PMID- 23623830
OWN - NLM
STAT- MEDLINE
DCOM- 20130819
LR  - 20211021
IS  - 1095-6859 (Electronic)
IS  - 0090-8258 (Linking)
VI  - 130
IP  - 1
DP  - 2013 Jul
TI  - A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 
      12 months of prior platinum-based chemotherapy.
PG  - 19-24
LID - S0090-8258(13)00305-3 [pii]
LID - 10.1016/j.ygyno.2013.04.049 [doi]
AB  - OBJECTIVES: The efficacy and safety of bevacizumab and docetaxel were evaluated 
      in women who developed recurrent epithelial ovarian, fallopian, or peritoneal 
      cancer within 12 months of platinum-based therapy. METHODS: Patients received 
      docetaxel (40 mg/m(2)) on days 1 and 8 and bevacizumab (15 mg/kg) on day 1 of a 
      21-daycycle. Primary endpoint was 6-month progression-free survival (PFS). 
      RESULTS: Forty-one patients were evaluable for PFS and 38 for best response; 46% 
      had platinum-free intervals (PFI) of <6 months and 54% between 6 and 12 months. 
      The 6-month PFS was 43.9% (95% confidence interval (CI(95%))=28.6-58.2%). Median 
      PFS (months) was 5.2 (CI(95%)=4.4-7.2) for all patients, 6.2 (CI(95%)=4.1-7.4) 
      for patients with PFI <6 months, and 5.1 (CI(95%)=3.0-7.2) for those with PFI >/= 6 
      months. Twenty-two patients showed overall response (CR+PR) (57.9%; 
      CI(95%)=40.8-73.7%), and 32 showed clinical benefit (CR+PR+SD) (84.2%; 
      CI(95%)=68.8-94.0%). For those with complete or partial responses, median 
      duration of response was 4.8 months (0.7-14.5). Median overall survival was 12.4 
      months (CI(95%)=10.0-21.9). The most common grade 3/4 adverse events (AEs) were 
      neutropenia (14.6% of patients), followed by leukopenia, fatigue, metabolic, and 
      gastrointestinal, with 66% showing any grade 3/4 toxicity. Most common AEs of any 
      grade were gastrointestinal (93%), fatigue (73%), and pain (73%). Four (10%) 
      patients developed hypertension, 1 a gastrointestinal perforation, and another a 
      colovesicular fistula. CONCLUSIONS: Bevacizumab and docetaxel administered in 
      patients with recurrent ovarian cancer is an active regimen without new 
      unanticipated toxicities. This combination should be an option for further study 
      or clinical use in recurrent ovarian cancer.
CI  - Copyright (c) 2013. Published by Elsevier Inc.
FAU - Wenham, Robert M
AU  - Wenham RM
AD  - H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA. 
      Robert.wenham@moffitt.org
FAU - Lapolla, James
AU  - Lapolla J
FAU - Lin, Hui-Yi
AU  - Lin HY
FAU - Apte, Sachin M
AU  - Apte SM
FAU - Lancaster, Johnathan M
AU  - Lancaster JM
FAU - Judson, Patricia L
AU  - Judson PL
FAU - Gonzalez-Bosquet, Jesus
AU  - Gonzalez-Bosquet J
FAU - Herschberger, Amber
AU  - Herschberger A
FAU - Havrilesky, Laura J
AU  - Havrilesky LJ
FAU - Secord, Angeles Alvarez
AU  - Secord AA
LA  - eng
GR  - P30 CA076292/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130425
PL  - United States
TA  - Gynecol Oncol
JT  - Gynecologic oncology
JID - 0365304
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
RN  - 2S9ZZM9Q9V (Bevacizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Bevacizumab
MH  - Carcinoma, Ovarian Epithelial
MH  - Disease-Free Survival
MH  - Docetaxel
MH  - Drug Resistance, Neoplasm
MH  - Drug Synergism
MH  - Fallopian Tube Neoplasms/drug therapy
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/*drug therapy
MH  - Neoplasms, Glandular and Epithelial/*drug therapy
MH  - Organoplatinum Compounds/therapeutic use
MH  - Ovarian Neoplasms/*drug therapy
MH  - Peritoneal Neoplasms/drug therapy
MH  - Taxoids/administration & dosage/adverse effects
EDAT- 2013/04/30 06:00
MHDA- 2013/08/21 06:00
CRDT- 2013/04/30 06:00
PHST- 2013/02/26 00:00 [received]
PHST- 2013/04/15 00:00 [revised]
PHST- 2013/04/17 00:00 [accepted]
PHST- 2013/04/30 06:00 [entrez]
PHST- 2013/04/30 06:00 [pubmed]
PHST- 2013/08/21 06:00 [medline]
AID - S0090-8258(13)00305-3 [pii]
AID - 10.1016/j.ygyno.2013.04.049 [doi]
PST - ppublish
SO  - Gynecol Oncol. 2013 Jul;130(1):19-24. doi: 10.1016/j.ygyno.2013.04.049. Epub 2013 
      Apr 25.