Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, oestrogen-receptor positive breast cancer patients. An update at 7 years of the 1st GROCTA (breast cancer adjuvant chemo-hormone therapy cooperative group) trial

Boccardo, Francesco; Rubagotti, Alessandra; Amoroso, Domenico; Sismondi, P; Genta, Franco Tarro; Nenci, Italo; Piffanelli, A; Farris, A.; Castagnetta, L.; Traina, Adele; Cappellini, Maria-Domenica; Pacini, P; Sassi, M.; Malacarne, P; Donati, D.; Mustacchi, Giorgio; Galletto, L.; Schieppati, G.; Villa, Eugenio; Bolognesi, Angelo; Gallo, Luigi

doi:10.1016/s0959-8049(05)80123-6

Cited by 62 publications

(26 citation statements)

References 29 publications

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“…The GROCTA trial group found tamoxifen to be superior to six courses of CMF followed by four courses of epirubicin in lymph node-positive patients, especially for postmenopausal women. 16 Hubay et al reported that 40 mg of daily tamoxifen for 1 year led to improved DFS compared with oral CMF for 12 months. 17 In addition, there have been studies demonstrating no survival benefit from adding polychemotherapy to tamoxifen.…”

Section: Discussionmentioning

confidence: 99%

A Phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma

Assikis

Buzdar

Yang

et al. 2003

Cancer

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BACKGROUNDThe current study was performed to assess whether sequential potentially noncross‐resistant chemotherapy prolongs disease‐free survival (DFS) and overall survival (OS) in patients with operable breast carcinoma.METHODSSeven hundred eighty‐nine patients were registered and followed for a median of 10 years. They were treated in two groups. In Group 1, patients age < 50 years or age > 50 years but with either negative or unknown estrogen receptor (ER) status were randomized to receive 6 cycles of 5‐fluorouracil, doxorubicin, and cyclophosphamide (FAC) alone or followed by 4 cycles of methotrexate and vinblastine (MV). In Group 2, patients age ≥ 50 years with ER‐positive disease were randomized to receive either tamoxifen or combination chemotherapy (FAC + MV) for 10 cycles. Analysis was performed according to allocated treatment (intention to treat), with all randomized patients included.RESULTSIn Group 1 there were no significant differences with regard to DFS or OS between the two treatment arms. The DFS at 5 years was 0.70 and 0.76, respectively, for FAC compared with FAC+MV (P = 0.26). The OS was similar for both groups (0.84 vs. 0.83). It is interesting to note that there was a statistically nonsignificant trend for improved DFS in the FAC + MV arm for patients who were ER‐positive. In Group 2, tamoxifen alone led to more prolonged DFS compared to FAC+MV (0.78 vs. 0.66, respectively) but this did not reach statistical significance (P = 0.28). OS also was associated with a trend (P = 0.86) toward prolonged survival for the tamoxifen arm compared with the FAC+MV arm (0.85 vs. 0.74, respectively).CONCLUSIONSThe results of the current trial concerning sequential adjuvant chemotherapy for operable breast carcinoma, which to our knowledge contains the longest follow‐up presented to date, failed to demonstrate any additional benefit from the addition of 4 cycles of MV to 6 cycles of FAC chemotherapy. Cancer 2003;97:2716–23. © 2003 American Cancer Society.DOI 10.1002/cncr.11396

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Section: Discussionmentioning

confidence: 99%

A Phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma

Assikis

Buzdar

Yang

et al. 2003

Cancer

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“…Details about study design, assigned treatments and main results have been previously published [6,13]. Five hundred and four, 35-65 year old patients with node-positive, ER-positive tumors and no evidence of distant metastases were recruited.…”

Section: Patients and Proceduresmentioning

confidence: 99%

Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, oestrogen receptor-positive breast cancer patients. Very late results of the ‘gruppo di ricerca per la chemio-ormonoterapia adiuvante (GROCTA)’ 01-Trial in early breast cancer

Boccardo

Guglielmini

Parodi

et al. 2011

Breast Cancer Res Treat

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“…Meta-analyses of adjuvant tamoxifen trials by the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) have repeatedly demonstrated highly significant reductions in recurrence and mortality with the use of tamoxifen (Early Breast Cancer Trialists' Collaborative Group 1988, 1992. Tamoxifen, when administered for 5 years to women with estrogen receptor (ER)-positive breast cancer in the adjuvant (postoperative) setting, reduces the risk of recurrence by 47% and mortality by 26% based on the most recent overview analysis (Early Breast Cancer Trialists' Collaborative Group 1998a).…”

Section: Adjuvant Hormone Therapymentioning

confidence: 99%

“…In addition, the combination of both modalities further increases the benefit compared with either therapy alone (Boccardo et al 1992, Wils et al 1999. The Ludwig III trial randomized 463 postmenopausal, node-positive patients to 1 year of CMF with prednisone and tamoxifen, 1 year of prednisone and tamoxifen or surgery alone.…”

Section: Chemohormonal Therapymentioning

confidence: 99%

“…However, it is now evident that the vast majority of patients with invasive breast cancer will derive benefit from systemic adjuvant therapy. The EBCTCG has conducted worldwide meta-analyses (the Oxford Overviews) of all randomized adjuvant chemotherapy trials to evaluate the quantitative benefit of systemic therapy among specific subsets of patients with invasive breast cancer (Early Breast Cancer Trialists ' Collaborative Group 1988, 1992, 1998b. The most recent 1998 Oxford Overview demonstrated substantial benefit for all patients regardless of their age, axillary nodal status, ER status and menopausal status, although the absolute benefit for each patient depends on her initial risk of recurrence.…”

Section: Benefits Of Adjuvant Chemotherapymentioning

confidence: 99%

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New paradigms in adjuvant systemic therapy of breast cancer.

Thomas¹,

Hortobágyi²

2003

Endocrine-Related Cancer

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Since the initial studies of adjuvant therapy in the 1970s, it has become increasingly clear that chemotherapy and hormone therapy have had a substantial effect on the survival of women with early breast cancer. It was originally assumed that only women with high-risk features would derive benefit from adjuvant therapy, but it is now apparent from numerous studies that adjuvant therapy improves survival in all subgroups of women with invasive breast cancer, although the absolute benefit varies depending on tumor stage and other prognostic features. Considerable progress has been made in elucidating effective adjuvant therapy regimens, but there continue to be many unanswered questions that are being addressed in ongoing clinical trials of adjuvant hormone therapy and chemotherapy. This paper reviews the current paradigms in adjuvant therapy, the published data that have affected current practice patterns, and the current controversies.

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Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, oestrogen-receptor positive breast cancer patients. An update at 7 years of the 1st GROCTA (breast cancer adjuvant chemo-hormone therapy cooperative group) trial

Cited by 62 publications

References 29 publications

A Phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma

A Phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma

Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, oestrogen receptor-positive breast cancer patients. Very late results of the ‘gruppo di ricerca per la chemio-ormonoterapia adiuvante (GROCTA)’ 01-Trial in early breast cancer

New paradigms in adjuvant systemic therapy of breast cancer.

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