Adjuvant Cytotoxic and Endocrine Therapy in Pre- and Postmenopausal Patients with Breast Cancer and One to Nine Infiltrated Nodes: Five-Year Results of the Hellenic Cooperative Oncology Group Randomized HE 10/92 Study
Date
2004Author
Fountzilas, GeorgeStathopoulos, G. P.
Kouvatseas, G.
Polychronis, A.
Klouvas, G. D.
Samantas, E.
Zamboglou, N.
Kyriakou, K.
Adamou, A.
Pectasides, Dimitrios
Economopoulos, T.

Bafaloukos, Dimitrios
Georgoulias, V.
Razi, E. D.
Koukouras, D.
Zombolas, V.
Kosmidis, Paraskevas A.
Skarlos, Dimosthenis V.

Source
American Journal of Clinical Oncology: Cancer Clinical TrialsVolume
27Issue
1Pages
57-67Google Scholar check
Keyword(s):
Metadata
Show full item recordAbstract
The present randomized phase III trial was designed to detect a 15% benefit in relapse-free survival (RFS) or overall survival (OS) from the incorporation of adjuvant tamoxifen to the combination of CNF [cyclophosphamide, 500 mg/m2; mitoxantrone (Novantrone), 10 mg/m2; fluorouracil, 500 mg/m2 chemotherapy and ovarian ablation in premenopausal patients with node-positive breast cancer and conversely from the incorporation of CNF chemotherapy to adjuvant tamoxifen in node-positive postmenopausal patients. From April 1992 until March 1998, 456 patients with operable breast cancer and one to nine infiltrated axillary nodes entered the study. Premenopausal patients were treated with six cycles of CNF chemotherapy followed by ovarian ablation with monthly injections of triptoreline 3.75 mg for 1 year (Group A, 84 patients) or the same treatment followed by 5 years of tamoxifen (Group B, 92 patients). Postmenopausal patients received 5 years of tamoxifen (Group C, 145 patients) or 6 cycles of CNF followed by 5 years of tamoxifen (Group D, 135 patients). Adjuvant radiation was administered to all patients with partial mastectomy. After a median follow-up period of 5 years, 125 patients (27%) relapsed and 79 (17%) died. The 5-year actuarial RFS for premenopausal patients was 65% in Group A and 68% in Group B (p = 0.86) and for postmenopausal patients 70% in Group C and 67% in Group D (p = 0.36). Also, the respective OS rates were 77% and 80% (p = 0.68) for premenopausal and 84% and 78% (p = 0.10) for postmenopausal patients. Severe toxicities were infrequently seen, with the exception of leukopenia (18%), among the 311 patients treated with CNF. In conclusion, the present study failed to demonstrate a 15% difference in RFS in favor of node-positive premenopausal patients treated with an additional 5 years of tamoxifen after CNF adjuvant chemotherapy and ovarian ablation. Similarly, six cycles of CNF preceding 5 years of tamoxifen did not translate to a 15% RFS benefit in node-positive postmenopausal patients.
Collections
Cite as
Related items
Showing items related by title, author, creator and subject.
-
Article
Paclitaxel-carboplatin combination chemotherapy in advanced breast cancer: Accumulating evidence for synergy, efficacy, and safety
Pentheroudakis, George; Razi, E. D.; Athanasiades, A.; Pavlidis, Nicholas; Fountzilas, George (2006)Patients with metastatic breast cancer receive multiple lines of cytotoxic chemotherapy, with taxane and anthracycline-based regimens being the most active. Anthracyclines carry the risk of significant cardiotoxicity at ...
-
Article
Gene expression of estrogen receptor, progesterone receptor and microtubule-associated protein Tau in high-risk early breast cancer: A quest for molecular predictors of treatment benefit in the context of a Hellenic Cooperative Oncology Group trial
Pentheroudakis, George; Kalogeras, K. T.; Wirtz, R. M.; Grimani, I.; Zografos, G.; Gogas, H.; Stropp, U.; Pectasides, Dimitrios; Skarlos, Dimosthenis V.; Hennig, G.; Samantas, E.; Bafaloukos, Dimitrios; Papakostas, P.; Kalofonos, H. P.; Pavlidis, Nicholas; Fountzilas, George (2009)Background Estrogen receptor (ER) and progesterone receptor (PgR) protein expression carry weak prognostic and moderate predictive utility for the outcome of early breast cancer patients on adjuvant chemohormonotherapy. ...
-
Article
Juvenile cancer: Improving care for adolescents and young adults within the frame of medical oncology
Pentheroudakis, George; Pavlidis, Nicholas (2005)Despite unique tumour epidemiology, a higher cancer incidence and modest survival improvement compared to paediatric patients, adolescents and young adults aged 15-30 have not been considered as a separate, 'special' group ...