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Int J Radiat Oncol Biol Phys ; 109(3): 701-711, 2021 03 01.
Article in English | MEDLINE | ID: mdl-33045316

ABSTRACT

PURPOSE: Low-dose fractionated whole abdominal radiation therapy (LDFWART) has synergistic activity with paclitaxel in preclinical models. The aim of this phase 1 trial was to determine the recommended phase 2 dose and preliminary activity of weekly paclitaxel (wP) concurrent with LDFWART in patients with platinum-resistant ovarian cancer (PROC). METHODS AND MATERIALS: Patients were enrolled at de-escalating dose levels of wP (part A), starting at 80 mg/m2, concurrent with fixed-dose LDFWART delivered in 60 cGy fractions twice-daily, 2 days per week, for 6 continuous weeks. After completing the 6-week course of wP + LDFWART, patients received wP until disease progression. Dose-limiting toxicity was evaluated during the first 3 weeks of wP + LDFWART. At wP (80 mg/m2) + LDFWART, no dose-limiting toxicities were observed; this was the established maximum tolerated dose. The trial was expanded (part B) with 7 additional patients with platinum-resistant, high-grade serous ovarian cancer to confirm toxicity and activity. RESULTS: A total of 10 heavily pretreated patients were recruited (3 patients to part A, 7 patients to part B). They had received a median of 5 prior lines of therapy, and 70% of patients had received prior wP; 60% of patients completed 6 weeks of wP + LDFWART. Common related grade ≥3 adverse events were neutropenia (60%) and anemia (30%). Median progression-free survival was 3.2 months, and overall survival was 13.5 months. Of patients evaluable for response, 33% (3 of 9) achieved confirmed biochemical response (CA125 decrease >50% from baseline), 11% (1) achieved a partial response, and 5 patients had stable disease, giving a disease control rate of 66.7% (6 of 9). Four patients had durable disease control of ≥12 weeks, completing 12 to 21 weeks of wP. CONCLUSIONS: The recommended phase 2 dose of wP + LDFWART for 6 weeks is 80 mg/m2. Encouraging efficacy in heavily pretreated PROC patients was observed, suggesting that further development of this therapeutic strategy in PROC should be considered.


Subject(s)
Antineoplastic Agents, Phytogenic/administration & dosage , Chemoradiotherapy/methods , Ovarian Neoplasms/therapy , Paclitaxel/administration & dosage , Abdomen , Adult , Aged , Anemia/chemically induced , Antineoplastic Agents, Phytogenic/adverse effects , Disease Progression , Dose Fractionation, Radiation , Drug Administration Schedule , Drug Resistance, Neoplasm , Female , Humans , Maximum Tolerated Dose , Middle Aged , Neutropenia/etiology , Ovarian Neoplasms/mortality , Paclitaxel/adverse effects , Patient Reported Outcome Measures , Platinum Compounds/therapeutic use , Progression-Free Survival
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