Patient-Specific Therapeutic Vaccines for Metastatic Melanoma

References

• Balch CM, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol. 2009;27(36):6199–6206.
   PubMed Web of Science ®Google Scholar
• American Joint Committee on Cancer. Edge SB, Byrd DR, Comton CC, et al, eds. Melanoma of the skin. In AJCC Cancer Staging Handbook, 7th ed.; New York: Springer; 2010;387–415.
   Google Scholar
• Chapman PB, et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999;17(9):2745–2751.
   PubMed Web of Science ®Google Scholar
• Middleton MR, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18(1):158–166.
   PubMed Web of Science ®Google Scholar
• Chapman PB, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364(26):2507–2516.
   PubMed Web of Science ®Google Scholar
• Robert C, et al. Ipilimumab plus dacarbazine for previously untreated melanoma. N Engl J Med. 2011;364(26):2517–2526.
   PubMed Web of Science ®Google Scholar
• Eton O, et al. Sequential biochemotherapy versus chemotherapy for metastatic melanoma: Results from a phase III randomized trial. J Clin Oncol. 2002;20(8):2045–2052.
   PubMed Web of Science ®Google Scholar
• Atkins MB, et al. Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): A trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2008;26(35):5748–5754.
   PubMed Web of Science ®Google Scholar
• Hauschild A, et al. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009;27(17):2823–2830.
   PubMed Web of Science ®Google Scholar
• Kim KB, et al. BEAM: A randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma. J Clin Oncol. 2011;30(1):34–41.
   Web of Science ®Google Scholar
• Kaufman HL, et al. The Society for Immunotherapy of Cancer consensus statement on tumour immunotherapy for treatment of cutaneous melanoma. Nat Rev Clin Oncol. 2013;10:588–98.
   PubMed Web of Science ®Google Scholar
• Essner R, et al. Contemporary surgical treatment of advanced-stage melanoma. Arch Surg. 2004;139(9):961–966.
   PubMedGoogle Scholar
• McLoughlin JM, et al. Treatment options for limited or symptomatic metastatic melanoma. Cancer Control. 2008;15(3):239–247.
   Google Scholar
• Howard JH, et al. Metastasectomy for distant metastatic melanoma: Analysis of data from the first Multicenter Selective Lymphadenectomy Trial (MSLT-I). Ann Surg Oncol. 2012;19(8):2547–2555.
   PubMed Web of Science ®Google Scholar
• Morton DL, et al. An international, randomized, phase III trial of bacillus Calmette-Guerin (BCG) plus allogeneic melanoma vaccine (MCV) or placebo after complete resection of melanoma metastatic to regional or distant sites. J Clin Oncol. 2007;25:474s (abstr 8508).
   Web of Science ®Google Scholar
• Lawson DH, et al. E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage II-IV melanoma. J Clin Oncol. 2010;28:15s (suppl; abstr 8504).
   PubMed Web of Science ®Google Scholar
• Flaherty KT, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med. 2010;363(9):809–819.
   PubMed Web of Science ®Google Scholar
• Sosman JA, et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafinib. N Engl J Med. 2012;366(8):707–714.
   PubMed Web of Science ®Google Scholar
• Hauschild A, et al. Dabrafenib in BRAF-mutated metastatic melanoma: A multicenter, open-label phase III randomized controlled trial. Lancet. 2012;380:1893–1901.
   Web of Science ®Google Scholar
• Flaherty KT, et al. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012;367(2):107–114.
   PubMed Web of Science ®Google Scholar
• Flaherty KT, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med. 2010;367(18):1694–1703.
   Web of Science ®Google Scholar
• Ribas A, et al. Combination of vemurafenib and cobimetinib in patients with advanced BRAF(V600)-mutated melanoma: A phase 1b study. Lancet Oncol. 2014;15:954–965.
   PubMed Web of Science ®Google Scholar
• Solit DB, et al. Resistance to BRAF inhibition in melanoms. N Engl J Med. 2011;364:772–774.
   PubMed Web of Science ®Google Scholar
• Frederick DT, et al. BRAF inhibition is associated with enhanced melanoma antigen expression and a more favorable tumor microenvironment in patients with metastatic melanoma. Clin Cancer Res. 2013;19(5):1225–1231.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Should high-dose interleukin-2 still be the preferred treatment for patients with metastatic melanoma? Cancer Biother Radiopharm. 2012;27(6):337–343.
   Web of Science ®Google Scholar
• Atkins MB, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: Analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17(7):2105–2116.
   PubMed Web of Science ®Google Scholar
• Atkins MB, et al. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: Long-term survival update. Cancer J Sci Am. 2000;6(suppl 1): S11–S14.
