A phase 2 trial of R1507, a monoclonal antibody to the insulin-like growth factor-1 receptor (IGF-1R), in patients with recurrent or refractory rhabdomyosarcoma, osteosarcoma, synovial sarcoma, and other soft tissue sarcomas: Results of a Sarcoma Alliance for Research Through Collaboration study

Cancer

Volumn 120, Issue 16, 2014, Pages 2448-2456

  Pappo, Alberto S ^a   Vassal, Gilles ^b   Crowley, John J ^c   Bolejack, Vanessa ^c   Hogendoorn, Pancras C W ^d   Chugh, Rashmi ^e   Ladanyi, Marc ^f   Grippo, Joseph F ^g   Dall, Georgina ^g   Staddon, Arthur P ^h   Chawla, Sant P ⁱ   Maki, Robert G ^j   Araujo, Dejka M ^k   Geoerger, Birgit ^b   Ganjoo, Kristen ^l   Marina, Neyssa ^m   Blay, Jean Yves ⁿ   Schuetze, Scott M ^e   Chow, Warren A ^o   Helman, Lee J ^p  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b INSTITUT GUSTAVE ROUSSY   (France)

^c Fred Hutchinson Cancer Research Center   (United States)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^f MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^g F HOFFMANN LA ROCHE LTD   (Switzerland)

^h UNIVERSITY OF PENNSYLVANIA   (United States)

ⁱ Sarcoma Oncology Center   (United States)

^j MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^k UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^l STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^m STANFORD CANCER INSTITUTE   (United States)

ⁿ CENTRE LÉON BÉRARD   (France)

^o CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^p NATIONAL INSTITUTES OF HEALTH   (United States)

more..

Author keywords

IGF 1R; insulin like growth factor; SARC; sarcoma

Indexed keywords

MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY R1507; SOMATOMEDIN C RECEPTOR; UNCLASSIFIED DRUG; R-1507 MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; AGED; ALVEOLAR SOFT PART SARCOMA; ARTICLE; CHILD; CLEAR CELL SARCOMA; DEHYDRATION; DESMOPLASTIC SMALL ROUND CELL TUMOR; DISTRIBUTION VOLUME; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; EXTRASKELETAL MYXOID CHONDROSARCOMA; FATIGUE; FEMALE; HISTOLOGY; HUMAN; HYPERGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; MUSCLE SPASM; MYXOSARCOMA; NAUSEA; OSTEOSARCOMA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; RHABDOMYOSARCOMA; SOFT TISSUE SARCOMA; SYNOVIAL SARCOMA; VERY ELDERLY; WORLD HEALTH ORGANIZATION; BONE NEOPLASMS; CLINICAL TRIAL; DISEASE FREE SURVIVAL; IMMUNOLOGY; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; SARCOMA, EWING; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; BONE NEOPLASMS; CHILD; DISEASE-FREE SURVIVAL; HUMANS; MIDDLE AGED; RECEPTOR, IGF TYPE 1; SARCOMA, EWING; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84905586194     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.28728     Document Type: Article

References (43)

