PMID- 22987083
OWN - NLM
STAT- MEDLINE
DCOM- 20130304
LR  - 20220311
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 30
IP  - 31
DP  - 2012 Nov 1
TI  - Randomized, open-label, phase III study comparing patupilone (EPO906) with 
      pegylated liposomal doxorubicin in platinum-refractory or -resistant patients 
      with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal 
      cancer.
PG  - 3841-7
LID - 10.1200/JCO.2011.38.8082 [doi]
AB  - PURPOSE: This study compared the efficacy and safety of patupilone with those of 
      pegylated liposomal doxorubicin (PLD) in patients with platinum-refractory or 
      -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal 
      cancer. PATIENTS AND METHODS: Patients with three or fewer prior regimens were 
      eligible if they had received first-line taxane/platinum-based combination 
      chemotherapy and were platinum refractory or resistant. Patients were randomly 
      assigned to receive patupilone (10 mg/m(2) intravenously every 3 weeks) or PLD 
      (50 mg/m(2) intravenously every 4 weeks). RESULTS: A total of 829 patients were 
      randomly assigned (patupilone, n = 412; PLD, n = 417). There was no statistically 
      significant difference in overall survival (OS), the primary end point, between 
      the patupilone and PLD arms (P = .195; hazard ratio, 0.93; 95% CI, 0.79 to 1.09), 
      with median OS rates of 13.2 and 12.7 months, respectively. Median 
      progression-free survival was 3.7 months for both arms. The overall response rate 
      (all partial responses) was higher in the patupilone arm than in the PLD arm 
      (15.5% v 7.9%; odds ratio, 2.11; 95% CI, 1.36 to 3.29), although disease control 
      rates were similar (59.5% v 56.3%, respectively). Frequently observed adverse 
      events (AEs) of any grade included diarrhea (85.3%) and peripheral neuropathy 
      (39.3%) in the patupilone arm and mucositis/stomatitis (43%) and hand-foot 
      syndrome (41.8%) in the PLD arm. CONCLUSION: Patupilone did not demonstrate 
      significant improvement in OS compared with the active control, PLD. No new or 
      unexpected serious AEs were identified.
FAU - Colombo, Nicoletta
AU  - Colombo N
AD  - Dipartimento di Scienze Chirurgiche, Universita Milano-Bicocca, Medico Direttore, 
      Unita Ginecologia Oncologica Medica, Divisione di Ginecologia, Via Ripamonti, 
      435-20141 Milano, Italy. nicoletta.colombo@ieo.it
FAU - Kutarska, Elzbieta
AU  - Kutarska E
FAU - Dimopoulos, Meletios
AU  - Dimopoulos M
FAU - Bae, Duk-Soo
AU  - Bae DS
FAU - Rzepka-Gorska, Izabella
AU  - Rzepka-Gorska I
FAU - Bidzinski, Mariusz
AU  - Bidzinski M
FAU - Scambia, Giovanni
AU  - Scambia G
FAU - Engelholm, Svend Aage
AU  - Engelholm SA
FAU - Joly, Florence
AU  - Joly F
FAU - Weber, Dirk
AU  - Weber D
FAU - El-Hashimy, Mona
AU  - El-Hashimy M
FAU - Li, Jingjin
AU  - Li J
FAU - Souami, Farida
AU  - Souami F
FAU - Wing, Patricia
AU  - Wing P
FAU - Engelholm, Silke
AU  - Engelholm S
FAU - Bamias, Aristotelis
AU  - Bamias A
FAU - Schwartz, Peter
AU  - Schwartz P
LA  - eng
SI  - ClinicalTrials.gov/NCT00262990
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120917
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibiotics, Antineoplastic)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Epothilones)
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (liposomal doxorubicin)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 80168379AG (Doxorubicin)
RN  - UEC0H0URSE (epothilone B)
SB  - IM
CIN - J Clin Oncol. 2012 Nov 1;30(31):3779-80. PMID: 22987092
CIN - J Clin Oncol. 2013 Jun 20;31(18):2362. PMID: 23669225
CIN - J Clin Oncol. 2013 Jun 20;31(18):2363. PMID: 23930277
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibiotics, Antineoplastic/adverse effects/therapeutic use
MH  - Antineoplastic Agents/adverse effects/therapeutic use
MH  - Carcinoma, Ovarian Epithelial
MH  - Doxorubicin/adverse effects/*analogs & derivatives/therapeutic use
MH  - Drug Resistance, Neoplasm
MH  - Epothilones/adverse effects/*therapeutic use
MH  - Fallopian Tube Neoplasms/*drug therapy
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/*drug therapy/pathology
MH  - Neoplasms, Glandular and Epithelial/*drug therapy/pathology
MH  - Organoplatinum Compounds/therapeutic use
MH  - Ovarian Neoplasms/*drug therapy/pathology
MH  - Peritoneal Neoplasms/*drug therapy/pathology
MH  - Polyethylene Glycols/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2012/09/19 06:00
MHDA- 2013/03/05 06:00
CRDT- 2012/09/19 06:00
PHST- 2012/09/19 06:00 [entrez]
PHST- 2012/09/19 06:00 [pubmed]
PHST- 2013/03/05 06:00 [medline]
AID - JCO.2011.38.8082 [pii]
AID - 10.1200/JCO.2011.38.8082 [doi]
PST - ppublish
SO  - J Clin Oncol. 2012 Nov 1;30(31):3841-7. doi: 10.1200/JCO.2011.38.8082. Epub 2012 
      Sep 17.