A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer.
Ye Won Jeon,Tae Hyun Kim,Hyun Jo Youn,Sehwan Han,Yong Sik Jung,Geumhee Gwak,Young Sam Park,Jeong Soo Kim,Young Jin Suh +8 more
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The combination of docetaxel and gemcitabine did not improve pCR, but this regimen has shown potential as a NAC by producing a reasonable rate of breast-conserving surgery and favorable responses in patients with locally advanced breast cancer.Abstract:
Purpose The current multicenter phase II study was conducted to evaluate the efficacy and safety of the combination of docetaxel and gemcitabine as neoadjuvant chemotherapy (NAC) for locally advanced breast cancer. Methods A total of 98 patients with stage II-III breast cancer were enrolled. The primary endpoint was pathological complete response (pCR) rate of invasive cancer after the completion of the fourth cycle of NAC. The secondary endpoints included response rate (RR), rate of breast-conserving surgery, toxicity, and disease-free survival (DFS). This study is registered with ClinicalTrials.gov (NCT01352494). Results pCR in the breast and the axillary lymph node was observed in seven of the 98 enrolled patients (7.1%). The overall clinical RR, including partial responses, was 65.3%. Breast-conserving surgery was performed in 75 of the 98 assessable patients (76.5%). Neutropenia was frequent and was observed in 92 of the 98 patients (93.9%), including grade 3 and 4 in 24 patients (24.5%) and 63 patients (64.3%), respectively. Dose reductions were required for 30 of the 92 patients (32.6%). After a median follow-up of 24 months, the overall DFS of the group was 86.7%. Conclusion The combination of docetaxel and gemcitabine did not improve pCR. However, this regimen has shown potential as a NAC by producing a reasonable rate of breast-conserving surgery and favorable responses in patients with locally advanced breast cancer. The therapeutic efficacy of this regimen will be determined in additional trials to overcome the limitations of the current study.read more
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References
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Definition and Impact of Pathologic Complete Response on Prognosis After Neoadjuvant Chemotherapy in Various Intrinsic Breast Cancer Subtypes
Gunter von Minckwitz,Michael Untch,Jens-Uwe Blohmer,SD Costa,Holger Eidtmann,Peter A. Fasching,Bernd Gerber,Wolfgang Eiermann,Jörn Hilfrich,Jens Huober,Christian Jackisch,Manfred Kaufmann,Gottfried E. Konecny,Carsten Denkert,Valentina Nekljudova,Keyur Mehta,Sibylle Loibl +16 more
TL;DR: The exact definition of pathologic complete response (pCR) and its prognostic impact on survival in intrinsic breast cancer subtypes is uncertain this paper, however, it is known that pCR is associated with long-term outcome of 6,377 patients with primary breast cancer receiving neoadjuvant anthracycline-taxane-based chemotherapy in seven randomized trials.
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Clinical Course of Breast Cancer Patients With Complete Pathologic Primary Tumor and Axillary Lymph Node Response to Doxorubicin-Based Neoadjuvant Chemotherapy
Henry Mark Kuerer,Lisa A. Newman,Terry L. Smith,Fred C. Ames,Kelly K. Hunt,Kapil Dhingra,Richard L. Theriault,Gurpreet Singh,Susan M. Binkley,Nour Sneige,Thomas A. Buchholz,Merrick I. Ross,Marsha D. McNeese,Aman U. Buzdar,Gabriel N. Hortobagyi,S. Eva Singletary +15 more
TL;DR: Neoadjuvant chemotherapy has the capacity to completely clear the breast and axillary lymph nodes of invasive tumor before surgery and patients with LABC who have a pCR in the breastand axillary nodes have a significantly improved disease-free survival rate.
Journal ArticleDOI
Superior Survival With Capecitabine Plus Docetaxel Combination Therapy in Anthracycline-Pretreated Patients With Advanced Breast Cancer: Phase III Trial Results
Joyce A. O'Shaughnessy,David Miles,Svetislava J. Vukelja,Vladimir Moiseyenko,Jean-Pierre M. Ayoub,Guadalupe Cervantes,Pierre Fumoleau,Stephen E. Jones,Wing-Yiu Lui,Louis Mauriac,Chris Twelves,Guy van Hazel,Shailendra Verma,Robert C. F. Leonard +13 more
TL;DR: The significantly superior TTP and survival achieved with the addition of capecitabine to docetaxel 75 mg/m(2), with the manageable toxicity profile, indicate that this combination provides clear benefits over single-agent docetAXel 100 mg/ m(2).
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Preoperative Chemotherapy in Primary Operable Breast Cancer: Results From the European Organization for Research and Treatment of Cancer Trial 10902
Jos A. van der Hage,Cornelis J.H. van de Velde,Jean-Pierre Julien,M. Tubiana-Hulin,Cecile Vandervelden,Luc Duchateau +5 more
TL;DR: The use of preoperative chemotherapy yields similar results in terms of PFS, OS, and locoregional control compared with conventional postoperative chemotherapy and enables more patients to be treated with breast-conserving surgery.
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Recommendations From an International Expert Panel on the Use of Neoadjuvant (Primary) Systemic Treatment of Operable Breast Cancer: An Update
Manfred Kaufmann,Gabriel N. Hortobagyi,Aron Goldhirsch,Suzy Scholl,Andreas Makris,Pinuccia Valagussa,Jens-Uwe Blohmer,Wolfgang Eiermann,Raimund Jackesz,Walter Jonat,Annette Lebeau,Sibylle Loibl,William B. Miller,Sigfried Seeber,Vladimir Semiglazov,Roy E. Smith,Rainer Souchon,Vered Stearns,Michael Untch,Gunter von Minckwitz +19 more
TL;DR: A second international panel of representatives of a number of breast cancer clinical research groups was convened in September 2004 to update recommendations regarding neoadjuvant treatment for operable disease and data published to date were reviewed critically and indications were newly defined.