A systematic review on topoisomerase 1 inhibition in the treatment of metastatic breast cancer

Breast Cancer Research and Treatment

Volumn 138, Issue 2, 2013, Pages 347-358

  Kümler, Iben ^a   Brünner, Nils ^b   Stenvang, Jan ^b   Balslev, Eva ^a   Nielsen, Dorte L ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Metastatic breast cancer; Systematic review; Topoisomerase 1 inhibitors; Treatment

Indexed keywords

7 HYDROXYSTAUROSPORINE; BEVACIZUMAB; CAPECITABINE; CARBOPLATIN; CETUXIMAB; CISPLATIN; DNA TOPOISOMERASE; DOCETAXEL; ETIRINOTECAN PEGOL; ETOPOSIDE; FIRTECAN PEGOL; FLUOROURACIL; GEMCITABINE; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; INIPARIB; IRINOTECAN; LAPATINIB; MITOMYCIN; PACLITAXEL; TAXANE DERIVATIVE; TEMOZOLOMIDE; TOPOTECAN; TRASTUZUMAB;

BLOOD TOXICITY; BREAST CANCER; BREAST METASTASIS; CANCER COMBINATION CHEMOTHERAPY; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DYSPNEA; ENZYME INHIBITION; FATIGUE; HUMAN; MAJOR CLINICAL STUDY; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; REVIEW; SKIN TOXICITY; SYSTEMATIC REVIEW; TREATMENT OUTCOME; VOMITING;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CAMPTOTHECIN; CLINICAL TRIALS AS TOPIC; DNA TOPOISOMERASES, TYPE I; FEMALE; HUMANS; NEOPLASM METASTASIS; TOPOISOMERASE I INHIBITORS; TOPOTECAN; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 84879409543     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-013-2476-3     Document Type: Review

References (72)

1. Brewster AM, Hortobagyi GN, Broglio KR, Kau SW, Santa-Maria CA, Arun B, Buzdar AU, Booser DJ, Valero V, Bondy M, Esteva FJ (2008) Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst 100(16):1179-1183. doi: 1093/jnci/djn233
2. Cardoso F, Bedard PL, Winer EP, Pagani O, Senkus-Konefka E, Fallowfield LJ, Kyriakides S, Costa A, Cufer T, Albain KS (2009) International guidelines for management of metastatic breast cancer: combination vs. sequential single-agent chemotherapy. J Natl Cancer Inst 101(17):1174-1181. doi: 10.1093/jnci/djp235
3. Roche H, Vahdat LT (2011) Treatment of metastatic breast cancer: second line and beyond. Ann Oncol 22(5):1000-1010. doi: 10.1093/annonc/mdq429
4. Cobleigh MA (2011) Other options in the treatment of advanced breast cancer. Semin Oncol 38(suppl 2):S11-S16. doi: 10.1053/j.seminoncol.2011.04.005
5. Rivera E (2010) Management of metastatic breast cancer: monotherapy options for patients resistant to anthracyclines and taxanes. Am J Clin Oncol 33(2):176-185. doi: 10.1097/COC.0b013e3181931049
6. Moukharskaya J, Verschraegen C (2012) Topoisomerase 1 inhibitors and cancer therapy. Hematol Oncol Clin North Am 26(3):507-525. doi: 10.1016/j.hoc.2012.03.002
7. Azim HA Jr, Awada A (2012) Clinical development of new formulations of cytotoxics in solid tumors. Curr Opin Oncol 24(3):325-331. doi: 10.1097/CCO.0b013e328351fb29
8. Jameson GS, Hamm JT, Weiss GJ, Alemany C, Anthony S, Basche M, Ramanathan RK, Borad MJ, Tibes R, Cohn A, Hinshaw I, Jotte R, Rosen LS, Hoch U, Eldon MA, Medve R, Schroeder K, White E, Von Hoff DD (2012) A multicenter, phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of etirinotecan pegol in patients with refractory solid tumors. Clin Cancer Res 19(1):268-278. doi: 10.1158/1078-0432.CCR-12-1201
9. Beretta GL, Perego P, Zunino F (2008) Targeting topoisomerase I: molecular mechanisms and cellular determinants of response to topoisomerase I inhibitors. Expert Opin Ther Targets 12(10):1243-1256. doi: 10.1517/14728222.12. 10.1243
