EFFECTIVENESS OF ADJUVANT CHEMOTHERAPY IN COMBINATION WITH TAMOXIFEN FOR NODE-POSITIVE POSTMENOPAUSAL BREAST-CANCER PATIENTS

Authors
CASTIGLIONEGERTSCH M GOLDHIRSCH A GUSTERSON B BETTELHEIM R REED R GUSSET H GEISER K HURNY C BERNHARD J HANGARTNER A MAIBACH R PEDOWSKI R GELBER R PRICE K PETERSON H ZELEN M ISLEY M HINKLE R KAY RG HOLDAWAY IM HARVEY VJ JAGUSCH MF NEAVE L MASON BM EVANS B BENJAMIN CS CARTER JF GILLMAN JC MACK D BENSONCOOPER D MONFARDINI S GALLIGIONI E CRIVELLARI D BUONADONNA A MASSARUT S ROSSI C CANDIANI E CARBONE A VOLPE R TROVO MG RONCADIN M SANTINI GF VILLALTA D CORAN F MORASSUT S MARINI G SIMONCINI E MARPICATI P ZANIBONI A SARTORI U BARNI A CERUTTI L ALGHISI A RAFFAGLIO E GARATTINI MP ALBERTINI A GRIGOLATO F MORASSI L BERGONZINI R LAURIOLA C GUDGEON A DENT DM TILTMAN A HACKING A DOWDLE E STEYNOR P TOOP J SCHNURCH HG MOSNY D BENDER HG BOJAR H VERONESI A FOLADORE S PAMICH G BIANCHI G TORRETTA A RUDENSTAM CM WALLGREN A PERSSON S MATTSSON J CAHLIN E HAFSTROM LO HOLMBERG S HULTBORN R COLLDAHLJADERSTROM G GUSTAVSSON B CARLSSON G IVARSSON L THOREN O RUUSVIK O NICKLASSON LG DAHLIN S KARLSSON G LINDBERG B SUNDBACK A BERGEGARDH S SALANDER H ANDERSSON C HESSMAN Y NELZEN O HEIDEMAN M RAMHULT T SVENSSON JH LIDBERG P BJORK S LINDTNER J ERZEN D CERAR O STABUC B GOLOUH R LAMOVEC J SEBEK S KRAMBERGER M VRHOVEC I CORTESFUNES H MARTINEZTELLO F MENDIOLA C CRUZVIGO F LARRODERA ML SIERRA A MIRANDA P ALONSO S COLLINS J SNYDER R GREGORY P BURAS WI GREEN M GALE T HENDERSON M HART S NEIL S KITCHEN P LOVELL R MCLENNAN R REED R RUSSELL I SCHWARZ M BASSER R ROBERTSON A GILL P CARTER ML MALYCHA P YEOH E WARD G LEONG ASY LOMMAXSMITH J HOOSFALL D DANGELO R BYRNE M VANHAZEL G DEWAR J BUCK M SHEINER HJ INGRAM D STERRETT G HAHNEL R FORBES JF STEWARD J DARBAR SW BISHOP JM SIMMS B ZIOGAS V TATTERSALL MHN COATES A NIESCHE F WEST R RENWICK S DONOVAN J DUVAL P SIMES RJ NG A GLENN D NORTH RA BEITH J OCONNOR RG RICE M STEVENS G FEY M BARTH A DREHER E ISENSCHMID M SCHNEIDER H BUSER K LUDIN J LUTHI JM ALTERMATT HJ LAISSUE JA MARKWALDER R BURGI H SENN HJ THURLIMANN B JUNGI WF MORANT R OEHLSCHLEGEL C HARDMEIER T LUSCHER K RIES G TOPFER M LORENZ U BENZ D SCHILTKNECHT O SPATI B SCHMID L CAVALLI F SESSA C BRONZ L MARTINELLI G MULLER W LUSCIETI P PASSEGA E PEDRINIS E REY P MARTINOLI S SPINELLI A GALFETTI MA LOMBARDI A PEDRAZZINI A LOSA G VARINI M GINIER M HERRMANN R HARDER JF LAFFER U ALMENDRAL AC EPPENBERGER U TORHORST J SIEGENTHALER P PIGUET D BARRELET V BAUMANN RP JOSS R SAUTER C METZGER U ENGELER V HALLER U KOCHLI O LEYVRAZ S PEREY L ANANI P GOMEZ F MIRIMANOFF RO CHAPUIS G DEGRANDI P REYMOND P ALBERTO P SCHAFER P KRAUER F FORNI M AAPRO M EGELI R MEGEVAND R JACOTDESCOMBES E SCHINDLER A NOSEDA G WEBER W LEHMANN W
Citation
M. Castiglionegertsch et al., EFFECTIVENESS OF ADJUVANT CHEMOTHERAPY IN COMBINATION WITH TAMOXIFEN FOR NODE-POSITIVE POSTMENOPAUSAL BREAST-CANCER PATIENTS, Journal of clinical oncology, 15(4), 1997, pp. 1385-1394
Citations number
22
Categorie Soggetti
Oncology
Journal title
Journal of clinical oncology → ACNP
ISSN journal
0732183X
Volume
15
Issue
4
Year of publication
1997
Pages
1385 - 1394
Database
ISI
SICI code
0732-183X(1997)15:4<1385:EOACIC>2.0.ZU;2-U
Abstract
Purpose: Adjuvant tamoxifen has been shown to reduce relapse and morta lity among node-positive postmenopausal breast cancer patients. The va lue of adding chemotherapy to tamoxifen is controversial. Patients and Methods: Between July 1986 and April 1993, 1,266 postmenopausal breas t cancer patients with node-positive disease were randomly assigned to receive one of four adjuvant therapy regimens: (A) tamoxifen alone fo r 5 years; (B) tamoxifen plus three courses of early cyclophosphamide, methotrexate, and fluorouracil (CMF) on months 1, 2, and 3; (C) tamox ifen plus delayed single courses of CMF on months 9, 12, and 15; (D) t amoxifen plus early and delayed CMF on months 1, 2, 3, 9, 12, and 15. The two-by-two factorial design allowed two direct comparisons: early CMF (B and D) versus no early CMF (A and C), and delayed CMF (C and D) versus no delayed CMF (A and B). Estrogen receptor (ER) status was kn own for all patients and was used to stratify the randomization. A tot al of 1,212 patients (96%) were eligible and assessable. The median fo llowup duration was 60 months. Results: The results of the two-by-two factorial comparison were as follows: (1) early CMF added to tamoxifen significantly improved 5-year disease-free survival (DFS; 64% v 57%; hazards ratio [HR], 0.79; 95% confidence interval [CI], 0.66 to 0.95; P = .01); and (2) delayed CMF added to tamoxifen did not improve DFS ( 5-year DFS, 61% v 60%; HR, 0.97; 95% CI, 0.81 to 1.17; P = .77). For p atients with ER-positive tumors, the addition of CMF, either early or delayed or both, reduced the relative risk of relapse by 22% to 36%. I n contrast, for patients with ER-negative tumors, tamoxifen with delay ed CMF was associated with a nonsignificant increased risk of relapse (HR, 1.27; 95% CI, 0.92 to 1.76; P = .15). Conclusion: Postmenopausal patients with node-positive breast cancer should be offered combinatio n chemotherapy in addition to tamoxifen. Tamoxifen should not be initi ated before CMF, as this might be detrimental, especially for patients with ER-negative tumors. (C) 1997 by American Society of Clinical Onc ology.