PMID- 26320479
OWN - NLM
STAT- MEDLINE
DCOM- 20160614
LR  - 20220330
IS  - 2476-762X (Electronic)
IS  - 1513-7368 (Linking)
VI  - 16
IP  - 14
DP  - 2015
TI  - A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of 
      Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and 
      High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer.
PG  - 5957-61
AB  - BACKGROUND: We designed this randomized controlled trial (RCT) to assess whether 
      lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based 
      concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of 
      efficacy and safety. MATERIALS AND METHODS: This prospective, open-label RCT aims 
      to enroll 180 patients with FIGO stage II and III cervical cancer, randomly 
      allocated to one of the three treatment groups (cisplatin 15mg/m2, cisplatin 
      20mg/m2 and lobaplatin 35mg/m2), with 60 patients in each group. All patients 
      will receive external beam irradiation (EBRT) and high-dose-rate intracavitary 
      brachytherapy (HDR-ICBT). Patients in cisplatin 15mg/m2 and 20mg/m2 groups will 
      be administered four cycles of 15mg/m2 or 20mg/m2 cisplatin intravenously once 
      weekly from the second week to the fifth week during EBRT, while patients inthe 
      lobaplatin 35mg/m2 group will be administered two cycles of 35mg/m2 lobaplatin 
      intravenously in the second and fifth week respectively during pelvic EBRT. All 
      participants will be followed up for at least 12 months. Complete remission rate 
      and progression-free survival (PFS) will be the primary endpoints. Overall 
      survival (OS), incidence of adverse events (AEs), and quality of life will be the 
      secondary endpoints. RESULTS: Between March 2013 and March 2014, a total of 61 
      patients with FIGO stage II and III cervical cancer were randomly assigned to 
      cisplatin 15mg/m2 group (n=21), cisplatin 20mg/m2 group (n=21) and lobaplatin 
      35mg/m2 group (n=19). We conducted a preliminary analysis of the results. Similar 
      rates of complete remission and grades 3-4 gastrointestinal reactions were 
      observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 
      3-4 hematologic toxicity was more frequent in the lobaplatin group than the 
      cisplatin group. CONCLUSIONS: This proposed study will be the first RCT to 
      evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, 
      compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, 
      OS, AEs and quality of life for FIGO stage II and III cervical cancer.
FAU - Wang, Ji-Quan
AU  - Wang JQ
AD  - Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong 
      University, Xi'an, China E-mail : liuzmail@163.com.
FAU - Wang, Tao
AU  - Wang T
FAU - Shi, Fan
AU  - Shi F
FAU - Yang, Yun-Yi
AU  - Yang YY
FAU - Su, Jin
AU  - Su J
FAU - Chai, Yan-Lan
AU  - Chai YL
FAU - Liu, Zi
AU  - Liu Z
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Thailand
TA  - Asian Pac J Cancer Prev
JT  - Asian Pacific journal of cancer prevention : APJCP
JID - 101130625
RN  - 0 (Cyclobutanes)
RN  - 0 (Organoplatinum Compounds)
RN  - OX5XK1JD8C (lobaplatin)
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects
MH  - Brachytherapy/*adverse effects
MH  - Carcinoma, Squamous Cell/mortality/pathology/therapy
MH  - Chemoradiotherapy/*adverse effects
MH  - Cisplatin/administration & dosage
MH  - Cyclobutanes/administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - Gastrointestinal Diseases/*etiology/mortality/pathology
MH  - Humans
MH  - Leukopenia/*etiology/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Organoplatinum Compounds/administration & dosage
MH  - Prognosis
MH  - Radiotherapy Dosage
MH  - Thrombocytopenia/*etiology/mortality/pathology
MH  - Uterine Cervical Neoplasms/mortality/pathology/*therapy
EDAT- 2015/09/01 06:00
MHDA- 2016/06/15 06:00
CRDT- 2015/09/01 06:00
PHST- 2015/09/01 06:00 [entrez]
PHST- 2015/09/01 06:00 [pubmed]
PHST- 2016/06/15 06:00 [medline]
AID - 10.7314/apjcp.2015.16.14.5957 [doi]
PST - ppublish
SO  - Asian Pac J Cancer Prev. 2015;16(14):5957-61. doi: 10.7314/apjcp.2015.16.14.5957.