Park, Yeon Hee; Jung, Kyung Hae; Im, Seock-Ah; Sohn, Joo Hyuk; Ro, Jungsil; Ahn, Jin-Hee; Kim, Sung-Bae; Nam, Byung-Ho; Oh, Do Youn; Han, Sae-Won; Lee, Soohyeon; Park, In Hae; Lee, Keun Seok; Kim, Jee Hyun; Kang, Seok Yun; Lee, Moon Hee; Park, Hee Sook; Ahn, Jin Seok; Im, Young-Hyuck
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
2013May ; 31 ( 14 ) :1732-9.
PMID : 23569309
ÀúÀÚ »ó¼¼Á¤º¸
Park, Yeon Hee -
Jung, Kyung Hae -
Im, Seock-Ah -
Sohn, Joo Hyuk -
Ro, Jungsil -
Ahn, Jin-Hee -
Kim, Sung-Bae -
Nam, Byung-Ho -
Oh, Do Youn -
Han, Sae-Won -
Lee, Soohyeon -
Park, In Hae -
Lee, Keun Seok -
Kim, Jee Hyun -
Kang, Seok Yun -
Lee, Moon Hee -
Park, Hee Sook -
Ahn, Jin Seok -
Im, Young-Hyuck -
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.
na
MESH
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use, Breast Neoplasms/*drug therapy/mortality/*pathology, Deoxycytidine/administration & dosage/analogs & derivatives, Disease-Free Survival, Drug Administration Schedule, Female, Humans, *Maintenance Chemotherapy/methods, Middle Aged, Neoplasm Staging, Paclitaxel/administration & dosage, Prospective Studies, Republic of Korea, Treatment Outcome, Watchful Waiting
¸µÅ©