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PubMed2002

Preoperative neoadjuvant androgen withdrawal therapy in prostate cancer: the Canadian experience.

The goal of radical prostatectomy is the complete removal of all cancer cells--no more, no less. Unfortunately, this is not always possible, especially in men with higher risk pathologic features. It is recognized that preoperative staging underestimates the extent of disease in < or =66% of cases, and that positive margin rates may be as high as 30% to 60%. Over the past 7 years in Canada, researchers have been investigating therapies that optimize the complete extirpation of all cancer cells with a minimum of morbidity and mortality. An example of this therapy is the combined modality approach of shrinking the prostate and tumor with androgen withdrawal therapy before surgical removal. The availability of potent, reversible, and well-tolerated forms of medical castration, and the sensitivity of serum prostate-specific antigen as a marker of response to therapy, makes neoadjuvant hormone therapy before localized therapy possible and appealing. In this article, we will review the Canadian experience, from the laboratory to the clinic.

Androgen Antagonists↗
PubMed2002

Usefulness of positron emission tomography for assessing the response of neoadjuvant chemoradiotherapy in patients with esophageal cancer.

BACKGROUND: In this study, we retrospectively assessed the performance of 18-F-fluorodeoxyglucose positron emission tomography (FDG-PET) compared with computed tomography (CT) and esophagography for assessing the response of advanced esophageal squamous cell carcinoma (SCC) to neoadjuvant chemoradiotherapy. METHODS: We studied 10 patients with thoracic esophageal SCC who received neoadjuvant chemoradiotherapy followed by surgery. Tumor response was assessed by CT, endoscopy, esophagography and FDG-PET before and after neoadjuvant treatment. RESULTS: Assessment of the rate of decrease in standardized uptake value (SUV) revealed a partial response (more than 50% decrease) in 5 (50%) of the patients, and assessment of length decrease of FDG uptake showed a partial response in 9 (90%) of the patients. Comparison of the histological response and the rate of decrease of various parameters revealed significant associations between histological response and tumor length (P <0.05), SUV after neoadjuvant therapy (P <0.05), and reduction in the extent of FDG uptake (P <0.01). However histological response was not significantly correlated with the rate of reduction of SUV, for both CT and esophagography. CONCLUSIONS: FDG-PET may be of considerable value for predicting the pathologic response of esophageal SCC to neoadjuvant therapy. Despite assessment of SUV before neoadjuvant therapy, low FDG uptake after therapy and reduction in the extent of FDG uptake may provide a reliable assessment of the response to therapy.

Adult↗
PubMed2004

Is neoadjuvant hormonal therapy before radical prostatectomy indicated?

INTRODUCTION: Despite the success of surgical monotherapy in treating patients with organ-confined disease, nearly half of all patients undergoing radical prostatectomy will be pathologically upstaged on evaluation of the operative specimen. One possible means of improving the proportion of patients with organ-confined disease and cancer-negative margins at surgery is implementing neoadjuvant androgen deprivation therapy. Studies evaluating the use of neoadjuvant hormonal therapy (NHT) before radical prostatectomy will be reviewed, and outcomes will be discussed. METHODS: Review of the past and recent literature regarding the use and role of NHT before radical prostatectomy was performed. In particular, special attention was paid to the seven prospective, randomized studies that have been reported in the literature. In addition, review of other pertinent and appropriate texts and journals regarding the impact of hormonal therapy on histopathological evaluation and outcomes was performed. RESULTS: Upon review of the prospective, randomized, clinical trials of NHT before radical prostatectomy, there remains no clear evidence that NHT improves disease-free survival for any stage of prostate cancer. Although positive surgical margins appear to be reduced for patients with clinical stage T2 disease only, significance and validity of such an end point remain uncertain. In addition, the use of NHT appears to come with a significant cost with regard to financial expense, patient morbidity, and possibly increased surgical difficulty. CONCLUSIONS: The routine use of NHT before radical prostatectomy is not justified, and only in controlled investigational trials should its use be considered.

Antineoplastic Agents, Hormonal↗
PubMed2004

Feasibility of sentinel node biopsy for breast cancer after neoadjuvant endocrine therapy: a pilot study.

