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Results for “Neoadjuvant therapy”

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At least 91 records · Page 5Linked to original sources

PubMed2001

Neoadjuvant therapy of esophageal squamous cell carcinoma: response evaluation by positron emission tomography.

OBJECTIVE: To evaluate the use of positron emission tomography using [(18)F]-fluorodeoxyglucose (FDG-PET) to assess the response to neoadjuvant radiotherapy and chemotherapy in patients with locally advanced esophageal cancer. SUMMARY BACKGROUND DATA: Imaging modalities, including endoscopy, endoscopic ultrasound, computed tomography, and magnetic resonance imaging, currently used to evaluate response to neoadjuvant treatment in esophageal cancer do not reliably differentiate between responders and nonresponders. METHODS: Twenty-seven patients with histopathologically proven squamous cell carcinoma of the esophagus, located at or above the tracheal bifurcation, underwent neoadjuvant therapy consisting of external-beam radiotherapy and 5-fluorouracil as a continuous infusion. FDG-PET was performed before and 3 weeks after the end of radiotherapy and chemotherapy (before surgery). Quantitative measurements of tumor FDG uptake were correlated with histopathologic response and patient survival. RESULTS: After neoadjuvant therapy, 24 patients underwent surgery. Histopathologic evaluation revealed less than 10% viable tumor cells in 13 patients (responders) and more than 10% viable tumor cells in 11 patients (nonresponders). In responders, FDG uptake decreased by 72% +/- 11%; in nonresponders, it decreased by only 42% +/- 22%. At a threshold of 52% decrease of FDG uptake compared with baseline, sensitivity to detect response was 100%, with a corresponding specificity of 55%. The positive and negative predictive values were 72% and 100%. Nonresponders to PET scanning had a significantly worse survival after resection than responders. CONCLUSION: FDG-PET is a valuable tool for the noninvasive assessment of histopathologic tumor response after neoadjuvant radiotherapy and chemotherapy.

Adult↗

PubMed1999

Neoadjuvant Therapy for Cancer of the Esophagus.

BACKGROUND: The standard of care for esophageal cancer has historically been surgical resection. However, survival following surgical treatment of esophageal cancer remains poor. In inoperable patients, both radiation therapy and chemotherapy alone and in combination have been used with some success. Consequently, these therapies have been utilized in the neoadjuvant setting to improve palliation and prolong survival. METHODS: The author reviewed the literature regarding clinical trials that employed neoadjuvant chemotherapy and radiation therapy in the treatment of squamous cell carcinoma and adenocarcinoma of the esophagus. RESULTS: In most patients, surgery alone is noncurative therapy, even when performed with curative intent. Most phase III trials of neoadjuvant therapy have not been designed with adequate statistical power to detect clinically relevant improvement. The available data are insufficient to determine a benefit to preoperative radiation therapy alone. Preoperative chemotherapy with 5-FU plus cisplatin followed by surgery probably offers little or no improvement over surgery alone. Trials of combined preoperative chemoradiation therapy have yielded promising but not definitive results. CONCLUSIONS: Outside of a clinical trial, neoadjuvant therapy for esophageal cancer should be reserved for only a select group of patients. Future clinical trials may determine a role for neoadjuvant chemoradiation and identify more active chemotherapeutic agents and populations most likely to benefit.

Journal Article↗

PubMed2005

Neoadjuvant therapy for gastric cancer.

Gastric cancer is a global health issue. Most cases are diagnosed at an advanced stage with poor prognosis. Current therapies have a modest impact on survival. Surgery remains the only potentially curative treatment, but is associated with a high rate of locoregional recurrence and distant metastases. Total gastrectomy for proximal cancers is complicated by postoperative morbidity and quality-of-life impairment. Combined-modality therapy may improve outcomes in this disease. Adjuvant therapy for gastric cancer has now become the standard in the Western world. However, adjuvant therapy improves survival by only a few months and is associated with high morbidity. Neoadjuvant therapy is commonly used for esophageal and gastroesophageal junction cancers, but is still regarded as investigational in gastric cancer. Several small phase II studies indicate the feasibility of neoadjuvant strategies. The incorporation of novel, targeted agents into neoadjuvant programs and an assessment of biologic changes within the tumor may refine therapy. This article provides a concise review of the literature on neoadjuvant therapy for gastric cancer and suggests avenues for further investigation.

