Capecitabine and paclitaxel combination chemotherapy for inoperable or recurrent breast cancer: A phase I dose-finding study by the Kinki Breast Cancer Study Group

Cancer Chemotherapy and Pharmacology

Volumn 61, Issue 6, 2008, Pages 989-995

  Masuda, Norikazu ^a   Taguchi, Tetsuya ^b   Nakayama, Takahiro ^c   Shiba, Eiichi ^d   Watatani, Masahiro ^e   Kurebayashi, Junichi ^f   Takatsuka, Yuichi ^g   Sakamoto, Junichi ^h   Noguchi, Shinzaburo ^b  

^a OSAKA NATIONAL HOSPITAL   (Japan)

^b OSAKA UNIVERSITY   (Japan)

^c SAKAI MUNICIPAL HOSPITAL   (Japan)

^d OSAKA KOSEI NENKIN HOSPITAL   (Japan)

^e KINDAI UNIVERSITY HOSPITAL   (Japan)

^f KAWASAKI MEDICAL SCHOOL   (Japan)

^g KANSAI ROSAI HOSPITAL   (Japan)

^h NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

Capecitabine; Metastatic breast cancer; Paclitaxel; Phase I; Weekly

Indexed keywords

CAPECITABINE; DEXAMETHASONE; DIPHENHYDRAMINE; PACLITAXEL; RANITIDINE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD TOXICITY; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DESQUAMATION; DIARRHEA; DOSE CALCULATION; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG TOLERABILITY; DYSGEUSIA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; HUMAN CELL; HUMAN TISSUE; HYPERTENSION; LEUKOPENIA; MYALGIA; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OUTPATIENT; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT CANCER; SIDE EFFECT; VOMITING;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FLUOROURACIL; HUMANS; MIDDLE AGED; PACLITAXEL;

EID: 41049088218     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-007-0555-z     Document Type: Article

References (41)

