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PubMed2002

Neoadjuvant hormonal therapy and older age are associated with adverse sexual health-related quality-of-life outcome after prostate brachytherapy.

OBJECTIVES: Brachytherapy is increasingly used as a treatment for localized prostate cancer but information regarding long-term, postimplantation, patient-reported sexual health-related quality-of-life (HRQOL) is scant. Neoadjuvant hormonal therapy is commonly administered with brachytherapy, yet its potentially adverse effects on subsequent sexual health have not been described using a validated HRQOL instrument. We used a validated HRQOL survey to characterize the significance of neoadjuvant hormonal therapy and other baseline factors on postimplantation sexual function and impairment. METHODS: A cross-sectional survey using the expanded prostate cancer index composite HRQOL instrument was administered to all 114 localized prostate cancer patients who underwent ultrasound-guided, transperineal brachytherapy during a 4-year period and to 142 age-matched control men. Multivariable models measured the association of baseline factors and covariates with postimplantation sexual HRQOL. RESULTS: Older age (P = 0.01) and neoadjuvant hormonal therapy (P = 0.009) were independently associated with diminished sexual HRQOL after prostate brachytherapy. Among patients younger than 69 years old, 33% reported at least fair sexual function after brachytherapy alone compared with 19% of men after brachytherapy with neoadjuvant hormonal therapy. Of the age-matched control men younger than 69 years old, 78% reported at least fair sexual function. Among patients older than 69 years, 26% reported at least fair sexual function after brachytherapy alone compared with 5% after brachytherapy with neoadjuvant hormonal therapy, and 61% of age-matched controls reported at least fair sexual function. CONCLUSIONS: Patient age and neoadjuvant hormonal therapy are independent, significant determinants of sexual HRQOL after prostate brachytherapy. These factors should be taken into consideration when counseling patients with localized prostate cancer regarding the expected, postimplantation sexual HRQOL outcome.

Age Factors↗

PubMed2001

Evaluation of response to neoadjuvant chemoradiotherapy for locally advanced breast cancer with dynamic contrast-enhanced MRI of the breast.

AIMS: This study aimed to examine the feasibility of utilizing dynamic contrast-enhanced MRI (DCE-MRI) of the breast for the planning of surgical intervention following neoadjuvant therapy for locally advanced breast cancer (LABC). METHODS: Following their neoadjuvant therapy, women with LABC were followed-up by DCE-MRI in addition to clinical examination and mammography. If any modality suggested residual disease, surgery was carried out--initially salvage mastectomy and then breast-conserving surgery where appropriate. RESULTS: Seventeen women were recruited: stage III (n=16), stage IV (n=1) mean age 55 (range 34-74). Following neoadjuvant therapy, 10 mastectomies and two local excisions were performed for 10 histologically confirmed residual cancers. Median follow-up for those women not undergoing surgery is 3.24 (IQR 2.8-3.5) years. DCE-MRI proved 100% accurate for the delineation of residual disease and facilitated the planning of the local excisions. Clinical examination and mammography proved inaccurate (PPV 83% and 75% and NPV 55% and 80%, respectively). CONCLUSIONS: DCE-MRI is a potentially accurate method of delineating residual tumour following neoadjuvant therapy for LABC and may be used to plan appropriate operative intervention where required.

Adult↗

PubMed2005

Quantification of the response of circulating epithelial cells to neodadjuvant treatment for breast cancer: a new tool for therapy monitoring.

INTRODUCTION: In adjuvant treatment for breast cancer there is no tool available with which to measure the efficacy of the therapy. In contrast, in neoadjuvant therapy reduction in tumour size is used as an indicator of the sensitivity of tumour cells to the agents applied. If circulating epithelial (tumour) cells can be shown to react to therapy in the same way as the primary tumour, then this response may be exploited to monitor the effect of therapy in the adjuvant setting. METHOD: We used MAINTRAC analysis to monitor the reduction in circulating epithelial cells during the first three to four cycles of neoadjuvant therapy in 30 breast cancer patients. RESULTS: MAINTRAC analysis revealed a patient-specific response. Comparison of this response with the decline in size of the primary tumour showed that the reduction in number of circulating epithelial cells accurately predicted final tumour reduction at surgery if the entire neoadjuvant regimen consisted of chemotherapy. However, the response of the circulating tumour cells was unable to predict the response to additional antibody therapy. CONCLUSION: The response of circulating epithelial cells faithfully reflects the response of the whole tumour to adjuvant therapy, indicating that these cells may be considered part of the tumour and can be used for therapy monitoring.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2005

Neoadjuvant endocrine therapy in breast cancer.

