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PubMed1989

Neoadjuvant therapy of esophageal cancer.

Neoadjuvant (preoperative) chemotherapy, with or without radiotherapy, is under intense study. There are theoretical and practical reasons for the preoperative use of systemic therapy: (a) laboratory studies support the use of preoperative treatment in animal models, (b) the relapse pattern of esophageal cancer is primarily systemic and (c) the impact on palliation if response is associated with an improved resection rate. Three techniques involving systemic therapy are currently under investigation: (a) chemotherapy alone followed by a planned surgical procedure; (b) chemotherapy and concurrent radiotherapy followed by a planned surgical procedure; (c) chemotherapy and radiotherapy without surgery. Phase II trials of the first technique have demonstrated its feasibility without an increase in operative morbidity or mortality. Two small-scale phase III trials have confirmed chemotherapy's efficacy but have not clearly demonstrated an impact on survival. Large-scale phase III trials are under way, or about to begin, to test definitively the hypothesis that neoadjuvant chemotherapy improves disease-free and overall survival in operable patients. The second technique has also been tested in small-scale phase II trials. Most recently, a large-scale phase II trial has been reported which suggests that this technique has not had a major effect on resection rates or on long-term survival for most patients. These treatment plans are tolerable if careful attention to detail is given. Definitive phase III trials testing the superiority of multimodality treatments over radiotherapy alone or surgery alone are under way.

Adjuvants, Pharmaceutic↗

PubMed1996

The role of neoadjuvant therapy in surgically resectable esophageal cancer.

OBJECTIVE: To determine the effect of neoadjuvant therapy (NT) (preoperative chemotherapy, radiation therapy, or both) in surgically resectable esophageal cancer. DESIGN: A retrospective review over a 20-year period. SETTING: A tertiary academic medical center. PARTICIPANTS: All patients undergoing surgical resection for esophageal cancer (N = 316) over this time period. MAIN OUTCOME MEASURES: Perioperative morbidity and mortality, local and distant recurrences, and overall survival. RESULTS: Patients undergoing NT (n = 106) had prognostic factors similar to those treated with surgery alone (n = 210). No increase was noted in surgical morbidity with NT (anastomotic leaks, reoperation rates, complications, or extended hospital stays). Overall survival was not improved by NT (median survival, 14 months) except in the subset of patients (11/83) who responded completely (100% histological necrosis) to preoperative chemotherapy (median survival, 79.2 months; P < .02). Complete response to radiation therapy alone was not associated with improved survival. Partial necrosis of the primary tumor was seen in 13 (15%) of 83 patients but conferred no survival advantage. Complete response to preoperative chemotherapy was associated with squamous cell pathological features and excellent performance status as measured by preanesthesia evaluation. CONCLUSIONS: The addition of NT did not increase perioperative morbidity or mortality. Only the subset of patients who had a complete response to preoperative chemotherapy showed a survival advantage. Excellent performance status and squamous cell pathological features were associated with an increased chance of complete pathological response following preoperative chemotherapy.

Adult↗

PubMed2004

Neoadjuvant therapy for rectal cancer: histologic response of the primary tumor predicts nodal status.

PURPOSE: This study was designed to compare histologic T and N stages in patients with rectal adenocarcinoma undergoing various neoadjuvant radiotherapy regimens and proctectomy, in an attempt to determine if final histologic stage of the mural tumor predicts nodal status. METHODS: Data were collected from computerized databases at two institutions on 649 consecutive patients who underwent neoadjuvant radiotherapy or chemoradiotherapy and proctectomy for primary adenocarcinoma of the rectum from 1990 to 2002. RESULTS: Five patients were excluded because of incomplete pathology data sets, leaving a study population of 644. Patients underwent neoadjuvant radiotherapy alone (2000 cGy in 5 fractions, n = 191; or 4500 cGy in 25 fractions, n = 259) or chemoradiation (4500 cGy in 25 fractions with concurrent 5-fluorouracil, n = 194). Histologic stage of the remaining mural tumor (ypT) correlated with nodal status (ypN). Lymph nodes harboring metastatic tumor were found in 1 of 42 (2 percent) ypT0 patients, 2 of 45 (4 percent) ypT1 patients, 43 of 186 (23 percent) ypT2 patients, 158 of 338 (47 percent) ypT3 patients, and 16 of 33 (48 percent) ypT4 patients ( P < 0.001, chi-squared test). The probability of finding ypN+ disease was 3 of 87 (3 percent) in patients with ypT0-1 residual primary tumors vs. 220 of 557 (39 percent) in patients with ypT2-4 residual primary tumors ( P < 0.0001; Fisher's exact test). CONCLUSIONS: Nodal metastases are rare in patients whose mural tumor burden shrinks to ypT0-1 after neoadjuvant radiotherapy. If transanal excision is offered to select patients with distal rectal cancer, it is reasonable to select those who have an excellent clinical response to neoadjuvant therapy for transanal excision, and then reserve proctectomy for patients proven to have residual ypT2-4 disease.