1. Early Breast Cancer Trialists' Collaborative Group (1998) Polychemotherapy for early breast cancer: an overview of the randomised trials. Lancet 352:930-942
2. Nabholtz JM, Gelmon K, Bontenbal M, Spielmann M, Catimel G, Conte P, Klaassen U, Namer M, Bonneterre J, Fumoleau P, Winograd B (1996) Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J Clin Oncol 14:1858-1867
3. Biganzoli L, Cufer T, Bruning P, Coleman R, Duchateau L, Calvert AH, Gamucci T, Twelves C, Fargeot P, Epelbaum R, Lohrisch C, Piccart MJ (2002) Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: the European Organization for Research and Treatment of Cancer 10967 multicenter phase III trial. J Clin Oncol 20:3114-3121
4. Jassem J, Pienkowski T, Pluzanska A, Jelic S, Gorbunova V, Mrsic-Krmpotic Z, Berzins J, Nagykalnai T, Wigler N, Renard J, Munier S, Weil C, Central & Eastern Europe, Israel Pacitaxel Breast Cancer Study Group (2001) Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trial. J Clin Oncol 19:1707-1715
5. Smith RE, Brown AM, Mamounas EP, Anderson SJ, Lembersky BC, Atkins JH, Shibata HR, Baez L, DeFusco PA, Davila E, Tipping SJ, Bearden JD, Thirlwell MP (1999) Randomized trial of 3-hour versus 24-hour infusion of high-dose paclitaxel in patients with metastatic or locally advanced breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-26. J Clin Oncol 17:3403-3411
6. Jones SE, Erban J, Overmoyer B, Budd GT, Hutchins L, Lower E, Laufman L, Sundaram S, Urba WJ, Pritchard KI, Mennel R, Richards D, Olsen S, Meyers ML, Ravdin PM (2005) Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23:5542-5551
7. Ito Y, Horikoshi N, Watanabe T, Sasaki Y, Tominaga T, Okawa T, Tabei T, Kuraishi Y, Tamura K, Abe R, Kitajima M, Yamaguchi S, Kobayashi T, Koyama H, Orita K, Takashima S, Nomura Y, Ogawa M (1998) Phase II study of paclitaxel (BMS-181339) intravenously infused over 3 hours for advanced or metastatic breast cancer in Japan. BMS-181339 Breast Cancer Study Group. Invest New Drugs 16:183-190
8. Seidman AD, Berry D, Cirrincione C, Harris L, Dressler L, Muss H, Naughton M, Norton L, Winer E, Hudis C (2004) CALGB 9840: phase III study of weekly (W) paclitaxel via 1-hour(h) infusion versus standard (S) 3 hr infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. J Clin Oncol 22(14S):512
9. Verrill MW, Lee J, Cameron D, Agrawal R, Coleman RE, McAdam K, Wardley A, Bowman A, Ferrigan L, Yellowlees A (2007) Anglo-Celtic IV: first results of a UK National Cancer Research Network randomised phase 3 pharmacogenetic trial of weekly versus 3 weekly paclitaxel in patients with locally advanced or metastatic breast cancer (ABC). J Clin Oncol 25(18S):LBA1005
10. Seidman AD, Hudis CA, Albanell J, Tong W, Tepler I, Currie V, Moynahan ME, Theodoulou M, Gollub M, Baselga J, Norton L (1998) Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol 16:3353-3361
11. Taguchi T, Aihara T, Takatsuka Y, Shin E, Motomura K, Inaji H, Noguchi S, Kinki Breast Cancer Study Group (2004) Phase II study of weekly paclitaxel for docetaxel-resistant metastatic breast cancer in Japan. Breast J 10:509-513
12. Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, Shimma N, Umeda I, Ishitsuka H (1998) Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34:1274-1281
13. Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, Osterwalder B, Burger HU, Brown CS, Griffin T (1999) Multicenter phase II study of capecitabine in paclitaxel refractory metastatic breast cancer. J Clin Oncol 17:485-493
14. Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, Osterwalder B (2001) Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer 92:1759-1768
15. Fumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Cure H, Vuillemin E, Morere JF, Montestruc F, Mouri Z, Namer M (2004) Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer 40:536-542
16. ®) with paclitaxel in patients with metastatic/advanced breast cancer pretreated with anthracyclines. Br J Cancer 86:1367-1372
17. ®) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol 14:1227-1233
18. Stockler MR, Sourjina T, Harvey V, Frances P, Byrne M, van Hazel G, Fitzharris B, Ackland S, Finch K, Lindsay D, Kato-Fong A, Paksec L, Gebski V, Simes RJ, Coates AS, Forbes J (2006) A randomized trial of capecitabine given intermittently versus continuously versus classical CMF as first line chemotherapy for women with advanced breast cancer unsuited to more intensive treatment. Breast Cancer Res Treat 100(Suppl 1):S278
19. O'Shaughnessy 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 12:1247-1254
20. Bajetta E, Procopio G, Celio L, Gattinoni L, Della Torre S, Mariani L, Catena L, Ricotta R, Longarini R, Zilembo N, Buzzoni R (2005) Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. J Clin Oncol 23:2155-2161
21. Soto C, Torrecillas L, Reyes S, Ramirez M, Perez L, Cervantes G, González F, Tellez E, Benitez H (2006) Capecitabine (X) and taxanes in patients (pts) with anthracycline-pretreated metastatic breast cancer (MBC): sequential vs. combined therapy results from a MOSG randomized phase III trial. J Clin Oncol 24(18S):570
