A phase II study evaluating the toxicity and efficacy of single-agent temsirolimus in chemotherapy-naïve castration-resistant prostate cancer

British Journal of Cancer

Volumn 109, Issue 7, 2013, Pages 1711-1716

  Kruczek, K ^a,d   Ratterman, M ^a   Tolzien, K ^b   Sulo, S ^a   Lestingi, T M ^b   Nabhan, C ^c  

^a ADVOCATE LUTHERAN GENERAL HOSPITAL   (United States)

^b Oncology Specialists   (United States)

^c UNIVERSITY OF CHICAGO   (United States)

^d LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

castration resistant prostate cancer; hormone refractory; prostate cancer; temsirolimus; torisel

Indexed keywords

PROSTATE SPECIFIC ANTIGEN; TEMSIROLIMUS;

ADULT; AGED; ANEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL ARTICLE; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; FATIGUE; FOLLOW UP; GLEASON SCORE; HUMAN; HYPERGLYCEMIA; HYPERTRIGLYCERIDEMIA; HYPOPHOSPHATEMIA; LYMPHOCYTOPENIA; MALE; MULTIPLE CYCLE TREATMENT; OPEN STUDY; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; QUALITY OF LIFE; THROMBOCYTOPENIA; TREATMENT RESPONSE;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DISEASE PROGRESSION; HUMANS; MALE; MIDDLE AGED; ORCHIECTOMY; PROSPECTIVE STUDIES; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; PROTEIN KINASE INHIBITORS; QUALITY OF LIFE; SIROLIMUS; TOR SERINE-THREONINE KINASES; TREATMENT OUTCOME;

EID: 84885175489     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2013.530     Document Type: Article

References (46)

