Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer

Stephen A. Cannistra, Ursula A. Matulonis, Richard T. Penson, Julie Hambleton, Jakob Dupont, Howard Mackey, Jeffrey Douglas, Robert A. Burger, Deborah Kay Armstrong, Robert Wenham, William McGuire

Research output: Contribution to journalArticle

Abstract

Purpose: We evaluated the efficacy and safety of bevacizumab in patients with platinum-resistant epithelial ovarian carcinoma (EOC) or peritoneal serous carcinoma (PSC) who had experienced disease progression during, or within 3 months of discontinuing, topotecan or liposomal doxorubicin. Patients and Methods: No more than three prior treatment regimens were allowed. Patients received single-agent bevacizumab 15 mg/kg intravenously every 3 weeks. Response was assessed by computed tomography (CT) scan every 6 weeks using Response Evaluation Criteria in Solid Tumors (RECIST). Results: Of 44 patients treated, 83.7% were primarily platinum resistant, 59.1% had received liposomal doxorubicin, 25% topotecan, 15.9% both agents, and 47.7% had received three prior chemotherapy regimens. A median of five (range, two to 16) bevacizumab doses were administered. Partial responses were observed in seven patients (15.9%). Median progression-free survival was 4.4 months (95% CI, 3.1 to 5.5 months), with a median survival duration of 10.7 months at study termination. Bevacizumab-associated grade 3 to 4 events included hypertension (9.1%), proteinuria (15.9%), bleeding (2.3%), and wound-healing complications (2.3%). The incidence of GI perforation (GIP; 11.4%) was higher than reported in bevacizumab trials of other tumor types. GIP occurred in 23.8% of patients receiving three prior chemotherapy regimens, compared with 0% of patients receiving two prior chemotherapy regimens (P <.01). A trend toward higher risk of GIP was observed for patients with bowel wall thickening or bowel obstruction on CT scan. Arterial thromboembolic events occurred in three patients (6.8%). Three deaths were related to bevacizumab treatment. Conclusion: Bevacizumab has single-agent activity in patients with platinum-resistant EOC or PSC. A higher than expected incidence of GIP was noted in these heavily pretreated patients.

Original languageEnglish (US)
Pages (from-to)5180-5186
Number of pages7
JournalJournal of Clinical Oncology
Volume25
Issue number33
DOIs
StatePublished - Nov 20 2007

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Platinum
Ovarian Neoplasms
Neoplasms
Topotecan
Carcinoma
Drug Therapy
Bevacizumab
Tomography
Incidence
Proteinuria
Wound Healing
Disease-Free Survival
Disease Progression
Hemorrhage
Hypertension
Safety
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Cannistra, S. A., Matulonis, U. A., Penson, R. T., Hambleton, J., Dupont, J., Mackey, H., ... McGuire, W. (2007). Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. Journal of Clinical Oncology, 25(33), 5180-5186. https://doi.org/10.1200/JCO.2007.12.0782

Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. / Cannistra, Stephen A.; Matulonis, Ursula A.; Penson, Richard T.; Hambleton, Julie; Dupont, Jakob; Mackey, Howard; Douglas, Jeffrey; Burger, Robert A.; Armstrong, Deborah Kay; Wenham, Robert; McGuire, William.

In: Journal of Clinical Oncology, Vol. 25, No. 33, 20.11.2007, p. 5180-5186.

Research output: Contribution to journalArticle

Cannistra, SA, Matulonis, UA, Penson, RT, Hambleton, J, Dupont, J, Mackey, H, Douglas, J, Burger, RA, Armstrong, DK, Wenham, R & McGuire, W 2007, 'Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer', Journal of Clinical Oncology, vol. 25, no. 33, pp. 5180-5186. https://doi.org/10.1200/JCO.2007.12.0782
Cannistra, Stephen A. ; Matulonis, Ursula A. ; Penson, Richard T. ; Hambleton, Julie ; Dupont, Jakob ; Mackey, Howard ; Douglas, Jeffrey ; Burger, Robert A. ; Armstrong, Deborah Kay ; Wenham, Robert ; McGuire, William. / Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 33. pp. 5180-5186.
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T1 - Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer

AU - Cannistra, Stephen A.