The clinical benefits of endocrine therapy for patients with hormonosensitive breast cancer are well established. For many years, five years' treatment with tamoxifen was the gold standard of adjuvant treatment. The recent development of new endocrine agents provides physicians with the opportunity to take a more effective therapeutic approach. Nevertheless, the success of neoadjuvant endocrine therapy is much more recent and less frequently reported in the literature. This article reviews the studies published on neoadjuvant endocrine treatment (tamoxifen and aromatase inhibitors). According to the literature, neoadjuvant endocrine therapy seems to be effective and well tolerated. The newer generation of aromatase inhibitors (letrozole, anastrozole, exemestane) appear to result in better overall response rates and more conservative surgery than tamoxifen. Patients with an ER Allred score of 6 and over are most likely to respond and gain clinical benefit. The optimal duration of neoadjuvant therapy has not yet been investigated in detail. These preliminary results are interesting and should be confirmed by further studies.

Antineoplastic Agents, Hormonal↗

PubMed2003

Current limits of knowledge in adjuvant and neoadjuvant endocrine therapy of breast cancer: the need for more clinical research.

Adjuvant endocrine therapy following surgical resection of early, endocrine sensitive breast cancer has proven benefits in reducing risk of recurrence and death, as demonstrated in many mature well controlled clinical trials. The introduction of new endocrine therapies as potential alternatives to tamoxifen or ovarian ablation and the incorporation of neoadjuvant endocrine therapy into the overall management strategy continue to provide exciting challenges for clinical research. In this article the focus is on as yet unanswered questions pertinent to adjuvant or neoadjuvant endocrine therapy for breast cancer. In the process, we broadly outline the current limits of knowledge as we understand it. Many relevant and current clinical trials are ongoing and a list of these with contact details or references are provided. Definitive data is urgently needed in many areas and, when available, will provide important evidence on which the management of breast cancer patients in future can be based. Participation in relevant clinical trials is vital for future progress.

Adult↗

PubMed2006

Surgical management after neoadjuvant imatinib therapy in gastrointestinal stromal tumours (GISTs) with respect to imatinib resistance caused by secondary KIT mutations.

BACKGROUND: In metastasized GISTs, resistance to imatinib after initial tumour response has been associated with observation of secondary mutations in the activation loop of KIT. The aim of the current study was to evaluate the tumour response and observance of secondary KIT mutations in a case of GIST undergoing neoadjuvant imatinib therapy. METHODS: We report on a case of an initially unresectable gastric GIST with curative resection after 10 months of neoadjuvant imatinib therapy. Mutation analysis of KIT was performed on a pretherapeutic biopsy specimen, as well as on the resected tumour specimen. RESULTS: The pretherapeutic biopsy revealed cKit positive tumour cells with mutation of KIT exon 11 Del 560-576. The remaining tumour mass after neoadjuvant imatinib therapy almost exclusively consisted of hypocellular myxohyalinale stroma with rare microfoci of cKit positive tumour cells. Laser microdissection of several tumour microfoci revealed two additional point mutations located in the activation loop of KIT exon 17, C809G and N822Y, each observed separately in a distinct microfocus. Neither of these two point mutations has been reported in a GIST so far. CONCLUSIONS: Neoadjuvant imatinib therapy successfully reduces tumour size in GISTs. Since resistance relevant secondary mutations of the activation loop of KIT may be observed after neoadjuvant imatinib therapy, the time elapse with preoperative imatinib therapy should be chosen as short as curative tumour resection or function sparing surgery can be carried out. The determination of the optimal time point for surgery is therefore a critical event and will be discussed.

