Pembrolizumab for patients with melanoma or non-small-cell lung cancer and untreated brain metastases: early analysis of a non-randomised, open-label, phase 2 trial

The Lancet Oncology

Volumn 17, Issue 7, 2016, Pages 976-983

  Goldberg, Sarah B ^a   Gettinger, Scott N ^a   Mahajan, Amit ^a   Chiang, Anne C ^a   Herbst, Roy S ^a   Sznol, Mario ^a   Tsiouris, Apostolos John ^b   Cohen, Justine ^a   Vortmeyer, Alexander ^a   Jilaveanu, Lucia ^a   Yu, James ^a   Hegde, Upendra ^c   Speaker, Stephanie ^a   Madura, Matthew ^a   Ralabate, Amanda ^a   Rivera, Angel ^a   Rowen, Elin ^a   Gerrish, Heather ^a   Yao, Xiaopan ^a   Chiang, Veronica ^a   Kluger, Harriet M ^a   more..

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b WEILL CORNELL MEDICAL CENTER   (United States)

^c UNIVERSITY OF CONNECTICUT HEALTH CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ACUTE KIDNEY FAILURE; ADULT; AGED; ANOREXIA; ARTHRALGIA; ARTICLE; BRAIN METASTASIS; CEREBROVASCULAR ACCIDENT; COGNITIVE DEFECT; COLITIS; DIARRHEA; DIZZINESS; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; ENDOCRINE DISEASE; FATIGUE; FEMALE; HEADACHE; HEMATOLOGIC DISEASE; HUMAN; HYPERKALEMIA; HYPERTRANSAMINASEMIA; INTERSTITIAL NEPHRITIS; MAJOR CLINICAL STUDY; MALE; MELANOMA; NON SMALL CELL LUNG CANCER; OPEN STUDY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SEIZURE; SKIN DISEASE; ADENOCARCINOMA; BRAIN NEOPLASMS; CANCER STAGING; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; FOLLOW UP; LUNG NEOPLASMS; LYMPH NODE METASTASIS; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PROGNOSIS; SECONDARY; SKIN NEOPLASMS; SURVIVAL RATE;

ADENOCARCINOMA; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; BRAIN NEOPLASMS; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; FOLLOW-UP STUDIES; HUMANS; LUNG NEOPLASMS; LYMPHATIC METASTASIS; MALE; MELANOMA; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; SKIN NEOPLASMS; SURVIVAL RATE;

EID: 84971619894     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(16)30053-5     Document Type: Article

References (31)