BACKGROUND AND OBJECTIVES: Sentinel node biopsy (SNB) is used for evaluation of axillary lymph node status of patients with breast cancer. The usefulness of SNB after neoadjuvant chemotherapy is not established. In addition, SNB after endocrine therapy has rarely been evaluated. We assessed the feasibility of dye guided SNB after neoadjuvant endocrine therapy in comparison with those of SNB after chemotherapy. METHODS: A total of 36 patients subjected to SNB after endocrine therapy alone (n = 16) (tamoxifen, anastrozole or combination of goserelin and tamoxifen) or after chemotherapy (n = 20) (anthracycline and/or taxane) were included. SNB was performed with indigocarmine dye prior to the wide resection of the tumor or mastectomy. RESULTS: Sentinel nodes were successfully identified in 100% (16/16) of patients after endocrine therapy and in 85% (17/20) of patients after chemotherapy. The mean number of harvested sentinel nodes was 2.2 after endocrine therapy and 1.8 after chemotherapy. There was no false negative case after endocrine therapy and there was one false negative case after chemotherapy (8% of overall false negative rate). CONCLUSIONS: SNB seemed feasible and accurate after neoadjuvant endocrine therapy in patients with breast cancer.

Adult↗
PubMed2002

Predictive factors for success of neo-adjuvant therapy in upper gastrointestinal cancer.

BACKGROUND: Predicting response to treatment has long been the Holy Grail of clinicians treating patients with upper gastrointestinal malignancy. The widespread use of neoadjuvant therapy for esophageal cancer has provided an added urgency to the issue and at the same time brought success a step closer because accurate response can be determined from analysis of the resected specimen. METHODS: A search was undertaken of the Medline database for text references to neoadjuvant therapy, esophagus, stomach and predicting response. The references of these publications were further scanned for appropriate references in the text and reference lists. RESULTS: Publications describing predictive markers to neoadjuvant therapy for esophageal cancer, which were most likely to be of clinical significance, were selected for inclusion in this report. CONCLUSIONS: The most reliable tissue markers of response based on analysis of pretreatment biopsy specimens include P53, Ki-67, EGFR and the most impressive serum marker for monitoring response are CYFRA 21-1 and CEA. The results, however, are inconsistent, and the markers of relatively low sensitivity and none reliably identifies individual patients who will respond.

Biomarkers↗
PubMed2004

Expression of insulin-like growth factor binding protein-3 before and after neoadjuvant hormonal therapy in human prostate cancer tissues: correlation with histopathologic effects and biochemical recurrence.

OBJECTIVES: To determine the effects of neoadjuvant hormonal therapy (NHT) on insulin-like growth factor binding protein (IGFBP)-3 expression and whether IGFBP-3 expression influences the pathologic effect of NHT and biochemical recurrence after radical prostatectomy in patients with prostate cancer. IGFBP-3 has pro-apoptotic activity, and its expression correlates negatively with prostate cancer cell growth. Castration induces IGFBP-3 expression and apoptosis in the rat prostate. METHODS: We used tissue specimens from 42 patients who underwent NHT and radical prostatectomy. The pre-NHT and post-NHT specimens were examined for expression of IGFBP-3 using an immunohistochemical technique and for apoptosis using the terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling method. The histopathologic effect was evaluated by the standardized rules for estimating the response of prostate cancer to NHT, determined by the percentage of remaining viable cancer cells, as advocated by the General Rule for Clinical and Pathological Study on Prostate Cancer published by the Japanese Urological Association. RESULTS: NHT resulted in a statistically significant increase in IGFBP-3 expression compared with baseline (P = 0.01). Such an increase in expression correlated significantly with the induction of apoptotic cells (r = 0.40 and P = 0.01). The post-NHT/pre-NHT IGFBP-3 ratio was significantly greater in the NHT-effective group than in the NHT-noneffective group (P = 0.02). Patients with high IGFBP-3 expression in the post-NHT specimens had a good prognosis (P = 0.03, log-rank test). CONCLUSIONS: Induction of IGFBP-3 by NHT was associated with apoptosis and a histopathologic effect. IGFBP-3 expression in post-NHT specimens is a potentially useful predictor of biochemical recurrence in patients with prostate cancer.

