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Comparison of the International Workshop Criteria and the Response Evaluation Criteria in Solid Tumors for indolent B-cell lymphoma

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Abstract

Background

[18F] fluorodeoxyglucose-positron emission tomography is incorporated in response criteria currently used for lymphoma; however, the primary endpoint in earlier phase study is an overall response, which includes the partial response of 50% shrinkage in two dimensions. Therefore, the measurement of target lesions is still prerequisite to determine the destiny of new, promising agents. Since required is calculating the sum of the product of bidimensional diameters of maximal six target lesions, the International Workshop Criteria (IWC) used as response evaluation in lymphoma is more time-consuming than the Response Evaluation Criteria in Solid Tumors (RECIST). This study aimed to examine whether the RECIST could replace the IWC using data from a phase II/III study of R-CHOP-21 versus R-CHOP-14 for advanced-stage indolent B-cell lymphoma, JCOG0203.

Methods

To evaluate the degree of agreement between them, the Kappa coefficient (KC) was calculated. Excluding patients without target lesions for the RECIST following central pathological review, 269 patients were evaluable. We determined which criterion was more predictive for progression-free survival. The criterion showing the lower point estimate of the hazard ratio (HR) of a complete response (CR) vs. a non-CR was defined as more useful.

Results

The KC between them was 0.34 (95% confidence interval [CI] 0.26–0.42); namely, indicating poor agreement. The HR of the IWC (0.47: 95% CI 0.33–0.68, log-rank test p < 0.001) was lower than that of the RECIST (0.64: 95% CI 0.45–0.89, p = 0.0075).

Conclusion

We conclude that unidimensional measurements cannot be substituted for the bidimensional ones for indolent lymphoma.

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Acknowledgements

The authors are grateful to patients who participated in JCOG0203, attending physicians of the Hospital, and the members of Lymphoma Study Group of JCOG and to the member of the JCOG operations office for his support in preparing manuscript and this study (Dr Hideaki Kitahara).

Funding

This work was supported in part by the National Cancer Center Research and Development Fund (26-A-4, 29-A-3).

Author information

Authors and Affiliations

  1. Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center, 5-1-1, Tsukiji, Chu-o-ku, Tokyo, 104-0045, Japan

    Kenichi Miyamoto, Masashi Wakabayashi, Kenichi Nakamura, Yuko Watanabe & Haruhiko Fukuda

  2. Department of Personalized Cancer Immunotherapy, Mie University Graduate School of Medicine, Mie, Japan

    Takashi Watanabe

  3. Department of Hematology, National Cancer Center Hospital, Tokyo, Japan

    Takashi Watanabe, Dai Maruyama & Kensei Tobinai

  4. Department of Hematology, International Medical Center, Saitama Medical University, Saitama, Japan

    Kunihiro Tsukasaki

Authors
  1. Kenichi Miyamoto
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  2. Takashi Watanabe
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  3. Masashi Wakabayashi
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  4. Kenichi Nakamura
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  5. Yuko Watanabe
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  6. Dai Maruyama
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  7. Kensei Tobinai
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  8. Kunihiro Tsukasaki
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  9. Haruhiko Fukuda
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Corresponding author

Correspondence to Kenichi Miyamoto.

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Conflict of interest

KM: No conflicts to disclose. TW: Received honoraria from Bristol-Meyers Squibb, AstraZeneca Pharmaceutical, and Chugai Pharmaceutical, received funding resources from Takara Bio Inc, United Immunity, Co., Ltd., and BrightPath Biotherapeutics Co., Ltd. MW: No conflicts to disclose. KN: No conflicts to disclose. YW: No conflicts to disclose. DM: Received patent licensing fees from Mundi Pharma, Janssen Pharmaceutical, Chugai Pharmaceutical, Eisai, received research funding from Mundi Pharma, Janssen Pharmaceutical, Chugai Pharmaceutical, Eisai, Ono Pharmaceutical, Celgene, AbbVie. KT: Advisory role of Mundi Pharma, Zenyaku Kogyo, HUYA Bioscience International, Daiichi Sankyo, Ono Pharmaceutical, Takeda Pharmaceutical, received honoraria from Mundi Pharma, Zenyaku Kogyo, HUYA Bioscience International, Eisai, Kyowa Kirin, Ono Pharmaceutical, Takeda Pharmaceutical, Celgene, and Chugai Pharmaceutical, received research funding from Mundi Pharma, Kyowa Kirin, Janssen Pharmaceutical, Chugai Pharmaceutical, Eisai, Ono Pharmaceutical, Celgene, Takeda Pharmaceutical, AbbVie. KT: Advisory role of HUYA Bioscience International, Daiichi Sankyo, Ono Pharmaceutical, received honoraria from Mundi Pharma, Eisai, Kyowa Kirin, Bayer, Takeda Pharmaceutical, Celgene, and Chugai Pharmaceutical, received research funding from Daiichi Sankyo, HUYA Bioscience International, Chugai Pharmaceutical, Eisai, Bayer, Celgene. HF: No conflicts to disclose.

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Miyamoto, K., Watanabe, T., Wakabayashi, M. et al. Comparison of the International Workshop Criteria and the Response Evaluation Criteria in Solid Tumors for indolent B-cell lymphoma. Int J Clin Oncol 26, 429–437 (2021). https://doi.org/10.1007/s10147-020-01800-z

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  • DOI: https://doi.org/10.1007/s10147-020-01800-z

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