Antineoplastic Agents↗

PubMed2004

Importance of correlative science in advancing hormonal therapy and a new clinical paradigm for neoadjuvant therapy.

Improvement in endocrine therapy for estrogen receptor (ER)-positive breast cancer will require prevention or modulation of resistance, based on identification and targeting of the responsible molecular mechanisms. Our approach to this problem has been to focus on neoadjuvant endocrine treatment because that permits comparative evaluation of pretreatment tumor biopsies and surgical tumor specimens. We have begun utilizing this clinical paradigm by exploring semiquantitative changes in the expression of molecular markers within tumors treated with either tamoxifen or the aromatase inhibitor letrozole in a randomized trial. This investigation is beginning to elucidate the influence of growth factor pathways that interact with the ER, especially HER1 (epidermal growth factor receptor [EGFR]) and HER2. The results indicate that the distinct mechanisms by which tamoxifen and letrozole inhibit ER signaling may produce quite marked differences in clinical and biomarker outcomes in the subset of tumors that coexpress HER1 and/or HER2 with ER, favoring estrogen-deprivation therapy. Ongoing investigations are examining gene expression profile changes associated with neoadjuvant endocrine therapy, as well as inhibitors of growth factor signaling that may modulate tamoxifen resistance.

Antineoplastic Agents, Hormonal↗

PubMed2005

[A case of Giant GIST of the stomach successfully treated with imatinib mesylate neoadjuvant therapy and followed postoperatively].

Since the advent of imatinib mesylate (IM), its clinical efficacy against gastrointestinal stromal tumor (GIST) has been widely acknowledged, and therapeutic strategies for this disease have undergone great changes. We recently experienced a case of giant GIST of the stomach that was successfully treated with IM neoadjuvant therapy prior to surgical resection, but liver metastasis recurred 1 year and 7 months after the operation. The patient was a 65-year-old male who presented at our department with the chief complaints of dizziness, malaise, and fever in April 2002. An abdominal CT revealed a mass with a maximum diameter of 17 cm, as well as a cystic septate mass, 12 cm in diameter, with a thick capsule in the left lobe of the liver. The patient was diagnosed with GIST of the stomach and liver metastasis. Since radical operation was considered difficult at that point, IM (400 mg/day) was started on May 9. The result of treatment was determined to be PR, and radical operation was considered feasible. On March 18, 2003, total gastrectomy and left hepatic lobectomy/S 6 partial lobectomy were performed in the surgery department of our hospital. The postoperative course was favorable and oral administration of IM was resumed soon after the operation. However, the drug was discontinued for financial reasons and a decreased white blood cell count (grade 3) 2 months after the operation. Recurrence in the liver and abdominal wall was found in October 2004, and oral administration of IM was resumed again. Currently, treatment with IM is ongoing. Case reports on the efficacy of IM neoadjuvant therapy are occasionally found in the literature, but there are few reports on its long-term prognosis. We report this case with a discussion of future therapeutic options.

Aged↗

PubMed2000

[What is the value of neoadjuvant therapy in bronchial carcinoma?].

Neoadjuvant chemotherapy is obligatory for small-cell lung cancer. When combined with radio-therapy, it reduces the incidence of recurrence and increases the survival rate to a level similar to that seen in non-small-cell lung cancer. Preliminary results suggest that complete remissions (3-year-survival rate 56%) can be achieved through the use of chemotherapy, possibly including high-dose chemotherapy for advanced stage III A cancer. The use of pre-operative chemotherapy in advanced stage III non-small-cell lung cancer is firmly established. In one study the 3-year-survival rate reached 25% in the chemotherapy group as compared to 15% in the group treated by surgery only. Early results of pre-operative chemo- and radiotherapy for stages III A and III B are encouraging. In studies comparing neoadjuvant chemotherapy alone to a combination of neoadjuvant chemo-radiotherapy a higher resection rate (32 to 76%) as well as a longer disease-free survival time could be shown for the combination therapy. To date, a number of innovative neoadjuvant chemoradiotherapy protocols using new substances as well as various modifications of radiotherapy are being studied. It is to be expected that new standard therapies for non-small-cell lung cancer will develop from these studies.

Carcinoma, Non-Small-Cell Lung↗

PubMed2001

Neoadjuvant therapy with interleukin-12-loaded polylactic acid microspheres reduces local recurrence and distant metastases.

