Designing a definitive trial for adjuvant targeted therapy in genotype defined lung cancer: The ALCHEMIST trials

Chinese Clinical Oncology

Volumn 4, Issue 3, 2015, Pages

  Alden, Ryan S ^a   Mandrekar, Sumithra J ^b   Oxnard, Geoffrey R ^a  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b MAYO CLINIC   (United States)

Author keywords

Adjuvant therapy; Clinical trial design; Non small cell lung cancer (NSCLC); Targeted therapy

Indexed keywords

ANAPLASTIC LYMPHOMA KINASE; CARBOPLATIN; CRIZOTINIB; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; ERLOTINIB; GEFITINIB; GEMCITABINE; PEMETREXED; PROTEIN KINASE INHIBITOR;

CANCER ADJUVANT THERAPY; CANCER RECURRENCE; DISEASE FREE SURVIVAL; GENOMICS; GENOTYPE; HUMAN; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; REVIEW; ADJUVANT CHEMOTHERAPY; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL (TOPIC); GENETICS; LUNG NEOPLASMS; METASTASIS; METHODOLOGY; MOLECULARLY TARGETED THERAPY; PATHOLOGY; PROCEDURES;

CARCINOMA, NON-SMALL-CELL LUNG; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS AS TOPIC; GENOTYPE; HUMANS; LUNG NEOPLASMS; MOLECULAR TARGETED THERAPY; NEOPLASM METASTASIS; PROTEIN KINASE INHIBITORS; RESEARCH DESIGN;

EID: 84960344783     PISSN: 23043865     EISSN: 23043873     Source Type: Journal    
DOI: 10.3978/j.issn.2304-3865.2015.09.03     Document Type: Review

References (37)

1. Paez JG, Jänne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497-500.
2. Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010;362:2380-8.
3. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-703.
4. Zhou C, Wu YL, Chen G, et al. 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.
5. Gridelli C, De Marinis F, Di Maio M, et al. Gefitinib as first-line treatment for patients with advanced non-small-cell lung cancer with activating Epidermal Growth Factor Receptor mutation: implications for clinical practice and open issues. Lung Cancer 2011;72:3-8.
6. Fukuoka M, Wu YL, Thongprasert S, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol 2011;29:2866-74.
7. Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013;368:2385-94.
8. Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 2014;371:2167-77.
9. von Mehren M, Blanke C, Joensuu H, et al. High incidence of durable responses induced by imatinib mesylate in patients with unresectable and metastatic gastrointestinal stromal tumor (abstract 1608). Proc Am Soc Clin Oncol 2002;21:403a.
10. Heinrich MC, Corless CL, Demetri GD, et al. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol 2003;21:4342-9.
11. Debiec-Rychter M, Sciot R, Le Cesne A, et al. KIT mutations and dose selection for imatinib in patients with advanced gastrointestinal stromal tumours. Eur J Cancer 2006;42:1093-103.
12. Demetri GD, Benjamin RS, Blanke CD, et al. NCCN Task Force report: management of patients with gastrointestinal stromal tumor (GIST)-update of the NCCN clinical practice guidelines. J Natl Compr Canc Netw 2007;5 Suppl 2:S1-29; quiz S30.
13. Sawka CA, Pritchard KI, Shelley W, et al. A randomized crossover trial of tamoxifen versus ovarian ablation for metastatic breast cancer in premenopausal women: a report of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) trial MA.1. Breast Cancer Res Treat 1997;44:211-5.
14. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-92.
15. Andersson M, Lidbrink E, Bjerre K, et al. Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: the HERNATA study. J Clin Oncol 2011;29:264-71.
16. Valero V, Forbes J, Pegram MD, et al. Multicenter phase III randomized trial comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer (BCIRG 007 study): two highly active therapeutic regimens. J Clin Oncol 2011;29:149-56.
17. Dematteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet 2009;373:1097-104.
18. Joensuu H, Eriksson M, Sundby Hall K, et al. One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial. JAMA 2012;307:1265-72.
19. International Breast Cancer Study Group, Colleoni M, Gelber S, et al. Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: International Breast Cancer Study Group Trial 13-93. J Clin Oncol 2006;24:1332-41.
20. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353:1659-72.
21. Goss GD, O'Callaghan C, Lorimer I, et al. Gefitinib versus placebo in completely resected non-small-cell lung cancer: results of the NCIC CTG BR19 study. J Clin Oncol 2013;31:3320-6.
22. Kelly K, Altorki NK, Eberhardt WE, et al. A randomized, double-blind phase 3 trial of adjuvant erlotinib (E) versus placebo (P) following complete tumor resection with or without adjuvant chemotherapy in patients (pts) with stage IB-IIIA EGFR positive (IHC/FISH) non-small cell lung cancer (NSCLC): RADIANT results. J Clin Oncol 2014;32:abstr 7501.
23. D'Angelo SP, Janjigian YY, Ahye N, et al. Distinct clinical course of EGFR-mutant resected lung cancers: results of testing of 1118 surgical specimens and effects of adjuvant gefitinib and erlotinib. J Thorac Oncol 2012;7:1815-22.
24. Pennell NA, Neal JW, Chaft JE, et al. SELECT: A multicenter phase II trial of adjuvant erlotinib in resected early-stage EGFR mutation-positive NSCLC. J Clin Oncol 2014;32:abstr 7514.
25. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005;365:1687-717.
26. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 2007;369:29-36.
27. Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, et al. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet 2013;382:1021-8.
28. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353:1673-84.
29. American Cancer Society. Cancer Facts & Figures 2015. Atlanta: American Cancer Society, 2015.
30. Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington (DC): National Academies Press (US), 2010.
31. Soria JC, Mok TS, Cappuzzo F, et al. EGFR-mutated oncogene-addicted non-small cell lung cancer: current trends and future prospects. Cancer Treat Rev 2012;38:416-30.
32. Shepherd FA, Altorki NK, Eberhardt WEE, et al. Adjuvant erlotinib (E) versus placebo (P) in non-small cell lung cancer (NSCLC) patients (pts) with tumors carrying EGFR-sensitizing mutations from the RADIANT trial. J Clin Oncol 2014;32:abstr 7513.
33. Neal JW, Pennell NA, Govindan R, et al. The SELECT study: a multicenter phase II trial of adjuvant erlotinib in resected epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). J Clin Oncol 2012;30:abstr 7010.
34. Yang P, Kulig K, Boland JM, et al. Worse disease-free survival in never-smokers with ALK+ lung adenocarcinoma. J Thorac Oncol 2012;7:90-7.
35. Garassino MC, Marsoni S, Floriani I. Testing epidermal growth factor receptor mutations in patients with non-small-cell lung cancer to choose chemotherapy: the other side of the coin. J Clin Oncol 2011;29:3835-7; author reply 3837-9.
36. Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009;361:958-67.
37. Marks JL, Broderick S, Zhou Q, et al. Prognostic and therapeutic implications of EGFR and KRAS mutations in resected lung adenocarcinoma. J Thorac Oncol 2008;3:111-6.