Phase I-II trial of prolonged gemcitabine infusion plus paclitaxel as a biweekly schedule for advanced breast cancer patients pretreated with anthracyclines

Cancer Chemotherapy and Pharmacology

Volumn 67, Issue 3, 2011, Pages 687-693

  Vici, Patrizia ^a   Fabi, Alessandra ^a   Metro, Giulio ^a   Sergi, Domenico ^a   Giannarelli, Diana ^a   Di Lauro, Luigi ^a   Bepler, Gerold ^b   Tomao, Federica ^c   Cognetti, Francesco ^a   Conti, Francesca ^a   Lopez, Massimo ^a  

^a REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^b H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^c SAPIENZA UNIVERSITY OF ROME   (Italy)

Author keywords

Advanced breast cancer; Fixed dose rate; Gemcitabine; HER2 negative breast cancer; Paclitaxel

Indexed keywords

ANTHRACYCLINE; BRCA1 PROTEIN; DOCETAXEL; GEMCITABINE; ONCOPROTEIN; PACLITAXEL; PROTEIN RRM1; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; RRM1 PROTEIN, HUMAN; TUMOR SUPPRESSOR PROTEIN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RECURRENCE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERTRANSAMINASEMIA; LONG TERM CARE; MUCOSA INFLAMMATION; MUSCULOSKELETAL PAIN; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; THROMBOCYTOPENIA; TREATMENT RESPONSE; BREAST TUMOR; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; GENETICS; MIDDLE AGED; PATHOLOGY; SURVIVAL; TIME; TREATMENT OUTCOME; TUMOR RECURRENCE;

ADULT; AGED; ANTHRACYCLINES; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRCA1 PROTEIN; BREAST NEOPLASMS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PACLITAXEL; SURVIVAL; TIME FACTORS; TREATMENT OUTCOME; TUMOR SUPPRESSOR PROTEINS; YOUNG ADULT;

EID: 79953767581     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-010-1369-y     Document Type: Article

References (40)