BACKGROUND: We previously demonstrated that the intratumoral injection of biodegradable polylactic acid microspheres that were loaded with interleukin (IL)-12 can induce a systemic antitumor immunity. We sought to investigate the clinical potential as neoadjuvant therapy. METHODS: Mice were inoculated with 5 x 10(7) Line-1 cells subcutaneously. Six days later, a single intratumoral injection of IL-12- or BSA-loaded microspheres were given; 14 days later, autopsy was performed to document metastases. Mice were inoculated with 5 x 10(7) Line-1 cells and 10 days later either treated with IL-12- or BSA-loaded microspheres or resected. Treated tumors were resected 6 days after treatment. Mice were observed 45 days for local recurrence before autopsy. RESULTS: Intratumoral injection of IL-12 microspheres resulted in significant suppression of tumor growth compared with controls (599 +/- 255 mm(3) vs 1591 +/- 372 mm(3); P =.001) and pulmonary metastases (0.4 vs 3.8 nodules per mouse; P =.003). Given before the operation, IL-12-loaded microspheres both decreased the local recurrence rate (100% to 40%) and pulmonary metastases (5.2 vs 0.6 nodules per mouse; P =.06). Earlier resection did not improve local recurrence or distant metastases. CONCLUSIONS: Intratumoral injection of IL-12-loaded polylactic acid microspheres promotes the development of systemic antitumor immunity that can eradicate micrometastases. As a neoadjuvant therapy, this can result in decreased local and distant recurrence.

Adenocarcinoma↗

PubMed1988

Neoadjuvant therapy of stage III non-small cell lung cancer.

During the past several years, there has been a resurgence of interest in preoperative or postoperative chemotherapy in patients with Stage III lung cancer. The staging system for lung cancer has recently been modified, and at the present time Stage III disease is now subdivided into Stage III-A (potentially surgically resectable for cure) and Stage III-B (unresectable). This article will review five recently completed studies utilizing neoadjuvant therapy in various types of Stage III lung cancer. The thoracic surgeon is faced with the dilemma of reviewing this literature and trying to make a conclusion as to what is appropriate therapy for Stage III disease. Unquestionably, neoadjuvant therapy appears to increase the resectability rate in Stage III-A disease and can make some Stage III-B patients anatomically resectable. It is hoped that future well-designed phase III studies can be accomplished in Stages III-A and III-B disease so that we can determine whether neoadjuvant chemotherapy is or is not beneficial for these patients.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2001

Adjuvant and neoadjuvant therapy in prostate cancer.

While surgery and radiation therapy remain the only definitive treatments for prostate cancer, single modality therapy has been associated with high failure rates in patients with aggressive disease. Although hormonal therapy has been effective in cases of metastatic disease, the timing of treatment with respect to definitive therapy remains controversial. This review will explore the efficacy of hormonal and chemotherapy in both the adjuvant and neoadjuvant settings. A MEDLINE search was performed to identify pertinent articles regarding both adjuvant and neoadjuvant therapy in prostate cancer. Articles of historical relevance in addition to those using large patient numbers with a randomized design were reviewed preferentially. Since hormonal therapy has been considered standard treatment at the time of cancer progression after definitive therapy, many of the randomized trials essentially compared adjuvant therapy to delayed therapy. Historical trials using adjuvant hormonal therapy have been limited due to difficulties in clinical staging, as well as toxicities attributed to the formulations used. More recently, hormonal therapy has been found to delay disease progression, increase disease-free survival, and decrease mortality when given immediately after prostatectomy or radiation therapy in selected patients. Neoadjuvant hormonal therapy can improve disease-free survival and local control when given before radiation therapy; it has only decreased positive surgical margins when given prior to radical prostatectomy. Although hormonal therapy given immediately after either radical prostatectomy or radiation therapy is highly effective, the side effects of persistent long-term use must be weighed for each patient. While the use of chemotherapy has been limited by the lack of active agents, newer combinations have shown effectiveness in patients with hormone refractory disease, raising the possibility of their use in the adjuvant setting.

Antineoplastic Agents↗

PubMed1994

Neoadjuvant therapy of esophageal carcinoma.