10. Wang JC (2002) Cellular roles of DNA topoisomerases: a molecular perspective. Nat Rev Mol Cell Biol 3(6):430-440. doi: 10.1038/nrm831nrm831 (Pubitemid 34685700)
11. Chabot GG (1997) Clinical pharmacokinetics of irinotecan. Clin Pharmacokinet 33(4):245-259 (Pubitemid 27429892)
12. Stein A, Arnold D (2012) Oxaliplatin: a review of approved uses. Expert Opin Pharmacother 13(1):125-137. doi: 10.1517/14656566.2012.643870
13. Bittoni A, Maccaroni E, Scartozzi M, Berardi R, Cascinu S (2010) Chemotherapy for locally advanced and metastatic gastric cancer: state of the art and future perspectives. Eur Rev Med Pharmacol Sci 14(4):309-314
14. Gebbia V, Maiello E, Giuliani F, Borsellino N, Arcara C, Colucci G (2010) Irinotecan plus bolus/infusional 5-Fluorouracil and leucovorin in patients with pretreated advanced pancreatic carcinoma: a multicenter experience of the Gruppo Oncologico Italia Meridionale. Am J Clin Oncol 33(5):461-464. doi: 10.1097/COC.0b013e3181b4e3b0
15. Jakobsen JN, Hasselbalch B, Stockhausen MT, Lassen U, Poulsen HS (2011) Irinotecan and bevacizumab in recurrent glioblastoma multiforme. Expert Opin Pharmacother 12(5):825-833. doi: 10.1517/14656566.2011.566558
16. Naumann RW, Coleman RL (2011) Management strategies for recurrent platinum-resistant ovarian cancer. Drugs 71(11):1397-1412. doi: 10.2165/11591720-000000000-000003
17. Hartwell D, Jones J, Loveman E, Harris P, Clegg A, Bird A (2011) Topotecan for relapsed small cell lung cancer: a systematic review and economic evaluation. Cancer Treat Rev 37(3):242-249. doi: 10.1016/j.ctrv.2010.07. 005S0305-7372(10)00130-1
18. Lorusso D, Pietragalla A, Mainenti S, Masciullo V, Di Vagno G, Scambia G (2010) Review role of topotecan in gynaecological cancers: current indications and perspectives. Crit Rev Oncol Hematol 74(3):163-174. doi: 10.1016/j.critrevonc.2009.08.001S1040-8428(09)00158-9
19. Fracasso PM, Williams KJ, Chen RC, Picus J, Ma CX, Ellis MJ, Tan BR, Pluard TJ, Adkins DR, Naughton MJ, Rader JS, Arquette MA, Fleshman JW, Creekmore AN, Goodner SA, Wright LP, Guo Z, Ryan CE, Tao Y, Soares EM, Cai SR, Lin L, Dancey J, Rudek MA, McLeod HL, Piwnica-Worms H (2011) A Phase 1 study of UCN-01 in combination with irinotecan in patients with resistant solid tumor malignancies. Cancer Chemother Pharmacol 67(6):1225-1237. doi: 10.1007/s00280-010-1410-1
20. Ikeda H, Koshiba R (2000) A pilot study of irinotecan hydrochloride for metastatic breast cancer-efficacy as a salvage therapy. Gan To Kagaku Ryoho 27(5):723-727
21. Ikeda M, Kurebayashi J, Sonoo H, Oota Y, Fujii S, Shimo T, Miyake A, Seki M, Souda M, Nomura T, Yamamoto Y, Shiiki S, Nakashima K, Tanaka K (2009) Evaluation of irinotecan hydrochloride (CPT-11) and trastuzumab combination therapy as salvage treatment in patients with HER2 overexpressing metastatic breast cancer. Gan To Kagaku Ryoho 36(5):773-777
22. Okubo S, Kurebayashi J, Sonoo H, Hirono M, Nomura N, Udagawa K, Yamamoto Y, Ikeda M, Nakashima K, Tanaka K (2003) Retrospective study on utility of irinotecan hydrochloride in patients with advanced and recurrent breast cancer. Gan To Kagaku Ryoho 30(10):1441-1445
23. Doihara H, Takashima S, Yokoyama N (1994) Four cases of recurrent breast cancer effectively treated by the new antitumor agent, CPT-11 (irinotecan). Gan To Kagaku Ryoho 21(8):1263-1266 (Pubitemid 24248047)
24. Murata T, Fujii M, Aoki M, Oda K (2011) A case of spindle cell carcinoma of the breast, in which irinotecan was effective against respiratory failure due to pulmonary metastases. Gan To Kagaku Ryoho 38(3):431-434
