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PubMed2003

Adjuvant endocrine therapy in postmenopausal breast cancer.

Adjuvant endocrine therapy with tamoxifen has a clearly established benefit in postmenopausal women with resected early breast cancer that expresses the estrogen receptor and/or progesterone receptor. Whereas there is a vast and long experience with tamoxifen, the major focus of clinical trials over the past 6 years has involved the study of the third-generation aromatase inhibitors. Recently published data from the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial, which involved only postmenopausal women and is the largest adjuvant trial ever conducted, has demonstrated superior efficacy for anastrozole over tamoxifen alone or in combination with anastrozole. These data have engendered a great deal of discussion as to whether they provide a sufficient basis for changing the standard of practice in terms of choice of agent. Currently, a case can be made that further maturation of the ATAC trial is necessary and that tamoxifen should remain the standard of endocrine adjuvant therapy for most women, with anastrozole being used in those with a contraindication or intolerance to tamoxifen. However, close attention must be paid to new information as it develops not only related to efficacy but also to other end organ effects.

Anastrozole↗
PubMed1981

Symposium on the management of early breast cancer (stages I and II). Part II: Clinical experience with treatment methods. 5. Adjuvant endocrine therapy.

A number of trials of adjuvant therapy, including endocrine therapy, for primary breast cancer are in progress. There is an urgent need for increased international cooperation in study design, for defining stratification parameters and coordinating treatment strategy in future adjuvant trials of operable breast cancer. In this way the results of treatment in the different trials will be comparable. On the basis of encouraging clinical and experimental data, adjuvant endocrine therapy is expected to play a major role in the effort to improve the prognosis of primary breast cancer.

Breast Neoplasms↗
PubMed2001

Current status of adjuvant endocrine therapy for breast cancer.

Adjuvant endocrine therapy is a vitally important modality for treatment of women with resected hormone-sensitive breast cancer as indicated by the presence of estrogen and/or progesterone receptors in the tumor. It is not recommended in those patients whose tumors lack these hormone receptors. Tamoxifen for 5 years has been shown to reduce the risk of recurrence and death irrespective of menopausal status or use of adjuvant chemotherapy. In postmenopausal women, the major research emphasis relates to the use of third-generation aromatase inhibitors in sequence with, instead of, and in combination with tamoxifen. In premenopausal women, ovarian ablation/suppression has demonstrated efficacy comparable with some chemotherapy regimens, but its role in women receiving chemotherapy remains to be determined.

Antineoplastic Agents, Hormonal↗
PubMed2005

Patients' preferences for adjuvant endocrine therapy in early breast cancer: what makes it worthwhile?

Adjuvant endocrine therapy improves recurrence and survival rates, but has side effects and is inconvenient. The aim of this study was to determine the preferences of premenopausal women who had adjuvant endocrine therapy in a randomised trial. In all, 85 (or eighty-five) women completed semistructured interviews 6-30 months after finishing adjuvant endocrine therapy. Hypothetical scenarios based on known potential survival times (5 or 15 years) and rates (60% or 80% at 5 years) without adjuvant endocrine therapy were used to determine the smallest gains women judged necessary to make their adjuvant endocrine therapy worthwhile. Although a third of the women considered gains of 1% in survival rates or 6 months in survival times sufficient to make their adjuvant endocrine therapy worthwhile, more than half the women required gains of at least 5% in survival rates or 3 years in survival time as necessary to make adjuvant endocrine therapy worthwhile. Larger benefits were required by women who had longer treatment, worse side effects, and by those who were treated with goserelin alone. The route of administration (tablet vs injection) did not affect preferences and some women judged small benefits sufficient to make their adjuvant endocrine therapy worthwhile, but many women required larger benefits than their counterparts in similar studies of preferences for adjuvant chemotherapy.

Adult↗
PubMed2003

Progesterone receptor status significantly improves outcome prediction over estrogen receptor status alone for adjuvant endocrine therapy in two large breast cancer databases.

