Adjuvant trial for stage II receptor-positive breast cancer: CMF vs. CMF+ tamoxifen in a single centre

Mauriac, L.; Durand, M.; Chauvergne, J; Bonichon, F.; Avril, A.; Mage, P; Dilhuydy, M. H.; Treut, A. Le; Wafflart, J.; Marée, D; Lagarde, C

doi:10.1007/bf01805842

Cited by 21 publications

(10 citation statements)

References 20 publications

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“…There was no difference between the groups in terms of incidence of changes in leucocyte counts, impaired liver function, pigmentation, etc., suggesting no potentiation of adverse effects by addition of TAM to FT (Table VI). tulated that there would be a greater advantage from TAM in a group with tumours 3 cm or larger in size than those with tumours less than 3 cm in size (Mauriac et al, 1988). This study was performed as a part of nationwide Japanese trials on post-operative adjuvant chemo-endocrine therapy for stage II and stage IIIa breast cancer with ftorafur (FT) alone and FT plus tamoxifen (TAM) and six districts.…”

Section: Resultsmentioning

confidence: 99%

Positive effect of tamoxifen as part of adjuvant chemo-endocrine therapy for breast cancer

Uchino

Samejima²,

Tanabe³

et al. 1994

Br J Cancer

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Summary A prospective randomised multicentre clinical study was undertaken for 2 years and 3 months from November 1982, with the aim of examining the significance of using a combination of ftorafur (FT) and tamoxifen (TAM) invasive primary breast cancer. Women with any of the following characteristics were considered ineligible for this trial: previous treatment of cancer, post-operative radiotherapy, surgical endocrine manipulations such as oophorectomy or preoperative leucocyte counts <3,000mm-3, platelet counts < 100,000 mm-or total protein < 6.0 g dl-'.Patients with bilateral breast cancer, inflammatory breast cancer or who were pregnant or nursing, or those with concomitant malignancy, were excluded.The eligible patients (stage II or IIIa breast cancer) were randomised to receive either treatment A or treatment B using the envelope method. Treatment A: DOX was given intravenously at the dose 20 mg immediately after operation and at 10 mg the following day, and 2 years of FT monotherapy (600 mg day-', p.o.) was started 14 days after surgery. Treatment B: DOX was given as in group A. A 2 year oral combination therapy including 600 mg day-' FT and 20 mg day-' TAM was started 14 days after surgery (Figure 1).Of the 546 patients randomised during a period of 2 years and 2 months from November 1982 to January 1985, 34 (6.2%) were excluded from statistical analyses for the following reasons: inappropriate stage in 15 patients, non-invasive cancer in 11, previous cancer treatment in three, age over 75 years in two, and TIS, bilateral breast cancer and concomitant malignancy in one each. Consequently the followup included 512 eligible patients (Table I).Oestrogen receptor (ER) status was measured by the dextran-coated charcoal (DCC) method at Mitsubishi Yuka Biomedical Laboratories, Tokyo, and tumours containing more than 3 fmol mg-' protein were considered positive.Chi-square tests or Mann-Whitney U-tests were used for between-group comparison of background factors. The Kaplan-Meier method for calculations of overall survival (OS) and DFS rates and the log-rank test for significance tests of differences in the OS and DFS rates were used. ResultsThe two groups were similar in terms of age, menopausal status, type of operation, histological type and ER status. An

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Section: Resultsmentioning

confidence: 99%

Positive effect of tamoxifen as part of adjuvant chemo-endocrine therapy for breast cancer

Uchino

Samejima²,

Tanabe³

et al. 1994

Br J Cancer

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“…Adjuvant therapy with chemotherapy and/or hormone therapy was decided according to nodal status and hormone receptor determination results. 15,16 All patients were followed-up every 3 months for 2 years, twice a year for the next year and then once a year. The median follow-up was 178 months (CI 95%: 174-183).…”

Section: Patientsmentioning

confidence: 99%

“…Each slice was put in as many separate cassettes as necessary and paraffin embedded. The median of blocks per patients was 3 (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17). In total, 3 blocks per tumor were obtained in 68 cases (72%) and 4-17 blocks in 14 cases.…”

Section: Tissue Samples and Histological Examinationmentioning

confidence: 99%

D2-40 in breast cancer: should we detect more vascular emboli?