25. Wolff AC, O'Neill A, Kennedy MJ, Stewart JA, Gradishar WJ, Lord RS 3rd, Davidson NE, Wood WC (2005) Single-agent topotecan as first-line chemotherapy in women with metastatic breast cancer: final results of eastern cooperative oncology group trial E8193. Clin Breast Cancer 6(4):334-339. doi: 10.3816/CBC.2005.n.037 (Pubitemid 41715695)
26. Fleming GF, Kugler JW, Hoffman PC, Ansari R, Bitran JD, Klepsch A, Malone D, Fasanmade AA, Ratain MJ, Vokes EE (1998) Phase II trial of paclitaxel and topotecan with granulocyte colony-stimulating factor support in stage IV breast cancer. J Clin Oncol 16(6):2032-2037 (Pubitemid 28265037)
27. Chang H, Han S, Oh D, Im S, Kim T, Bang Y (2009) Combination chemotherapy of irinotecan with fluoropyrimidine in taxane, anthracycline and fluoropyrimidine-pretreated metastatic breast cancer. J Clin Oncol 27 (Suppl):abstract e12003
28. Espinós J, Olier-Garate C, Aramendia JM, Hidalgo OF, Reyna C, De La Cruz S, del Barrio A, Garcia-Foncillas J (2008) Efficacy of the combination of irinotecan and bevacizumab in heavely pretreated metastatic breast cancer. J Clin Oncol 26 (May 20 suppl):abstract 12001
29. Mrozek E, Kolesar J, Young D, Allen J, Villalona-Calero M, Shapiro CL (2008) Phase II study of sequentially administered low-dose mitomycin-C(MMC) and irinotecan (CPT-11) in women with metastatic breast cancer (MBC). Ann Oncol 19(8):1417-1422. doi: 10.1093/annonc/mdn154
30. Vukelja S, O′Shaughnessy J, Campos L, Vahdat J, Blum J, Yardley P, Mainwaring F, Senecal R, Benner R, Denis L, Perez E (2005) Activity of oral irinotecan n metastatic breast cancer patients after prior anthracycline, taxane and capecitabine: phase 2 study results. J Clin Oncol 23(16S):619
31. Tan WW, Hillman DW, Salim M, Northfelt DW, Anderson DM, Stella PJ, Niedringhaus R, Bernath AM, Gamini SS, Palmieri F, Perez EA (2010) N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group (NCCTG) Trial. Ann Oncol 21(3):493-497. doi: 10.1093/annonc/mdp328
32. Lin NU, Eierman W, Greil R, Campone M, Kaufman B, Steplewski K, Lane SR, Zembryki D, Rubin SD, Winer EP (2011) Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases. J Neurooncol 105(3):613-620. doi: 10.1007/s11060-011-0629-y
33. Hayashi H, Tsurutani J, Satoh T, Masuda N, Okamoto W, Morinaga R, Terashima M, Miyazaki M, Okamoto I, Nishida Y, Tominaga S, Tokunaga Y, Yamaguchi M, Sakamoto J, Nakayama T, Nakagawa K (2011) Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer: KMBOG0610B. Breast Cancer 6(8):e23849. doi: 10.1007/s12282-011-0316-z
34. Perez EA, Hillman DW, Mailliard JA, Ingle JN, Ryan JM, Fitch TR, Rowland KM, Kardinal CG, Krook JE, Kugler JW, Dakhil SR (2004) Randomized phase II study of two irinotecan schedules for patients with metastatic breast cancer refractory to an anthracycline, a taxane, or both. J Clin Oncol 22(14):2849-2855. doi: 10.1200/JCO.2004.10.047 (Pubitemid 41079903)
35. Shigeoka Y, Itoh K, Igarashi T, Ishizawa K, Saeki T, Fujii H, Minami H, Imoto S, Sasaki Y (2001) Clinical effect of irinotecan in advanced and metastatic breast cancer patients previously treated with doxorubicin- and docetaxel-containing regimens. Jpn J Clin Oncol 31(8):370-374 (Pubitemid 32958588)
36. Garcia AA, Awada A, Chan S, Jerusalem G, Coleman RE, Huizing MT, Mehdi A, O′Reilly SM, Hamm JT, Barrett-Lee PJ, Cocquyt V, Sideras K, Young D, Brown M, Zhao C, Hannah AL, Leung AC, Masuoka LK, Perez EA (2011) Final results of NKTR-102, a topoisomeraseI inhibitor-polymer conjugate in patients with pretreated metastatic breast cancer demonstrating significant antitumor activity. J Clin Oncol 29 (suppl 27):abstract 269
