Prospective multicenter randomized phase III study of weekly versus standard docetaxel (D2) for first-line treatment of metastatic breast cancer

Oncology

Volumn 79, Issue 3-4, 2011, Pages 197-203

  Stemmler, Hans Joachim ^a   Harbeck, Nadia ^b   Gröll De Rivera, Isolde ^d   Vehling Kaiser, Ursula ^e   Rauthe, Gerhard ^f   Abenhardt, Wolfgang ^c   Artmann, Almut ^b   Sommer, Harald ^a   Meerpohl, Hans Gerd ^g   Kiechle, Marion ^b   Heinemann, Volker ^a  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^b TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^c Onkologische Praxis   (Germany)

^d Klinikum Ebersberg   (Germany)

^e Onkologische Praxis   (Germany)

^f Schlossbergklinik Oberstaufen ^*  (Germany)

^g Department of Gynaecology and Obstetrics   (Germany)

Author keywords

Combination chemotherapy; Docetaxel; Metastatic breast cancer; Weekly application

Indexed keywords

ALKALINE PHOSPHATASE; BILIRUBIN; CORTICOSTEROID; CREATININE; DOCETAXEL; GAMMA GLUTAMYLTRANSFERASE;

ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANEMIA; ARTICLE; BILIRUBIN BLOOD LEVEL; BLOOD TOXICITY; BREAST CANCER; BREAST METASTASIS; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CONSTIPATION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; FEVER; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL SYMPTOM; HEART ARRHYTHMIA; HUMAN; INFECTION; KARNOFSKY PERFORMANCE STATUS; LEUKOPENIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NAIL DISEASE; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PERICARDIAL EFFUSION; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN DISEASE; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; VOMITING;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; FEMALE; HUMANS; LIVER NEOPLASMS; LUNG NEOPLASMS; LYMPHATIC METASTASIS; MIDDLE AGED; SKIN NEOPLASMS; SURVIVAL RATE; TAXOIDS; TREATMENT OUTCOME;

EID: 79952057170     PISSN: 00302414     EISSN: None     Source Type: Journal    
DOI: 10.1159/000320640     Document Type: Article

References (22)