PURPOSE: To determine whether progesterone receptor (PgR) status provides additional value to estrogen receptor (ER) status and improves prediction of benefit from endocrine treatment among patients with primary breast cancer. PATIENTS AND METHODS: Clinical outcomes of patients in two large databases were analyzed as a function of steroid receptor status. The first database (PP), contained 3,739 patients who did not receive any systemic adjuvant therapy and 1,688 patients who received adjuvant endocrine therapy but no chemotherapy. The second database (SPORE), contained 10,444 patients who received adjuvant endocrine therapy but no chemotherapy. Biochemical ER and PgR assays were identically performed in two different central laboratories. RESULTS: In univariate and multivariate analyses, the prognostic significance of PgR status among systemically untreated patients is modest. Among endocrine-treated patients, however, multivariate analyses, including lymph-node involvement, tumor size, and age, demonstrate that PgR status is independently associated with disease-free and overall survival. For recurrence, the reduction in relative risk (RR) was 25% for ER-positive/PgR-negative patients and 53% for ER-positive/PgR-positive patients, compared with ER-negative/PgR-negative patients (P <.0001, PP patients). Patients with ER-positive/PgR-negative tumors have a reduction in RR of death of 30% (SPORE patients) and 38% (PP patients), compared with patients with ER-negative/PgR-negative tumors (P <.0001). For ER-positive/PgR-positive tumors, the reduction of the risk of death was greater than 46% in SPORE patients and 58% in PP patients, indicating that ER-positive/PgR-positive patients derive more benefit from endocrine therapy (P <.0001). CONCLUSION: When accurately measured, PgR status is an independent predictive factor for benefit from adjuvant endocrine therapy. Therefore, PgR status should be taken into account when discussing RR reductions expected from endocrine treatment with individual patients.

Adult↗
PubMed1994

[A randomized clinical trial of adjuvant endocrine therapy after breast conserving surgery for early breast cancer. Cooperative Study Group for Breast Conserving Therapy].

To evaluate the clinical efficacy of adjuvant endocrine therapy after breast conserving surgery for early breast cancer, we have conducted a randomized controlled study since 1989. One hundred twelve-patients having a small breast tumor, less than 2 cm in diameter, and no palpable axillary lymph node, were the subjects of this study. All these patients underwent partial mastectomy with axillary lymph node dissection and were randomly divided into two groups according to the type of postoperative adjuvant endocrine therapy: Group I, tamoxifen (20 mg/day) for 2 years; Group II, no tamoxifen administration. The median follow-up period was 32.2 months. The incidence of local recurrence in the ipsilateral breast was 1.9% in Group I, which was lower than in Group II (6.8%). Three-year disease-free survival rates were also more favorable in Group I (94.2%) than in Group II (88.9%). This difference in prognosis was evident in patients with ER-positive tumors but not related to the menopausal status. These results suggest that adjuvant endocrine therapy with tamoxifen may be recommended for patients who underwent breast conserving surgery for early breast cancer, especially in those with ER-positive tumors.

Adult↗
PubMed2005

[Clinical significance of adjuvant endocrine therapy in treatment of endometrial carcinoma: study of 171 patients].

