Adjuvant immunotherapy of melanoma and development of new approaches using the neoadjuvant approach

Clinics in Dermatology

Volumn 31, Issue 3, 2013, Pages 237-250

  Davar, Diwakar ^a   Tarhini, Ahmad A ^a   Kirkwood, John M ^a  

^a UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; ALPHA2A INTERFERON; ALPHA2B INTERFERON; ARRY 438162; CISPLATIN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4 ANTIBODY; DABRAFENIB; DACARBAZINE; FOTEMUSTINE; GAMMA INTERFERON; INTERLEUKIN 2; IPILIMUMAB; PEGINTERFERON ALPHA2B; PLACEBO; SELUMETINIB; TEMOZOLOMIDE; TRAMETINIB; VEMURAFENIB; VINBLASTINE;

ARTICLE; CANCER ADJUVANT THERAPY; CANCER IMMUNOTHERAPY; CANCER RECURRENCE; CANCER STAGING; CANCER SURVIVAL; CONTINUOUS INFUSION; DRUG DOSE COMPARISON; DRUG MEGADOSE; HUMAN; IMMUNE RESPONSE; LOCAL RECURRENCE FREE SURVIVAL; LOW DRUG DOSE; MELANOMA; MITOSIS; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; TREATMENT INDICATION; TUMOR VOLUME; UNSPECIFIED SIDE EFFECT;

CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNOTHERAPY; MELANOMA; NEOADJUVANT THERAPY; SKIN NEOPLASMS;

EID: 84876702868     PISSN: 0738081X     EISSN: 18791131     Source Type: Journal    
DOI: 10.1016/j.clindermatol.2012.08.012     Document Type: Article

References (58)

