A phase-1b study of everolimus plus paclitaxel in patients with small-cell lung cancer

British Journal of Cancer

Volumn 109, Issue 6, 2013, Pages 1482-1487

  Sun, J M ^a   Kim, J R ^a   Do, I G ^a   Lee, S Y ^a   Lee, J ^a   Choi, Y L ^a   Ahn, J S ^a   Ahn, M J ^a   Park, K ^a  

^a Sungkyunkwan University School of Medicine   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; EVEROLIMUS; PACLITAXEL;

ADULT; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER RECURRENCE; CLINICAL ARTICLE; DIARRHEA; DRUG CLEARANCE; DRUG FATALITY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERGLYCEMIA; LEUKOPENIA; LUNG SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; NEUROPATHY; NEUTROPENIA; OPEN STUDY; PAIN; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; PACLITAXEL; SIROLIMUS; SMALL CELL LUNG CARCINOMA;

EID: 84884593936     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2013.467     Document Type: Article

References (29)

1. Andre F, Campone M, O'Regan R, Manlius C, Massacesi C, Sahmoud T, Mukhopadhyay P, Soria JC, Naughton M, Hurvitz SA (2010) Phase I study of everolimus plus weekly paclitaxel and trastuzumab in patients with metastatic breast cancer pretreated with trastuzumab. J Clin Oncol 28: 5110-5115.
2. Baselga J, Campone M, Piccart M, Burris 3rd HA, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN (2012) Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 366: 520-529.
3. Bjornsti MA, Houghton PJ (2004) The TOR pathway: A target for cancer therapy. Nat Rev Cancer 4: 335-348.
4. Campone M, Levy V, Bourbouloux E, Berton Rigaud D, Bootle D, Dutreix C, Zoellner U, Shand N, Calvo F, Raymond E (2009) Safety and pharmacokinetics of paclitaxel and the oral mTOR inhibitor everolimus in advanced solid tumours. Br J Cancer 100: 315-321.
5. Dong S, Zhang XC, Cheng H, Zhu JQ, Chen ZH, Zhang YF, Xie Z, Wu YL (2012) Everolimus synergizes with gefitinib in non-small-cell lung cancer cell lines resistant to epidermal growth factor receptor tyrosine kinase inhibitors. Cancer Chemother Pharmacol 70: 707-716.
6. Ellard SL, Clemons M, Gelmon KA, Norris B, Kennecke H, Chia S, Pritchard K, Eisen A, Vandenberg T, Taylor M, Sauerbrei E, Mishaeli M, Huntsman D, Walsh W, Olivo M, McIntosh L, Seymour L (2009) Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. J Clin Oncol 27: 4536-4541.
7. Faried LS, Faried A, Kanuma T, Nakazato T, Tamura T, Kuwano H, Minegishi T (2006) Inhibition of the mammalian target of rapamycin (mTOR) by rapamycin increases chemosensitivity of CaSki cells to paclitaxel. Eur J Cancer 42: 934-947.
8. Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J (2006) Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: Analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol 24: 4539-4544.
9. Hanna N, Bunn Jr PA, Langer C, Einhorn L, Guthrie Jr T, Beck T, Ansari R, Ellis P, Byrne M, Morrison M, Hariharan S, Wang B, Sandler A (2006) Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol 24: 2038-2043.
10. Hu L, Hofmann J, Lu Y, Mills GB, Jaffe RB (2002) Inhibition of phosphatidylinositol 3'-kinase increases efficacy of paclitaxel in in vitro and in vivo ovarian cancer models. Cancer Res 62: 1087-1092.
11. Kovarik JM, Hartmann S, Figueiredo J, Rordorf C, Golor G, Lison A, Budde K, Neumayer HH (2002) Effect of food on everolimus absorption: Quantification in healthy subjects and a confirmatory screening in patients with renal transplants. Pharmacotherapy 22: 154-159.
12. Marinov M, Ziogas A, Pardo OE, Tan LT, Dhillon T, Mauri FA, Lane HA, Lemoine NR, Zangemeister-Wittke U, Seckl MJ, Arcaro A (2009) AKT/mTOR pathway activation and BCL-2 family proteins modulate the sensitivity of human small cell lung cancer cells to RAD001. Clin Cancer Res 15: 1277-1287.
13. Mondesire WH, Jian W, Zhang H, Ensor J, Hung MC, Mills GB, Meric- Bernstam F (2004) Targeting mammalian target of rapamycin synergistically enhances chemotherapy-induced cytotoxicity in breast cancer cells. Clin Cancer Res 10: 7031-7042.
