Pembrolizumab in a BRAF-mutant metastatic melanoma patient following a severe immune-related adverse event with ipilimumab

Immunotherapy

Volumn 8, Issue 6, 2016, Pages 687-692

  Aya, Francisco ^a,b   Fernández Martínez, Aranzazu ^a,b   Gaba, Lydia ^a,b   Victoria, Iván ^a,b   Tosca, Mónica ^a,b   Carrera, Cristina ^a,c,d   Prat, Aleix ^a,b   Arance, Ana ^a,b  

^a HOSPITAL CLÍNIC   (Spain)

^b INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^c INSTITUTO DE SALUD CARLOS III   (Spain)

^d UNIVERSITY OF BARCELONA   (Spain)

Author keywords

anti CTLA 4; anti PD 1; immune related adverse event; melanoma

Indexed keywords

B RAF KINASE; DACARBAZINE; FIBRIN; INFLIXIMAB; IPILIMUMAB; ISONIAZID; LOPERAMIDE; METHYLPREDNISOLONE; PEMBROLIZUMAB; PIPERACILLIN; PREDNISONE; PYRIDOXINE; RIFAMPICIN; SELUMETINIB; TAZOBACTAM; VEMURAFENIB; BRAF PROTEIN, HUMAN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; MONOCLONAL ANTIBODY; PDCD1 PROTEIN, MOUSE; PROGRAMMED DEATH 1 RECEPTOR;

ABDOMINAL PAIN; ABSCESS; ADULT; ARTICLE; BLOATING; BRAF GENE; BRAIN METASTASIS; CANCER STAGING; CANCER SURGERY; CASE REPORT; COLITIS; COLON BIOPSY; COLON ULCER; COLONOSCOPY; COMPUTER ASSISTED TOMOGRAPHY; CRYPTIC ABSCESS; CRYPTITIS; DIARRHEA; DIET THERAPY; DISEASE COURSE; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ENTERITIS; ERYTHEMA; FIBROCOLONOSCOPY; GENE MUTATION; HOSPITAL ADMISSION; HUMAN; HUMAN TISSUE; IMMUNOPATHOLOGY; INTERFERON GAMMA RELEASE ASSAY; LUNG METASTASIS; LYMPH NODE METASTASIS; MALE; MELANOMA; METASTATIC MELANOMA; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; NONHUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT DURATION; TUBERCULOSIS; COMPLICATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GENETICS; IMMUNOLOGY; METASTASIS; MUTATION; QUALITY OF LIFE; TREATMENT WITHDRAWAL;

ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; COLITIS; CTLA-4 ANTIGEN; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; MALE; MELANOMA; MIDDLE AGED; MUTATION; NEOPLASM METASTASIS; PROGRAMMED CELL DEATH 1 RECEPTOR; PROTO-ONCOGENE PROTEINS B-RAF; QUALITY OF LIFE; WITHHOLDING TREATMENT;

EID: 84971301554     PISSN: 1750743X     EISSN: 17507448     Source Type: Journal    
DOI: 10.2217/imt-2015-0025     Document Type: Article

References (23)

1. Garbe C, Eigentler TK, Keilholz U, Hauschild A, Kirkwood JM. Systematic review of medical treatment in melanoma: current status and future prospects. Oncologist 16(1), 5-24 (2011).
2. Teply BA, Lipson EJ. Identifcation and management of toxicities from immune checkpoint-blocking drugs. Oncology (Williston Park) 28(Suppl. 3), 30-38 (2014).
3. Sharma P, Allison JP. Immune checkpoint targeting in cancer therapy: toward combination strategies with curative potential. Cell 161(2), 205-214 (2015).
4. Schadendorf D, Hodi FS, Robert C et al. Pooled analysis of long-term survival data from Phase II and Phase III trials of ipilimumab in unresectable or metastatic melanoma. J. Clin. Oncol. 33(17), 1889-1894 (2015).
5. Robert C, Long GV, Brady B et al. Nivolumab in previously untreated melanoma without BRAF mutation. N. Engl. J. Med. 372(4), 320-330 (2015).
6. Robert C, Schachter J, Long GV et al. Pembrolizumab versus ipilimumab in advanced melanoma. N. Engl. J. Med. 372(26), 2521-2532 (2015).
7. Ribas A, Puzanov I, Dummer R et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, Phase 2 trial. Lancet Oncol. 16(8), 908-918 (2015).
8. Weber JS, D'angelo SP, Minor D et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, Phase 3 trial. Lancet Oncol. 16(4), 375-384 (2015).
9. Weber JS, Dummer R, De Pril V, Lebbe C, Hodi FS. Investigators MDX. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer 119(9), 1675-1682 (2013).
10. Naidoo J, Page DB, Li BT et al. Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Ann. Oncol. 26(12), 2375-2391 (2015).
11. Balch CM, Gershenwald JE, Soong SJ et al. Final version of 2009 AJCC melanoma staging and classifcation. J. Clin. Oncol. 27(36), 6199-6206 (2009).
12. Robert C, Dummer R, Gutzmer R et al. Selumetinib plus dacarbazine versus placebo plus dacarbazine as frst-line treatment for BRAF-mutant metastatic melanoma: a Phase 2 double-blind randomised study. Lancet Oncol. 14(8), 733-740 (2013).
13. Clinical trials database: NCT01515189. www.clinicaltrials.gov/ct2/show/NCT01515189
14. Clinical trials database: NCT01378975. https://clinicaltrials.gov/ct2/show/NCT01378975
15. Avril MF, Aamdal S, Grob JJ et al. Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a Phase III study. J. Clin. Oncol. 22(6), 1118-1125 (2004).
16. Weber JS, Kudchadkar RR, Gibney GT et al. Updated survival, toxicity, and biomarkers of nivolumab with/without peptide vaccine in patients naive to, or progressed on, ipilimumab (IPI). J. Clin. Oncol. 32(15), 3009 (2014).
17. Wolchok JD, Neyns B, Linette G et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, Phase 2, dose-ranging study. Lancet Oncol. 11(2), 155-164 (2010).
18. Topalian SL, Hodi FS, Brahmer JR et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N. Engl. J. Med. 366(26), 2443-2454 (2012).
19. Langer CJ. Emerging immunotherapies in the treatment of non-small cell lung cancer (NSCLC): the role of immune checkpoint inhibitors. Am. J. Clin. Oncol. 38(4), 422-430 (2015).
20. Weber JS, Yang JC, Atkins MB, Disis ML. Toxicities of immunotherapy for the practitioner. J. Clin. Oncol. 33(18), 2092-2099 (2015).
21. Hamid O, Robert C, Daud A et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N. Engl. J. Med. 369(2), 134-144 (2013).
22. Dummer R, Daud A, Puzanov I et al. A randomized controlled comparison of pembrolizumab and chemotherapy in patients with ipilimumab-refractory melanoma. Presented at: Melanoma Bridge Meeting 2014 Naples, Italy 3-6 December 2014.
23. Shoushtary AN, Postow MA, Horvat TZ, Adel NG, Dang T, Chapman PB. Safety of pembrolizumab (pem) in patients (pts) who stopped ipilimumab (ipi) due to immune-related adverse events. J. Clin. Oncol. 33(Suppl.), Abstract e20023 (2015).