Aged↗
PubMed2003

Pathological effects of neoadjuvant hormonal therapy help predict progression of prostate cancer after radical prostatectomy.

BACKGROUND: It is not clear whether pathological changes following neoadjuvant hormonal therapy (NHT) prior to radical prostatectomy have any value as predictors of progression in prostate cancer. METHODS: We conducted a study of 100 patients with prostate cancer who underwent radical prostatectomy following NHT. We used the Japanese general rule as the criterion to assess the biochemical recurrence rate and pathological changes after NHT. RESULTS: In terms of preoperative risk factors, the probability of recurrence was significantly higher for patients with more than 20 ng/mL of pretreatment serum prostate-specific antigen (PSA) and/or a Gleason score of 7 or higher for biopsy specimens. We defined these pretreatment findings as high-risk factors. Among 65 patients with high-risk factors, patients with a post-NHT pathological effect of grade 3 according to the Japanese general rule showed no recurrence, whereas patients with a grade 0 had a poor prognosis. Patients with a PSA nadir 0.5 ng/mL or less tended to have a better prognosis. CONCLUSION: Despite preoperative high-risk factors, patients showing good pathological effects after NHT tend to have a favorable prognosis after radical prostatectomy. Therefore; assessment of the pathological effects of NHT using the Japanese general rule as the criterion proved to be useful for the prediction of biochemical recurrence.

Aged↗
PubMed1999

Neoadjuvant Hormonal Therapy in Stage C Adenocarcinoma of the Prostate and Incidence of Biochemical Recurrence.

This report describes the effects of neoadjuvant hormonal therapy (NHT) in 31 patients with clinical stage T3 adenocarcinoma of the prostate (CaP) who underwent radical prostatectomy (RP) and the incidence of biochemical recurrence, as evidenced by serum prostate specific antigen (PSA) >0.2 ng/mL after RP. Twenty-six patients received combined androgen blockade consisting of a gonadotropin-releasing hormone (GnRH) agonist (leuprolide) and an antiandrogen (flutamide), and the remaining five received flutamide alone. The mean Gleason score was 7.1 +/- 0.3. Five patients were found to have pathologic stage T(2c), 14 stage T(3a), 7 stage T(3b), and 4 stage T(3c) disease. One specimen had no evidence of adenocarcinoma in the whole-mount specimen. The mean PSA concentration decreased from 25.4 ng/mL (Hybritech method) to 1.18 ng/mL. The prostate volume decreased a mean of 47%, and pathologic effects of hormonal deprivation were observed in all patients. Approximately 39% of the patients (12/31) demonstrated evidence of biochemical recurrence, with the mean time to biochemical failure being 28.9 months after NHT. Follow-up ranged from 5 to 83 months with a mean of 52.7 months. Of the variables studied (pretreatment PSA, Gleason score, final pathologic stage, and nadir PSA before surgery), pretreatment PSA (p = 0.001, Fisher's exact test) and pathologic stage T(3c) (p = 0.012, Fisher's exact test) were found to have a statistically significant correlation with biochemical recurrence. Although there was a 39% biochemical recurrence rate in our study, we conclude that NHT offers an alternative mode of management for patients with stage T(3) CaP.

Journal Article↗
PubMed2003

High-risk localised prostate cancer: multimodal treatment strategies combining neoadjuvant hormonal therapy and/or chemotherapy with radical prostatectomy.

For patients with newly diagnosed prostate cancer, clinical tumour stage, Gleason score of the diagnostic biopsy specimen and serum prostate-specific antigen (PSA) level can be combined to identify a group of men at increased risk of treatment failure after radiotherapy or radical prostatectomy. For these high-risk, but still clinically localised prostate cancers, multimodal treatment strategies may result in improved cancer control outcomes. Indeed, in the setting of clinical stage T3 - T4 tumours, the combination of radiotherapy followed by hormonal therapy has improved patient survival. The benefits of adjuvant or neoadjuvant hormonal and/or chemotherapy followed by radical prostatectomy in this setting are unclear, but are the subject of ongoing or planned Phase III clinical trials. These studies will help define the role of multimodal treatment strategies in this high-risk patient population.

