Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: A Japan Clinical Oncology Group trial (JCOG 0102)

N. Katsumata, H. Yoshikawa, H. Kobayashi, T. Saito, K. Kuzuya, T. Nakanishi, T. Yasugi, N. Yaegashi, H. Yokota, S. Kodama, T. Mizunoe, M. Hiura, T. Kasamatsu, T. Shibata, T. Kamura

Research output: Contribution to journalArticle

59 Citations (Scopus)

Abstract

Background:A phase III trial was conducted to determine whether neoadjuvant chemotherapy (NACT) before radical surgery (RS) improves overall survival.Methods:Patients with stage IB2, IIA2, or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg days 1-5, vincristine 0.7 mg m-2 day 5, mitomycin 7 mg m-2 day 5, cisplatin 14 mg m-2 days 1-5, every 3 weeks for 2 to 4 cycles) plus RS (NACT group) or RS alone (RS group). Patients with pathological high-risk factors received postoperative radiotherapy (RT). The primary end point was overall survival.Results:A total of 134 patients were randomly assigned to treatment. This study was prematurely terminated at the first planned interim analysis because overall survival in the NACT group was inferior to that in the RS group. Patients who received postoperative RT were significantly lower in the NACT group (58%) than in the RS group (80%; P=0.015). The 5-year overall survival was 70.0% in the NACT group and 74.4% in the RS group (P=0.85).Conclusion: Neoadjuvant chemotherapy with BOMP regimen before RS did not improve overall survival, but reduced the number of patients who received postoperative RT.

Original languageEnglish
Pages (from-to)1957-1963
Number of pages7
JournalBritish Journal of Cancer
Volume108
Issue number10
DOIs
Publication statusPublished - 2013 May

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of 'Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: A Japan Clinical Oncology Group trial (JCOG 0102)'. Together they form a unique fingerprint.

  • Cite this

    Katsumata, N., Yoshikawa, H., Kobayashi, H., Saito, T., Kuzuya, K., Nakanishi, T., Yasugi, T., Yaegashi, N., Yokota, H., Kodama, S., Mizunoe, T., Hiura, M., Kasamatsu, T., Shibata, T., & Kamura, T. (2013). Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: A Japan Clinical Oncology Group trial (JCOG 0102). British Journal of Cancer, 108(10), 1957-1963. https://doi.org/10.1038/bjc.2013.179