37. Lee KS, Park IH, Nam BH, Ro J (2013) Phase II study of irinotecan plus capecitabine in anthracycline- and taxane-pretreated patients with metastatic breast cancer. Invest New Drugs 31(1):152-159. doi: 10.1007/s10637-012-9824-8
38. O'Connor T, Rustum Y, Levine E, Creaven P (2008) A phase I study of capecitabine and a modulatory dose of irinotecan in metastatic breast cancer. Cancer Chemother Pharmacol 61(1):125-131. doi: 10.1007/s00280-007-0456-1 (Pubitemid 47512634)
39. Tanaka M, Furusawa H, Kamada Y, Sagara Y, Anan K, Miyara K, Kai Y, Wakamatsu S, Uga T, Tamura K, Mitsuyama S (2010) Pilot study of irinotecan and S-1 for advanced and metastatic breast cancer. Cancer Res 70(suppl 24)
40. Hobday TJ, Stella PJ, Fitch TR, Jaslowski A, LaPlant B, Ames MM, Goetz MP, Perez EA (2008) NO436: A phase II trial of irinotecan plus cetuximab in patients with metastatic breast cancer and prior anthracycline and/or taxane-containing therapy. J Clin Oncol 26 (May 20 suppl):abstract 1081
41. Ma CX, Ellis MJ, Petroni GR, Lockhart AC, Naughton M, Pluard TJ, Brenin C, Picus J, Creekmore AN, Mwandoro TN, Guo Z, Cai S, Ryan C, Yarde E, Hoog J, Dancey J, Watson M, Piwnica-Worms H, Fracasso PM (2012) Clinical and correlative science results in a phase II study of UCN-01 in combination with irinotecan in recurrent triple-negative breast cancer. J Clin Oncol 30 (suppl):abstract 3047
42. Moulder S, Mita M, Bradley C, Rocha C, Harris L (2010) A phase 1b study to assess the safety and tolerability of the PARP inhibitor iniparib in combination with irinotecan for the treatment of patients with metastatic breast cancer. Presented at SABC:abstract P6-15-01
43. Moulder S, Valkov N, Neuger A, Choi J, Lee JH, Minton S, Munster P, Gump J, Lacevic M, Lush R, Sullivan D (2008) Phase 2 study of gemcitabine and irinotecan in metastatic breast cancer with correlatives to determine topoisomerase I localization as a predictor of response. Cancer 113(10):2646-2654. doi: 10.1002/cncr.23916
44. Von Hoff DD, Jameson GS, Borad MJ, Rosen LS, Utz J, Basche M, Alemany C, Dhar S, Acosta L, Barker T, Walling J, Hamm JT (2008) First phase I trial of NKTR-102 (Peg-Irinotecan) reveals early ecidence of broad anti-tumor activity in three different schedules. In: EORTC-NCI-AACR symposium on "molecular targets and cancer therapeutics" Poster no. 595, Geneva
45. Zander SA, Sol W, Greenberger L, Zhang Y, van Tellingen O, Jonkers J, Borst P, Rottenberg S (2012) EZN-2208 (PEG-SN38) overcomes ABCG2-mediated topotecan resistance in BRCA1-deficient mouse mammary tumors. PLoS One 7(9):45248. doi: 10.1371/journal.pone.0045248PONE-D-12-18536
46. Frasci G, D'Aiuto G, Thomas R, Comella P, Di Bonito M, Lapenta L, D'Aiuto M, Botti G, Vallone P, De Rosa V, D'Aniello R, Giordano R, Comella G (2005) Biweekly docetaxel-irinotecan treatment with filgrastim support is highly active in antracycline-paclitaxel-refractory breast cancer patients. Oncology 68(4-6):391-397. doi: 10.1159/000086980 (Pubitemid 41160969)
47. Stathopoulos GP, Tsavdaridis D, Malamos NA, Rigatos SK, Kosmas C, Pergantas N, Stathopoulos JG, Xynotroulas J (2005) Irinotecan combined with docetaxel in pre-treated metastatic breast cancer patients: a phase II study. Cancer Chemother Pharmacol 56(5):487-491. doi: 10.1007/s00280-005-1006-3 (Pubitemid 41549150)
48. Katz A, Hoff PM, Simon SD, Gansl RC, Tabacof J, Abramoff R, Pietrocola M, Smaletz O, Novis Y (2003) Itinotecan and cisplatin in heavily pre-treated metastatic breast cancer patients. Proc Am Soc Clin Oncol 22: abstract 335