   PubMed Web of Science ®Google Scholar
• Sosman JA, et al. Three phase II Cytokine Working Group trials of gp100 (210M) peptide plus high-dose interleukin-2 in patients with HAL-A2-positive advanced melanoma. J Clin Oncol. 2008;26:2292–2298.
   PubMed Web of Science ®Google Scholar
• Schwartzentruber DJ, et al. Gp100 peptide vaccine and interleukin-2 in patients with advanced melanoma. N Engl J Med. 2011;364(22):2119–2127.
   PubMed Web of Science ®Google Scholar
• Eton O, et al. Sequential biochemotherapy versus chemotherapy for metastatic melanoma: Results from a phase III randomized trial. J Clin Oncol. 2002;20(8):2045–2052.
   PubMed Web of Science ®Google Scholar
• Atkins MB, et al. Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): A trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2008;26:5748–5754.
   PubMed Web of Science ®Google Scholar
• Schwartz RN, et al. Managing toxicities of high-dose interleukin-2. Oncol. 2002;16(11 Suppl 13):11–20.
   Google Scholar
• Lindsey KR, et al. Impact of the number of treatment courses on the clinical response of patients who receive high-dose bolus interleukin-2. J Clin Oncol. 2000;18(9):1954–1959.
   Web of Science ®Google Scholar
• Dillman RO, et al. High-dose IL-2 in metastatic melanoma: Better survival in patients immunized with antigens from autologous tumor cell lines. Cancer Biother Radiopharm. 2014;29:53–57.
   Web of Science ®Google Scholar
• Pardoll D. The blockade of immune checkpoints in cancer immunotherapy. Nature Cancer Reviews. 2012;12:252–264.
   PubMed Web of Science ®Google Scholar
• Dolan DE, et al. PD-1 pathway inhibitors: Changing the landscape of cancer immunotherapy. Cancer Control. 2014;21:231–237.
   PubMed Web of Science ®Google Scholar
• Hodi FS, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–723.
   PubMed Web of Science ®Google Scholar
• Wolchok JD, et al. Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials. Ann Oncol. 2013; 24:2174–2180.
   PubMed Web of Science ®Google Scholar
• Weber J. Ipilimumab: Controversies in its development, utility and autoimmune adverse events. Cancer Immunol Immunother. 2009;58:823–830.
   PubMed Web of Science ®Google Scholar
• Topolian SL, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366:2443–2454.
   PubMed Web of Science ®Google Scholar
• Brahmer JR, et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012;366:2455–2466.
   PubMed Web of Science ®Google Scholar
• Hamid O, et al. Safety and tumor responses with lambrolizumab (Anti-PD-1) in melanoma. N Engl J Med. 2013;369:134–144.
   PubMed Web of Science ®Google Scholar
• Robert C, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: A randomised dose-comparison cohort of a phase 1 trial. Lancet. 2014;384(9948):1109–1117.
   PubMed Web of Science ®Google Scholar
• Topalian SL, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014;32,1020–1030.
   PubMed Web of Science ®Google Scholar
• Wolchok JD, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: Immune-related response criteria. Clin Cancer Res. 2009;15:7412–7420.
   PubMed Web of Science ®Google Scholar
• Wolchok JD, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013;369:122–133.
   PubMed Web of Science ®Google Scholar
• Chen DS, Mellman I. Oncology meets immunology: The cancer-immunity cycle. Immunity. 2013;39:1–10.
   PubMed Web of Science ®Google Scholar
• Mittal D, et al. New insights into cancer immunoediting and its three component phases—elimination, equilibrium and escape. Curr Opin Immunol. 2014;27:16–25.
   PubMed Web of Science ®Google Scholar
• Van Elsas A, et al. Combination immunotherapy of B16 melanoma using anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and granulocyte/macrophage colony- stimulating factor (GM-CSF)-producing vaccines induces rejection of subcutaneous and metastatic tumors accompanied by autoimmune depigmentation. J Exp Med. 1999;190:355–366.
   PubMed Web of Science ®Google Scholar
• Li B, et al. Anti-programmed death-1 synergizes with granulocyte macrophage colony-stimulating factor—secreting tumor cell immunotherapy providing therapeutic benefit to mice with established tumors. Clin Cancer Res. 2009;15:1623–1634.
   PubMed Web of Science ®Google Scholar
• Lawrence MS, et al. Mutational heterogeneity in cancer and the search for new cancer genes. Nature. 2013;499:214–218.
   PubMed Web of Science ®Google Scholar
• Robbins PF, et al. Mining exomic sequencing data to identify mutated antigens recognized by adoptively transferred tumor-reactive T cells. Nat Med. 2013;19:747–752.
   PubMed Web of Science ®Google Scholar
• Tran E, et al. Cancer immunotherapy based on mutation-specific CD4+ T cells in a patient with epithelial cancer. Science. 2014;344:641–645.