Antineoplastic Agents, Hormonal↗
PubMed2002

Normalization of serum testosterone levels in patients treated with neoadjuvant hormonal therapy and three-dimensional conformal radiotherapy for prostate cancer.

PURPOSE: To determine the expected time to serum testosterone normalization after short-course neoadjuvant androgen deprivation therapy (NAAD) and three-dimensional conformal radiotherapy for patients with localized prostate cancer and to identify pretreatment predictors that correlated with the time to testosterone normalization. METHODS: Between 1993 and 1999, 88 patients with localized prostate cancer, treated with NAAD and external beam radiotherapy, were prospectively monitored after treatment with sequential testosterone levels. NAAD was administered before and during the entire course of radiotherapy and discontinued at the end of treatment. The median duration of NAAD was 6 months. The actuarial rate of serum testosterone normalization from the end of treatment was evaluated, and the presence or absence of androgen deprivation-related symptoms was correlated with serum testosterone levels. Symptoms assessed included weight gain, loss of libido, breast tenderness, breast enlargement, hot flashes, and fatigue. RESULTS: Serum testosterone levels returned to the normal range in 57 (65%) of the 88 patients and failed to normalize in 31 patients (35%). The median time to normalization was 18.3 months. The actuarial rate of normalization at 3, 6, 12, and 24 months was 10%, 26%, 38%, and 59%, respectively. In a multivariate analysis, a pretreatment testosterone level in the lower range of normal was the only variable that predicted for delayed testosterone normalization after NAAD (p = 0.00047). Among 45 patients with information concerning androgen deprivation-related symptoms recorded 1 year after cessation of NAAD, 24 (53%) had normalized testosterone levels, but in 21 patients (47%), the levels had not yet returned to normal. At 1 year, only 1 (4%) of 24 patients whose testosterone level had returned to normal experienced NAAD-related symptoms compared with 14 (67%) of 21 patients who did not have normal testosterone levels (p <0.001). CONCLUSION: Testosterone levels often remain depressed for extended periods after cessation of short-course NAAD. Lower baseline testosterone levels predict for a delay in testosterone normalization, and the persistence of symptoms related to androgen deprivation correlates with low testosterone levels.

Androgen Antagonists↗
PubMed1998

[A study on androgen deprivation therapy prior to radical prostatectomy with special reference to the tumor volume].

BACKGROUND: The aim of this study is to analyze correlation between the tumor volume (TV) and the final pathological stage in patients undergoing neoadjuvant therapy. PATIENTS AND METHODS: Twenty-six patients underwent radical prostatectomy alone (group S). The remaining 28 patients had undergone neoadjuvant therapy (group N) which mainly consisted of LH-RH agonist. TV and the final pathological stage were retrospectively reviewed. RESULTS: The likelihood of positive surgical margin was statistically higher in group S than in group N (p = 0.009). The correlation between TV and the pathological stage was observed not only in group S (rho = 0.646, p = 0.0012) but also in group N (rho = 0.716, p = 0.0002). The mean TV was statistically smaller in group N in patients with baseline PSA level more than 10.1 ng/ml (p = 0.024). CONCLUSION: A decrease in tumor volume caused by neoadjuvant therapy may play an important role in reducing the likelihood of positive surgical margin.

Antineoplastic Agents, Hormonal↗
PubMed2006

Neoadjuvant endocrine therapy in breast cancer.

The use of endocrine therapy is well established as a primary treatment for locally advanced breast cancer. However, despite the current popularity of neoadjuvant chemotherapy for operable tumours, there is relatively little published evidence for pre-operative endocrine therapy in operable disease, particularly outside of the elderly population. The wider use of aromatase inhibitors (AIs) has encouraged studies that compare the efficacy of AIs with tamoxifen in the neoadjuvant setting, but there remains a lack of comparison of neoadjuvant with adjuvant endocrine therapies. This review discusses the current evidence regarding primary endocrine therapy, along with the factors involved in choosing appropriate patients for neoadjuvant therapy and the current opinions on length of treatment time and measurement of response prior to surgery.