Aged↗

PubMed2026

Neoadjuvant Systemic Therapy for Resectable Intrahepatic Cholangiocarcinoma: From Retrospective Studies to Randomized Evidence.

Complete resection remains the only potentially curative treatment for localized intrahepatic cholangiocarcinoma (iCCA), yet postoperative recurrence is common, particularly in patients with high-risk disease. Neoadjuvant systemic therapy may permit earlier control of occult micrometastatic disease, optimize the delivery of systemic treatment, and provide an in vivo assessment of tumor biology prior to major hepatectomy. These potential benefits must be balanced against treatment-related toxicity, surgical delay, and the risk of disease progression precluding resection. Early evidence was primarily derived from retrospective studies, which yielded inconsistent survival outcomes and exhibited substantial vulnerability to confounding and treatment-selection bias. The single-arm NEO-GAP trial subsequently demonstrated the feasibility of administering neoadjuvant gemcitabine, cisplatin, and nab-paclitaxel followed by surgical resection. More recently, the randomized phase II-III ZSAB-neoGOLP trial showed that neoadjuvant gemcitabine-oxaliplatin, lenvatinib, and toripalimab followed by surgery prolonged median event-free survival compared with upfront surgery (median: 18.0 vs. 8.7 months) without substantially compromising surgical feasibility. However, the interim overall survival analysis was inconclusive, and the generalizability of these findings beyond selected, medically fit patients treated at Chinese centers remains uncertain. This narrative review critically appraises the evolving evidence, discusses patient selection and perioperative treatment, and identifies priorities for future research. Current evidence supports the selective consideration of neoadjuvant therapy in medically fit patients with technically resectable but oncologically high-risk iCCA, rather than its routine use in all resectable cases.

GOLP↗

PubMed2001

Neoadjuvant hormone therapy and radical prostatectomy: the jury is still out.

Radical prostatectomy may lead to cure as long as the cancer is confined to the prostate and all malignant cells are removed. However, clinical staging is inaccurate and a significant proportion of cT1-T2 patients have positive margins which increases the likelihood of disease progression within 5 years of surgery. Neoadjuvant hormone therapy is one option being used to increase the likelihood of prostate cancer cure after radical prostatectomy. Randomized clinical trials using neoadjuvant hormone therapy and radical prostatectomy have been conducted mainly in patients with cT1 and cT2 prostate cancer. A decrease in the number of positive surgical margins was found in cT1 and cT2 prostate cancer patients receiving neoadjuvant hormone therapy, with a further decrease in those receiving treatment over longer periods. In cT3 prostate cancer patients equivocal results have been obtained and further research is needed. None of the studies reported so far were able to define the impact of neoadjuvant treatment on the surgical management of locally advanced prostate cancer. Additional studies are required to determine the optimal type and duration of hormone treatment. Furthermore, long-term follow-up is needed to evaluate whether neoadjuvant therapy will improve overall survival. In the meantime, patients must be informed of the advantages and disadvantages of treatment to allow them to make informed treatment decisions.

Androgen Antagonists↗

PubMed2004

Neoadjuvant hormonal therapy in men being treated with radiotherapy for localized prostate cancer.

Several prospective randomized trials have demonstrated that men with localized prostate cancer benefit from the use of short-term neoadjuvant hormonal therapy (NHT) in combination with external beam radiotherapy (EBRT). Seven randomized trials were summarized in 6 publications including patients treated with NHT in combination with EBRT on 1 or more arms. A total of 17 different arms were compared including radiotherapy alone (n = 3), and NHT and concurrent hormonal therapy (N&CHT) (n = 12) with or without short-term adjuvant hormonal therapy (SAHT) (n = 5) or long-term hormonal therapy (n = 1). Patients treated with EBRT alone had a worse outcome than those treated with NHT. Intermediate-risk patients treated with 2 to 3 months of NHT did as well as those treated with longer neoadjuvant therapy or SAHT. The preponderance of data supports the use of NHT in combination with EBRT in intermediate-risk patients.

Journal Article↗

PubMed2000

Neoadjuvant hormonal therapy in radical prostatectomy and radiation-treated patients.

