PMID- 18509179
OWN - NLM
STAT- MEDLINE
DCOM- 20080625
LR  - 20161124
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 26
IP  - 16
DP  - 2008 Jun 1
TI  - Phase III study of valspodar (PSC 833) combined with paclitaxel and carboplatin 
      compared with paclitaxel and carboplatin alone in patients with stage IV or 
      suboptimally debulked stage III epithelial ovarian cancer or primary peritoneal 
      cancer.
PG  - 2674-82
LID - 10.1200/JCO.2007.14.9807 [doi]
AB  - PURPOSE: To compare the safety and efficacy of carboplatin and paclitaxel 
      administered with or without the multidrug resistance modulator valspodar (PSC 
      833) in untreated patients with advanced ovarian or primary peritoneal cancer. 
      PATIENTS AND METHODS: Seven hundred sixty-two patients with stage IV or 
      suboptimally debulked stage III ovarian or primary peritoneal cancer were 
      randomly assigned to receive either valspodar 5 mg/kg every 6 hours for 12 doses, 
      paclitaxel 80 mg/m(2), and carboplatin area under the curve (AUC) 6 (PC-PSC; n = 
      381) or paclitaxel 175 mg/m(2) and carboplatin AUC 6 (PC; n = 381). Time to 
      disease progression (TTP) was the primary end point. Secondary end points were 
      overall survival time (OS), response rate (RR), safety, and tolerability. 
      RESULTS: With a median follow-up of 736 days (range, 1 to 2,280 days), the median 
      TTP was 13.2 and 13.5 months in the PC-PSC and PC groups, respectively (P = .67); 
      the median OS was 32 and 28.9 months, respectively (P = .94). The overall RR was 
      higher in the PC group (41.5% v 33.6%; P = .02). Central and peripheral nervous 
      system and GI toxicities were more common in the PC-PSC group. Ataxia occurred in 
      53.5% and 3.2% of PC-PSC-and PC-treated patients, respectively. Febrile 
      neutropenia occurred more frequently in the PC-PSC group. More PC-PSC-treated 
      patients discontinued therapy because of adverse events (AEs), experienced 
      serious AEs, and required paclitaxel dose reductions. CONCLUSION: The addition of 
      valspodar to PC did not improve TTP or OS and was more toxic compared with PC in 
      untreated patients with advanced ovarian or primary peritoneal cancer.
FAU - Lhomme, Catherine
AU  - Lhomme C
AD  - Institut Gustave-Roussy, Service de Gynecologie, 39 rue Camille Desmoulins, 94805 
      Villejuif Cedex, France. lhomme@igr.fr
FAU - Joly, Florence
AU  - Joly F
FAU - Walker, Joan L
AU  - Walker JL
FAU - Lissoni, Andrea A
AU  - Lissoni AA
FAU - Nicoletto, Maria O
AU  - Nicoletto MO
FAU - Manikhas, Gregory M
AU  - Manikhas GM
FAU - Baekelandt, Mark M O
AU  - Baekelandt MM
FAU - Gordon, Alan N
AU  - Gordon AN
FAU - Fracasso, Paula M
AU  - Fracasso PM
FAU - Mietlowski, William L
AU  - Mietlowski WL
FAU - Jones, Gary J
AU  - Jones GJ
FAU - Dugan, Margaret H
AU  - Dugan MH
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
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 (Cyclosporins)
RN  - BG3F62OND5 (Carboplatin)
RN  - P88XT4IS4D (Paclitaxel)
RN  - Q7ZP55KF3X (valspodar)
SB  - IM
CIN - J Clin Oncol. 2008 Jun 1;26(16):2616-8. PMID: 18509172
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Carboplatin/administration & dosage/adverse effects
MH  - Cyclosporins/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Ovarian Neoplasms/*drug therapy/mortality/pathology
MH  - Paclitaxel/administration & dosage/adverse effects
MH  - Peritoneal Neoplasms/*drug therapy/mortality/pathology
MH  - Survival Analysis
EDAT- 2008/05/30 09:00
MHDA- 2008/06/26 09:00
CRDT- 2008/05/30 09:00
PHST- 2008/05/30 09:00 [pubmed]
PHST- 2008/06/26 09:00 [medline]
PHST- 2008/05/30 09:00 [entrez]
AID - 26/16/2674 [pii]
AID - 10.1200/JCO.2007.14.9807 [doi]
PST - ppublish
SO  - J Clin Oncol. 2008 Jun 1;26(16):2674-82. doi: 10.1200/JCO.2007.14.9807.