Antineoplastic Agents, Hormonal↗
PubMed2005

Neoadjuvant systemic therapy for breast cancer: an overview and review of recent clinical trials.

Neoadjuvant chemotherapy (NAC) is long established as part of the multi-modality management of locally advanced breast cancer or inflammatory breast cancer, leading to significantly improved outcome. Numerous recent studies have compared the use of anthracycline-based NAC with adjuvant chemotherapy in earlier-stage disease, and have shown equivalent disease-free and overall survival rates with increased breast conservation rates. These studies have also shown that a pathological complete response after NAC is associated with improved long-term outcome. More recently, the taxanes have been introduced into clinical trials of NAC with increased overall and pCR rates. However, there is no evidence that the addition of taxanes to neoadjuvant anthracycline-based chemotherapy significantly improves long-term disease free survival or overall survival. This paper reviews these trials, as well as trials of dose-dense and trastuzumab-containing NAC regimens. The review discusses the potential for NAC to replace prolonged adjuvant trials in the assessment of new therapeutic agents (using pathological complete response as a surrogate for long-term outcome), to be used as an in vivo chemosensitivity assay to guide further treatment, and to identify molecular markers that correlate with tumour sensitivity or resistance to chemotherapeutic agents so that the treatment of patients can be individualised.

Animals↗
PubMed2003

Follow-up of nondetectable prostate carcinoma (pT0) after prolonged PSA-monitored neoadjuvant hormonal therapy followed by radical prostatectomy.

OBJECTIVES: To test the hypothesis that in patients with Stage pT0 after prolonged prostate-specific antigen (PSA)-monitored neoadjuvant endocrine therapy, biochemical relapse is extremely rare and derives from systemic tumor recurrence. METHODS: A total of 227 patients with Stage cT1-3 carcinoma underwent PSA-monitored prolonged neoadjuvant endocrine treatment followed by radical prostatectomy. In all pT0 patients, PSA follow-up data were obtained. Patients with a PSA relapse (0.2 ng/mL or greater) underwent biopsy from the vesicourethral anastomosis, and some underwent radiotherapy. RESULTS: Stage pT0 was diagnosed in 38 (16.7%) of 227 patients. The pT0 rate in those with cT1, cT2, and cT3 cancer was 28.2% (11 of 39), 26.3% (20 of 76), and 6.25% (7 of 112), respectively. In Gleason score 2 to 4, 5 to 6, and 7 to 10 carcinoma, the pT0 rate was 50% (3 of 6), 28.4% (25 of 88), and 7.1% (9 of 126), respectively. The median follow-up was 47.0 months (range 20 to 180). PSA relapse was seen in 7 (18.4%) of 38 patients. PSA relapse derived from local tumor relapse in 2 cases, local and systemic tumor relapse in 1 case, and local benign prostate glands in 2 cases. In 2 cases, the nature of the PSA relapse remained unknown. CONCLUSIONS: Mainly clinically organ-confined, low and intermediate-grade tumors were converted to Stage pT0. Local PSA relapse was surprisingly frequent. In part, its malignant nature was confirmed histologically. However, the finding of residual benign prostate glands shows that PSA relapse does not always correspond with tumor relapse. Whether the prognosis in pT0 patients is significantly improved compared with nonpretreated patients cannot be answered on the basis of our data. Nevertheless, the presented results were disappointing.

Antineoplastic Agents, Hormonal↗
PubMed2000

Nodal stage after induction therapy for stage IIIA lung cancer determines patient survival.

