High complete remission rates with primary neoadjuvant infusional chemotherapy for large early breast cancer.

Ie, Smith; Walsh, Geraldine; Jones, Alison; Prendiville, Joseph A; Johnston, Stephen; Gusterson, Barry A.; Ramage, F.; Robertshaw, H.; Sacks, N. P. M.; Ebbs, S. R.

doi:10.1200/jco.1995.13.2.424

Cited by 170 publications

(81 citation statements)

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“…PMT consisted of epirubicin, cisplatin and protracted infusional 5-fluorouracil (ECisF) as previously described (Jones et al, 1994;Smith et al, 1995), for 6-8 cycles of 21 days. In brief, this regimen comprises epirubicin 50-60 mg m-2 and cisplatin 60 mg m-2 on day 1, with continuous ambulatory venous infusion of 5-fluorouracil 200 mg m-2 per 24 h throughout the cycle (days 1-21).…”

Section: Treatment and Assessment Protocolmentioning

confidence: 99%

“…As an alternative, several groups are investigating primary medical (or 'neoadjuvant') therapy (PMT): immediate drug therapy with surgery deferred until later (Bonadonna et al, 1990;Fisher et al, 1994;Smith et al 1995;Powles et al, 1995). Reversal of the conventional sequence of treatments may have several potential advantages, including regression of the primary tumour and a reduced need for subsequent mastectomy (Powles et al, 1995;Smith et al, 1995). High response rates, with complete clinical remission rates of up to 60%, can be achieved even in large primary cancers by the use of moderately dose-intensive infusionbased chemotherapy regimens not requiring growth factor or progenitor cell support (Smith et al, 1995).…”

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confidence: 99%

“…Reversal of the conventional sequence of treatments may have several potential advantages, including regression of the primary tumour and a reduced need for subsequent mastectomy (Powles et al, 1995;Smith et al, 1995). High response rates, with complete clinical remission rates of up to 60%, can be achieved even in large primary cancers by the use of moderately dose-intensive infusionbased chemotherapy regimens not requiring growth factor or progenitor cell support (Smith et al, 1995).…”

mentioning

confidence: 99%

“…In the recent USA National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 trial of primary chemotherapy, the extent of surgery was left to the discretion of the treating surgeon: 19% of patients who had achieved clinical CR, and 39% of those with partial response (PR), still underwent mastectomy, whereas 50% of those with no change or progressive disease had breastconserving operations (Fisher et al, 1994). In other series, patients who have achieved clinical CR are treated with radiotherapy alone (Smith et al, 1995), whereas others have omitted surgery even in patients with only partial response after primary chemotherapy, deferring the decision until after radiotherapy (Weil et al, 1995).…”

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confidence: 99%

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Ultrasound assessment of residual abnormalities following primary chemotherapy for breast cancer

Seymour

Moskovic²,

Walsh³

et al. 1997

Br J Cancer

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Summary The purpose of this study was to assess the usefulness of ultrasonography (US) in the assessment of the breast following primary medical therapy (PMT) of large operable breast cancer. A total of 52 patients were studied; all had invasive breast cancer, confirmed by core biopsy, with initial size > 4 cm by palpation, T2-3, NO-1, MO. PMT was with epirubicin, cisplatin and continuous infusional 5-fluorouracil, as previously described (Jones et al, 1994, J Clin Oncol 12: 1259-1265. Independent clinical and US assessments were made during PMT before surgery or biopsy. A total of 31 (60%) patients achieved complete clinical response (cCR), but in only five of these was the posttreatment ultrasound normal. Post-treatment sonographic findings of diffuse parenchymal distortion or a mass lesion without Doppler signal were associated with more favourable histology (pathological CR, non-invasive or microinvasive carcinoma), whereas a mass with Doppler positivity was more often associated with residual macroscopic invasive carcinoma. Patients who did not achieve cCR had a high incidence of residual macroscopic carcinoma (71 %) regardless of the sonographic characteristics. With median follow-up of 27 months (range 12-43), ten (19%) patients have relapsed and six (12%) have died, but only one relapse has occurred within treated breast. Ultrasonography is a sensitive technique for assessing the response to PMT, particularly in patients who achieve cCR. It may be helpful in selecting those patients who do not require post-PMT surgery and in localizing abnormalities in those who do, particularly in those with cCR. However, clinicians should be aware that a residual US abnormality is by no means pathognomonic of residual cancer.

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Section: Treatment and Assessment Protocolmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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confidence: 99%

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Ultrasound assessment of residual abnormalities following primary chemotherapy for breast cancer

Seymour

Moskovic²,

Walsh³

et al. 1997

Br J Cancer

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“…A phase II study of eight courses of ECF in 43 patients with metastatic and locally advanced breast cancer (Jones et al, 1994) gave an overall response rate of 84%. This regimen has also been used in a phase II study in patients with large but operable breast cancer in the neoadjuvant setting (Smith et al, 1995). A total of 50 patients were treated with an overall response rate of 98% and 66% complete response rate.…”