1. Pappo AS, Devidas M, Jenkins J, et al. Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study. J Clin Oncol. 2005; 23: 4031-4038.
2. Arndt CA, Stoner JA, Hawkins DS, et al. Vincristine, actinomycin, and cyclophosphamide compared with vincristine, actinomycin, and cyclophosphamide alternating with vincristine, topotecan, and cyclophosphamide for intermediate-risk rhabdomyosarcoma: Children's Oncology Group Study D9803. J Clin Oncol. 2009; 27: 5182-5188.
3. Howlader N, Noone AM, Krapcho M, Garshell J, Neyman N, Altekruse SF, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Cho H, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA, (eds). SEER Cancer Statistics Review, 1975-2010, National Cancer Institute. Bethesda, MD, HYPERLINK "/csr/1975-2010/" http://seer.cancer.gov/csr/1975-2010/, based on November 2012 SEER data submission, posted to the SEER web site, April 2013.
4. Stahl M, Ranft A, Paulussen M, et al. Risk of recurrence and survival after relapse in patients with Ewing sarcoma. Pediatr Blood Cancer. 2011; 57: 549-553.
5. Kempf-Bielack B, Bielack SS, Jurgens H, et al. Osteosarcoma relapse after combined modality therapy: an analysis of unselected patients in the Cooperative Osteosarcoma Study Group (COSS). J Clin Oncol. 2005; 23: 559-568.
6. Smith MA, Seibel NL, Altekruse SF, et al. Outcomes for children and adolescents with cancer: challenges for the twenty-first century. J Clin Oncol. 2010; 28: 2625-2634.
7. Van Glabbeke M, van Oosterom AT, Oosterhuis JW, et al. Prognostic factors for the outcome of chemotherapy in advanced soft tissue sarcoma: an analysis of 2,185 patients treated with anthracycline-containing first-line regimens-a European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. J Clin Oncol. 1999; 17: 150-157.
8. Oeffinger KC, Mertens AC, Sklar CA, et al. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006; 355: 1572-1582.
9. Hudson MM, Mertens AC, Yasui Y, et al. Health status of adult long-term survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. JAMA. 2003; 290: 1583-1592.
10. Taylor BS, Barretina J, Maki RG, Antonescu CR, Singer S, Ladanyi M,. Advances in sarcoma genomics and new therapeutic targets. Nat Rev Cancer. 2011; 11: 541-557.
11. Atzori F, Traina TA, Ionta MT, Massidda B,. Targeting insulin-like growth factor type 1 receptor in cancer therapy. Target Oncol. 2009; 4: 255-266.
12. Cao L, Yu Y, Darko I, et al. Addiction to elevated insulin-like growth factor I receptor and initial modulation of the AKT pathway define the responsiveness of rhabdomyosarcoma to the targeting antibody. Cancer Res. 2008; 68: 8039-8048.
13. Kim SY, Wan X, Helman LJ,. Targeting IGF-1R in the treatment of sarcomas: past, present and future. Bull Cancer. 2009; 96: E52-E60.
14. Maki RG,. Small is beautiful: insulin-like growth factors and their role in growth, development, and cancer. J Clin Oncol. 2010; 28: 4985-4995.
15. Minniti CP, Helman LJ,. IGF-II in the pathogenesis of rhabdomyosarcoma: a prototype of IGFs involvement in human tumorigenesis. Adv Exp Med Biol. 1993; 343: 327-343.
16. Cao L, Yu Y, Bilke S, Walker RL, Mayeenuddin LH, Azorsa DO, et al. Genome-wide identification of PAX3-FKHR binding sites in rhabdomyosarcoma reveals candidate target genes important for development and cancer. Cancer Res. 2010; 70: 6497-6508.
17. Olmos D, Postel-Vinay S, Molife LR, et al. Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol. 2010; 11: 129-135.
18. Pappo AS, Patel SR, Crowley J, et al. R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: results of a phase II Sarcoma Alliance for Research through Collaboration study. J Clin Oncol. 2011; 29: 4541-4547.
19. Tolcher AW, Sarantopoulos J, Patnaik A, et al. Phase I, pharmacokinetic, and pharmacodynamic study of AMG 479, a fully human monoclonal antibody to insulin-like growth factor receptor 1. J Clin Oncol. 2009; 27: 5800-58007.
20. Kurzrock R, Patnaik A, Aisner J, et al. A phase I study of weekly R1507, a human monoclonal antibody insulin-like growth factor-I receptor antagonist, in patients with advanced solid tumors. Clin Cancer Res. 2010; 16: 2458-2465.
21. Juergens H, Daw NC, Geoerger B, et al. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011; 29: 4534-4540.
22. Miller AB, Hoogstraten B, Staquet M, Winkler A,. Reporting results of cancer treatment. Cancer. 1981; 47: 207-214.