Neoadjuvant hormonal therapy (NHT) prior to radical prostatectomy or radiation therapy for clinically localized prostate cancer has regained interest in recent years but proof of its clinical benefit with respect to patient survival is still pending. We reviewed the literature regarding NHT in prostate cancer; only studies with a high evidence level were included for analysis. Five prospective randomized trials of NHT in radical prostatectomy-treated patients could be identified. Despite significantly lower numbers of positive surgical margins in the NHT group, prostate specific antigen failure rates were similar in the NHT group and the surgery only group. Data on disease-free and overall survival are not yet available. The two prospective randomized studies of NHT in radiation-treated patients could demonstrate better local control of the tumor in the NHT group. However, there was no difference in overall survival between the NHT arm and the radiation only arm. Future clinical research should consider type and duration of hormonal treatment and evaluate potential surrogate end points. To date, there is no hard evidence in favor of NHT prior to radical prostatectomy or external beam irradiation. NHT in prostate cancer should only be applied within controlled trials.

Antineoplastic Agents, Hormonal↗

PubMed1993

Neoadjuvant hormonal therapy in stage C adenocarcinoma of the prostate.

This report describes the effects of neoadjuvant hormonal therapy on 16 patients (mean age = 65 y) with clinical stage C adenocarcinoma of the prostate (CaP) who underwent radical prostatectomy from December 1991 to June 1993 at the University of Colorado Health Sciences Center. Staging of CaP was determined by digital rectal exam, transrectal ultrasonography (TRUS), radionuclide bone scanning, abdominal and pelvic computed tomography scanning, transrectal coil magnetic resonance imaging, and serum acid phosphatase. Most patients underwent a laparoscopic lymph node dissection to rule out micrometastasis. Every patient was treated for 4 months with a combination of a gonadotrophin-releasing hormone (GnRH) agonist (Lupron) and an anti-androgen (flutamide, Eulexin). Serial prostate-specific antigen (PSA) levels, post-treatment prostate volume measured by TRUS, and whole-mount sectioning of the surgical specimen were studied. The PSA levels decreased from a mean of 39.1 ng/ml (Hybritech method) to a mean of 0.43 ng/ml; (p < 0.0001). Prostate volumes in all patients demonstrated a mean decrease of 52% (p < 0.0001), and pathological effects of hormonal deprivation were observed in all patients. By whole-mount sectioning of the radical prostatectomy specimens, 3 patients had organ-confined disease (stage B), 6 showed invasion of the capsule with surgical margins free of tumor (stage C1), 3 had extracapsular extension with positive surgical margins (stage C2), and 4 had extracapsular extension with seminal vesicle involvement (stage C3). We conclude that by downsizing and markedly decreasing serum PSA values, neoadjuvant hormonal therapy offers an alternative treatment for stage C carcinoma of the prostate.(ABSTRACT TRUNCATED AT 250 WORDS)

Adenocarcinoma↗

PubMed2000

Difficulties in interpreting specimens after neoadjuvant hormonal therapy and radiation with illustration of neuroendocrine differentiation.

Pattern and cellular changes attributable to neoadjuvant hormonal therapy (NHT) might cause the unwary pathologist to overgrade or fail to recognize a treated prostatic cancer. Overdiagnosis and overgrading of surgical resections and biopsies can be avoided if an appropriate history of therapy is conveyed with the surgical specimen and if the pathologist is aware of the altered morphology of prostatic cancer treated by NHT alone or NHT plus radiation. Study of three prostatectomy specimens with post-NHT predominance of neuroendocrine cells showed positive staining for prostate specific antigen (PSA) and prostatic acid phosphatase (PAP), as well as staining for chromogranin and synaptophysin in Paneth-like and small neuroendocrine cells. Difficult-to-interpret needle biopsies and transurethral resection (TUR) biopsies of prostate, where the urologic pathologist's suspicion of a radiation effect was confirmed by additional history, showed absence of the basal cell layer with 34 beta E12 keratin immunostaining in prostatic cancer glands, while basal cells were present in the nonneoplastic glands with radiation-induced atypia. Postradiation salvage prostatectomy specimens showed greater apoptosis after combined NHT and radiation than after radiation without NHT. Changes attributable to radiation and radiation plus NHT are illustrated.

