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Prospective feasibility study of neoadjuvant dose-dense paclitaxel plus carboplatin with bevacizumab therapy followed by interval debulking surgery for advanced ovarian, fallopian tube, and primary peritoneal cancer patients

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Abstract

Background

This study aimed to investigate the clinical benefit of dose-dense paclitaxel plus carboplatin (TC) with bevacizumab therapy for advanced ovarian, fallopian tube, and primary peritoneal cancer patients in the neoadjuvant setting.

Methods

Ovarian, fallopian tube or primary peritoneal cancer patients with stage III–IV disease received neoadjuvant chemotherapy (NAC) every 3 weeks consisting of paclitaxel (80 mg/m2) on days 1, 8, and 15; carboplatin (AUC 6.0 mg/mL × min.) on day 1; and bevacizumab (15 mg/kg) on day 1. Interval debulking surgery (IDS) was performed after 3 cycles of dose-dense TC-bevacizumab therapy. The primary endpoint was the rate of complete resection by IDS. Secondary endpoints were treatment completion rate, treatment exposure, response rate to NAC, adverse events, and perioperative complications.

Results

Twenty-four patients were included in this study. The median age was 55.5 years (37–80 years), and most patients had high-grade serous carcinoma accounted (n = 18). IDS was performed in all patients with complete resection achieved in 75% (95% confidence interval: 57.7–92.3%). The lower limit exceeded the preset threshold rate of 55%. The response rate to NAC was 79%, and serum CA125 levels were in the normal range after NAC in 57% of patients. Grade 4 hematological toxicities and grade 3/4 non-hematological toxicities occurred in 29% and 17% of patients during NAC, respectively. Grade 3/4 perioperative complications were seen in 29% of patients, but no gastrointestinal perforations or treatment-related deaths occurred.

Conclusions

Neoadjuvant dose-dense TC-bevacizumab therapy was well tolerated, and a satisfactory rate of complete resection by IDS was achieved.

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Acknowledgements

This work was supported by JSPS KAKENHI Grant Number JP18K09297.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan

    Naomi Iwasa-Inoue, Hiroyuki Nomura, Fumio Kataoka, Tatsuyuki Chiyoda, Tomoko Yoshihama, Yoshiko Nanki, Kensuke Sakai, Yusuke Kobayashi, Wataru Yamagami, Tohru Morisada, Akira Hirasawa & Daisuke Aoki

  2. Department of Obstetrics and Gynecology, National Hospital Organization Saitama Hospital, Saitama, Japan

    Naomi Iwasa-Inoue

  3. Department of Obstetrics and Gynecology, School of Medicine, Fujita Health University, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, Japan

    Hiroyuki Nomura

  4. Department of Obstetrics and Gynecology, International University of Health and Welfare School of Medicine, Chiba, Japan

    Fumio Kataoka

  5. Department of Clinical Genomic Medicine, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan

    Akira Hirasawa

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  1. Naomi Iwasa-Inoue
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Correspondence to Hiroyuki Nomura.

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Conflict of interest

Hiroyuki Nomura reports grants from Japan Society for the Promotion of Science, during the conduct of the study. All other authors declare that they have no conflicts of interest.

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Iwasa-Inoue, N., Nomura, H., Kataoka, F. et al. Prospective feasibility study of neoadjuvant dose-dense paclitaxel plus carboplatin with bevacizumab therapy followed by interval debulking surgery for advanced ovarian, fallopian tube, and primary peritoneal cancer patients. Int J Clin Oncol 27, 441–447 (2022). https://doi.org/10.1007/s10147-021-02050-3

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  • DOI: https://doi.org/10.1007/s10147-021-02050-3

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