1. Alvarez EA, Brady WE, Walker JL, Rotmensch J, Zhou XC, Kendrick JE, Yamada SD, Schilder JM, Cohn DE, Harrison CR, Moore KN, Aghajanian C (2013) Phase II trial of combination bevacizumab and temsirolimus in the treatment of recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol 129(1): 22-27.
2. Armstrong A, Shen T, Halabi S, Kemeny G, Bitting R, Kartcheske P, Embree E, Morris K, Winters C, Jaffe T, Fleming M, George D (2013) A phase II trial of temsirolimus in men with castration-resistant metastatic prostate cancer. Clin Genitourin Cancer; e-pub ahead of print 3 July 2013; doi:10.1016/j.clgc.2013.05. 007.
3. Behbakht K, Sill MW, Darcy KM, Rubin SC, Mannel RS, Waggoner S, Schilder RJ, Cai KQ, Godwin AK, Alpaugh RK (2011) Phase II trial of the mTOR inhibitor, temsirolimus and evaluation of circulating tumor cells and tumor biomarkers in persistent and recurrent epithelial ovarian and primary peritoneal malignancies: a Gynecologic Oncology Group study. Gynecol Oncol 123(1): 19-26.
4. Bhojani N, Jeldres C, Patard JJ, Perrotte P, Suardi N, Hutterer G, Patenaude F, Oudard S, Karakiewicz PI (2008) Toxicities associated with the administration of sorafenib, sunitinib, and temsirolimus and their management in patients with metastatic renal cell carcinoma. Eur Urol 53(5): 917-930.
5. Burgio SL, Fabbri F, Seymour IJ, Zoli W, Amadori D, De Giorgi U (2012) Perspectives on mTOR inhibitors for castration-refractory prostate cancer. Curr Cancer Drug Targets 12(8): 940-949.
6. Caffo O, Sava T, Comploj E, Fariello A, Zustovich F, Segati R, Sacco C, Veccia A, Galligioni E (2011) Impact of docetaxel-based chemotherapy on quality of life of patients with castration-resistant prostate cancer: results from a prospective phase II randomized trial. BJU Int 108(11): 1825-1832.
7. Carver BS, Chapinski C, Wongvipat J, Hieronymus H, Chen Y, Chandarlapaty S, Arora VK, Le C, Koutcher J, Scher H, Scardino PT, Rosen N, Sawyers CL (2011) Reciprocal feedback regulation of PI3K and androgen receptor signaling in PTEN-deficient prostate cancer. Cancer Cell 19(5): 575-586.
8. Chen CD, Welsbie DS, Tran C, Baek SH, Chen R, Vessella R, Rosenfeld MG, Sawyers CL (2004) Molecular determinants of resistance to antiandrogen therapy. Nature Med 10(1): 33-39.
9. Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC (2000) Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer 89(7): 1634-1646.
10. Cleeland CS, Ryan KM (1994) Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 23(2): 129-138.
11. Colloca G, Colloca P (2011) Health-related quality of life assessment in prospective trials of systemic cytotoxic chemotherapy for metastatic castration-resistant prostate cancer: which instrument we need? Med Oncol 28(2): 519-527.
12. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman Jr OB, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI. Investigators C-A-(2011) Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 364(21): 1995-2005.
13. de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO (2010) Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 376(9747): 1147-1154.
14. de Muga S, Hernandez S, Agell L, Salido M, Juanpere N, Lorenzo M, Lorente JA, Serrano S, Lloreta J (2010) Molecular alterations of EGFR and PTEN in prostate cancer: association with high-grade and advanced-stage carcinomas. Mod Pathol 23(5): 703-712.
15. Debes JD, Tindall DJ (2004) Mechanisms of androgen-refractory prostate cancer. N Engl J Med 351(15): 1488-1490.
16. Fleming GF, Ma CX, Huo D, Sattar H, Tretiakova M, Lin L, Hahn OM, Olopade FO, Nanda R, Hoffman PC, Naughton MJ, Pluard T, Conzen SD, Ellis MJ (2012) Phase II trial of temsirolimus in patients with metastatic breast cancer. Breast Cancer Res Treat 136(2): 355-363.
17. Gore ME (2007) Temsirolimus in the treatment of advanced renal cell carcinoma. Ann Oncol 18(Suppl 9): ix87-ix88.
18. He L, Teng Y, Jin B, Zhao M, Yu P, Hu X, Zhang J, Li S, Gao Y, Liu Y (2010) Initial partial response and stable disease according to RECIST indicate similar survival for chemotherapeutical patients with advanced non-small cell lung cancer. BMC Cancer 10: 681.
19. Hoskin PJ, Rojas AM, Ostler PJ, Hughes R, Lowe GJ, Bryant L (2013) Quality of life after radical radiotherapy for prostate cancer: longitudinal study from a randomised trial of external beam radiotherapy alone or in combination with high dose rate brachytherapy. Clin Oncol 25(5): 321-327.
20. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF (2010) Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 363(5): 411-422.
21. Kim HR, Kang MS, Na II, Yang SH, Choi YH, Kang HJ, Kim CH, Lee JC (2010) The similar survival benefits of stable disease and partial response to pemetrexed in previously treated non-small cell carcinoma patients. J Cancer Res Clin Oncol 136(4): 547-552.
22. Komiya A, Fujiuchi Y, Ito T, Morii A, Yasuda K, Watanabe A, Nozaki T, Iida H, Nomura K, Fuse H (2013) Early quality of life outcomes in patients with prostate cancer managed by high-dose-rate brachytherapy as monotherapy. Int J Urol 20(2): 185-192.
