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Efficacy and safety of ramucirumab and docetaxel in previously treated patients with squamous cell lung cancer: a multicenter retrospective cohort study

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Summary

Objective. Ramucirumab plus docetaxel (RAM/DOC) therapy is currently the standard for previously treated advanced non-small cell lung cancer (NSCLC), irrespective of histology. However, in the clinical trial, only the first-line platinum-based chemotherapy refractory patients were enrolled and the eligible criteria was strict to avoid hemoptysis, especially in squamous cell NSCLC (Sq). Thus, the efficacy and safety data on ramucirumab for Sq in real-world settings after immune checkpoint inhibitors monotherapy or combination therapy approved as novel first-line therapy is lacking. Methods. We retrospectively analyzed previously treated patients with advanced NSCLC who underwent RAM/DOC therapy at four institutions. Clinical data on the initiation of RAM/DOC were collected from medical records. Treatment outcomes were assessed according to the Response Evaluation Criteria in Solid Tumors version 1.1. Incidence of pulmonary hemorrhage was assessed according to the Common Terminology Criteria for Adverse Events version 5.0. Results. Overall, 237 patients with NSCLC were included and 38 (16%) had squamous cell carcinoma. There were no significant differences in median progression-free survival and overall survival between Sq and non-Sq patients (5.8 months vs. 4.3 months, P = 0.0937; 15.2 months vs. 13.4 months, P = 0.714, respectively). Of all patients, 13 (5%) developed pulmonary hemorrhage. According to histological analysis, there was no significant difference in pulmonary hemorrhage proportion between Sq and non-Sq cohorts (2/38 vs. 11/199, respectively, P = 0.947). Conclusions. For previously treated patients with Sq, the efficacy and safety of RAM/DOC therapy were confirmed in a real-world setting and were similar to non-Sq.

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Data availability

The datasets generated during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We are grateful to all the patients and investigators in this study.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan

    Hayato Kawachi, Motohiro Tamiya & Toru Kumagai

  2. Department of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan

    Hayato Kawachi

  3. Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan

    Kinnosuke Matsumoto & Akihiro Tamiya

  4. Department of Thoracic Oncology, Osaka Habikino Medical Center, Osaka, Japan

    Takafumi Yanase

  5. Department of Respiratory Medicine, Osaka General Medical Center, Osaka, Japan

    Satoshi Tanizaki

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  1. Hayato Kawachi
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Contributions

All authors contributed to the study conception and design. Material preparation and data collection were performed by Hayato Kawachi, Motohiro Tamiya, Kinnosuke Matsumoto, Akihiro Tamiya, Takafumi Yanase, and Satoshi Tanizaki. Data analysis and interpretation were performed by Hayato Kawachi and Motohiro Tamiya. The first draft of the manuscript was written by Hayato Kawachi and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Hayato Kawachi.

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Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was approved by the review board of each of the four institutions. The patient’s informed consent was waived due to the retrospective nature of study, and an opt-out method was included so that patients and families could refuse to participate in the study.

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Not applicable.

Informed consent

The patient’s informed consent was waived for the retrospective nature of study, and an opt-out method was included so that patients and families could refuse to participate in the study.

Research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was approved by the review board of each of the four institutions.

Conflict of interests

Hayato Kawachi reports personal fees from Ono Pharmaceutical, personal fees from Chugai Pharmaceutical, personal fees from AstraZeneca, personal fees from Taiho Pharmaceutical, personal fees from Eli Lilly, and personal fees from MSD, outside the submitted work. Motohiro Tamiya reports grants and personal fees from Boehringer Ingelheim, grants and personal fees from Ono Pharmaceutical, grants and personal fees from Bristol-Myers Squibb, personal fees from Chugai Pharmaceutical, personal fees from AstraZeneca, personal fees from Taiho Pharmaceutical, personal fees from Eli Lilly, personal fees from Asahi Kasei Pharmaceutical, and personal fees from MSD, outside the submitted work. HS reports personal fees from Chugai Pharmaceutical, personal fees from MSD, and personal fees from AstraZeneca, outside the submitted work. Akihiro Tamiya reports personal fees from Chugai Pharmaceutical, grants and personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, grants and personal fees from Ono Pharmaceutical, grants and personal fees from Bristol-Myers Squibb, personal fees from MSD, personal fees from Taiho Pharmaceutical, personal fees from Pfizer, personal fees from Eli Lilly, personal fees from Takeda Pharmaceutical, personal fees from Kissei, personal fees from Amgen, and personal fees from Merck Bio Pharma, outside the submitted work. Toru Kumagai reports grants and personal fees from Ono Pharmaceutical, grants from MSD, grants and personal fees from Chugai Pharmaceutical, grants and personal fees from AstraZeneca, grants and consulting fees from Takeda Pharmaceutical, consulting fees from Nitto Denko Corporation, grants and personal fees from Eli Lilly, grants from Merck Bio Pharma, grants and personal fees from Pfizer, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Taiho Pharmaceutical, personal fees from Bristol-Myers Squibb, personal fees from Novartis Pharma, and grants from The Osaka Foundation for The Prevention of Cancer and Life-style related Diseases (Public Interest Incorporated Foundation), outside the submitted work.

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Kawachi, H., Tamiya, M., Matsumoto, K. et al. Efficacy and safety of ramucirumab and docetaxel in previously treated patients with squamous cell lung cancer: a multicenter retrospective cohort study. Invest New Drugs 40, 634–642 (2022). https://doi.org/10.1007/s10637-022-01214-w

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