49. Levine EG, Cirrincione CT, Szatrowski TP, Canellos G, Norton L, Henderson IC (1999) Phase II trial of topotecan in advanced breast cancer: a Cancer and Leukemia Group B study. Am J Clin Oncol 22(3):218-222 (Pubitemid 30263311)
50. Mainwaring PN, Nicolson MC, Hickish T, Penson R, Joel S, Slevin M, Smith IE (1997) Continuous infusional topotecan in advanced breast and non-small-cell lung cancer: no evidence of increased efficacy. Br J Cancer 76(12):1636-1639 (Pubitemid 27520594)
51. Oberhoff C, Kieback DG, Wurstlein R, Deertz H, Sehouli J, van Soest C, Hilfrich J, Mesrogli M, von Minckwitz G, Staab HJ, Schindler AE (2001) Topotecan chemotherapy in patients with breast cancer and brain metastases: results of a pilot study. Onkologie 24(3):256-260 (Pubitemid 32664555)
52. Cardoso F, Costa A, Norton L, Cameron D, Cufer T, Fallowfield L, Francis P, Gligorov J, Kyriakides S, Lin N, Pagani O, Senkus E, Thomssen C, Aapro M, Bergh J, Di Leo A, El Saghir N, Ganz PA, Gelmon K, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Leadbeater M, Mayer M, Rodger A, Rugo H, Sacchini V, Sledge G, Van't Veer L, Viale G, Krop I, Winer E (2012) 1st International consensus guidelines for advanced breast cancer (ABC 1). Breast 21(3):242-252. doi: 10.1016/j.breast.2012.03.003
53. Sledge GW, Neuberg D, Bernardo P, Ingle JN, Martino S, Rowinsky EK, Wood WC (2003) Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 21(4):588-592 (Pubitemid 46621890)
54. Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C (2008) Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol 26(10):1642-1649. doi: 10.1200/JCO.2007.11.6699
55. Ejlertsen B, Mouridsen HT, Langkjer ST, Andersen J, Sjostrom J, Kjaer M (2004) Phase III study of intravenous vinorelbine in combination with epirubicin versus epirubicin alone in patients with advanced breast cancer: a Scandinavian Breast Group Trial (SBG9403). J Clin Oncol 22(12):2313-2320. doi: 10.1200/JCO.2004.11.503 JCO.2004.11.503 [pii] (Pubitemid 41115387)
56. Nielsen D, Dombernowsky P, Larsen SK, Hansen OP, Skovsgaard T (2000) Epirubicin or epirubicin and cisplatin as first-line therapy in advanced breast cancer. A phase III study. Cancer Chemother Pharmacol 46(6):459-466
57. Albain KS, Nag SM, Calderillo-Ruiz G, Jordaan JP, Llombart AC, Pluzanska A, Rolski J, Melemed AS, Reyes-Vidal JM, Sekhon JS, Simms L, O'Shaughnessy J (2008) Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 26(24):3950-3957. doi: 10.1200/JCO.2007.11.9362
58. Blackstein M, Vogel CL, Ambinder R, Cowan J, Iglesias J, Melemed A (2002) Gemcitabine as first-line therapy in patients with metastatic breast cancer: a phase II trial. Oncology 62(1):2-8 (Pubitemid 34124219)
59. Oshaughnessy JA, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, Rosso R, Mauriac L, Osterwalder B, Burger HU, Laws S (2001) Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 12(9):1247-1254 (Pubitemid 32994752)
60. Kusama M, Nomizu T, Aogi K, Yoshimoto M, Horikoshi N, Tabei T, Noguchi S, Miura S, Yoshimura N, Kimura M, Toyama K, Shin E (2010) Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer. Breast Cancer 17(4):233-240. doi: 10.1007/s12282-009-0137-5
61. Stockler MR, Harvey VJ, Francis PA, Byrne MJ, Ackland SP, Fitzharris B, Van Hazel G, Wilcken NR, Grimison PS, Nowak AK, Gainford MC, Fong A, Paksec L, Sourjina T, Zannino D, Gebski V, Simes RJ, Forbes JF, Coates AS (2011) Capecitabine versus classical cyclophosphamide, methotrexate, and fluorouracil as first-line chemotherapy for advanced breast cancer. J Clin Oncol 29(34):4498-4504. doi: 10.1200/JCO.2010.33.9101
