한빛사 논문
Abstract
Yeon Hee Park, Kyung Hae Jung, Seock-Ah Im, Joo Hyuk Sohn, Jungsil Ro, Jin-Hee Ahn, Sung-Bae Kim, Byung-Ho Nam, Do Youn Oh, Sae-Won Han, Soohyeon Lee, In Hae Park, Keun Seok Lee, Jee Hyun Kim, Seok Yun Kang, Moon Hee Lee, Hee Sook Park, Jin Seok Ahn and Young-Hyuck Im*
Yeon Hee Park, Jin Seok Ahn, and Young-Hyuck Im, Samsung Medical Center, Sungkyunkwan University School of Medicine; Kyung Hae Jung, Jin-Hee Ahn, and Sung-Bae Kim, Asan Medical Center, University of Ulsan College of Medicine; Seock-Ah Im, Do Youn Oh, and Sae-Won Han, Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine; Joo Hyuk Sohn and Soohyeon Lee, Yonsei University College of Medicine; Hee Sook Park, Soonchunhyang University Hospital, Seoul; Jungsil Ro, Byung-Ho Nam, In Hae Park, and Keun Seok Lee, National Cancer Center, Goyang; Jee Hyun Kim, Seoul National University Bundang Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seongnam; Seok Yun Kang, Ajou University School of Medicine, Suwon; Moon Hee Lee, Inha University School of Medicine, Incheon, Korea.
*Corresponding author: Young-Hyuck Im, MD, PhD, Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong Gangnam-gu, Seoul 135-710, Korea
Both Y.H.P. and K.H.J. contributed equally to this work.
Abstract
Purpose The primary purpose of our study was to evaluate whether maintenance chemotherapy with paclitaxel/gemcitabine (PG) was superior to observation in improving progression-free survival (PFS) in patients with metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG as their first-line treatment.
Patients and Methods The study was a prospective, randomized, multicenter, phase III trial. Patients MBC with who achieved disease control after six cycles of PG chemotherapy were randomly assigned to maintenance chemotherapy or observation until progression.
Results Of 324 patients from 10 centers enrolled, 231 patients with MBC exhibited disease control (complete response + partial response + stable disease) with first-line PG and were randomly assigned to maintenance chemotherapy (n = 116) or observation (n = 115). The median age was 48 years (range, 28 to 76 years), median follow-up was 33 months, and median number of chemotherapy cycles in the maintenance group after random assignment was six. The median PFS time after random assignment was longer in the maintenance group than in the observation group (7.5 v 3.8 months, respectively; P = .026). The median overall survival (OS) time was longer in the maintenance group than in the observation group (32.3 v 23.5 months, respectively; P = .047). The rate of grade 3 or higher neutropenia after random assignment was higher in the maintenance group than in the observation group (61% v 0.9%, respectively; P < .001).
Conclusion In patients with MBC who achieved disease control with an initial six cycles of PG chemotherapy, maintenance PG chemotherapy resulted in better PFS and OS compared with observation.
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