To quote Steiger, the "multimodality treatment of esophageal cancer brings creativity and imagination to a field of medicine plagued with failure." However, acceptance of neoadjuvant chemotherapy or chemoradiotherapy as routine must await the results of large phase III studies. Even with a positive response, many questions will remain. The ability to stage patients more accurately might allow us to apply neoadjuvant therapy with more discrimination. The role of radiation therapy--the fractionation schedule, total dose, and sequencing--will require evaluation. Creativity and innovation must be applied to the quest of predicting who will respond to neoadjuvant treatment. Better drug combinations and methods to reduce toxicity must be sought. The neoadjuvant therapy of esophageal cancer is a field requiring continued rigorous scientific investigation, honesty, and hope.

Adenocarcinoma↗

PubMed1997

Using endosonography to assess the effects of neoadjuvant therapy in patients with advanced esophageal cancer.

OBJECTIVE: The aim of this study was to determine the usefulness of endosonography for evaluating the effect of neoadjuvant therapy for advanced esophageal carcinoma. MATERIALS AND METHODS: Thirty-four patients with esophageal carcinoma (stage II, 16 patients; stage III, 18 patients) underwent various preoperative treatment. In all patients, endosonography was performed before and after treatment, and the percentage reduction in tumor size was calculated from the maximum area of the tumor. In the 27 patients who underwent surgery, the percentage reduction was compared with the pathologic response. Also, the overall survival rates were compared with the percentage reduction in tumor area. RESULTS: Reduction in tumor area ranged from 0% to 47%. The patients were divided into three groups according to the percentage reduction in tumor area. Pathologic response was graded according to the number of viable cells in the entire lesion. Correlation between pathologic response and percentage reduction in tumor area was strong. We found a significant difference in survival rates among the three groups. CONCLUSION: The percentage reduction in tumor area estimated by means of endosonography reflects the histologic effectiveness of neoadjuvant therapy in patients with advanced esophageal carcinoma and may enable clinicians to predict the prognosis of the disease.

Aged↗

PubMedDate not supplied

Immunohistochemical status of the p53 protein and Ki-67 antigen using biopsied specimens can predict a sensitivity to neoadjuvant therapy in patients with esophageal cancer.

BACKGROUND/AIMS: The prediction of an effective adjuvant therapy is essential in order to increase the number of esophageal cancer cases demonstrating an excellent response. Correlation of the immunohistochemical expression of p53 protein and Ki-67 antigen were studied using biopsied specimens of advanced esophageal cancer. The combined staining status of both can help predict the efficacy of neoadjuvant therapy in patients with esophageal cancer. METHODOLOGY: The overexpression of p53 protein and the Ki-67 labeling percentage were immunohistochemically investigated in 95 biopsied specimens of advanced esophageal carcinoma resected between 1988 and 1996. All patients preoperatively received 1 course of either chemoradiotherapy or hyperthermo-chemoradiotherapy. RESULTS: Thirty-nine specimens were positive for p53 protein staining (41.1%), and the treatment modalities were histopathologically effective in 71.8% of these 39 patients (28/39), while the efficiency rate was 58.9% (33/56) in patients with p53(-). On the other hand, the efficiency rate of patients with a high Ki-67 labeling percentage (> or = 30%) was 73.9%, which was significantly higher than that of those with a low Ki-67 labeling percentage (< 30%) (38.5%, P = 0.0013). The efficacy rate of the patients with both a high Ki-67 labeling percentage and p53(+) was 80%, while that of the patients with a low Ki-67 labeling percentage and p53(-) was only 35.3% (P = 0.0098). The combination of a high Ki-67 labeling percentage and p53(-) particularly showed a high sensitivity to hyperthermo-chemoradiotherapy since the efficiency rate of these patients with hyperthermo-chemoradiotherapy was 81.5%, while the rate for those with chemoradiotherapy was 41.7% (P = 0.0129). CONCLUSIONS: An immunohistochemical analysis of p53 and the Ki-67 labeling percentage using biopsied specimens was thus found to effectively predict the efficacy of neoadjuvant therapies in patients with esophageal cancer.

