International Expert Panel on the Use of Primary (Preoperative) Systemic Treatment of Operable Breast Cancer: Review and Recommendations

2003 ◽  
Vol 21 (13) ◽  
pp. 2600-2608 ◽  
Author(s):  
Manfred Kaufmann ◽  
Gunter von Minckwitz ◽  
Roy Smith ◽  
Vicente Valero ◽  
Luca Gianni ◽  
...  

Primary systemic therapy (PST) represents the standard of care in patients with locally advanced breast cancer. In addition, there is increasing information on PST in operable breast disease that supports the use of PST in routine practice. However, current regimens and techniques vary. To address this concern, a group of representatives from breast cancer clinical research groups in France, Germany, Italy, the United Kingdom, and the United States reviewed all available data on prospective randomized trials in this setting. Recommendations are made regarding terminology, indications, regimen, diagnosis before treatment, monitoring of efficacy, tumor localization, surgery, pathologic evaluation, and postoperative treatment.

2009 ◽  
Vol 27 (4) ◽  
pp. 535-541 ◽  
Author(s):  
Jörg Schwarz-Dose ◽  
Michael Untch ◽  
Reinhold Tiling ◽  
Stefanie Sassen ◽  
Sven Mahner ◽  
...  

Purpose To evaluate positron emission tomography (PET) using [18F]fluorodeoxyglucose (FDG) for prediction of histopathologic response early during primary systemic therapy of large or locally advanced breast cancer. Patients and Methods In a prospective multicenter trial, 272 FDG-PET scans were performed in 104 patients at baseline (n = 104) and after the first (n = 87) and second cycle (n = 81) of chemotherapy. The level and relative changes in standardized uptake value (SUV) of FDG uptake were assessed regarding their ability to predict histopathologic response. All patients underwent surgery after chemotherapy, and histopathologic response defined as minimal residual disease or gross residual disease served as the reference standard. Results Seventeen (16%) of 104 patients were histopathologic responders and 87 were (84%) nonresponders. All patients for whom baseline SUV was less than 3.0 (n = 24) did not achieve a histopathologic response. SUV decreased by 51% ± 18% after the first cycle of chemotherapy in histopathologic responders (n = 15), compared with 37% ± 21% in nonresponders (n = 54; P = .01). A threshold of 45% decrease in SUV correctly identified 11 of 15 responders, and histopathologic nonresponders were identified with a negative predictive value of 90%. Similar results were found after the second cycle when using a threshold of 55% relative decrease in SUV. Conclusion FDG-PET allows for prediction of treatment response by the level of FDG uptake in terms of SUV at baseline and after each cycle of chemotherapy. Moreover, relative changes in SUV after the first and second cycle are a strong predictor of response. Thus, FDG-PET may be helpful for individual treatment stratification in breast cancer patients.


2003 ◽  
Vol 11 (3) ◽  
pp. 145-147
Author(s):  
Ljubomir Muzikravic ◽  
Dragutin Donat ◽  
Jasna Pesic ◽  
Jasna Trifunovic

Locally advanced breast cancer is a specific clinic entity, comprising various degrees of breast cancer local and regional extension. This term is applied to nonmetastatic large primary tumors (including inflammatory breast carcinoma), with or without extensive regional lymph node involvement, with a rapid or slow evolution, and usually with poor prognosis. This clinical presentation of mammary carcinoma is common in developing countries (30% to 60%), but also with a remarkable incidence in developed countries (10% to 20%). During many decades patients were treated with radical surgery or radiation therapy and with their combination, but always with poor results. The inclusion of neoadjuvant chemotherapy in the treatment enabled more favorable treatment results. The mortality from disseminated disease is the main problem in these patients, inducing the question of need for additional postoperative adjuvant systemic therapy. For steroid receptor positive patients hormonotherapy is a convenient choice of maintaining treatment. In endocrine non-responsive tumors, the role of postoperative chemotherapy is doubtful, having in mind preoperative chemotherapy and cumulative toxic effects. New trials including the large number of patients are necessary to obtain the definite answer whether the maintaining chemotherapy is useful but today it seems that additive postoperative treatment is not more efficient than preoperative alone.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11000-11000
Author(s):  
N. Mizuta ◽  
H. Nakajima ◽  
K. Sakaguchi ◽  
Y. Hachimine ◽  
I. Fujiwara