1. KM King S Lupichuk L Baig M Webster S Basi D Whyte S Rix 2009 Optimal use of taxanes in metastatic breast cancer Curr Oncol 16 8 20 1:STN:280: DC%2BD1MvhvFShtw%3D%3D 10.3747/co.v16i3.377 19526080
2. W Plunkett P Huang YZ Xu V Heinemann R Grunewald V Gandhi 1995 Gemcitabine: metabolism, mechanisms of action, and self-potentiation Semin Oncol 22 S11 3 10 1:CAS:528:DyaK2MXpsFGntbY%3D 7481842
3. G Bepler I Kusmartseva S Sharma A Gautam A Cantor A Sharma G Simon 2006 RRM1 modulated in vitro and in vivo efficacy of gemcitabine and platinum in non-small-cell lung cancer J Clin Oncol 24 4731 4737 1:CAS:528: DC%2BD28XhtFynsr3K 10.1200/JCO.2006.06.1101 16966686 (Pubitemid 46646245)
4. S Nakahira S Nakamori M Tsujie Y Takahashi J Okami S Yoshioka M Yamasaki S Marubashi I Takemasa A Miyamoto Y Takeda H Nagano K Dono K Umeshita M Sakon M Monden 2007 Involvement of ribonucleotide reductase M1 subunit overexpression in gemcitabine resistance of human pancreatic cancer Int J Cancer 120 1355 1363 1:CAS:528:DC%2BD2sXhvVOisr0%3D 10.1002/ijc.22390 17131328
5. M Blackstein CL Vogel R Ambinder J Cowan J Iglesias A Melemed 2002 Gemcitabine as first-line therapy in patients with metastatic breast cancer: a phase II trial Oncology 62 2 8 1:CAS:528:DC%2BD38XntFCmtA%3D%3D 10.1159/000048240 11810037 (Pubitemid 34124219)
6. JR Kroep G Giaccone DA Voorn EF Smit JH Beijnen H Rosing CJ van Moorsel CJ van Groeningen PE Postmus HM Pinedo GJ Peters 1999 Gemcitabine and paclitaxel: pharmacokinetic and pharmacodynamic interactions in patients with non-small-cell lung cancer J Clin Oncol 17 2190 2197 1:CAS:528: DyaK1MXkvVSmurs%3D 10561275 (Pubitemid 29318852)
7. JR Kroep G Giaccone C Tolis DA Voorn WJ Loves CJ Groeningen HM Pinedo GJ Peters 2000 Sequence dependent effect of paclitaxel on gemcitabine metabolism in relation to cell cycle and cytotoxicity in non-small-cell lung cancer cell lines Br J Cancer 83 1069 1976 1:CAS:528:DC%2BD3cXnsF2hsL4%3D 10.1054/bjoc.2000.1399 10993656
8. R Colomer A Llombart-Cussac A Lluch A Barnadas B Ojeda V Carañana Y Fernández J García-Conde S Alonso S Montero J Hornedo V Guillem 2004 Biweekly paclitaxel plus gemcitabine in advanced breast cancer: phase II trial and predictive value of HER2 extracellular domain Ann Oncol 15 201 206 1:STN:280:DC%2BD2c%2FlvVantg%3D%3D 10.1093/annonc/mdh048 14760109 (Pubitemid 38262615)
9. C Delfino G Caccia LR Gonzáles E Mickiewicz J Rodger L Balbiani DF Morales AZ Comba C Brosio 2004 Gemcitabine plus paclitaxel as first-line chemotherapy for patients with advanced breast cancer Oncology 66 18 23 1:CAS:528:DC%2BD2cXitlyitL0%3D 10.1159/000076330 15031594 (Pubitemid 38410675)
10. AM Murad RC Guimarães BC Aragão AO Scalabrini-Neto VH Rodrigues R Garcia 2001 Phase II trial of the use of paclitaxel and gemcitabine as a salvage treatment in metastatic breast cancer Am J Clin Oncol 24 264 268 1:STN:280:DC%2BD3MzjsFenuw%3D%3D 10.1097/00000421-200106000-00011 11404498 (Pubitemid 32520632)
11. O'Shaughnessy J, Nag S, Calderillo-Ruiz G, Jordaan J, Llombart A, Pluzanska A, Pawlicki M, Reyes JM, Sekhon J, Albain KS (2003) Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first-line treatment for anthracycline pre-treated metastatic breast cancer (MBC): interim results of a global phase III study. Proc Am Soc Clin Oncol 22 (abstract 25)
12. ML Rothenberg A Sharma GR Weiss MA Villalona-Calero JR Eckardt C Aylesworth MA Kraynak DA Rinaldi GI Rodriguez HA Burris 3rd SG Eckhardt CD Stephens K Forral SJ Nicol DD Von Hoff 1998 Phase I trial of paclitaxel and gemcitabine administered every two weeks in patients with refractory solid tumors Ann Oncol 9 733 738 1:STN:280:DyaK1cvhtFOmtA%3D%3D 10.1023/A: 1008286908930 9739439 (Pubitemid 28394159)
13. Sanchez P, Medina MB, Mohedano N, Jaen A, Porras I, Gonzales E, Fernandez M, Lozano A (1998) Results from a phase II study of gemcitabine in combination with paclitaxel in metastatic breast cancer. Ann Oncol 9(S4):77P (abstract)
