ESSAIS DE PHASE III DE DOXORUBICINE ET CYCLOPHOSPHAMIDE VERSUS DOXORUBICINE ET CYCLOPHOSPHAMIDE SUIVI DE PACLITAXEL EN SEQUENTIEL DANS LE TRAITEMENT ADJUVANT DU CANCER DU SEIN AVEC ENVAHISSEMENT GANGLIONNAIRE
ESSAIS DE PHASE III DE DOXORUBICINE ET CYCLOPHOSPHAMIDE VERSUS DOXORUBICINE ET CYCLOPHOSPHAMIDE SUIVI DE PACLITAXEL EN SEQUENTIEL DANS LE TRAITEMENT ADJUVANT DU CANCER DU SEIN AVEC ENVAHISSEMENT GANGLIONNAIRE
dc.contributor.author | Dr. Ilham Lahfa-Merad | |
dc.date.accessioned | 2023-05-01T10:23:36Z | |
dc.date.available | 2023-05-01T10:23:36Z | |
dc.date.issued | 2012-10-15 | |
dc.description.sponsorship | Title: Improved outcomes from adding sequential paclitaxel to doxorubicin /cyclophosphamide in an adjuvant chemotherapy regimen for patients with node positive primary breast cancer. Introduction Breast carcinoma is a major problem of public health worldwide and in Algeria because it is the first most frequent cause of cancer related death for women. Early breast cancer treatment is surgical then chemotherapy or hormonotherapy added to this radiotherapy and biological treatment according to prognostic factors. Early breast cancer median survival is 80 % however, 30 % of patients treated will develop metastases. Anthacyclines are an important treatment regardless of other drugs added to a combination regimen in the metastatic or adjuvant settings. The taxanes in combination with Anthacyclines in sequential strategy did it improve outcome of breast cancer in the adjuvant setting. Purpose The primary end of this study was to determine whether four cycles of adjuvant paclitaxel [PTX) after four cycles of adjuvant doxorubicine / cyclophosphamide [AC) will prolong disease –free survival [DFS) and overall survival [OS) compared with four cycles of AC alone in patients with resected operable breast cancer and histological positive axillary nodes. Patients and methods Between January 2006 and January 2011 103 patients were enrolled [AC: 52) et AC- PTX [ 51) median age was 46 old, patients with hormonal receptors positive received tamoxifen for five years in 67 % the median follow up was 38 month. Results The addition of paclitaxel to AC significantly reduced the hazard for DFS events by 18 % [Relative Risk RR 0, 82 95 % IC [0, 66-1, 02] p= 0,002...At three years the disease free survival was 84,3% and 69,2 % and the overall survival was 84,3% and 73,1% after AC plus paclitaxel and AC alone respectively. Improvement for OS was small [14 %) and not statistical significant [RR= 0,86 95% IC [ 0,70-1,06 ] p=0,10. Subsets analysis of the effect of paclitaxel according to number of node positive pN1 reveal a statistical difference with hazard ratio of 0,57 IC 95%[ 0,43-0,77 ] p=0,008, and no difference for more than four nodes positive.for the tumor size the HR was 0,59 IC 95%[ 0,31-1,11 ], 0,71 IC 95%[ 0,36-1,38 ] et 1 IC 95%[ 0,59-1,6 7] for T1, T2 and T3 respectively. The hazard ratio of AC plus paclitaxel versus AC alone was 0,53 IC 95%[ 0,320,89 ] p=0,005 for those with estrogen receptor negative tumors and only 1,54 IC 95% [ 0,97-2,44] 250 for those with estrogen receptor positive tumors.according to the HER 2 status the hazard ratio of AC plus paclitaxel versus AC alone was 0,30 IC 95%[ 0,11-0,79 ] p =0,041 and 4,51 IC 95 % [ 1,27-16,07 ]p=0,0041. Toxicity with the AC-P regimen was acceptable for the adjuvant setting.comparable with the AC alone the major toxicity was hematologic Grade II and neutropenia grade III and IV was found in the same proportion for AC plus paclitaxel[29%) versus AC alone [28%) without significant difference, neurologic GI and II[55% v 14%) and myalgia G II[ 70% v 5 %) was the most frequent but reversible after completion of the cycles of chemotherapy.there was not severe cardiac toxicity observed in the AC alone and one death after a heart failure 6 month after completion of the chemotherapy in AC plus paclitaxel arm associated with distant recurrence. Conclusion The addition of four cycles of paclitaxel after the completion of four cycles of AC resulted in significant improvement in DFS but not statistically significant in OS with acceptable toxicity. Keywords: Brest cancer, adjuvant chemotherapy, paclitaxel; sequential, doxorubicin,cyclophosphamide | |
dc.identifier.uri | http://pubmed.mesrs.dz/handle/123456789/244 | |
dc.language.iso | fr | |
dc.title | ESSAIS DE PHASE III DE DOXORUBICINE ET CYCLOPHOSPHAMIDE VERSUS DOXORUBICINE ET CYCLOPHOSPHAMIDE SUIVI DE PACLITAXEL EN SEQUENTIEL DANS LE TRAITEMENT ADJUVANT DU CANCER DU SEIN AVEC ENVAHISSEMENT GANGLIONNAIRE | |
dc.type | Thesis | |
dspace.entity.type |
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