14. Morrow PK, Wulf GM, Ensor J, Booser DJ, Moore JA, Flores PR, Xiong Y, Zhang S, Krop IE, Winer EP, Kindelberger DW, Coviello J, Sahin AA, Nunez R, Hortobagyi GN, Yu D, Esteva FJ (2011) Phase I/II study of trastuzumab in combination with everolimus (RAD001) in patients with HER2-overexpressing metastatic breast cancer who progressed on trastuzumab-based therapy. J Clin Oncol 29: 3126-3132.
15. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Figlin RA, Hollaender N, Urbanowitz G, Berg WJ, Kay A, Lebwohl D, Ravaud A (2008) Efficacy of everolimus in advanced renal cell carcinoma: A double-blind, randomised, placebo-controlled phase III trial. Lancet 372: 449-456.
16. Noda K, Nishiwaki Y, Kawahara M, Negoro S, Sugiura T, Yokoyama A, Fukuoka M, Mori K, Watanabe K, Tamura T, Yamamoto S, Saijo N (2002) Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med 346: 85-91.
17. O'Donnell A, Faivre S, Burris III HA, Rea D, Papadimitrakopoulou V, Shand N, Lane HA, Hazell K, Zoellner U, Kovarik JM, Brock C, Jones S, Raymond E, Judson I (2008) Phase I pharmacokinetic and pharmacodynamic study of the oral mammalian target of rapamycin inhibitor everolimus in patients with advanced solid tumors. J Clin Oncol 26: 1588-1595.
18. O'Reilly T, McSheehy PM, Wartmann M, Lassota P, Brandt R, Lane HA (2011) Evaluation of the mTOR inhibitor, everolimus, in combination with cytotoxic antitumor agents using human tumor models in vitro and in vivo. Anticancer Drugs 22: 58-78.
19. Ramalingam SS, Harvey RD, Saba N, Owonikoko TK, Kauh J, Shin DM, Sun SY, Strychor S, Tighiouart M, Egorin MJ, Fu H, Khuri FR (2010) Phase 1 and pharmacokinetic study of everolimus, a mammalian target of rapamycin inhibitor, in combination with docetaxel for recurrent/refractory nonsmall cell lung cancer. Cancer 116: 3903-3909.
20. Ren H, Chen M, Yue P, Tao H, Owonikoko TK, Ramalingam SS, Khuri FR, Sun SY (2012) The combination of RAD001 and NVP-BKM120 synergistically inhibits the growth of lung cancer in vitro and in vivo. Cancer Lett 325: 139-146.
21. Rodon J, Dienstmann R, Serra V, Tabernero J (2013) Development of PI3K inhibitors: Lessons learned from early clinical trials. Nat Rev Clin Oncol 10: 143-153.
22. Schmid K, Bago-Horvath Z, Berger W, Haitel A, Cejka D, Werzowa J, Filipits M, Herberger B, Hayden H, Sieghart W (2010) Dual inhibition of EGFR and mTOR pathways in small cell lung cancer. Br J Cancer 103: 622-628.
23. Smit EF, Fokkema E, Biesma B, Groen HJ, Snoek W, Postmus PE (1998) A phase II study of paclitaxel in heavily pretreated patients with small-cell lung cancer. Br J Cancer 77: 347-351.
24. Sun SY, Fu H, Khuri FR (2006) Targeting mTOR signaling for lung cancer therapy. J Thorac Oncol 1: 109-111.
25. Tanaka C, O'Reilly T, Kovarik JM, Shand N, Hazell K, Judson I, Raymond E, Zumstein-Mecker S, Stephan C, Boulay A, Hattenberger M, Thomas G, Lane HA (2008) Identifying optimal biologic doses of everolimus (RAD001) in patients with cancer based on the modeling of preclinical and clinical pharmacokinetic and pharmacodynamic data. J Clin Oncol 26: 1596-1602.
26. Tarhini A, Kotsakis A, Gooding W, Shuai Y, Petro D, Friedland D, Belani CP, Dacic S, Argiris A (2010) Phase II study of everolimus (RAD001) in previously treated small cell lung cancer. Clin Cancer Res 16: 5900-5907.
27. VanderWeele DJ, Zhou R, Rudin CM (2004) Akt up-regulation increases resistance to microtubule-directed chemotherapeutic agents through mammalian target of rapamycin. Mol Cancer Ther 3: 1605-1613.
28. Xu CX, Li Y, Yue P, Owonikoko TK, Ramalingam SS, Khuri FR, Sun SY (2011) The combination of RAD001 and NVP-BEZ235 exerts synergistic anticancer activity against non-small cell lung cancer in vitro and in vivo. PLoS One 6: E20899.
29. Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Oberg K (2011) Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 364: 514-523.