OBJECTIVE: To study the effectiveness of adjuvant endocrine therapy on the prognosis of endometrial carcinoma and to analyze the influence of progesterone receptor on the curative effect of adjuvant endocrine therapy. METHODS: A retrospective study was carried out on 171 patients of endometrial carcinoma with similar pathological examination. 82 of the 171 patients with endometrial carcinoma (48.0%), aged (57 +/- 9) years, underwent endocrine therapy, mainly by progesterone (245 +/- 51) mg/d for (1.3 +/- 0.9) years. 55 cases (67.1%), aged (57 +/- 10) years, underwent endocrine therapy for more-than-one-year (more-than-one-year subgroup), and 27 cases (32.9%), aged (59 +/- 9) years, underwent endocrine therapy for less-than-one-year (less-than-one-year subgroup). 24 of the 82 patients (29.3%) underwent adjuvant radiotherapy. 89 of the 171 patients (52.0%), aged (57 +/- 11) years, were in the control group 31 of the 89 patients in the control group (34.8%) underwent adjuvant radiotherapy, and 39 patients (43.8%) underwent adjuvant endocrine therapy. Follow-up was performed by correspondence, phone call, or outpatient department visit for 3 approximately 4 years. RESULTS: The rate of recurrence and/or metastasis of the endocrine therapy group was 13.4%, not significantly different from that of the control group (23.6%, P > 0.05); the death rate of the endocrine therapy group was 12.2%, not significantly different from that of the control group (20.2%, P > 0.05). The rate of recurrence and/or metastasis of the less- than-one-year subgroup was 25.9%, significantly higher than that of the more-than-one-year subgroup (7.3%, P = 0.012); the death rate of the less- than-one-year subgroup was 22.2%, significantly higher than that of the more-than-one-year subgroup (7.3%, P = 0.036). Cox regression showed that stage, the operation, tumor cell differentiation, and duration of endocrine therapy significantly affected the recurrence/metastasis remarkably (OR = 5.199, OR = 0.507, OR = 1.796, OR = 0.538) and the death rater (OR = 5.488, OR = 0.482, OR = 1.516, OR = 0.547). The rate of recurrence/metastasis of the endocrine therapy group patients with positive progesterone receptor was 4.7%, significantly higher than that of the patients with negative progesterone receptor (26.7%, P = 0.034). CONCLUSIONS: The prognosis of endometrial carcinoma patients can be improved with adjuvant endocrine therapy, especially for those with positive progesterone receptor. Endocrine therapy should be continued no less than 1 year.

Aged↗
PubMed2004

Adjuvant endocrine therapy.

Endocrine therapy remains a cornerstone of systemic therapy for breast cancer even though it was first introduced more than a century ago. In the past three decades a large number of randomized trials involving several tens of thousands of patients have been performed to determine the role of endocrine therapy in the adjuvant setting. The results of these studies indicate that hormonal therapy should be considered the standard adjuvant systemic treatment for the majority of patients with invasive breast cancer irrespective of age, menopausal status or tumour stage. This chapter aims to describe the "state of the art" relative to the use of adjuvant endocrine therapy with special focus on a number of salient issues, including: (i) the role of ovarian ablation and luteinising hormone releasing hormone (LHRH) analogues among pre-menopausal patients; (ii) optimal duration of tamoxifen; (iii) adjuvant therapy with third-generation, selective aromatase inhibitors; (iv) predictive biomarkers; (v) side-effects; (vi) combination endocrine therapy; (vii) future development of endocrine therapy.

Antineoplastic Agents, Hormonal↗
PubMed2006

Adjuvant endocrine therapy in hormone receptor-positive postmenopausal breast cancer: evolution of NCCN, ASCO, and St Gallen recommendations.

Endocrine therapy has a firm role in adjuvant treatment of women with hormone receptor-positive invasive breast cancer. Until recently, tamoxifen was the most commonly used adjuvant endocrine therapy in premenopausal and postmenopausal women. Several randomized clinical trials have studied the third-generation selective aromatase inhibitors (AIs) (anastrozole, letrozole, and exemestane) as adjuvant endocrine therapy in postmenopausal women. These studies compared therapy with an AI alone versus tamoxifen alone; 2 to 3 years of tamoxifen followed by switching to an AI versus continuation of tamoxifen; or extended therapy with an AI after approximately 5 years of tamoxifen therapy. No statistically significant differences in overall survival were observed. A single trial using extended treatment with an adjuvant AI suggests a small, statistically significant survival advantage in women with axillary lymph node-positive disease while showing no statistically significant decrease in survival with the use of an AI. The toxicities of the AIs are generally acceptable, with fewer endometrial cancers, gynecologic complaints, and thromboembolic events, but more bone fractures and arthralgias compared with tamoxifen alone. Three widely disseminated treatment guidelines, the National Comprehensive Cancer Network Breast Cancer Clinical Practice Guidelines in Oncology, the American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors, and the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer, now incorporate AIs in the adjuvant therapy of postmenopausal women with estrogen receptor-positive breast cancer.

