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Prognostic factors from a randomized phase III trial of paclitaxel and carboplatin versus paclitaxel and cisplatin in metastatic or recurrent cervical cancer: Japan Clinical Oncology Group (JCOG) trial: JCOG0505-S1

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Abstract

Purpose

The Japan Clinical Oncology Group (JCOG) trial JCOG0505 demonstrated the statistically significant non-inferiority of paclitaxel plus carboplatin (TC) to paclitaxel plus cisplatin (TP) in terms of overall survival (OS) in metastatic or recurrent cervical cancer. In that trial, patients were randomly assigned, adjusting for institution and known prognostic factors. The objective of this ancillary study was to evaluate the appropriateness of the adjustment factors used to have randomly assigned treatments and to investigate new potentially useful prognostic factors of paclitaxel plus platinum for future randomized trials in metastatic or recurrent cervical cancer.

Methods

The study subjects comprised 244 eligible patients in the JCOG0505 who were merged to have received either TC or TP. The effects of the following factors on OS were investigated using a Cox regression model taking into consideration the adjustment factors used in randomization in this trial (e.g., performance status [PS]) and other baseline factors, including platinum-free interval (PFI), pretreatment hemoglobin levels (PHLs), and pretreatment platelet counts (PPCs).

Results

The median follow-up was 17.6 months, and median OS was 18.0 months. The hazard ratio was 1.83 in patients with a PS of 1 or 2 (vs. 0; P = 0.0004; 95 % confidence interval [CI] 1.31–2.55), 2.92 in patients with a PFI of <6 months (vs. PFI of ≥12 months; P < 0.0001; 95 % CI 1.73–4.91), 2.09 in patients with a PFI of <12 months (vs. PFI of ≥12 months; P = 0.0034; 95 % CI 1.28–3.44), and 0.69 in patients with PHL higher than or equal to the median value (vs. less than the median; P = 0.016; 95 % CI 0.51–0.93). No significant differences were obtained for PPC or the other known factors.

Conclusions

In addition to the known prognostic factor of PS, which was used as an adjusting factor, a PFI of <12 months and lower PHL were newly demonstrated to be associated with poor outcomes in patients with metastatic or recurrent cervical cancer. These new prognostic factors should be validated in future prospective trials.

Clinical trial information

UMIN-CTR[http://www.umin.ac.jp/ctr/] ID: C000000335.

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Acknowledgments

This work was supported in part by the National Cancer Research and Development Fund (23-A-16, 23-A-17, 26-A-4). We are grateful to the members of the JCOG Data Center and JCOG Operations Office for their support in preparing the manuscript (Drs. Junko Eba, Tomonori Mizutani, Keisuke Kanato, Kenichi Nakamura, and Haruhiko Fukuda), statistical analysis (Mr. Junki Mizusawa), and data management (Ms. Kazumi Kubota).

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan

    Shin Nishio, Kimio Ushijima & Toshiharu Kamura

  2. Department of Obstetrics and Gynecology, Tohoku Medical and Pharmaceutical University Hospital, 1-12-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8512, Japan

    Ryo Kitagawa

  3. JCOG Data Center, Center for Research Administration and Support, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Taro Shibata

  4. Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan

    Hiroyuki Yoshikawa

  5. Department of Gynecology and Obstetrics, Kyoto University Hospital, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Kyoto, 606-8507, Japan

    Ikuo Konishi

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  1. Shin Nishio
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  2. Ryo Kitagawa
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Correspondence to Shin Nishio.

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Nishio, S., Kitagawa, R., Shibata, T. et al. Prognostic factors from a randomized phase III trial of paclitaxel and carboplatin versus paclitaxel and cisplatin in metastatic or recurrent cervical cancer: Japan Clinical Oncology Group (JCOG) trial: JCOG0505-S1. Cancer Chemother Pharmacol 78, 785–790 (2016). https://doi.org/10.1007/s00280-016-3133-4

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  • DOI: https://doi.org/10.1007/s00280-016-3133-4

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