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Phase II study of docetaxel in combination with epirubicin and protracted venous infusion 5-fluorouracil (ETF) in patients with recurrent or metastatic breast cancer. A Yorkshire breast cancer research group study

et al. 2004

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This study was originally designed as a phase I/II study, with a dose escalation of docetaxel in combination with epirubicin 50 mg m À2 and 5-fluorouracil (5-FU) 200 mg m À2 day À1 . However, as dose escalation was not possible, the study is reported as a phase II study of the combination to assess response and toxicity. A total of 51 patients with locally advanced or metastatic breast cancer were treated on this phase II study, with doses of docetaxel 50 mg m À2 , epirubicin 50 mg m À2 and infusional 5-FU 200 mg m À2 day À1 for 21 days. The main toxicity of this combination was neutropenia with 89% of patients having grade 3 and 4 neutropenia, and 39% of patients experiencing febrile neutropenia. Nonhaematological toxicity was mild. The overall response rate in the assessable patients was 64%, with median progression-free survival of 38 weeks, and median survival of 70 weeks. The ETF regimen was found to be toxic, and it was not possible to escalate the dose of docetaxel above the first dose level. This regimen has therefore not been taken any further, but as a development of this a new study is ongoing, combining 3-weekly epirubicin, weekly docetaxel and capecitabine, days 1 -14. The treatment of metastatic or advanced breast cancer has evolved over the last few years, and in the 1990s this was largely due to the introduction of the taxane family of drugs. Docetaxel (taxotere) is a semisynthetic taxane derived from 10-deacetyl baccatin III, a precursor isolated from the needles of Taxus baccata. As with the other taxane compounds, it acts by promoting microtubule assembly and inhibiting microtubule depolymerisation. This blocks cells in M phase and so prevents cell division.Docetaxel has well-documented activity in advanced breast cancer with a single agent dose of 100 mg m À2 . The dose-limiting toxicity of docetaxel is grade 3 and 4 neutropenia. The response rate ranges from 19 -57% in pretreated patients and 54 -67% in those with minimal pretreatment (Clemons et al, 1997).Following the single-agent studies, docetaxel was combined with other active agents. The most attractive combination, initially, was with anthracyclines, as docetaxel is known to have activity in anthracycline-resistant disease (Miller et al, 2001). Studies were carried out using epirubicin and docetaxel. For example, docetaxel was escalated with a fixed dose of epirubicin (Venturini et al, 2001). It was found that the dose-limiting toxicity was neutropenia, which was ameliorated to some extent by G-CSF. Other side effects were mild. There were however two toxic deaths. The recommended doses for further investigation were epirubicin 75 mg m À2 and docetaxel 80 mg m À2 . In a further study (Viens et al, 2001), escalating doses of epirubicin were given with a fixed dose of docetaxel 75 mg m À2 . Dose-limiting toxicities were grade 3 and 4 asthenia, febrile neutropenia and stomatitis and diarrhoea. There was an overall response rate of 69.4%, and a median duration of response of 7.8 months. The recommended dose was epirubicin 100 mg m À2 with...

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A pilot evaluation of alternating preoperative chemotherapy in the management of patients with locoregionally advanced breast carcinoma

Pisansky

Loprinzi

Stephen

et al. 1996

Cancer

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BACKGROUND This prospective trialiu was conducted to evaluate the outcome of patients treated with preoperative and postoperative chemotherapy, mastectomy, and irradiation for locoregionally advanced breast carcinoma. METHODS Between June 1986 and September 1990, 71 patients received 2 cycles of doxorubicin that alternated with 2 cycles of cyclophosphamide, methotrexate, and 5‐fluorouracil prior to mastectomy; irradiation was administered when the tumor was not amenable to surgical resection. Additional chemotherapy and tamoxifen, in hormone receptor‐positive tumors, was used after mastectomy. Postoperative irradiation was given on a selective basis for patients at high risk for locoregional disease recurrence. RESULTS Although 5 patients (7%) had disease progression, clinical partial or complete tumor response to preoperative chemotherapy was noted in 46 patients (65%). Sixty‐eight patients (96%) underwent mastectomy. With a median follow‐up of 52 months, the relapse‐free and overall survival rates at 5 years were 42% and 57%, respectively. Locoregional tumor recurrence occurred in 14 patients (20%), and 28 patients (39%) developed metastatic disease. Menopausal status, clinical presentation (noninflammatory vs. inflammatory), and American Joint Committee on Cancer clinical stage were independent covariates associated with patient outcome. CONCLUSIONS Preoperative alternating chemotherapy, with the selective use of irradiation, resulted in significant locoregional disease regression and the successful integration of mastectomy into the therapeutic strategy. Locoregional tumor control and relapse‐free and overall survival estimates for the approach described herein compared favorably with other contemporary reports for this condition. Cancer 1996;77:2520‐8.

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High complete remission rates with primary neoadjuvant infusional chemotherapy for large early breast cancer.

Abstract: Primary infusional ECF appears to be more active on clinical and histopathologic grounds than conventional chemotherapy for large operable breast cancer and is well tolerated. This approach now merits randomized comparison to determine if high CR rates may translate into improved survival.

Cited by 170 publications

References 0 publications

Ultrasound assessment of residual abnormalities following primary chemotherapy for breast cancer

Ultrasound assessment of residual abnormalities following primary chemotherapy for breast cancer

Phase II study of docetaxel in combination with epirubicin and protracted venous infusion 5-fluorouracil (ETF) in patients with recurrent or metastatic breast cancer. A Yorkshire breast cancer research group study

A pilot evaluation of alternating preoperative chemotherapy in the management of patients with locoregionally advanced breast carcinoma

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