11000 Background: Various regimens of primary systemic therapy (PST) have been performed to patients with locally advanced breast cancer to decrease the size of the primary tumor and allow for effective local and distant control. In terms of pathological complete response (pCR) rate, however, satisfactory results were not obtained. Therefore, in this study, we have tried to determine whether the addition of trastuzumab on PST could increase pCR rate. Methods: Two prospective nonrandomized studies were performed that used different regimens as PST, followed by breast conserving surgery. Group-A ; Eighty-fore HER2-negative patients with operable breast cancer were assigned to 4 cycles of epirubicin and cyclophosphamide followed by 12 cycles of weekly paclitaxel. GroupB; Eighteen HER2-positive patients were assigned to 4 cycles of epirubicin and cyclophosphamide followed by 12 cycles of weekly paclitaxel and trastuzumab. Results: A total of 102 assessable patients were enrolled, and all the patients have completed the above 2 regimens of PST. Pathological complete response (pCR) rates were 12% in Group-A and 61.1% in Group-B, respectively. Following the PST, 75% of Group-A and all of Group-B patients were able to be subjected to breast conserving surgery. All the toxicities happened in both groups were well controlled in grade 1 or 2. Conclusion: These results indicate that both the PST regimens were safely performed in women with locally advanced breast cancer and allow breast conserving surgery in a high fraction of patients (90%). In addition, significantly high rates of pCR were obtained in patients with use of trastuzumab (p<0.01). No significant financial relationships to disclose.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 592-592
Author(s):  
C. H. Arce-Salinas ◽  
F. U. Lara ◽  
E. Leon

592 Background: LABC in Mexico represents between 50–60% of the new diagnosed cases, and 25–30% of those cancers are HER-2/neu positive. Primary systemic therapy trastuzumab-based combination chemotherapy (ChT) has shown clinical benefit and pathologic complete response rates are obtained between 17%-67%. The aim of this study was evaluate the complete pathologic response (pR) rate with the combination of four cyles of FAC (5FU/Doxorubicin/Cyclophosphamide) followed by weekly paclitaxel (PTX) and trastuzumab. As secondary endpoint was evaluate cardiac safety. Methods: All patients with LABC HER-2 positive (IHC 3+ or FISH amplification) with stages IIb-IIIc were included, patients with palpable nodes underwent fine needle aspiration to confirm metastatic nodal disease (MND), other inclusion criteria was FEVI ≥55% determined by MUGA, hematologic, renal and hepatic function normal. We exclude inflammatory breast cancer. All patients received 4 cycles of FAC followed by weekly PTX (80 mg/m2) concomitantly with trastuzumab, 2 mg/kg, at the end of treatment surgery was performed, and pR was evaluable. Complete pR was defined as the absence of tumor cells in breast and axillary nodes. Disease free survival (DFS) was calculated with Kaplan-Meier method. Protocol was approved by local ethical committee. NCT 00533936. Results: We included 92 patients, median age was 48 (27–68) yrs. Median tumor size was 6 (5.4–6.5) cm, 84.9% had MND. Efficacy analysis was made in 71 patients; 21 patients are still under treatment. Overall clinical response was reached in 71% (complete 37% and partial 42%). Eleven patients were considered inoperable (skin affection, larger size > 5 cm or fixed to chest wall and received radiotherapy 50 Gy). Complete pR was reported in 48% of cases. Median follow-up was 17.4 (CI95% 14.9, 17.6) mo and media of DFS was 25.1 (CI95% 23.5, 26.7) mo. We found cardiac toxicity (CT) grade 3 in 1.1%, and grade 2 in 3.2%. Conclusions: Combination of PTX and trastuzumab after 4 cycles of FAC is highly active in terms of complete pR. This scheme was tolerated, with CT grade 3–4 in less than 2%. No significant financial relationships to disclose.


2016 ◽  
Vol 468 (6) ◽  
pp. 675-686 ◽  
Author(s):  
Tímea Tőkés ◽  
Anna-Mária Tőkés ◽  
Gyöngyvér Szentmártoni ◽  
Gergő Kiszner ◽  
Lilla Madaras ◽  
...  

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