1. Chan S, Friedrichs K, Noel D, Pinter T, Van Belle S, Vorobiof D, Duarte R, Gil Gil M, Bo-drogi I, Murray E, Yelle L, von Minckwitz G, Korec S, Simmonds P, Buzzi F, Gonzalez Mancha R, Richardson G, Walpole E, Ron-zoni M, Murawsky M, Alakl M, Riva A, Crown J: Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999; 17: 2341-2354. (Pubitemid 29368232)
2. Bonneterre J, Roche H, Monnier A, Guastal-la JP, Namer M, Fargeot P, Assadourian S: Docetaxel vs. 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracy-cline therapy failure. Br J Cancer 2002; 87: 1210-1215. (Pubitemid 36009124)
3. Nabholtz JM, Senn HJ, Bezwoda WR Mel-nychuk D, Deschenes L, Douma J, Vanden-berg TA, Rapoport B, Rosso R, Trillet-Lenoir V, Drbal J, Molino A, Nortier JW, Richel DJ, Nagykalnai T, Siedlecki P, Wilking N, Genot JY, Hupperets PS, Pannuti F, Skarlos D, Tomiak EM, Murawsky M, Alakl M, Aapro M, et al: Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer pro-gressing despite previous anthracycline-containing chemotherapy. 304 study group. J Clin Oncol 1999; 17:1413-1424. (Pubitemid 29220847)
4. Sjostrom J, Blomqvist C, Mouridsen H, Plu-zanska A, Ottosson-Lonn S, Bengtsson NO, Ostenstad B, Mjaaland I, Palm-Sjovall M, Wist E, Valvere V, Anderson H, Bergh J: Docetaxel compared with sequential metho-trexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandina-vian Breast Group. Eur J Cancer 1999; 35: 1194-1201. (Pubitemid 29359178)
5. Hainsworth JD, Burris HA, 3rd, Greco FA: Weekly administration of docetaxel (Tax-otere): summary of clinical data. Semin On-col 1999; 26: 19-24. (Pubitemid 29368113)
6. Aihara T, Kim Y, Takatsuka Y: Phase II study of weekly docetaxel in patients with meta-static breast cancer. Ann Oncol 2002; 13: 286-292. (Pubitemid 34704982)
7. Stemmler J, Mair W, Stauch M, Papke J, Deutsch G, Abenhardt W, Dorn B, Ken-tenich C, Malekmohammadi M, Jackisch C, Leinung S, Brudler O, Vehling-Kaiser U, Stamp J, Heinemann V: High efficacy and low toxicity of weekly docetaxel given as first-line treatment for metastatic breast can-cer. Oncology 2005; 68: 71-78. (Pubitemid 40675012)
8. Stemmler HJ, Gutschow K, Sommer H, Malekmohammadi M, Kentenich CH, Forst-pointner R, Geuenich S, Bischoff J, Hid-demann W, Heinemann V: Weekly docetax-el (Taxotere) in patients with metastatic breast cancer. Ann Oncol 2001; 12: 1393-1398. (Pubitemid 33100243)
9. Burstein HJ, Manola J, Younger J, Parker LM, Bunnell CA, Scheib R, Matulonis UA, Gar-ber JE, Clarke KD, Shulman LN, Winer EP: Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 2000; 18: 1212-1219. (Pubitemid 30159838)
10. Rivera E, Mejia JA, Arun BK, Adinin RB, Walters RS, Brewster A, Broglio KR, Yin G Esmaeli B, Hortobagyi GN, Valero V: Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Can-cer 2008; 112:1455-1461. (Pubitemid 351459423)
11. Tabernero J, Climent MA, Lluch A, Albanell J, Vermorken JB, Barnadas A, Anton A, Lau-rent C, Mayordomo JI, Estaun N, Losa I, Guillem V, Garcia-Conde J, Tisaire JL, Basel-ga J: A multicentre, randomised phase II study of weekly or 3-weekly docetaxel in pa-tients with metastatic breast cancer. Ann Oncol 2004; 15:1358-1365. (Pubitemid 39295024)
12. Salminen E, Bergman M, Huhtala S, Ekholm E: Docetaxel: standard recommended dose of 100 mg/m(2) is effective but not feasible for some metastatic breast cancer patients heav-ily pretreated with chemotherapy - a phase II single-center study. J Clin Oncol 1999; 17: 1127.
13. Ajani JA, Welch SR, Raber MN, Fields WS, Krakoff IH: Comprehensive criteria for as-sessing therapy-induced toxicity. Cancer In-vest 1990; 8:147-159. (Pubitemid 20350387)
14. Kaplan EL, Meier P: Nonparametric estima-tion from incomplete observations. J Am Stat Assoc 1959; 53: 457-481.
15. Cox DR: The Analysis of Binary Data. London, Methuen, 1970
16. Esmaeli B, Valero V, Ahmadi MA, Booser D: Canalicular stenosis secondary to docetaxel (Taxotere): a newly recognized side effect. Ophthalmology 2001; 108: 994-995. (Pubitemid 32374259)
17. Mavroudis D, Alexopoulos A, Ziras N, Mala-mos N, Kouroussis C, Kakolyris S, Agelaki S, Kalbakis K, Tsavaris N, Potamianou A, Riga-tos G, Georgoulias V: Front-line treatment of advanced breast cancer with docetaxel and epirubicin: a multicenter phase II study. Ann Oncol 2000; 11:1249-1254.
18. Pagani O, Sessa C, Nole F, Crivellari D, Lombardi D, Thurlimann B, Hess D, Borner M, Bauer J, Martinelli G, Graffeo R, Zucchetti M, D'Incalci M, Goldhirsch A: Epidoxorubi-cin and docetaxel as first-line chemotherapy in patients with advanced breast cancer: a multicentric phase I-II study. Ann Oncol 2000; 11:985-991.
19. Milla-Santos A, Milla L, Rallo L, Solano V: High-dose epirubicin plus docetaxel at stan-dard dose with lenograstim support as first-line therapy in advanced breast cancer. Am J Clin Oncol 2001; 24: 138-142. (Pubitemid 32323350)
20. Morales S, Lorenzo A, Ramos M, Ballesteros P, Mendez M, Almanza C, Castellanos J, Moreno-Nogueira JA, Casal J, Lizon J, Oltra A, Frau A, Machengs I, Galan A, Belon J, Llorca C: Docetaxel plus epirubicin is a high-ly active, well-tolerated, first-line chemo-therapy for metastatic breast cancer: Results of a large, multicentre phase II study. Cancer Chemother Pharmacol 2004; 53: 75-81. (Pubitemid 38161192)
21. Gamucci T, D'Ottavio AM, Magnolfi E, Bar-duagni M, Vaccaro A, Sperduti I, Moscetti L, Belli F, Meliffi L: Weekly epirubicin plus docetaxel as first-line treatment in metastat-ic breast cancer. Br J Cancer 2007; 97:1040-1045. (Pubitemid 47587004)
22. Perez-Manga G, Lopez P, Sancho J, Mendez M, Cassinello J, Dominguez S, Enrech S, Pal-omero M, Menendez P, Quiben R, Lopez-Martin J: Phase II study of weekly docetaxel and doxorubicin as first-line treatment of lo-cally advanced or metastatic breast cancer: preliminary results. Proc Am Soc Clin Oncol 2000; 19: 407.