23. Green SJ, Dahlberg S,. Planned versus attained design in phase II clinical trials. Stat Med. 1992; 11: 853-862.
24. Van Glabbeke M, Verweij J, Judson I, Nielsen OS,. Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer. 2002; 38: 543-549.
25. Tap WD, Demetri G, Barenette P, et al. Phase II study of ganitumab, a fully human anti-type-1 insulin-like growth factor receptor antibody, in patients with metastatic Ewing family tumors or desmoplastic small round cell tumors. J Clin Oncol. 2012; 30: 1849-1856.
26. Atzori F, Tabernero J, Cervantes A, et al. A phase I pharmacokinetic and pharmacodynamic study of dalotuzumab (MK-0646), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res. 2011; 17: 6304-6312.
27. Schoffski P, Adkins D, Blay JY, et al. An open-label, phase 2 study evaluating the efficacy and safety of the anti-IGF-1R antibody cixutumumab in patients with previously treated advanced or metastatic soft-tissue sarcoma or Ewing family of tumours. Eur J Cancer. 2013; 49: 3219-3228.
28. O'Neill A, Shah N, Zitomersky N, et al. Insulin-like growth factor 1 receptor as a therapeutic target in Ewing sarcoma: lack of consistent upregulation or recurrent mutation and a review of the clinical trial literature [serial online]. Sarcoma 2013: 450478, 2013.
29. Potratz JC, Saunders DN, Wai DH, et al. Synthetic lethality screens reveal RPS6 and MST1R as modifiers of insulin-like growth factor-1 receptor inhibitor activity in childhood sarcomas. Cancer Res. 2010; 70: 8770-8781.
30. Subbiah V, Naing A, Brown RE, et al. Targeted morphoproteomic profiling of Ewing's sarcoma treated with insulin-like growth factor 1 receptor (IGF1R) inhibitors: response/resistance signatures [serial online]. PLoS One. 2011; 6: e18424.
31. Garofalo C, Mancarella C, Grilli A, et al. Identification of common and distinctive mechanisms of resistance to different anti-IGF-IR agents in Ewing's sarcoma. Mol Endocrinol. 2012; 26: 1603-1616.
32. Mayeenuddin LH, Yu Y, Kang Z, Helman LJ, Cao L,. Insulin-like growth factor 1 receptor antibody induces rhabdomyosarcoma cell death via a process involving AKT and Bcl-x(L). Oncogene. 2010; 29: 6367-6377.
33. Scotlandi K, Manara MC, Serra M, et al. Expression of insulin-like growth factor system components in Ewing's sarcoma and their association with survival. Eur J Cancer. 2011; 47: 1258-1266.
34. Huang F, Hurlburt W, Greer A, et al. Differential mechanisms of acquired resistance to insulin-like growth factor-I receptor antibody therapy or to a small-molecule inhibitor, BMS-754807, in a human rhabdomyosarcoma model. Cancer Res. 2010; 70: 7221-7231.
35. Abraham J, Prajapati SI, Nishijo K, et al. Evasion mechanisms to Igf1r inhibition in rhabdomyosarcoma. Mol Cancer Ther. 2011; 10: 697-707.
36. Katayama R, Khan TM, Benes C, et al. Therapeutic strategies to overcome crizotinib resistance in non-small cell lung cancers harboring the fusion oncogene EML4-ALK. Proc Natl Acad Sci U S A. 2011; 108: 7535-7540.
37. Puzanov I, Burnett P, Flaherty KT,. Biological challenges of BRAF inhibitor therapy. Mol Oncol. 2011; 5: 116-123.
38. Fleuren ED, Versleijen-Jonkers YM, van de Luijtgaarden AC, et al. Predicting IGF-1R therapy response in bone sarcomas: immuno-SPECT imaging with radiolabeled R1507. Clin Cancer Res. 2011; 17: 7693-7703.
39. Kurmasheva RT, Dudkin L, Billups C, Debelenko LV, Morton CL, Houghton PJ,. The insulin-like growth factor-1 receptor-targeting antibody, CP-751871, suppresses tumor-derived VEGF and synergizes with rapamycin in models of childhood sarcoma. Cancer Res. 2009; 69: 7662-7671.
40. Huang F, Greer A, Hurlburt W, Han X, Hafezi R, Wittenberg GM, et al. The mechanisms of differential sensitivity to an insulin-like growth factor-1 receptor inhibitor (BMS-536924) and rationale for combining with EGFR/HER2 inhibitors. Cancer Res. 2009; 69: 161-170.
41. Naing A, Kurzrock R, Burger A, Gupta S, Lei X, Busaidy N, et al. Phase I trial of cixutumumab combined with temsirolimus in patients with advanced cancer. Clin Cancer Res. 2011; 17: 6052-6060.
42. Yeung C, Ngo V, Grohar P, et al. Loss-of-function screen in rhabdomyosarcoma identifies CRKL-YES as a critical signal for tumor growth. Oncogene. 2013; 32: 5429-5438.
43. Schwartz GK, Tap WD, Qin LX, et al. Cixutumumab and temsirolimus for patients with bone and soft-tissue sarcoma: a multicentre, open-label, phase 2 trial. Lancet Oncol. 2013; 14: 371-382.