Adenocarcinoma↗

PubMed2005

Imaging breast cancer response during neoadjuvant systemic therapy.

Neoadjuvant systemic therapy is used to enable breast-conserving surgery in patients with large primary operable breast cancers. It is important to be able to accurately assess response to systemic therapy, both to assist the surgeon and for prognostic purposes. Moreover, a proportion of women will fail to respond to treatment and would potentially benefit from either a change in therapy or earlier surgery rather than continuing completion of the planned course of treatment. Conventional techniques of assessing response (clinical examination, x-ray mammography and breast ultrasound) rely on changes in tumor size, which are often delayed and do not always correlate with pathologic response. This review examines the evidence for functional imaging techniques including scintimammography, functional computed tomography, dynamic magnetic resonance imaging, spectroscopy and positron emission tomography. These techniques measure changes in tumor vasculature, metabolism or proliferation and may prove to be earlier and more sensitive measures of response to systemic therapy, thus enabling tailoring of an individual's treatment.

Breast Neoplasms↗

PubMed2001

[Certain aspects of neoadjuvant therapy of locally advanced breast cancer].

The paper presents the results of a complex investigation of patients with locally-advanced breast cancer who received neoadjuvant chemotherapy or chemoradiation at initial stage. The clinical and pathomorphological effects, nature of neoadjuvant therapy and number of courses were followed up for 5- and 10-year periods. A direct correlation was found between number of courses for chemotherapy-sensitive patients, on the one hand, and greater effect, more intensive medicinal pathomorphism and longer recurrence-free survival, particularly, at later stages, on the other.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2003

Surgery for esophageal carcinoma and the role of neoadjuvant therapy.

Esophagectomy is a major surgical procedure. Due to the related morbidity and mortality, this operation should be carried out in high-volume referral centers by expert surgeons. Only patients in whom a complete resection is predictable at preoperative staging can consistently benefit from the operation. Chemoradiation therapy should be the first-line approach in patients with locally advanced tumors. A pathological complete response to neoadjuvant therapy is associated with a significantly improved long-term survival.

Esophageal Neoplasms↗

PubMed2000

Significance of the Gleason scoring system after neoadjuvant hormonal therapy.

Neoadjuvant hormonal therapy (NHT) induces morphologic changes in prostate adenocarcinoma that result in the assignment of higher Gleason scores on average than in pretreatment biopsy specimens. This outcome has led to the recommendation that the Gleason scoring system not be applied to prostate adenocarcinoma specimens after NHT. We reviewed the radical prostatectomy specimens of 116 patients who had received NHT. Gleason scores were assigned on the post-treatment specimens by applying the usual criteria; in addition, an estimated pretreatment Gleason score was assigned on the basis of knowledge of the morphologic alterations associated with NHT. Finally, an estimate of the degree of therapy effect was assigned: little or no evidence of hormonal effect (grade 1) to marked therapy-related changes (grade 3). Both the post-treatment and the estimated pretreatment Gleason score correlated significantly with biochemical progression (P = 0.03 and P = 0.03, respectively; log-rank test). The degree of therapy effect did not correlate with progression (P = 0.46; log-rank test). This limited analysis suggests that despite the morphologic alterations induced by NHT, post-treatment Gleason score remains a significant prognostic measure. Further studies in more uniformly treated populations are required to confirm this observation.

Adenocarcinoma↗

PubMed2003

Liposomal anthracyclines: adjuvant and neoadjuvant therapy for breast cancer.

Conventional anthracyclines, particularly doxorubicin, have played an important role in the treatment of patients with breast cancer for many decades. Conventional doxorubicin has shown excellent antitumor activity in the metastatic, neoadjuvant, and adjuvant settings. However, its clinical utility is limited due to acute and chronic toxicities, particularly cardiotoxicity, myelosuppression, nausea and vomiting, and alopecia. Liposomal doxorubicin formulations (liposomal doxorubicin [D-99] and pegylated liposomal doxorubicin) currently under investigation for the treatment of breast cancer have demonstrated similar efficacies and favorable toxicity profiles compared with conventional doxorubicin in patients with metastatic breast cancer. These agents have also shown efficacy and tolerability in several small studies as neoadjuvant therapy in patients with locally advanced breast cancer. While there are currently no studies with liposomal doxorubicin or pegylated liposomal doxorubicin as adjuvant therapy, their demonstrated activities and tolerabilities in the metastatic and neoadjuvant settings provide the rationale for the future study of these agents in adjuvant therapy for patients with early-stage breast cancer.

