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A phase II study of a paclitaxel and oxaliplatin combination in platinum-sensitive recurrent advanced ovarian cancer patients

P Viens, T Petit, A Yovine, P Bougnoux, G Deplanque, P Cottu, R Delva, J Lotz, Simon Van Belle UGent and J Extra, et al. (2006) ANNALS OF ONCOLOGY. 17(3). p.429-436
abstract
Purpose: A multicentric, phase II study to evaluate the efficacy and safety of the combination paclitaxel and oxaliplatin in patients with platinum-sensitive recurrent ovarian cancer. Patients and methods: Patients received 175 mg/m(2) paclitaxel (over 3 h) followed by 130 mg/m(2) oxaliplatin (over 2 h) every 21 days for up to nine cycles without hydration or primary granulocyte colony-stimulating factor prophylaxis. Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2 and to have received no more than one prior cisplatin- and/or carboplatin-containing chemotherapy regimen with a platinum-progression-free interval >= 6 months. Results: Of the 105 patients enrolled and treated, 98 were eligible. An overall response rate of 81% (79 of 98 patients) (95% confidence interval 71% to 88%) was observed according to RECIST criteria (third party reviewed), and 88% (86 of 98) when this was complemented with CA-125 response. With a median follow up of 43.6 months (range 30.2-64.2) the median progression-free survival was 10.2 months (range 0.3-21.4) and the overall survival 32.4 months. Seven hundred and eight cycles were administered (median seven per patient; range one to nine). A total of 67% of patients experienced National Cancer Institute Common Toxicity Criteria grade 3-4 neutropenia, including 8% with concomitant febrile episode, without treatment-related deaths. Ninety-three per cent of patients experienced neuropathy of grade 1 or more, including 25% with cumulative reversible peripheral neuropathy of grade 3-4. Oxaliplatin doses were reduced in 30 patients due to neurotoxicity. Conclusions: The oxaliplatin/paclitaxel combination can be administered in an outpatient setting every 3 weeks without specific measures. The high level of activity and its duration observed warrants further evaluation of this combination in pretreated platinum-sensitive advanced ovarian cancer patients.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
DNA MISMATCH REPAIR, GYNECOLOGIC-ONCOLOGY-GROUP, 2ND-LINE THERAPY, SINGLE-AGENT, CLINICAL-TRIAL, SOLID TUMORS, STAGE-III, CISPLATIN, CARBOPLATIN, CARCINOMA, ovarian cancer, oxaliplatin, paclitaxel, phase II, platinum-sensitive
journal title
ANNALS OF ONCOLOGY
Ann. Oncol.
volume
17
issue
3
pages
429 - 436
Web of Science type
Article
Web of Science id
000235770700011
JCR category
ONCOLOGY
JCR impact factor
5.179 (2006)
JCR rank
21/125 (2006)
JCR quartile
1 (2006)
ISSN
0923-7534
DOI
10.1093/annonc/mdj097
language
English
UGent publication?
yes
classification
A1
id
356871
handle
http://hdl.handle.net/1854/LU-356871
date created
2007-03-19 15:38:00
date last changed
2011-11-29 14:09:32
@article{356871,
  abstract     = {Purpose: A multicentric, phase II study to evaluate the efficacy and safety of the combination paclitaxel and oxaliplatin in patients with platinum-sensitive recurrent ovarian cancer. Patients and methods: Patients received 175 mg/m(2) paclitaxel (over 3 h) followed by 130 mg/m(2) oxaliplatin (over 2 h) every 21 days for up to nine cycles without hydration or primary granulocyte colony-stimulating factor prophylaxis. Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2 and to have received no more than one prior cisplatin- and/or carboplatin-containing chemotherapy regimen with a platinum-progression-free interval {\textrangle}= 6 months. Results: Of the 105 patients enrolled and treated, 98 were eligible. An overall response rate of 81\% (79 of 98 patients) (95\% confidence interval 71\% to 88\%) was observed according to RECIST criteria (third party reviewed), and 88\% (86 of 98) when this was complemented with CA-125 response. With a median follow up of 43.6 months (range 30.2-64.2) the median progression-free survival was 10.2 months (range 0.3-21.4) and the overall survival 32.4 months. Seven hundred and eight cycles were administered (median seven per patient; range one to nine). A total of 67\% of patients experienced National Cancer Institute Common Toxicity Criteria grade 3-4 neutropenia, including 8\% with concomitant febrile episode, without treatment-related deaths. Ninety-three per cent of patients experienced neuropathy of grade 1 or more, including 25\% with cumulative reversible peripheral neuropathy of grade 3-4. Oxaliplatin doses were reduced in 30 patients due to neurotoxicity. Conclusions: The oxaliplatin/paclitaxel combination can be administered in an outpatient setting every 3 weeks without specific measures. The high level of activity and its duration observed warrants further evaluation of this combination in pretreated platinum-sensitive advanced ovarian cancer patients.},
  author       = {Viens, P and Petit, T and Yovine, A and Bougnoux, P and Deplanque, G and Cottu, P and Delva, R and Lotz, J and Van Belle, Simon and Extra, J and Cvitkovic, E},
  issn         = {0923-7534},
  journal      = {ANNALS OF ONCOLOGY},
  keyword      = {DNA MISMATCH REPAIR,GYNECOLOGIC-ONCOLOGY-GROUP,2ND-LINE THERAPY,SINGLE-AGENT,CLINICAL-TRIAL,SOLID TUMORS,STAGE-III,CISPLATIN,CARBOPLATIN,CARCINOMA,ovarian cancer,oxaliplatin,paclitaxel,phase II,platinum-sensitive},
  language     = {eng},
  number       = {3},
  pages        = {429--436},
  title        = {A phase II study of a paclitaxel and oxaliplatin combination in platinum-sensitive recurrent advanced ovarian cancer patients},
  url          = {http://dx.doi.org/10.1093/annonc/mdj097},
  volume       = {17},
  year         = {2006},
}

Chicago
Viens, P, T Petit, A Yovine, P Bougnoux, G Deplanque, P Cottu, R Delva, et al. 2006. “A Phase II Study of a Paclitaxel and Oxaliplatin Combination in Platinum-sensitive Recurrent Advanced Ovarian Cancer Patients.” Annals of Oncology 17 (3): 429–436.
APA
Viens, P., Petit, T., Yovine, A., Bougnoux, P., Deplanque, G., Cottu, P., Delva, R., et al. (2006). A phase II study of a paclitaxel and oxaliplatin combination in platinum-sensitive recurrent advanced ovarian cancer patients. ANNALS OF ONCOLOGY, 17(3), 429–436.
Vancouver
1.
Viens P, Petit T, Yovine A, Bougnoux P, Deplanque G, Cottu P, et al. A phase II study of a paclitaxel and oxaliplatin combination in platinum-sensitive recurrent advanced ovarian cancer patients. ANNALS OF ONCOLOGY. 2006;17(3):429–36.
MLA
Viens, P, T Petit, A Yovine, et al. “A Phase II Study of a Paclitaxel and Oxaliplatin Combination in Platinum-sensitive Recurrent Advanced Ovarian Cancer Patients.” ANNALS OF ONCOLOGY 17.3 (2006): 429–436. Print.