14. R Colomer A Llombart A Lluch B Ojeda A Barnadas V Carañana Y Fernández L De Paz V Guillem S Alonso 2000 Paclitaxel/gemcitabine administered every two weeks in advanced breast cancer: preliminary results of a phase II trial Semin Oncol 27 S2 20 24 1:CAS:528:DC%2BD3cXhs1Gqtrk%3D 10697032 (Pubitemid 30108680)
15. Vici P, Foggi P, Capomolla E, Santiccioli S, Cauchi C, Giacinti L, Lopez M (2002) Biweekly paclitaxel/gemcitabine (P/G) as salvage treatment in breast cancer patients (pts): preliminary result. Proc Am Soc Clin Oncol 21 (abstract 2054)
16. JL Abbruzzese R Grunewald EA Weeks D Gravel T Adams B Nowak S Mineishi P Tarassoff W Satterlee MN Raber 1991 A phase I clinical, plasma, and cellular pharmacology study of gemcitabine J Clin Oncol 9 491 498 1:STN:280: DyaK3M7lsVymtg%3D%3D 1999720
17. R Grunewald H Kantarjian M Du K Faucher P Tarassoff W Plunkett 1992 Gemcitabine in leukemia: a phase I clinical, plasma, and cellular pharmacology study J Clin Oncol 10 406 413 1:STN:280:DyaK387ls1ylug%3D%3D 1740680
18. A Ceribelli C Gridelli F De Marinis A Fabi T Gamucci E Cortesi M Barduagni M Antimi P Maione MR Migliorino D Giannarelli F Cognetti 2003 Prolonged gemcitabine infusion in advanced non-small cell lung carcinoma: a randomized phase II study of two different schedules in combination with cisplatin Cancer 98 337 343 1:CAS:528:DC%2BD3sXlvFChsro%3D 10.1002/cncr.11501 12872354 (Pubitemid 36828459)
19. P Schmid K Akrivakis B Flath Y Grosse O Sezer HG Mergenthaler K Possinger 1999 Phase II trial of gemcitabine as prolonged infusion in metastatic breast cancer Anticancer Drugs 10 625 631 1:CAS:528:DyaK1MXmtlSls7g%3D 10.1097/00001813-199908000-00001 10507311 (Pubitemid 29450203)
20. J Feliu R Mel P Borrega L López Gómez P Escudero J Dorta J Castro SE Vázquez-Estévez M Bolaños E Espinosa M González Barón 2002 Phase II study of a fixed dose-rate infusion of gemcitabine associated with uracil/tegafur in advanced carcinoma of the pancreas Ann Oncol 13 1756 1762 1:STN:280:DC%2BD38nlvFaiug%3D%3D 10.1093/annonc/mdf286 12419748 (Pubitemid 35446267)
21. F Estephan V Valero FJ Esteva JA Mejia DK Frye NK Ibrahim 2009 Phase I study of prolonged-infusion gemcitabine combined with cyclophosphamide in patients with metastatic carcinoma of the breast: tolerability of an optimal dose schedule Oncology 77 63 70 1:CAS:528:DC%2BD1MXot12kt74%3D 10.1159/000226213 19556811
22. M Tempero W Plunkett V Ruiz Van Haperen J Hainsworth H Hochster R Lenzi J Abbruzzese 2003 Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma J Clin Oncol 21 3402 3408 1:CAS:528:DC%2BD2cXpsVKjtLs%3D 10.1200/JCO.2003.09.140 12885837 (Pubitemid 46594072)
23. P Therasse SG Arbuck EA Eisenhauer J Wanders RS Kaplan L Rubinstein J Verweij M van Glabbeke AT van Oosterom MC Christian SG Gwyther 2000 New guidelines to evaluate the response to treatment in solid tumors J Natl Cancer Inst 92 205 216 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10.1093/jnci/92.3.205 10655437 (Pubitemid 30099779)
24. G Metro Z Zheng A Fabi M Schell B Antoniani M Mottolese AN Monteiro P Vici S Lara Rivera D Boulware F Cognetti G Bepler 2010 In situ protein expression of RRM1, ERCC1, and BRCA1 in metastatic breast cancer patients treated with gemcitabine-based chemotherapy Cancer Invest 28 172 180 1:CAS:528:DC%2BC3cXhsFCrtbk%3D 10.3109/07357900903095722 19968494
25. G Metro A Fabi M Russillo P Papaldo M De Laurentiis G Ferretti D Pellegrini C Nuzzo V Graziano P Vici M Introna A Felici F Cognetti P Carlini 2008 Taxanes and gemcitabine doublets in the management of HER-2 negative metastatic breast cancer: towards optimization of association and schedule Anticancer Res 28 1245 1258 1:CAS:528:DC%2BD1cXmt1ehur0%3D 18505062 (Pubitemid 351578863)
26. KS Albain SM Nag G Calderillo-Ruiz JP Jordaan AC Llombart A Pluzanska J Rolski AS Melemed JM Reyes-Vidal JS Sekhon L Simms J O'Shaughnessy 2008 Gemcitabine plus Paclitaxel versus Paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment J Clin Oncol 26 3950 3957 10.1200/JCO.2007.11.9362 18711184
27. V Gudena AJ Montero S Glück 2008 Gemcitabine and taxanes in metastatic breast cancer: a systematic review Ther Clin Risk Manag 4 1157 1164 1:CAS:528:DC%2BD1MXjvFOgt7c%3D 19337423