1. Lens M.B., Dawes M. Interferon alfa therapy for malignant melanoma: a systematic review of randomized controlled trials. J Clin Oncol 2002, 20:1818-1825.
2. Wheatley K., Ives N., Hancock B., et al. Does adjuvant interferon-alpha for high-risk melanoma provide a worthwhile benefit? A meta-analysis of the randomised trials. Cancer Treat Rev 2003, 29:241-252.
3. Wheatley K., Hancock B., Gore M., et al. Interferon-{alpha} as adjuvant therapy for melanoma: an individual patient data meta-analysis of randomised trials. J Clin Oncol 2007, 25. [Abstract 8526].
4. Mocellin S., Pasquali S., Rossi C.R., et al. Interferon alpha adjuvant therapy in patients with high-risk melanoma: a systematic review and metaanalysis. J Natl Cancer Inst 2010, 102:493-501.
5. Kirkwood J.M., Strawderman M.H., Ernstoff M.S., et al. Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial EST 1684. J Clin Oncol 1996, 14:7-17.
6. Kirkwood J.M., Ibrahim J.G., Sondak V.K., et al. High- and low-dose interferon alfa-2b in high-risk melanoma: first analysis of intergroup trial E1690/S9111/C9190. J Clin Oncol 2000, 18:2444-2458.
7. Kirkwood J.M., Ibrahim J.G., Sosman J.A., et al. High-dose interferon alfa-2b significantly prolongs relapse-free and overall survival compared with the GM2-KLH/QS-21 vaccine in patients with resected stage IIB-III melanoma: results of intergroup trial E1694/S9512/C509801. J Clin Oncol 2001, 19:2370-2380.
8. Tatsumi T., Kierstead L.S., Ranieri E., et al. Disease-associated bias in T helper type 1 (Th1)/Th2 CD4(+) T cell responses against MAGE-6 in HLA-DRB10401(+) patients with renal cell carcinoma or melanoma. JExp Med 2002, 196:619-628.
9. Chapman P.B., Hauschild A., Robert C., et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011, 364:2507-2516.
10. Hodi F.S., O'Day S.J., McDermott D.F., et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010, 363:711-723.
11. Robert C., Thomas L., Bondarenko I., et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011, 364:2517-2526.
12. Balch C.M., Gershenwald J.E., Soong S.J., et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009, 27:6199-6206.
13. Kettlewell S., Moyes C., Bray C., et al. Value of sentinel node status as a prognostic factor in melanoma: prospective observational study. BMJ 2006, 332:1423.
14. van Akkooi A.C., de Wilt J.H., Verhoef C., Eggermont A.M. Isolated tumor cells and long-term prognosis of patients with melanoma. Ann Surg Oncol 2008, 15:1547-1548.
15. Tarhini A.A., Stuckert J., Lee S., et al. Prognostic significance of serum S100B protein in high-risk surgically resected melanoma patients participating in Intergroup Trial ECOG 1694. J Clin Oncol 2009, 27:38-44.
16. Boon T., Coulie P.G., Van den Eynde B.J., van der Bruggen P. Human T cell responses against melanoma. Annu Rev Immunol 2006, 24:175-208.
17. Speeckaert R., van Geel N., Vermaelen K.V., et al. Immune reactions in benign and malignant melanocytic lesions: lessons for immunotherapy. Pigment Cell Melanoma Res 2011, 24:334-344.
18. Kirkwood J.M., Ernstoff M.S., Davis C.A., et al. Comparison of intramuscular and intravenous recombinant alpha-2 interferon in melanoma and other cancers. Ann Intern Med 1985, 103:32-36.
19. Creagan E.T., Dalton R.J., Ahmann D.L., et al. Randomized, surgical adjuvant clinical trial of recombinant interferon alfa-2a in selected patients with malignant melanoma. J Clin Oncol 1995, 13:2776-2783.
20. Kirkwood J.M., Ibrahim J., Lawson D.H., et al. High-dose interferon alfa-2b does not diminish antibody response to GM2 vaccination in patients with resected melanoma: results of the Multicenter Eastern Cooperative Oncology Group Phase II Trial E2696. J Clin Oncol 2001, 19:1430-1436.
21. Chiarion-Sileni V., Guida M., Romanini A., et al. Intensified high-dose intravenous interferon alpha 2b (IFNa2b) for adjuvant treatment of stage III melanoma: a randomized phase III Italian Melanoma Intergroup (IMI) trial [ISRCTN75125874]. J Clin Oncol 2011, 29. for Italian Melanoma Intergroup (IMI), [Abstract 8506].
22. Eggermont A.M., Suciu S., MacKie R., et al. Post-surgery adjuvant therapy with intermediate doses of interferon alfa 2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomised controlled trial. Lancet 2005, 366:1189-1196.
23. Bouwhuis M.G., Suciu S., Testori A., et al. Phase III trial comparing adjuvant treatment with pegylated interferon Alfa-2b versus observation: prognostic significance of autoantibodies-EORTC 18991. J Clin Oncol 2010, 28:2460-2466.
24. Hansson J., Aamdal S., Bastholt L. for Nordic Melanoma Cooperative Group. Two different durations of adjuvant therapy with intermediate-dose interferon alfa-2b in patients with high-risk melanoma (Nordic IFN trial): a randomised phase 3 trial. Lancet Oncol 2011, 12:144-152.
25. Pehamberger H., Soyer H.P., Steiner A., et al. Adjuvant interferon alfa-2a treatment in resected primary stage II cutaneous melanoma. Austrian Malignant Melanoma Cooperative Group. J Clin Oncol 1998, 16:1425-1429.
26. Grob J.J., Dreno B., de la Salmonière P., et al. Randomised trial of interferon alpha-2a as adjuvant therapy in resected primary melanoma thicker than 1.5 mm without clinically detectable node metastases. French Cooperative Group on Melanoma. Lancet 1998, 351:1905-1910.
27. Cascinelli N., Belli F., MacKie R.M., et al. Effect of long-term adjuvant therapy with interferon alpha-2a in patients with regional node metastases from cutaneous melanoma: a randomised trial. Lancet 2001, 358:866-869.
28. Cameron D.A., Cornbleet M.C., Mackie R.M., et al. Adjuvant interferon alpha 2b in high risk melanoma-the Scottish study. Br J Cancer 2001, 84:1146-1149.
29. Kleeberg U.R., Suciu S., Bröcker E.B., et al. Final results of the EORTC 18871/DKG 80-1 randomised phase III trial. rIFN-alpha2b versus rIFN-gamma versus ISCADOR M versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis. Eur J Cancer 2004, 40:390-402. for EORTC Melanoma Group in cooperation with the German Cancer Society (DKG).