et al. 2009

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Peritumoral emboli assessed on hematoxylin-eosin-stained slides are taken into account for treatment of patients with operable breast cancer. We assessed whether immunostaining with D2-40 improves the prognostic significance of emboli in a group of tumors with a large immunohistochemical sampling and a longterm follow-up. Topography, number, and extension of hematoxylin-eosin and D2-40 emboli were compared in 94 node-negative breast cancers (median number of immunostained slides per tumor: 3). Metastatasis-free survival of patients with or without hematoxylin-eosin and/or D2-40 emboli were evaluated (median follow-up of 178 months). Hematoxylin-eosin emboli were detected in 14 (15%) tumors and were located at distance from the tumor. D2-40 emboli were detected in 39 (41%) tumors and was often multiple (n ¼ 30), extensive (n ¼ 23), located within (n ¼ 13), close to (n ¼ 10) or at distance from the tumor (n ¼ 16). The 12 distant hematoxylin-eosin and D2-40 emboli were located in the same vessels (seven missed at the first hematoxylin-eosin examination and secondarily diagnosed by D2-40 staining). A difference in metastasis-free survival was found only between patients with no D2-40 emboli and those with distant D2-40 emboli (P ¼ 0.02). D2-40 emboli located within or close to the tumor had no prognostic value. Comparing the metastasis-free survival of patients with or without hematoxylin-eosin emboli, the prognostically unfavorable significance of hematoxylin-eosin emboli was improved when taking into account the seven patients with missed emboli at the first examination and secondarily diagnosed by D2-40 staining (P ¼ 0.006 vs 0.003). To conclude, D2-40 increases the diagnostic sensitivity of emboli in breast carcinoma and the high incidence of D2-40 emboli might be related to the number of immunostained slides per case. Nevertheless, only distant D2-40 þ emboli had a prognostic impact. In practice, D2-40 might be useful to detect missed hematoxylin-eosin emboli especially in cases without any other prognostically unfavorable criterion.

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“…Several controlled trials have been investigating the role of tamoxifen added to adjuvant chemotherapy in primary breast cancer (Bianco et al, 1988;Fisher et al, 1986;Fisher et al, 1981;Marshall et al, 1987;Mauriac et al, 1988;Tormey et al, 1990). The results of these trials have been confficting, most reporting a benefit of tamoxifen in receptor positive patients (Bianco et al, 1988;Fisher et al, 1986;Fisher et al, 1981;Marshall et al, 1987;Mauriac et al, 1988), while one trial found evidence of benefit in receptor negative patients only (Tormey et al, 1990 The patients were randomised into four groups:…”

mentioning

confidence: 99%

“…The results of these trials have been confficting, most reporting a benefit of tamoxifen in receptor positive patients (Bianco et al, 1988;Fisher et al, 1986;Fisher et al, 1981;Marshall et al, 1987;Mauriac et al, 1988), while one trial found evidence of benefit in receptor negative patients only (Tormey et al, 1990 The patients were randomised into four groups:…”

mentioning

confidence: 99%

The combination of radiotherapy, adjuvant chemotherapy (cyclophosphamide-doxorubicin-ftorafur) and tamoxifen in stage II breast cancer. Long-term follow-up results of a randomised trial

Blomqvist

Tiusanen²,

Elomaa³

et al. 1992

Br J Cancer

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Summary Two hundred patients with node positive stage II breast cancer were randomised to four groups after radical mastectomy and axillary evacuation: (1) Postoperative radiotherapy, (2) Adjuvant chemotherapy with eight courses of CAFt (cyclophosphamide 500 mg m-2 + doxorubicin 40 mg/m-2 + ftorafur 20 mg kg-' orally day 1-14) every fourth week, (3) Postoperative radiotherapy and adjuvant chemotherapy and (4) postoperative radiation, adjuvant chemotherapy and tamoxifen 40 mg daily for 2 years.Thirty-two per cent of the patients discontinued treatment due to GI-toxicity, while 26% required dose reductions due to leukopenia. Radiation pneumonitis was more frequent after the combination of postoperative radiotherapy with chemotherapy. There was a better relapse-free survival in the groups receiving chemotherapy compared to radiotherapy alone (P = 0.05), which was highly significant in a multivariate Cox analysis (P = 0.004). No significant survival differences were seen. Tamoxifen had no clear overall effect but there were better relapse-free (P = 0.04) and overall (P = 0.004) survival with tamoxifen in estrogen receptor positive patients, while estrogen receptor negative patients had a somewhat poorer survival (P = 0.07) after tamoxifen.Local control was better (NS) after the combination (93%) radiotherapy and chemotherapy compared to either treatment alone (76% with radiotherapy and 74% with chemotherapy at 5 years).

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Adjuvant trial for stage II receptor-positive breast cancer: CMF vs. CMF+ tamoxifen in a single centre

Cited by 21 publications

References 20 publications

Positive effect of tamoxifen as part of adjuvant chemo-endocrine therapy for breast cancer

Positive effect of tamoxifen as part of adjuvant chemo-endocrine therapy for breast cancer

D2-40 in breast cancer: should we detect more vascular emboli?

The combination of radiotherapy, adjuvant chemotherapy (cyclophosphamide-doxorubicin-ftorafur) and tamoxifen in stage II breast cancer. Long-term follow-up results of a randomised trial

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