Alopecia↗

PubMed2005

Adjuvant and neoadjuvant therapy in non-small cell lung cancer.

The 5-year survival rates for patients with non-small cell lung cancer (NSCLC) ranges from 9% to 61% following resection, depending on clinical stage; survival rates post-surgery (pathologic stage) range from 25% to 67%. Most stage I and II patients eventually experience recurrent disease: two thirds occur systemically, one third locally. Surgical resection remains the standard of care in early stage NSCLC, although the role of surgery in stage IIIA [N 2 ] disease is controversial. Despite resection, the vast majority of lung cancer patients will experience recurrent and/or metastatic disease; therefore, supplementing surgery with adjuvant therapy is a rational treatment strategy. Recent data indicate that adjuvant chemotherapy should now be considered the standard of care for the treatment of patients with completely resected early stage NSCLC, with the single exception of patients with stage IA disease, where the prognosis is relatively favorable and there is currently no evidence supporting the efficacy of adjuvant therapy. While recent data from trials of adjuvant chemotherapy have shown promising results, no study has yet compared the utility of adjuvant versus neoadjuvant, or induction, chemotherapy. From the current data, more than 90% of patients receiving neoadjuvant chemotherapy undergo the planned surgical resection. Neoadjuvant chemotherapy may also downstage the disease before surgery and decrease perioperative tumor seeding, and molecularly targeted approaches with neoadjuvant therapy appear promising.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1997

Neoadjuvant therapy for surgically staged IIIA N2 non-small cell lung cancer (NSCLC).

INTRODUCTION: Neoadjuvant therapy in patients with Stage IIIA NSCLC is associated with a 50-70% resection rate and a 3-5 year survival of 20-32%, but few trials have required meticulous staging of the mediastinum to ensure homogeneity of the study population. Continuous infusion cisplatin 25 mg/m2/day 1-5, 5-fluorouracil 800 mg/m2/day 2-5, and high-dose leukovorin 500 mg/m2/day 1-5 (PFL) given every 4 weeks achieved a 41% response rate in metastatic NSCLC (Lynch TJ, Kalish LA, Kass F, Strauss G, Elias A, Skarin A, Shulman L, Sugarbaker D, Frei E. Continuous infusion cisplatin, 5-fluorouracil, and leukovorin for advanced non-small cell lung cancer. Cancer 1994; 73: 1171-1176). The regimen was therefore evaluated in 34 patients with pathologic Stage IIIA N2 disease between 3/91 and 10/92. METHODS: Staging consisted of chest, liver, brain computerized tomography and bone scan, bronchoscopy and surgical mediastinal node mapping. Patients received PFL for 3 cycles, followed by thoracotomy and thoracic radiotherapy (TRT) to 54-60 Gy. RESULTS: Median age was 57 (42-68) years. Demographic factors included: male 56%; adenocarcinoma 59%, squamous cell carcinoma 24%; Stage T3N2 26%, T2N2 56%, and T1N2 18%. No treatment related deaths occurred. Radiographically defined response to PFL was 65% (6% complete). Thoracotomy was performed in 28 patients (82%) (6 had no attempt due to disease progression). Complete resection was achieved in 21 (75%) and seven were unresectable. Pathologic complete response was observed in five patients (15%) and an additional unresectable patient had fibrosis-only documented at thoracotomy for an overall clinicopathologic response rate of 76% (18% pathologic CR). Another ten patients had residual primary with or without hilar disease with resolution of previously documented mediastinal involvement. Six (18%) patients remain alive and disease-free with a median follow-up of 46 (33-50) months, four of whom had achieved pathologic complete response at time of surgery. CONCLUSIONS: Long-term event-free survival was associated with complete surgical resection which in turn was associated with clinical response to chemotherapy. There was a possible trend associating pathologic downstaging (absent residual disease in mediastinal nodes), particularly pathologic complete response observed in patients with non-bulky mediastinal disease, with improved event-free survival. Pathologic downstaging might therefore be a useful surrogate endpoint in trials evaluating the preoperative activity of new chemotherapy regimens. While radiographic response generally correlated with findings at surgery, response as determined by histologic examination of resected tissue was generally more extensive and may more accurately reflect the systemic impact of the chemotherapy regimen.

Adult↗

PubMedDate not supplied

Neoadjuvant therapy for esophageal cancer: surgical considerations.