30. Hancock B.W., Wheatley K., Harris S., et al. Adjuvant interferon in high-risk melanoma: the AIM HIGH Study-United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon alfa-2a in high-risk resected malignant melanoma. J Clin Oncol 2004, 22:53-61.
31. Hauschild A., Weichenthal M., Rass K., et al. Efficacy of low-dose interferon {alpha}2a 18 versus 60 months of treatment in patients with primary melanoma of >= 1.5 mm tumor thickness: results of a randomized phase III DeCOG trial. J Clin Oncol 2010, 28:841-846.
32. Garbe C., Radny P., Linse R., et al. Adjuvant low-dose interferon {alpha}2a with or without dacarbazine compared with surgery alone: a prospective-randomized phase III DeCOG trial in melanoma patients with regional lymph node metastasis. Ann Oncol 2008, 19:1195-1201.
33. Pectasides D., Dafni U., Bafaloukos D., et al. Randomized phase III study of 1 month versus 1 year of adjuvant high-dose interferon alfa-2b in patients with resected high-risk melanoma. J Clin Oncol 2009, 27:939-944.
34. Agarwala S.S., Lee S.J., Flaherty L.E., et al. Randomized phase III trial of high-dose interferon alfa-2b (HDI) for 4 weeks induction only in patients with intermediate- and high-risk melanoma (Intergroup Trial E 1697). J Clin Oncol 2011, 29. [Abstract 8505].
35. Grossman H.B., Natale R.B., Tangen C.M., et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med 2003, 349:859-866.
36. Fisher B., Brown A., Mamounas E., et al. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol 1997, 15:2483-2493.
37. Medical Research Council Oesophageal Cancer Working Group Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet 2002, 359:1727-1733.
38. Ribas A., Hersey P., Middleton M.R., et al. New challenges in endpoints for drug development in advanced melanoma. Clin Cancer Res 2012, 18:336-341.
39. Tatsumi T., Herrem C.J., Olson W.C., et al. Disease stage variation in CD4+ and CD8+ T-cell reactivity to the receptor tyrosine kinase EphA2 in patients with renal cell carcinoma. Cancer Res 2003, 63:4481-4489.
40. Buzaid A.C., Colome M., Bedikian A., et al. Phase II study of neoadjuvant concurrent biochemotherapy in melanoma patients with local-regional metastases. Melanoma Res 1998, 8:549-556.
41. Gibbs P., Anderson C., Pearlman N., et al. A phase II study of neoadjuvant biochemotherapy for stage III melanoma. Cancer 2002, 94:470-476.
42. Shah G.D., Socci N.D., Gold J.S., et al. Phase II trial of neoadjuvant temozolomide in resectable melanoma patients. Ann Oncol 2010, 21:1718-1722.
43. Atkins M.B., Hsu J., Lee S., 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.
44. Keilholz U., Punt C.J., Gore M., et al. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol 2005, 23:6747-6755.
45. Moschos S.J., Edington H.D., Land S.R., et al. Neoadjuvant treatment of regional stage IIIB melanoma with high-dose interferon alfa-2b induces objective tumor regression in association with modulation of tumor infiltrating host cellular immune responses. J Clin Oncol 2006, 24:3164-3171.
46. Tarhini A.A., Pahuja S., Kirkwood J.M. Neoadjuvant therapy for high-risk bulky regional melanoma. J Surg Oncol 2011, 104:386-390.
47. Maio M, Hoos A, Ibrahim R, et al. Efficacy and safety of ipilimumab in patients with advanced melanoma who had progressed on one or more prior therapies: results from a single-arm, multicenter study. Poster no. 776PD presented at the European Society for Medical Oncology, September 15, 2008. (Study 008).
48. Lebbe C, Hoos A, Chin K, et al. Effect of dose on efficacy and safety in ipilimumab-treated patients with advanced melanoma: results from a phase II, randomized, dose-ranging study. Oral Presentation No. 769O presented at the European Society for Medical Oncology, September 15, 2008. (Study 022).
49. Ridolfi R, Berman D, Siegel J, et al. Efficacy and safety of treatment naïve and previously treated patients with advanced melanoma receiving ipilimumab. Poster no. 778PD presented at the European Society for, Medical Oncology, September 15, 2008. (Study 007).
50. Sarnaik A.A., Yu B., Yu D., et al. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res 2011, 17:896-906.
51. Margolin K., Ernstoff M.S., Hamid O., et al. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol 2012, 13:459-465.
52. Di Giacomo A.M., Ascierto P.A., Pilla L., et al. Phase II multicenter trial of ipilimumab combined with fotemustine in patients with metastatic melanoma: The Italian Network for Tumor Biotherapy (NIBIT)-M1 trial. J Clin Oncol 2012, 30. [Abstract 8513].
53. Tarhini A.A., Edington H., Butterfield L.H., et al. Neoadjuvant ipilimumab in patients with stage IIIB/C melanoma: immunogenicity and biomarker analysis. J Clin Oncol 2011, 29. [Abstract 8536].
54. Tarhini A.A., Edington H., Butterfield L.H., et al. Neoadjuvant ipilimumab in locally/regionally advanced melanoma: clinical outcome and immune monitoring. J Clin Oncol 2012, 30. [Abstract 8533].
55. Eggermont A.M., Suciu S., Santinami M., et al. EORTC 18991 phase III trial: Long-term adjuvant pegylated interferon-α2b (PEG-IFN) versus observation in resected stage III melanoma: long-term results at 7.6-years follow-up. J Clin Oncol 2011, 29. [Abstract 8506b].
56. Curtin J.A., Fridlyand J., Kageshita T., et al. Distinct sets of genetic alterations in melanoma. N Engl J Med 2005, 353:2135-2147.
57. Boni A., Cogdill A.P., Dang P., et al. Selective BRAFV600E inhibition enhances T-cell recognition of melanoma without affecting lymphocyte function. Cancer Res 2010, 70:5213-5219.
58. Prowell T.M., Pazdur R. Pathological complete response and accelerated drug approval in early breast cancer. N Engl J Med 2012, 366:2438-2441.