Adult↗

PubMed1997

mdr1 mRNA expression by RT-PCR in patients with primary breast cancer submitted to neoadjuvant therapy.

mdr1 expression by reverse transcription and polymerase chain reaction (RT-PCR) has been compared to P-glycoprotein (Pgp) expression by immunohistochemistry (IHC) and correlated with clinical response to neoadjuvant therapy. RNA has been recovered from glass slide smears of fine-needle aspiration from 57 untreated primary breast cancers prior to neoadjuvant chemotherapy (33 cases), hormone therapy (23 cases), or both (1 case). Furthermore, mdr1 mRNA has been analyzed in 6 cases after 2 months of treatment. The neoadjuvant therapy consisted of 4 cycles of adriamycin and cyclophosphamide or tamoxifen. Of 57 tumor specimens, an interpretable result was obtained in 52 cases, indicating the feasibility of the analysis by RT-PCR with very small tumor specimens. The presence of mdr1 mRNA has been documented in 44/52 (84%) tumor samples with a spectrum of expression levels. The expression of mdr1 mRNA was compared with P-glycoprotein (Pgp) expression by IHC using JSB-1, 4E3, and C494 monoclonal antibodies in 48 of the 52 interpretable tumor samples. 12/48 (25%) expressed Pgp by IHC. All tumors expressing Pgp by IHC were also positive by RT-PCR. The results confirm the higher prevalence of mdr1 mRNA compared to the protein expression. However, mdr1 mRNA expression was found to correlate significantly with resistance to neoadjuvant hormone therapy only while Pgp expression detected by JSB-1 immunostaining only correlated with chemoresistance. The lack of convincing correlation with chemoresistance suggests that mRNA and Pgp may not be directly or solely responsible for clinical response to drugs. Further studies should focus on the post-translational modulation of P-glycoprotein and other mechanisms of drug resistance.

ATP Binding Cassette Transporter, Subfamily B, Mem↗

PubMed2001

Neoadjuvant therapy for non-small cell lung cancer.

Clinical trials evaluating neoadjuvant or preoperative therapy for locally advanced non-small cell lung cancer (NSCLC) have demonstrated the feasibility, tolerability and activity of this approach. Three randomized trials have reported improved survival in patients with stage III NSCLC treated with preoperative chemotherapy followed by surgical resection compared to surgery alone. Combinations of neoadjuvant chemotherapy plus thoracic radiotherapy have also been investigated, generally resulting in higher rates of pathologic response, but higher toxicity rates as well. The best approach to neoadjuvant therapy remains to be determined and may well be substage dependent. In bulky stage III NSCLC, the role of surgery itself remains unclear and is the subject of an ongoing intergroup trial in the US. Regardless, neoadjuvant therapy has emerged as an important paradigm for clinical research since it serves as an in vivo test of chemosensitivity in patients, and represents a 'window of opportunity' for testing new chemotherapeutic agents and novel strategies. Among the new chemotherapeutic agents being investigated in this setting is docetaxel, one of the most active agents in first- and second-line chemotherapy of NSCLC, and a potent radiosensitizer. Preliminary studies have confirmed the feasibility of integrating docetaxel into neoadjuvant treatment strategies and encouraging results have been reported.

Antineoplastic Agents, Phytogenic↗

PubMed2004

Repeat FDG-PET after neoadjuvant therapy is a predictor of pathologic response in patients with non-small cell lung cancer.

BACKGROUND: Repeat positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) and chest computed tomography (CT) are used to assess the effectiveness of chemoradiotherapy in patients with non-small cell lung cancer (NSCLC); however, the change in the standardized uptake values (SUV) has not been correlated with the pathologic change of the primary tumor. METHODS: This is a retrospective cohort study of a prospective database of 56 patients who had NSCLC, FDG-PET, and chest CT scans both before and after neoadjuvant therapy, followed by complete resection of their cancer. Maximum SUVs (maxSUV) and tumor size were measured, and the percentage of change was compared with the percentage of nonviable tumor cells. The primary objective was to measure the degree of correlation between these values. RESULTS: The change in the maxSUV has a near linear relationship to the percent of nonviable tumor cells in the resected tumors. FDG-PET's maxSUV is better correlated to pathology than the change in size on CT scan (r2 = 0.75, r2 = 0.03, p < 0.001). When the maxSUV decreased by 80% or more, a complete pathologic response could be predicted with a sensitivity of 90%, specificity of 100%, and accuracy of 96%. CONCLUSIONS: The change in maxSUV on FDG-PET scan after neoadjuvant therapy holds a near linear relationship with pathologic response. It is a more accurate predictor than the change of size on CT scan. When the maxSUV decreases by 80% or more it is likely that the patient is a complete responder irrespective of cell type, neoadjuvant treatment, or the final absolute maxSUV. These findings may help guide treatment strategies.

Adult↗

PubMed1998

[The German EORTC Study of neoadjuvant therapy of stomach carcinoma].