AU - Matulonis, Ursula A.

AU - Penson, Richard T.

AU - Hambleton, Julie

AU - Dupont, Jakob

AU - Mackey, Howard

AU - Douglas, Jeffrey

AU - Burger, Robert A.

AU - Armstrong, Deborah Kay

AU - Wenham, Robert

AU - McGuire, William

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N2 - Purpose: We evaluated the efficacy and safety of bevacizumab in patients with platinum-resistant epithelial ovarian carcinoma (EOC) or peritoneal serous carcinoma (PSC) who had experienced disease progression during, or within 3 months of discontinuing, topotecan or liposomal doxorubicin. Patients and Methods: No more than three prior treatment regimens were allowed. Patients received single-agent bevacizumab 15 mg/kg intravenously every 3 weeks. Response was assessed by computed tomography (CT) scan every 6 weeks using Response Evaluation Criteria in Solid Tumors (RECIST). Results: Of 44 patients treated, 83.7% were primarily platinum resistant, 59.1% had received liposomal doxorubicin, 25% topotecan, 15.9% both agents, and 47.7% had received three prior chemotherapy regimens. A median of five (range, two to 16) bevacizumab doses were administered. Partial responses were observed in seven patients (15.9%). Median progression-free survival was 4.4 months (95% CI, 3.1 to 5.5 months), with a median survival duration of 10.7 months at study termination. Bevacizumab-associated grade 3 to 4 events included hypertension (9.1%), proteinuria (15.9%), bleeding (2.3%), and wound-healing complications (2.3%). The incidence of GI perforation (GIP; 11.4%) was higher than reported in bevacizumab trials of other tumor types. GIP occurred in 23.8% of patients receiving three prior chemotherapy regimens, compared with 0% of patients receiving two prior chemotherapy regimens (P <.01). A trend toward higher risk of GIP was observed for patients with bowel wall thickening or bowel obstruction on CT scan. Arterial thromboembolic events occurred in three patients (6.8%). Three deaths were related to bevacizumab treatment. Conclusion: Bevacizumab has single-agent activity in patients with platinum-resistant EOC or PSC. A higher than expected incidence of GIP was noted in these heavily pretreated patients.

AB - Purpose: We evaluated the efficacy and safety of bevacizumab in patients with platinum-resistant epithelial ovarian carcinoma (EOC) or peritoneal serous carcinoma (PSC) who had experienced disease progression during, or within 3 months of discontinuing, topotecan or liposomal doxorubicin. Patients and Methods: No more than three prior treatment regimens were allowed. Patients received single-agent bevacizumab 15 mg/kg intravenously every 3 weeks. Response was assessed by computed tomography (CT) scan every 6 weeks using Response Evaluation Criteria in Solid Tumors (RECIST). Results: Of 44 patients treated, 83.7% were primarily platinum resistant, 59.1% had received liposomal doxorubicin, 25% topotecan, 15.9% both agents, and 47.7% had received three prior chemotherapy regimens. A median of five (range, two to 16) bevacizumab doses were administered. Partial responses were observed in seven patients (15.9%). Median progression-free survival was 4.4 months (95% CI, 3.1 to 5.5 months), with a median survival duration of 10.7 months at study termination. Bevacizumab-associated grade 3 to 4 events included hypertension (9.1%), proteinuria (15.9%), bleeding (2.3%), and wound-healing complications (2.3%). The incidence of GI perforation (GIP; 11.4%) was higher than reported in bevacizumab trials of other tumor types. GIP occurred in 23.8% of patients receiving three prior chemotherapy regimens, compared with 0% of patients receiving two prior chemotherapy regimens (P <.01). A trend toward higher risk of GIP was observed for patients with bowel wall thickening or bowel obstruction on CT scan. Arterial thromboembolic events occurred in three patients (6.8%). Three deaths were related to bevacizumab treatment. Conclusion: Bevacizumab has single-agent activity in patients with platinum-resistant EOC or PSC. A higher than expected incidence of GIP was noted in these heavily pretreated patients.

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