22. Endo M, Shinbori N, Fukase Y, Sawada N, Ishikawa T, Ishitsuka H, Tanaka Y (1999) Induction of thymidine phosphorylase expression and enhancement of efficacy by cyclophosphamide in mammary tumor models. Int J Cancer 83:127-134
23. Sawada N, Ishikawa T, Fukase Y, Nishika M, Yoshikubo T, Ishitsuka H (1998) Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by Taxol/Taxotere in human cancer xenografts. Clin Cancer Res 4:1013-1019
24. O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, Fumoleau P, Jones S, Lui WY, Mauriac L, Twelves C, Van Hazel G, Verma S, Leonard R (2002) Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20:2812-2823
25. Beslija S, Obralic N, Basic H, Tatarevic A, Naila M, Banjin M, Cardzic A, Sosevic A, Pasic A, Ceric T, Salkic B (2006) Randomized trial of sequence vs. combination of capecitabine (X) and docetaxel (T): XT vs. T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC). J Clin Oncol 24(18S):571
26. Batista N, Perez-Manga G, Constenla M, Ruiz A, Carabantes F, Castellanos J, Gonzalez Baron M, Villman K, Soderberg M, Ahlgren J, Casinello J, Regueiro P, Murias A (2004) Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer. Br J Cancer 90:1740-1746
27. Gradishar WJ, Meza LA, Amin B, Samid D, Hill T, Chen YM, Lower EE, Marcom PK (2004) Capecitabine plus paclitaxel as front-line combination therapy for metastatic breast cancer: a multicenter phase II study. J Clin Oncol 22:2321-2327
28. Bari M, D'Andrea MR, Azzarello G, Pappagallo G, Sartori D, Iop A, Gaion F, Rosetti F, Silvestri B, Bonura S, D'Alessio A, Vinante O (2005) Salvage therapy with capecitabine plus weekly paclitaxel in heavily pretreated advanced breast cancer. A multicenter phase II study. Am J Cancer 4:307-313
29. Blum JL, Dees EC, Chacko A, Doane L, Ethirajan S, Hopkins J, McMahon R, Merten S, Negron A, Neubauer M, Ilegbodu D, Boehm KA, Asmar L, O'Shaughnessy JA (2006) Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 24:4384-4390
30. Lück HJ, Thomssen C, Untch M, Kuhn W, Eidtmann H, du Bois A, Olbricht S, Moebus V, Steinfeld D, Bauknecht T, Schroeder W, Jackisch C (2000) Multicentric phase III study in first line treatment of advanced metastatic breast cancer (ABC). Epirubicin/paclitaxel (ET) vs. epirubicin/cyclophosphamide (EC). A study of the AGO breast cancer group. Proc Am Soc Clin Oncol 19:abstract 280
31. Saeki T, Kimura T, Toi M, Taguchi T (2006) A pilot phase II study of capecitabine in patients with advanced or recurrent breast cancer. Breast Cancer 13:49-57
32. Kusama M, Sano M, Ikeda T, Sonoo H, Takashima S (2001) A phase II study of Xeloda (capecitabine) in patients with advanced/metastatic breast carcinoma-the Cooperative Study Group of Capecitabine for Breast Carcinoma. Proc Am Soc Clin Oncol 20:abstract 1924
33. Watanabe T, Katsumata N, Saski Y, Saeki T, Aogi K, Toi M, Holdener E (2001) A multicenter phase II trial of Xeloda (capecitabine) in patients with docetaxel-refractory advanced/metastatic breast cancer. Proc Am Soc Clin Oncol 20:abstract 1991
34. Saeki T, Takashima S, Terashima S, Satoh A, Toi M, Osaki A, Toge T, Ohno S, Nomura N, Fukuyama Y, Koizumi W, Taguchi T (2005) A Japanese phase I study of continuous oral capecitabine in patients with malignant solid tumors. Int J Clin Oncol 10:51-57
35. Miles D, Vukelja S, Moiseyenko V, Cervantes G, Mauriac L, Van Hazel G, Liu WY, Ayoub JP, O'Shaughnessy JA (2004) Survival benefit with capecitabine/docetaxel versus docetaxel alone: analysis of therapy in a randomized phase III trial. Clin Breast Cancer 5:273-278
36. Susnjar S, Bosnjak S, Radulovic S, Stefanovic J, Gajic-Dobrosavljevic M, Kreacic M (2005) Weekly paclitaxel (TAX) and capecitabine (CAP) for metastatic breast cancer (MBC) patients (PTS) previously treated with anthracycline- containing therapy: a phase I dose-finding study. J Clin Oncol 23(16S):851
37. Di Costanzo F, Gasperoni S, Papaldo P, Bilancia D, Manzione L, Landucci E, Mazzoni F, Cognetti F, Gruppo Oncologico Italiano di Ricerca clinica, Gruppo Oncologico del Lazio (2006) Weekly paclitaxel plus capecitabine in advanced breast cancer patients: dose-finding trial of GOIRC and GOL. Ann Oncol 17:79-84
38. Uhlmann C, Ballabeni P, Rijken N, Brauchli P, Mingrone W, Rauch D, Pestalozzi BC, Rochlitz C, Aebi S, Swiss Group for Clinical Cancer Research, Swiss Institute for Applied Cancer Research (2004) Capecitabine with weekly paclitaxel for advanced breast cancer: a phase I dose-finding trial. Oncology 67:117-122
39. Haller DG, Cassidy J, Clarke S, Cunningham D, Van Cutsem E, Hoff P, Rothenberg M, Saltz L, Schmoll HJ, Twelves C (2006) Tolerability of fluoropyrimidines appears to differ by region. J Clin Oncol 24(18S):3514
40. Theodoulou M, Traina TA, Dugan U, Lake D, Fornier M, Feigin K, Patil S, Edwards C, Norton L, Hudis C (2007) Phase I study of a novel capecitabine schedule based on Norton-Simon mathematical modeling. J Clin Oncol 25(18S):1045
41. Norton L, Dugan U, Young D, Farrell C, Tanaka Y, Theodoulou M, Traina T, Hudis C (2005) Optimizing chemotherapeutic dose-schedule (CDS) by Norton-Simon modeling: capecitabine (Xeloda® = X) Proc Am Assoc Cancer Res (abstract 5007)