Female↗
PubMed2005

Adjuvant endocrine therapy in postmenopausal women with early breast cancer: where are we now?

Tamoxifen has been the standard of care for adjuvant endocrine therapy of early breast cancer. In postmenopausal women, data now suggest that alternative agents (aromatase inhibitors [AIs]) may have improved long-term risk:benefit profiles and thus have the potential to improve outcome. The 'Arimidex', Tamoxifen, alone or in combination (ATAC) trial has shown that anastrozole provides improved disease-free survival (DFS) and time to recurrence, significantly reduced time to distant metastases and superior overall tolerability compared with tamoxifen when used as initial adjuvant therapy. Results have already led to a reconsideration of current recommendations for adjuvant therapy. Other ongoing trials include studies that are evaluating the benefits of sequencing of endocrine agents both within the standard 5-year adjuvant treatment period and as additional therapy in the post-adjuvant period. Three recently reported trials have suggested that switching from tamoxifen to an AI after 2-3 years of treatment leads to better outcomes than 5 years of tamoxifen. Finally, the NCIC MA 17 trial has shown that switching to an AI after 5 years of tamoxifen improves DFS compared with placebo. These are momentous discoveries that have improved our biological understanding and will inevitably change the management of breast cancer in the near future.

Anastrozole↗
PubMed1991

Adjuvant endocrine therapy for operable breast cancer.

A brief resume of adjuvant endocrine therapy for operable breast cancer is given. This was first suggested in the 1930's but has only become accepted in the last 10-15 years. The reason for the lack of survival benefit in the first randomised trial, which began in 1948 in Manchester, was thought to be due to the increasing use of hormone therapy for metastases. Revival of interest came with the survival gain reported in the Toronto ovarian trial and the success in post-menopausal patients of the non-toxic anti-oestrogen tamoxifen. The different dose schedules used in the various large tamoxifen trials could explain the confusingly variable results in the literature. Combined analysis of trial results indicates that CMF is the adjuvant therapy of choice for pre-menopausal patients but this therapy may in part be acting through the ovaries. The Scottish and NATO trials have an overall survival advantage from adjuvant tamoxifen, even in pre-menopausal patients, and both have shown results to be independent of oestrogen receptor (ER) status. Whether the extra 3 years given in Scotland adds an additional benefit over the more commonly used 2-year course is uncertain. A statistically invalid look at selected data in the Scottish trial suggests that, in ER positive cases, post-relapse tamoxifen may have as great an effect on total survival as adjuvant use, a finding similar to that suggested by the first ovarian ablation trial and one requiring continued review.

Breast Neoplasms↗
PubMed1999

Early results of radical prostatectomy and adjuvant endocrine therapy for prostate cancer with or without preoperative androgen deprivation. The Prostate Cancer Study Group.