23. Lee CK, Marschner IC, Simes RJ, Voysey M, Egleston B, Hudes G, de Souza P (2012) Increase in cholesterol predicts survival advantage in renal cell carcinoma patients treated with temsirolimus. Clin Cancer Res 18(11): 3188-3196.
24. Li J, Yen C, Liaw D, Podsypanina K, Bose S, Wang SI, Puc J, Miliaresis C, Rodgers L, McCombie R, Bigner SH, Giovanella BC, Ittmann M, Tycko B, Hibshoosh H, Wigler MH, Parsons R (1997) PTEN, a putative protein tyrosine phosphatase gene mutated in human brain, breast, and prostate cancer. Science 275(5308): 1943-1947.
25. Lin HK, Hu YC, Lee DK, Chang C (2004) Regulation of androgen receptor signaling by PTEN (phosphatase and tensin homolog deleted on chromosome 10) tumor suppressor through distinct mechanisms in prostate cancer cells. Mol Endocrinol 18(10): 2409-2423.
26. Mc Caughan E, Mc Sorley O, Prue G, Parahoo K, Bunting B, Sullivan JO, McKenna H (2013) Quality of life in men receiving radiotherapy and neoadjuvant androgen deprivation for prostate cancer: results from a prospective longitudinal study. J Adv Nurs 69(1): 53-65.
27. Nabhan C, Parsons B, Touloukian EZ, Stadler WM (2011) Novel approaches and future directions in castration-resistant prostate cancer. Ann Oncol 22(9): 1948-1957.
28. Neppl-Huber C, Zappa M, Coebergh JW, Rapiti E, Rachtan J, Holleczek B, Rosso S, Aareleid T, Brenner H, Gondos A, Group ESW (2012) Changes in incidence, survival and mortality of prostate cancer in Europe and the United States in the PSA era: additional diagnoses and avoided deaths. Ann Oncol 23(5): 1325-1334.
29. Pourmand G, Ziaee AA, Abedi AR, Mehrsai A, Alavi HA, Ahmadi A, Saadati HR (2007) Role of PTEN gene in progression of prostate cancer. Urol J 4(2): 95-100.
30. Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE (2013) Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 368(2): 138-148.
31. Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS (2012) Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 367(13): 1187-1197.
32. Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M (2008) Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 26(7): 1148-1159.
33. Schmitz M, Grignard G, Margue C, Dippel W, Capesius C, Mossong J, Nathan M, Giacchi S, Scheiden R, Kieffer N (2007) Complete loss of PTEN expression as a possible early prognostic marker for prostate cancer metastasis. Int J Cancer 120(6): 1284-1292.
34. Shen MM, Abate-Shen C (2007) Pten inactivation and the emergence of androgen-independent prostate cancer. Cancer Res 67(14): 6535-6538.
35. Shibata A, Whittemore AS (2001) Re: Prostate cancer incidence and mortality in the United States and the United Kingdom. J Natl Cancer Inst 93(14): 1109-1110.
36. Siegel R, Naishadham D, Jemal A (2013) Cancer statistics, 2013. CA Cancer J Clin 63(1): 11-30.
37. Slack NH, Brady MF, Murphy GP (1984) Stable versus partial response in advanced prostate cancer. Prostate 5(4): 401-415.
38. Slack NH, Mittelman A, Brady MF, Murphy GP (1980) The importance of the stable category for chemotherapy treated patients with advanced and relapsing prostate cancer. Cancer 46(11): 2393-2402.
39. Slingluff Jr CL, Petroni GR, Molhoek KR, Brautigan DL, Chianese-Bullock KA, Shada AL, Smolkin ME, Olson WC, Gaucher A, Chase CM, Grosh WW, Weiss GR, Wagenseller AG, Olszanski AJ, Martin L, Shea SM, Erdag G, Ram PT, Gershenwald JE, Weber MJ (2013) Clinical activity and safety of combination therapy with temsirolimus and bevacizumab for advanced melanoma: A Phase II trial (CTEP 7190/Mel47). Clin Cancer Res 19(13): 3611-3620.
40. Takahashi Y, Mai M, Taguchi T, Urushizaki I, Nishioka K (2000) Prolonged stable disease effects survival in patients with solid gastric tumor: analysis of phase II studies of doxifluridine. Int J Oncol 17(2): 285-289.
41. Templeton AJ, Dutoit V, Cathomas R, Rothermundt C, Bartschi D, Droge C, Gautschi O, Borner M, Fechter E, Stenner F, Winterhalder R, Muller B, Schiess R, Wild PJ, Ruschoff JH, Thalmann G, Dietrich PY, Aebersold R, Klingbiel D, Gillessen S. Swiss Group for Clinical Cancer R (2013) Phase 2 trial of single-agent everolimus in chemotherapy-naive patients with castration-resistant prostate cancer (SAKK 08/08). Eur Urol 64(1): 150-158.
42. Therasse P, Eisenhauer EA, Verweij J (2006) RECIST revisited: a review of validation studies on tumour assessment. Eur J Cancer 42(8): 1031-1039.
43. Tinker AV, Ellard S, Welch S, Moens F, Allo G, Tsao MS, Squire J, Tu D, Eisenhauer EA, Mackay H (2013) Phase II study of temsirolimus (CCI-779) in women with recurrent, unresectable, locally advanced or metastatic carcinoma of the cervix. A trial of the NCIC Clinical Trials Group (NCIC CTG IND 199). Gynecol Oncol 130(2): 269-274.
44. Tsuchida Y, Therasse P (2001) Response evaluation criteria in solid tumors (RECIST): new guidelines. Med Pediatr Oncol 37(1): 1-3.
45. van Tol-Geerdink JJ, Leer JW, van Oort IM, van Lin EJ, Weijerman PC, Vergunst H, Witjes JA, Stalmeier PF (2013) Quality of life after prostate cancer treatments in patients comparable at baseline. Br J Cancer 108(9): 1784-1789.
46. Wang Y, Romigh T, He X, Tan MH, Orloff MS, Silverman RH, Heston WD, Eng C (2011) Differential regulation of PTEN expression by androgen receptor in prostate and breast cancers. Oncogene 30(42): 4327-4338.