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Real-World Treatment Sequencing in Vulnerable Patients with Metastatic Colorectal Cancer: A Multicenter Retrospective Study

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Abstract

Background

Data regarding treatment sequence for vulnerable patients with metastatic colorectal cancer (mCRC) in a real-world setting are lacking.

Objective

We aimed to assess treatment outcomes in second-line or later chemotherapy for vulnerable patients with mCRC in a real-world setting.

Patients and Methods

Vulnerable patients with mCRC who received less intensive treatment (‘vulnerable’) regimens, i.e. fluoropyrimidines with or without biologics (FP), reduced-dose doublet regimens with or without biologics (Doublet), and anti-epidermal growth factor receptor monotherapy (Anti-EGFR), as first-line therapy between June 2015 and December 2018 were retrospectively reviewed.

Results

A total of 210 patients from 15 hospitals were analyzed. The median age was 78 years (range 28–90), and 44 patients (21%) had an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 2. In the entire population, the median time to treatment failure (TTF) and overall survival (OS) were 7.6 and 21.4 months, respectively. Following the failure of first-line therapy in 195 patients, 74 (38%), 24 (12%), and 13 (7%) patients received vulnerable regimens, full-dose doublet regimens with or without biologics, and other regimens, respectively, whereas 84 (43%) received best supportive care (BSC). In patients receiving vulnerable regimens as second-line therapy, the median TTF and OS were 4.4 and 13.7 months, respectively, while response rate and disease control rate were 18% and 62%, respectively. In 84 patients who received BSC, the median OS was 3.5 months.

Conclusions

Second-line chemotherapy for vulnerable patients with mCRC showed clinically meaningful outcomes; however, few patients received second-line therapy, and survival among patients who received BSC was dismal.

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Acknowledgments

The authors would like to thank Enago (www.enago.jp) for the English language review.

Author information

Author notes

  1. Seiichiro Mitani and Yosuke Kito contributed equally to this study.

Authors and Affiliations

  1. Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan

    Seiichiro Mitani & Hisato Kawakami

  2. Department of Medical Oncology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan

    Yosuke Kito

  3. Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan

    Kaori Hino & Azusa Komori

  4. Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan

    Kentaro Kawakami

  5. Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan

    Naoki Izawa

  6. Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan

    Fumiyasu Hanamura

  7. Department of Gastroenterology and Hepatology, University of Tsukuba Hospital, Tsukuba, Japan

    Yoshiyuki Yamamoto

  8. Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan

    Hirokazu Shoji

  9. Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan

    Azusa Komori

  10. Cancer Treatment Center, Kansai Medical University Hospital, Hirakata, Japan

    Shogen Boku & Toshihiko Matsumoto

  11. Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan

    Kenji Tsuchihashi

  12. Department of Medical Oncology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan

    Kyoko Kato

  13. Department of Medical Oncology, Kishiwada City Hospital, Kishiwada, Japan

    Yoshikane Nonagase

  14. Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan

    Toshihiko Matsumoto

  15. Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan

    Mitsuhiro Furuta

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  1. Seiichiro Mitani
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Corresponding author

Correspondence to Hisato Kawakami.

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Funding

No external funding was used in the preparation of this manuscript.

Conflicts of Interest

Seiichiro Mitani received payment or honoraria from Taiho Pharmaceutical Co. and MSD K.K., and participation on the advisory board of Chugai Pharmaceutical Co. Ltd. Yosuke Kito received honoraria from Taiho Pharmaceutical Co., Ono Pharmaceutical Co., and Daiichi Sankyo. Kenji Tsuchihashi received grants from Ono Pharmaceutical Co. Toshihiko Matsumoto received payment or honoraria from Bayer Co. Ltd, Bristol Myers Squibb Co. Ltd, Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Eli Lilly Japan K.K., Merck Biopharma Co. Ltd, MSD Co. Ltd, Ono Pharmaceutical Co. Ltd, Sanofi Co. Ltd, Taiho Pharmaceutical Co. Ltd, Takeda Pharmaceutical Co. Ltd, and Teijin Pharmaceutical Co. Hisato Kawakami received consulting fees from Daiichi-Sankyo Co. Ltd; honoraria from Bristol-Myers Squibb Co. Ltd, Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd, Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Merck Biopharma Co., Ltd, Takeda Pharmaceutical Co. Ltd, Yakult Pharmaceutical Industry, Teijin Pharma Ltd, Incyte Biosciences Japan, Yakult Pharmaceutical Industry, Taiho Pharmaceutical Co. Ltd, Glaxo Smith Kline K.K., and Otsuka Pharmaceutical Co., Ltd; and research funding from Chugai Pharmaceutical Co. Ltd, Taiho Pharmaceutical Co. Ltd, Kobayashi Pharmaceutical. Co., Ltd, and Eisai Co. Ltd. Kaori Hino, Kentaro Kawakami, Naoki Izawa, Fumiyasu Hanamura, Yoshiyuki Yamamoto, Hirokazu Shoji, Azusa Komori, Shogen Boku, Kyoko Kato, Yoshikane Nonagase, Mitsuhiro Furuta have no potential conflicts of interest to declare.

Ethics Approval

All procedures were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and its later versions. This study was reviewed and approved by the Institutional Review Boards of Kindai University (number: R03-183), and, subsequently, approval by all the participating Institutional Review Boards was obtained.

Consent to Participate and for Publication

Informed consent, or a substitute for it, was obtained from all patients included in this study.

Availability of Data and Material

No datasets were generated or analyzed during the current study.

Code Availability

Not applicable.

Author Contributions

SM, YK, and HK contributed to the study’s conception and design. Material preparation and data collection were performed by SM, YK, KH, KK, NI, FH, YY, HS, AK, SB, KT, KK, YN, TM, and MF. Data analysis was conducted by YK. The first draft of the manuscript was written by SM and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Mitani, S., Kito, Y., Hino, K. et al. Real-World Treatment Sequencing in Vulnerable Patients with Metastatic Colorectal Cancer: A Multicenter Retrospective Study. Targ Oncol 18, 707–715 (2023). https://doi.org/10.1007/s11523-023-00996-0

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