609&rank=1. Accessed September 21, 2016.
131. Hellmann, M.D., Rizvi, N.A., Goldman, J.W., et al. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study. Lancet Oncol 18 (2017), 31–41.