1. 1 Hodi, FS, O'Day, SJ, McDermott, DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363 (2010), 711–723.
2. 2 Robert, C, Schachter, J, Long, GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 372 (2015), 2521–2532.
3. 3 Robert, C, Long, GV, Brady, B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 372 (2015), 320–330.
4. 4 Brahmer, J, Reckamp, KL, Baas, P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 373 (2015), 123–135.
5. 5 Borghaei, H, Paz-Ares, L, Horn, L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 373 (2015), 1627–1639.
6. 6 Garon, EB, Rizvi, NA, Hui, R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 372 (2015), 2018–2028.
7. 7 Davis, FG, Dolecek, TA, McCarthy, BJ, Villano, JL, Toward determining the lifetime occurrence of metastatic brain tumors estimated from 2007 United States cancer incidence data. Neuro-oncology 14 (2012), 1171–1177.
8. 8 Retsas, S, Gershuny, AR, Central nervous system involvement in malignant melanoma. Cancer 61 (1988), 1926–1934.
9. 9 Sloan, AE, Nock, CJ, Einstein, DB, Diagnosis and treatment of melanoma brain metastasis: a literature review. Cancer Control 16 (2009), 248–255.
10. 10 de la Monte, SM, Moore, GW, Hutchins, GM, Patterned distribution of metastases from malignant melanoma in humans. Cancer Res 43 (1983), 3427–3433.
11. 11 Sorensen, JB, Hansen, HH, Hansen, M, Dombernowsky, P, Brain metastases in adenocarcinoma of the lung: frequency, risk groups, and prognosis. J Clin Oncol 6 (1988), 1474–1480.
12. 12 Gavrilovic, IT, Posner, JB, Brain metastases: epidemiology and pathophysiology. J Neuro-oncology 75 (2005), 5–14.
13. 13 Flanigan, JC, Jilaveanu, LB, Faries, M, et al. Melanoma brain metastases: is it time to reassess the bias?. Curr Probl Cancer 35 (2011), 200–210.
14. 14 Flanigan, JC, Jilaveanu, LB, Chiang, VL, Kluger, HM, Advances in therapy for melanoma brain metastases. Clin Dermatol 31 (2013), 264–281.
15. 15 Mathieu, D, Kondziolka, D, Cooper, PB, et al. Gamma knife radiosurgery for malignant melanoma brain metastases. Clin Neurosurg 54 (2007), 241–247.
16. 16 Redmond, AJ, Diluna, ML, Hebert, R, et al. Gamma Knife surgery for the treatment of melanoma metastases: the effect of intratumoral hemorrhage on survival. J Neurosurg 109 (2008), 99–105.
17. 17 Yushak, ML, Chiang, VL, Kluger, HM, Clinical trials in melanoma patients with brain metastases. Pigment Cell Melanoma Res 28 (2015), 741–743.
18. 18 Ribas, A, Puzanov, I, Drummer, R, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refracgtory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol 16 (2015), 908–918.
19. 19 Eisenhauer, EA, Therasse, P, Bogaerts, J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45 (2009), 228–247.
20. 20 Cohen, JV, Alomari, AK, Vortmeyer, AO, et al. Melanoma brain metastasis pseudoprogression after pembrolizumab treatment. Cancer Immunol Res 4 (2015), 179–182.
21. 21 Greene-Schloesser, D, Robbins, ME, Radiation-induced cognitive impairment: from bench to bedside. Neuro Oncol 14:suppl 4 (2012), 37–44.
22. 22 Khan, AJ, Dicker, AP, On the merits and limitations of whole-brain radiation therapy. J Clin Oncol 31 (2013), 11–13.
23. 23 Alomari, A, Rauch, PJ, Orsaria, M, Minja, FJ, Chiang, VL, Vortmeyer, AO, Radiologic and histologic consequences of radiosurgery for brain tumors. J Neurooncol 117 (2014), 33–42.
24. 24 Di Giacomo, AM, Ascierto, PA, Pilla, L, et al. Ipilimumab and fotemustine in patients with advanced melanoma (NIBIT-M1): an open-label, single-arm phase 2 trial. Lancet Oncol 13 (2012), 879–886.
25. 25 Margolin, K, Ernstoff, MS, Hamid, O, et al. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol 13 (2012), 459–465.
26. 26 Long, GV, Trefzer, U, Davies, MA, et al. Dabrafenib in patients with Val600Glu or Val600Lys BRAF-mutant melanoma metastatic to the brain (BREAK-MB): a multicentre, open-label, phase 2 trial. Lancet Oncol 13 (2012), 1087–1095.
27. 27 Barlesi, F, Gervais, R, Lena, H, et al. Pemetrexed and cisplatin as first-line chemotherapy for advanced non-small-cell lung cancer (NSCLC) with asymptomatic inoperable brain metastases: a multicenter phase II trial (GFPC 07-01). Ann Oncol 22 (2011), 2466–2470.
28. 28 Bearz, A, Garassino, I, Tiseo, M, et al. Activity of Pemetrexed on brain metastases from Non-Small Cell Lung Cancer. Lung Cancer 68 (2010), 264–268.
29. 29 Wu, YL, Zhou, C, Cheng, Y, et al. Erlotinib as second-line treatment in patients with advanced non-small-cell lung cancer and asymptomatic brain metastases: a phase II study (CTONG-0803). Ann Oncol 24 (2013), 993–999.
30. 30 Gerber, NK, Yamada, Y, Rimner, A, et al. Erlotinib versus radiation therapy for brain metastases in patients with EGFR-mutant lung adenocarcinoma. Int J Radiat Oncol Biol Phys 89 (2014), 322–329.
31. 31 Costa, DB, Shaw, AT, Ou, SH, et al. Clinical experience with crizotinib in patients with advanced ALK-rearranged non-small-cell lung cancer and brain metastases. J Clin Oncol 33 (2015), 1881–1888.