Phase II study of intraperitoneal paclitaxel plus cisplatin and intravenous paclitaxel plus bevacizumab as adjuvant treatment of optimal stage II/III epithelial ovarian cancer Journal Article


Authors: Konner, J. A.; Grabon, D. M.; Gerst, S. R.; Iasonos, A.; Thaler, H.; Pezzulli, S. D.; Sabbatini, P. J.; Bell-Mcguinn, K. M.; Tew, W. P.; Hensley, M. L.; Spriggs, D. R.; Aghajanian, C. A.
Article Title: Phase II study of intraperitoneal paclitaxel plus cisplatin and intravenous paclitaxel plus bevacizumab as adjuvant treatment of optimal stage II/III epithelial ovarian cancer
Abstract: Purpose: Intraperitoneal (IP) cisplatin and intravenous (IV) or IP paclitaxel constitute a standard therapy for optimally debulked ovarian cancer. Bevacizumab prolongs progression-free survival (PFS) when included in first-line IV chemotherapy. In this study, the safety and feasibility of adding bevacizumab to a first-line IP regimen were assessed. Patients and Methods: Treatment was as follows: paclitaxel 135 mg/m2 IV over 3 hours day 1, cisplatin 75 mg/m2 IP day 2, and paclitaxel 60 mg/m2 IP day 8. Bevacizumab 15 mg/kg IV was given after paclitaxel on day 1 beginning in cycle 2. After six cycles of chemotherapy, bevacizumab was given every 3 weeks for 17 additional treatments. The primary end point was safety and tolerability determined by whether 60% of patients completed six cycles of IV/IP chemotherapy. Results: Of 41 treated patients, 30 (73%) received six cycles of IV/IP chemotherapy and 35 (85%) received at least four cycles. Three (27%) of those who discontinued chemotherapy did so because of complications related to bevacizumab (hypertension, n = 2; perforation, n = 1). Grades 3 to 4 toxicities included neutropenia (34%), vasovagal syncope (10%), hypertension (7%), nausea/ vomiting (7%), hypomagnesemia (7%), and abdominal pain (7%). There were three grade 3 small bowel obstructions (7%) during cycles 3, 9, and 15. One patient died following rectosigmoid anastomotic dehiscence during cycle 4. Estimated median PFS is 28.6 months (95% CI, 19.1 to 38.9 months). Three patients (7%) had IP port malfunction. Conclusion: The addition of bevacizumab to this IP regimen is feasible; however, bevacizumab may increase the risk of bowel obstruction/perforation. The observed median PFS is similar to that seen with IP/IV chemotherapy alone. © 2011 by American Society of Clinical Oncology.
Keywords: adult; clinical article; aged; disease-free survival; middle aged; drug tolerability; fatigue; neutropenia; bevacizumab; cisplatin; cancer growth; drug efficacy; drug safety; drug withdrawal; hypertension; side effect; treatment duration; paclitaxel; adjuvant therapy; chemotherapy, adjuvant; cancer staging; neoplasm staging; ovarian neoplasms; multiple cycle treatment; ovary cancer; anemia; leukopenia; thrombocytopenia; antineoplastic combined chemotherapy protocols; myalgia; vagina disease; deep vein thrombosis; abdominal pain; arthralgia; dizziness; drug hypersensitivity; febrile neutropenia; hypomagnesemia; lymphocytopenia; syncope; drug induced headache; hypokalemia; hyponatremia; add on therapy; pilot projects; conservative treatment; adjuvant chemotherapy; patient compliance; single drug dose; nausea and vomiting; platinum derivative; intestine perforation; taxane derivative; intestine obstruction; recombinant granulocyte colony stimulating factor; epistaxis; brain hemorrhage; infusions, parenteral; bone marrow toxicity; tumor perforation; neoplasms, glandular and epithelial; novel erythropoiesis stimulating protein; peritonitis; pharynx disease; abdonial pain; anastomosis dehiscence; mouth infection; nose disease; vagina irritation; voice change; antibodies, monoclonal, humanized
Journal Title: Journal of Clinical Oncology
Volume: 29
Issue: 35
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2011-12-01
Start Page: 4662
End Page: 4668
Language: English
DOI: 10.1200/jco.2011.36.1352
PROVIDER: scopus
PUBMED: 22067389
PMCID: PMC3667619
DOI/URL:
Notes: --- - "Export Date: 3 January 2012" - "CODEN: JCOND" - "Source: Scopus"
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MSK Authors
  1. Jason Konner
    84 Konner
  2. Paul J Sabbatini
    199 Sabbatini
  3. Alexia Elia Iasonos
    179 Iasonos
  4. Scott R Gerst
    42 Gerst
  5. Martee L Hensley
    220 Hensley
  6. William P Tew
    122 Tew
  7. David R Spriggs
    312 Spriggs
  8. Howard T Thaler
    191 Thaler
  9. Diana M Grabon
    2 Grabon