Esophageal carcinoma is often diagnosed at an advanced, non resectable stage. Only early stages show a better prognosis. Surgical treatment represents the gold standard. The various surgical techniques do not seem to affect survival. Based on the severity of esophageal cancer and on poor outcome achievable with surgery alone, multimodality treatments are the most suitable. The possible negative impact on the complication rate after neoadjuvant therapy is still debated. Most randomized trials have not demonstrated as yet an improvement in prognosis in patients undergoing a three-modality treatment. However, patients with complete pathologic response after surgical resection were shown to have a better prognosis. In conclusion, additional randomized trials are required, aimed at evaluating all technical and therapeutic variables which affect prognosis.

Chemotherapy, Adjuvant↗

PubMed2001

Neoadjuvant therapy for esophageal cancer: standard of care or elusive myth?

Although surgical resection as the sole treatment modality for esophageal carcinoma has historically been associated with poor survival rates, improvements have recently been reported using varied neoadjuvant chemo-radiation protocols. This study evaluates the outcome of patients undergoing surgery for esophageal carcinoma at the University of Miami/Jackson Memorial Hospital between July 1991 and June 1996. Seventy-two patients underwent esophageal resection; 51 males and 21 females with a median age of 62.5 years (range = 42-82). Histology was equally distributed between adenocarcinoma (36 patients; 50%) and squamous cell carcinoma (36 patients; 50%). Pathological stage distribution consisted of 6 stage 0 (8%), 10 stage I (14%), 23 stage II (32%), 31 stage III (43%), and 2 stage IV (3%) lesions. Patients were divided into three groups according to the type of preoperative treatment; Group 1 (n = 44); surgery alone; Group 2 (n = 18); neoadjuvant 5-fluorouracil based chemotherapy, and Group 3 (n = 9); neoadjuvant 5-fluorouracil based chemotherapy in conjunction with external beam radiation (XRT). One patient received preoperative XRT alone. All survivors were followed for a minimum of 1 year and statistical analysis was performed using Kaplan-Meier curves, log-rank, and chi-square tests. In the 28 patients receiving any form of neoadjuvant therapy only one patient had a pathological complete response (CR) (3.5%). The overall 5 year and median survival rates were 18 per cent and 20.5 months (range = 0-73), respectively. Individual treatment group survival rates at 5 years were 28% for Group 1; 21% for Group 2; and 0% for Group 3, showing no survival difference between Groups 1 and 2; Group 3 fared significantly worse than the other two, probably as a result of the high operative mortality in this group. These results indicate that surgical resection continues to be an important treatment modality for esophageal carcinoma. Neoadjuvant chemotherapy in our experience failed to improve these survival rates and pre-operative chemoradiation was associated with a high perioperative mortality rate. Chemotherapy regimens with higher CRs may further improve these survival rates.

Adenocarcinoma↗

PubMed2006

Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy.

Neoadjuvant chemoradiation therapy (CRT) is the preferred treatment option for distal rectal cancer. Complete pathological response after CRT has led to the proposal of nonoperative approach as an alternative treatment for highly selected patients with complete clinical response. However, patterns of failure following this strategy remains undetermined. Three hundred sixty-one patients with distal rectal cancer were managed by neoadjuvant CRT including 5-FU, leucovorin, and 5040 cGy. Tumor response assessment was performed at 8 weeks following CRT. Patients with complete clinical response were not immediately operated on and were closely followed. One hundred twenty-two patients were considered to have complete clinical response after the first tumor response assessment. Of these, only 99 patients sustained complete clinical response for at least 12 months and were considered stage c0 (27.4%) and managed nonoperatively. Mean follow-up was 59.9 months. There were 13 (13.1%) recurrences: 5 (5%) endorectal, 7 (7.1%) systemic, and 1 (1%) combined recurrence. All 5 isolated endorectal recurrences were salvaged. Mean recurrence interval was 52 months for local failure and 29.5 months for systemic failure. There were five cancer-related deaths after systemic recurrences. Overall and disease-free 5-year survivals were 93% and 85%. Even though surgery remains the standard treatment for rectal cancer, nonoperative treatment after complete clinical response following neoadjuvant CRT may be safe and associated with good survival rates in a highly selected group of patients. Survival in these patients is significantly affected by systemic failure. Exclusive local failure occurs late after CRT completion and is frequently amenable to salvage therapy.

Aged↗

PubMed2002

[A case of stomach cancer in which TS-1 neoadjuvant therapy was effective against multiple hepatic metastasis, allowing a radical cure A surgery].