BACKGROUND: The effects of preoperative androgen deprivation were explored in the patients who received radical prostatectomy and subsequent adjuvant endocrine therapy for prostate cancer. METHODS: Stage A2, B or C prostate cancers were randomized to one of two groups: (i) group I (n=90), who received androgen deprivation (leuploride and chlormadinone acetate) for 3 months preoperatively followed by radical prostatectomy and adjuvant endocrine therapy (leuploride only); and (ii) group II (n=86), who underwent the surgery followed by 3 month androgen deprivation and subsequent adjuvant endocrine therapy. The effects of preoperative androgen deprivation on clinical relapse (serum prostate specific antigen (PSA) > 1.98 ng/mL, local recurrence or distant metastasis) and PSA relapse (PSA >0.2ng/mL) were evaluated at 2 years after randomization. RESULTS: There was no significant difference in clinical or PSA relapse-free survival and quality of life measures between the two groups, although relapses occurred significantly more frequently in patients who had more advanced stages, higher pretreatment PSA values or lower histologic differentiation in either group. Subgroup analysis indicated that clinical relapse-free survival in stage C cancer tended to be better in patients with preoperative androgen deprivation than in those patients without it (P< 0.1). CONCLUSIONS: Preoperative androgen deprivation may be beneficial for stage C prostate cancer patients receiving radical prostatectomy and adjuvant endocrine therapy over the 2 year observation period. A longer follow up is needed to clarify the exact extent of benefit in terms of survival and quality of life.

Aged↗
PubMed2004

Radical prostatectomy and adjuvant endocrine therapy for prostate cancer with or without preoperative androgen deprivation: Five-year results.

BACKGROUND: The effects of preoperative androgen deprivation on the outcomes of prostate cancer patients who received radical prostatectomy and subsequent adjuvant endocrine therapy have not yet been fully evaluated. METHODS: Patients with stage A(2), B or C prostate cancers were randomized to one of two groups: group I (n = 90), who received androgen deprivation (leuprolide and chlormadinone acetate) for 3 months followed by radical prostatectomy and subsequent adjuvant endocrine therapy (leuprolide alone), and group II (n = 86), who underwent the surgery followed by 3-month androgen deprivation (leuprolide and chlormadinone acetate) and subsequent adjuvant endocrine therapy (leuprolide alone). The effects of preoperative androgen deprivation on survival, clinical relapse (serum prostate specific antigen, PSA, above the normal level, local recurrence, or distant metastases), and PSA relapse (PSA above the detectable level) were evaluated at 5 years or later after treatment. RESULTS: There were no significant differences in overall, cause-specific, clinical relapse-free, or PSA relapse-free survival rates between the two groups. In a subanalysis, no prostate cancer deaths or clinical relapses were noted in 29 patients with organ-confined disease (OCD: negativity of capsular invasion, seminal vesicle invasion, surgical margins or nodal involvement). The odds ratio for OCD depending on group assignment was 2.44 (95% confidence interval, CI 1.04-5.72), for group I, demonstrating a higher probability of having OCD. This ratio was increased to 4.00 (95% CI 1.06-15.16) if the analysis was conducted in a subpopulation with prostate specific antigen levels less than 35.6 ng/mL and with clinical stage B or C cancers. CONCLUSION: Preoperative androgen deprivation has no demonstrable benefit in 5-year outcomes for patients undergoing radical prostatectomy and adjuvant endocrine therapy. However, it did increase the probability of OCD, which was associated with no clinical relapse during the follow-up. A longer observation is needed to clarify the exact extent of the benefits in terms of survival.

Aged↗
PubMed2001

Selection of primary breast cancer patients for adjuvant endocrine therapy--is oestrogen receptor alone adequate?

Among 834 patients who had primary breast cancer treated by surgery without adjuvant systemic therapy, 363 had relapse treated by endocrine therapy alone. Patients with oestrogen receptor positive tumours (median: 70 vs. 45 months, p < 0.0001) or with non-progression at 6 months of therapy (median: 111 vs. 37 months, p < 0.0001) survived longer than those with oestrogen receptor negative tumours or with disease progression respectively, presumably due to the effect of therapy. On the other hand, the median disease-free interval, uninfluenced by therapy, showed a similar difference: oestrogen receptor positive versus negative = 29 versus 21 months, p < 0.005; non-progression versus progression = 40 versus 19 months, p < 0.0001. Patients with oestrogen receptor-positive tumours and non-progression at 6 months had the longest disease-free interval. The present study has established that there are factors, other than the oestrogen receptor, inherent in the primary tumour as reflected by the disease-free interval, which affect hormone sensitivity. Selection of adjuvant endocrine therapy based on the oestrogen receptor alone would deem inadequate. Further studies to elucidate other possible factors are warranted to refine the use of endocrine therapy, especially in the adjuvant setting when no indication of response is available.

