Phase II study of bevacizumab and pemetrexed for recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer

Andrea R. Hagemann, Akiva P. Novetsky, Israel Zighelboim, Feng Gao, L. Stewart Massad, Premal H. Thaker, Matthew A. Powell, David G. Mutch, Jason D. Wright

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Objective We aimed to evaluate the efficacy and safety of combination bevacizumab/pemetrexed for the treatment of recurrent epithelial ovarian cancer (EOC). Methods Platinum-sensitive or-resistant patients with recurrent or persistent EOC were eligible if they had received up to 2 prior chemotherapy regimens, including a platinum/taxane regimen without prior bevacizumab. Pemetrexed 500 mg/m2 IV and bevacizumab 15 mg/kg IV were administered every 3 weeks. The primary endpoint was 6-month progression-free survival (PFS); other endpoints included toxicities, PFS and overall survival (OS). Results Thirty-four patients received a median of 7 treatment cycles (range, 2-26). Median follow-up was 25.7 months (range, 3.0-47.2). Six month progression-free survival (PFS) was 56% (95% CI: 38-71). The following response rates were documented (%; 95% CI): 0 complete response, 14 partial responses (41%; 25-59), 18 stable disease (53%; 35-70) and 2 progressive disease (6%; 1-20). Median PFS was 7.9 months (95% CI, 4.6-10.9), with a median OS of 25.7 months (95% CI, 15.4-29.8). Twenty-two patients (64.7%) had a platinum-free interval (PFI) of > 6 months prior to enrollment. Grade 3-4 hematologic toxicities included neutropenia (50%), leukopenia (26%), thrombocytopenia (12%) and anemia (9%). Non-hematologic grade 3-4 toxicities included metabolic (29%), constitutional (18%), pain (18%) and gastrointestinal (15%). Two patients developed hematologic malignancies within one year of treatment. Conclusions Combination bevacizumab/pemetrexed is an active option for both platinum-sensitive and-resistant recurrent EOC. Further investigation of cost and novel toxicities associated with this regimen may be warranted.

Original languageEnglish (US)
Pages (from-to)535-540
Number of pages6
JournalGynecologic Oncology
Volume131
Issue number3
DOIs
StatePublished - Dec 2013
Externally publishedYes

Fingerprint

Pemetrexed
Fallopian Tubes
Platinum
Disease-Free Survival
Neoplasms
Survival
Leukopenia
Hematologic Neoplasms
Neutropenia
Thrombocytopenia
Anemia
Therapeutics
Safety
Costs and Cost Analysis
Drug Therapy
Pain
Bevacizumab
Ovarian epithelial cancer

Keywords

  • Bevacizumab
  • Pemetrexed
  • Phase II
  • Recurrent ovarian cancer

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Hagemann, A. R., Novetsky, A. P., Zighelboim, I., Gao, F., Massad, L. S., Thaker, P. H., ... Wright, J. D. (2013). Phase II study of bevacizumab and pemetrexed for recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer. Gynecologic Oncology, 131(3), 535-540. https://doi.org/10.1016/j.ygyno.2013.09.032

Phase II study of bevacizumab and pemetrexed for recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer. / Hagemann, Andrea R.; Novetsky, Akiva P.; Zighelboim, Israel; Gao, Feng; Massad, L. Stewart; Thaker, Premal H.; Powell, Matthew A.; Mutch, David G.; Wright, Jason D.

In: Gynecologic Oncology, Vol. 131, No. 3, 12.2013, p. 535-540.

Research output: Contribution to journalArticle

Hagemann, AR, Novetsky, AP, Zighelboim, I, Gao, F, Massad, LS, Thaker, PH, Powell, MA, Mutch, DG & Wright, JD 2013, 'Phase II study of bevacizumab and pemetrexed for recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer', Gynecologic Oncology, vol. 131, no. 3, pp. 535-540. https://doi.org/10.1016/j.ygyno.2013.09.032
Hagemann, Andrea R. ; Novetsky, Akiva P. ; Zighelboim, Israel ; Gao, Feng ; Massad, L. Stewart ; Thaker, Premal H. ; Powell, Matthew A. ; Mutch, David G. ; Wright, Jason D. / Phase II study of bevacizumab and pemetrexed for recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer. In: Gynecologic Oncology. 2013 ; Vol. 131, No. 3. pp. 535-540.
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abstract = "Objective We aimed to evaluate the efficacy and safety of combination bevacizumab/pemetrexed for the treatment of recurrent epithelial ovarian cancer (EOC). Methods Platinum-sensitive or-resistant patients with recurrent or persistent EOC were eligible if they had received up to 2 prior chemotherapy regimens, including a platinum/taxane regimen without prior bevacizumab. Pemetrexed 500 mg/m2 IV and bevacizumab 15 mg/kg IV were administered every 3 weeks. The primary endpoint was 6-month progression-free survival (PFS); other endpoints included toxicities, PFS and overall survival (OS). Results Thirty-four patients received a median of 7 treatment cycles (range, 2-26). Median follow-up was 25.7 months (range, 3.0-47.2). Six month progression-free survival (PFS) was 56{\%} (95{\%} CI: 38-71). The following response rates were documented ({\%}; 95{\%} CI): 0 complete response, 14 partial responses (41{\%}; 25-59), 18 stable disease (53{\%}; 35-70) and 2 progressive disease (6{\%}; 1-20). Median PFS was 7.9 months (95{\%} CI, 4.6-10.9), with a median OS of 25.7 months (95{\%} CI, 15.4-29.8). Twenty-two patients (64.7{\%}) had a platinum-free interval (PFI) of > 6 months prior to enrollment. Grade 3-4 hematologic toxicities included neutropenia (50{\%}), leukopenia (26{\%}), thrombocytopenia (12{\%}) and anemia (9{\%}). Non-hematologic grade 3-4 toxicities included metabolic (29{\%}), constitutional (18{\%}), pain (18{\%}) and gastrointestinal (15{\%}). Two patients developed hematologic malignancies within one year of treatment. Conclusions Combination bevacizumab/pemetrexed is an active option for both platinum-sensitive and-resistant recurrent EOC. Further investigation of cost and novel toxicities associated with this regimen may be warranted.",
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T1 - Phase II study of bevacizumab and pemetrexed for recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer

AU - Hagemann, Andrea R.

AU - Novetsky, Akiva P.

AU - Zighelboim, Israel

AU - Gao, Feng

AU - Massad, L. Stewart

AU - Thaker, Premal H.

AU - Powell, Matthew A.

AU - Mutch, David G.

AU - Wright, Jason D.

PY - 2013/12

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N2 - Objective We aimed to evaluate the efficacy and safety of combination bevacizumab/pemetrexed for the treatment of recurrent epithelial ovarian cancer (EOC). Methods Platinum-sensitive or-resistant patients with recurrent or persistent EOC were eligible if they had received up to 2 prior chemotherapy regimens, including a platinum/taxane regimen without prior bevacizumab. Pemetrexed 500 mg/m2 IV and bevacizumab 15 mg/kg IV were administered every 3 weeks. The primary endpoint was 6-month progression-free survival (PFS); other endpoints included toxicities, PFS and overall survival (OS). Results Thirty-four patients received a median of 7 treatment cycles (range, 2-26). Median follow-up was 25.7 months (range, 3.0-47.2). Six month progression-free survival (PFS) was 56% (95% CI: 38-71). The following response rates were documented (%; 95% CI): 0 complete response, 14 partial responses (41%; 25-59), 18 stable disease (53%; 35-70) and 2 progressive disease (6%; 1-20). Median PFS was 7.9 months (95% CI, 4.6-10.9), with a median OS of 25.7 months (95% CI, 15.4-29.8). Twenty-two patients (64.7%) had a platinum-free interval (PFI) of > 6 months prior to enrollment. Grade 3-4 hematologic toxicities included neutropenia (50%), leukopenia (26%), thrombocytopenia (12%) and anemia (9%). Non-hematologic grade 3-4 toxicities included metabolic (29%), constitutional (18%), pain (18%) and gastrointestinal (15%). Two patients developed hematologic malignancies within one year of treatment. Conclusions Combination bevacizumab/pemetrexed is an active option for both platinum-sensitive and-resistant recurrent EOC. Further investigation of cost and novel toxicities associated with this regimen may be warranted.

AB - Objective We aimed to evaluate the efficacy and safety of combination bevacizumab/pemetrexed for the treatment of recurrent epithelial ovarian cancer (EOC). Methods Platinum-sensitive or-resistant patients with recurrent or persistent EOC were eligible if they had received up to 2 prior chemotherapy regimens, including a platinum/taxane regimen without prior bevacizumab. Pemetrexed 500 mg/m2 IV and bevacizumab 15 mg/kg IV were administered every 3 weeks. The primary endpoint was 6-month progression-free survival (PFS); other endpoints included toxicities, PFS and overall survival (OS). Results Thirty-four patients received a median of 7 treatment cycles (range, 2-26). Median follow-up was 25.7 months (range, 3.0-47.2). Six month progression-free survival (PFS) was 56% (95% CI: 38-71). The following response rates were documented (%; 95% CI): 0 complete response, 14 partial responses (41%; 25-59), 18 stable disease (53%; 35-70) and 2 progressive disease (6%; 1-20). Median PFS was 7.9 months (95% CI, 4.6-10.9), with a median OS of 25.7 months (95% CI, 15.4-29.8). Twenty-two patients (64.7%) had a platinum-free interval (PFI) of > 6 months prior to enrollment. Grade 3-4 hematologic toxicities included neutropenia (50%), leukopenia (26%), thrombocytopenia (12%) and anemia (9%). Non-hematologic grade 3-4 toxicities included metabolic (29%), constitutional (18%), pain (18%) and gastrointestinal (15%). Two patients developed hematologic malignancies within one year of treatment. Conclusions Combination bevacizumab/pemetrexed is an active option for both platinum-sensitive and-resistant recurrent EOC. Further investigation of cost and novel toxicities associated with this regimen may be warranted.

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KW - Recurrent ovarian cancer

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