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JGOG2046: a feasibility study of neoadjuvant chemotherapy followed by debulking surgery for clinically diagnosed FIGO stage IVb endometrial cancer

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Abstract

Background

We evaluated the feasibility of neoadjuvant chemotherapy, followed by debulking surgery, for clinically diagnosed FIGO stage IVb endometrial cancer (protocol number: JGOG2046).

Methods

The experimental treatment consisted of 3 cycles of paclitaxel (180 mg/m2) plus carboplatin (AUC5) followed by debulking surgery, including total abdominal hysterectomy, bilateral salpingo-oophorectomy, and 3 cycles of adjuvant chemotherapy. Patients were considered as eligible if they were pathologically diagnosed as primary endometrial cancer, and had both endometrial tumor and distant metastasis confirmed by imaging examinations. The primary endpoint was the incidence of patients who completed debulking surgery after the neoadjuvant chemotherapy.

Results

While 51 patients were enrolled from 23 hospitals, the final study cohort consisted of 49 patients with a mean age of 59.0 years. Although the response ratio of the neoadjuvant chemotherapy was 65.3% (95% CI 50.4–78.3%), 67.3% (95% confidence interval (CI) 52.5–80.1%) underwent debulking surgery after the neoadjuvant chemotherapy and 59.2% (95% CI 45.2–71.8%) completed the protocol treatment including 3 courses of adjuvant chemotherapy. The median disease-free survival time was 9.1 months (95% CI 6.5–11.9), while the median overall survival time was 23.2 months (95% CI 11.9–27.8). A patient with sigmoid colon cancer and another with cervical cancer were included in this study.

Conclusions

Neoadjuvant chemotherapy followed by debulking surgery was a feasible and acceptable treatment for metastatic endometrial cancer.

(225 words).

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Acknowledgements

We thank the patients, their families, all investigators, and onsite personnel of following institutions for participation in this study: Aichi Cancer Center Hospital, Kurume University, Keio University, National Defense Medical College, Kyushu Cancer Center, Ehime University, The Jikei University Kashiwa Hospital, Niigata Cancer Center Hospital, Ise Red Cross Hospital, Nara Prefecture General Medical Center, Kindai University, Gifu University, Saitama Medical University International Medical Center, Kagoshima City Hospital, Tohoku University, Toho University Ohashi Medical Center, Juntendo University Juntendo Hospital, Hiroshima Prefectural Hospital, Saitama Cancer Center Hospital, Hands City Hospital, Tokai University, Jichi Medical University, and Iwate Medical University. We thank Dr. Shiro Takahashi, Ms. Miwa Nonaka, Mr. Masahiko Watanabe, Dr Yuki Inokuchi, and Dr. Hirofumi Michimae, of the Japanese Gynecologic Oncology Group data center (Clinical Trial Coordinating Center, Kitasato Academic Research Organization, Kitasato University) for their role in data management and statistical analyses.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Faculty of Medicine, Tohoku Medical and Pharmaceutical University, 1-15-1 Fukumuro, Miyagino-Ku, Sendai, Miyagi, 983-8536, Japan

    Toru Nakanishi & Yo Watanabe

  2. Department of Gynecology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan

    Toru Nakanishi

  3. Gynecology Service, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan

    Toshiaki Saito

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

    Daisuke Aoki

  5. Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan

    Kimio Ushijima

  6. Department of Obstetrics and Gynecology, National Defense Medical College Hospital, Saitama, Japan

    Masashi Takano

  7. Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University, Morioka, Iwate, Japan

    Toru Sugiyama

  8. Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan

    Nobuo Yaegashi

  9. Department of Gynecologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan

    Kazuhiro Takehara

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  1. Toru Nakanishi
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  2. Toshiaki Saito
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  3. Daisuke Aoki
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  4. Yo Watanabe
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  5. Kimio Ushijima
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  6. Masashi Takano
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  7. Toru Sugiyama
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  8. Nobuo Yaegashi
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  9. Kazuhiro Takehara
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Correspondence to Toru Nakanishi.

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Nakanishi, T., Saito, T., Aoki, D. et al. JGOG2046: a feasibility study of neoadjuvant chemotherapy followed by debulking surgery for clinically diagnosed FIGO stage IVb endometrial cancer. Int J Clin Oncol 28, 436–444 (2023). https://doi.org/10.1007/s10147-022-02284-9

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  • DOI: https://doi.org/10.1007/s10147-022-02284-9

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