62. Martin M, Ruiz A, Munoz M, Balil A, Garcia-Mata J, Calvo L, Carrasco E, Mahillo E, Casado A, Garcia-Saenz JA, Escudero MJ, Guillem V, Jara C, Ribelles N, Salas F, Soto C, Morales-Vasquez F, Rodriguez CA, Adrover E, Mel JR (2007) Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol 8(3):219-225. doi: 10.1016/S1470-2045(07)70041-4 (Pubitemid 46291704)
63. Dumez H, Awada A, Piccart M, Assadourian S, Semiond D, Guetens G, de Boeck G, Maes RA, de Bruijn EA, van Oosterom A (2006) A phase I dose-finding clinical pharmacokinetic study of an oral formulation of irinotecan (CPT-11) administered for 5 days every 3 weeks in patients with advanced solid tumours. Ann Oncol 17(7):1158-1165. doi: 10.1093/annonc/mdl071 (Pubitemid 43985254)
64. Kuppens IE, Dansin E, Boot H, Feger C, Assadourian S, Bonneterre ME, Beijnen JH, Schellens JH, Bonneterre J (2006) Dose-finding phase I clinical and pharmacokinetic study of orally administered irinotecan in patients with advanced solid tumors. Clin Cancer Res 12(12):3774-3781. doi: 10.1158/1078-0432.CCR-05-2368 (Pubitemid 44000259)
65. Pitot HC, Adjei AA, Reid JM, Sloan JA, Atherton PJ, Rubin J, Alberts SR, Duncan BA, Denis L, Schaaf LJ, Yin D, Sharma A, McGovren P, Miller LL, Erlichman C (2006) A phase I and pharmacokinetic study of a powder-filled capsule formulation of oral irinotecan (CPT-11) given daily for 5 days every 3 weeks in patients with advanced solid tumors. Cancer Chemother Pharmacol 58(2):165-172. doi: 10.1007/s00280-005-0138-9
66. Schoemaker NE, Kuppens IE, Huinink WW, Lefebvre P, Beijnen JH, Assadourian S, Sanderink GJ, Schellens JH (2005) Phase I study of an oral formulation of irinotecan administered daily for 14 days every 3 weeks in patients with advanced solid tumours. Cancer Chemother Pharmacol 55(3):263-270. doi: 10.1007/s00280-004-0874-2 (Pubitemid 40142891)
67. Braun MS, Richman SD, Quirke P, Daly C, Adlard JW, Elliott F, Barrett JH, Selby P, Meade AM, Stephens RJ, Parmar MK, Seymour MT (2008) Predictive biomarkers of chemotherapy efficacy in colorectal cancer: results from the UK MRC FOCUS trial. J Clin Oncol 26(16):2690-2698. doi: 10.1200/JCO.2007.15.5580
68. Koopman M, Knijn N, Richman S, Seymour M, Quirke P, van Tinteren H, van Krieken JHJM, Punt CJ, Nagtegaal ID (2009) The correlation between Topoisomerase-I expression and outcome of treatment with capecitabine and irinotecan in advanced colorectal cancer patients treated in the CAIRO study of the Dutch Colorectal Cancer Group. EJC Supplements 7:321-322
69. Romer MU, Jensen NF, Nielsen SL, Muller S, Nielsen KV, Nielsen HJ, Brunner N (2012) TOP1 gene copy numbers in colorectal cancer samples and cell lines and their association to in vitro drug sensitivity. Scand J Gastroenterol 47(1):68-79. doi: 10.3109/00365521.2011.638393
70. Stenvang J, Smid M, Nielsen SL, Timmermans M, Rømer M, Nielsen D, Foekens J, Brünner N, Martens J (2012) Topoisomerase 1 gene copy aberrations in 52 human breast cancer cell lines and association to gene expression. Cancer Res 72(suppl)
71. Stenvang J, Smid M, Nielsen S, Balslev E, Timmerman J, Rømer M, Nygaard S, Christensen I, Nielsen D, Foekens J, Brünner N, Martens J (2012) Topoisomerase 1 gene copy aberration is a frequent finding in clinical breast cancer samples. Cancer Res 72(suppl)
72. Lynch BJ, Bronstein IB, Holden JA (2001) Elevations of DNA topoisomerase I in invasive carcinoma of the breast. Breast J 7(3):176-180 (Pubitemid 32619779)