Breast Neoplasms↗
PubMed2001

Role of adjuvant endocrine therapy in early-stage breast cancer.

The value of adjuvant endocrine therapy in saving lives of women with estrogen receptor-positive (ER(+)) early-stage breast cancer cannot be disputed. Tamoxifen has proven to be effective in improving relapse-free and overall survival in both pre- and postmenopausal women with ER(+) early-stage breast cancer. In the meta-analysis of the Early Breast Cancer Trialists' Collaborative Group, the proportional reduction in recurrence and mortality for 5 years of tamoxifen therapy was 50% and 28% respectively for patients with ER(+) tumors. These reductions in recurrence and mortality were similar in both lymph node-negative (N(-)) and lymph node-positive (N(+)) patients and translate to an absolute improvement in 10-year survival of approximately 11% in N(+) patients and 6% in N(-) patients. Current data suggest that about 5 years of tamoxifen therapy is the optimal duration of treatment. For women with ER(-)/progesterone receptor-negative (PR(-)) tumors, tamoxifen does not lower the risk of distant metastases or improve survival. In ER(+) patients, the addition of tamoxifen to chemotherapy further lowers the risk of recurrence by about 30% to 40% when compared to chemotherapy alone. In premenopausal women with ER(+) breast cancer, ovarian ablation has proven to be as effective as chemotherapy in improving both relapse-free and overall survival and the potential additive role of ovarian ablation to chemotherapy and/or tamoxifen is presently being explored in clinical trials. The combination of tamoxifen and ovarian ablation is currently being tested and may be superior to tamoxifen alone. In addition, newer, more effective, and less toxic aromatase inhibitors are also being evaluated in clinical trials in the adjuvant setting and have great promise. "Pure" antiestrogens or selective estrogen receptor down-regulators (SERDs) will be studied in adjuvant clinical trials in the near future. Recent data also suggest that molecular markers such as HER-2/neu may predict the response to endocrine therapy, and other predictive factors are currently being evaluated. Lastly, there is renewed interest in neoadjuvant endocrine therapy, a treatment option that may select those patients with early-stage breast cancer most likely to benefit from endocrine therapy.

Antineoplastic Agents, Hormonal↗
PubMed2001

[Prospective randomized trial on the efficacy of adjuvant endocrine therapy for ER-positive breast cancer patients after radical mastectomy].

OBJECTIVE: To asses the efficacy of adjuvant endocrine therapy in ER-positive breast cancer patients after radical mastectomy. METHODS: 369 estrogen receptor (ER)-positive breast cancer patients were divided into two groups after radical mastectomy: 1. Endocrine group (N-194). The postmenopausal patients in this group received oral tamoxifen (TAM) for five years and the premenopausal patients were first treated with bilateral ovary ablation and, then, given TAM for five years. 2. The chemotherapy group patients (N-175) received CTX + MTX + 5-Fu + VCR + DXM) (CMFVP) or CTX + MTX + 5-Fu (CMF) multi-drug chemotherapy. RESULTS: Postmenopausal patients in the endocrine and chemotherapy groups gave disease-free survival rates (DFSR) of 78.4% and 45.4% (P < 0.01). Their overall survival rates were 83.3% and 52.9% (P < 0.05). The premenopausal patients gave DFSR of 72.8% and 35.7% (P < 0.01), and their overall survival rates were 80.7% and 60.6% (P < 0.05). But, no significant difference was observed in the stage I patients and those having > or = 8 axillary lymph node metastases (P > 0.05). CONCLUSION: For ER-positive breast cancer patients, the adjuvant endocrine therapy gives results superior or equal to multi-drug chemotherapy after radical mastectomy.