   PubMed Web of Science ®Google Scholar
• Lu Y-C, et al. Efficient identification of mutated cancer antigens recognized by T cells associated with durable tumor regressions. Clin Cancer Res. 2014;20:3401–3410.
   PubMed Web of Science ®Google Scholar
• Dillman RO. Melanoma Vaccines: Trials and Tribulations. Vaccine Dev Ther. 2013;3:57–78.
   Google Scholar
• Andtbacka RHI, et al. OPTiM: A randomized phase III trial of talimogene laherparepvec (T-VEC) versus subcutaneous (SC) granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment (tx) of unresected stage IIIB/C and IV melanoma. J Clin Oncol. 31, 2013 (suppl; abstr LBA9008).
   Google Scholar
• Postow MW, et al. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med. 2012;366:925–931.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Establishing in vitro cultures of autologous tumor cells for use in active specific immunotherapy. J Immunother. 1993;14:65–69.
   Web of Science ®Google Scholar
• Dillman RO, et al. Cancer stem cell antigen-based vaccines: The preferred strategy for active specific immunotherapy of metastatic melanoma? Expert Opin Biol Ther. 2013;13:643–656.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. The feasibility of using short-term cultures of ovarian cancer cells for use as autologous tumor cell vaccines as adjuvant treatment of advanced ovarian cancer. Cancer Biother Radiopharm. 1999;14:443–449.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Irradiated cells from autologous tumor cell lines as patient-specific vaccine therapy in 125 patients with metastatic cancer: Induction of delayed-type hypersensitivity to autologous tumor is associated with improved survival. Cancer Biother Radiopharm. 2002;17:51–66.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Autologous tumor cell line-derived vaccine for patient-specific treatment of advanced renal cell carcinoma. Cancer Biother Radiopharm. 2004;19:570–580.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Phase I/II trial of autologous tumor cell line-derived vaccine for recurrent or metastatic sarcomas. Cancer Biother Radiopharm. 2004;19:581–588.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Patient-specific dendritic cell vaccines for metastatic melanoma. N Engl J Med. 2006;355:1179–1181.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Patient-specific vaccines derived from autologous tumor cell lines as active specific immunotherapy: Results of exploratory phase I/II trials in patients with metastatic melanoma. Cancer Biother Radiopharm. 2007;22:309–321.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Phase II trial of dendritic cells loaded with antigens from self-renewing, proliferating autologous tumor cells as patient-specific anti-tumor vaccines in patients with metastatic melanoma: Final Report. Cancer Biother Radiopharm. 2009;24:311–319.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Tumor stem cell antigens as consolidative active specific immunotherapy: A randomized phase II trial of dendritic cells versus tumor cells in patients with metastatic melanoma. J Immunother. 2012;35:641–649.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. Durable complete response of refractory, progressing metastatic melanoma after treatment with a patient-specific vaccine. Cancer Biother Radiopharm. 2010;25:553–557.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. 5-year survival for patients with metastatic melanoma who had no evidence of disease at time of treatment with patient specific tumor stem cell vaccines. 105th Annual Meeting of the American Association for Cancer Research, 06 April 2014. Proc Am Assoc Cancer Res. 55: 2014. (abstract #197)
   Google Scholar
• Tagawa ST, et al. Survival analysis after resection of metastatic disease followed by peptide vaccines in patients with stage IV melanoma. Cancer. 2006;106:1353–1357.
   PubMed Web of Science ®Google Scholar
• Dillman RO, et al. 5-year survival for patients with detectable metastatic melanoma at time of treatment with patient-specific tumor stem cell vaccines. American Society of Clinical Oncology 50th Annual Meeting, Chicago, IL. 01 June 2014. J Clin Oncol. 32:2014. (abstract #3090).
   Google Scholar
• Dillman RO, et al. Tissue banking in community cancer centers. Oncol Issues. 2008;23:22–26.
   Google Scholar
• Selvan SR, et al. Establishment of stable cell lines for personalized melanoma cell vaccine. Melanoma Res. 2010;20:280–292.
   PubMed Web of Science ®Google Scholar
• Kantoff PW, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411–422.
   PubMed Web of Science ®Google Scholar
• Spitler LE, et al. Adjuvant therapy of stage III and IV malignant melanoma using granulocyte-macrophage colony-stimulating factor. J Clin Oncol. 2000;18:1614–1621.
   PubMed Web of Science ®Google Scholar
• Spitler LE, et al. Recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered for 3 years as adjuvant therapy of stages II(T4), III, and IV melanoma. J Immunother. 2009;32:632–637.
   PubMed Web of Science ®Google Scholar
• Therasse P, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–216.
   PubMed Web of Science ®Google Scholar
• Schmidt P, et al. Eradication of melanomas by targeted elimination of a minor subset of tumor cells. Proc Natl Acad Sci USA. 2011;8:108:2474–2479.
   Google Scholar