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Original research
Assessment of postoperative therapy de-escalation for early-stage, intermediate-risk cervical cancer
  1. Koji Matsuo1,2,
  2. Muneaki Shimada3,
  3. Shinya Matsuzaki4,
  4. Hiroko Machida5,
  5. Shogo Shigeta3,
  6. Hiroshi Yoshida5,
  7. Kazuyoshi Kato6,
  8. Hiroyuki Kanao7,
  9. Munetaka Takekuma8,
  10. Mikio Mikami5 and
  11. Aiko Okamoto9
    1. 1Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Southern California, Los Angeles, CA, USA
    2. 2Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA
    3. 3Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
    4. 4Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan
    5. 5Department of Obstetrics and Gynecology, Tokai University School of Medicine, Isehara, Kanagawa, Japan
    6. 6Department of Obstetrics and Gynecology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan
    7. 7Department of Gynecology, Cancer Institute Hospital of JFCR, Tokyo, Tokyo, Japan
    8. 8Department of Gynecology, Shizuoka Cancer Center Hospital, Sunto-gun, Shizuoka, Japan
    9. 9Department of Obstetrics and Gynecology, Jikei University School of Medicine, Minato-ku, Japan
    1. Correspondence to Professor Dr Koji Matsuo, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Southern California, Los Angeles, CA, USA; koji.matsuo{at}med.usc.edu; Dr Muneaki Shimada, Department of Obstetrics and Gynecology, Tohoku University School of Medicine, Sendai, Miyagi, Japan; muneaki.shimada.b7{at}tohoku.ac.jp

    Abstract

    Objective The objective of this study was to assess the oncologic outcome of surgically-treated patients with early-stage, intermediate-risk cervical cancer according to postoperative therapy modality.

    Methods This retrospective cohort study queried the Japanese Gynecologic Oncology Group’s nationwide surgical data platform. The study population was 1084 patients with stage IB cervical cancer who underwent primary radical hysterectomy and lymphadenectomy from 2004 to 2008. Histology type-incorporated intermediate-risk factor patterns were clustered into three groups based on recurrence risk. Oncologic outcomes were assessed per postoperative therapy: external beam radiotherapy alone, concurrent chemo-radiotherapy, chemotherapy alone, and no treatment.

    Results Histology-incorporated intermediate-risk groups included: no lympho-vascular space invasion in any histology, or squamous cell carcinoma with lympho-vascular space invasion but no deep stromal invasion (n=559, 51.6%, group 1); squamous cell carcinoma with both lympho-vascular space invasion and deep cervical stromal invasion (n=281, 25.9%; group 2); and non-squamous histology with lympho-vascular space invasion (n=244, 22.5%; group 3). The 5-year disease-free survival rates were 93.3%, 89.3%, and 82.5% for group 1,–2, and −3, respectively (p<0.001), with group 3 exhibiting an almost three-fold increased recurrence risk compared with group 1 (adjusted-hazard ratio (aHR) 2.70, 95% confidence interval (CI) 1.70–4.32), followed by group 2 (aHR 1.67, 95% CI 1.01 to 2.75). Disease-free survival was similar across the postoperative therapy groups: 5 year rates for external beam radiotherapy alone, concurrent chemo-radiotherapy, chemotherapy alone, and no postoperative treatment, 94.8%, 87.2%, 93.6%, and 94.2% for group 1 (p=0.294); 85.0%, 93.3%, 87.3%, and 90.5% for group 2 (p=0.578); and 85.4%, 83.1%, 80.5%, and 83.3% for group 3 (p=0.876). The aHR for disease-free survival comparing no postoperative treatment to external beam radiotherapy alone was 1.10 (95% CI 0.37 to 3.28), 0.71 (95% CI 0.29 to 1.79), and 1.21 (95% CI 0.42 to 3.51) for group 1, group 2, and group 3, respectively. The observed exposure-outcome associations were similar for cause-specific survival (all, p>0.05).

    Conclusion In this retrospective investigation in Japan, active surveillance without postoperative therapy following radical hysterectomy and lymphadenectomy was not associated with oncologic outcome in early-stage, intermediate-risk cervical cancer.

    • Cervical Cancer

    Data availability statement

    No data are available. This study was conducted via the Japanese Gynecologic Oncology Group that forbids the transfer, rent, or sale of the data to any third party without prior approval. For inquiries about access to the data used for this study, the Japanese Gynecologic Oncology Group can be contacted at 4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, 162-0825, Japan (+81-35206-1982).

    https://doi.org/10.1136/ijgc-2024-005597

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      Data availability statement

      No data are available. This study was conducted via the Japanese Gynecologic Oncology Group that forbids the transfer, rent, or sale of the data to any third party without prior approval. For inquiries about access to the data used for this study, the Japanese Gynecologic Oncology Group can be contacted at 4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, 162-0825, Japan (+81-35206-1982).

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      Footnotes

      • Contributors Conceptualization: KM, MS; Data curation: MS; Formal analysis: KM; Funding acquisition: KM; Investigation: all authors; Methodology: KM; Project administration: MS; Resources: MS, MT, MM, AO; Software: KM; Supervision: MS, MT, MM, AO; Validation: KM; Visualization: KM; Writing original draft: KM; Writing, review and editing: all authors. KM and MS accept full responsibility for the finished work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

      • Funding Ensign Endowment for Gynecologic Cancer Research (KM). The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

      • Competing interests Research grant, Bristol Myers Squibb, honorarium, AstraZenaca (MH); none for the other authors.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.