Androgen Antagonists↗

PubMed2000

[Utilization of multimodal therapy concepts in stomach carcinoma in Germany].

INTRODUCTION: In view of disappointing results after surgery alone multimodal therapeutic regimes are used to improve long-term prognosis in locally advanced gastric carcinomas. In presence of many reports about encouraging results ("down staging", improved R0-resection rates) but simultaneously missing evidence of efficiency of neoadjuvant therapies in respect to long-term survival (large randomized multicenter trials do not exist until today) and the herewith related uncertainties, we started an inquiry among many surgical units with the intention to evaluate the clinical practice of multimodal treatment for gastric cancer patients in Germany today. METHODS: In a questionnaire (3/99) we asked among 97 surgical units (41 university hospitals, 56 big community hospitals) in Germany for the management of gastric cancer patients with special interest to practice and state of adjuvant and neoadjuvant therapeutic strategies. Further we analyzed all resected gastric cancer patients (1986-1995) without neoadjuvant treatment in advanced stage of disease (pT3/4NxMx; stage III/IV (UICC'92) in respect to R0-resection rate and long-term prognosis (Kaplan-Meier). RESULTS: Overall feedback amounted to 78% (76/97) and was higher in university hospitals (90%) than in big community hospitals (70%). Today, neoadjuvant therapies are of more interest than adjuvant therapeutic regimes. But also neoadjuvant therapy is only used in 32% as a rule (in 16% with, in 16% without study conditions). 25% of all surgical units do not employ any neoadjuvant therapy in locally advanced gastric cancer until today. In all other surgical units neoadjuvant treatment is performed more individually and sporadically (43%) only in some patients. Neoadjuvant therapies are practiced by haematooncologists in 50%, gastroenterologists in 32% and surgeons in 27%. The predominant neoadjuvant therapeutic strategy is chemotherapy alone (84%). Many surgical units in Germany are interested to participate in a multicenter trial with more interest in neoadjuvant than adjuvant therapy. 185 of 309 resected gastric cancer patients (60%) were classified as stage IIIa, stage IIIb or stage IV patients. R0-resection rate of these advanced gastric cancer patients amounted to 37%; only 24% of them survived 5 years or more. CONCLUSIONS: Considering the missing evidence that multimodal therapies are able to prolong long-term survival in advanced gastric cancer patients, its use without study conditions is questionable. Conclusions, taken from data of clinical trials regarding carcinomas of the esophagus and esophagealgastric junction, are inconsistent in respect to long-term prognosis and results are not transferable to gastric carcinomas. A prospective randomized multicenter trial in advanced gastric cancer patients is of great importance. Following our data, in Germany a high readiness to participate in the forthcoming EORTC-study is present.

Chemotherapy, Adjuvant↗

PubMed2000

Neoadjuvant photodynamic therapy before curative resection of proximal bile duct carcinoma.

BACKGROUND: Hilar bile duct carcinoma has an 80% probability of local recurrence after curative resection, which might be reduced if neoadjuvant photodynamic therapy is feasible. CASE AND TREATMENT: After intravenous injection of sodium porfimer we treated an adenocarcinoma of the proximal common bile duct (T2 N0 M0, Bismuth type II) in a 72-year-old man with red laser light (applied from the lumen at a dose 250 Joules/cm2), and the adjacent right and left hepatic and common bile duct at a dose of 125 Joules/cm2. After 23 days the tumor was completely resected (adenocarcinoma pT2 pNO; G2). RESULTS: In the lumenal, 4-mm-thick layer the bile duct specimen exhibited complete tumor necrosis with pigmentation of photodegraded porfimer and no viable tumor cells, while in the outer layer of the wall (at 5-8-mm depth) viable cancer cell nests without degraded porfimer were seen. The bile duct tissue showed little damage. Eighteen months after surgery, neither tumor recurrence nor stricture formation was found at the pretreated bilioenteric anastomoses. CONCLUSIONS: a) Photodynamic therapy with sodium porfimer seems to be confined to the superficial 4-mm layer of bile duct cancer. b) Neoadjuvant photodynamic therapy is feasible for hilar bile duct carcinoma.

