Phase II Study of Intraperitoneal Paclitaxel Plus Cisplatin and Intravenous Paclitaxel Plus Bevacizumab As Adjuvant Treatment of Optimal Stage II/III Epithelial Ovarian Cancer
| Autor: | Martee L. Hensley, Jason A. Konner, David R. Spriggs, Alexia Iasonos, Paul Sabbatini, Katherine M. Bell-McGuinn, Scott R. Gerst, S. Pezzulli, Carol Aghajanian, Diana M. Grabon, William P. Tew, Howard T. Thaler |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Paclitaxel Bevacizumab medicine.medical_treatment Urology Phases of clinical research Pilot Projects Carcinoma Ovarian Epithelial Antibodies Monoclonal Humanized Disease-Free Survival chemistry.chemical_compound Internal medicine Antineoplastic Combined Chemotherapy Protocols Original Reports medicine Humans Infusions Parenteral Neoplasms Glandular and Epithelial Aged Neoplasm Staging Ovarian Neoplasms Cisplatin Chemotherapy business.industry Middle Aged medicine.disease Regimen Tolerability chemistry Chemotherapy Adjuvant Female Ovarian cancer business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 29:4662-4668 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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