The improvement of the prognosis of gastric cancer after neoadjuvant therapy was shown in a phase II study with etoposide, adriamycin and cisplatinum (EAP). Due to high-grade toxicity with EAP, the verification of this therapeutic concept in a randomized phase III study with a less toxic regimen had to be demonstrated in a second phase II study. A combination with cisplatinum, leucovorin and 5-FU in comparison to EAP was less toxic, but clinical response after chemotherapy was shown to be identical. Of 41 patients, 36 patients underwent surgery with a R0-resection rate of 73.2% (n = 26). After a median follow-up of 18.3 months, 23 patients with R0 resection were alive, 19 patients (73%) showed no evidence of recurrent disease. There was no major morbidity and no postoperative mortality observed. Thus, chemotherapy with cisplatinum, 5-FU and leucovorin seems to be suitable for a randomized multicenter trial sponsored by the EORTC. For entrance into the study the following requirements should be met: prospective diagnostic procedures including endoscopic ultrasound (EUS) and surgical laparoscopy; standardised surgery (gastrectomy with D2-lymphadenectomy): prospective histopathological work up of the resected specimen including ypTNM category, ypUICC stages and R classification; prospectively scheduled follow-up intervals. Aim of the study, including 198 patients per treatment arm with a recruitment of 3 years and a minimum follow-up of 2 years, is the verification of the positive prognostic impact of neoadjuvant chemotherapy followed by surgery compared with surgery alone in locally advanced gastric cancer (cuT 3cN1-3cM0).

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2002

Correlation of EUS measurement with pathologic assessment of neoadjuvant therapy response in esophageal carcinoma.

BACKGROUND: EUS-measured reduction in tumor size after neoadjuvant therapy has previously been correlated with downstaging and improved survival in patients with esophageal cancer. The aim of this study was to determine whether tumor changes measured by EUS correspond to pathologically assessed chemoradiotherapy-induced tumor regression. METHODS: Forty-one patients with esophageal cancer treated with combined modality treatment were studied. After initial EUS, patients completed a cisplatin/carboplatinum, 5-fluorouracil, and radiotherapy regimen and underwent repeat EUS before resection. A positive response on EUS was defined as a 50% reduction in maximal tumor cross-sectional area. Chemoradiotherapy-induced tumor regression was assessed in resection specimens by using a previously defined pathologic scoring system based on the extent of tumor proliferation into adjacent fibrosis. RESULTS: Pathologic tumor regression was present in 23, indeterminate in 5, and minimal or absent in 13 patients. EUS measured a positive response in 20 of 23 (87%) patients with CRT-induced tumor regression and a negative response in 10 of 13 (77%) patients with absent tumor regression (p < 0.001). EUS had a positive predictive value of 80% for pathologic tumor regression. CONCLUSIONS: Measurement of tumor size by EUS is a reliable clinical method for assessing pathologic tumor regression before surgery.

Adult↗

PubMed1999

Prospective evaluation of paclitaxel versus combination chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with operable breast cancer.

PURPOSE: To compare prospectively the antitumor activity of single-agent paclitaxel to the three-drug combination of fluorouracil, doxorubicin, and cyclophosphamide (FAC) as neoadjuvant therapy in patients with operable breast cancer. PATIENTS AND METHODS: Patients with T1-3N0-1M0 disease were randomized to receive either paclitaxel (250 mg/m(2)) as 24-hour infusion or FAC in standard doses at every-3-week intervals. Each patient was treated with four cycles of preoperative chemotherapy. Clinical response and extent of residual disease in the breast and lymph nodes was assessed after four cycles of induction chemotherapy. RESULTS: A total of 174 patients were registered, and 87 were randomized to each arm of the study. Clinical response, ie, complete and partial responses, was similar in both arms of the study. Three patients in the FAC arm and one patient in the paclitaxel subgroup had progressive disease. The extent of residual disease by intent-to-treat analysis at the time of surgery was similar between the two arms of the study. CONCLUSION: The results of this prospective study demonstrated that single-agent paclitaxel as neoadjuvant therapy has significant antitumor activity, and this was clinically comparable to FAC. Similar fractions of patients had clinical complete and partial responses, and very few patients had no response to either therapy. The value of alternate non-cross-resistant therapies as used in this protocol on the clinical course of this disease would require longer follow-up.

Adult↗