It is believed that multiple hepatic metastases from stomach cancer are highly refractory, and resistant to clinical treatment. In the present study, TS-1 neoadjuvant therapy administered orally in a single course brought about CR in the hepatic metastatic foci and PR in the primary foci, thus enabling grade A radical extirpation in a case of advanced stomach cancer. The patient continued to be treated on an ambulatory basis. His peri- and post-operative courses were satisfactory and the treatment was completed without the development of adverse effects.

Adenocarcinoma, Scirrhous↗

PubMed1994

[Combination neoadjuvant therapy with continuous intra-arterial CDDP infusion and radiotherapy for locally advanced breast cancer].

Neoadjuvant therapy combined with intra-arterial continuous infusion of CDDP and external radiation was evaluated in a patient with locally advanced breast cancer. Although only MR was observed on the primary tumor, PR was found in several metastatic lymph nodes and daughter nodules. All tumor markers elevated before treatment decreased to normal ranges only by this therapy, and histological damage was also recognized remarkably with a high concentration of free Pt (8.89 micrograms/g) in cancer tissues. Since no severe side effects appeared during the present therapy, extended radical mastectomy with wide skin resection could be performed following additional intra-arterial chemotherapy using 5-FU, epi-ADM and MMC. From this experience, it was suggested that CDDP was an useful drug in the chemotherapy for breast cancer.

Adult↗

PubMed2003

Influence of neoadjuvant therapy with epirubicin and docetaxel on the expression of HER2/neu in patients with breast cancer.

BACKGROUND: In primary breast cancer, the expression levels of biological markers relevant to the progression of the disease may be altered by administration of anticancer drugs. Since neoadjuvant chemotherapy with epirubicin and docetaxel is increasingly used in advanced breast cancer, our purpose was to assess the influence of this neoadjuvant chemotherapy on the expression of the growth factor receptor HER2/neu. PATIENTS AND METHODS: We investigated changes of HER2/neu status by immunohistochemistry (IHC) and applied additional fluorescence in situ hybridization (FISH) in patients with potential modulation of HER2/neu status after administration of neoadjuvant chemotherapy with docetaxel and epirubicin in 97 breast cancer patients. The influence of neoadjuvant chemotherapy on HER2/neu expression was calculated by correlation of HER2/neu status before and after chemotherapy. RESULTS: The accuracy of HER2/neu assessment before and after neoadjuvant chemotherapy by IHC combined with FISH analysis in selected cases was 100%. The evaluation of HER2/neu status in these patients by IHC alone yielded accuracy of 93%. Neoadjuvant chemotherapy with epirubicin and docetaxel caused no significant modulation of HER2/neu status (p = 0.66). DISCUSSION: The administration of epirubicin and docetaxel in the neoadjuvant setting is not associated with significant changes of HER2/neu status in primary breast cancer. As a consequence, drug resistance or sensitivity is not induced by modulation of HER2/neu expression. Moreover, the time of assessment of the HER2/neu status is not a critical factor under neoadjuvant therapy with epirubicin and docetaxel.

Adult↗

PubMed2004

Neoadjuvant therapy for resectable pancreatic cancer.

The length and quality of life of patients with localized pancreatic cancer will be maximized by accurate preoperative assessment of resectability, a standardized technique of tumor resection, and the routine use of protocol-based adjuvant or neoadjuvant therapy. Continued efforts to enroll patients with localized and advanced pancreatic cancer into well-designed clinical trials should remain a high priority for oncologists across all disciplines. At present, preoperative therapy remains investigational but has a sound clinical basis and remains a reasonable alternative to up front surgery. Future clinical trials for resectable pancreatic cancer will lead to progress only if the principles of multidisciplinary cancer care and quality assurance are incorporated into their design and conduct.

Adenocarcinoma↗

PubMed2006

[Rectal carcinoma: is too much neoadjuvant therapy performed? Proposals for a more selective MRI based indication].

The present-day optimised surgery (concept of total mesorectal excision) with quality assurance by standardized pathologic examination, advances in radiotherapy and the possibilities of high-spatial-resolution MR imaging require reconsideration of pros and contras of neoadjuvant therapy and respective data. According to the resulting new proposal neoadjuvant long-course radiochemotherapy is indicated for patients with 1) fixed questionably R0 resectable tumors, 2) mobile tumors with the MRT finding of tumor involving the mesorectal fascia or 1 mm or less from it, 3) low rectal tumors extending below the levator origin and invading beyond the muscularis propria. If a high risk of local recurrence becomes apparent during surgery (tumor perforation, incision into or through tumor) or after pathologic examination (incomplete mesorectal excision, tumor 1 mm or less from the circumferential resection margin) adjuvant radiochemotherapy is indicated. In case of lymph node metastasis postoperative chemotherapy is given.

Combined Modality Therapy↗