Adenocarcinoma↗

PubMed2004

Laparoscopic radical prostatectomy after neoadjuvant hormonal therapy: an apparently safe and effective procedure.

OBJECTIVE: In an effort to determine the safety and efficacy of laparoscopic radical prostatectomy (LRP) in patients who have received neoadjuvant hormonal therapy (NHT), our initial series of 65 patients undergoing successful LRP was analyzed, specifically comparing 5 patients who received neoadjuvant hormonal therapy to 60 who did not. METHODS: From March 2000 to March 2002, 68 patients were scheduled for LRP. Three cases, none post-NHT, were converted to open radical retropubic prostatectomy (RRP). Clinical and pathologic data were recorded on the remaining 65 patients, 5 of who had received NHT. Forty-two bilateral and 16 unilateral nerve sparing LRP were performed in the non-NHT cohort, and 3 bilateral and 1 unilateral nerve sparing LRP in the NHT cohort. RESULTS: The mean patient age, preoperative prostate specific antigen (PSA), clinical stage, and biopsy grade were similar for the NHT and the non-NHT LRP cohorts. The mean estimated blood loss (EBL) and serum hemoglobin decrease (preoperative to postoperative day 1) were lower in the NHT cohort than the non-NHT cohort: 160 mL and 2.4 g/dL vs. 317 mL and 3.1 g/dL, respectively. The mean operative time and hospital stay were similar: 5.7 hours and 2.4 days for the NHT cohort and 5.8 hours and 2.8 days for the non-NHT cohorts. As expected, the mean prostate weight was lower for the NHT cohort: 36.8 g vs. 46.5 g. All NHT cohort tumors were pathologic stage pT2, with negative margins. Eleven (18%) of the non-NHT cohort had pathologic T3 (10 patients) or T4 (1 patient) tumors and 10 (17%) specimens had a positive surgical margin. Four of 5 (80%) NHT cohort and 21 of 25 (84%) non-NHT cohort patients are continent (no pad use) 3 to 6 months postsurgery. One NHT cohort patient (20%) and 20 (33%) non-NHT cohort patients had an elevated drain fluid creatinine 24 hours postoperatively. There were no other complications in the NHT cohort. All 5 NHT cohort patients have no evidence of recurrent disease, whereas 2 non-NHT cohort patients (3.3%) have developed PSA recurrence. No NHT patient and only 1 non-NHT patient received a blood transfusion postoperatively. CONCLUSION: LRP appears to be a safe and efficacious procedure in patients who have received NHT. Perioperative morbidity of NHT patients undergoing LRP appears equivalent to non-NHT patients, with slightly lower EBL, hemoglobin decrease, urinary extravasation, positive margin, and complication rates.

Antineoplastic Agents, Hormonal↗

PubMed2003

The rational principles of neo-adjuvant therapy for rectal cancer.

BACKGROUND: Aim of the study is to analyze rational principles which at present govern the neoadjuvant therapy for rectal cancer and justify his application. First step is definition of targets: cellular replication block, volumetric reduction of rectal cancer, mesorectum and lateral nodes (Down staging), reduction of side-effects on close organs, radiation on more limited tissue volumes, major series of sphincter saving procedures, minor risk of microscopic tumour deposits. Second step regards standards which Protocols strive in order to: patients selection, therapeutic index, restaging before surgery, total mesorectal excision (TME). Further step accounts for evidence of drawbacks, related to Neoadjuvant approach, both Radiotherapy alone (RT) or Radiochemotherapy (CH-RT). METHODS: Indications for neoadjuvant therapy, basing a difference between the absolute and relative one, are explained. Given that granting role to such therapy still now remain partially unclear, we have outlined the following topics: A) survey of main protocols is managed, taking care on dose/response ratio, focusing on enhanced supply for fixed tumours, checking on a list of several drugs (oxaliplatinum, capecitabin, raltitrexed, CPT-11, eniluracil), which are medicated with RT and furthermore on a list of substitute RT methods (HART, IORT, Endocavitary). B) following whole treatments, according such a different approaches, analysis of obtained outcomes in the literature are carried out. C) Personal experience, basing on a previous series where Down-staging has been sought, comparing indicatively clinical and diagnostic data before neoadjuvant therapy and before surgery. D) List of open issues, not solved at present, is shown CONCLUSIONS: Neoadjuvant therapy may be considered a rational approach for treatment of curative rectal cancer; indeed, preliminary results seem to introduce a real advantage compared to adjuvant therapy, even if is mandatory to associate proper surgical procedure, as TME, to warrant low local recurrences. Targets, related to such therapy, may be noticed ideal even though outcomes don't come up always to statements. So, continuous efforts to ameliorate rates of free-disease series, as well mortality rates and toxical effects are advised.