BACKGROUND: This study was undertaken to determine the predictive value of nodal status at resection in regards to long-term outcome of patients undergoing neoadjuvant therapy and resection for stage IIIA N2-positive non-small cell lung cancer (NSCLC). METHODS: We reviewed the medical records of all patients found on surgical staging to have N2-positive NSCLC and who underwent induction therapy followed by resection between 1988 and 1996 at our hospital. Complete follow-up information was examined utilizing Kaplan-Meier survival analysis and Cox proportional hazards multivariate analysis. RESULTS: One hundred three patients (59 men) with stage IIIA N2-positive NSCLC received neoadjuvant therapy before surgical resection. Preoperative therapy consisted of platinum-based chemotherapy (76), radiotherapy (18), or chemoradiation (9). Operations included pneumonectomy (38), bilobectomy (6), and lobectomy (59). There were four deaths and seven major complications. Eighty-five patients were followed until death. Median survival among 18 living patients is 60.9 months (range 29 to 121 months). Twenty-nine patients were downstaged to N0 and had 5-year survival of 35.8% (median survival 21.3 months). Seventy-four patients with persistent tumor in their lymph nodes (25 N1 and 49 N2) had significantly worse, 9%, 5-year survival, p = 0.023 (median survival 15.9 months). Other negative prognostic factors were adenocarcinoma and pneumonectomy. CONCLUSIONS: Patients with N2-positive NSCLC whose nodal disease is eradicated after neoadjuvant therapy and surgery enjoy significantly improved cancer-free survival. These data support surgical resection for patients downstaged by induction therapy; however, patients who are not downstaged do not benefit from surgical resection. Direct effort should be made to improve the accuracy of restaging before resection.

Adult↗
PubMed2004

Neoadjuvant hormonal therapy impairs sexual outcome among younger men who undergo external beam radiotherapy for localized prostate cancer.

OBJECTIVES: To evaluate the effects of treatment factors and other covariates on sexual health-related quality of life (HRQOL) after radiotherapy (RT) for prostate cancer. The effects of clinical and treatment factors on sexual health after external beam RT have not been fully characterized by patient-reported, validated questionnaires. METHODS: A total of 259 subjects (147 patients who had undergone RT for prostate cancer and 112 age-matched controls) participated in a cross-sectional assessment of HRQOL using the validated expanded prostate cancer index to measure patient-reported sexual function and bother. Multivariable models were used to determine the association of 13 prospectively measured clinical and treatment factors with post-RT sexual HRQOL. RESULTS: Increasing age, time since RT, and use of neoadjuvant hormonal therapy (NHT) were independently associated with sexual function (P <0.01) after RT. The effects of NHT on sexual HRQOL were most notable among the youngest (younger than 67 years) patients and among those closest to treatment. These effects may be conceptualized by examining the distribution of responses to individual Expanded Prostate Cancer Index Composite questions. For example, among the youngest patients, those treated with NHT were less than half as likely to report a fair ability to have erections compared with hormone-naive men. CONCLUSIONS: These patient-reported data, elicited using a validated HRQOL instrument, indicate that older age and NHT significantly and independently hinder post-RT sexual HRQOL outcome among men with localized prostate cancer and provide a framework for counseling patients regarding long-term sexual outcome on the basis of treatment plan and age.

Age Factors↗
PubMed2004

Neoadjuvant endocrine therapy as a drug development strategy.

The aromatase inhibitors offer both toxicity and efficacy advantages over tamoxifen, but to date, their overall impact on breast cancer outcomes has been modest. Advanced breast cancer remains incurable, and for early stage disease, an improvement in survival with AI versus tamoxifen has yet to be demonstrated. Resistance to endocrine manipulation is at the core of the problem and must be overcome to make additional progress. A number of signal transduction inhibitors (STIs) are now under development as endocrine resistance modulators, including those targeting cyclooxygenase-2, HER1 and/or 2 kinase, mTOR, and farnesyl transferase. Developing STIs for this indication is a challenge, however, because we still do not have a clear understanding of the molecular basis of resistance. A complete understanding could translate into a series of endocrine therapy/STI combinations that would be tailored according to the biology of the individual tumor to achieve optimal efficacy and safety. The development of this strategy will require the ability to diagnose resistance mechanisms on a tumor-by-tumor basis, and this can only be attained through careful clinical investigation. Neoadjuvant endocrine therapy is an appealing context to conduct research in this area because clinical outcomes can be obtained within a few months of treatment, and repeated tumor sampling for biomarker analysis (pharmacodynamic tumor profiling) can be readily achieved. However, the optimal clinical investigative approaches, analytical techniques, and appropriate surrogate end points have yet to be identified and are the subject of several ongoing or planned clinical studies.

Androstadienes↗