Adult↗
PubMed2026

Differential Effectiveness of Adjuvant Endocrine Therapy According to Menopausal Status, Body Mass Index, and Molecular Subtype in Hormone Receptor-Positive Breast Cancer.

The effectiveness of adjuvant endocrine therapy for hormone receptor-positive (HR+) breast cancer (BC) varies according to menopausal status, body mass index (BMI), and tumor biology. We evaluated the association between selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), and BC-specific mortality according to menopausal status, BMI, and molecular subtype in a nationwide Korean cohort. We analyzed data from 31,030 patients with HR+ BC who were registered in the Korean Breast Cancer Society Registry, diagnosed between 2000 and 2008, and followed through 2013. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for BC-specific mortality after adjusting for demographic and clinical factors. Of the 31,030 patients, 19,634 received SERM therapy, and 3,354 received AI therapy. SERM use was associated with lower BC-specific mortality in premenopausal women (HR, 0.75; 95% CI, 0.63-0.91), whereas AI therapy was more strongly associated with lower BC-specific mortality among postmenopausal women (HR, 0.76; 95% CI, 0.61-0.94). Lower BC-specific mortality was observed among patients with a BMI &#x2265; 23 kg/m&#xb2; who received SERM (HR, 0.84; 95% CI, 0.72-0.98) or AI therapy (HR, 0.78; 95% CI, 0.62-0.99). The strongest association with lower BC-specific mortality was observed in postmenopausal women with luminal B tumors (HR, 0.59; 95% CI, 0.42-0.83). The association between adjuvant endocrine therapy and BC-specific mortality differed according to menopausal status, BMI, and molecular subtype. These findings suggest that menopausal status, BMI, and molecular subtype are important considerations when evaluating endocrine treatment strategies.

Aromatase Inhibitors↗
PubMed1988

A randomized trial of adjuvant endocrine therapy, chemotherapy, and chemoendocrine therapy for operable breast cancer stratified by estrogen receptors.

Based on estrogen receptor (ER) status and menopausal status, operable breast cancer (International Union Against Cancer [UICC] Stage I, II, and III) patients were randomized for adjuvant endocrine therapy, chemotherapy, and chemoendocrine therapy, and the effects on the disease-free survival (DFS) and overall survival (OS) were compared. Adjuvant endocrine therapy was composed of tamoxifen (TAM) 20 mg/day orally for 2 years in postmenopausal patients. In premenopausal patients, oophorectomy (OVEX) was done before TAM administration. In the chemotherapy arm, the patients were given 0.06 mg/kg of body weight of mitomycin C (MMC) intravenously (IV) and then an oral administration of cyclophosphamide (CPA) 100 mg/body orally in an administration of a 3-month period and a 3-month intermission. This 6-month schedule was repeated four times in 2 years. As the chemoendocrine therapy arm, TAM with MMC + CPA chemotherapy was added. The patients were randomized according to ER and menopausal status. Estrogen receptor-positive (ER+) cancer patients were randomized to three arms: TAM +/- OVEX, MMC + CPA, or MMC + CPA + TAM. For estrogen receptor-negative (ER-) patients, there were two arms: MMC + CPA, or MMC + TAM. The study started in September 1978, and 692 patients entered until the end of 1984 were evaluated. The median follow-up was about 46 months. Totally, a 9.8% rate (68/692) of recurrence was noted, a 7.5% rate (52/692) of mortality. There were no significant differences in DFS or OS among the treatment arms in ER+ or ER- patients. There was significant differences in adverse effects such as bone marrow suppression, gastrointestinal disturbances, cystitis, hair loss between endocrine therapy and chemotherapy or chemoendocrine therapy groups. In this preliminary study, it was concluded that because of less adverse effects of endocrine therapy, it seems rational to select the operable breast cancer patients by the presence or absence of ER, namely, endocrine therapy for ER+ and chemotherapy for ER- cancer patients.

Antineoplastic Combined Chemotherapy Protocols↗