Chemotherapy, Adjuvant↗

PubMed2001

Neoadjuvant endocrine therapy for breast cancer: medical perspectives.

The indolent nature of estrogen-dependent breast cancer is the most important obstacle for development of new adjuvant endocrine treatments. Clinical trials require thousands of study participants and at least a decade of clinical investigation. How can we be sure that a new endocrine agent warrants this extraordinary level of investment? Traditionally, we have relied on advanced breast cancer trials to determine which drugs are suitable for adjuvant studies. However, with endocrine agents the high incidence of resistance in metastatic breast cancer may mask important advances in efficacy. Recent clinical results with the aromatase inhibitor letrozole suggest that neoadjuvant endocrine therapy is a highly informative additional approach to consider when planning adjuvant studies. In this report, new neoadjuvant endocrine therapy study designs are discussed that address the following issues: (a) the scientific opportunities afforded by gene microarray studies and other genetic technologies to investigate the molecular basis of estrogen-dependent breast cancer; (b) studies that address critical drug development questions as a prelude to adjuvant studies; and (c) the conduct of randomized trials that compare neoadjuvant chemotherapy with neoadjuvant aromatase inhibitor therapy to establish a place for neoadjuvant endocrine therapy in routine clinical practice.

Antineoplastic Agents, Hormonal↗

PubMed2002

Changes in extent and zonal distribution of prostatic adenocarcinoma in patients preoperatively treated with neoadjuvant endocrine therapy: analysis on whole-mounted prostatectomy specimens.

BACKGROUND: An increasing number of pharmacologic agents that induce reversible androgen deprivation are available for neoadjuvant endocrine therapy (NET) for prostatic adenocarcinoma (PCA). If information about the regression pattern of PCA after NET is recognized, more effective decision-making for subsequent therapies such as prostatectomy and radiotherapy, will be possible. METHODS: The extent and zonal distribution of PCA with or without NET were examined in totally embedded radical prostatectomy specimens obtained from 103 patients with PCA. Seventy-nine of the 103 patients received androgen deprivation therapy (castrated). The zonal location of PCA lesions (non-transition vs transition zone), was identified in three slices from the inferior, middle and superior parts of the prostate. The area of the PCA lesions in these zones was measured. RESULTS: Prostatic adenocarcinoma was identified in 94 of 103 cases: 24 of 24 cases (100%) and 70 of 79 cases (87%) in the non-castrated and castrated groups, respectively. The NET induced a mean of 21% reduction of the prostate volume and lowered the serum PSA level by one eighth. The frequency of capsular penetration in the castrated cases (57%) was lower than in the non-castrated cases (83%) and confinement of the PCA lesion was found in 32% of the castrated and 17% of the non-castrated cases. The reduction rate of the extent of the PCA lesions in the non-transition and transition zone was 33% and 28%, respectively. The extent of the PCA lesions were smaller in the anterior parts, especially at the superior portion of the prostate. CONCLUSION: Neoadjuvant endocrine therapy induced involutional changes of the PCA evenly across both the non-transition and transition zones. The density of the PCA lesions was low in the anterior part of the prostate. This information is useful for decision-making in post-NET.

Adenocarcinoma↗