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• W2416520496 abstract "Objectives: To determine if one or both intraperitoneal chemotherapy (IP) regimens improve the progression-free survival (PFS) compared to intravenous (IV) chemotherapy for first-line treatment of patients diagnosed with optimally surgically resected stage II and III ovarian, peritoneal, or fallopian tube cancer.Methods: Eligible patients had stage II-IV epithelial ovarian, peritoneal, or fallopian tube carcinoma. They were treated with bevacizumab 15mg/kg IV on cycles 2-22, and randomized to receive six cycles of: Arm 1) IV carboplatin AUC 6/ IV weekly paclitaxel 80 mg/m2 (IV arm), or Arm 2) IP carboplatin AUC 6/ IV weekly paclitaxel 80 mg/m2/ (IP-carbo arm), or Arm 3) IV paclitaxel 135 mg/m2 day 1/IP cisplatin 75 mg/m2 day 2/IP paclitaxel 60 mg/m2 day 8 (IP-cis arm).Results: Among 1,560 trial participants, the median age was 58 years. Eighty-four percent had stage III disease, 72% had high grade serous histology, and 57% had no visible residual disease following optimal cytoreduction. Completion rates of platinum, taxane, or bevacizumab appear in Table 1. Cross-over to the IV-only therapy occurred in 16% randomized to IP carbo arm and 28% randomized to IP cis arm. Fifteen deaths possibly due to toxicity were relatively evenly distributed among treatment arms. Similarly, GI perforations/fistula/leak occurred in all three arms (range, 3.7% - 5.3%). While nearly 30% of patients in each arm reported grade 2+ peripheral neuropathy, treatment-induced HTN (20.5%) and grade 3/4 nausea and vomiting (11.2%) were observed more often in the IP cis arm. IP therapy did not confer a significant PFS advantage over IV only, with the median PFS by intent-to-treat being 24.9 (IV), 27.3 (IP carbo), and 26.0 mos (IP cis). Median PFS for stage II/III patients with 1 cm or less visible tumor was 26.8 (IV), 28.7 (IP carbo), and 27.8 mos (IP cis). Median PFS for stage III patients with no visible residual disease was 31.3, 31.8, and 33.8 months respectively. No statistically significant PFS benefit for IP was identified.Table 1Completion rates of platinum, taxane, or bevacizumab. Objectives: To determine if one or both intraperitoneal chemotherapy (IP) regimens improve the progression-free survival (PFS) compared to intravenous (IV) chemotherapy for first-line treatment of patients diagnosed with optimally surgically resected stage II and III ovarian, peritoneal, or fallopian tube cancer. Methods: Eligible patients had stage II-IV epithelial ovarian, peritoneal, or fallopian tube carcinoma. They were treated with bevacizumab 15mg/kg IV on cycles 2-22, and randomized to receive six cycles of: Arm 1) IV carboplatin AUC 6/ IV weekly paclitaxel 80 mg/m2 (IV arm), or Arm 2) IP carboplatin AUC 6/ IV weekly paclitaxel 80 mg/m2/ (IP-carbo arm), or Arm 3) IV paclitaxel 135 mg/m2 day 1/IP cisplatin 75 mg/m2 day 2/IP paclitaxel 60 mg/m2 day 8 (IP-cis arm). Results: Among 1,560 trial participants, the median age was 58 years. Eighty-four percent had stage III disease, 72% had high grade serous histology, and 57% had no visible residual disease following optimal cytoreduction. Completion rates of platinum, taxane, or bevacizumab appear in Table 1. Cross-over to the IV-only therapy occurred in 16% randomized to IP carbo arm and 28% randomized to IP cis arm. Fifteen deaths possibly due to toxicity were relatively evenly distributed among treatment arms. Similarly, GI perforations/fistula/leak occurred in all three arms (range, 3.7% - 5.3%). While nearly 30% of patients in each arm reported grade 2+ peripheral neuropathy, treatment-induced HTN (20.5%) and grade 3/4 nausea and vomiting (11.2%) were observed more often in the IP cis arm. IP therapy did not confer a significant PFS advantage over IV only, with the median PFS by intent-to-treat being 24.9 (IV), 27.3 (IP carbo), and 26.0 mos (IP cis). Median PFS for stage II/III patients with 1 cm or less visible tumor was 26.8 (IV), 28.7 (IP carbo), and 27.8 mos (IP cis). Median PFS for stage III patients with no visible residual disease was 31.3, 31.8, and 33.8 months respectively. No statistically significant PFS benefit for IP was identified." @default.
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• W2416520496 date "2016-06-01" @default.
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• W2416520496 title "A phase III trial of bevacizumab with IV versus IP chemotherapy for ovarian, fallopian tube, and peritoneal carcinoma: An NRG Oncology Study" @default.
• W2416520496 doi "https://doi.org/10.1016/j.ygyno.2016.04.535" @default.
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