28. KS Khoo SH Manzoor Zaidi V Srimuninnimit S Song R Nair CA Ngelangel A Bustam WH Reece M Lehnert 2006 Gemcitabine and split-dose paclitaxel or docetaxel in metastatic breast cancer: a randomised phase II study Eur J Cancer 42 1797 1806 1:CAS:528:DC%2BD28XotFyltLc%3D 10.1016/j.ejca.2006.05.001 16846734 (Pubitemid 44149088)
29. S Dawood K Broglio AU Buzdar GN Hortobagyi SH Giordano 2010 Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review J Clin Oncol 28 92 98 1:CAS:528:DC%2BC3cXhtF2rsr0%3D 10.1200/JCO.2008.19.9844 19933921
30. SS Shord SR Faucette HH Gillenwater SL Pescatore RL Hawke MA Socinski C Lindley 2003 Gemcitabine pharmacokinetics and interaction with paclitaxel in patients with advanced non-small-cell lung cancer Cancer Chemother Pharmacol 51 328 336 1:CAS:528:DC%2BD3sXjt1OmsL4%3D 12721761 (Pubitemid 36629811)
31. P Grimison P Galettis S Manners M Jelinek E Metharom PL de Souza W Liauw MJ Links 2007 Randomized crossover study evaluating the effect of gemcitabine infusion dose rate: evidence of auto-induction of gemcitabine accumulation J Clin Oncol 25 5704 5709 1:CAS:528:DC%2BD1cXnsFOhtA%3D%3D 10.1200/JCO.2007.10. 7078 18089865
32. P Vici E Capomolla P Foggi S Carpano F Conti G Paoletti C Cauchi L Giacinti C Leonetti D Giannarelli M Lopez 2006 High activity of salvage treatment with biweekly paclitaxel-gemcitabine combination in heavily pretreated breast cancer patients J Exp Clin Cancer Res 25 39 44 1:CAS:528: DC%2BD28XkvVaktbY%3D 16761616
33. JT De Ligio A Velkova DA Zorio AN Monteiro 2009 Can the status of the breast and ovarian cancer susceptibility gene 1 product (BRCA1) predict response to taxane-based cancer therapy? Anticancer Agents Med Chem 9 543 549 19519295
34. F Cappuzzo S Novello F De Marinis G Selvaggi GV Scagliotti F Barbieri M Maur M Papi E Pasquini S Bartolini L Marini L Crinò 2006 A randomized phase II trial evaluating standard (50 mg/min) versus low (10 mg/min) infusion duration of gemcitabine as first-line treatment in advanced non-small-cell lung cancer patients who are not eligible for platinum-based chemotherapy Lung Cancer 52 319 325 1:STN:280:DC%2BD283mvFOksg%3D%3D 10.1016/j.lungcan.2006.03.004 16630670 (Pubitemid 44275321)
35. C Gridelli C Gallo A Ceribelli V Gebbia T Gamucci F Ciardiello F Carozza A Favaretto B Daniele D Galetta S Barbera F Rosetti A Rossi P Maione F Cognetti A Testa M Di Maio A Morabito F Perrone 2007 Factorial phase III randomised trial of rofecoxib and prolonged constant infusion of gemcitabine in advanced non-small-cell lung cancer: the GEmcitabine-COxib in NSCLC (GECO) study Lancet Oncol 8 500 512 1:CAS:528:DC%2BD2sXmtVGgt7k%3D 10.1016/S1470-2045(07)70146-8 17513173 (Pubitemid 46805905)
36. C Gridelli E De Maio S Barbera M Sannicolo E Piazza F Piantedosi L Brancaccio A Morabito P Maione F Renda G Signoriello F Perrone 2008 The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients Lung Cancer 61 67 72 10.1016/j.lungcan.2007.12.002 18683299 (Pubitemid 351862324)
37. E Poplin Y Feng J Berlin ML Rothenberg H Hochster E Mitchell S Alberts P O'Dwyer D Haller P Catalano D Cella AB Benson 3rd 2009 Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group J Clin Oncol 27 5859 1:CAS:528:DC%2BC3cXksVagsL0%3D 10.1200/JCO.2008.20.9007
38. K Miller M Wang J Gralow M Dickler M Cobleigh EA Perez T Shenkier D Cella NE Davidson 2007 Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer N Engl J Med 357 2666 2676 1:CAS:528: DC%2BD1cXisVOnsg%3D%3D 10.1056/NEJMoa072113 18160686
39. Phase II Gemzar, Taxol and Avastin combination as 1st line Tx for metastatic breast CA. Available from URL: http://clinicaltrials.gov/ct2/show/ NCT00403130?term=bevacizumab+and+gemcitabine+and+breast+cancer&rank=11 (Accessed 1 March 2010)
40. Docetaxel, gemcitabine and bevacizumab for metastatic breast cancer. Available from URL: http://clinicaltrials.gov/ct2/show/NCT00754351?term= bevacizumab+and+gemcitabine+and+breast+cancer&rank=2 (Accessed 1 March 2010)